VALSARTAN KRKA 320 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Krka 320 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 Package Leaflet

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 320 mg film-coated tablets can be used to treat high blood pressure in adults and adolescents aged 6 to less than 18 years.

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.

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

If any of these 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 received 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 medicines (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 medicines that increase the amount of potassium in your blood. These include potassium supplements, salt substitutes containing 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 where 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 production),
• if you are taking any of the following medicines used to treat high blood pressure:
• • an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have diabetes related to kidney problems.
  • aliskiren.

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 during the first few months of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

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

Children and adolescents

If you are under 18 years of age and take valsartan in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor will check your kidney function and potassium levels in your blood at regular intervals.

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 production), 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 your blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan Krka,
• lithium, a medicine used to treat certain types of psychiatric diseases.

Taking Valsartan Krka with food and drink

You can take Valsartan Krka with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant.Your doctor will normally advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to lower your blood pressure instead. Valsartan is not recommended during the first few months of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

• Tell your doctor if you are going to start or are already breastfeeding, as it is not recommended to take valsartan during this period. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

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 Krka 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. Check with your doctor or pharmacist if you are not sure. 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 see your doctor regularly, even if you feel well.

Adults 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 may also be given 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).

Doses below 160 mg are not possible with Valsartan Krka 320 mg film-coated tablets.

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 experience severe 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 a forgotten dose.

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some symptoms 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, tongue, or throat,
• difficulty breathing or swallowing,
• hives, 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, postural dizziness,
• low blood pressure with symptoms such as dizziness,
• reduced kidney function (signs of kidney impairment).

Uncommon(may affect up to 1 in 100 people)

• angioedema (see section “Some symptoms require 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(frequency cannot be estimated from the available data)

• blistering of the skin (sign of bullous dermatitis),
• skin rash, itching, along with some of the following signs or symptoms: fever, joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to 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, which can cause fatigue and confusion, muscle contractions, convulsions, 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 yellowing of the skin and eyes),
• increase in blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function disorders).

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 patients treated for hypertension than in patients treated for heart failure or after a recent heart attack.

Additional side effects in children and adolescents

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 Valsartan 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 EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Valsartan Krka

• The active substance is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, silica colloidal anhydrous, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), and red iron oxide (E172) in the coating.

See section 2 “Valsartan Krka contains lactose and sodium”

Appearance of Valsartan Krka and contents of the pack

320 mg film-coated tablets are light brown, capsule-shaped, biconvex, and marked on one side. The tablet can be divided into equal doses.

320 mg film-coated tablets are available in packs of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 obtain further information on this medicine from the representative of the marketing authorisation holder:

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

Date of 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/