Package leaflet: Information for the patient

Walsartan Krka, 40 mg, film-coated tablets
valsartanum
Please read carefully all the information in this 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Walsartan Krka is and what it is used for
Important information before taking Walsartan Krka
How to take Walsartan Krka
Possible side effects
How to store Walsartan Krka
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 present in the body that causes blood vessels to narrow, thereby increasing blood pressure. Walsartan Krka blocks the action of angiotensin II, resulting in relaxation of blood vessels and lowering of blood pressure.
Walsartan Krka, 40 mg, film-coated tablets can be used in the treatment of three different conditions:

Treatment of high blood pressure 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.
Treatment of adult patients following a recent myocardial infarction. "Recent" refers to the period from 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 (medicines used in the treatment of heart failure) cannot be administered, or Walsartan Krka may be used concomitantly with ACE inhibitors when other medicines used in the treatment of heart failure cannot be used.
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 to any of the other ingredients of this medicine (listed in section 6);
in case of severe liver disease;
after the 3rd month of pregnancy (use of Walsartan Krka should also be avoided during early pregnancy - see section "Pregnancy and breastfeeding");
if the patient has diabetes and 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 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 during treatment with Walsartan Krka, treatment must be stopped immediately and the medicine must not be restarted (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 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.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of
electrolytes (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
discontinue Walsartan Krka on your own initiative.
Inform the doctor if the patient is pregnant, suspects she may be pregnant, or is 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 "Pregnancy and breastfeeding").
If any of the above situations apply to the patient, inform the doctor
before starting treatment with Walsartan Krka.
Walsartan Krka and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines. This applies to both prescription and over-the-counter medicines, and particularly includes:

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;
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 infection (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 suffered 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.

It is essential to inform the doctor about pregnancy, suspected pregnancy, or plans for pregnancy. The doctor will usually recommend discontinuing Walsartan Krka before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe 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 the doctor about breastfeeding or plans to breastfeed. Use of Walsartan Krka is not recommended during breastfeeding. The doctor may recommend an alternative medicine if the patient intends to breastfeed, especially when breastfeeding a newborn or 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 their doctor that they have an intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to use Walsartan Krka

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Patients with high blood pressure often experience no symptoms of the condition. 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.
Children and adolescents (aged 6 to below 18 years) with high blood pressure: in children with a
body weight below 35 kg, the usual dose of valsartan is 40 mg once daily. In patients with a body
weight of 35 kg or more, the usual starting dose is 80 mg of valsartan once daily.
In some cases, the doctor may prescribe higher doses (the dose may be increased up to 160 mg, and
maximum up to 320 mg).
Adult patients following a recent heart attack: treatment is usually started within 12 hours after
the heart attack, typically at a low dose of 20 mg twice daily. The 20 mg dose is obtained by
splitting a 40 mg tablet. The doctor gradually increases the dose over several weeks to the 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
following 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,
the doctor gradually increases the dose over several weeks to the 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 daily at the same time.
Taking more Walsartan Krka than prescribed
If severe dizziness and/or fainting occur, 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 forget to take a dose, take it as soon as you remember. However, if it is almost time for the
next dose, skip the missed dose.
Stopping Walsartan Krka
Stopping treatment may worsen the condition being treated. Do not stop taking the medicine unless
your doctor advises you to do so.
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, stop taking Walsartan Krka immediately and contact your doctor straight away (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.

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.

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 (vestibular dizziness)
severe 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.

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

skin blisters (symptoms of bullous dermatitis)
allergic reactions 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 oral ulceration due to infection (symptoms of low white blood cell count, known as neutropenia)
decreased haemoglobin concentration 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 concentration (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 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 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 after 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 in this medicinal product is valsartan. Each coated tablet contains 40 mg of valsartan.
Other components of the medicinal product are: monohydrate lactose, microcrystalline cellulose, povidone K-25, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate in the tablet core; 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 biconvex coated tablets with a division 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 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 on 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