Valsartan krka

Package leaflet: Information for the patient

Walsartan Krka, 320 mg, film-coated tablets
valsartanum
Please read all of 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, 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 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 effects of angiotensin II, leading to relaxation of blood vessels and a reduction in blood pressure.
Walsartan Krka, 320 mg, film-coated tablets can be used in the 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 blood vessels. If left untreated, it may damage the blood vessels of 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 of hypertension.

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 (Walsartan Krka should also be avoided 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, do not take Walsartan Krka.
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 swelling of the face and tongue due to an allergic reaction called angioedema while taking another medicine (e.g. an angiotensin-converting enzyme 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 diuretics, and heparin – periodic monitoring of blood potassium levels may be necessary;
• in patients with aldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone) – use of Walsartan Krka is not recommended in patients with aldosteronism;
• in patients who have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or taking high doses of diuretics;
• 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 called 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 blood electrolyte levels (e.g. potassium).
See also the section "When not to use Walsartan Krka".
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Walsartan Krka, this should be discussed with the doctor. The doctor will decide on further treatment. Do not make independent decisions to stop taking Walsartan Krka.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy – use of Walsartan Krka is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
If any of the above situations apply, inform your doctor before starting treatment with Walsartan Krka.
Walsartan Krka and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
The effect of the medicine may change if Walsartan Krka is taken at the same time as certain other medicines. This may require a dose adjustment, 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 "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 diuretics, and heparin;
• some 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.

Walsartan Krka with food and drink
Walsartan Krka may be taken 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, consult your doctor or pharmacist before using this medicine.

• You must inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Your doctor will usually advise stopping Walsartan Krka before becoming pregnant or immediately after pregnancy is confirmed, and will recommend an alternative medicine. 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 your doctor if you are breastfeeding or intend to breastfeed. Walsartan Krka is not recommended during breastfeeding. Your doctor may recommend an alternative medicine if you plan to breastfeed, especially if breastfeeding a newborn or preterm infant.

Driving and operating machinery
Before driving, operating machinery, or performing other tasks requiring concentration, patients 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 you have been told by your doctor that you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Walsartan Krka

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Patients with high blood pressure often do not experience any symptoms. 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 recommend 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 with
body weight below 35 kg, the usual dose of valsartan is 40 mg once daily. In patients with body
weight of 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases,
your doctor may recommend higher doses (the dose may be increased up to 160 mg, and a maximum
of 320 mg).
Walsartan Krka may be taken with or without food. Walsartan Krka should be swallowed with a
glass of water. The medicine should be taken at the same time every day.
Taking more Walsartan Krka than prescribed
If severe dizziness and/or fainting occurs, contact your doctor immediately and lie down. In case of
accidental overdose, contact your doctor immediately or go to the nearest hospital emergency
department.
Missing a dose of Walsartan Krka
Do not take a double dose to make up for a missed dose.
If you miss 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 cause the condition being treated to worsen. 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 everyone 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 stopped immediately and medical advice sought without delay (see section 2 “Warnings and precautions”).

Other adverse reactions:
Common (may occur in fewer than 1 in 10 patients):

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

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

• angioedema (see “Symptoms requiring immediate medical attention”)
• sudden loss of consciousness (fainting)
• sensation of spinning (vertigo)
• serious kidney function disorders (symptoms of acute kidney failure)
• muscle cramps, heart rhythm disorders (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 fewer 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 the 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, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness)
• purple-red skin 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, 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 and increased serum creatinine levels (may indicate kidney dysfunction)
• low blood sodium levels (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 seen 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 Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization 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 should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This 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 320 mg of valsartan.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, povidone K-25, sodium croscarmellose, anhydrous colloidal silicon dioxide and magnesium stearate in the tablet core; hypromellose 6 cP, 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 contents of the pack
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.
Pack sizes: 7, 10, 14, 20, 28, 30, 56, 60, 84, 90 or 98 film-coated tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about the product name in other countries of the European Economic Area, 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