Valsartan krka

Package leaflet: Information for the patient

Walsartan Krka, 80 mg, film-coated tablets
valsartan
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Walsartan Krka is and what it is used for
2. What you need to know 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 Walsartan Krka is and what it is 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 in the body that causes blood vessels to narrow, thereby increasing blood pressure. Walsartan Krka blocks the action of angiotensin II, leading to relaxation of blood vessels and a reduction in blood pressure.

Walsartan Krka, 80 mg, film-coated tablets can be used to treat three different conditions:

• Treatment of high blood pressure in adults and in children and adolescents aged 6 to below 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of these complications.
• Treatment of adult patients following a recent heart attack. "Recent" means within 12 hours to 10 days after the event.
• Treatment of symptomatic heart failure in adult patients. Walsartan Krka is used when medicines known as angiotensin-converting enzyme (ACE) inhibitors cannot be used (medicines used in the treatment of heart failure), or Walsartan Krka may be used in combination with ACE inhibitors when other medicines used in heart failure treatment cannot be used.
• Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. These occur when the heart muscle is unable to pump enough blood to meet the body's needs.

2. Important information before using Walsartan Krka

When not to use Walsartan Krka

• if the patient is allergic to 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 (the use of Walsartan Krka should also be avoided during 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, Walsartan Krka must not be taken.
Warnings and precautions
Before starting Walsartan Krka, discuss this with your doctor

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• in patients with renal artery stenosis;
• in patients who have recently undergone kidney transplantation;
• in patients with severe heart disease other than heart failure or myocardial infarction;
• if the patient has ever experienced angioedema (a type of allergic reaction causing swelling of the face and tongue) while taking another medicine (including an angiotensin-converting enzyme (ACE) inhibitor) – if such symptoms occur while taking Walsartan Krka, treatment must be stopped immediately and the medicine must not be taken again (See also section 4 “Possible side effects”);
• in patients taking medicines that increase blood potassium levels, such as: potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin – periodic monitoring of blood potassium levels may be necessary;
• in patients with hyperaldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone) – the use of Walsartan Krka is not recommended in patients with hyperaldosteronism;
• in patients who have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or taking high doses of diuretic medicines;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (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, known as mineralocorticoid receptor antagonists (MRAs), such as spironolactone, eplerenone, or with beta-blockers, such as metoprolol.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section “When not to use Walsartan Krka”.
If abdominal pain, nausea, vomiting, or diarrhoea occur after taking Walsartan Krka, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Walsartan Krka on your own.
Inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant – the use of Walsartan Krka is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnacy and breastfeeding”).
If any of the above situations apply to the patient, inform the doctor before starting Walsartan Krka.
Walsartan Krka and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
The effect of the medicine may change if Walsartan Krka is taken at the same time as certain other medicines. This may require dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines. This applies to both prescription and over-the-counter medicines, particularly:

• other blood pressure-lowering medicines, especially diuretics, angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under the headings “When not to use Walsartan Krka” and “Warnings and precautions”);
• medicines that increase blood potassium levels, such as: potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (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 psychiatric disorders.

In addition:

• in patients who have recently had a heart attack, combination with ACE inhibitors (medicines used to treat heart attack) is not recommended;
• in patients being treated for heart failure, simultaneous use of Walsartan Krka with ACE inhibitors and other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) and beta-blockers (e.g. metoprolol), is not recommended.

Walsartan Krka with food and drink
Walsartan Krka may be taken with or without food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

• It is essential to inform the doctor about pregnancy, suspected pregnancy, or planning pregnancy. The doctor will usually advise stopping Walsartan Krka before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Walsartan Krka is not recommended during early pregnancy. Walsartan Krka must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
• Inform the doctor about breastfeeding or plans to breastfeed. The use of Walsartan Krka is not recommended during breastfeeding. The doctor may recommend an alternative medicine if the patient intends to breastfeed, especially if breastfeeding a newborn or a premature infant.

