Valsartan Krka

Package Leaflet: Information for the Patient

Walsartan Krka, 40 mg, film-coated tablets
valsartan

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms 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 Walsartan Krka and what is it used for
• 2. Important information before taking Walsartan Krka
• 3. How to take Walsartan Krka
• 4. Possible side effects
• 5. How to store Walsartan Krka
• 6. Contents of the pack and other information

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

Walsartan Krka belongs to a group of medicines called 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. Walsartan Krka blocks the action of angiotensin II, leading to the relaxation of blood vessels and a decrease in blood pressure.
Walsartan Krka, 40 mg, film-coated tablets can be used to treat three different diseases:

• Treatment of high blood pressure 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 left untreated, it can lead to damage to the blood vessels in the brain, heart, and kidneys, and can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of these complications.
• Treatment of adult patients after a recent heart attack."Recent" means 12 hours to 10 days.
• Treatment of symptomatic heart failure in adult patients.Walsartan Krka is used when an ACE inhibitor (a type of medicine used to treat heart failure) cannot be used or in combination with an ACE inhibitor when other treatments for heart failure cannot be used.
• Symptoms of heart failure include shortness of breath and swelling of the feet and ankles due to fluid accumulation. They occur when the heart muscle is unable to pump blood in sufficient quantities to supply the entire body.

2. Important information before taking Walsartan Krka

When not to take Walsartan Krka

• if you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
• in case of severe liver disease;
• after the third month of pregnancy(you should also avoid taking Walsartan Krka during early pregnancy - see section "Pregnancy and breast-feeding").
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to you, do not take Walsartan Krka

Warnings and precautions

Before taking Walsartan Krka, discuss it with your doctor

• if you have liver disease;
• if you have severe kidney disease or are undergoing dialysis;
• in patients with narrowing of the renal artery;
• in patients who have recently undergone kidney transplantation;
• in patients with severe heart disease other than heart failure or heart attack;
• if you have ever had swelling of the face, lips, throat, or tongue with any other medicine (a condition called angioedema); if such symptoms occur while taking Walsartan Krka, stop taking the medicine and do not take it again (see also section 4 "Possible side effects");
• in patients taking medicines that increase potassium levels in the blood, such as potassium supplements, potassium-sparing diuretics, and heparin - periodic monitoring of potassium levels in the blood may be necessary;
• in patients with aldosteronism (a condition where the adrenal glands produce too much of a hormone called aldosterone) - Walsartan Krka is not recommended for patients with aldosteronism;
• in patients who have lost a lot of fluid (dehydrated) due to diarrhea, vomiting, or taking high doses of diuretics;
• if you are taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.
• if you are being treated with an ACE inhibitor in combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs), such as spironolactone, eplerenone, or beta-blockers, such as metoprolol.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.
See also the section "When not to take Walsartan Krka".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Walsartan Krka, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Walsartan Krka on your own.
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant - Walsartan Krka should not be taken during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breast-feeding").

If any of the above situations apply to you, inform your doctor before taking Walsartan Krka.

Walsartan Krka with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The effect of the medicine may change if Walsartan Krka is taken with certain other medicines. This may require a change in dose, the use of other precautions, or in some cases, stopping one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other blood pressure-lowering medicines, especially diuretics; ACE inhibitors such as enalapril, lisinopril, etc. or aliskiren (see also the information under the heading "When not to take Walsartan Krka" and "Warnings and precautions").
• medicines that increase potassium levels in the blood, such as potassium supplements or potassium-sparing diuretics and heparin;
• certain painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (such as rifamycin), a medicine used to prevent transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Walsartan Krka.
• lithium, a medicine used to treat certain mental illnesses.

In addition:

• in patients who have had a recent heart attack, it is not recommended to combine with ACE inhibitors(medicines used to treat heart attack);
• in patients being treated for heart failure, it is not recommended to take Walsartan Krka with ACE inhibitors and other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) and beta-blockers (such as metoprolol).

Walsartan Krka with food and drink

Walsartan Krka can be taken with or without food.

Pregnancy and breast-feeding

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

• You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.Your doctor will normally advise you to stop taking Walsartan Krka before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Walsartan Krka should not be taken during early pregnancy. Do not take Walsartan Krka after the third month of pregnancy, as it may seriously harm the baby.
• You must inform your doctor if you are breast-feeding or plan to breast-feed.Walsartan Krka is not recommended during breast-feeding. Your doctor may prescribe another medicine if you want to breast-feed, especially if you are breast-feeding a newborn or premature baby.

