Bespres

Leaflet accompanying the packaging: information for the user

Bespres, 160 mg, coated tablets

Valsartan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 narrow, which increases blood pressure. Valsartan works by blocking the action of angiotensin II. As a result, blood vessels relax, and blood pressure decreases.
Bespres 160 mg, coated tablets may 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 burden on the heart and arteries. If left untreated, it can cause damage to blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level reduces the risk of developing these events.
• Treatment of adult patients after 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 inhibitors (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 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. This situation occurs when the heart muscle cannot pump blood with sufficient force to supply the entire body with the necessary blood.

2. Important information before taking Bespres

When not to take Bespres

• If the patient is allergicto 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 pregnant more than 3 months(it is also recommended to avoid taking Bespres 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 applies to the patient, they should inform their doctor and not take Bespres.

Warnings and precautions

Before starting to take Bespres, the patient should discuss it with their 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 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 potassium levels in the blood, such as potassium preparations or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of potassium levels in the blood may be necessary.
• If the patient has aldosteronism. A condition in which the adrenal glands produce too much of a hormone called aldosterone. In such patients, taking Bespres is not recommended.
• If the patient has lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics.
• If the patient has ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), they should inform their doctor. If such symptoms occur while taking Bespres, the patient should stop taking Bespres immediately and never take it again. (See section 4 "Possible side effects").
• The patient should inform their doctor if they think they are (or may be) pregnant. Bespres is not recommended during pregnancy and should not be taken by women who are more than 3 months pregnant, as it may harm the baby if taken during this period (see section 2: Pregnancy, breastfeeding, and fertility).
• If the patient is taking any of the following medicines for high blood pressure:
• 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 Bespres".

If any of the above warnings apply to the patient, they should inform their doctor before starting to take Bespres.

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

Bespres and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Some medicines taken at the same time as Bespres may affect its action.
It may be necessary to modify the dosage, take certain precautions, or, in some cases, discontinue one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• Other blood pressure-lowering medicines, with particular attention to diuretics.
• Medicines that increase potassium levels in the blood. Such as potassium preparations or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• A type of pain reliever called non-steroidal anti-inflammatory drugs (NSAIDs).
• Certain antibiotics (from the 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 action of Bespres.
• Lithium, a medicine used to treat certain types of mental illness.

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

In addition:

• In the case of patients after a heart attack, treated with Bespres, 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• The patient should inform their doctor if they think they are (or may be) pregnant.The doctor will usually recommend stopping Bespres before the patient becomes pregnant or as soon as they become pregnant. The doctor will recommend taking another 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 harm the baby if taken during this period.
• The patient should inform their doctor if they are breastfeeding or plan to breastfeed.Bespres is not recommended for breastfeeding mothers, especially if the baby is a newborn or premature, the doctor may recommend other blood pressure medicines.

Driving and using machines

Before driving, using tools, or operating machines, or performing other activities that require concentration, the patient should be well aware of their body's reaction to Bespres. Like many other blood pressure medicines, Bespres may cause dizziness and concentration problems.

Bespres contains sodium

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

3. How to take Bespres

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. Patients with high blood pressure often do not have symptoms of this disease. Many of them feel completely normal. Therefore, it is essential to follow the established plan of visits to the doctor, even if the patient feels well.
Adult patients with high blood pressure:The recommended dose is 80 mg per day. In some cases, the 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 per day. In patients with a body weight of 35 kg or more, the recommended initial dose is 80 mg of valsartan per day. In some cases, the doctor may prescribe higher doses (the dose can be increased to 160 mg, up to a maximum of 320 mg).
Condition after a recent heart attack in adult patients:In the case of a heart attack, treatment usually starts 12 hours after the attack, usually with a small dose of 20 mg twice a day. The 20 mg dose is obtained by dividing a 40 mg tablet into two equal parts. The doctor will gradually increase the dose of Bespres over several weeks to a maximum dose of 160 mg twice a day. The target dose of the medicine depends on the patient's individual tolerance.
Bespres can be used in combination with other medicines used to treat heart attack. The doctor decides which medicine is suitable for the patient.
Heart failure in adult patients:Treatment usually starts with a dose of 40 mg twice a day. The doctor will gradually increase the dose of Bespres over several weeks to a maximum dose of 160 mg twice a day. The target dose depends on the patient's individual tolerance.
Bespres can be used in combination with other medicines used to treat heart failure. The doctor decides which medicine is suitable for the patient.
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

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

Missing a dose of Bespres

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, they should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping Bespres treatment

Stopping Bespres treatment may worsen the patient's condition. The patient should not stop taking Bespres without consulting their doctor first.
If the patient has any further doubts about taking this medicine, they should consult their 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:

The patient may experience symptoms of angioedema (a specific allergic reaction), a not very common side effect, such as:

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

If the patient experiences any of the above symptoms, they should stop taking Bespres immediately and contact their 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 of labyrinthine origin),
• 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; the following symptoms may occur: 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, dryness in the throat 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 values (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 worsen or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.

5. How to store Bespres

The medicine should be stored out of 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 the 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 should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bespres contains

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

What Bespres looks like and what the packaging contains

Bespres is yellow, oval, coated tablets with a score line on one side of the tablet and 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 of: 28, 30, 56, 60, 84, 90, 98, and 100 coated tablets.
Hospital packaging: 50 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
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

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: January 2025