Bespres

Package leaflet: Information for the user

Bespres, 160 mg, film-coated tablets
Valsartanum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 personally. Do not give it 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.

Contents of the leaflet:

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 in the treatment of 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 effects of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Bespres 160 mg, film-coated tablets may be used for three different indications:

• Treatment of essential hypertension in adult patients 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, 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). "Recent" means in this case between 12 hours and 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 in the treatment of 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 occurs when the heart muscle is unable to 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 is allergic to valsartan or any of the other ingredients 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 in 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, they 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 (narrowing of the artery to the kidney).
• If the patient has recently received a kidney transplant (a new kidney).
• If the patient has severe heart disease other than heart failure or a heart attack.
• If the patient is taking medicines that increase blood potassium levels, such as: potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, 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 tongue and face due to an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), they must inform their doctor. If such symptoms occur while taking Bespres, treatment must be stopped immediately and the medicine must never be used again. (See section 4: "Possible side effects").
• The patient must inform their 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 (MRA) (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 apply to the patient, they 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 stop taking Bespres
on your own initiative.

Bespres and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently
taken, or plans to take.
Some medicines taken together with Bespres may affect its effectiveness. It may be necessary to
adjust the dose, take special precautions, or in some cases discontinue one of the medicines. This
applies to both prescription and over-the-counter medicines, and 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 medicines, and heparin.
• 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 to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Bespres.
• Lithium, a medicine used to treat certain psychiatric disorders.

The treating doctor may need to adjust the dose and/or take additional precautions:
If the patient is taking an ACE inhibitor or aliskiren (see also information under “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 who have had a heart attack, combination treatment with ACE inhibitors (medicines used to treat heart attack) is not recommended.

Bespres with food and drink
Bespres may 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 your doctor if you think you are (or might be) pregnant. The treating doctor will usually advise stopping treatment with Bespres before becoming 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 beyond the third month of pregnancy.
• Inform your doctor if you are breastfeeding or plan to start breastfeeding. 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 other activity requiring
concentration, the patient should be 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, meaning the medicine is considered "sodium-free".

3. How to use Bespres

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

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) or recommend taking an additional medicine (e.g. a diuretic).

Use in children and adolescents (aged 6 to under 18 years) with high blood pressure: In patients with body weight below 35 kg, the recommended initial dose is 40 mg of valsartan once daily. In 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, with a maximum of 320 mg).

After recent myocardial infarction in adult patients: Treatment is usually started within 12 hours after the heart attack, typically beginning 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 up to the 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 decision on the appropriate medicine for a given patient is made by the doctor.

Heart failure in adult patients: Treatment is usually started at a dose of 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to the 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 failure. The decision on the appropriate medicine for a given patient is made by the doctor.

Bespres may be taken with or without food. The tablet should be swallowed with a glass of water. Bespres should be taken at the same times 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 forget to take Bespres

If you miss 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 the forgotten tablet.

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 throat,
• difficulty breathing or swallowing,
• hives, itching.
  If any of the above symptoms occur, treatment with Bespres must be stopped immediately and medical advice must be sought 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 renal 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 heart rhythm (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: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• skin blisters (symptoms of bullous dermatitis),
• allergic reaction with rash, itching and urticaria; symptoms may include fever, joint swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness),
• purpuric skin lesions, 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 heart rhythm disturbances 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 some adverse reactions may vary depending on the patient's condition. For example, adverse reactions such as dizziness and impaired kidney function have been reported less frequently in adult patients treated for hypertension compared to adult patients treated for heart failure or after a 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 a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to 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 Bespres

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following 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 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. These measures help protect the environment.

6. Contents of the packaging and other information

What Bespres contains

• The active substance is valsartan. Each coated tablet contains 160 mg of valsartan.
• Other ingredients are: colloidal anhydrous silica, sodium carboxymethyl starch (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172), red iron oxide (E172).

What Bespres looks like and contents of the pack
Bespres is a yellow, oval, film-coated tablet, with a score line on one side enabling division of the tablet. The tablet is marked with the inscription “V” on one side of the score line and “160” on the other side of the score line.
Bespres is available in packs containing 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets.
Hospital pack: 50 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. 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, The Netherlands
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Santé SA, Rue Bellocier, 89107 Sens, France
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler, Germany
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
This medicinal product is authorised for marketing in the European Economic Area under the following names: