Valtap

Package Leaflet: Information for the Patient

VALTAP, 80 mg, film-coated tablets

VALTAP, 160 mg, film-coated tablets

Valsartan

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Valtap is and what it is used for
• 2. Before you take 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 to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, thus increasing blood pressure. Valtap works by blocking the action of angiotensin II. As a result, blood vessels widen, and blood pressure is lowered. Valtap can be used to treat three different conditions:

• to treat high blood pressure in adult patients and in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the workload on the heart and arteries. If not treated, it can lead to damage to the blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, 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.
• to treat adult patients after a recent heart attack (myocardial infarction).Recent means 12 hours to 10 days.
• to treat symptomatic heart failure in adult patients.Valtap is used when a group of medicines called ACE inhibitors (used to treat heart failure) cannot be used or in addition to ACE inhibitors when other treatments for heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and ankles due to fluid build-up because the heart is not able to pump blood sufficiently to supply the body.

2. Before you take Valtap

Do not take Valtap

• If you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease.
• If you are more than 3 months pregnant (it is also not recommended in early pregnancy - see section on "Pregnancy").
• If you have diabetes or kidney disease and are treated with aliskiren.

If any of these apply to you, do not take Valtap and tell your doctor.

Warnings and precautions

Before taking Valtap, tell your doctor if:

• You have liver disease.
• You have severe kidney disease or are undergoing dialysis.
• You have narrowing of the arteries that supply blood to your kidneys.
• You have recently had a kidney transplant.
• You have heart failure or other serious heart conditions.
• Tell your doctor if you have ever had a reaction called angio-oedema (which can cause swelling of the face, lips, throat, and/or tongue) after taking another medicine (including ACE inhibitors). If you get such symptoms, stop taking Valtap and contact your doctor immediately (see also section 4, "Possible side effects").
• If you are taking any of the following medicines used to increase potassium levels in your blood: potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics, or heparin. Regular monitoring of potassium levels in your blood may be necessary.
• Do not take Valtap if you have hyperaldosteronism (a condition where your adrenal glands produce too much of a hormone called aldosterone).
• If you have lost a lot of fluid (e.g., through vomiting, diarrhea, or taking high doses of diuretics).
• If you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney disease related to diabetes,
• aliskiren.
• If you are taking an ACE inhibitor in combination with certain other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may want to monitor your kidney function, blood pressure, and potassium levels in your blood. See also "Do not take Valtap" above. If you experience dizziness and/or fainting, you should lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

Valtap with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and those you plan to take. Taking Valtap with other medicines may affect your treatment. Your doctor may need to change your dose and/or take other precautions, or in some cases, stop one of your medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines to lower blood pressure, such as diuretics,
• ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also "Do not take Valtap" and "Warnings and precautions" above),
• ACE inhibitors in combination with certain other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, etc.) or beta-blockers (such as metoprolol),
• medicines that increase potassium levels in your blood, including potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics, and heparin,
• certain painkillers, called non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (such as rifamycin), a medicine used to prevent transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir) - these medicines may increase the effect of Valtap,
• lithium (a medicine used to treat certain mental illnesses).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy You should tell your doctor if you are pregnant or think you might be pregnant. Your doctor will normally advise you to stop taking Valtap before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valtap. You must not take Valtap if you are more than 3 months pregnant, as it may seriously harm your baby.

Driving and using machines

Before driving, using machines, or performing other activities that require concentration, you should make sure you know how Valtap affects you. Like many other medicines used to treat high blood pressure, Valtap may cause dizziness and affect your ability to concentrate.

Valtap contains lactose, sorbitol, and sodium

This medicine contains lactose monohydrate and sorbitol (E420), which are sugars. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Valtap, 80 mg: This medicine contains 9.25 mg of sorbitol in each tablet. Valtap, 160 mg: This medicine contains 18.50 mg of sorbitol in each tablet. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Valtap

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Patients with high blood pressure often do not feel unwell, but it is very important to continue taking your medicine to control the condition and prevent damage to your organs. If you have any questions, ask your doctor or pharmacist.

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 in combination with another medicine (e.g., a diuretic).

