Valsacor 320 mg tablets, coated

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Valsacor 320 mg film-coated tablets
Valsartanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Valsacor is and what it is used for
2. Important information before taking Valsacor
3. How to take Valsacor
4. Possible side effects
5. How to store Valsacor
6. Contents of the pack and other information

1. What Valsacor is and what it is used for

Valsacor 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. Valsacor blocks the action of angiotensin II, leading to relaxation of blood vessels and lowering of blood pressure.
Valsacor 320 mg film-coated tablets can be used

• for 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 arteries. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart 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.

2. Important information before using Valsacor

When not to use Valsacor:

• if the patient is allergic (hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6);
• in case of severe liver disease;
• during pregnancy beyond 3 months (Valsacor 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 situations apply, do not take Valsacor.

Warnings and precautions
Before starting treatment with Valsacor, discuss this with your doctor or pharmacist:

• 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 after recent kidney transplantation (transplantation of a new kidney);
• 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 other medicines (including ACE inhibitors). Inform your doctor about this. If such symptoms occur, stop taking Valsacor immediately and contact your doctor. The patient should never take Valsacor 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. Regular monitoring of blood potassium levels may be necessary;
• in patients with aldosteronism—a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. Valsacor is not recommended in patients with aldosteronism;
• in patients who have lost large amounts of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretic medicines (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.

The treating physician may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "When not to use Valsacor".
Inform your doctor if you suspect you are pregnant (or are planning pregnancy). Use of Valsacor is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used at this stage (see section "Pregnancy").
If any of the above situations apply, inform your doctor before starting treatment with Valsacor.

Children and adolescents
If the patient is under 18 years of age and is taking Valsacor in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines lowering blood pressure), the doctor will regularly monitor kidney function and blood potassium levels.

Valsacor with 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 Valsacor is taken together with 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 medicines that lower blood pressure, especially diuretics (water pills), angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under the headings "When not to use Valsacor" 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 (rifampicin), a medicine used to prevent organ transplant rejection (cyclosporine), or antiretroviral medicines used in the treatment of HIV/AIDS (ritonavir). These medicines may enhance the effect of Valsacor;

• lithium, a medicine used in the treatment of certain psychiatric disorders.

Taking Valsacor with food and drink
Valsacor 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.

• It is essential to inform the doctor about pregnancy, suspected pregnancy, or plans to become pregnant. The doctor will usually recommend discontinuing Valsacor before becoming pregnant or as soon as pregnancy is confirmed and will prescribe an alternative medicine. Valsacor is not recommended during early pregnancy. Valsacor must not be used beyond 3 months of pregnancy, as it may seriously harm the unborn child at this stage.
• Inform the doctor if breastfeeding or planning to breastfeed. Valsacor is not recommended during breastfeeding. The doctor may choose an alternative medicine if the patient intends to breastfeed, especially when breastfeeding a newborn or premature infant.

Driving and operating machinery
Before driving, using tools, operating mechanical equipment, or performing any other tasks requiring concentration, the patient should ensure how Valsacor affects them. Like many other medicines used to treat high blood pressure, Valsacor may cause dizziness and affect the ability to concentrate.

Valsacor contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their 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 Valsacor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
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.
Adults 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 an additional medicine (e.g. a diuretic).
Children and adolescents (aged 6 to under 18 years) with high blood pressure
For patients with body weight below 35 kg, the usual dose of valsartan is 40 mg once daily. For 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).
It is not possible to obtain a dose lower than 160 mg from Valsacor 320 mg tablets.
Valsacor may be taken with or without food. Swallow the tablet with a glass of water.
Valsacor should be taken at approximately the same time each day.
Taking more Valsacor than prescribed
If severe dizziness and/or fainting occur, contact your doctor immediately and lie down.
In case of accidental overdose, contact your doctor, pharmacist or hospital immediately.
Missing a dose of Valsacor
Do not take a double dose to make up for a missed dose.
If you forget to take your dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Stopping treatment with Valsacor
Stopping treatment may cause your condition to worsen. Do not stop taking this 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 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, stop taking Valsacor immediately and contact your doctor straight away (see section 2 "Warnings and precautions").

Other adverse reactions:
Common adverse reactions (may affect fewer than 1 in 10 people):

• dizziness,
• low blood pressure with or without symptoms such as dizziness and fainting upon standing,
• impaired kidney function (symptoms of kidney dysfunction).

Uncommon adverse reactions (may affect fewer than 1 in 100 people):

• angioedema (see "Some symptoms requiring immediate medical attention"),
• sudden loss of consciousness (fainting),
• sensation of spinning (vertigo),
• severe impairment of kidney function (symptoms of severe kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalaemia),
• 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.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• skin blisters (symptoms of bullous dermatitis),
• allergic reactions presenting with rash, itching and urticaria; 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 thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat or oral ulceration due to infection (symptoms of low white blood cell count, known as neutropenia),
• decreased haemoglobin concentration and reduced proportion of red blood cells in blood (in severe cases may lead to anaemia),
• increased potassium levels in blood (in severe cases may cause muscle cramps and heart rhythm disturbances),
• low sodium levels in blood (in severe cases may cause fatigue, confusion, muscle twitching and/or seizures),
• increased liver enzyme activity (may indicate liver damage), including increased blood bilirubin levels (in severe cases may cause yellowing of the skin and eyes),
• increased blood urea nitrogen and increased serum creatinine (may indicate impaired kidney function).

The frequency of some adverse reactions may vary depending on the underlying condition. 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 after a recent heart attack.

Additional adverse reactions in children and adolescents
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 to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Valsacor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 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 Valsacor contains

• The active substance is valsartan. Each coated tablet contains 320 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, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172) and red iron oxide (E 172) in the tablet coating.
• See section 2 "Valsacor contains monohydrate lactose and sodium".

What Valsacor looks like and contents of the pack
Light brown, capsule-shaped, biconvex coated tablets with a division line on one side. The tablet can be divided into equal doses.
Pack: 28 or 30 coated tablets in PVC/PE/PVDC//Aluminium blisters, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in the Czech Republic, country of export: 58/078/10-C
Parallel import authorisation number: 200/21
This medicinal product is authorised for marketing in the European Economic Area countries under the following names: