Bisoprolol Teva-Ratiopharm 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bisoprolol Teva-ratiopharm 5 mg tablets EFG

Bisoprolol Teva-ratiopharm 10 mg tablets EFG

bisoprolol fumarate

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What BISOPROLOL RATIOPHARM 5 mg is and what it is used for

Bisoprolol belongs to a group of medicines called beta-blockers. This medicine is used to treat high blood pressure and chronic stable angina. Angina is a condition in which the heart muscles (heart) receive less oxygen than they need. This usually occurs during physical exertion, and the most common symptom associated with this condition is chest pain.

2. What you need to know before taking BISOPROLOL RATIOPHARM 5 mg

Do not take Bisoprolol Teva-ratiopharm

• if you are allergic to bisoprolol or to any of the other ingredients of this medicine (listed in section 6),
• if you have acute heart failure or require injection of inotropic medicines (medicines that increase the force of the heart's contraction),
• if you have experienced cardiogenic shock (when the heart is unable to pump enough blood to your body),
• if you have certain heart conditions causing a very slow heart rate or irregular heartbeat and you do not have a pacemaker implanted,
• if you have very poor blood circulation or Raynaud's syndrome,
• if you have extremely low blood pressure,
• if you have a tumor of the adrenal gland (pheochromocytoma) that is not being treated,
• if you have severe asthma or serious breathing difficulties,
• if you have metabolic acidosis (a metabolic disorder causing the blood to become acidic).

Warnings and precautions

Talk to your doctor or pharmacist before taking Bisoprolol Teva-ratiopharm

• if you have asthma or any other breathing difficulties,
• if you have diabetes mellitus, as low blood sugar levels may be masked by this medicine,
• if you have excessive production of thyroid hormone,
• if you have a history of allergies, including any for which you are undergoing desensitization treatment,
• if you are fasting,
• if you have an irregular heartbeat,
• if you have circulatory problems (for example, milder forms of Raynaud's syndrome resulting in temporary skin discoloration and numbness in fingers and toes, or peripheral arterial disease causing pain, discomfort or cramps in the legs when walking),
• if you experience sudden chest pain, or have previously had angina,
• if you have pheochromocytoma (high blood pressure, rapid heartbeat, and headache). This condition must be treated first before taking Bisoprolol ratiopharm,
• if you have or have had psoriasis (characterized by severe skin rashes).

Inform the anaesthetist or medical staff if you are being admitted to hospital for surgery that you are taking Bisoprolol Teva-ratiopharm.

If you have heart problems, treatment must not be stopped abruptly. The dose should be gradually reduced. For further advice, contact your doctor.

Children and adolescents

Bisoprolol Teva-ratiopharm is not recommended for use in children or adolescents.

Taking Bisoprolol Teva-ratiopharm with other medicines

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

• Verapamil, diltiazem (medicines used in the treatment of angina and high blood pressure).
• Clonidine (a medicine used to treat high blood pressure), and other centrally acting antihypertensives such as methyldopa, guanfacine, moxonidine and rilmenidine, and reserpine.
• Any other medicine used to treat high blood pressure.
• Medicines for depression or mental illnesses (monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines).
• Disopyramide, quinidine, lidocaine, phenytoin, flecainide, propafenone or amiodarone (medicines used to treat irregular heartbeat).
• Calcium channel blockers or beta-blockers (medicines used in the treatment of angina and high blood pressure, including beta-blocker eye drops).
• Anticholinesterase medicines (including Tacrine) – medicines used in Alzheimer's disease.
• Insulin or other medicines for diabetes.
• Anaesthetics.
• Digitalis glycosides (medicines used in heart failure).
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, tenderness, inflammation and stiffness caused by gout, arthritis and other inflammatory conditions).
• Ergotamine derivatives (medicines for migraine).
• Sympathomimetic agents (medicines used for heart problems or low blood pressure) such as epinephrine, norepinephrine.
• Barbiturates (medicines used in sleep disorders).
• Baclofen (used to treat muscle spasms associated with multiple sclerosis and spinal cord injuries).
• Mefloquine (an antimalarial medicine).
• Corticosteroids (medicines used to treat asthma).
• Amifostine (a medicine belonging to a class known as chemoprotectors).

Taking Bisoprolol Teva-ratiopharm with food, drinks and alcohol

Avoid drinking excessive amounts of alcohol, as it may enhance the blood pressure-lowering effect of bisoprolol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Bisoprolol tablets may be harmful during pregnancy and/or to the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and reduced heart rate in the newborn. The baby's growth may also be affected. Therefore, bisoprolol should not be taken during pregnancy.

It is not known whether bisoprolol passes into breast milk; therefore, this medicine is not recommended during breastfeeding.

Driving and using machines

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medicine. Be especially careful at the start of treatment, when the dose is increased, or when medication is changed, and also when combined with alcohol. Examples of adverse effects include visual disturbances, numbness, or dizziness. If you experience any of these adverse effects, you are advised to refrain from driving or using machinery. No effects on the ability to drive and use machinery have been observed.

Bisoprolol Teva-ratiopharm contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take BISOPROLOL RATIOPHARM 5 mg

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets should be swallowed whole with a glass of water and must not be chewed or crushed. Try to take the tablets at the same time each day, preferably in the morning, before, with or after breakfast.

The tablet may be divided into equal doses.

It is important that you take this medicine for the length of time prescribed by your doctor. Do not stop treatment without first consulting your doctor.

Adults and elderly patients

Your doctor will decide the dose you need and will take into account any other medicines you are taking. In some patients, 5 mg daily may be appropriate. The usual dose is 10 mg once daily, with a maximum recommended dose of 20 mg.

Patients with renal impairment

Patients with severe renal impairment must not exceed 10 mg of bisoprolol once daily. This dose may be reduced by half. Consult your doctor before starting to take this medicine.

Patients with hepatic disease

Patients with severe liver disease must not exceed 10 mg of bisoprolol once daily. Consult your doctor before starting to take this medicine.

If you take more Bisoprolol Teva-ratiopharm than you should

Contact your nearest hospital or inform your doctor or pharmacist immediately. Take this leaflet or any remaining tablets with you to show them.

If you have taken too many tablets, you may experience a slow heart rate, low blood pressure, severe difficulty breathing, dizziness or trembling (due to low blood sugar).

In case of overdose or accidental ingestion, contact the Toxicology Information Service, Telephone 91 562 04 20.

If you forget to take Bisoprolol Teva-ratiopharm

Try to take your tablets daily as prescribed; however, if you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.

If you stop taking Bisoprolol Teva-ratiopharm

Do not stop treatment suddenly or change the prescribed dose without first consulting your doctor. If treatment needs to be discontinued, it should be done gradually to avoid adverse effects.

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

4. Possible adverse effects

Like all medicines, Bisoprolol ratiopharm can cause adverse effects, although not everyone experiences them.

Stop taking this medicine and seek immediate medical attention if you experience any of the following rare adverse effects:

• Allergic reaction – skin itching, rash, swelling of the face, lips, tongue, throat, or difficulty breathing or swallowing.

Other adverse effects:

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

• Cold sensation or numbness in the extremities (hands or feet, ears or nose), Raynaud's phenomenon (a disorder in which blood supply to the fingertips and toes may become so restricted as to cause tissue damage), worsening of cramp-like pain (intermittent claudication) occurring in the legs when walking.
• Hypotension.
• Fatigue, exhaustion, dizziness, headache (especially at the beginning of treatment; these are usually mild and often disappear within 1–2 weeks).
• Nausea, vomiting, diarrhea, abdominal pain, constipation.

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

• Muscle weakness, muscle cramps, and joint pain.
• Feeling of weakness.
• Slow or irregular heartbeat.
• Worsening of heart failure (a disorder in which the pumping action of the left ventricle of the heart is insufficient).
• Sleep disorders, depression.
• Patients with asthma or a history of respiratory problems may experience difficulty breathing.
• Dizziness, especially when standing up.

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

• Nightmares, hallucinations.
• Low blood glucose levels.
• Increased liver enzymes (you may notice a yellowish discoloration of the skin or whites of the eyes).
• Increased triglycerides (certain lipids in the blood).
• Hepatitis (inflammation of the liver).
• Skin inflammatory disease (lupus-like syndrome), which resolves upon discontinuation of treatment.
• Reduced sexual performance.
• Hearing disturbances, runny nose.
• Decreased tear flow (especially if the patient wears contact lenses).
• Fainting.

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

• This medicine may worsen psoriasis or induce psoriasis-like symptoms—hair loss.
• Itching or redness of the eyes.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BISOPROLOL RATIOPHARM 5 mg

Keep out of the sight and reach of children.

Do not store above 25 °C. Keep in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the blister and on the outer carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Bisoprolol Teva-ratiopharm

• The active substance is bisoprolol fumarate.

Each tablet contains 5 mg/10 mg of bisoprolol fumarate.

• The other components are:
  1. Bisoprolol Teva-ratiopharm 5 mg tablets EFG
  2. Lactose monohydrate, microcrystalline cellulose, magnesium stearate, crospovidone, yellow iron oxide (E-172)
  3. Bisoprolol 10 mg Teva-ratiopharm tablets EFG

lactose monohydrate, microcrystalline cellulose, magnesium stearate, crospovidone, yellow iron oxide (E-172), red iron oxide (E172).

Appearance of the product and contents of the container

Bisoprolol Teva-ratiopharm 5 mg tablets EFG

Bisoprolol ratiopharm are pale yellow, speckled, round, convex tablets with a score on one side and a "5" on the right-hand side.

Bisoprolol Teva-ratiopharm 10 mg tablets EFG

The tablets are beige, speckled, round and convex, with a score line, and engraved with a "1" on the left side and a "0" on the right.

The following pack sizes are available:

Bisoprolol Teva-ratiopharm 5 mg tablets: 20, 28, 30, 50, 56, 60, 98, 100 (unit dose), or 100 tablets.

Bisoprolol Teva-ratiopharm 10 mg tablets: 20, 28, 30, 50, 56, 60, 90, 98, 100 (unit dose), or 100 tablets.

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, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

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

Germany: Bisoprolol AbZ 5/10 mg Tabletten

Austria: Bisoprolol "ratiopharm" 5/10 mg - Tabletten

Spain: Bisoprolol Teva-ratiopharm 5 mg/10 mg tablets EFG

Finland: Bisoprolol ratiopharm 5/10 mg tabletti

Netherlands: Bisoprololfumaraat ratiopharm 5/10 mg, tabletten

Sweden: Bisoprolol Teva

Date of the most recent review of this summary: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63518/P_63518.html