Bespres

Patient Information Leaflet

Bespres 80 mg, film-coated tablets
Valsartan
Please read this leaflet carefully before taking this medicine, as 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 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 inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Bespres is and what it is used for

Bespres belongs to a group of medicines called angiotensin II receptor antagonists, which are used
to treat high blood pressure. Angiotensin II is a substance in the human body that causes blood
vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the action of
angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Bespres 80 mg, film-coated tablets can be used for three different indications:

• Treatment of high blood pressure in adult patients and in 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 damage blood vessels in the brain, heart, and kidneys, and may lead 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 events.
• Treatment of adult patients following a recent heart attack (myocardial infarction). In this context, "recent" means within 12 hours to 10 days.
• Treatment of symptomatic heart failure in adult patients. Bespres is used when a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or Bespres may be used in combination with ACE inhibitors when other medicines used in the treatment of heart failure cannot be used. Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. This condition occurs when the heart muscle cannot pump blood with sufficient force to supply the body's needs.

2. Important information before using Bespres

When not to use Bespres

• If the patient has a hypersensitivity to valsartan or to any of the other components 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 Bespres is also not recommended during early pregnancy - see section 2: Pregnancy, breastfeeding and fertility).
• 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 apply to the patient, the patient must inform their doctor and
must not take Bespres.
Warnings and precautions
Before starting treatment with Bespres, discuss this with 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 renal artery stenosis.
• If the patient has recently received a kidney transplant (received a new kidney).
• If the patient has severe heart disease other than heart failure or heart attack.
• 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 been diagnosed with aldosteronism, a condition in which the adrenal glands produce too much of a hormone called aldosterone. In such patients, use of Bespres is not recommended.
• If the patient has lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretic medicines.
• If the patient has ever experienced swelling of the face or tongue due to an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), the doctor should be informed. If such symptoms occur while taking Bespres, the patient must stop taking Bespres immediately and must never take it again. (See section 4: Possible side effects).
• The patient should inform the doctor if she thinks she is (or might be) pregnant. Bespres 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 2: Pregnancy, breastfeeding and fertility).
• If the patient is taking any of the following medicines used to treat high blood pressure:
  • ACE inhibitors (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 (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g.
potassium) at regular intervals.
See also the information under the heading "When not to use Bespres".
If any of the above contraindications or precautions apply to the patient, the patient must inform
their doctor before starting treatment with Bespres.
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Bespres,
discuss this with the doctor. The doctor will decide on further treatment. Do not make a decision to
stop taking Bespres on your own.

Bespres and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take.
Some medicines taken together with Bespres may affect its effectiveness.
It may be necessary to adjust the dose, take specific precautions, or, in some cases, discontinue one
of the medicines. This applies to both prescription and over-the-counter medicines, particularly:

• Other blood pressure-lowering medicines, especially diuretics.
• Medicines that increase blood potassium levels, such as potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, and heparine.
• One type of painkiller known as non-steroidal anti-inflammatory drugs ( NSAIDs ).
• Certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used in the treatment of HIV/AIDS (ritonavir). These medicines may enhance the effect of Bespres.
• Lithium, a medicine used in the treatment of certain psychiatric disorders.

The treating doctor may need to adjust the dose and/or take other precautions:
If the patient is taking an ACE inhibitor or aliskiren (see also information under the heading "When
not to use Bespres" 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).
In addition:

• In patients after a heart attack, treatment with Bespres in combination with ACE inhibitors (medicines used to treat heart attack) is not recommended.

Bespres with food and drink
Bespres can be taken with or without food.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.

• Inform the doctor if the patient thinks she is (or might be) pregnant. The treating doctor will usually recommend stopping treatment with Bespres before the patient becomes pregnant, or as soon as pregnancy is confirmed. The doctor will recommend an alternative medicine to Bespres. Bespres 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 taken after the third month.
• Inform the doctor if the patient is breastfeeding or intends to breastfeed. Bespres is not recommended for breastfeeding mothers. If the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely, the treating doctor may recommend an alternative antihypertensive medicine.

Driving and using machines
Before driving, using tools, operating machinery, or performing any activity requiring concentration, the patient should become well aware of how their body reacts to Bespres. Like many other medicines used to treat high blood pressure, Bespres may cause dizziness and problems with concentration.
Bespres contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Bespres

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist. People with high blood pressure often have no symptoms of the condition and may feel perfectly well. For this reason, it is very important to keep regular check-up appointments with your doctor, even if you feel well.

