Leaflet: Information for the User

Bisoprolol Teva 5mg Film-Coated Tablets

Bisoprolol Teva 10mg Film-Coated Tablets

bisoprolol fumarate

Read this leaflet carefully before you start taking the medicine, as 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.

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

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

3. How to take Bisoprolol Teva

4. Possible side effects

5. Storage of Bisoprolol Teva

6. Contents of the pack and additional information

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

Bisoprolol is used to treat:

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

Do not take Bisoprolol Teva:

- If you are allergic to bisoprolol fumarate or to any of the other ingredients of this medication (listed in section 6).

• If you have heart weakness that occurs suddenly (acute heart failure) or worsening of heart failure that requires medications administered directly into a vein to stimulate the heart.
• If you are in shock caused by heart dysfunction.
• If you have certain conduction disorders of the heart (second- or third-degree AV block without a pacemaker, sinoatrial block).
• If you have certain heart rhythm disorders (sinus dysfunction 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 any other breathing problem such as chronic respiratory disorders (COPD).
• If you have severe circulatory problems in your fingers, toes, arms, and legs, such as Raynaud's phenomenon. See also “Warnings and precautions”
• If you have an untreated pheochromocytoma, a tumor of the adrenal gland that can cause excessively high blood pressure. See also “Warnings and precautions”.
• If you have a metabolic acidosis, a condition where there is a change in the body's acid-base balance.
• If you are being treated with floctafenine (a medication used to relieve pain and inflammation) or sulpiride (a medication used to treat nervous system disorders). See also “Use of Bisoprolol Teva with other medications”.

Warnings and precautions

Consult your doctor before starting to take Bisoprolol Teva:

• If you frequently have respiratory problems such as asthma or respiratory disorders. In sensitive patients, Bisoprolol may narrow the airways; in this case, your doctor will probably examine your lungs before starting treatment and may prescribe a bronchodilator (or increase the dose of the same).
• If you are to undergo 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 may mask the symptoms of low blood sugar (hypoglycemia). You should regularly check your blood glucose levels. See also “Use of Bisoprolol Teva with other medications”.
• If you have a thyroid problem, as Bisoprolol may mask the symptoms of an overactive thyroid.
• If you are fasting.
• If you are being treated for allergic reactions (allergic treatments) or if you suffer from an allergic reaction. Bisoprolol may potentiate hypersensitivity to substances to which you are allergic 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 may increase the number and duration of attacks.
• If you have circulatory problems in your fingers, toes, arms, and legs (Raynaud's phenomenon) or a painful cramp in your calves caused by exercise or walking (intermittent claudication). The condition may worsen, particularly at the start of treatment.
• If you have a pheochromocytoma, a tumor of the adrenal gland; Bisoprolol can only be used in combination with certain medications (alpha-blockers).
• If you have (or have had) a recurring skin disorder that involves a dry, scaly rash (psoriasis).

Your doctor will regularly examine you (especially in the treatment of elderly patients).

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

Children and adolescents

Bisoprolol is not recommended for use in children as there is not enough experience of the use of this medication in children.

Use of Bisoprolol Teva with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Do not take Bisoprolol Teva in combination with:

Inform your doctor especially if you are taking one of the following medications because the risk of heart problems and/or changes in blood pressure increases if bisoprolol is used in combination with the products listed below.

• Medications used to treat heart rhythm disorders and high blood pressure, such as calcium channel blockers (verapamil, diltiazem, and bepridil).
• Medications used to treat high blood pressure, such as clonidine and other blood pressure-lowering medications that affect the part of the brain that controls blood pressure, such as methyldopa, guanfacine, moxonidine, and rilmenidine.
• Medications used to treat multiple sclerosis (fingolimod).
• Other medications used to treat high blood pressure.
• Medications used to treat severe depression, such as monoamine oxidase inhibitors (moclobemide).
• With medications used to treat heart rhythm disorders, such as class I antiarrhythmics (e.g. disopyramide and quinidine) and class III antiarrhythmics (e.g. amiodarone).
• Medications used to treat chest pain and high blood pressure, such as calcium channel blockers (nifedipine and amlodipine, called dihydropyridine derivatives).
• Medications 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.
• Medications 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”.
• Medications used to treat severe depression, such as tricyclic antidepressants (amitriptyline or clomipramine).
• Medications used to treat severe mental disorders, such as phenothiazines (chlorpromazine or perphenazine).
• Medications used to treat epilepsy, such as barbiturates (phenobarbital).
• Other blood pressure-lowering medications.

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

Pregnancy, breastfeeding, and fertility

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

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

The excretion of bisoprolol in breast milk is unknown. Therefore, breastfeeding is not recommended during the use of this medication.

Driving and operating machinery

The use of bisoprolol may cause dizziness or fatigue (see “Possible side effects”) at times. If you experience these side effects, do not operate vehicles and/or 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 medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

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 can be taken better with an abundant 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 a day. The maximum recommended dose is 20 mg per day.

Older patients

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

Patients with severely reduced renal function

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

Patients with severely reduced liver function

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

Use in children and adolescents

Use of bisoprolol is not recommended since there is not enough experience in the use of this medication 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 taking too high a dose are: reduced heart rate, reduced blood pressure, difficulty breathing, insufficient heart action, and low blood glucose levels (which implies hunger, sweating, dizziness, and palpitations). In severe cases, the doctor may perform a stomach wash (gastric lavage).

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

If you forgot to take Bisoprolol Teva

If you forgot 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 compensate for the missed doses.

If you interrupt treatment with Bisoprolol Teva

If you stop using Bisoprolol abruptly, a worsening of a heart condition may occur or your blood pressure may rise again. Therefore, it is best not to stop using this medication abruptly. Your doctor will gradually reduce the dose.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following side effects, do not take Bisoprolol and visit 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)
• Respiratory problems and wheezing due to narrowing of the airways in patients with asthma or respiratory tract diseases (broncho spasm) (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, rashes; are symptoms of a disease called lupus syndrome) (may affect up to 1 in 1,000 people).
• Yellowing of the white 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 present (hallucinations) (may affect up to 1 in 1,000 people).
• Worsening of a recurrent skin disease that involves rashes, dry skin (psoriasis) (may affect 1 in 10,000 people).

The following side effects may also occur:

Frequent: may affect up to 1 in 10 people

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

Rare: may affect up to 1 in 100 people

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

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

• Increased liver enzymes (AST, ALT) that may be seen in a blood test.
• Low blood sugar levels (hypoglycemia) that includes hunger, sweating, dizziness, palpitations.
• Increased levels of a type of fat found in the blood (triglycerides).
• Male impotence.
• Inflammation of the nasal mucous membrane characterized by nasal congestion and discharge (allergic rhinitis).
• Dry eyes (may be very problematic if you wear contact lenses)
• Nightmares
• Auditory 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 type of side effect, consult your doctor or pharmacist or nurse, 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 for the 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Bisoprolol Teva 5 mg film-coated tablets

Container: Do not store at a temperature above 25°C. Keep the container perfectly closed to protect it from light and/or moisture.

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

Bisoprolol Teva 10 mg film-coated tablets

Container: Do not store at a temperature above 30°C. Keep the container perfectly closed to protect it from light and/or moisture.

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

Medications should not be disposed of through drains or in the trash. Dispose of unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 components are:

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

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

Appearance of the product and contents of the package

Bisoprolol Teva 5 mg film-coated tablets are white, round, convex film-coated tablets containing the inscription BISOPROLOL 5 on one face.

Bisoprolol Teva 10 mg film-coated tablets are white, round, convex film-coated tablets containing the inscription BISOPROLOL 10 on one face.

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 some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid

Responsible for manufacturing

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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names

BelgiumBisoprolol TEVA 5 mg filmomhulde tabletten

Bisoprolol TEVA 10 mg filmomhulde tabletten

FranceBisoprolol TEVA 5 mg, comprimé pelliculé

Bisoprolol TEVA 10 mg, comprimé pelliculé

NetherlandsBisoprololfumaraat 5 PCH, omhulde tabletten 5 mg

Bisoprololfumaraat 10 PCH, omhulde tabletten 10 mg

SpainBisoprolol Teva 5 mg comprimidos recubiertos con película EFG

Bisoprolol Teva 10 mg comprimidos recubiertos con película EFG

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

Date of the last review of this leaflet:December 2022

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