Tensart

Package Leaflet: Information for the User

Tensart, 80 mg, Film-Coated Tablets

Valsartan

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

• Keep this package 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What is Tensart and what is it used for

Tensart contains the active substance valsartan and belongs to a group of medicines called angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Tensart works by blocking the action of angiotensin II. As a result, blood vessels widen and blood pressure decreases. Tensart 80 mg film-coated tablets can be used to treat three different conditions:

• 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 workload on the heart and arteries. If not treated, it can lead to damage to the blood vessels in the brain, heart, and kidneys, and may 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 developing 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. Tensart can be used in adult patients to treat symptomatic heart failure. Tensart is used when a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) (medicines used to treat heart failure) cannot be used or Tensart can be used in combination with ACE inhibitors when other medicines used to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and ankles due to fluid accumulation. They are caused by the heart muscle not being able to pump blood with sufficient force to supply the body with the blood it needs.

2. Important information before taking Tensart

When not to take Tensart:

• if you are allergic to valsartan, soybean oil, peanuts, 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 better to avoid taking Tensart in early pregnancy - see section "Pregnancy and breastfeeding");
• if you have diabetes or kidney problems and are treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before taking Tensart, tell your doctor or pharmacist:

• if you have liver disease;
• if you have severe kidney disease or are undergoing dialysis;
• if you have narrowing of the renal arteries;
• if you have recently had a kidney transplant (received a new kidney);
• if you are being treated for heart attack or heart failure, your doctor may check your kidney function;
• if you have severe heart disease, other than heart failure or heart attack;
• if you have ever had swelling of the face, lips, throat, or tongue, caused by an allergic reaction, known as angioedema, after taking other medicines (including ACE inhibitors). If such symptoms occur while taking Tensart, stop taking Tensart and contact your doctor immediately. You should never take Tensart again. See also section 4;
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin. Regular monitoring of potassium levels in the blood may be necessary;
• if you have hyperaldosteronism - a condition where the adrenal glands produce too much of a hormone called aldosterone. In such patients, it is not recommended to take Tensart;
• if you have had significant fluid loss (dehydration) due to diarrhea, vomiting, or taking high doses of diuretics (water pills);
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.
• if you are being treated with an ACE inhibitor in combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor will monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under "When not to take Tensart".

• tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Do not take Tensart if you are more than 3 months pregnant, as it may harm your baby. See section "Pregnancy and breastfeeding".

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Tensart, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Tensart without consulting your doctor.

Tensart and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription. Taking some other medicines with Tensart may affect your treatment. Your doctor may need to change your dose and/or take other precautions. This applies to both prescription and non-prescription medicines, especially:

• if you are taking an ACE inhibitor or aliskiren(see also the information under "When not to take Tensart" and "Warnings and precautions").
• if you are taking an ACE inhibitorin combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).
• other blood pressure-lowering medicines, especially diuretics(water pills),
• medicines that increase potassium levels in the blood- these include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• certain types of painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Tensart;
• lithium(a medicine used to treat certain mental illnesses).

In addition:

• in the treatment of heart attack, it is not recommended to combine Tensart with ACE inhibitors(medicines used to treat heart attack);
• in the treatment of heart failure, it is not recommended to take Tensart with ACE inhibitors and beta-blockers(medicines used to treat heart failure).

Taking Tensart with food and drink

Tensart can be taken with or without food.

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.

• tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will normally advise you to stop taking Tensart before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tensart. Do not take Tensart if you are more than 3 months pregnant, as it may harm your baby.
• tell your doctor if you are breastfeeding or are planning to breastfeed. Tensart is not recommended during breastfeeding. Your doctor may prescribe a different medicine, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

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

Tensart contains lactose, soybean oil, and sodium

The medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains soybean oil. If you are allergic to peanuts or soy, do not take this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Tensart

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Patients with high blood pressure often do not feel unwell. However, it is important to continue taking your medicine to control your blood pressure.

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

Adult patients after a recent heart attack

Treatment usually starts 12 hours after a heart attack, typically with a low dose of 20 mg twice daily. The 20 mg dose is achieved by dividing a 40 mg tablet. Your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on your tolerance to the medicine. Tensart can be given with other medicines used to treat heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure

Treatment usually starts with a dose of 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on your tolerance to the medicine. Tensart can be given with other medicines used to treat heart failure, and your doctor will decide which treatment is suitable for you.

Use in 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 recommended starting dose of valsartan is 40 mg once daily. In patients with a body weight of 35 kg or more, the recommended starting dose is usually 80 mg of valsartan once daily. In some cases, your doctor may prescribe a higher dose (the dose can be increased to 160 mg, and up to a maximum of 320 mg). For children who are unable to swallow tablets, other suitable pharmaceutical forms of valsartan should be used. Tensart can be taken with or without food. Tensart should be swallowed with a glass of water. Tensart should be taken at the same time each day.

Overdose

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

Missed dose

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

Stopping treatment

Stopping treatment with Tensart may cause your condition to worsen. Do not stop taking Tensart 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, Tensart can cause side effects, although not everybody gets them.

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

Angioedema may occur, with symptoms such as:

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

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

Other side effects:

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

• dizziness, dizziness related to body position.
• low blood pressure with symptoms, such as dizziness and fainting when standing up or without such symptoms,
• kidney problems (symptoms of kidney problems).

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

• angioedema (see section 4 "Some side effects may be serious and require immediate medical attention"),
• sudden loss of consciousness (fainting),
• feeling of spinning (vertigo),
• severe kidney problems (symptoms of acute 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,
• stomach pain,
• nausea,
• diarrhea,
• feeling tired,
• weakness.

Rare (may affect up to 1 in 10,000 people)

• angioedema of the intestine: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea

Not known (frequency cannot be estimated from the available data):

• blistering of the skin, which may be a sign of bullous pemphigoid,
• allergic reactions with rash, itching, fever, joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (symptoms of serum sickness),
• purple or red spots, fever, itching (symptoms of vasculitis),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or mouth ulcers due to infection (symptoms of neutropenia),
• decreased hemoglobin and decreased red blood cell count in the blood (which may lead to anemia in severe cases),
• increased potassium levels in the blood (which may lead to muscle cramps and irregular heartbeat in severe cases),
• increased liver enzyme levels (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases),
• increased urea and creatinine levels in the blood (which may indicate kidney problems),
• low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps, and/or seizures in severe cases).

The frequency of some side effects may vary depending on the disease. For example, such side effects 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 adult patients.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tensart

PVC/PE/PVDC/Aluminum blisters: do not store above 30°C. Polyethylene containers: no special storage precautions are necessary. 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, blister, and bottle after "EXP". The expiry date refers to the last day of that month. 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 Tensart contains

The active substance is valsartan. Each film-coated tablet contains 80 mg of valsartan. The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K29-K32, talc, magnesium stearate, colloidal anhydrous silica; tablet coating: polyvinyl alcohol; macrogol 3350, talc, lecithin (contains soybean oil) (E322), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).

What Tensart looks like and contents of the pack

Pink, round, biconvex film-coated tablets, 8 mm in diameter, with a score line on both sides and marked with the letter V on one side. Pack sizes: PVC/PE/PVDC/Aluminum blisters: 7, 14, 28, 30, 56, 98, or 280 tablets. Polyethylene containers with polyethylene caps: 7, 14, 28, 56, 98, 100, or 280 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:

Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

For further information, please contact the marketing authorization holder.

EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone: +48 22 417 92 00

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

Date of last revision of the package leaflet:11.01.2025