VALSARTAN TEVA-RATIOPHARM 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Teva-ratiopharm 160 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.

• 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 Teva-ratiopharm and what is it used for

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

3. How to take Valsartan Teva-ratiopharm

4. Possible side effects

5. How to store Valsartan Teva-ratiopharm

6. Contents of the pack and other information

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

Valsartan Teva-ratiopharm belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance produced in the body that causes the blood vessels to narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Valsartan 160 mg film-coated tablets can be used for three different conditions:

• To treat high blood pressure in adults and in children and adolescents from 6 to less than 18 years of age. High blood pressure increases the strain on the heart and arteries. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and may lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering the blood pressure to normal reduces the risk of developing these disorders.
• To treat adult patients after a recent heart attack(myocardial infarction). "Recent" means here between 12 hours and 10 days.
• To treat symptomatic heart failure in adult patients. Valsartan Teva-ratiopharm is used when it is not possible to use a group of medicines called Angiotensin-Converting Enzyme (ACE) inhibitors (a medication for treating heart failure) or can be used in addition to ACE inhibitors when it is not possible to use other medications for the treatment of heart failure.

Among the symptoms of heart failure are difficulty breathing and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to supply the body with the blood it needs.

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

Do not take Valsartan Teva-ratiopharm

• If you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease.
• If you are more than 3 months pregnant, (it is also better to avoid Valsartan Teva-ratiopharm during the first months of pregnancy, see section 2. Pregnancy, breast-feeding and fertility).
• If you have diabetes or kidney problems and are being treated with a medicine for high blood pressure that contains aliskiren.

If any of the above applies to you, tell your doctor and do not take Valsartan Teva-ratiopharm.

Tell your doctor if you have stomach pain, nausea, vomiting, or diarrhea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan on your own.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Valsartan Teva-ratiopharm.

• If you have liver disease
• If you have severe kidney disease or are on dialysis
• If you have narrowing of the kidney artery
• If you have recently had a kidney transplant(received a new kidney).
• If you have severe heart disease other than heart failure or heart attack.
• If you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check the amount of potassium in your blood.
• If you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartan Teva-ratiopharm.
• If you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics(medicines to increase urine production).
• If you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines(including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking valsartan, stop taking valsartan immediately and do not take it again (see section 4 "Possible side effects").
• Tell your doctor if you are pregnant (or think you might be). It is not recommended to use Valsartan Teva-ratiopharm at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see section "Pregnancy, breast-feeding and fertility").
• 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), especially if you have kidney problems related to diabetes.
  • aliskiren.
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs)(e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may need to check 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 Teva-ratiopharm".

If you are in any of these situations, tell your doctor before taking Valsartan Teva-ratiopharm.

Other medicines and Valsartan Teva-ratiopharm

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

The effect of Valsartan Teva-ratiopharm treatment may be affected if taken with other medicines. It may be necessary to change the dose, take other precautions, or in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, especially diuretics(medicines to increase urine production).
• medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin.
• certain medicines for pain relief called non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of valsartan.
• lithium, a medicine used to treat certain types of psychiatric diseases.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren(see also the information under the headings "Do not take Valsartan Teva-ratiopharm" and "Warnings and precautions").

If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs)(e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Additionally:

• if you are being treated after a heart attack, it is not recommended to combine with ACE inhibitors.

Taking Valsartan Teva-ratiopharm with food and drinks

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Valsartan Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valsartan Teva-ratiopharm. It is not recommended to use Valsartan Teva-ratiopharm at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

• Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to use Valsartan Teva-ratiopharm during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is newborn or premature.

Driving and using machines

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

Valsartan Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Valsartan Teva-ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

Adult patients with high blood pressure: The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). You may also take Valsartan Teva-ratiopharm in combination with another medicine (e.g., a diuretic).

Children and adolescents (6 to less than 18 years of age) with high blood pressure:

In patients who weigh less than 35 kg, the recommended starting dose is 40 mg of valsartan once daily.

In patients who weigh 35 kg or more, the recommended starting dose is 80 mg of valsartan once daily.

In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack: Treatment is usually started at 12 hours, normally with a low dose of 20 mg, given twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan Teva-ratiopharm can be given with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure: Treatment is usually started with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan Teva-ratiopharm can be given with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take Valsartan Teva-ratiopharm with or without food. Swallow Valsartan Teva-ratiopharm with a glass of water.

Take Valsartan Teva-ratiopharm at about the same time each day.

The tablet can be divided into equal doses.

If you take more Valsartan Teva-ratiopharm than you should

If you notice severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan 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 Teva-ratiopharm

If you stop taking Valsartan Teva-ratiopharm, your condition 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 will suffer from them.

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

You may experience symptoms of angioedema (a specific allergic reaction), such as

• Swelling of the face, lips, tongue, or throat.
• Difficulty breathing or swallowing.
• Hives, itching.

If you experience any of these symptoms, stop taking valsartan and contact your doctor immediately (see also section 2 Warnings and Precautions).

Other adverse effects include:

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

• Dizziness.
• Low blood pressure with or without symptoms such as dizziness and fainting when standing up.
• Decreased kidney function (signs of renal insufficiency).

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

• Sudden loss of consciousness (syncope).
• Feeling of rotation (vertigo).
• Marked reduction of kidney function (signs of acute renal failure).
• Muscle spasms, abnormal heart rhythm (signs of hyperkalemia).
• Shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).
• Headache.
• Cough.
• Abdominal pain.
• Nausea.
• Diarrhea.
• Fatigue.
• Weakness.
• Increased creatinine levels in the blood (which may indicate renal function abnormalities).

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

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Blisters on the skin (sign of bullous dermatitis).

• Allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness).
• Purplish red spots, fever, itching (signs of vasculitis, also known as inflammation of blood vessels).
• Bleeding or bruising more frequently than usual (signs of thrombocytopenia).
• Muscle pain (myalgia).
• Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia).
• Reduction of hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can lead to anemia).
• Increased potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm).
• Elevation of liver function values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow).
• Increased urea nitrogen levels in the blood (which may indicate renal function abnormalities).
• Low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle contraction, and/or convulsions).

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse effects such as dizziness and decreased renal function were observed less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

The adverse effects in children and adolescents are similar to those observed in adults.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 Valsartán Teva-ratiopharm

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

Do not use this medicine after the expiry date that appears on the packaging and blister after CAD. The expiry date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from moisture.

Do not use Valsartán 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. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your 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 Valsartán Teva-ratiopharm

• The active ingredient is valsartan. Each film-coated tablet contains 160 mg of valsartan.
• The other ingredients are anhydrous colloidal silica, sodium starch glycolate, crospovidone, microcrystalline cellulose, cornstarch, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Valsartán 160 mg film-coated tablets are yellow, oval-shaped, scored on one side, and engraved with "V" on one side of the score and "160" on the other side of the score.

Valsartán 160 mg film-coated tablets are available in packs of 1, 14, 15, 28, 30, 56, 60, 84, 90, 98, 100, and 280 film-coated tablets. Hospital pack (EC): 50 film-coated tablets. Calendar pack of 28 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 - Madrid

Manufacturer:

Pharmachemie B.V.

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

Netherlands

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren-Weiler

Germany

TEVA Pharmaceutical Works Private Limited Company

Pallagi ùt 13, 4042 Debrecen

Hungary

TEVA Czech Industries s.r.o.

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

Czech Republic

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str., 31-546 Kraków

Poland

Date of the 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 smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71728/P_71728.html

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