Valsartan and hydrochlorothiazide Tecnigen: detailed information

Patient Information Leaflet: Information for the User

Valsartan and Hydrochlorothiazide TecniGen 80 mg/12.5 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen.
How to take Valsartan and Hydrochlorothiazide TecniGen.
Possible side effects.
How to store Valsartan and Hydrochlorothiazide TecniGen.
Contents of the pack and other information.

1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for

Valsartan and Hydrochlorothiazide TecniGen film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help control high blood pressure (hypertension).

Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water pills”). Hydrochlorothiazide increases urine production and, in this way, helps lower blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used to treat high blood pressure when blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload of the heart and arteries. If left untreated, this can damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure.
High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you should know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

If you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the excipients of this medicine (listed in section 6).
if you are more than 3 months pregnant (use of Valsartan and Hydrochlorothiazide TecniGen is advised to be avoided even during the first months of pregnancy - see the section on pregnancy).
if you have severe kidney disease.
if you are unable to urinate (anuria).
if you are undergoing treatment with an artificial kidney.
if your blood levels of potassium or sodium are lower than normal, or if your blood calcium level is higher than normal despite treatment.
if you have gout.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Valsartan and Hydrochlorothiazide TecniGen.

if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your blood potassium levels regularly.
if your blood potassium levels are low.
if you have diarrhoea or severe vomiting.
if you are taking high doses of medicines that increase fluid elimination (diuretics).
if you have serious heart problems.
if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully regarding the starting dose of treatment. Your doctor will also monitor your kidney function.
if you have renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant.
if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
if you have liver or kidney disease.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide TecniGen, stop taking the medicine immediately and never take it again. See section 4, "Possible side effects," if you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
if you have diabetes, gout, or elevated cholesterol or triglyceride levels in the blood.
if you have had allergic reactions when using other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If untreated, this may lead to permanent vision loss. If you have previously been allergic to penicillins or sulphonamides, you may have a higher risk of developing this condition.
it may cause increased sensitivity of the skin to sunlight.
If you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren.
if you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays during treatment with Valsartan and Hydrochlorothiazide TecniGen.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the section "Do not take Valsartan and Hydrochlorothiazide TecniGen."

If any of these situations apply to you, consult your doctor.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents (under 18 years of age).

Inform your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide TecniGen is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to the unborn child if taken during this period (see the section on pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment may be affected if Valsartan and Hydrochlorothiazide TecniGen is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, discontinue one of the medicines. This particularly applies to the following medicines:

Lithium, a medicine used to treat certain psychiatric disorders.
Medicines or substances that may increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
Medicines that may decrease potassium levels in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
Certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide TecniGen.
Medicines that may cause "torsades de pointes" (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics.
Medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics.
Medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone.
Therapeutic supplements of vitamin D and calcium.
Medicines used to treat diabetes (oral such as metformin or insulin).
Other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
Medicines that may increase blood pressure, such as noradrenaline or adrenaline.
Digoxin or other digitalis glycosides (medicines used to treat heart problems).
Medicines that may increase blood sugar levels, such as diazoxide or beta-blockers.
Cytotoxic medicines (used in cancer treatment), such as methotrexate or cyclophosphamide.
Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g.
Muscle relaxants such as tubocurarine.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and to facilitate anaesthesia).
Amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases).
Cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels).
Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
Alcohol, sedatives, and anaesthetics (medicines with narcotic or painkilling effects, used, for example, during surgical procedures).
Iodinated contrast media (used in radiological examinations).

Your doctor may consider it necessary to adjust the dose and/or take additional precautions.

If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Valsartan and Hydrochlorothiazide TecniGen" and "Warnings and precautions").

Valsartan and Hydrochlorothiazide TecniGen with food, drinks, and alcohol

Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.

Avoid consuming alcohol before speaking with your doctor.

Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Talk to your doctor if you suspect (or are planning) a pregnancy.

Your doctor will usually advise you to stop treatment with Valsartan and Hydrochlorothiazide TecniGen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during early pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may cause severe harm to your unborn child if taken after the third month of pregnancy.

Breastfeeding

Talk to your doctor if you are breastfeeding or planning to breastfeed.

Valsartan and Hydrochlorothiazide TecniGen is not recommended for breastfeeding mothers. If you wish to continue breastfeeding, your doctor may decide to prescribe an alternative treatment, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Before driving a vehicle, operating tools or machinery, or performing other activities requiring concentration, make sure you are aware of how you react to Valsartan and Hydrochlorothiazide TecniGen.

Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide TecniGen may occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Hydrochlorothiazide TecniGen

Take this medicine exactly as directed by your doctor or pharmacist.
This will help you achieve the best results and reduce the risk of unwanted side effects. If you have any doubts,
consult your doctor or pharmacist.
People who suffer from high blood pressure often do not notice any signs of this condition. Many
may feel just as well as usual. For this reason, it is very important that you keep regular
appointments with your doctor, even if you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide TecniGen you should
take. Depending on your response to treatment, your doctor may recommend a higher or
lower dose.

The usual dose of Valsartan and Hydrochlorothiazide TecniGen is one tablet daily.
Do not change the dose and do not stop treatment without first consulting your doctor.
This medicine should be taken every day at the same time, usually in the morning.
You may take Valsartan and Hydrochlorothiazide TecniGen with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide TecniGen than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, consult your doctor, pharmacist or go to hospital.
If you forget to take Valsartan and Hydrochlorothiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost time for your next dose,
skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide TecniGen
Stopping treatment with Valsartan and Hydrochlorothiazide TecniGen may cause your blood pressure to worsen.
Do not stop taking this medicine unless your doctor has told you to do so.
If you have any questions about how to use this medicine, consult your doctor, pharmacist or
nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
Adverse effects may occur with different frequencies defined as follows:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects fewer than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

Some adverse effects can be serious and require immediate medical attention:
Contact your doctor immediately if you experience symptoms of angioedema, such as:

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide TecniGen and contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other adverse effects include:
Uncommon

Cough
Drop in blood pressure
Feeling of light-headedness
Dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
Muscle pain
Fatigue
Tingling or numbness
Blurred vision
Ringing in the ears (e.g. tinnitus, buzzing)

Very rare

Dizziness
Diarrhea
Joint pain

Not known

Difficulty breathing
Marked decrease in urine output
Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or seizures in severe cases)
Low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
Low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
Increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
Increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
Increased blood uric acid levels (which may, in severe cases, lead to gout)
Syncope (fainting)

Adverse effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsartan and Hydrochlorothiazide TecniGen:
Valsartan
Uncommon

Dizziness
Abdominal pain

Not known

Appearance of blisters on the skin (sign of bullous dermatitis)
Skin rash with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
Skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
Low platelet count in the blood (sometimes with unusual bleeding or bruising)
Increased potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
Allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
Swelling, especially of the face and throat; skin rash; itching
Increased liver function test values
Decreased haemoglobin levels and red blood cell percentage in the blood (which, in severe cases, may both lead to anaemia)
Renal failure
Low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)

Hydrochlorothiazide
Very common

Low potassium levels in the blood
Increased blood lipid levels

Common

Low sodium levels in the blood
Low magnesium levels in the blood
High uric acid levels in the blood
Itchy skin rashes and other types of skin rashes
Loss of appetite
Mild nausea and vomiting
Dizziness, fainting upon standing
Inability to achieve or maintain an erection

Rare

Swelling and blistering of the skin (due to increased sensitivity to sunlight)
High calcium levels in the blood
High blood sugar levels
Sugar in the urine
Worsening of diabetic metabolic control
Constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the skin and eyes
Irregular heartbeat
Headache
Sleep disturbances
Sadness (depression)
Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
Dizziness
Tingling or numbness
Vision disturbances

Very rare

Inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Severe skin diseases causing skin rash, redness of the skin, blistering of lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
Skin rashes of the face, joint pain, muscle disorders, fever (lupus erythematosus)
Severe pain in the upper abdomen (pancreatitis)
Difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary oedema)
Fever, sore throat, more frequent infections (agranulocytosis)
Pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia)
Fever, sore throat or mouth ulcers due to infections (leucopenia)
Confusion, fatigue, tremor and muscle cramps, rapid breathing (hypochloraemic alkalosis)

Not known

Fatigue, bruising and frequent infections (aplastic anaemia)
Severe decrease in urine output (possible sign of kidney disorder or renal failure)
Decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Skin rash, redness of the skin, blistering of lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
Muscle cramps
Fever (pyrexia)
Weakness (asthenia)
Skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse effects directly via the national reporting system. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Exp.”.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Tecnigen contains

The active substances are valsartan and hydrochlorothiazide. Each film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6 cP, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Tecnigen and contents of the pack
Valsartan and Hydrochlorothiazide Tecnigen 80 mg/12.5 mg film-coated tablets are pink, oblong, biconvex, film-coated tablets.
Valsartan and Hydrochlorothiazide Tecnigen 80 mg/12.5 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder and manufacturer
Marketing Authorization Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal

Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Valsartan/Hidroclorotiazida Pentafarma
Italy: Valsartan and Hydrochlorothiazide Tecnigen 80 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Valsartan and Hydrochlorothiazide TecniGen 160 mg/12.5 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen.
How to take Valsartan and Hydrochlorothiazide TecniGen.
Possible side effects.
How to store Valsartan and Hydrochlorothiazide TecniGen.
Contents of the pack and other information.

1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for

Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in this way, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used to treat high blood pressure when it is not adequately controlled by a single medicine.
High blood pressure increases the workload on the heart and arteries. Without proper treatment, this can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure.
High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you should know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the excipients of this medicine (listed in section 6).
if you are more than 3 months pregnant (it is advisable to avoid the use of Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy – see the section on pregnancy).
if you have severe liver problems, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
if you have a severe kidney disease.
if you are unable to urinate (anuria).
if you are undergoing treatment with an artificial kidney.
if your blood potassium or sodium levels are lower than normal, or if your blood calcium level remains higher than normal despite treatment.
if you have gout.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and consult your doctor.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Valsartan and Hydrochlorothiazide TecniGen.

if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your blood potassium levels regularly.
if your blood potassium levels are low.
if you have diarrhea or severe vomiting.
if you are taking high doses of medicines that increase fluid elimination (diuretics).
if you have serious heart problems.
if you have heart failure or have had a heart attack. Follow your doctor’s instructions carefully regarding the starting dose of treatment. Your doctor will also monitor your kidney function.
if you have renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant.
if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In such cases, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
if you have liver or kidney diseases.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide TecniGen, stop taking it immediately and never take it again. See section 4, "Possible side effects".
if you have fever, skin rashes, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
if you have diabetes, gout, or elevated cholesterol or triglyceride levels in the blood.
if you have had allergic reactions to other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.
it may cause increased skin sensitivity to sunlight.
if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
aliskiren
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Valsartan and Hydrochlorothiazide TecniGen.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section "Do not take Valsartan and Hydrochlorothiazide TecniGen".
If any of these situations apply to you, consult your doctor.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents (under 18 years of age).
Inform your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide TecniGen is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see the section on pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be altered if Valsartan and Hydrochlorothiazide TecniGen is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, stop taking one of the medicines. This particularly applies to the following medicines:

Lithium, a medicine used to treat certain psychiatric disorders.
Medicines or substances that may increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
Medicines that may decrease blood potassium levels, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
Certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide TecniGen.
Medicines that may cause "torsades de pointes" (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics.
Medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics.
Medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone.
Therapeutic supplements of vitamin D and calcium.
Medicines used to treat diabetes (oral such as metformin or insulin).
Other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
Medicines that may increase blood pressure, such as noradrenaline or adrenaline.
Digoxin or other digitalis glycosides (medicines used to treat heart problems).
Medicines that may increase blood sugar levels, such as diazoxide or beta-blockers.
Cytotoxic medicines used to treat cancer, such as methotrexate or cyclophosphamide.
Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g, and muscle relaxants such as tubocurarine.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and to facilitate anesthesia).
Amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral diseases), cholestyramine, and colestipol (medicines mainly used to treat high blood lipid levels).
Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
Alcohol, sedatives, and anesthetics (medicines with narcotic or pain-relieving effects, used, for example, during surgical procedures), and iodinated contrast agents (used in radiological examinations).

Your doctor may consider it necessary to adjust the dose and/or take additional precautions.
If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Valsartan and Hydrochlorothiazide TecniGen" and "Warnings and precautions").

Valsartan and Hydrochlorothiazide TecniGen with food, drinks, and alcohol
Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Avoid consuming alcohol before discussing it with your doctor.
Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Talk to your doctor if you suspect (or are planning) a pregnancy.
Usually, your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide TecniGen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during the early stages of pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding
Talk to your doctor if you are breastfeeding or plan to start breastfeeding.
Valsartan and Hydrochlorothiazide TecniGen is not recommended for breastfeeding mothers. If you wish to continue breastfeeding, your doctor may decide to prescribe an alternative treatment, especially if the baby is a newborn or was born prematurely.

Driving and using machines
Before driving a vehicle, operating tools or machinery, or performing other activities requiring concentration, make sure you know how you react to Valsartan and Hydrochlorothiazide TecniGen.
Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide TecniGen may occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Hydrochlorothiazide TecniGen

Take this medicine exactly as instructed by your doctor or pharmacist.
This will help you achieve the best results and reduce the risk of side effects. If you have any doubts,
ask your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms. Many may feel just as well as usual.
For this reason, it is very important that you keep regular appointments with your doctor, even if you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide TecniGen you should take.
Depending on your response to treatment, your doctor may recommend a higher or lower dose.

The usual dose of Valsartan and Hydrochlorothiazide TecniGen is one tablet daily.
Do not change the dose and do not stop treatment without consulting your doctor.
This medicine should be taken every day at the same time, usually in the morning.
You may take Valsartan and Hydrochlorothiazide TecniGen with or without food.
Swallow the tablet with a glass of water.

The break line is intended to make it easier to split the tablet if you have difficulty swallowing it whole.
If you take more Valsartan and Hydrochlorothiazide TecniGen than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor, pharmacist, or go to hospital.
If you forget to take Valsartan and Hydrochlorothiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide TecniGen
Stopping treatment with Valsartan and Hydrochlorothiazide TecniGen may cause your high blood pressure to worsen. Do not stop taking this medicine unless your doctor has told you to do so.
If you have any doubts about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur at different frequencies, defined as follows:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

Some side effects may be serious and require immediate medical attention:
Contact your doctor immediately if you experience symptoms of angioedema, such as:

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and breathing difficulties

Cough
Drop in blood pressure
Feeling of light-headedness
Dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
Muscle pain
Fatigue
Tingling or numbness
Blurred vision
Ringing in the ears (e.g. tinnitus, buzzing)

Very rare

Dizziness
Diarrhoea
Joint pain

Not known

Difficulty breathing
Marked decrease in urine output
Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or, in severe cases, seizures)
Low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
Low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
Increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
Increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
Increased blood uric acid levels (which may, in severe cases, cause gout)
Syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsartan and Hydrochlorothiazide TecniGen:
Valsartan
Uncommon

Dizziness
Abdominal pain

Not known

Appearance of blisters on the skin (sign of bullous dermatitis)
Skin rash with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
Skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
Low platelet count in the blood (sometimes with unusual bleeding or bruising)
Increased potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
Allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
Swelling, especially of the face and throat; skin rash; itching
Increased liver function test values
Decreased haemoglobin levels and red blood cell percentage in the blood (which, in severe cases, may both lead to anaemia)
Kidney failure
Low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)

Hydrochlorothiazide
Very common

Low potassium levels in the blood
Increased blood lipid levels

Common

Low sodium levels in the blood
Low magnesium levels in the blood
High uric acid levels in the blood
Itchy skin rashes and other types of skin rashes
Reduced appetite
Mild nausea and vomiting
Dizziness, fainting when standing up
Inability to achieve or maintain an erection

Rare

Skin swelling and blistering (due to increased sensitivity to sunlight)
High calcium levels in the blood
High blood sugar levels
Sugar in the urine
Worsening of diabetic metabolic control
Constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the skin and eyes
Irregular heartbeat
Headache
Sleep disturbances
Sadness (depression)
Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
Dizziness
Tingling or numbness
Vision disturbances

Very rare

Inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Severe skin diseases causing skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
Facial rashes, joint pain, muscle disorders, fever (lupus erythematosus)
Severe upper abdominal pain (pancreatitis)
Difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty, including pneumonia and pulmonary oedema)
Fever, sore throat, more frequent infections (agranulocytosis)
Pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia)
Fever, sore throat or mouth ulcers due to infections (leucopenia)
Confusion, fatigue, tremor and muscle cramps, laboured breathing (hypochloraemic alkalosis)

Not known

Fatigue, easy bruising and frequent infections (aplastic anaemia)
Severe decrease in urine output (possible sign of kidney disorder or kidney failure)
Decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
Muscle cramps
Fever (pyrexia)
Weakness (asthenia)
Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Tecnigen contains

The active substances are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6 cP, talc, macrogol 8000, titanium dioxide (E171), red iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Tecnigen and the contents of the pack
Valsartan and Hydrochlorothiazide Tecnigen 160 mg/12.5 mg film-coated tablets are red, oblong, convex film-coated tablets with a score line on one side.
Valsartan and Hydrochlorothiazide Tecnigen 160 mg/12.5 mg is available in blister packs of 28 tablets.

Marketing Authorization Holder and manufacturer
Marketing Authorization Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal

Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Valsartan/Hidroclorotiazida Pentafarma
Italy: Valsartan e Idroclorotiazide Tecnigen 160 mg/12.5 mg compresse rivestite con film

Package leaflet: Information for the user

Valsartan and Hydrochlorothiazide TecniGen 160 mg/25 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen.
How to take Valsartan and Hydrochlorothiazide TecniGen.
Possible side effects.
How to store Valsartan and Hydrochlorothiazide TecniGen.
Contents of the pack and other information.

1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for

Valsartan and Hydrochlorothiazide TecniGen film-coated tablets contain two active substances: valsartan and hydrochlorothiazide. Both of these substances help control high blood pressure (hypertension).

Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in this way, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used to treat high blood pressure when blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload on the heart and arteries. Without proper treatment, this may damage blood vessels in the brain, heart, and kidneys, potentially leading to stroke, heart failure, or kidney failure.
High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the excipients of this medicine (listed in section 6).
if you are more than 3 months pregnant (it is advisable to avoid the use of Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy – see the section on pregnancy).
if you have severe liver problems, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis), or if you suffer from severe kidney disease.
if you are unable to urinate (anuria).
if you are undergoing treatment with an artificial kidney.
if your blood potassium or sodium levels are lower than normal, or if your blood calcium level is higher than normal despite treatment.
if you have gout.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Valsartan and Hydrochlorothiazide TecniGen.

if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may need to check your blood potassium levels regularly.
if your blood potassium levels are low.
if you have diarrhoea or severe vomiting.
if you are taking high doses of medicines that increase fluid elimination (diuretics).
if you suffer from serious heart problems.
if you have heart failure or have had a heart attack. Follow your doctor’s instructions carefully regarding the starting dose of therapy. Your doctor will also monitor your kidney function.
if you have renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant.
if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
if you have liver or kidney disease.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide TecniGen, stop taking it immediately and never take it again. See section 4, "Possible side effects".
if you have fever, skin rashes, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
if you have diabetes, gout, high cholesterol, or high triglyceride levels in the blood.
if you have had allergic reactions when using other blood pressure-lowering medicines of the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.
it may cause increased skin sensitivity to sunlight.
if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking Valsartan and Hydrochlorothiazide TecniGen.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the section "Do not take Valsartan and Hydrochlorothiazide TecniGen".

If any of these situations apply to you, consult your doctor.

For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents (under 18 years of age).

Inform your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide TecniGen is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (see the section on pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment may be influenced if Valsartan and Hydrochlorothiazide TecniGen is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, stop taking one of the medicines. This particularly applies to the following medicines:

Lithium, a medicine used in the treatment of certain psychiatric disorders.
Medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
Medicines that may decrease blood potassium levels, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
Certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide TecniGen.
Medicines that may induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics.
Medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics.
Medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone.
Therapeutic supplements of vitamin D and calcium.
Medicines used to treat diabetes (oral, such as metformin, or insulin).
Other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
Medicines that may increase blood pressure, such as noradrenaline or adrenaline.
Digoxin or other digitalis glycosides (medicines used to treat heart problems).
Medicines that may increase blood sugar levels, such as diazoxide or beta-blockers.
Cytotoxic medicines used in cancer treatment, such as methotrexate or cyclophosphamide.
Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g.
Muscle relaxants such as tubocurarine.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and to facilitate anaesthesia).
Amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral diseases).
Cholestyramine and colestipol (medicines used mainly in the treatment of high blood lipid levels).
Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
Alcohol, sedatives, and anaesthetics (medicines with narcotic or pain-relieving effects, used, for example, during surgical procedures).
Iodinated contrast agents (used in radiological examinations).

Your doctor may consider it necessary to adjust the dose and/or take other precautions.

If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Valsartan and Hydrochlorothiazide TecniGen" and "Warnings and precautions").

Valsartan and Hydrochlorothiazide TecniGen with food, drinks, and alcohol

Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.

Avoid consuming alcohol before speaking with your doctor.

Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Talk to your doctor if you suspect (or are planning) a pregnancy.

Usually, your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide TecniGen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during early pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Talk to your doctor if you are breastfeeding or plan to start breastfeeding.

Driving and using machines

Before driving, operating tools or machinery, or performing other activities requiring concentration, make sure you know how Valsartan and Hydrochlorothiazide TecniGen affects you.

Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide TecniGen may occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Hydrochlorothiazide TecniGen

Take this medicine exactly as directed by your doctor or pharmacist.
This will help you achieve the best results and reduce the risk of unwanted side effects. If you have any doubts,
consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms of this condition. Many may feel as well as usual.
For this reason, it is very important that you keep regular appointments with your doctor, even if you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide TecniGen you should take.
Depending on your response to treatment, your doctor may recommend a higher or lower dose.

The usual dose of Valsartan and Hydrochlorothiazide TecniGen is one tablet daily.
Do not change the dose or stop treatment without first consulting your doctor.
This medicine should be taken every day at the same time, usually in the morning.
You may take Valsartan and Hydrochlorothiazide TecniGen with or without food.
Swallow the tablet with a glass of water.

The score line on the tablet is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.
If you take more Valsartan and Hydrochlorothiazide TecniGen than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor, pharmacist, or go to hospital.
If you forget to take Valsartan and Hydrochlorothiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide TecniGen
Stopping treatment with Valsartan and Hydrochlorothiazide TecniGen may cause your blood pressure to worsen. Do not stop taking this medicine unless your doctor has instructed you to do so.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects may occur with different frequencies, defined as follows:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects fewer than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

Some side effects may be serious and require immediate medical attention:
Seek immediate medical advice if you experience symptoms of angioedema, such as:

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and breathing difficulties

Cough
Low blood pressure
Feeling of light-headedness
Dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
Muscle pain
Fatigue
Tingling or numbness
Blurred vision
Ringing in the ears (e.g. buzzing, whistling)

Very rare

Dizziness
Diarrhea
Joint pain

Not known

Breathing difficulties
Marked decrease in urine output
Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or seizures in severe cases)
Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
Low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
Increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
Increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
Increased blood uric acid levels (which may, in severe cases, lead to gout)
Syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsartan and Hydrochlorothiazide TecniGen:
Valsartan
Uncommon

Dizziness
Abdominal pain

Not known

Appearance of blisters on the skin (sign of bullous dermatitis)
Skin rash with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
Skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
Low platelet count in the blood (sometimes with unusual bleeding or bruising)
Increased potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
Allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
Swelling, especially of the face and throat; skin rash; itching
Increased liver function test values
Decreased haemoglobin levels and red blood cell percentage in the blood (which, in severe cases, may both lead to anaemia)
Kidney failure
Low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)

Hydrochlorothiazide
Very common

Low potassium levels in the blood
Increased blood lipid levels

Common

Low sodium levels in the blood
Low magnesium levels in the blood
High uric acid levels in the blood
Itchy skin rashes and other types of skin eruptions
Loss of appetite
Mild nausea and vomiting
Dizziness, fainting upon standing
Inability to achieve or maintain erection

Rare

Swelling and blistering of the skin (due to increased sensitivity to sunlight)
High calcium levels in the blood
High blood sugar levels
Sugar in the urine
Worsening of diabetic metabolic control
Constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the skin and eyes
Irregular heartbeat
Headache
Sleep disturbances
Sadness (depression)
Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
Dizziness
Tingling or numbness
Vision disturbances

Very rare

Inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Severe skin diseases causing skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
Facial rashes, joint pain, muscle disorders, fever (lupus erythematosus)
Severe upper abdominal pain (pancreatitis)
Breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory difficulties, including pneumonia and pulmonary oedema)
Fever, sore throat, more frequent infections (agranulocytosis)
Pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia)
Fever, sore throat or mouth ulcers due to infections (leucopenia)
Confusion, fatigue, tremor and muscle cramps, laboured breathing (hypochloraemic alkalosis)

Not known

Fatigue, easy bruising and frequent infections (aplastic anaemia)
Severe decrease in urine output (possible sign of kidney disorder or kidney failure)
Decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
Muscle cramps
Fever (pyrexia)
Weakness (asthenia)
Skin and lip cancer (non-melanoma skin cancer)

5. How to store Valsartan and Hydrochlorothiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Tecnigen contains

The active substances are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, macrogol 8000, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Tecnigen and contents of the pack
Valsartan and Hydrochlorothiazide Tecnigen 160 mg/25 mg film-coated tablets are orange, oblong, biconvex, film-coated tablets with a score line on one side.
Valsartan and Hydrochlorothiazide Tecnigen 160 mg/25 mg is available in blister packs containing 28 tablets.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal
Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal: Valsartan/Hidroclorotiazida Pentafarma
Italy: Valsartan e Idroclorotiazide Tecnigen 160 mg/25 mg compresse rivestite con film

Package leaflet: Information for the user

Valsartan and Hydrochlorothiazide TecniGen 320 mg/12.5 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen.
How to take Valsartan and Hydrochlorothiazide TecniGen.
Possible side effects.
How to store Valsartan and Hydrochlorothiazide TecniGen.
Contents of the pack and other information.

1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for

Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in this way, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used for the treatment of high blood pressure when blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload on the heart and arteries. Without adequate treatment, this can damage the blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure.
High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the excipients of this medicine (listed in section 6).
if you are more than 3 months pregnant (use of Valsartan and Hydrochlorothiazide TecniGen is advised to be avoided even during the first months of pregnancy - see section on pregnancy).
if you have severe liver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis), or if you have a severe kidney disease.
if you are unable to urinate (anuria).
if you are undergoing treatment with an artificial kidney.
if your blood potassium or sodium levels are lower than normal, or if your blood calcium level is higher than normal despite treatment.
if you have gout.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Valsartan and Hydrochlorothiazide TecniGen.

if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your blood potassium levels regularly.
if your blood potassium levels are low.
if you have diarrhoea or severe vomiting.
if you are taking high doses of medicines that increase fluid elimination (diuretics).
if you have heart failure or have had a heart attack. Follow your doctor’s instructions carefully regarding the starting dose of therapy. Your doctor will also monitor your kidney function.
if you have serious heart problems.
if you have renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant.
if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In such cases, use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
if you have liver or kidney diseases.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide TecniGen, stop taking it immediately and never take it again. See section 4, "Possible side effects".
if you have fever, skin rashes, and joint pain, which could be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
if you have diabetes, gout, or elevated cholesterol or triglyceride levels in the blood.
if you have had allergic reactions when using other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have an increased risk of developing this condition.
it may cause increased skin sensitivity to sunlight.
If you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren.
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Valsartan and Hydrochlorothiazide TecniGen.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the section "Do not take Valsartan and Hydrochlorothiazide TecniGen".

If any of these situations apply to you, consult your doctor.

For those engaged in sports: using the medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents (under 18 years of age).

Inform your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide TecniGen is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section on pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment may be influenced if Valsartan and Hydrochlorothiazide TecniGen is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases stop taking one of the medicines. This particularly applies to the following medicines:

Lithium, a medicine used in the treatment of certain psychiatric disorders.
Medicines or substances that can increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
Medicines that can decrease potassium levels in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
Certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan and Hydrochlorothiazide TecniGen.
Medicines that may cause torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics.
Medicines that can reduce sodium levels in the blood, such as antidepressants, antipsychotics, and antiepileptics.
Medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone.
Therapeutic vitamin D and calcium supplements.
Medicines used to treat diabetes (oral such as metformin or insulin).
Other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
Medicines that increase blood pressure, such as noradrenaline or adrenaline.
Digoxin or other digitalis glycosides (medicines used to treat heart problems).
Medicines that can increase blood sugar levels, such as diazoxide or beta-blockers.
Cytotoxic medicines used to treat cancer, such as methotrexate or cyclophosphamide.
Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g.
Muscle relaxants such as tubocurarine.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and to facilitate anaesthesia).
Amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral illnesses).
Cholestyramine and colestipol (medicines used mainly to treat high blood lipid levels).
Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
Alcohol, sedatives, and anaesthetics (medicines with narcotic or pain-relieving effects, used, for example, during surgical procedures).
Iodinated contrast agents (used in radiological examinations).

Your doctor may consider it necessary to adjust the dose and/or take other precautions.

If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Valsartan and Hydrochlorothiazide TecniGen" and "Warnings and precautions").

Valsartan and Hydrochlorothiazide TecniGen with food, drinks, and alcohol

Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.

Avoid consuming alcohol before discussing it with your doctor.

Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Talk to your doctor if you suspect (or are planning) a pregnancy.

Your doctor will usually advise you to stop treatment with Valsartan and Hydrochlorothiazide TecniGen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during early pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your unborn child if taken after the third month of pregnancy.

Breastfeeding

Talk to your doctor if you are breastfeeding or planning to breastfeed.

Driving and using machines

Before driving a vehicle, operating tools or machinery, or performing other activities requiring concentration, make sure you know how you react to Valsartan and Hydrochlorothiazide TecniGen. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide TecniGen may occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Hydrochlorothiazide TecniGen

Take this medicine exactly as prescribed by your doctor or pharmacist.
This will help you achieve the best results and reduce the risk of side effects. If you have any doubts,
consult your doctor or pharmacist.
People with high blood pressure often do not experience any noticeable symptoms and may feel just as
usual. For this reason, it is very important that you keep regular appointments with your doctor, even
if you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide TecniGen you
should take. Depending on your response to treatment, your doctor may recommend a higher or lower
dose.

The usual dose of Valsartan and Hydrochlorothiazide TecniGen is one tablet daily.
Do not change the dose or stop treatment without first consulting your doctor.
This medicine should be taken every day at the same time, usually in the morning.
You may take Valsartan and Hydrochlorothiazide TecniGen with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide TecniGen than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor, pharmacist or go to hospital.
If you forget to take Valsartan and Hydrochlorothiazide TecniGen
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your
next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide TecniGen
Stopping treatment with Valsartan and Hydrochlorothiazide TecniGen may cause your high blood
pressure to worsen. Do not stop taking this medicine unless your doctor has told you to do so.
If you have any questions about using this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur at different frequencies defined as follows:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects fewer than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

Some side effects may be serious and require immediate medical attention:
Contact your doctor immediately if you experience symptoms of angioedema, such as:

Swelling of the face, tongue or pharynx
Difficulty swallowing
Hives and difficulty breathing

Cough
Low blood pressure
Feeling of light-headedness
Dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
Muscle pain
Fatigue
Tingling or numbness
Blurred vision
Ringing in the ears (e.g. tinnitus, buzzing)

Very rare

Dizziness
Diarrhea
Joint pain

Not known

Difficulty breathing
Marked decrease in urine output
Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or, in severe cases, seizures)
Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
Low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
Increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
Increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
Increased blood uric acid levels (which may, in severe cases, lead to gout)
Syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsartan and Hydrochlorothiazide TecniGen:
Valsartan
Uncommon

Dizziness
Abdominal pain

Not known

Appearance of blisters on the skin (sign of bullous dermatitis)
Skin rash with or without itching together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
Skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
Low platelet count in the blood (sometimes with unusual bleeding or bruising)
Increased potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
Allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
Swelling, especially of the face and throat; skin rash; itching
Increased liver function test values
Decreased haemoglobin levels and red blood cell count (which, in severe cases, may both lead to anaemia)
Renal failure
Low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)

Hydrochlorothiazide
Very common

Low potassium levels in the blood
Increased blood lipid levels

Common

Low sodium levels in the blood
Low magnesium levels in the blood
High uric acid levels in the blood
Itchy skin rashes and other types of skin rashes
Reduced appetite
Mild nausea and vomiting
Dizziness, fainting upon standing
Inability to achieve or maintain an erection

Rare

Swelling and blistering of the skin (due to increased sensitivity to sunlight)
High calcium levels in the blood
High blood sugar levels
Sugar in the urine
Worsening of diabetic metabolic control
Constipation, diarrhea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the skin and eyes
Irregular heartbeat
Headache
Sleep disturbances
Sadness (depression)
Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
Dizziness
Tingling or numbness
Vision disturbances

Very rare

Inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Severe skin diseases causing skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
Facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
Severe upper abdominal pain (pancreatitis)
Difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulties, including pneumonia and pulmonary oedema)
Fever, sore throat, more frequent infections (agranulocytosis)
Pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia)
Fever, sore throat or mouth ulcers due to infections (leucopenia)
Confusion, fatigue, tremor and muscle cramps, shortness of breath (hypochloraemic alkalosis)

Not known

Fatigue, bruising and frequent infections (aplastic anaemia)
Severe decrease in urine output (possible sign of kidney disorder or kidney failure)
Decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
Muscle cramps
Fever (pyrexia)
Weakness (asthenia)
Skin and lip cancer (non-melanoma skin cancer)

5. How to store Valsartan and Hydrochlorothiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Valsartan and Hydrochlorothiazide Tecnigen Contains

The active substances are valsartan and hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, macrogol 8000, titanium dioxide (E171), red iron oxide (E172).

Description of the Appearance of Valsartan and Hydrochlorothiazide Tecnigen and Package Contents
Valsartan and Hydrochlorothiazide Tecnigen 320 mg/12.5 mg film-coated tablets are
orange, oval-shaped, biconvex film-coated tablets with a score line on one side.
Valsartan and Hydrochlorothiazide Tecnigen 320 mg/12.5 mg is available in blister packs containing 28
tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal
Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal
This medicinal product is authorized in the Member States of the European Economic Area under the following
names:
Portugal: Valsartan/Hidroclorotiazida Pentafarma
Italy: Valsartan e Idroclorotiazide Tecnigen 320 mg/12.5 mg compresse rivestite con film

Package leaflet: Information for the user

Valsartan and Hydrochlorothiazide TecniGen 320 mg/25 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen.
How to take Valsartan and Hydrochlorothiazide TecniGen.
Possible side effects.
How to store Valsartan and Hydrochlorothiazide TecniGen.
Contents of the pack and other information.

1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for

Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in this way, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used for the treatment of high blood pressure when blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload on the heart and arteries. Without proper treatment, this can damage the blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure.
High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the excipients of this medicine (listed in section 6).
if you are more than 3 months pregnant (it is advisable to avoid the use of Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy - see the section on pregnancy).
if you have severe liver problems, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis), or if you suffer from a severe kidney disease.
if you are unable to urinate (anuria).
if you are undergoing treatment with an artificial kidney.
if your blood potassium or sodium levels are lower than normal, or if your blood calcium level is higher than normal despite treatment.
if you have gout.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Valsartan and Hydrochlorothiazide TecniGen.

if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your blood potassium levels regularly.
if your blood potassium levels are low.
if you have diarrhea or severe vomiting.
if you are taking high doses of medicines that increase fluid elimination (diuretics).
if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully regarding the starting dose of treatment. Your doctor will also monitor your kidney function.
if you have serious heart problems.
if you have narrowing of the renal artery.
if you have recently undergone a kidney transplant.
if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
if you have liver or kidney diseases.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur when taking Valsartan and Hydrochlorothiazide TecniGen, stop taking it immediately and never take it again. See section 4, "Possible side effects".
if you have fever, skin rashes, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
if you have diabetes, gout, elevated cholesterol or triglyceride levels in the blood.
if you have had allergic reactions when using other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.
it may cause increased skin sensitivity to sunlight.
If you are taking any of the following medicines for high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren
if you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancers. Protect your skin from sun and UV exposure while taking Irbesartan and Hydrochlorothiazide TecniGen.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section "Do not take Valsartan and Hydrochlorothiazide TecniGen".
If any of these situations apply to you, consult your doctor.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents (under 18 years of age).
Inform your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide TecniGen is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (see the section on pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan and Hydrochlorothiazide TecniGen is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, stop taking one of the medicines. This particularly applies to the following medicines:

Lithium, a medicine used in the treatment of certain psychiatric disorders.
Medicines or substances that may increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
Medicines that may decrease potassium levels in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
Certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide TecniGen.
Medicines that may induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics.
Medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics.
Medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone.
Therapeutic vitamin D and calcium supplements.
Medicines used to treat diabetes (oral such as metformin or insulin).
Other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
Medicines that may increase blood pressure, such as noradrenaline or adrenaline.
Digoxin or other digitalis glycosides (medicines used to treat heart problems).
Medicines that may increase blood sugar levels, such as diazoxide or beta-blockers.
Cytotoxic medicines used to treat cancer, such as methotrexate or cyclophosphamide.
Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g.
Muscle relaxants such as tubocurarine.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and to facilitate anesthesia).
Amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases).
Cholestyramine and colestipol (medicines mainly used in the treatment of high blood lipid levels).
Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
Alcohol, sedatives, and anesthetics (medicines with narcotic or pain-relieving effects used, for example, during surgical procedures).
Iodinated contrast media (used in radiological examinations).

