Valtap

Package leaflet: Information for the patient

VALTAP, 80 mg, film-coated tablets
VALTAP, 160 mg, film-coated tablets
Valsartanum
Please read this leaflet carefully before using this medicine because it contains important
information for you.

• Keep this leaflet as 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 a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Valtap is and what it is used for

Valtap contains valsartan as the active substance and belongs to a group of medicines called
angiotensin II receptor antagonists, which help control high blood pressure.
Angiotensin II is a substance produced in the human body that causes blood vessels to narrow, thereby increasing blood pressure. Valtap works by blocking the effects of angiotensin II. As a result, blood vessels widen and blood pressure is lowered.
Valtap may be used to treat three different conditions:

• for the treatment of high blood pressure in adult patients and 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 lead to damage of blood vessels in the brain, heart, and kidneys, possibly resulting in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels helps reduce the risk of these complications.
• for the treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. Valtap is used when medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used in treating heart failure) cannot be used, or Valtap may be used in addition to ACE inhibitors when other medicines used in treating heart failure cannot be used. Symptoms of heart failure include: shortness of breath and swelling of the feet and legs due to fluid accumulation. These occur because the heart muscle is unable to pump blood strongly enough to meet the body's needs.

2. Important information before using Valtap

When not to use Valtap

• If the patient is allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe liver disease.
• If the patient is more than 3 months pregnant (use of Valtap is also not recommended during early pregnancy – see section "Pregnancy").
• 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 conditions apply, the patient should inform their doctor and must not use Valtap.

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

• The patient has liver disease.
• The patient has severe kidney disease or is undergoing dialysis.
• The patient has renal artery stenosis (narrowing of the artery to the kidney).
• The patient has recently received a kidney transplant (the patient has been given a new kidney).
• The patient has severe heart disease other than heart failure or myocardial infarction.
• The patient has ever experienced swelling of the face, lips, tongue or throat (called angioedema), due to an allergic reaction, while taking another medicine (including ACE inhibitors). If such symptoms occur while taking Valtap, the patient must stop taking Valtap immediately and must never take it again. See also section 4, "Possible side effects".
• The patient is taking medicines that increase blood potassium levels, such as potassium supplements or potassium-containing salt substitutes, potassium-sparing diuretics, or heparin. Regular monitoring of blood potassium levels may be necessary.
• Use of Valtap is not recommended if the patient has hyperaldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone).
• The patient has experienced significant fluid loss (dehydration) due to diarrhoea, vomiting, or use of high doses of diuretics (water tablets).
• The patient is taking any of the following medicines for high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems due to diabetes,
  • aliskiren.
• The patient is being treated with an ACE inhibitor in combination with certain other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Valtap".

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Valtap, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Valtap without medical advice.

Tell the doctor if the patient suspects she is pregnant (or is planning a pregnancy). Use of Valtap 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 during this period (see section "Pregnancy").

Valtap with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take in the future.

Taking Valtap with certain other medicines may affect treatment. The doctor may recommend adjusting the dose and/or taking other precautions, or in some cases discontinuing one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• Other blood pressure-lowering medicines, particularly diuretics (water tablets),
• Use of an ACE inhibitor (such as enalapril, lisinopril, etc.) or aliskiren (see also sections "When not to use Valtap" and "Warnings and precautions"),
• Use of an ACE inhibitor together with certain other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (e.g. spironolactone, eplerenone, etc.) or beta-blockers (e.g. metoprolol),
• Medicines that increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin,
• Certain painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs),
• Certain antibiotics (rifamycin group), a medicine used to prevent rejection of a transplanted organ (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir) – these medicines may enhance the effect of Valtap,
• Lithium (a medicine used to treat certain psychiatric disorders).

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.

Pregnancy
Tell the doctor if the patient suspects she is pregnant (or is planning a pregnancy). The doctor will usually advise stopping Valtap before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Valtap 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 beyond the third month of pregnancy.

Breastfeeding
Inform the doctor if the patient is breastfeeding or planning to breastfeed. Use of Valtap is not recommended for breastfeeding mothers; the doctor may choose an alternative treatment for a patient who plans to breastfeed. This is particularly important when breastfeeding a newborn or premature infant.

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

Valtap contains monohydrate lactose, sorbitol, and sodium

This medicine contains monohydrate lactose and sorbitol (E420), which are sugars. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Valtap 80 mg: This medicine contains 9.25 mg of sorbitol per tablet.
Valtap 160 mg: This medicine contains 18.50 mg of sorbitol per tablet.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Valtap

This medicine should always be taken exactly as prescribed by your doctor or pharmacist in order to achieve the best results and minimize the risk of adverse effects. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not experience any noticeable symptoms and may feel quite well. For this reason, it is especially important to attend regular medical check-ups, even if you feel well.

Adult patients with high blood pressure:
The recommended 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 Valtap together with another 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 recommended initial dose of valsartan is 40 mg once daily.
For patients with body weight of 35 kg or more, the recommended initial 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 to 320 mg).
For children and adolescents who cannot swallow tablets, it is recommended to use other formulations available on the market.

Adult patients after recent myocardial infarction (heart attack):
Treatment usually begins within 12 hours after the heart attack, typically starting 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 this dose over several weeks up to the maximum dose of 160 mg twice daily. The final dose depends on the individual patient's tolerance to the medicine.

Valtap may be given together with other medicines used in the treatment of heart attack. Your doctor will decide which treatment is appropriate in each individual case.

Adult patients with heart failure:
The usual initial dose is typically 40 mg twice daily. 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 the individual patient's tolerance to the medicine.

Valtap may be given together with other medicines used in the treatment of heart failure. Your doctor will decide which treatment is appropriate in each individual case.

Valtap may be taken with or without food. Swallow the tablet with a glass of water.
Take Valtap every day at approximately the same time.
The tablet may be divided into equal doses.

Taking more Valtap 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 go to a hospital immediately.

If you miss a dose of Valtap
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping Valtap
Stopping treatment with Valtap may worsen your condition. Do not discontinue treatment unless instructed by your doctor.

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 Valtap immediately
and contact your doctor (see also section 2 "Important information before taking Valtap").
Other adverse reactions:
Common (may occur in up to 1 in 10 patients):

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

Uncommon (may occur in up to 1 in 100 patients):

• angioedema (see "Some symptoms require immediate medical attention")
• sudden loss of consciousness (fainting)
• sensation of spinning (vertigo)
• severe kidney dysfunction (symptoms of acute kidney failure)
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• feeling of fatigue
• weakness

Rare (may occur in up to 1 in 10,000 patients):

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

Unknown frequency (cannot be estimated from available data):

• blistering of the skin (symptoms of bullous dermatitis)
• allergic reactions presenting with rash, itching and hives; symptoms such as fever, swelling, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness)
• purple-red spots, fever, itching (symptoms of vasculitis)
• unusual bleeding or bruising (symptoms of thrombocytopenia)
• muscle pain
• fever, sore throat or ulceration of the oral mucosa due to infection (symptoms of low white blood cell count, so-called neutropenia)
• decreased hemoglobin concentration and reduced proportion of red blood cells in blood (which may lead to anemia in severe cases)
• increased blood potassium concentration (which may cause muscle cramps and heart rhythm disturbances in severe cases)
• increased liver function parameters (which may indicate liver damage), including increased blood bilirubin concentration (which may cause yellow discoloration of the skin and eyes in severe cases)
• increased blood urea nitrogen and increased serum creatinine concentration (which may indicate impaired kidney function)
• low sodium concentration in blood (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)

The frequency of some adverse reactions may vary depending on the underlying condition.
For example, adverse reactions such as dizziness and kidney dysfunction have been observed 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 observed 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland.
Tel: +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 the medicine Valtap

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep 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 packaging and other information

What Valtap contains

• The active substance in this medicine is valsartan.
  Valtap 80 mg: Each tablet contains 80 mg of valsartan.
  Valtap 160 mg: Each tablet contains 160 mg of valsartan.
• Other components are:
  in the tablet core: microcrystalline cellulose, colloidal anhydrous silica, sorbitol (E 420), magnesium carbonate, maize starch gelatinised, povidone K-25, sodium stearyl fumarate, sodium lauryl sulphate, crospovidone (type A);

in the tablet coating: lactose monohydrate, hypromellose, talc, macrogol 6000.
Valtap 80 mg, coated tablets: iron oxide red (E 172).
Valtap 160 mg, coated tablets: iron oxide yellow and brown (E 172) and indigo carmine (E 132).

What Valtap looks like and contents of the pack
Valtap 80 mg: pink, round, film-coated tablets with a score line on one side.
Valtap 160 mg: yellow-brown, round, film-coated tablets with a score line on one side.
The tablets can be divided into halves.
The medicine is available in packs containing 28, 30, 56, 84 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

This medicine is authorised in the following countries of the European Economic Area under the following names:
Czech Republic, Slovakia, Lithuania: Valzap
Poland: Valtap
Hungary: Alvastan
Bulgaria: ВАЛЗАП

For further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00