Driving and operating machinery
Before driving, operating machinery, or performing other tasks requiring concentration, the patient should ensure how Walsartan Krka affects them. Like many other medicines used to treat high blood pressure, Walsartan Krka may cause dizziness and affect the ability to concentrate.
Walsartan Krka contains lactose and sodium
If the patient has been informed by a doctor that they have an intolerance to certain sugars, they should consult the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Walsartan Krka

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Patients with high blood pressure often do not experience any symptoms of the disease. Many of
them may feel perfectly well. For this reason, it is important to attend regular check-ups with your doctor,
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). Your doctor may also prescribe Walsartan Krka together with
an additional medicine (e.g. a diuretic).
Children and adolescents (aged 6 to under 18 years) with high blood pressure: in children weighing less than 35 kg,
the usual dose of valsartan is 40 mg once daily. In patients weighing 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 may be increased up to
160 mg, and a maximum of 320 mg).
Adult patients after a recent heart attack: treatment usually begins within 12 hours after the heart attack,
typically with a low dose of 20 mg twice daily. The 20 mg dose is achieved by splitting a 40 mg tablet.
Your doctor will gradually increase the dose over several weeks up to a maximum dose of 160 mg twice daily.
The final dose depends on the patient's tolerance to the medicine.
Walsartan Krka may be used together with other medicines used in the treatment of patients after a
heart attack. Your doctor will decide on the appropriate treatment regimen.
Heart failure in adult patients: treatment usually starts with a dose of 40 mg twice daily. Then, your doctor
gradually increases the dose over several weeks up to a maximum dose of 160 mg twice daily. The final dose
depends on the patient's tolerance to the medicine.
Walsartan Krka may be used together with other medicines used in the treatment of
heart failure. Your doctor will decide on the appropriate treatment regimen.
Walsartan Krka may be taken with or without food. Swallow the tablet with a glass of water.
The medicine should be taken at the same time each day.
Taking more Walsartan Krka than prescribed
If severe dizziness and/or fainting occur, 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.
Missing a dose of Walsartan Krka
Do not take a double dose to make up for a missed 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.
Stopping Walsartan Krka
Stopping treatment may worsen the condition being treated. Do not stop taking this medicine unless your doctor
tells you to.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Some adverse reactions may be serious and require immediate medical attention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:

• swelling of the face, lips, tongue or throat,
• difficulty breathing or swallowing,
• hives, itching.

If any of these symptoms occur, treatment with Walsartan Krka must be discontinued immediately and medical advice sought without delay (see section 2 "Warnings and precautions").
Other adverse reactions:
Common (may occur in less than 1 in 10 patients):

• dizziness,
• low blood pressure with symptoms such as dizziness and fainting upon standing, or without such symptoms,
• kidney function disorders.

Uncommon (may occur in less than 1 in 100 patients):

• angioedema (see "Some symptoms requiring immediate medical attention"),
• sudden loss of consciousness (fainting),
• sensation of spinning (vertigo),
• severe kidney function disorders (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of elevated blood potassium levels),
• shortness of breath, breathing difficulties when lying down, swelling of feet or legs (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhoea,
• fatigue,
• weakness.

Very rare (may occur in less than 1 in 10,000 patients):

• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• skin blisters (symptoms of bullous dermatitis),
• allergic reactions presenting with rash, itching and hives; symptoms may include: fever, joint swelling and joint pain, muscle pain, enlarged lymph nodes and/or flu-like symptoms (symptoms of serum sickness),
• purple-red skin lesions, 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, known as neutropenia),
• decreased haemoglobin levels and reduced number of red blood cells in blood (in severe cases may lead to anaemia),
• increased blood potassium levels (in severe cases may cause muscle cramps and heart rhythm disturbances),
• increased liver enzyme activity (may indicate liver damage), increased blood bilirubin levels (in severe cases may cause yellowing of the skin and eyes),
• increased blood urea nitrogen levels and increased serum creatinine levels (may indicate kidney function disorders),
• low sodium levels in blood (in severe cases may cause fatigue, confusion, muscle twitching and/or seizures).

The frequency of some adverse reactions may vary depending on the underlying disease.
For example, adverse reactions such as dizziness or impaired kidney function occurred less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or recent myocardial infarction.
Adverse reactions observed in children and adolescents are similar to those occurring in adult patients.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Walsartan Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Walsartan Krka contains

• The active substance is valsartan. Each coated tablet contains 80 mg of valsartan.
• The other ingredients are: monohydrate lactose, 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 iron oxide red (E 172) in the tablet coating.
• See section 2 "Walsartan Krka contains lactose and sodium".

What Walsartan Krka looks like and contents of the packaging
Pink, round, slightly biconvex coated tablets with a dividing line on one side, 7 mm in diameter.
The tablet can be divided into equal doses.
Packaging: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120 or 180 coated tablets in blisters,
in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For more detailed information regarding the product name in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Tel. 22 57 37 500