BISOPROLOL TEVA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Teva 5mg film-coated tablets EFG

Bisoprolol Teva 10mg film-coated tablets EFG

bisoprolol fumarate

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Bisoprolol Teva and what is it used for
2. What you need to know before you take Bisoprolol Teva
3. How to take Bisoprolol Teva
4. Possible side effects
5. Storage of Bisoprolol Teva
6. Contents of the pack and other information

1. What is Bisoprolol Teva and what is it used for

Bisoprolol belongs to a group of medicines called beta-blockers. These products protect the heart from excessive activity, which makes the heart more relaxed and reduces blood pressure.

Bisoprolol is used for the treatment of:

• High blood pressure (hypertension).
• Chest pain (angina pectoris).

2. What you need to know before you take Bisoprolol Teva

Do not take Bisoprolol Teva:

• If you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
• If you have sudden heart weakness (acute heart failure) or worsening of heart failure that requires intravenous medicines that stimulate the heart.
• If you are in a state of shock caused by heart dysfunction.
• If you have certain heart conduction disorders (second or third degree AV block without a pacemaker, sinoatrial block).
• If you have certain heart rhythm disorders (sick sinus syndrome or sinoatrial block).
• If you have a slow heart rate (less than 60 beats per minute) before starting treatment.
• If you have very low blood pressure (hypotension, systolic blood pressure less than 100).
• If you have severe asthma or other breathing problems such as chronic respiratory disorders (COPD).
• If you have severe blood circulation problems in your fingers, toes, arms, and legs, such as Raynaud's phenomenon. See also “Warnings and precautions”
• If you have a tumor of the adrenal gland that can cause excessively high blood pressure (an untreated pheochromocytoma). See also “Warnings and precautions”.
• If you have a disease where there is a change in the acid-base balance of the body (metabolic acidosis).
• If you are being treated with floctafenine (a medicine used to relieve pain and inflammation) or sultopride (a medicine used to treat nervous system disorders). See also “Using Bisoprolol Teva with other medicines”.

Warnings and precautions

Consult your doctor before starting to take Bisoprolol Teva:

• If you frequently have lung disorders such as asthma or respiratory disorders. In sensitive patients, Bisoprolol can narrow the airways; in this case, your doctor will probably examine your lungs before starting treatment and possibly prescribe a bronchodilator (or increase the dose of the same).
• If you are going to have surgery. Your heart rate and blood pressure may change when anesthetics are used with Bisoprolol. Inform the anesthesiologist that you are taking Bisoprolol.
• If you need to undergo an X-ray examination with a contrast medium (the so-called contrast media that contain iodine). Inform your doctor that you are using Bisoprolol Teva.
• If you have diabetes, as Bisoprolol can mask the symptoms of low blood sugar (hypoglycemia). You should regularly check your blood glucose levels. See also “Using Bisoprolol Teva with other medicines”.
• If you have a thyroid problem, as Bisoprolol can mask the symptoms of an overactive thyroid.
• If you are fasting.
• If you are being treated for hypersensitivity reactions (antiallergic treatments) or if you suffer from an allergic reaction. Bisoprolol can enhance hypersensitivity to substances you are allergic to and increase the severity of allergic reactions.
• If you have a heart conduction disorder (called first-degree AV block).
• If you have a feeling of pressure and pain in the chest at rest (Prinzmetal's angina). Bisoprolol can increase the number and duration of attacks.
• If you have blood circulation problems in your fingers, toes, arms, and legs (Raynaud's phenomenon) or a painful cramp in the calves caused by exercise or walking (intermittent claudication). The condition may worsen, particularly at the start of treatment.
• If you have an adrenal gland tumor (pheochromocytoma); Bisoprolol can only be used in combination with certain medicines (the so-called alpha-blockers).
• If you have (or have had) a recurrent skin disorder that involves a rash with dry and scaly skin (psoriasis).

At the start of treatment, your doctor will regularly examine you (especially in the treatment of elderly patients).

Consult your doctor if any of the above warnings affect you, or have affected you in the past.

Children and adolescents

The use of bisoprolol is not recommended as there is not enough experience with the use of this medicine in children.

Using Bisoprolol Teva with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Do not take Bisoprolol Teva in combination with:

Tell your doctor especially if you are taking one of the following medicines because the possibility of adverse effects on the heart and/or changes in blood pressure increases if bisoprolol is used in combination with the products mentioned below.

• Medicines used to treat heart rhythm disorders and high blood pressure, such as calcium antagonists (verapamil, diltiazem, and bepridil).
• Medicines used to treat high blood pressure, such as clonidine and other blood pressure-lowering medicines that work by affecting the part of the brain that controls blood pressure, such as methyldopa, guanfacine, monoxidine, and rilmenidine.
• Medicines used to treat multiple sclerosis (fingolimod).
• Other medicines used to treat high blood pressure.
• Medicines used to treat severe depression, such as MAO-A inhibitors (moclobemide).
• With medicines used to treat heart rhythm disorders, such as class I antiarrhythmics (e.g., disopyramide and quinidine) and class III antiarrhythmics (e.g., amiodarone).
• Medicines used to treat chest pain and high blood pressure, such as calcium antagonists (nifedipine and amlodipine, called dihydropyridine derivatives).
• Medicines used to treat Alzheimer's disease, such as acetylcholinesterase inhibitors (rivastigmine, galantamine, and tacrine).
• Other beta-blockers, such as atenolol or metoprolol.
• Eye drops containing beta-blockers, such as timolol or betaxolol.
• Medicines used to treat heart weakness and certain heart rhythm disorders, such as digitalis glycosides (digoxin).
• Anesthetics, such as propofol and lidocaine. See also the section “Warnings and precautions”.
• Medicines used to treat severe depression, such as tricyclic antidepressants (amitriptyline or clomipramine).
• Medicines used to treat severe mental illnesses, such as phenothiazines (chlorpromazine or perphenazine).
• Medicines used to treat epilepsy, such as barbiturates (phenobarbital).
• Other medicines that lower blood pressure.

• The muscle relaxant baclofen.
• Medicines used to protect the body against the consequences of certain cancer treatments, such as amifostine.
• The antimalarial medicine mefloquine.
• Medicines used to control the immune system and symptoms of inflammation, such as corticosteroids.
• Medicines used to treat diabetes, such as insulin, metformin, and tolbutamide; Bisoprolol can enhance the glucose-lowering effect of these products and can mask the symptoms of low blood sugar. See also “Warnings and precautions”.
• Medicines used to treat migraines, such as ergotamine, as it can increase blood circulation disorders in arms and legs.
• Medicines that have a stimulating effect on a certain part of the nervous system, such as sympathomimetics. Taking these medicines with Bisoprolol can reduce the effect of both products (dobutamine and isoprenaline) or cause an increase in blood pressure and worsen intermittent claudication (adrenaline and noradrenaline). Adrenaline is also used to treat allergic reactions. Higher doses of adrenaline may be necessary to treat allergic reactions if you are taking bisoprolol at the same time.
• A certain group of pain relievers (the so-called NSAIDs), such as ibuprofen, naproxen, and diclofenac; these can reduce the effect of bisoprolol.
• Medicines for treating Alzheimer's disease (donepezil).
• Medicines for treating a disease called myasthenia gravis (neostigmine)
• An antibiotic used mainly in the treatment of tuberculosis (rifampicin).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Bisoprolol may be harmful to pregnancy and/or the child (increases the risk of premature birth, abortion, growth retardation, low blood sugar, and reduced heart rate of the child). Therefore, this medicine is not recommended during pregnancy unless clearly necessary.

It is not known whether bisoprolol is excreted in breast milk. Therefore, breastfeeding is not recommended during the use of this medicine.

Driving and using machines

The use of bisoprolol may sometimes cause dizziness or fatigue (see “Possible side effects”). If you experience these side effects, do not drive or use machines that require your full attention. In particular, attention is required at the start of treatment, with changes in medication, and with the use in combination with alcohol.

Bisoprolol Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is, essentially “sodium-free”.

3. How to take Bisoprolol Teva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets can be taken best with a large amount of water (1 glass).

The recommended dose is:

Adults

Initial dose: Your doctor will start treatment with the lowest possible dose. Sometimes 5 mg per day (24 hours) may be sufficient.

The usual maintenance dose is 10 mg once daily. The maximum recommended dose is 20 mg per day.

Elderly patients

In general, no dose adjustment is necessary. It is recommended to start with the lowest possible dose.

Patients with severely reduced kidney function

The maximum dose is 10 mg per day (24 hours). This dose may possibly be divided into 2 administrations.

Patients with severely reduced liver function

The maximum dose is 10 mg per day (24 hours).

Use in children and adolescents

The use of bisoprolol is not recommended as there is not enough experience with the use of this medicine in children.

If you take more Bisoprolol Teva than you should

If you have taken too much bisoprolol, consult your doctor or pharmacist immediately.

The symptoms that may occur when a dose that is too high is taken are: reduced heart rate, reduced blood pressure, difficulty breathing, insufficient heart action, and low blood sugar levels (which includes a feeling of hunger, sweating, dizziness, and palpitations). In severe cases, the doctor will probably perform a stomach wash (gastric lavage).

In case of overdose or accidental ingestion, consult the Toxicological Information Service, telephone 91 562 04 20.

If you forget to take Bisoprolol Teva

If you have forgotten a dose, take this dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your normal dosing schedule. Do not take a double dose of bisoprolol to make up for missed doses.

If you stop taking Bisoprolol Teva

If you suddenly stop using Bisoprolol, your heart disorder may worsen or your blood pressure may rise again. Therefore, it is better not to stop using this medicine abruptly. Your doctor will gradually reduce the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, do not take Bisoprolol and see your doctor or go to the nearest hospital immediately.

• Difficulty breathing and swelling of the legs, which is a symptom of worsening heart failure (may affect up to 1 in 100 people)
• Breathing problems and wheezing due to narrowing of the airways in patients with asthma or respiratory disorders (bronchospasm) (may affect up to 1 in 100 people).
• Hypersensitivity reactions such as itching, redness, skin rash, swelling (hands, feet, face, neck, tongue, mouth, or throat), difficulty breathing (may affect up to 1 in 1,000 people).
• Fever, fatigue, joint pain, rash; these are symptoms of a disease called lupus syndrome (may affect up to 1 in 1,000 people).
• Yellowing of the whites of the eyes and skin (jaundice), dark urine, fatigue, and abdominal pain, which are symptoms of liver inflammation (hepatitis) (may affect up to 1 in 1,000 people).
• Seeing things that are not there (hallucinations) (may affect up to 1 in 1,000 people).
• Worsening of a recurrent skin disorder that involves a rash with dry and scaly skin (psoriasis) (may affect up to 1 in 10,000 people).

The following side effects may occur:

Common: may affect up to 1 in 10 people

• (Fatigue), dizziness, or headache (these side effects occur especially at the start of treatment and are generally mild and usually disappear within 1-2 weeks).
• Cold and/or numb hands and feet, worsening of leg pain, and weakness (intermittent claudication, Raynaud's phenomenon).
• Nausea, vomiting, diarrhea, abdominal pain, or constipation.
• Low blood pressure (hypotension)

Uncommon: may affect up to 1 in 100 people

• Reduced heart rate, worsening of existing heart rhythm disorders, such as AV block.
• Decreased blood pressure, for example, due to standing up quickly from a sitting or lying position, sometimes including dizziness (orthostatic hypotension)
• Depression.
• Muscle weakness and muscle cramps, joint problems.
• Sleep disorders.
• Feeling of weakness.

Rare: may affect up to 1 in 1,000 people

• Increased liver enzymes (AST, ALT) that can be seen in a blood test.
• Low blood sugar levels (hypoglycemia) that include a feeling of hunger, sweating, dizziness, and palpitations.
• Increased levels of a type of fat found in the blood (triglycerides).
• Male impotence.
• Inflammation of the nasal mucous membrane characterized by a congested nose, runny nose (allergic rhinitis).
• Dry eyes (can be very problematic if you wear contact lenses)
• Nightmares
• Hearing disorders.
• Fainting

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

• Hair loss.
• Inflammation of the eye or eyelid (conjunctivitis).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Bisoprolol Teva 5 mg film-coated tablets

Bottle: Do not store above 25°C. Keep the bottle tightly closed to protect from light and/or moisture.

Blister: Do not store above 25°C. Keep the blister in the original packaging to protect from light and/or moisture.

Bisoprolol Teva 10 mg film-coated tablets

Bottle: Do not store above 30°C. Keep the bottle tightly closed to protect from light and/or moisture.

Blister: Do not store above 30°C. Keep the blister in the original packaging to protect from light and/or moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of medicines no longer needed at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bisoprolol Teva film-coated tablets

Bisoprolol Teva 5 mg film-coated tablets

The active ingredient is bisoprolol fumarate: 5 mg per tablet. Each film-coated tablet contains 5 mg of bisoprolol fumarate.

Bisoprolol Teva 10 mg film-coated tablets

The active ingredient is bisoprolol fumarate. Each film-coated tablet contains 10 mg of bisoprolol fumarate.

The other ingredients are:

Core:microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose (E466), magnesium stearate (E572);

Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000.

Appearance and Packaging of the Product

Bisoprolol Teva 5 mg film-coated tablets are white, round, convex, film-coated tablets engraved with “5” on one side.

Bisoprolol Teva 10 mg film-coated tablets are white, round, convex, film-coated tablets engraved with “10” on one side.

The tablets are packaged in blisters of 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, and 105 each, and in bottles of 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, and 105 each.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid

Manufacturer

Pharmachemie B.V.

Swensweg 5, 2031 GA, Haarlem

PO Box 552

2003 RN Haarlem

Netherlands

Teva Pharmaceutical Works Private Limited

Pallagi út 13

H-4042 Debrecen

Hungary

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names

Belgium Bisoprolol TEVA 5 mg film-coated tablets

Bisoprolol TEVA 10 mg film-coated tablets

France Bisoprolol TEVA 5 mg, film-coated tablet

Bisoprolol TEVA 10 mg, film-coated tablet

Netherlands Bisoprololfumaraat 5 PCH, film-coated tablets 5 mg

Bisoprololfumaraat 10 PCH, film-coated tablets 10 mg

Spain Bisoprolol Teva 5 mg film-coated tablets EFG

Bisoprolol Teva 10 mg film-coated tablets EFG

United Kingdom (Northern Ireland) Bisoprolol Fumarate 5 mg Film-coated Tablets

Date of the last revision of this leaflet:December 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es