VALSARTAN/HYDROCHLOROTHIAZIDE TEVA-RATIOPHARM 160 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan/HydrochlorothiazideTeva-ratiopharm160 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 further questions, ask your doctor or pharmacist.

???????This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

???????If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Valsartan/Hydrochlorothiazide Teva-ratiopharm and what is it used for

Valsartan/Hydrochlorothiazide Teva-ratiopharm film-coated tablets contain two active ingredients known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

???????Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” that 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.

???????Hydrochlorothiazidebelongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases blood pressure.

Valsartan/Hydrochlorothiazide Teva-ratiopharm is used to treat high blood pressure that is not adequately controlled with the use of a single component.

High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage the blood vessels in the brain, heart, and kidneys, and can lead to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.

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

Do not take Valsartan/HydrochlorothiazideTeva-ratiopharm

• If you are allergic 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 pregnant more than 3 months. (In any case, it is best to avoid taking this medicine also at the start of your 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 low potassium or sodium levels 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 kidney failure 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

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

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

If you have low potassium levels 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 kidney artery.

• If you have recently undergone a kidney transplant.
• If you have hyperaldosteronism, a disease 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, caused by 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 Valsartan/Hydrochlorothiazide immediately and do not take it again. See section 4 “Possible side effects”.

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

• If you have diabetes, gout, high cholesterol or triglyceride levels in your blood.
• If you have previously had an allergic reaction with the use of another medicine in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

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

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

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

• If you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Teva-ratiopharm.
• If you have experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking this medicine, seek medical attention immediately.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood at regular intervals.

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

Valsartan/Hydrochlorothiazide Teva-ratiopharm may cause increased sensitivity of the skin to the sun.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended for use at the start of pregnancy (first 3 months) and should not be taken from the third month of pregnancy onwards, 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 produce a positive result in doping tests.

Taking Valsartan/Hydrochlorothiazide with other medicines

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

The effect of treatment with Valsartan/Hydrochlorothiazide Teva-ratiopharm may be altered if taken with certain medicines. It may be necessary to change the dose, take other precautions, or in some cases, stop treatment with one of the medicines. This is especially applicable to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders,

medicines or substances that may increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, heparin,

• medicines that may reduce the amount of potassium in your blood, such as diuretics, corticosteroids, laxatives, ACTH (a hormone), carbenoxolone, amphotericin, penicillin G, salicylic acid, and derivatives.

some antibiotics (rifampicin group), a medicine used to protect against transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan/Hydrochlorothiazide,

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

medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, and antiepileptics,

• medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone, therapeutic vitamin D, and calcium supplements,

medicines for treating diabetes (oral antidiabetics such as metformin or insulins),

• other medicines for lowering blood pressure, including methyldopa, angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide” and “Warnings and precautions”),
• medicines that increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (medicines for treating 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,

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

muscle relaxants, such as tubocurarine,

• anticholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, bladder spasms, asthma, dizziness, muscle spasms, Parkinson's disease, and 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 diseases),

• cholestyramine and colestipol (medicines used primarily to treat high lipid levels in the blood),

cyclosporin, a medicine used for organ transplantation to prevent organ rejection.

• alcohol, sleeping medicines, and anesthetics (sleeping or pain-relieving medicines used, for example, during surgery,

iodine-containing contrast media (agents used for imaging tests).

Valsartan/HydrochlorothiazideTeva-ratiopharmwith food, drinks, and alcohol

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

Avoid taking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the risk 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, think you may be pregnant, or plan to become pregnant.

Normally, your doctor will advise you to stop taking Valsartan/Hydrochlorothiazide Teva-ratiopharm before you become pregnant or as soon as you find out you are pregnant, and will recommend taking another blood pressure-lowering medicine instead. Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended for use at the start of pregnancy and should not be taken from the third month of pregnancy onwards, as it may cause serious harm to your baby.

Breastfeeding

• Tell your doctor if you are about to start or are breastfeeding

Valsartan/Hydrochlorothiazide Teva-ratiopharm is not recommended for use in women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or performing other activities that require concentration, make sure you know how Valsartan/Hydrochlorothiazide Teva-ratiopharm affects you. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide Teva-ratiopharm may cause, in rare cases, dizziness and affect your ability to concentrate.

Valsartan/HydrochlorothiazideTeva-ratiopharmcontains sodium

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

3. How to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

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

People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your appointments with your doctor, even if you feel well.

Your doctor will tell you exactly how many Valsartan/Hydrochlorothiazide Teva-ratiopharm tablets 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 per day.

???????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 can 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 notice severe dizziness and/or fainting, lie down and contact your doctor immediately.

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

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 missed doses.

If you stop taking Valsartan/Hydrochlorothiazide Teva-ratiopharm

If you stop your treatment with Valsartan/Hydrochlorothiazide Teva-ratiopharm, your high blood pressure may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on 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 all people suffer from them.

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

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

• swelling of the face, tongue, or pharynx
• difficulty swallowing
• hives and difficulty breathing

• 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)

The frequency of these adverse effects is "unknown" (the frequency cannot be estimated based on the available data)

• acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion)
• severe skin disease that causes rash, skin redness, blisters on 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 directly (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 of thirst, dry mouth and tongue, reduced urine frequency, dark urine, dry skin)

? muscle pain

? fatigue

? tingling or numbness

? blurred vision

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

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

? dizziness

? diarrhea

? joint pain

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

? breathing difficulties

? severe decrease in diuresis

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

? low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)

? 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, can cause the skin and eyes to turn yellow)

? increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)

? increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)

? fainting (syncope)

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

Valsartan

Uncommon(may affect up to 1 in 100 people)

? sensation of rotation

? abdominal pain

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

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

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

? blisters on the skin (sign of bullous dermatitis)

? rash with or without itching along with any of the following signs or symptoms:

fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms

? rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)

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

? high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)

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

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

? elevated liver function values

? decreased hemoglobin levels and reduced red blood cell percentage in the blood (which, in severe cases, can cause anemia)

? kidney failure

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

Hydrochlorothiazide

Very common(may affect more than 1 in 10 people)

? low potassium levels in the blood

? increased lipids in the blood

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

? rash with itching and other types of rash

? loss of appetite

? vomiting and mild nausea

? dizziness, dizziness when standing up

? inability to achieve or maintain an erection

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

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

? high calcium levels in the blood

? high blood sugar levels

? sugar in the urine

? worsening of diabetes mellitus

? constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may occur along with yellowing of the skin and eyes

? irregular heartbeat

? headache

? sleep disturbances

? sadness (depression)

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

? dizziness

? sensation of tingling or numbness

? vision disturbances

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

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

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

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

? breathing difficulties, with fever, cough, difficulty swallowing, shortness of breath (respiratory distress including pneumonia and pulmonary edema)

? pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)

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

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

? lack or low levels of different blood cells

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

? weakness, bruising, and frequent infections (aplastic anemia)

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

? rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)

? muscle spasms

? fever (pyrexia)

? weakness (asthenia)

• skin and lip cancer (non-melanoma skin cancer)

Reporting of Adverse Effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Teva-ratiopharm

? Keep this medicine out of the sight and reach of children.

? Do not use this medicine after the expiration date stated on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

? Do not store above 30°C.

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

? Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide Teva-ratiopharm

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

? The other ingredients are: anhydrous colloidal silica, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, cornstarch, 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 Package Contents

? The film-coated tablets of Valsartan/Hydrochlorothiazide Teva-ratiopharm 160 mg/12.5 mg are round, convex, red, 9.5 mm in diameter, with the inscription "VH" on one side.

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

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

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 Last Revision of this Leaflet: March 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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