VALSARTAN KRKA 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Krka 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 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 Krka and what is it used for
2. What you need to know before you take Valsartan Krka
3. How to take Valsartan Krka
4. Possible side effects
5. Storage of Valsartan Krka

Contents of the pack and further information

1. What is Valsartan Krka and what is it used for

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

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

• to treat high blood pressure in adults and children and adolescents from 6 to less than 18 years of age.Hypertension increases the strain on the heart and arteries. If left uncontrolled, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal reduces the risk of developing these disorders,
• to treat patients after a recent heart attack(myocardial infarction). “Recent” here means between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patients.Valsartan Krka can be used to treat symptomatic heart failure in adult patients. Valsartan Krka is used when a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure) cannot be used or can be used in combination with ACE inhibitors when it is not possible to use other medications for the treatment of heart failure,
• Among the symptoms of heart failure are shortness of breath and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to provide all the blood needed for the body.

2. What you need to know before you take Valsartan Krka

Do not take Valsartan Krka

• 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 pregnant for more than 3 months. (In any case, it is better to avoid taking this medicine also at the start of your pregnancy - see section Pregnancy),
• if you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of these situations apply to you, do not take Valsartan Krka.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with valsartan:

• if you have liver disease,
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan on your own,
• if you have severe kidney disease or are undergoing dialysis,
• if you have narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (received a new kidney),
• if you have severe heart disease other than heart failure or heart attack,
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan, stop treatment with valsartan immediately and never take it again. See also section 4 “Possible side effects”,
• 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. It may be necessary to regularly monitor the amount of potassium in the 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 Krka,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine elimination),
• if you are taking any of the following medications used to treat high blood pressure:
• • an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes related to kidney problems.
  • aliskiren.
• if you are being treated with an ACE inhibitor along with other medications 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 the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the information under the heading "Do not take Valsartan Krka".

You must inform your doctor if you think you are (or might become) pregnant. Valsartan is not recommended at the start of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy (see the section on pregnancy).

If any of these situations apply to you, inform your doctor before taking Valsartan Krka.

Other medicines and Valsartan Krka

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

The effect of treatment with valsartan may be affected if taken with certain other medicines. It may be necessary to change the dose, take other precautions, or in some cases, stop treatment with 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 elimination), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan Krka” and “Warnings and precautions”),
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (rifampicin group), a drug used to protect against transplant rejection (cyclosporin), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartan Krka,
• lithium,a medicine used to treat certain types of psychiatric illnesses.

In addition:

• if you are being treated after a heart attack,it is not recommended to combine with ACE inhibitors(a medication for treating heart attack),
• if you are being treated for heart failure,it is not recommended to combine with ACE inhibitors and other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Taking Valsartan Krka with food and drink

You can take Valsartan Krka with or without food.

Pregnancy and breast-feeding

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.

• You must inform your doctor if you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant.Normally, your doctor will advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine to control your blood pressure. Valsartan is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

• Inform your doctor if you are about to start or are already breast-feedingas it is not recommended to take valsartan while breast-feeding. Your doctor may decide to prescribe a different treatment if you want to breast-feed, especially if your baby is a newborn or was born prematurely.

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 affects you. Like many other medicines used to treat high blood pressure, valsartan can cause dizziness and affect your ability to concentrate.

Valsartan Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to take Valsartan Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. This will help you get the best results and reduce the risk of side effects. 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 usual dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan Krka can also be taken 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 usual dose is 40 mg of valsartan once daily.

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

In some cases, your doctor may prescribe higher doses (the dose can 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 at a low dose of 20 mg 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 Krka can be given with other treatments for 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 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 Krka can be given with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartan Krka with or without food. Swallow Valsartan Krka with a glass of water. Take Valsartan Krka at approximately the same time each day.

If you take more Valsartan Krka than you should

If you notice a strong dizziness or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

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 ingested.

If you forget to take Valsartan Krka

Do not take a double dose to make up for forgotten doses.

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.

If you stop taking Valsartan Krka

If you stop taking Valsartan Krka, 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and may need 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,
• skin rash, itching.

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

Other side effects include:

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

• dizziness,
• low blood pressure with or without symptoms such as dizziness and fainting when standing up,
• reduced kidney function (signs of kidney impairment).

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

• angioedema (see section “Some symptoms need immediate medical attention”),
• sudden loss of consciousness (syncope),
• feeling of spinning (vertigo),
• marked reduction in kidney function (signs of acute kidney 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.

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

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

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

• blistering of the skin (sign of bullous dermatitis),
• allergic reaction with skin rash, itching, urticaria, symptoms of fever, joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness),
• red spots on the skin, fever, itching (signs of vasculitis),
• bleeding or bruising more often 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 and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia),
• increase in potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm),
• decrease in sodium levels in the blood (which can cause fatigue and confusion, muscle spasms, seizures, or coma),
• 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),
• increase in blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function abnormalities).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function were observed less frequently in adult patients treated for hypertension 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.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Krka

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 carton after CAD. The expiry date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartán Krka

• The active ingredient is valsartan. Each tablet contains 80 mg of valsartan.
• The other ingredients of the tablet core are lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate.
• The other ingredients of the tablet coating are hypromellose, titanium dioxide (E171), macrogol 4000, and red iron oxide (E172).

See section 2 “Valsartán Krka contains lactose and sodium”.

Appearance of Valsartán Krka and Package Contents

The 80 mg film-coated tablets are pink, round, biconvex, and marked on one side.

The tablets of the three doses can be divided into equal doses.

The film-coated tablets are presented in blisters of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120, and 180 tablets, in a box.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warszawa, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the last revision of this leaflet: April 2025

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