Valsacor 80 mg tablets, coated

Patient Information Leaflet

Valsacor 80 mg film-coated tablets
valsartan
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else, 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.

Leaflet Contents

1. What Valsacor is and what it is used for
2. What you need to know 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 80 mg film-coated tablets can be used to treat 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 the blood vessels of 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 after a recent heart attack. "Recent" refers to the period from 12 hours to 10 days after the heart attack.
• Treatment of symptomatic heart failure in adult patients. Valsacor is used when a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or may be used in combination 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 enough blood to meet the body's needs.

2. Important Information Before Using Valsacor

When not to use Valsacor

• 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;
• 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, the patient must not take Valsacor.
Warnings and precautions
Before starting treatment with Valsacor, 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 after recent kidney transplantation (new kidney transplant);
• in patients with severe heart disease other than heart failure or heart attack;
• if the patient has previously experienced angioedema (a type of allergic reaction causing swelling of the face and tongue) while taking another medicine (angiotensin-converting enzyme inhibitors, including ACE inhibitors), inform the doctor. If such symptoms occur while taking Valsacor, 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 medicines, and heparin. Regular 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. 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 (water tablets);
• 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) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

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".
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Valsacor,
this should be discussed with the doctor. The doctor will decide on further treatment. Do not
discontinue Valsacor without medical advice.
Inform the doctor if the patient suspects she is pregnant (or is planning pregnancy). Valsacor is not recommended during early pregnancy and must not be used after

3 months 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 the doctor before starting treatment with Valsacor.
Valsacor 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 Valsacor 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, stop taking one of the medicines. This applies to both prescription and over-the-counter medicines, particularly:

• other blood pressure-lowering medicines, especially diuretics (water tablets), angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under "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 medicines, and heparin.
• certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (rifampicin 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 Valsacor.
• lithium, a medicine used to treat certain psychiatric disorders.

In addition:

• in patients treated after a heart attack, concomitant use with ACE inhibitors (medicines used to treat heart attack) is not recommended;
• in patients treated for heart failure, concomitant use of Valsacor 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.

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 a pregnancy, she should consult her doctor or pharmacist before using this medicine.

• It is essential to inform the doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping 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 about breastfeeding or intended breastfeeding. Valsacor is not recommended during breastfeeding. The doctor may choose an alternative medicine if the patient intends to breastfeed, particularly if breastfeeding a newborn or premature infant.

Driving and operating machinery
Before driving, using tools, or operating mechanical devices 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 lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they 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 used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist. If in doubt, contact your doctor or pharmacist again.
Patients with high blood pressure often do not notice any symptoms and many of them feel quite well.
Therefore, it is very important to visit your doctor regularly, 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 Valsacor together with an additional medicine (e.g. a diuretic).

Children and adolescents (aged 6 to below 18 years) with high blood pressure:
in patients weighing less than 35 kg, the usual dose of valsartan is 40 mg once daily. In patients weighing
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
maximum up to 320 mg).

Adults after recent heart attack: treatment usually begins within 12 hours after the heart attack,
typically 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 up to the maximum dose of 160 mg
twice daily. The final dose depends on how well the patient tolerates the medicine.
Valsacor 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.
Your doctor will then gradually increase the dose over several weeks up to the maximum dose of
160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.
Valsacor may be used together with other medicines used in the treatment of heart failure.
Your doctor will decide on the appropriate treatment regimen.

Valsacor may be taken with or without food. Swallow the tablet with a glass of water.
The medicine should be taken at approximately the same time each day.

Taking more Valsacor 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, pharmacist, or hospital immediately.

If you forget to take Valsacor
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose,
skip the missed dose and take the next dose at the usual time.

Stopping Valsacor
Stopping treatment may worsen the condition being treated. Do not stop taking this medicine unless
your doctor tells 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 gets 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,
• breathing or swallowing difficulties,
• urticaria, 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 occur in less 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 occur in less 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

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• blisters on the skin (symptoms of bullous dermatitis)
• allergic reactions 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 mouth ulcers due to infection (symptoms of low white blood cell count, called neutropenia)
• decreased haemoglobin levels and reduced proportion of red blood cells in blood (which in severe cases may lead to anaemia)
• increased potassium levels in blood (which in severe cases may cause muscle cramps and heart rhythm disturbances)
• low sodium levels in blood (which 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 levels (may indicate kidney dysfunction).

The frequency of some adverse reactions may vary depending on the 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.
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 for 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 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 following the EXP abbreviation.
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 package and other information

What Valsacor contains

• The active substance is valsartan. Each coated tablet contains 80 mg of valsartan.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate in the tablet core; hypromellose, titanium dioxide (E 171), macrogol 4000 and red iron oxide (E 172) in the tablet coating.
• See section 2, "Valsacor contains lactose and sodium".

What Valsacor looks like and contents of the pack
Pink, round, biconvex coated tablets with a division line on one side.
The tablet can be divided into equal doses.
Pack sizes: 28, 30, 50, 60, 84, 90 or 120 coated tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland
This medicinal product is authorised in the European Economic Area countries under the following names: