Valsartan krka

Package leaflet: Information for the patient

Walsartan Krka, 160 mg, film-coated tablets
valsartanum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Walsartan Krka is and what it is 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 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 lowering of blood pressure.
Walsartan Krka, 160 mg, film-coated tablets can be used in the treatment of 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 blood vessels. 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 increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of these complications of hypertension.
• Treatment of adult patients following a recent myocardial infarction. "Recent" means within 12 hours to 10 days.
• Treatment of symptomatic heart failure in adult patients. Walsartan Krka is used when medicines known as angiotensin-converting enzyme inhibitors – ACE inhibitors (medicines used in the treatment of heart failure) cannot be used, or Walsartan Krka may be used concomitantly with ACE inhibitors when other medicines used in the treatment of heart failure cannot be administered.
• Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. These occur when the heart muscle is unable to pump sufficient 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 (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, 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 or tongue due to an allergic reaction called angioedema 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 used 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 agents, 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 use of 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 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 abdominal pain, nausea, vomiting, or diarrhoea occur after taking Walsartan Krka, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Walsartan Krka on your own.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy – 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 you, inform your doctor
before starting 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. It may then be necessary to adjust the dose, take additional precautions, or in some cases discontinue 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 agents, 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.

Additionally:

• 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, concomitant 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 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 pregnancy, or are planning pregnancy. Your doctor will usually advise stopping Walsartan Krka before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. 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 your doctor if you are breastfeeding or intend to breastfeed. Use of 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 using machines
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, consult your doctor before taking this medicine.
This 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 your doctor or pharmacist has instructed.
If you are unsure, 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 prescribe a higher dose (e.g. 160 mg or 320 mg). Your doctor may also prescribe Walsartan Krka together with another 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 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 starting with a low dose of 20 mg twice daily. The 20 mg dose is obtained by splitting 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 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 will gradually increase the dose over several weeks 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 every day.

Taking more Walsartan Krka than prescribed
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to take 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 everyone experiences 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 must be 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 "Some 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 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 fewer than 1 in 10,000 patients):

• intestinal angioedema: swelling in the intestine 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 such as fever, joint swelling and joint pain, muscle pain, enlarged 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 levels and increased serum creatinine levels (may indicate kidney function disorders)
• 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 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 Adverse Drug Reactions 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
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. This will help protect
the environment.

6. Contents of the pack and other information

What Walsartan Krka contains

• The active substance is valsartan. Each coated tablet contains 160 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; 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
Yellowish-brown, round, slightly biconvex coated tablets with a division line on one side,
13.5 mm x 7 mm in size.
The tablet can be divided into equal doses.
Pack sizes: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120 or 180 coated tablets in blisters,
packaged 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 further information on 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