VALSACOR 320 mg Film-Coated Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Valsacor 320 mg film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Valsacor and what is it used for
5. Important information before taking Valsacor
   1. When not to take Valsacor:
   2. If any of the above situations apply to you, do not take Valsacor.
   3. Warnings and precautions
   4. If any of the above situations apply to you, inform your doctor before starting to take Valsacor.
   5. Children and adolescents
   6. Valsacor and other medicines
   7. Taking Valsacor with food and drink
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Valsacor contains lactose monohydrate and sodium
6. How to take Valsacor
   1. Adults with high blood pressure
   2. Children and adolescents (from 6 to less than 18 years of age) with high blood pressure
   3. Taking a higher dose of Valsacor than recommended
   4. Missing a dose of Valsacor
   5. Stopping treatment with Valsacor
7. Possible side effects
   1. Some side effects may be serious and require immediate medical attention:
   2. If you experience any of these symptoms, stop taking Valsacor and contact your doctor immediately (see section 2 "Warnings and precautions").
   3. Other side effects:
   4. Common side effects (may occur in less than 1 in 10 people):
   5. Uncommon side effects (may occur in less than 1 in 100 people):
   6. Side effects with unknown frequency (frequency cannot be estimated from available data):
   7. Additional side effects in children and adolescents
   8. Reporting side effects
8. How to store Valsacor
9. Contents of the packaging and other information
   1. What Valsacor contains
   2. What Valsacor looks like and contents of the pack
   3. Marketing authorization holder in the Czech Republic, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Valsacor 320 mg film-coated tablets

Valsartan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

• 1. What is Valsacor and what is it 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 packaging and other information

1. What is Valsacor and what is it 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 present in the body that causes blood vessels to narrow, resulting in increased blood pressure. Valsacor blocks the action of angiotensin II, leading to the dilation of blood vessels and a decrease in blood pressure.
Valsacor 320 mg film-coated tablets may be used

• to treat high blood pressure in adults and in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the strain on the heart and arteries. If left untreated, it may cause damage to blood vessels in the brain, heart, and kidneys, and lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of these disorders.

2. Important information before taking Valsacor

When not to take Valsacor:

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6);
• in cases of severe liver disease;
• in pregnancy over 3 months(you should also avoid Valsacor in early pregnancy - see section "Pregnancy and breastfeeding");
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, do not take Valsacor.

Warnings and precautions

Before starting to take Valsacor, discuss it with your doctor or pharmacist:

• if you have liver disease;
• if you have severe kidney disease or are undergoing dialysis;
• in patients with narrowing of the renal artery;
• in patients who have recently undergone kidney transplantation (received a new kidney);
• in patients with severe heart disease, other than heart failure or heart attack;
• if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors). You should inform your doctor. If you experience such symptoms, stop taking Valsacor and contact your doctor immediately. You should never take Valsacor again. See also section 4 "Possible side effects";
• in patients taking medicines that increase potassium levels in the blood, such as potassium supplements or potassium-sparing diuretics, heparin. It may be necessary to periodically check potassium levels in the blood;
• in patients with aldosteronism. This is a disease in which the adrenal glands produce too much of a hormone called aldosterone. Valsacor is not recommended for patients with aldosteronism;
• in patients who have lost a lot of fluid (dehydrated) due to diarrhea, vomiting, or high doses of diuretics;
• if you are taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Valsacor".
Tell your doctor if you are pregnant or think you may be pregnant (or plan to become pregnant). Valsacor should not be used in early pregnancy and should not be used after 3 months of pregnancy, as it may seriously harm the baby if used at this stage (see "Pregnancy").

If any of the above situations apply to you, inform your doctor before starting to take Valsacor.

Children and adolescents

If you are under 18 years of age and taking Valsacor in combination with other medicines that affect the renin-angiotensin-aldosterone system (blood pressure-lowering medicines), your doctor will regularly check your kidney function and potassium levels in your blood.

Valsacor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
The effect of the medicine may change if Valsacor is taken with certain other medicines. It may be necessary to change the dose, take other precautions, or stop taking one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other blood pressure-lowering medicines, especially diuretics, ACE inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also the information under the heading "When not to take Valsacor" and "Warnings and precautions");
• medicines that increase potassium levels in the blood, such as potassium supplements or potassium-sparing diuretics and heparin;
• certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (rifampicin), a medicine used to prevent the rejection of a transplanted organ (cyclosporin), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsacor;
• lithium, a medicine used to treat certain mental illnesses.

Taking Valsacor with food and drink

Valsacor can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

• It is essential to inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy.Your doctor will usually recommend stopping Valsacor before becoming pregnant or as soon as pregnancy is confirmed and prescribe another medicine. Valsacor should not be used in early pregnancy. Valsacor should not be used after 3 months of pregnancy, as it may seriously harm the baby at this stage.
• Inform your doctor about breastfeeding or intention to breastfeed.Valsacor is not recommended during breastfeeding. Your doctor may choose another medicine if you intend to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, you should make sure you know how Valsacor affects you. Like many other blood pressure-lowering medicines, Valsacor may cause dizziness and affect your ability to concentrate.

Valsacor contains lactose monohydrate and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Valsacor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Patients with high blood pressure often do not notice any symptoms of the disease. Many of them may feel perfectly well. Therefore, it is essential to attend your doctor's appointments, even if you feel well.

Adults with high blood pressure

The usual dose is 80 mg once a day. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Your doctor may also prescribe another additional medicine (e.g., a diuretic).

Children and adolescents (from 6 to less than 18 years of age) with high blood pressure

In patients with a body weight of less than 35 kg, the dose of valsartan is usually 40 mg once a day. In patients with a body weight of 35 kg or more, the initial dose is usually 80 mg of valsartan once a day. In some cases, your doctor may prescribe higher doses (the dose of the medicine can be increased to 160 mg, and up to a maximum of 320 mg).
It is not possible to obtain a dose of Valsacor 320 mg that is less than 160 mg.
Valsacor can be taken with or without food. Valsacor should be swallowed with a glass of water. The medicine should be taken at about the same time each day.

Taking a higher dose of Valsacor than recommended

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, pharmacist, or hospital.

Missing a dose of Valsacor

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. If it is almost time for your next dose, skip the missed dose.

Stopping treatment with Valsacor

Stopping treatment may worsen the disease being treated. Do not stop taking the medicine unless your doctor tells you to.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsacor can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

Angioedema (a specific allergic reaction) may occur, with symptoms such as:

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

If you experience any of these symptoms, stop taking Valsacor and contact your doctor immediately (see section 2 "Warnings and precautions").

Other side effects:

Common side effects (may occur in less than 1 in 10 people):

• dizziness,
• low blood pressure with symptoms such as dizziness and fainting when standing up, or without these symptoms,
• weakness of kidney function (symptoms of kidney problems).

Uncommon side effects (may occur in less than 1 in 100 people):

• angioedema (see "Some side effects may be serious and require immediate medical attention"),
• sudden loss of consciousness (fainting),
• feeling of spinning (vertigo),
• severe weakness of kidney function (symptoms of severe kidney failure),
• muscle cramps, irregular heartbeat (symptoms of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• fatigue,
• weakness.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• blisters on the skin (symptoms of bullous dermatitis),
• allergic reactions with rash, itching, and hives; symptoms may include fever, joint swelling, and joint pain, muscle pain, swelling of lymph nodes, and (or) flu-like symptoms (symptoms of serum sickness),
• purple-red spots, fever, itching (symptoms of vasculitis),
• abnormal bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or mouth ulcers caused by infection (symptoms of neutropenia),
• decreased hemoglobin levels and decreased red blood cell count in the blood (which in severe cases may lead to anemia),
• increased potassium levels in the blood (which in severe cases may cause muscle cramps and irregular heartbeat),
• low sodium levels in the blood (which in severe cases may cause fatigue, confusion, muscle twitching, and (or) convulsions),
• increased liver enzyme activity (may indicate liver damage), including increased bilirubin levels in the blood (in severe cases may cause yellowing of the skin and eyes),
• increased urea and creatinine levels in the blood (may indicate kidney problems). The frequency of some side effects may vary depending on the disease. For example, side effects such as dizziness or weakness of kidney function were less common in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

Additional side effects in children and adolescents

The side effects seen in children and adolescents are similar to those seen in adult patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, or to the pharmaceutical company. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsacor

Keep this medicine out of the 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 month.
Store in a temperature below 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 packaging and other information

What Valsacor contains

• The active substance is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other ingredients are lactose monohydrate, 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 lactose monohydrate and sodium".

What Valsacor looks like and contents of the pack

Light brown, capsule-shaped, biconvex film-coated tablets with a score line on one side. The tablet can be divided into equal doses.
Packaging:28 or 30 film-coated tablets in PVC/PE/PVDC//Aluminum blisters, in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:58/078/10-C
Parallel import authorization number:200/21

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of leaflet approval: 12.04.2022
[Information about the trademark]