Valsacor 160 mg coated tablets

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, 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.

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 160 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 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 developing 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. 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 administered, or may be used concomitantly with ACE inhibitors when other heart failure treatments 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. Information before using Valsacor

When not to take 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, do not take Valsacor.
Warnings and precautions
Talk to your doctor before taking Valsacor.

• 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 (new kidney transplant);
• in patients with severe heart disease other than heart failure or myocardial infarction;
• if the patient has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (such as angiotensin-converting enzyme inhibitors, including ACE inhibitors), inform the doctor. If such symptoms occur while taking Valsacor, stop taking the medicine immediately and do not take it 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, or 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:
• an ACE inhibitor (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 (MRA) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

The treating doctor 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 take Valsacor".
If abdominal pain, nausea, vomiting, or diarrhoea occur after taking Valsacor, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Valsacor on your own initiative.
Tell the doctor if the patient suspects she is pregnant (or is planning pregnancy). Valsacor is not recommended in 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 the doctor before starting treatment with Valsacor.
Valsacor and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
The effect of Valsacor may be altered if taken together with 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, 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 take 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 (such as rifampicin), 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, combination 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 in heart failure treatment, known as mineralocorticoid receptor antagonists (MRA) (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 to have a baby, 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 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 after the 3rd month 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 if the infant is a newborn or premature.

Driving and using machines
Before driving, operating tools, handling machinery, or performing any activity requiring concentration, the patient should ensure they know 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 consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it 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,
you should consult your doctor or pharmacist. If you are still uncertain, you should 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.

Adult patients with high blood pressure: the usual dose is 80 mg once daily. In some cases, your
doctor may prescribe higher doses (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:
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 maximally up to 320 mg).

Adult patients after recent myocardial infarction: treatment is usually started within 12 hours
after the heart attack, initially at 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 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 is usually started at a dose of 40 mg twice daily. Your
doctor will then gradually increase the dose over several weeks 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 food or independently of meals. Valsacor should be swallowed with a
glass of water. The medicine should be taken at approximately the same time each day.

Taking more Valsacor than prescribed
If severe dizziness and/or fainting occurs, contact your doctor immediately and lie down. If you
accidentally take too many tablets, 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 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 your usual time.

Stopping Valsacor
Stopping treatment may worsen the condition being treated. 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 everyone 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 renal failure)
• muscle cramps, irregular heartbeat (symptoms of hyperkalaemia)
• shortness of breath, difficulty breathing 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 affect fewer than 1 in 10,000 people):

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

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 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, known as neutropenia)
• decreased haemoglobin concentration and reduced proportion of red blood cells in the blood (which in severe cases may lead to anaemia)
• 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 seizures)
• 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 blood urea nitrogen and increased serum creatinine levels (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 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 Reactions of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Valsacor 160 mg tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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 160 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, yellow iron oxide (E 172) 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
Yellow-brown, oval, 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: