Valsartan and hydrochlorothiazide Zentiva: detailed information

Valsartan and Hydrochlorothiazide Zentiva 80 mg/12.5 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before using 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

In this leaflet:

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

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

Valsartan and Hydrochlorothiazide Zentiva film-coated tablets contain two active substances,
called valsartan and hydrochlorothiazide. Both of these active 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 constrict, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases urine production, which also helps lower blood pressure.

Valsartan and Hydrochlorothiazide Zentiva is used for the treatment of high blood pressure that is not
adequately controlled by a single active substance.
High blood pressure increases the workload on the heart and arteries. If left untreated,
it can damage 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 attacks.
Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. Before taking Valsartan and Hydrochlorothiazide Zentiva

Do not take Valsartan and Hydrochlorotiazide Zentiva

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
if you are more than 3 months pregnant (it is also advisable to avoid the use of Valsartan and Hydrochlorothiazide Zentiva in early pregnancy - see section “Pregnancy”);
if you have severe liver disease - destruction of the small bile ducts within the liver

(biliary cirrhosis) leading to bile accumulation in the liver (cholestasis);

if you have severe kidney disease;
if you are unable to produce urine (anuria);
if you are undergoing treatment with an artificial kidney;
if your blood potassium or sodium levels are below normal, or if your blood calcium level is above normal, despite treatment;
if you suffer from gout;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these conditions apply to you, consult your doctor and do not take
Valsartan and Hydrochlorothiazide Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Zentiva:

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 regularly monitor your blood potassium levels;
if you have low levels of potassium in your blood;
if you have diarrhoea or severe vomiting;
if you are taking high doses of tablets that help eliminate water (diuretics);
if you have severe heart disease;
if you suffer from 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 narrowing of the renal arteries;
if you have recently received a new kidney;
if you suffer from hyperaldosteronism. This is a condition in which the adrenal glands produce excessive amounts of the hormone aldosterone. If this applies to you, the use of Valsartan and Hydrochlorothiazide Zentiva is not recommended;
if you have liver or kidney disease;
if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure within the eye and may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva. This condition can lead to permanent vision loss if untreated. If you previously had an allergy to penicillin or sulfonamides, you may be at high risk of developing such a reaction.
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 Zentiva, stop taking it immediately and never take it again. See also section 4, “Possible side effects”;
if you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease);
if you have diabetes, gout, or elevated cholesterol or triglyceride levels in your blood;
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly 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 and UV exposure while taking Valsartan and Hydrochlorothiazide Zentiva.
if you have had allergic reactions following the use of other blood pressure-lowering medicines belonging to this class (angiotensin II receptor antagonists) or if you suffer from allergy or asthma;
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. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the section “Do not take Valsartan and Hydrochlorothiazide Zentiva”.
Valsartan and Hydrochlorothiazide Zentiva may increase skin sensitivity to sunlight.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Zentiva is not recommended during 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 “Pregnancy”).

Children and adolescents
The use of Valsartan and Hydrochlorothiazide Zentiva in children and adolescents (under 18 years of age) is
not recommended.
For athletes: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva
Inform 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 Zentiva is taken
together with certain other drugs. Your doctor may consider it necessary to adjust the dose and/or take
other 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 blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
medicines that may reduce blood potassium levels, such as diuretics (water tablets), 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 Zentiva;
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 for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone;
therapeutic supplements of vitamin D and calcium;
medicines for the treatment of diabetes (oral antidiabetics such as metformin or insulins);
other medicines to lower blood pressure including methyldopa, an ACE inhibitor, or aliskiren (see also the section: “Do not take Valsartan and Hydrochlorothiazide Zentiva” and “Warnings and precautions”);
medicines that 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 anaesthesia);
amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral infections);
cholestyramine and colestipol (medicines mainly used to treat high lipid levels in the blood);
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);

Valsartan and Hydrochlorothiazide Zentiva with food, drinks and alcohol
Avoid consuming alcohol before discussing it with your doctor. Alcohol may further lower your
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
You must inform your doctor if you think you are pregnant (or if you could become pregnant).
Your doctor will advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva before
trying to conceive or as soon as pregnancy is confirmed and will recommend an alternative medicine instead of Valsartan and Hydrochlorothiazide Zentiva. Valsartan and Hydrochlorothiazide Zentiva
is not recommended during early pregnancy and must not be taken if you are more than
three months pregnant, as the medicine may cause serious harm to the unborn child if taken after the
third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Valsartan and Hydrochlorothiazide Zentiva is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating tools or machinery, or performing other activities requiring concentration, ensure you know how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva may occasionally cause dizziness and affect your ability to concentrate.
Valsartan and Hydrochlorothiazide Zentiva contains lactose, sorbitol and sodium
Valsartan and Hydrochlorothiazide Zentiva contains lactose and sorbitol, both sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially
'sodium-free'.

3. How to take Valsartan and Hydrochlorothiazide Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
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 notice any symptoms.
Many people may feel just as well as usual. For this reason, it is very important to keep
regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Zentiva to take.
Depending on your response to treatment, your doctor may adjust your dose to a higher or lower level.
Other strengths of the combination of valsartan and hydrochlorothiazide are available.

The recommended dose of Valsartan and Hydrochlorothiazide Zentiva is one tablet daily.
Do not change the dose or stop taking the tablets without consulting your doctor.
Take the medicine at the same time each day, usually in the morning.
You may take Valsartan and Hydrochlorothiazide Zentiva with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide Zentiva than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you have taken too many tablets by accident, contact your doctor, pharmacist, or go to a hospital.

If you stop taking Valsartan and Hydrochlorothiazide Zentiva
Stopping treatment with Valsartan and Hydrochlorothiazide Zentiva may cause your condition to worsen.
Do not stop taking this medicine unless your doctor tells you to.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical attention.
You should contact your doctor immediately if you experience symptoms of angioedema (an allergic reaction), such as:

Swelling of the face, tongue, or pharynx
Difficulty swallowing
Hives and difficulty breathing
Severe skin diseases causing rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Fever, sore throat, more frequent infections (agranulocytosis)

If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide Zentiva and contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects include:
Uncommon (may affect up to 1 in 100 people):

Cough
Low blood pressure
Mental confusion
Dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark-coloured urine, dry skin)
Muscle pain
Fatigue
Tingling and numbness
Blurred vision
Noises (e.g. whistling, buzzing) in the ears

Very rare (may affect up to 1 in 10,000 people):

Dizziness
Diarrhoea
Joint pain

Not known (frequency cannot be estimated from the available data):

Difficulty breathing
Marked decrease in the amount of urine produced
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 (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, lead to yellowing of the skin and eyes)
Increased blood urea nitrogen and creatinine levels in the blood (which may indicate abnormal kidney function)
Increased uric acid levels in the blood (which may, in severe cases, cause gout)
Syncope (fainting)

The following side effects have been reported with medicines containing valsartan or hydrochlorothiazide alone

Valsartan
Uncommon (may affect up to 1 in 100 people):

Dizziness
Abdominal pain

Not known (frequency cannot be estimated from the available data):

Skin rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms

Skin rashes, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
Low platelet count in the blood (sometimes with unusual bleeding or bruising)
High potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
Allergic reactions (with symptoms such as skin rashes, itching, hives, difficulty breathing or swallowing, dizziness)
Swelling, especially of the face and throat, skin rashes, itching
Increased liver function test values
Reduced haemoglobin levels and reduced percentage of red blood cells in the blood (both may lead, in severe cases, 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 (may affect more than 1 in 10 people):

Low potassium levels in the blood
Increased blood lipid levels

Common (may affect up to 1 in 10 people):

Low sodium levels in the blood
Low magnesium levels in the blood
High uric acid levels in the blood
Itchy skin rash and other types of skin rash
Reduced appetite
Mild nausea and vomiting
Dizziness, fainting when standing up
Difficulty achieving or maintaining an erection

Rare (may affect up to 1 in 1,000 people):

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
Depressed mood (depression)
Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
Dizziness
Tingling or numbness
Vision disturbances

Very rare (may affect up to 1 in 10,000 people):

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)
Facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
Severe upper abdominal pain (pancreatitis)
Difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary oedema)
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 (frequency cannot be estimated from the available data):

Skin and lip cancer (non-melanoma skin cancer)
Weakness, bruising and frequent infections (aplastic anaemia)
Severe decrease in urine output (possible sign of kidney disorder or kidney failure)
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)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice it 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. Other information

What Valsartan and Hydrochlorothiazide Zentiva contains
The active substances are valsartan and hydrochlorothiazide.
Each film-coated tablet of Valsartan and Hydrochlorothiazide Zentiva 80 mg/12.5 mg contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other components are:
Tablet core: microcrystalline cellulose, anhydrous colloidal silica, sorbitol (E420), magnesium carbonate, pregelatinized corn starch, povidone K-25, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone (Kollidon CL).
Tablet coating: lactose monohydrate, hypromellose, talc, macrogol 6000, indigo carmine (E 132), red iron oxide (E 172).