Your doctor may consider it necessary to adjust the dose and/or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Valsartan and Hydrochlorothiazide TecniGen" and "Warnings and precautions").

Valsartan and Hydrochlorothiazide TecniGen with food, drinks, and alcohol

Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Avoid taking alcohol before speaking with your doctor.
Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Talk to your doctor if you suspect (or are planning) a pregnancy.
Usually, your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide TecniGen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during early pregnancy, and the medicine must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Talk to your doctor if you are breastfeeding or plan to start breastfeeding.
Valsartan and Hydrochlorothiazide TecniGen is not recommended for breastfeeding mothers. If you wish to continue breastfeeding, your doctor may decide to prescribe an alternative treatment, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Before driving a vehicle, operating tools or machinery, or performing other activities requiring concentration, make sure you know how you react to Valsartan and Hydrochlorothiazide TecniGen.
Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide TecniGen may occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Hydrochlorothiazide TecniGen

Take this medicine exactly as directed by your doctor or pharmacist.
This will help you achieve the best results and reduce the risk of side effects. If you have any doubts,
ask your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms. Many may feel as well as usual.
For this reason, it is very important that you keep regular appointments with your doctor, even if you
feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide TecniGen
you should take. Depending on your response to treatment, your doctor may recommend a higher or
lower dose.

The usual dose of Valsartan and Hydrochlorothiazide TecniGen is one tablet daily.
Do not change the dose or stop treatment without consulting your doctor.
This medicine should be taken every day at the same time, usually in the morning.
You may take Valsartan and Hydrochlorothiazide TecniGen with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide TecniGen than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.
If you forget to take Valsartan and Hydrochlorothiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost time for the
next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide TecniGen
Stopping treatment with Valsartan and Hydrochlorothiazide TecniGen may cause your blood
pressure to worsen. Do not stop taking this medicine unless your doctor has advised you to do so.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur at different frequencies, defined as follows:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide
TecniGen and contact your doctor immediately (see also section 2 “Warnings and
precautions”).
Some side effects may be serious and require immediate medical attention:
Seek immediate medical help if you experience symptoms of angioedema such as:

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and difficulty breathing

Other side effects include:
Uncommon

Cough
Low blood pressure
Feeling of light-headedness
Dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
Muscle pain
Fatigue
Tingling or numbness
Blurred vision
Ringing in the ears (e.g. buzzing, ringing)

Very rare

Dizziness
Diarrhea
Joint pain

Not known

Difficulty breathing
Marked decrease in urine output
Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or seizures in severe cases)
Low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
Low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
Increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
Increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
Increased blood uric acid levels (which may, in severe cases, lead to gout)
Syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with
Valsartan and Hydrochlorothiazide TecniGen:
Valsartan
Uncommon

Dizziness
Abdominal pain

Not known

Appearance of blisters on the skin (sign of bullous dermatitis)
Skin rash with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
Skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
Low platelet count in the blood (sometimes with unusual bleeding or bruising)
Increased potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
Allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
Swelling, especially of the face and throat; skin rash; itching
Increased liver function test values
Decreased haemoglobin levels and red blood cell percentage in the blood (which, in severe cases, may both lead to anaemia)
Kidney failure
Low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)

Hydrochlorothiazide
Very common

Low potassium levels in the blood
Increased blood lipid levels

Common

Low sodium levels in the blood
Low magnesium levels in the blood
High uric acid levels in the blood
Itchy skin rashes and other types of skin rashes
Reduced appetite
Mild nausea and vomiting
Dizziness, fainting upon standing
Inability to achieve or maintain erection

Rare

Swelling and blistering of the skin (due to increased sensitivity to sunlight)
High calcium levels in the blood
High blood sugar levels
Sugar in the urine
Worsening of diabetic metabolic state, constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the skin and eyes
Irregular heartbeat
Headache
Sleep disturbances
Sadness (depression)
Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
Dizziness
Tingling or numbness
Vision disturbances

Very rare

Inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions), severe skin diseases causing skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis), facial skin rashes, joint pain, muscle disorders, fever (lupus erythematosus), skin peeling
Fever
Facial skin rashes associated with joint pain
Muscle disorders
Fever (cutaneous lupus erythematosus)
Severe upper abdominal pain (pancreatitis), difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty, including pneumonia and pulmonary oedema), fever, sore throat, more frequent infections (agranulocytosis)
Pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia)
Fever, sore throat or mouth ulcers due to infections (leucopenia)
Confusion, fatigue, tremor and muscle cramps, laboured breathing (hypochloraemic alkalosis)

Not known

Fatigue, easy bruising and frequent infections (aplastic anaemia)
Severe decrease in urine output (possible sign of kidney disorder or kidney failure)
Decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
Muscle cramps
Fever (pyrexia)
Weakness (asthenia)
Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Tecnigen contains

The active substances are valsartan and hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, polyethylene glycol 8000, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Tecnigen and package contents
Valsartan and Hydrochlorothiazide Tecnigen 320 mg/25 mg film-coated tablets are yellow, oval-shaped, biconvex film-coated tablets.
Valsartan and Hydrochlorothiazide Tecnigen 320 mg/25 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder and manufacturer
Marketing Authorization Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal
Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Valsartan/Hydrochlorothiazide Pentafarma
Italy: Valsartan and Hydrochlorothiazide Tecnigen 320 mg/25 mg film-coated tablets