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

For patients with a body weight of less than 35 kg, the recommended starting dose is 40 mg once daily. For patients with a body weight of 35 kg or more, the recommended starting dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (the dose can be increased to 160 mg and to a maximum of 320 mg). For children and adolescents who cannot swallow tablets, other formulations are available.

Adult patients after a recent heart attack:

Treatment with Valtap usually starts at a dose of 20 mg twice daily, initiated no earlier than 12 hours after the heart attack. Your doctor will adjust the dose to a maximum of 160 mg twice daily, depending on your tolerance to the medicine. Valtap can be given with other treatments for heart attack.

Adult patients with heart failure:

The usual starting dose is 40 mg twice daily. Your doctor will adjust the dose to a maximum of 160 mg twice daily, depending on your tolerance to the medicine. Valtap can be given with other treatments for heart failure. You can take Valtap with or without food. Swallow the tablet with a glass of water. Take Valtap at the same time each day.

If you take more Valtap than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

If you forget to take Valtap

If you forget to take a dose, take it as soon as you remember. 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 forgotten dose.

If you stop taking Valtap

Stopping treatment with Valtap may cause your disease to worsen. Do not stop taking Valtap unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

Angio-oedema (a specific allergic reaction) symptoms such as:

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

If you get any of these symptoms, stop taking Valtap and contact your doctor immediately (see also section 2, "Before you take Valtap").

Other side effects:

Common (may affect up to 1 in 10 people):

• dizziness
• low blood pressure with symptoms such as dizziness and fainting when standing up
• worsening of kidney function (signs of kidney problems)

Uncommon (may affect up to 1 in 100 people):

• angio-oedema (see "Some side effects can be serious and require immediate medical attention" above)
• sudden loss of consciousness (fainting)
• spinning sensation (vertigo)
• severe kidney problems (signs of acute kidney failure)
• muscle cramps, irregular heartbeat (signs of high potassium levels in the blood)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness

Rare (may affect up to 1 in 1,000 people):

• angio-oedema of the intestine: swelling of the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Very rare (may affect up to 1 in 10,000 people):

• blistering of the skin (signs of blistering skin disease)
• allergic reactions with symptoms such as rash, itching, and hives; may also include fever, swelling, and joint or muscle pain, swollen lymph nodes, and flu-like symptoms (signs of serum sickness)
• purple or red spots on the skin, fever, itching (signs of vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain
• fever, sore throat, or mouth ulcers due to infections (signs of low white blood cell count, neutropenia)
• low hemoglobin levels and reduced percentage of red blood cells in the blood (which can lead to anemia in severe cases)
• high potassium levels in the blood (which can cause muscle cramps and irregular heartbeat in severe cases)
• increased liver enzymes (which can indicate liver damage), including increased bilirubin levels in the blood (which can cause yellowing of the skin and eyes in severe cases)
• increased urea and creatinine levels in the blood (which can indicate kidney problems)
• low sodium levels in the blood (which can cause fatigue, confusion, muscle twitching, and convulsions in severe cases)

The frequency of some side effects may vary depending on the condition being treated. For example, side effects such as dizziness and kidney problems are less common in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack. Side effects in children and adolescents are similar to those in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valtap

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. Store in a cool, dry place, below 25°C. Store in the original package 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 pack and other information

What Valtap contains

• The active substance is valsartan. Valtap, 80 mg: Each tablet contains 80 mg of valsartan. Valtap, 160 mg: Each tablet contains 160 mg of valsartan.
• The other ingredients are: in the tablet core: microcrystalline cellulose, colloidal anhydrous silica, sorbitol (E420), magnesium carbonate, maize starch, povidone K-25, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone (type A);

in the tablet coating: lactose monohydrate, hypromellose, talc, macrogol 6000. Valtap, 80 mg, film-coated tablets: iron oxide red (E172). Valtap, 160 mg, film-coated tablets: iron oxide yellow and brown (E172) and indigo carmine (E132).

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 two equal doses. Valtap is available in packs of 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 Member States of the European Economic Area under the following names:

Czech Republic, Slovakia, Lithuania:Valzap Poland:VALTAP Hungary:ALVASTRAN Bulgaria:ВАЛЗАП For further information, please contact your local representative:Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:June 2025