Valsartan Krka

Leaflet attached to the packaging: patient information

Walsartan Krka, 320 mg, film-coated tablets valsartanum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 control high blood pressure. Angiotensin II is a substance present in the body that causes blood vessels to constrict, leading to increased blood pressure. Walsartan Krka blocks the action of angiotensin II, leading to the dilation of blood vessels and a decrease in blood pressure.
Walsartan Krka, 320 mg, film-coated tablets may be used to treat high blood pressure
in adults and in children and adolescents from 6 to less than 18 years of age.
High blood pressure increases the burden on the heart and arteries. If left untreated, it can cause damage to the blood vessels of the brain, heart, and kidneys, and lead to 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.

2. Important information before taking Walsartan Krka

When not to take Walsartan Krka:

• if the patient is allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
• in case of severe liver disease;
• after the 3rd month of pregnancy(it is also recommended to avoid taking Walsartan Krka in early pregnancy - see section "Pregnancy and breastfeeding").
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to the patient, they should not take Walsartan Krka.

Warnings and precautions

Before starting Walsartan Krka, the patient should discuss it with their doctor

• if the patient has liver disease;
• if the patient has severe kidney disease or is 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 the patient has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including an ACE inhibitor) - if such symptoms occur while taking Walsartan Krka, the patient should stop taking the medicine immediately and 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 or salt substitutes containing potassium, potassium-sparing medicines, and heparin - periodic measurement of potassium levels in the blood may be necessary;
• in patients with aldosteronism (a disease in which the adrenal glands produce too much of a hormone called aldosterone) - it is not recommended to take Walsartan Krka in patients with aldosteronism;
• in patients who have lost a lot of fluid (dehydrated) due to diarrhea, vomiting, or taking high doses of diuretics;
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.
• if the patient is being treated with an ACE inhibitor in combination with other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (MRAs), such as spironolactone, eplerenone, or beta-blockers, such as metoprolol.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also subsection "When not to take Walsartan Krka".
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Walsartan Krka, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Walsartan Krka on their own.
The patient should tell their doctor if they are pregnant, suspect they may be pregnant, or plan to become pregnant - it is not recommended to take Walsartan Krka in early pregnancy, and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").

If any of the above situations apply to the patient, they should inform their doctor before starting Walsartan Krka.

Walsartan Krka and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The effect of the medicine may change if Walsartan Krka is taken with certain other medicines. It may be necessary to change the dose, take other precautions, or stop taking one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other blood pressure-lowering medicines, especially diuretics, ACE inhibitors (e.g., enalapril, lisinopril, etc.) or aliskiren (see also 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 salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• certain painkillerscalled nonsteroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (from the rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Walsartan Krka.
• lithium, a medicine used to treat certain mental illnesses.

Walsartan Krka with food and drink

Walsartan Krka can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

• The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy .The doctor will usually recommend stopping Walsartan Krka before becoming pregnant or as soon as pregnancy is confirmed, and will recommend taking another medicine. It is not recommended to take Walsartan Krka in early pregnancy. Walsartan Krka should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby.
• The patient should inform their doctor about breastfeeding or intending to breastfeed.It is not recommended to take Walsartan Krka while breastfeeding. The doctor may recommend taking another medicine if the patient intends to breastfeed, especially if breastfeeding a newborn or premature baby.

Driving and using machines

Before starting to drive, operate machinery, or perform other activities that require concentration, the patient should make sure they know how Walsartan Krka affects them. Like many other medicines used to treat high blood pressure, Walsartan Krka can cause dizziness and affect concentration.

Walsartan Krka contains lactose and sodium

If the patient has been told by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Walsartan Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Patient with high blood pressure often do not notice any symptoms of the disease. Many of them may feel perfectly well. Therefore, it is essential to attend doctor's appointments, even if they feel well.
Adult patients with high blood pressure: the usual dose is 80 mg once a day. In some cases, the doctor may prescribe higher doses (e.g., 160 mg or 320 mg). The doctor may also prescribe Walsartan Krka in combination with another medicine (e.g., a diuretic).
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 a day. In patients with a body weight of 35 kg or more, the initial dose is usually 80 mg of valsartan once a day.
In some cases, the doctor may prescribe higher doses (the dose of the medicine can be increased to 160 mg, and up to a maximum of 320 mg).
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.

Taking a higher dose of Walsartan Krka than recommended

In case of severe dizziness and/or fainting, the patient should contact their doctor immediately and lie down. If the patient has taken too many tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Walsartan Krka

The patient should not take a double dose to make up for a missed dose.
If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose.

Stopping Walsartan Krka

Stopping treatment may worsen the treated disease. The patient should not stop taking Walsartan Krka unless their doctor recommends it.
If the patient has any further doubts about taking the medicine, they should consult their 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 the patient experiences any of these symptoms, they should stop taking Walsartan Krka and contact their doctor immediately

(see 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.

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.

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.

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

• blistering of the skin (symptoms of bullous dermatitis)
• allergic reactions with rash, itching, and hives; symptoms may include fever, joint swelling and pain, muscle pain, lymph node swelling, and/or flu-like symptoms (symptoms of serum sickness)
• purple-red spots, fever, itching (symptoms of vasculitis)
• abnormal bleeding or bruising (symptoms of thrombocytopenia)
• muscle pain
• fever, sore throat, or mouth ulcers caused by infection (symptoms of neutropenia)
• decreased hemoglobin levels and decreased red blood cell count in the blood (which in severe cases can lead to anemia)
• increased potassium levels in the blood (in severe cases, can cause muscle cramps and irregular heartbeat)
• increased liver enzyme activity (may indicate liver damage), increased bilirubin levels in the blood (in severe cases, can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (may indicate kidney problems)
• low sodium levels in the blood (in severe cases, can cause fatigue, confusion, tremors, and/or seizures).

The frequency of some side effects may vary depending on the underlying disease.
For example, side effects such as dizziness or kidney problems were less common in adult patients treated for high blood pressure than in adult patients treated for heart failure or recent heart attack.
The side effects observed in children and adolescents are similar to those seen in adult patients.
Reporting side effects
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Walsartan Krka

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Walsartan Krka contains

• The active substance of the medicine is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other ingredients of the medicine 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, yellow iron oxide (E 172), and red iron oxide (E 172) in the tablet coating.
• See section 2 "Walsartan Krka contains lactose and sodium".

What Walsartan Krka looks like and what the pack contains

Light brown, round, slightly biconvex film-coated tablets with a score line on one side, 16 mm x 8.5 mm in diameter.
The tablet can be divided into equal doses.
Packaging: 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, or 98 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
To obtain more detailed information on the product name in other EU member states, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
Date of last revision of the leaflet:24.04.2025