Tensart

Package Leaflet: Information for the User

Tensart, 160 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of 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 160 mg film-coated tablets can be used to treat three different diseases:

• 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, 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 can reduce 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.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 required amount of blood.

2. Important information before taking Tensart

When not to take Tensart:

• if the patient is allergicto valsartan, soybean oil, peanuts, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver disease;
• if the patient is at least 3 months pregnant(it is also recommended to avoid taking Tensart during 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.

Warnings and precautions

Before taking Tensart, tell your doctor or pharmacist:

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• if the patient has narrowing of the renal artery;
• if the patient has recently had a kidney transplant (received a new kidney);
• if the patient is being treated for heart attack or heart failure, the doctor may check kidney function;
• if the patient has severe heart disease, other than heart failure or heart attack;
• if the patient has ever had swelling of the tongue and face, caused by an allergic reaction, called angioedema, after taking other medicines (including ACE inhibitors). If such symptoms occur in the patient while taking Tensart, the patient should stop taking Tensart and contact a doctor immediately. The patient should never take Tensart again. See also section 4;
• if the patient is taking medicines that increase potassium levels in the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check potassium levels in the blood;
• if the patient has hyperaldosteronism - a disease in which the adrenal glands produce too much of a hormone called aldosterone. In such patients, it is not recommended to take Tensart;
• if the patient has had significant fluid loss (dehydration) due to diarrhea, vomiting, or taking high doses of diuretics (water pills);
• if 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 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 (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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

• tell the doctor about pregnancy, suspected pregnancy, or planning to become pregnant. It is not recommended to take Tensart during early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and breastfeeding").

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Tensart, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Tensart on their own.

Tensart and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
Taking some other medicines with Tensart may affect the treatment.
The doctor may need to change the dose and/or take other precautions. This applies to both prescription and non-prescription medicines, in particular:

• if the patient is taking an ACE inhibitor or aliskiren(see also the information under the headings "When not to take Tensart" and "Warnings and precautions").
• if the patient is 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 levelsin the blood - these include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• certain types of painkillers, known as non-steroidal anti-inflammatory drugs ( NSAIDs);
• some antibiotics (rifamycin group), a medicine used to prevent the rejection of a transplanted organ (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 disorders).

In addition:

• in the treatment of heart attack, it is not recommended to combine 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

• tell the doctor about pregnancy, suspected pregnancy, or planning to become pregnant. The doctor will usually recommend stopping Tensart before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking another medicine instead of Tensart. It is not recommended to take Tensart during early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period.
• inform the doctor if the patient is breastfeeding or plans to breastfeed.It is not recommended to take Tensart during breastfeeding. The doctor may recommend taking another medicine, especially when breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, or operating machines, or performing other activities that require attention, the patient should know their individual reaction to Tensart. Like many other medicines used to treat high blood pressure, Tensart may cause dizziness and affect the ability to concentrate.

Tensart contains lactose, soybean oil, and sodium

The medicine contains lactose. If the doctor has told the patient that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.
The medicine contains soybean oil. If the patient is allergic to peanuts or soy, they should not take this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Tensart

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. Patients with high blood pressure often do not notice any symptoms. Many of them feel quite well. Therefore, it is especially important to attend doctor's appointments, even if the patient feels well.

Adult patients with high blood pressure

The recommended dose is 80 mg once daily. In some cases, the doctor may recommend a higher dose (e.g., 160 mg or 320 mg). The 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 the heart attack, usually with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing a 40 mg tablet. The doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's tolerance to the medicine. Tensart can be taken with other medicines used to treat heart attack, and the doctor will decide which treatment is suitable for the patient.

Adult patients with heart failure

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

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

Overdose of Tensart

In case of severe dizziness and/or fainting, the patient should lie down and contact their doctor immediately. In case of accidental ingestion of too many tablets, the patient should contact their doctor, pharmacist, or go to the hospital.

Missed dose of Tensart

The patient should not take a double dose to make up for a missed dose.
If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose.

Stopping Tensart treatment

Stopping treatment with Tensart may worsen the disease. The patient should not stop taking Tensart unless their doctor tells them to.
If the patient has any further questions about taking this medicine, they should ask their 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 symptoms may occur, such as:

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

If the patient experiences any of these symptoms, they should stop taking Tensart and contact their 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, heart rhythm disturbances (symptoms of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure),
• headache,
• cough,
• abdominal 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 abdominal pain, nausea,

vomiting, and diarrhea

Unknown (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, swelling of 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 (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 can lead to anemia in severe cases),
• increased potassium levels in the blood (which can lead to muscle cramps and heart rhythm disturbances in severe cases),
• increased liver enzyme values (which may 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 may indicate kidney problems),
• low sodium levels in the blood (which can 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 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.
Side effects observed in children and adolescents are similar to those observed in adult patients.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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 .
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tensart

PVC/PE/PVDC/Aluminum blisters: do not store above 30°C.
Polyethylene containers: no special storage precautions for the medicinal product.
Keep the medicine out of the sight and reach of children
Do not use this medicine after the expiry date stated on the carton, blister, and bottle after EXP "Expiry date". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tensart contains

The active substance of Tensart is valsartan.
Each film-coated tablet contains 160 mg of valsartan.
The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, 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

Yellow, oval, biconvex, film-coated tablets, 15 mm x 6.5 mm with a score line on one side and marked with the letter V on the other 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 more information, please contact the representative of the marketing authorization holder.

EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone number: +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 leaflet:11.01.2025