Valsartan Teva-Ratiopharm 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Valsartan Teva-ratiopharm 80 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 and must not be given to other people,

even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if the side

effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

2.- What you need to know before taking 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 Valsartán Teva-ratiopharm is and what it is used for

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

Valsartán 80 mg film-coated tablets can be used for three different conditions:

• To treat high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. 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 also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these complications.
• 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. Valsartán Teva-ratiopharm is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure medications cannot be used.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This condition occurs because the heart muscle cannot pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Teva-ratiopharm

DO NOT take Valsartán Teva-ratiopharm

• If you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease.
• If you are more than three months pregnant (it is also better to avoid Valsartán Teva-ratiopharm during the first months of pregnancy; see section 2. Pregnancy, breastfeeding and fertility).

If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor and do not take Valsartán Teva-ratiopharm.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Valsartán.

• If you have liver disease.

• If you have severe kidney disease or are undergoing dialysis.

• If you have narrowing of the artery to the kidney (renal artery stenosis).

• If you have recently had a kidney transplant (received a new kidney).

• If you have a serious heart condition other than heart failure or heart attack.

• If you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary.

• If you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán Teva-ratiopharm is not recommended.

• If you have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics (medicines that increase urine elimination).

• If you have ever experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), consult your doctor. If these symptoms occur while taking valsartan, stop taking valsartan immediately and do not take it again (see section 4 “Possible side effects”).

• Inform your doctor if you are pregnant (or suspect you might be). Use of Valsartán Teva-ratiopharm is not recommended in early pregnancy, and it must not be used at all if you are more than three months pregnant, as it may cause serious harm to your baby when used from this stage onward (see section “Pregnancy, breastfeeding 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), particularly if you have kidney problems related to diabetes.
  • aliskiren.

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

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 Valsartán Teva-ratiopharm”.

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

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan on your own.

Other medicines and Valsartán Teva-ratiopharm

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

The effect of Valsartán Teva-ratiopharm treatment may be altered if taken together with other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, discontinue one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• Other medicines that lower blood pressure, particularly diuretics (medicines that increase urine elimination).
• Medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• Certain pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
• Some 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 increase the effect of valsartan.
• Lithium, a medicine used to treat certain psychiatric conditions.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartán Teva-ratiopharm” and “Warnings and precautions”).

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

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medicine used to treat heart attack) is not recommended.

Taking Valsartán Teva-ratiopharm with food and drink

You may take Valsartán Teva-ratiopharm with or without food.

Pregnancy, breastfeeding and fertility

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

• Pregnancy

You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Valsartán Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartán 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 when used from that time.

• Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Valsartán Teva-ratiopharm is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving, operating tools, handling machinery, or engaging in any activity requiring concentration, make sure you know how Valsartán Teva-ratiopharm affects you. Like many other medicines used to treat high blood pressure, Valsartán Teva-ratiopharm may cause dizziness and affect your ability to concentrate.

Valsartán Teva-ratiopharm contains sodium

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

3. How to take Valsartán Teva-ratiopharm

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any symptoms; many feel perfectly normal. Therefore, it is very important to attend your doctor's appointments regularly, 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). Your doctor may also combine Valsartán Teva-ratiopharm with another medicine (e.g., a diuretic).

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

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

In patients weighing 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: After a heart attack, treatment is usually started within 12 hours, typically 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 up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartán Teva-ratiopharm may be given together with other treatments for heart attack, and your doctor will decide which treatment is appropriate 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 up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartán Teva-ratiopharm may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

You may take Valsartán Teva-ratiopharm with or without food. Swallow the tablet with a glass of water.

Take Valsartán Teva-ratiopharm approximately at the same time each day.

The tablet may be divided into equal doses.

If you take more Valsartán Teva-ratiopharm than you should

If you experience 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartán 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 Valsartán Teva-ratiopharm

If you stop treatment with Valsartán Teva-ratiopharm, your condition may worsen. Do not stop taking this 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 may 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:

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

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

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

• Sudden loss of consciousness (syncope).
• Sensation of spinning (vertigo).
• Marked reduction in kidney function (signs of acute renal failure).
• Muscle spasms, irregular 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 in the blood (which may indicate abnormalities in kidney function).

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 diarrhea.

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

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

• Allergic reactions may occur with skin rash, itching, and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness).

• Purple-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis).

• Bleeding or bruising more easily 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 called neutropenia).

• Reduction in hemoglobin levels and reduction in the proportion of red blood cells in the blood (which, in severe cases, may lead to anemia).

• Increased potassium levels in the blood (which, in severe cases, may cause muscle spasms and irregular heartbeat).

• Elevation of liver function values (which may indicate liver damage), including increased bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes).

• Increased blood urea nitrogen levels (which may indicate abnormalities in kidney function).

• Low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle cramps, and/or seizures).

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 may also report them directly through 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 Valsartan Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from moisture.

Do not use Valsartan 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. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Valsartan Teva-ratiopharm

The active substance is valsartan. Each film-coated tablet contains 80 mg of valsartan.

• The other components are colloidal anhydrous silica, sodium starch glycolate from potato, crospovidone, microcrystalline cellulose, corn starch, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), talc, and red iron oxide (E172).

Appearance of the product and contents of the container

Valsartan 80 mg film-coated tablets are pink, oval-shaped, film-coated tablets, scored on one side and marked with a "V" on one side of the score and "80" on the other side of the score.

Valsartan 80 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 packs of 28 and 98 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 – Madrid, Spain

Manufacturer:

Pharmachemie B.V.

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

The Netherlands

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren-Weiler

Germany

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 Operations Poland Sp. z o.o.

Mogilska 80 Str., 31-546 Kraków

Poland

Date of latest revision of this product information: March 2025

Detailed and up-to-date information on this medicine 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/71727/P_71727.html

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