Driving and using machines

Before driving, using machines, or performing other activities that require concentration, you should make sure you know how Walsartan Krka affects you. Like many other medicines used to treat high blood pressure, Walsartan Krka can cause dizziness and affect your ability to concentrate.

Walsartan Krka contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Walsartan Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Patient with high blood pressure often do not feel ill. Many of them may feel perfectly well. For this reason, it is very important to go to your doctor's appointments, even if you feel fine.
Children and adolescents (from 6 to less than 18 years of age) with high blood pressure:in children with a body weight of less than 35 kg, the dose of valsartan is usually 40 mg once daily. In patients with a body weight of 35 kg or more, the initial dose is usually 80 mg of valsartan once daily.
In some cases, your doctor may prescribe higher doses (the dose of the medicine can be increased to 160 mg and up to a maximum of 320 mg).
Adult patients after a recent heart attack: treatment usually starts 12 hours after the heart attack, usually with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing a 40 mg tablet. Your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on your tolerance to the medicine.
Walsartan Krka can be taken with other medicines used to treat patients after a heart attack. Your doctor will decide on the choice of treatment.
Heart failure in adult patients: treatment usually starts with a dose of 40 mg twice daily. Then, your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on your tolerance to the medicine.
Walsartan Krka can be taken with other medicines used to treat heart failure. Your doctor will decide on the choice of treatment.
Walsartan Krka can be taken with or without food. Walsartan Krka should be swallowed with a glass of water. The medicine should be taken every day at the same time.

Take a higher dose of Walsartan Krka than prescribed

In case of severe dizziness and/or fainting, contact your doctor immediately and lie down. If you accidentally take too many tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.

Miss a dose of Walsartan 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.

Stop taking Walsartan Krka

Stopping treatment may worsen the disease being treated. Do not stop taking Walsartan Krka 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, Walsartan Krka can cause side effects, although not everybody gets them.

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

Angioedema (a specific allergic reaction) may occur, with symptoms 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 Walsartan Krka and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other side effects:

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

• dizziness
• low blood pressure with symptoms such as dizziness and fainting when standing up or without these symptoms
• kidney problems.

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

• angioedema of the intestine: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.

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

• angioedema (see "Some side effects may be serious and require immediate medical attention")
• sudden loss of consciousness (fainting)
• feeling of spinning (vertigo)
• severe kidney problems (symptoms of acute kidney failure)
• muscle cramps, irregular heartbeat (symptoms of high potassium levels in the blood)
• shortness of breath, breathing difficulties when lying down, swelling of the feet or ankles (symptoms of heart failure)
• headache
• cough
• stomach pain
• nausea
• diarrhea
• fatigue
• weakness.

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

• blisters on the skin (symptoms of blistering skin disease)
• allergic reactions with rash, itching, and hives; may occur with symptoms such as fever, joint pain, and muscle pain, swollen lymph nodes, and/or flu-like symptoms (symptoms of serum sickness)
• purple-red spots, fever, itching (symptoms of vasculitis)
• abnormal bleeding or bruising (symptoms of low platelet count)
• muscle pain
• fever, sore throat, or mouth ulcers due to infection (symptoms of low white blood cell count, called neutropenia)
• decreased hemoglobin and red blood cell count in the blood (which in severe cases can lead to anemia)
• increased potassium levels in the blood (which in severe cases can cause muscle cramps and irregular heartbeat)
• increased liver enzyme activity (which may indicate liver damage), increased bilirubin levels in the blood (which in severe cases can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate kidney problems)
• low sodium levels in the blood (which in severe cases can cause fatigue, confusion, tremors, and/or convulsions).

The frequency of some side effects may vary depending on the underlying disease.
For example, side effects such as dizziness or kidney problems occurred less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or recent heart attack.
The side effects seen in children and adolescents are similar to those seen in adult patients.
Reporting of side effects
If you get 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 to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Walsartan 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 packaging after EXP.
The expiry date refers to the last day of that month.
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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Walsartan Krka contains

• The active substance is valsartan. Each film-coated tablet contains 40 mg of valsartan.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K-25, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate in the tablet core, and hypromellose 6cp, titanium dioxide (E 171), macrogol 4000, and yellow iron oxide (E 172) in the tablet coating.
• See section 2 "Walsartan Krka contains lactose and sodium".

What Walsartan Krka looks like and contents of the pack

Yellow-brown, round, slightly convex film-coated tablets with a score line on one side, 6 mm in diameter.
The tablet can be divided into equal doses.
Pack sizes: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120, or 180 film-coated tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For more information on the medicinal product, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:24.04.2025