Leaflet: Information for the user

Bisoprolol Teva-ratiopharm 5 mg tablets EFG

Bisoprolol Teva-ratiopharm 10 mg tablets EFG

bisoprolol fumarate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Bisoprolol belongs to a group of medicines called beta-blockers. This medicine is used to treat high blood pressure and recurrent angina. Angina is a condition where the heart muscles receive less oxygen than they need. This usually occurs during exercise and the most common symptoms associated with this condition are chest pain.

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 drugs (drugs that increase the heart's contraction force),
• if you have experienced 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 or irregular heart rate and you have not been fitted with a pacemaker,
• if you have very poor blood circulation or Raynaud's syndrome,
• if you have extremely low blood pressure,
• if you have an adrenal gland tumor (pheochromocytoma) that is not being treated,
• if you have severe asthma or have severe difficulty breathing,
• if you have metabolic acidosis (a metabolic disorder 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 difficulty,
• if you have diabetes mellitus, as low blood sugar levels may be masked by this medicine,
• if you have an 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 heart rhythm,
• if you have circulatory problems (for example, milder forms of Raynaud's syndrome causing 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 condition must be treated first, before taking Bisoprolol ratiopharm,
• if you have or have had psoriasis (characterized by severe skin eruptions).

Inform your anesthetist or medical staff if you are to be admitted to a hospital for a surgical procedure that you are taking Bisoprolol Teva-ratiopharm.

If you have heart problems, the treatment should not be stopped abruptly. The dose should be gradually reduced. For better 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

Inform your doctor or pharmacist that you are using, have used recently or may have to use any other medicine.

• 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 anti-hypertensives, 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 in the treatment of angina and high blood pressure, including beta-blockers in eye drops).
• Cholinesterase inhibitors (including Tacrine) - medicines used in Alzheimer's disease.
• Insulin or other diabetes medicines.
• Anesthetics.
• Digitalis glycosides (medicines used in heart failure).
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, sensitivity, inflammation and stiffness caused by gout, arthritis and other inflammatory diseases).
• Ergotamine derivatives (medicines for migraine).
• Sympathomimetics (medicines used for heart problems or low blood pressure) such as adrenaline, noradrenaline.
• 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 class of medicines known as chemoprotectors).

Use of Bisoprolol Teva-ratiopharm with food, drinks and alcohol

Avoid excessive alcohol consumption, as it may increase the effect of bisoprolol's blood pressure-lowering effect

Pregnancy and breastfeeding

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

Bisoprolol tablets may be harmful to the pregnancy and/or the fetus. There is a higher risk of premature birth, spontaneous abortion, low blood sugar and decreased fetal heart rate. The baby's growth may also be affected. Therefore, bisoprolol should not be taken during pregnancy.

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

Driving and operating machinery

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medicine. Be especially cautious at the start of treatment, when the dose is increased or the medication is changed, and also in combination with alcohol. Examples of adverse effects include visual disturbances, numbness or dizziness. If you experience any of these adverse effects, it is recommended to abstain from driving or operating machinery. No effects on the ability to drive and operate machinery have been observed.

Bisoprolol Teva-ratiopharm contains lactose

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

Follow exactly the administration instructions of this medication indicated 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 every day, preferably in the morning, before, with or after breakfast.

The tablet can be divided into equal doses.

It is essential that you take this medication for the time your doctor has indicated.Do not interruptthe treatment without consulting your doctor first.

Adults and elderly patients

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

Patients with renal impairment

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

Patients with liver disease

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

If you take more Bisoprolol Teva-ratiopharm than you should

Consult your nearest hospital or immediately report to your doctor or pharmacist. Bring this leaflet or any remaining tablets 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 tremor (due to decreased blood sugar).

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

If you forgot to take Bisoprolol Teva-ratiopharm

Try to take your tablets daily as prescribed, however, if you forgot to take a dose, take it as soon as you remember.Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Bisoprolol Teva-ratiopharm

Do not interruptthe treatment abruptly or change the recommended dose without consulting your doctor first. If you need to interrupt the treatment, it should be done gradually to avoid adverse effects.

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

Like all medications, Bisoprolol ratiopharm can cause side effects, although not everyone will experience them

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

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

Other side effects:

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

• Sensation of coldness or numbness in the extremities (hands or feet, ears or nose), Raynaud's disease (a disorder where blood supply to the tips of the fingers and toes may be severely restricted, causing tissue damage), worsening of cramps - like pain (intermittent claudication) that occurs 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.

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

• Muscle weakness, muscle cramps, and joint pain.
• Sensation of weakness.
• Slow and irregular heartbeat.
• Worsening of heart failure (a disorder where the left ventricle of the heart is insufficient in pumping action).
• 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 sugar levels.
• Increased liver enzymes (may notice a yellowish color of the skin or the white of the eyes).
• Increased triglycerides (determined lipids in the blood).
• Hepatitis (inflammation of the liver).
• Inflammatory skin disease (lupus syndrome), which disappears when treatment is stopped,
• Reduced sexual performance.
• Auditory alteration, 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 medication may exacerbate psoriasis or induce psoriasis - hair loss.
• Itching or redness of the eyes.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not store at a temperature above 25 °C.Store in the original packaging to protect it from humidity.

Do not use this medication after the expiration date that appears on the blister pack and on the container after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Bisoprolol Teva-ratiopharm

• The active ingredient 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 package

Bisoprolol Teva-ratiopharm 5 mg tablets EFG

Bisoprolol ratiopharm are yellowish pale tablets, speckled, round, and convex with a groove on one face with a “5”on the right side.

Bisoprolol Teva-ratiopharm 10 mg tablets EFG

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

The following package sizes are available:

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143-Blaubeuren (Germany)

This medicine is authorized in the member states of the European Economic Area with 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:Bisoprololfumaraat ratiopharm 5/10 mg, tablets

Sweden:Bisoprolol Teva

Last review date of this leaflet:December 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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