Tensart

Package leaflet: Information for the user

Tensart 80 mg, film-coated tablets
Valsartanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 personally. 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, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Tensart is and what it is used for
2. What you need to know 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 Tensart is and what it is used for

Tensart contains the active substance: valsartan 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. Tensart works by blocking the effects 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:

• Treatment of high blood pressure (hypertension) 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 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.
• Treatment of adult patients after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days after the event.
• Treatment of symptomatic heart failure in adult patients. Tensart may be used in adult patients for the treatment of symptomatic heart failure. Tensart is used when a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or Tensart may be used in combination 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 symptoms occur because the heart muscle is unable to pump blood strongly enough to supply the body's needs.

2. Important information before using Tensart

When not to use Tensart:

• if the patient is allergic to 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 in the third month of pregnancy or beyond (it is also advisable to avoid using 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 starting treatment with Tensart, consult a doctor or pharmacist:

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• if the patient has renal artery stenosis;
• if the patient has recently received a kidney transplant;
• if the patient is being treated after a heart attack or due to heart failure, the doctor may monitor kidney function;
• if the patient has severe heart disease other than heart failure or heart attack;
• if the patient has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema after taking other medicines (including ACE inhibitors). If such symptoms occur while taking Tensart, stop taking Tensart immediately and contact a doctor without delay. Tensart must never be taken again. See also section 4;
• if the patient is 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;
• if the patient has hyperaldosteronism – a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. In such patients, use of Tensart is not recommended;
• if the patient has experienced significant fluid loss (dehydration) due to diarrhoea, vomiting, or use of high doses of diuretics (water tablets);
• 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 physician 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 use Tensart”.

• inform the doctor about pregnancy, suspected or planned pregnancy. Use of Tensart is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the unborn child if used during this period (see section “Pregnancy and breastfeeding”).

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Tensart,
discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions about stopping Tensart.

Tensart and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Taking certain other medicines while using Tensart may affect treatment. The treating doctor may need to adjust the dose and/or take additional precautions. This applies to both prescription and over-the-counter medicines, particularly:

• If the patient is taking an ACE inhibitor or aliskiren (see also information under the headings “When not to use Tensart” and “Warnings and precautions”).
• If the patient is taking an ACE inhibitor together 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 tablets);
• Medicines that increase blood potassium levels – such as potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, and heparin;
• Certain types of painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (rifamycin group), a medicine used to prevent organ transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Tensart;
• lithium (a medicine used to treat certain psychiatric disorders).

Additionally:

• in the case of treatment after a heart attack, combination with ACE inhibitors (medicines used to treat heart attack) is not recommended;
• in the case of treatment of heart failure, use of Tensart together with ACE inhibitors and beta-adrenergic blocking agents (medicines used to treat heart failure) is not recommended.

Taking Tensart with food and drink
Tensart can 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.

• Inform the doctor about pregnancy, suspected or planned pregnancy. The doctor will usually advise stopping Tensart before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend another medicine instead of Tensart. Use of Tensart is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
• Inform the doctor if the patient is breastfeeding or intends to start breastfeeding. Use of Tensart is not recommended during breastfeeding. The doctor may recommend another medicine, especially if breastfeeding a newborn or premature infant.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any activity requiring mental alertness, the patient should be aware of their individual response 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
This medicine contains lactose. If the patient has been diagnosed by a doctor with an intolerance to certain sugars, consult the doctor before taking this medicine.
This medicine contains soybean oil. If the patient is allergic to peanuts or soy, this medicine must not be used.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Tensart

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms related to it and may feel quite well. Therefore, it is especially important to attend regular check-ups with your doctor, 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 decide to use Tensart in combination with another medicine (e.g. a diuretic).

Adult patients after recent 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 the dose over several weeks up to a maximum dose of 160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.
Tensart may be given together with other medicines used in the treatment of heart attack. Your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure
Treatment usually starts at a dose of 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.
Tensart may be used together with other medicines used in the treatment of heart failure. Your doctor will decide which treatment is appropriate for you.

Use in children and adolescents (aged 6 to below 18 years) with high blood pressure
In patients with body weight below 35 kg, the recommended initial dose of valsartan is 40 mg once daily.
In patients with body weight of 35 kg or more, the recommended initial dose is usually 80 mg of valsartan once daily.
In some cases, your doctor may prescribe a higher dose (the dose may be increased up to 160 mg, and maximally up to 320 mg).
For children unable to swallow tablets, it is recommended to use valsartan in other suitable pharmaceutical forms.

Tensart may be taken with or without food. Swallow the tablet with a glass of water.
Take Tensart at approximately the same time each day.

Taking more Tensart than prescribed
If severe dizziness and/or fainting occur, lie down immediately and contact your doctor without delay. If you accidentally take too many tablets, contact your doctor, pharmacist, or go to a hospital immediately.

Missed dose of Tensart
Do not take a double dose to make up for a missed dose. If you remember the missed dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule.

Stopping Tensart
Stopping treatment with Tensart may cause your condition to worsen. Do not discontinue the medicine 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 everybody will get them.
Some adverse reactions may be serious and require immediate medical attention:
Symptoms of angioedema may occur, such as:

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

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

Other adverse reactions:
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 upon standing, or without such symptoms,
• impaired kidney function (symptoms of kidney dysfunction).

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

• angioedema (see section 4 "Some symptoms requiring immediate medical attention"),
• sudden loss of consciousness (fainting),
• sensation of spinning (dizziness),
• severe kidney function impairment (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disorders (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,
• feeling of fatigue,
• weakness.

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

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

Unknown frequency (cannot be estimated from available data):

• skin blisters, which may be a sign of bullous dermatitis,
• allergic reactions with rash, itching, fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness),
• purple-red skin spots, fever, itching (symptoms of inflammation of blood vessels, known as vasculitis),
• unusual 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, i.e. neutropenia),
• decreased haemoglobin levels and reduced proportion of red blood cells in blood (which may lead to anaemia in severe cases),
• increased blood potassium levels (which may in severe cases cause muscle cramps and heart rhythm disturbances),
• increased liver function parameters (which may indicate liver damage), including increased blood bilirubin levels (which may in severe cases cause yellowing of the skin and eyes),
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate impaired kidney function),
• low blood sodium levels (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases).

The frequency of some adverse reactions may vary depending on the underlying disease.
For example, adverse reactions such as dizziness and impaired kidney function 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 possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tensart

PVC/PE/PVDC/Aluminium blisters: do not store above 30°C.
Polyethylene containers: no special requirements for storage of the medicinal product.
Keep the medicine out of 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 the specified month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This 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: monohydrate lactose, 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
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/Aluminium 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 Authorisation Holder.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Telephone number: +48 22 417 92 00

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