Adult patients with hypertension: 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) or recommend adding another medicine (e.g. a diuretic).

Use in children and adolescents (aged 6 to below 18 years) with hypertension:
For patients with body weight below 35 kg, the recommended initial dose is 40 mg of valsartan 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 up to 320 mg).

Condition following recent myocardial infarction in adult patients:
After a heart attack, treatment is usually started within 12 hours of the event, typically with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing a 40 mg tablet into two equal parts. Your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The target dose depends on the individual patient's tolerance.

Bespres may be used in combination with other medicines used in the treatment of heart attack. The choice of appropriate therapy for a given patient is made by the doctor.

Heart failure in adult patients: Treatment is usually started with a dose of 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The target dose depends on the individual patient's tolerance.

Bespres may be used in combination with other medicines used in the treatment of heart failure. The choice of appropriate therapy for a given patient is made by the doctor.

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

The tablet may be divided into equal doses.

Taking more Bespres than prescribed
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In case of accidental overdose, contact your doctor, pharmacist, or hospital immediately.

If you miss a dose of Bespres
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.

Stopping Bespres
Stopping treatment with Bespres may worsen your condition. Do not discontinue the medicine without first consulting 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 will experience them.
Some adverse reactions may be serious and require immediate medical attention:
Patients may experience symptoms of angioedema (a specific allergic reaction), an uncommon adverse reaction, such as:

• swelling of the face, lips, tongue or larynx,
• difficulty breathing or swallowing,
• hives, itching. If any of the above symptoms occur, stop taking the medicine Bespres immediately and seek medical advice without delay (see also section 2 "Warnings and precautions").

Other adverse reactions include:
Common (may affect up to 1 in 10 people):

• dizziness,
• low blood pressure with symptoms such as dizziness and fainting upon standing, or without such symptoms,
• reduced kidney function (symptoms of kidney failure).

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

• sudden loss of consciousness (fainting),
• sensation of spinning (vertigo),
• acute reduction in kidney function (symptoms of acute kidney injury),
• muscle cramps, irregular heartbeat (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,
• fatigue,
• weakness,
• increased serum creatinine levels (which may indicate impaired kidney function).

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.

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

• skin blisters (symptoms of bullous dermatitis),
• allergic reaction with rash, itching and urticaria; the following symptoms may occur: fever, joint swelling and joint pain, muscle pain, enlarged lymph nodes and/or flu-like symptoms (symptoms of serum sickness),
• purpuric spots, fever, itching (symptoms of vasculitis),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, dry throat or mouth ulcers (symptoms of low white blood cell count - neutropenia),
• decreased haemoglobin levels and reduced number of red blood cells in blood (which may lead to anaemia in severe cases),
• increased potassium levels in blood (which may trigger muscle cramps and cardiac arrhythmias in severe cases),
• increased liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which may cause yellowing of the skin and whites of the eyes in severe cases),
• increased blood urea nitrogen levels (which may indicate impaired kidney function),
• low potassium levels in blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases).

The frequency of certain adverse reactions may vary depending on the patient's condition. For example, adverse reactions such as dizziness and impaired kidney function were reported less frequently in adult patients treated for hypertension compared to adult patients treated for heart failure or recent myocardial infarction.
Adverse reactions observed in children and adolescents are similar to those observed in adult patients.
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 this medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store the medicine Bespres

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after EXP:. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not use the medicine Bespres if the packaging is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater 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 packaging and other information

What Bespres contains

• The active substance is valsartan. Each coated tablet contains 80 mg of valsartan.
• The other ingredients are: colloidal anhydrous silica, sodium carboxymethyl starch (type A), crospovidone, microcrystalline cellulose, corn starch, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E171), talc, iron oxide red (E172).

What Bespres looks like and contents of the pack
Bespres is a pink, oval-shaped coated tablet, with a score line on one side allowing for division, and engraved with the letter “V” on one side of the score line and “80” on the other side of the score line.
Bespres is available in packs containing: 28, 30, 56, 60, 84, 90, 98 and 100 coated tablets.
Hospital pack: 50 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53
00-113 Warsaw
Poland

Manufacturer
Teva Czech Industries s.r.o., Ostravská 29, c.p. 305, 747 70 Opava-Komárov, Czech Republic
Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler, Germany
Teva Operations Poland Sp. z o.o., Mogilska 80, 31-546 Kraków, Poland

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