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva and pack contents
The 80 mg/12.5 mg film-coated tablets of Valsartan and Hydrochlorothiazide Zentiva are pink, cylindrical, biconvex, film-coated tablets.
Pack sizes: 7, 14, 28, 30, 56, 90, 98, 100, 280 (10 x 28 or 20 x 14) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio 37/B
20158 Milan, Italy

Manufacturer
Zentiva, k.s.
U Kabelovny 130, Dolní Měcholupy
102 37 Prague 10, Czech Republic

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Italy: Valsartan and Hydrochlorothiazide Zentiva
Portugal: Valsartan + Hidroclorotiazida Zentiva 80 mg + 12,5 mg comprimidos revestidos por película
Spain: Valsartán/Hidroclorotiazida Zentiva 80/12,5 mg comprimidos recubiertos con película EFG

This leaflet was last updated on:
Valsartan and Hydrochlorothiazide Zentiva 160 mg/25 mg film-coated tablets
Generic medicine

Please read this leaflet carefully before using 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

This leaflet contains:

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

1. What Valsartan and Hydrochlorothiazide Zentiva 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 contract, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartan and Hydrochlorothiazide Zentiva is used for the treatment of high blood pressure that is not
adequately controlled by a single active substance.
High blood pressure increases the workload on the heart and arteries. If left untreated,
it can damage the blood vessels of the brain, heart and kidneys, and may lead to stroke,
heart failure or kidney failure. High blood pressure increases the risk of heart attacks.
Lowering blood pressure to normal levels reduces the risk of developing these
conditions.

2. Before taking Valsartan and Hydrochlorothiazide Zentiva

Do not take Valsartan and Hydrochlorotiazide Zentiva

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
if you are more than 3 months pregnant (it is also better to avoid using Valsartan and Hydrochlorothiazide Zentiva in early pregnancy – see section “Pregnancy”);
if you have severe liver disease – destruction of the small bile ducts within the liver (biliary cirrhosis) leading to accumulation of bile in the liver (cholestasis);
if you have severe kidney disease;
if you are unable to produce urine (anuria);
if you are undergoing treatment with an artificial kidney;
if your blood potassium or sodium levels are below normal, or if your blood calcium level is above normal, despite treatment;
if you suffer from gout;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

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 regularly monitor your blood potassium levels;
if you have low levels of potassium in your blood;
in case of diarrhoea or severe vomiting;
if you are taking high doses of tablets that help eliminate water (diuretics);
if you have severe heart disease;
if you suffer from 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 narrowing of the renal arteries;
if you have recently received a new kidney;
if you suffer from hyperaldosteronism – a condition in which the adrenal glands produce excessive amounts of the hormone aldosterone. In such cases, use of Valsartan and Hydrochlorothiazide Zentiva is not recommended;
if you have liver or kidney disease;
if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure within the eye, which may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva. This condition may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing such a reaction;
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 Zentiva, stop taking it immediately and never take it again. See also section 4, “Possible side effects”;
if you have fever, skin rashes, and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease);
if you have diabetes, gout, or elevated cholesterol or triglyceride levels in the blood;
if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV radiation while taking Valsartan and Hydrochlorothiazide Zentiva.
if you have had allergic reactions after using other blood pressure-lowering medicines belonging to this class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma;
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. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the section “Do not take Valsartan and Hydrochlorothiazide Zentiva”.
Valsartan and Hydrochlorothiazide Zentiva may increase skin sensitivity to sunlight.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Zentiva is not recommended during 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 “Pregnancy”).

If any of these situations apply to you, consult your doctor.
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Zentiva in children and adolescents (under 18 years of age) is not recommended.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva
Inform 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 Zentiva is taken together with certain other medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions or, in some cases, discontinue one of the medicines. This is especially important for 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 reduce potassium levels in the blood, such as diuretics (water tablets), 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 Zentiva;
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 vitamin D and calcium supplements, diabetes medicines (oral antidiabetics such as metformin or insulin);
other blood pressure-lowering medicines including methyldopa, an ACE inhibitor, or aliskiren (see also sections: “Do not take Valsartan and Hydrochlorothiazide Zentiva” and “Warnings and precautions”);
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 conditions 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 lipid levels in the blood);
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);

Valsartan and Hydrochlorothiazide Zentiva with food, drinks, and alcohol
Avoid consuming alcohol before discussing it with your doctor. Alcohol may further lower your 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
You must inform your doctor if you think you are pregnant (or could become pregnant).
Your doctor will advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva before attempting pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Valsartan and Hydrochlorothiazide Zentiva is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Valsartan and Hydrochlorothiazide Zentiva is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating tools or machinery, or performing other activities requiring concentration, make sure you are aware of how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva may occasionally cause dizziness and affect your ability to concentrate.
Valsartan and Hydrochlorothiazide Zentiva contains lactose, sorbitol, and sodium
Valsartan and Hydrochlorothiazide Zentiva contains lactose and sorbitol, both sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially ‘sodium-free’.

