Valsartan/hydrochlorothiazide Teva-Ratiopharm 160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Valsartan/Hydrochlorothiazide Teva-ratiopharm 160 mg/12.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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 or pharmacist.

???????This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.

???????If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Valsartan/Hydrochlorothiazide Teva-ratiopharm is and what it is used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Teva-ratiopharm
3. How to take Valsartan/Hydrochlorothiazide Teva-ratiopharm
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide Teva-ratiopharm
6. Contents of the pack and other information

1. What Valsartán/Hidroclorotiazida Teva-ratiopharm is and what it is used for

Valsartán/Hidroclorotiazida Teva-ratiopharm film-coated tablets contain two active substances known as valsartan and hydrochlorothiazide. These components 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, resulting in increased 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 class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartán/Hidroclorotiazida Teva-ratiopharm is used to treat high blood pressure that is not adequately controlled with a single active ingredient.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading 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 complications.

2. What you need to know before starting to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

Do not take Valsartan/Hydrochlorothiazide Teva-ratiopharm

• If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other components of this medicine (listed in section 6).

• If you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy; see section “Pregnancy and Breastfeeding”).

• If you have severe liver disease, destruction of the small bile ducts in 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 dialysis.

• If you have abnormally low levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment.

• If you have gout.

• If you have diabetes mellitus or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these situations apply to you, inform your doctor and do not take Valsartan/Hydrochlorothiazide.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan/Hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking Valsartan/Hydrochlorothiazide on your own.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Valsartan/Hydrochlorothiazide.

• If you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider it necessary to monitor your potassium levels regularly.

• If you have low levels of potassium in your blood.

• If you experience severe diarrhea or vomiting.

• If you are taking high doses of a diuretic.

• If you have severe heart disease.

• If you have heart failure or have had a heart attack. Follow your doctor’s instructions carefully when starting treatment. Your doctor may also check your kidney function.

• 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. In this case, Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended.

• If you have kidney or liver disease.

• If you have ever experienced swelling of the tongue and face due to an allergic reaction called angioedema when taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking Valsartan/Hydrochlorothiazide, stop taking it immediately and do not take it again. See section 4 “Possible side effects”.

• If you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).

• If you have diabetes, gout, or high cholesterol or triglyceride levels in your blood.

• If you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

• If you experience vision changes or eye pain. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eyes, which may occur from hours to weeks after taking Valsartan/Hydrochlorothiazide. If left untreated, this may lead to vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing this condition.

• If you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren

• If you have had skin cancer or develop 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 cancer. Protect your skin from sun and UV exposure while taking Valsartan/Hydrochlorothiazide Teva-ratiopharm.

• If you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking this medicine, seek immediate medical attention.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Valsartan/Hydrochlorothiazide”.

Valsartan/Hydrochlorothiazide Teva-ratiopharm may increase your skin’s sensitivity to sunlight.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby (see section “Pregnancy and Breastfeeding”).

Children and adolescents

Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended for use in children and adolescents (under 18 years of age).

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

Taking Valsartan/Hydrochlorothiazide with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The effect of treatment with Valsartan/Hydrochlorothiazide Teva-ratiopharm may be altered if taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases discontinue treatment with one of the medicines. This is particularly important for 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, heparin,

• medicines that may reduce blood potassium levels, such as diuretics, corticosteroids, laxatives, ACTH (a hormone), carbenoxolone, amphotericin, penicillin G, salicylic acid and its derivatives.

• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may enhance the effect of Valsartan/Hydrochlorothiazide,

• medicines that may induce “torsades de pointes” (an irregular heart rhythm), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics,

• medicines that may reduce blood sodium levels, 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 antidiabetics such as metformin or insulin),

• other blood pressure-lowering medicines, including methyldopa,

• angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “Do not take Valsartan/Hydrochlorothiazide” 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 to treat cancer), such as methotrexate or cyclophosphamide,

• pain medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid >3g,

• muscle relaxants, such as tubocurarine,

• anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, dizziness, muscle spasms, Parkinson’s disease, and as anesthetic aids), such as atropine or biperiden.

• amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent certain viral infections),

• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels),

• cyclosporine, a medicine used in organ transplantation to prevent organ rejection.

• alcohol, sleeping medicines, and anesthetics (medicines used for sleep or pain relief, for example during surgery),

• iodinated contrast agents (substances used in imaging procedures).

Valsartan/Hydrochlorothiazide Teva-ratiopharm with food, drinks, and alcohol

You may take Valsartan/Hydrochlorothiazide Teva-ratiopharm with or without food.

Avoid alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

• You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant.

Generally, your doctor will advise you to stop taking Valsartan/Hydrochlorothiazide Teva-ratiopharm before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby if taken from that time.

Breastfeeding

• Inform your doctor if you are planning to start or are currently breastfeeding.

Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended for use in women during this period. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you are aware of how you react to Valsartan/Hydrochlorothiazide Teva-ratiopharm. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide Teva-ratiopharm may rarely cause dizziness and affect your ability to concentrate.

Valsartan/Hydrochlorothiazide Teva-ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e., essentially “sodium-free”.

3. How to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. This will help you achieve the best results and reduce the risk of adverse effects. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not experience any symptoms; many feel perfectly normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

Your doctor will tell you exactly how many tablets of Valsartan/Hydrochlorothiazide Teva-ratiopharm you should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

???????The recommended dose of Valsartan/Hydrochlorothiazide Teva-ratiopharm is one tablet daily.

???????Do not change the dose or stop treatment without consulting your doctor.

???????This medicine should be taken at the same time every day, usually in the morning.

???????You may take Valsartan/Hydrochlorothiazide Teva-ratiopharm with or without food.

???????Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Teva-ratiopharm than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

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 forgotten doses.

If you stop taking Valsartan/Hydrochlorothiazide Teva-ratiopharm

If you stop treatment with Valsartan/Hydrochlorothiazide Teva-ratiopharm, your hypertension may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects can be serious and require immediate medical attention:

• you should see your doctor immediately if you notice symptoms of angioedema, such as:

• swelling of the face, tongue or pharynx

• difficulty swallowing

• urticaria and difficulty breathing

• reduced 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)

The frequency of these adverse effects is “not known” (the frequency cannot be estimated from the available data)

• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)
• severe skin disease causing rash, redness of the skin, blisters in the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• fever, sore throat, increased frequency of infections (agranulocytosis)

These adverse effects are very rare (may affect up to 1 in 10,000 people)

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide and contact your doctor immediately (see also section 2 “Warnings and precautions”)

Other adverse effects include:

Uncommon (may affect up to 1 in 100 people)

? cough

? low blood pressure

? dehydration (with symptoms such as thirst, dry mouth and tongue, reduced frequency of urination, dark-coloured urine, dry skin)

? muscle pain

? fatigue

? tingling or numbness

? blurred vision

? noises (e.g. ringing or buzzing) in the ears

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

? dizziness

? diarrhoea

? joint pain

Frequency not known (frequency cannot be estimated from the available data)

? difficulty breathing

? severe reduction in urine output

? low sodium levels in the blood (which may lead to fatigue, confusion, muscle pain 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, in severe cases, may 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, in severe cases, may trigger an attack of gout)

? syncope (fainting)

Adverse effects observed with valsartan or hydrochlorothiazide separately, but not observed with Valsartan/Hydrochlorothiazide Teva-ratiopharm:

Valsartan

Uncommon (may affect up to 1 in 100 people)

? sensation of spinning

? abdominal pain

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

• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Frequency not known (frequency cannot be estimated from the available data)

? blisters on the skin (sign of bullous dermatitis)

? skin rash with or without itching along 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 inflammation of blood vessels)

? low platelet count (sometimes with bleeding or bruising more frequently than usual)

? high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)

? allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)

? swelling mainly of the face and throat; skin rash; itching

? elevated liver function test values

? decreased haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anaemia)

? renal failure

? low sodium levels in the blood (which may lead to fatigue, confusion, muscle pain and/or, in severe cases, seizures)

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 rash and other types of skin rash

? loss of appetite

? mild vomiting and nausea

? dizziness, dizziness upon standing

? inability to achieve or maintain an erection

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

? swelling and blisters on the skin (due to increased sensitivity to sunlight)

? high calcium levels in the blood

? high blood sugar levels

? sugar in the urine

? worsening of metabolic diabetes

? constipation, diarrhoea, stomach or intestinal discomfort, liver disorders which may occur together with yellowing of the skin or eyes

? irregular heartbeat

? headache

? sleep disturbances

? sadness (depression)

? low platelet count (sometimes with bleeding or bruising under the skin)

? dizziness

? tingling or numbness sensation

? vision disturbances

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

? inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)

? rash, itching, urticaria, difficulty breathing or choking, dizziness (hypersensitivity reactions)

? facial rash associated with pain, muscle disorders, fever (lupus erythematosus), severe pain in the upper stomach (pancreatitis)

? difficulty breathing, with fever, cough, difficulty swallowing, dyspnoea (breathing difficulty including pneumonia and pulmonary oedema)

? pale skin, fatigue, dyspnoea, dark urine (haemolytic anaemia)

? fever, sore throat or ulcers due to infections (leucopenia)

? confusion, fatigue, pulmonary contractions and spasms, rapid breathing (hypochloraemic alkalosis)

? absence or low levels of different blood cells

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

? weakness, bruising and frequent infections (aplastic anaemia)

? severe reduction in urine output (possible sign of kidney disorders or kidney failure)

? rash, redness of the skin, blisters on the 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 type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán/Hidroclorotiazida Teva-ratiopharm

? 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 packaging and
blister after EXP. The expiry date refers to the last day of the month indicated.

? Do not store above 30°C.

? Do not use Valsartán/Hidroclorotiazida Teva-ratiopharm if you notice that the packaging is damaged or shows
signs of deterioration.

? Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and
their packaging at the SIGRE point in your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging.
This way you will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán/Hidroclorotiazida Teva-ratiopharm

? The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

? The other components are: Anhydrous colloidal silica, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate.

? The tablet coating contains: Hypromellose, macrogol, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Appearance of the product and contents of the pack

? Valsartán/Hidroclorotiazida Teva-ratiopharm 160 mg/12.5 mg film-coated tablets are round, convex, red, 9.5 mm in diameter, with the imprint “VH” on one side.

? The tablets are available in blister packs containing 14, 28, 30, 56, 60, 84, 98 and 100 tablets.

Hospital pack: 56, 98 and 280 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Manufacturer

TEVA UK Ltd

Brampton Road, Hampden Park,

Eastbourne, East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5, P.O. Box 552, 2003 RN Haarlem

The Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

TEVA Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava – Komárov

Czech Republic

TEVA Pharma, S.L.U.

C/C nº 4, Polígono Industrial Malpica, 50016 Zaragoza,

Spain

Teva Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82

Gödöllő H-2100

Hungary

Teva Operations Poland Sp. z o.o.,

Mogilska 80 Str.

31-546 Kraków

Poland

Date of the most recent review of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73989/P_73989.html

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