Bespres

Package Leaflet: Information for the User

Bespres, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Bespres and what is it 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 is Bespres and what is it 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 constrict, leading to increased 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 in three different indications:

• Treatment of high blood pressure in adult patients and children and adolescents from 6 to less than 18 years of age. High blood pressure increases the workload of the heart and arteries. If left untreated, it can 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 a normal level reduces the risk of these events.
• Treatment of adult patients after a recent heart attack(myocardial infarction). "Recent" means between 12 hours and 10 days.
• Treatment of symptomatic heart failure in adult patients.Bespres is used when a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) cannot be used or Bespres can be used in combination with ACE inhibitors when other heart failure medicines cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and ankles due to fluid accumulation. This occurs when the heart muscle cannot pump blood with enough force to supply the entire body.

2. Important information before taking Bespres

When not to take Bespres

• If you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease.
• If you are pregnant more than 3 months(it is also recommended to avoid taking Bespres in early pregnancy - see section 2: Pregnancy, breastfeeding, and fertility).
• If you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren

If any of the above applies to you, tell your doctor and do not take Bespres.

Warnings and precautions

Before taking Bespres, discuss it with 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 artery.
• If you have recently received a kidney transplant.
• If you have severe heart disease other than heart failure or heart attack.
• If you are taking medicines that increase potassium levels in the blood, such as potassium preparations or potassium-sparing diuretics, and heparin. Regular monitoring of potassium levels in the blood may be necessary.
• If you have aldosteronism, a condition where the adrenal glands produce too much of a hormone called aldosterone. In such patients, taking Bespres is not recommended.
• If you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics.
• If you have ever had swelling of the tongue and face caused by an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), tell your doctor. If such symptoms occur while taking Bespres, stop taking the medicine immediately and never take it again. (See section 4 "Possible side effects").
• Tell your doctor if you think you are (or might become) pregnant. Bespres is not recommended during pregnancy and should not be taken by women who are more than 3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.
• If you are taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.
• If you are taking an ACE inhibitor in combination with other heart failure medicines, known as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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

If any of the above warnings and precautions apply to you, tell your doctor before taking Bespres.

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

Bespres and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Some medicines taken with Bespres may affect its action.
It may be necessary to modify the dosage, take certain precautions, or, in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• Other blood pressure-lowering medicines, particularly diuretics.
• Medicines that increase potassium levels in the blood. Such as potassium preparations or potassium-sparing diuretics, and heparin.
• A type of pain reliever called non-steroidal anti-inflammatory drugs (NSAIDs).
• Certain antibiotics (e.g., rifampicin), a medicine used to prevent transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Bespres.
• Lithium, a medicine used to treat certain mental illnesses.

Your doctor may need to change the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "When not to take Bespres" and "Warnings and precautions").
If you are taking an ACE inhibitor in combination with other heart failure medicines, known as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

In addition:

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

Bespres with food and drink

Bespres can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

• Tell your doctor if you think you are (or might be) pregnant.Your doctor will usually advise you to stop taking Bespres before you become pregnant or as soon as you find out you are pregnant. Your doctor will prescribe a different medicine instead of Bespres. Bespres is not recommended during pregnancy and should not be taken by women who are more than 3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.
• Tell your doctor if you are breastfeeding or plan to breastfeed.Bespres is not recommended for breastfeeding mothers, especially if the baby is a newborn or premature, your doctor may prescribe a different blood pressure-lowering medicine.

Driving and using machines

Before driving, using tools, or operating machines, or performing other activities that require concentration, make sure you know how your body reacts to Bespres. Like many other blood pressure-lowering medicines, Bespres can cause dizziness and problems with concentration.

Bespres contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Bespres

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 have symptoms. Many of them feel completely normal. Therefore, it is essential to follow the established plan for doctor's visits, 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) or recommend taking an additional medicine (e.g., a diuretic).

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 is 40 mg of valsartan once daily. In patients with a 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 (up to 160 mg, maximum 320 mg).
Condition after a recent heart attack in adult patients:Treatment usually starts 12 hours after the heart attack, 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 of Bespres over several weeks to a maximum dose of 160 mg twice daily. The target dose of Bespres depends on individual patient tolerance.
Bespres can be taken in combination with other medicines used to treat heart attack. The decision to choose a medicine suitable for a particular patient is made by the doctor.
Heart failure in adult patients:Treatment usually starts with a dose of 40 mg twice daily. Your doctor will gradually increase the dose of Bespres over several weeks to a maximum dose of 160 mg twice daily. The target dose depends on individual patient tolerance.
Bespres can be taken in combination with other medicines used to treat heart failure. The decision to choose a medicine suitable for a particular patient is made by the doctor.
Bespres can be taken with or without food. The tablet should be swallowed with a glass of water. Bespres should be taken at the same time every day.
The tablet can be divided into equal doses.

Taking a higher dose of Bespres than recommended

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

Missing a dose of 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 a missed dose.

Stopping treatment with Bespres

Stopping treatment with Bespres may worsen your condition. Do not stop taking Bespres without consulting your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bespres can cause side effects, although not everybody gets them.

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

You may experience symptoms of angioedema (a specific allergic reaction), a rare side effect, such as:

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

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

Other side effects include:

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

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

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

• sudden loss of consciousness (fainting),
• feeling of spinning (vertigo),
• acute decrease in kidney function (symptoms of acute kidney injury),
• 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,
• fatigue,
• weakness,
• increased creatinine levels in the blood (which may indicate impaired kidney function).

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.

Unknown(frequency cannot be estimated from the available data):

• blistering of the skin (symptoms of bullous dermatitis),
• allergic reaction with rash, itching, and hives; symptoms may include fever, joint swelling and pain, muscle pain, lymph node enlargement, and (or) flu-like symptoms (symptoms of serum sickness),
• purpura, fever, itching (symptoms of vasculitis),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, dry mouth or mouth ulcers (symptoms of neutropenia),
• decreased hemoglobin levels 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 cause muscle cramps and heart rhythm disturbances 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 whites of the eyes in severe cases),
• increased urea levels in the blood (which may indicate impaired kidney function),
• low potassium 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 patient's condition. For example, side effects such as dizziness and impaired kidney function were reported less frequently in adult patients treated for high blood pressure compared to 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.

If any of the side effects get worse or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your 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, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Bespres

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP:. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package to protect from moisture.
Do not use Bespres if you notice that the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bespres contains

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

What Bespres looks like and contents of the pack

Bespres is a pink, oval, film-coated tablet with a score line on one side and engraved with "V" on one side of the score line and "80" on the other side of the score line.
Bespres is available in packs of: 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 authorization holder and manufacturer

Marketing authorization 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, 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., ul. Mogilska 80, 31-546 Kraków

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: January 2025