3. How to take Valsartan and Hydrochlorothiazide Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
This will help you achieve the best results and reduce the risk of side effects.
If you are unsure, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms.
Many people may feel just as well as usual. For this reason, it is very important that you keep
regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Zentiva to take.
Depending on your response to treatment, your doctor may recommend a higher or lower dose. Other
strengths of the combination of valsartan and hydrochlorothiazide are available.

The recommended dose of Valsartan and Hydrochlorothiazide Zentiva is one tablet daily.
Do not change the dose or stop taking the tablets without consulting your doctor.
The medicine should be taken at the same time each day, usually in the morning.
You may take Valsartan and Hydrochlorothiazide Zentiva with or without food.
Swallow the tablet with a glass of water. If you take more Valsartan and Hydrochlorothiazide Zentiva 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 Zentiva
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 the forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide Zentiva
Stopping treatment with Valsartan and Hydrochlorothiazide Zentiva may cause your condition to worsen.
Do not stop taking the medicine unless your doctor tells you to.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical attention.
You should contact your doctor immediately if you experience symptoms of angioedema (an allergic reaction), such as:

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and difficulty breathing
Severe skin diseases causing rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Fever, sore throat, more frequent infections (agranulocytosis)

Cough
Low blood pressure
Mental confusion
Dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark-coloured urine, dry skin)
Muscle pain
Fatigue
Tingling and numbness
Blurred vision
Ringing or other noises (e.g. buzzing) in the ears

Very rare (may affect up to 1 in 10,000 people):

Dizziness
Diarrhoea
Joint pain
Not known (frequency cannot be estimated from the available data):
Difficulty breathing
Marked decrease in the amount of urine produced
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 (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 more severe cases, cause yellowing of the skin and eyes)
Increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
Increased uric acid levels in the blood (which may, in more severe cases, lead to gout)
Syncope (fainting)

The following side effects have been reported with medicines containing valsartan or hydrochlorothiazide alone.
Valsartan
Uncommon (may affect up to 1 in 100 people):

Dizziness
Abdominal pain

Not known (frequency cannot be estimated from the available data):

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 rashes, red-purple spots, fever, itching (symptoms of inflammation of blood vessels)
Low platelet count in the blood (sometimes with unusual bleeding or bruising)
High potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
Allergic reactions (with symptoms such as skin rashes, itching, hives, difficulty breathing or swallowing, dizziness)
Swelling, especially of the face and throat, skin rashes, itching
Increased liver function test values
Reduced haemoglobin levels and reduced percentage of red blood cells in the blood (both may lead to anaemia in severe cases)
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 (may affect more than 1 in 10 people):

Low potassium levels in the blood
Increased blood lipid levels

Common (may affect up to 1 in 10 people):

Low sodium levels in the blood
Low magnesium levels in the blood
High uric acid levels in the blood
Itchy skin rash and other types of skin rash
Loss of appetite
Mild nausea and vomiting
Dizziness, fainting when standing up
Difficulty achieving or maintaining erection
Rare (may affect up to 1 in 1,000 people):
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
Sad mood (depression)
Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
Dizziness
Tingling or numbness
Vision disturbances

Very rare (may affect up to 1 in 10,000 people):

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)
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)
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 (frequency cannot be estimated from the available data):
Skin and lip cancer (non-melanoma skin cancer)
Weakness, easy bruising and frequent infections (aplastic anaemia)
Severe decrease in urine output (possible sign of kidney disorder or kidney failure)
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)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that it 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. Other information

What Valsartan and Hydrochlorothiazide Zentiva contains
The active substances are valsartan and hydrochlorothiazide.
Each film-coated tablet of Valsartan and Hydrochlorothiazide Zentiva 160 mg/25 mg contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
The excipients are:
Tablet core: microcrystalline cellulose, anhydrous colloidal silica, sorbitol (E420), magnesium carbonate, pregelatinized corn starch, povidone K-25, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone (Kollidon CL).
Tablet coating: lactose monohydrate, hypromellose, talc, macrogol 6000, indigo carmine (E 132), yellow and brown iron oxides (E 172).

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva and pack contents
The Valsartan and Hydrochlorothiazide Zentiva 160 mg/25 mg tablets are brown, cylindrical, biconvex, film-coated tablets.
Pack sizes: 7, 14, 28, 30, 56, 90, 98, 100, 280 (10 x 28 or 20 x 14) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milan, Italy

Manufacturer
Zentiva, k.s.
U Kabelovny 130, Dolní Měcholupy
102 37 Prague 10, Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Valsartan and Hydrochlorothiazide Zentiva
Portugal: Valsartan + Hidroclorotiazida Zentiva 160 mg + 25 mg comprimidos revestidos por película
Spain: Valsartán/Hidroclorotiazida Zentiva 160/25 mg comprimidos recubiertos con película EFG

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