BISOPROLOL TEVA-RATIOPHARM 10 mg TABLETS

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

Do not take Bisoprolol Teva-ratiopharm

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

Warnings and precautions

Consult 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 an overactive thyroid gland,
• if you have a history of allergies, including any for which you are being desensitized,
• if you are fasting,
• if you have an irregular heartbeat,
• if you have circulatory problems (e.g., less severe forms of Raynaud's syndrome resulting in temporary skin discoloration and numbness of the fingers and toes or peripheral arterial disease causing pain, discomfort, or cramps in the legs when walking),
• if you experience sudden chest pain, or if you have already had angina,
• if you have pheochromocytoma (high blood pressure, rapid heart rate, and headache). This disorder must be treated first, before taking Bisoprolol ratiopharm,
• if you have or have had psoriasis (characterized by severe skin rashes).

Inform your anesthesiologist or medical staff if you are going to be hospitalized for surgery that you are taking Bisoprolol Teva-ratiopharm.

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

Children and adolescents

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

Taking Bisoprolol Teva-ratiopharm with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

• Verapamil, diltiazem, (medicines used to treat 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 illness (monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines).
• Disopyramide, quinidine, lidocaine, phenytoin, flecainide, propafenone, or amiodarone (medicines used to treat irregular heartbeats).
• Calcium channel blockers or beta-blockers (medicines used to treat angina and high blood pressure, including beta-blockers in eye drops).
• Anticholinesterase medicines (including Tacrine) - medicines used in Alzheimer's disease.
• Insulin or other medicines for diabetes.
• Anesthetics.
• Digitalis glycosides (medicines used in heart failure).
• Non-steroidal anti-inflammatory medicines (NSAIDs, medicines used to relieve pain, sensitivity, inflammation, and stiffness caused by gout, arthritis, and other inflammatory diseases).
• Ergotamine derivatives (medicines for migraine).
• Sympathomimetic agents (medicines used for heart problems or low blood pressure) such as epinephrine, norepinephrine.
• Barbiturates (medicines used for 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 class of medicines known as chemoprotectors).

Using Bisoprolol Teva-ratiopharm with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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 tablets may be harmful to pregnancy and/or the fetus. There is a higher risk of premature birth, spontaneous abortion, low blood sugar, and decreased heart rate in the baby. 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 use machines 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 the medication is changed, and also in combination with alcohol. Examples of side effects include visual disturbances, numbness, or dizziness. If you experience any of these side effects, it is recommended to avoid driving or using machines. No effects on the ability to drive or use machines have been observed.

Bisoprolol Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Bisoprolol Teva-ratiopharm

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 should be swallowed whole with a glass of water and should 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 can be divided into equal doses.

It is important that you take this medicine for the time your doctor has indicated. Do not interrupttreatment without consulting your doctor first.

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 per day may be sufficient. The normal dose is 10 mg once a day with a maximum recommended dose of 20 mg.

Patients with renal impairment

Patient with severe renal impairment should not exceed 10 mg of bisoprolol once a day. This dose may be reduced by half. Consult your doctor before starting to use this medicine.

Patients with liver disease

Patient with severe liver disease should not exceed 10 mg of bisoprolol once a day. Consult your doctor before starting to take this medicine.

If you take more Bisoprolol Teva-ratiopharm than you should

Consult your nearest hospital or inform your doctor or pharmacist immediately. Bring this leaflet or any remaining tablets to show them.

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

In case of overdose or accidental ingestion, consult the Toxicological 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 to take 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 stoptreatment abruptly or change the recommended dose without consulting your doctor first. If you need to stop treatment, it should be done gradually to avoid side effects.

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

4. Possible side effects

Like all medicines, Bisoprolol ratiopharm can cause side effects, although not everybody gets them

Stop your treatment and seek immediate medical attention if you experience any of the following rare side effects:

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

Other side effects:

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

• Feeling of cold or numbness of the extremities (hands or feet, ears or nose), Raynaud's disease (a disorder where the blood supply to the fingertips can become so restricted as to cause tissue damage), worsening of cramp-like pain (intermittent claudication) that occurs in the legs when walking.
• Hypotension.
• 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 and irregular heartbeat.
• Worsening of heart failure (a disorder where the pumping action of the left ventricle of the heart is insufficient).
• Sleep disorders, depression.
• Patient with asthma or a history of respiratory problems may experience breathing difficulties.
• Dizziness, especially when standing up.

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

• Nightmares, hallucinations.
• Low blood sugar levels.
• Increased liver enzymes (you may notice a yellowish color of the skin or the whites of your eyes).
• Increased triglycerides (certain lipids in the blood).
• Hepatitis (inflammation of the liver).
• Inflammatory disease of the skin (lupus syndrome), which disappears when treatment is stopped,
• Reduced sexual performance.
• Disturbance of hearing, runny nose.
• Reduced tear flow (especially if the patient uses contact lenses).
• Fainting.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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-ratiopharm

Keep out of the sight and reach of children.

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the packaging and any unused medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bisoprolol Teva-ratiopharm

• The active substance is bisoprolol fumarate.

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

• The other ingredients 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 packaging contents

Bisoprolol Teva-ratiopharm 5 mg tablets EFG

Bisoprolol ratiopharm are pale yellow, speckled, round, and convex tablets with a score line on one side with a “5” on the right side.

Bisoprolol Teva-ratiopharm 10 mg tablets EFG

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

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.

Not all 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 (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143-Blaubeuren (Germany)

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

Germany: Bisoprolol AbZ 5/10 mg Tablets

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

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

Finland: Bisoprolol ratiopharm 5/10 mg tablets

Netherlands: Bisoprololfumarate ratiopharm 5/10 mg, tablets

Sweden: Bisoprolol Teva

Date of last revision of this leaflet:December 2024

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/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63518/P_63518.html