Prospect: Patient Information

Valsartán Teva-ratiopharm 80 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, because

it contains important information for you.

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you and should not be given to other people,

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

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are

not listed in this prospect, See section 4.

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

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

3.- How to take Valsartán Teva-ratiopharm

4.- Possible adverse effects

5.- Storage of Valsartán Teva-ratiopharm

6.- Contents of the pack and additional information

Valsartán Teva-ratiopharm belongs to a class of medications 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 constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán 80 mg film-coated tabletsmay be used to treat three different conditions:

• For treating high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the load on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Reducing blood pressure to normal levels reduces the risk of developing these disorders.
• For treating adult patients after a recent heart attack (myocardial infarction). "Recent" means here between 12 hours and 10 days.
• For treating symptomatic heart failure in adult patients. Valsartán Teva-ratiopharm is used when it is not possible to use a group of medications called angiotensin-converting enzyme (ACE) inhibitors (a medication for treating heart failure) or it may 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 feet and legs due to fluid retention. This is because the heart muscle is not able to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán Teva-ratiopharm

• If you areallergicto valsartán or any of the other components of this medication (listed in section 6).
• If you have aserious liver disease.
• If you aremore than three months pregnant, (it is 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 insufficiency and are being treated with a medication to reduce blood pressure that containsaliskirén.

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

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

Warnings and precautions

Consult 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 a narrowing of the kidney artery
• If you have recently undergone a kidney transplant (received a new kidney).
• If you have a serious heart disease other than heart failure or heart attack.
• If you are taking medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to regularly control the amount of potassium in your blood.
• If you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartán Teva-ratiopharm.
• If you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications 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 medications (including ACE inhibitors), consult your doctor. If these symptoms occur when taking valsartán, stop taking valsartán immediately and do not take it again (see section 4 “Possible side effects”).
• Inform your doctor if you are pregnant (or if you suspect you may be). Valsartán Teva-ratiopharm is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point on (see section “Pregnancy, breastfeeding and fertility”).
• If you are taking any of the following medications used to treat high blood pressure:
• • An ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

• If you are being treated with an ACE inhibitor along with other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).

Your doctor may need to regularly check your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.

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.

Other medications and Valsartán Teva-ratiopharm

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

The effect of Valsartán Teva-ratiopharm treatment may be altered if taken with other medications. You may need to change the dose, take other precautions, or, in some cases, stop taking one of the medications. This applies to both prescription and non-prescription medications, especially:

• Other medications that lower blood pressure, especiallydiuretics(medications to increase urine production).
• Medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• Certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs).
• Some antibiotics (in the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporin) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartán.
• Lithium, a medication used to treat certain types of psychiatric disorders.

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

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

If you are being treated with an ACE inhibitor along with other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).

Additionally:

• ifyou are beingtreated after a heart attack,it is not recommended to combine withACE inhibitors(a medication to treat a heart attack).

Taking Valsartán Teva-ratiopharm with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

• Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be).Your doctor will usually recommend that you stop taking Valsartán Teva-ratiopharm as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán Teva-ratiopharm. Valsartán Teva-ratiopharm is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point on.

• Breastfeeding

Inform your doctor if you are breastfeeding or plan to start.Valsartán Teva-ratiopharm is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know how Valsartán Teva-ratiopharm affects you. Like many other medications used to treat high blood pressure, Valsartán Teva-ratiopharm may cause dizziness and affect your ability to concentrate.

Valsartán Teva-ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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.

Adult patients with high blood pressure: The recommended dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). You may also combineValsartán Teva-ratiopharmwith another medication (for example, a diuretic).

Children and adolescents (6 years of age or less) with high blood pressure:

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

In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartan once a day.

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 at 12 hours, usually with a low dose of 20 mg,

administered twice a day. 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 a day. The final dose will depend on your individual tolerance.

Valsartán Teva-ratiopharmmay be taken with other treatments for a heart attack, and your doctor will decide what treatment is suitable for you.

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

Valsartán Teva-ratiopharmmay be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You may takeValsartán Teva-ratiopharmwith or without food. SwallowValsartán Teva-ratiopharmwith a glass of water.

TakeValsartán Teva-ratiopharmapproximately at the same time every day.

The tablet may be divided into equal doses.

If you take moreValsartán Teva-ratiopharmthan you should

If you notice a strong 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to takeValsartán Teva-ratiopharm

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withValsartán Teva-ratiopharm

If you stop takingValsartán Teva-ratiopharmyour disease may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious and may require immediate medical attention:

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

• Swelling in 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 side 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).

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

• Sudden loss of consciousness (syncope).
• Sensation of rotation (vertigo).
• Marked reduction of kidney function (signs of acute renal insufficiency).
• 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 in the blood (which may indicate renal function abnormalities).

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 dermatitis bullosa)

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

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and renal insufficiency 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.

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

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

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

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration 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 useValsartán Teva-ratiopharmif you observe that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and

medications that you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition ofValsartán Teva-ratiopharm

The active ingredient is valsartán. Each film-coated tablet contains 80 mg of valsartán.

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

Appearance of the product and contents of the package

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

Valsartán 80 mg film-coated tablets are available in packages 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.

Only some package sizes may be marketed.

Holder of the Marketing Authorization and responsible manufacturer

Holder of the Marketing Authorization:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 – Madrid

Responsible 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 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

Last revision date of thisleaflet:March 2025

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

You can access detailed and updated information on this medication by scanning the QR code on the packaging with your smartphone. 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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