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Package leaflet: Information for the patient

Bisoprolol Orifarm 1.25 mg tablets

Bisoprolol Orifarm 2.5 mg tablets

bisoprolol fumarate

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Bisoprolol Orifarm is and what it is are used for.

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

3. How to take Bisoprolol Orifarm

4. Possible side effects

5. How to store Bisoprolol Orifarm

6. Contents of the pack and other Information.

1 What Bisoprolol Orifarm is and what it is used for

The active substance in this medicine is bisoprolol fumarate. Bisoprolol Fumarate belongs to a group of medicines called beta-blockers. These medicines work by affecting the body’s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body's needs.

Bisoprolol is used:

• To treat stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides).

• In treatment of coronary heart disease and chest pain (angina pectoris) caused by shortage of oxygen in the heart muscle.

• In treatment of high blood pressure (hypertension).

2 What you need to know before you take Bisoprolol Orifarm

Do not take Bisoprolol Orifarm:

Do not take Bisoprolol Orifarm if one of the following conditions applies to you:

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

• If you have severe asthma or severe chronic lung disease • severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue • untreated phaeochromocytoma, which is a rare tumour of the adrenal gland • metabolic acidosis, which is a condition when there is too much acid in the blood.

Do not take Bisoprolol Orifarm if you have one of the following heart problems:

• acute heart failure

• worsening heart failure requiring injection of medicines into a vein, that increase the force of contraction of the heart

• slow heart rate

• low blood pressure

• certain heart conditions causing a very slow heart rate or irregular heartbeat

• cardiogenic shock, which is an acute serious heart condition causing low blood pressure and

• circulatory failure.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Bisoprolol Orifarm

Take special care with Bisoprolol Orifarm :

If you have any of the following conditions tell your doctor before taking this medicine; he or she may want to take special care (for example give additional treatment or perform more frequent checks):

• diabetes

• strict fasting

• certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)

• kidney or liver problems

• less severe blood circulation problems in your limbs

• less severe asthma or chronic lung disease

• history of a scaly skin rash (psoriasis)

• tumour of the adrenal gland (phaeochromocytoma)

• thyroid disorder.

In addition, tell your doctor if you are going to have:

• desensitization therapy (for example for the prevention of hay fever), because bisoprolol may make it more likely that you experience an allergic reaction, or such reaction may be more severe

• anaesthesia (for example for surgery), because this medicine may influence how your body reacts to this situation

Other medicines and Bisoprolol Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take the following medicines with Bisoprolol Orifarm without special advice from your doctor:

• Certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)

• Certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (calcium antagonists such as verapamil and diltiazem)

• Certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine, rilmenidine. However, do not stop taking these medicines without checking with your doctor first.

Check with your doctor before taking the following medicines with Bisoprolol Orifarm; your doctor may need to check your condition more frequently:

• Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as felodipine and amlodipine)

• Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone)

• Beta-blocking agents applied locally (such as timolol eye drops for glaucoma treatment)

• Certain medicines used to treat for example Alzheimer’s disease or glaucoma (parasympathomimetics such as tacrine or carbachol) or medicines that are used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)

• Antidiabetic medicines including insulin

• Anaesthetic agents (for example during surgery)

• Digitalis, used to treat heart failure

• Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (for example ibuprofen or diclofenac)

• Any medicine, which can lower blood pressure as a desired or undesired effect such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines to treat mental illness characterized by a loss of contact with reality (phenothiazines such as levomepromazine)

• Moxisylate (which is used for treatment of impotence).

• Medicines containing ergotamines (used for treatment of migraine).

• Mefloquine, used for prevention or treatment of malaria

• Depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breast-feeding:

You should not take Bisoprolol Orifarm if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

Bisoprolol Orifarm may cause side effects that may affect a person's ability to drive and use machinery particularly during the first few weeks of your treatment. You may find that your reactions are impaired, especially if you have also consumed alcohol. Examples of side effects include visual disturbances, drowsiness or dizziness. If you suffer from any of these side effects it is advisable to refrain from driving or using machinery.

3 How to take Bisoprolol Orifarm

Keep out of reach and sight of children

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Bisoprolol Orifarm should be taken in the morning, before, with or after breakfast. Swallow the tablet/s whole with some water and do not chew or crush them.

This treatment should be initiated by a specialist in cardiology or internal medicine.

Use in children and adolescents: Bisoprolol Orifarm tablet/s is/are not recommended for use in children

Stable chronic heart failure

Adults including the elderly: Treatment with bisoprolol must be started at a low dose and increased gradually. Your doctor will decide how to increase the dose, and this will normally be done in the following way:

• 1.25 mg bisoprolol once daily for one week

• 2.5 mg bisoprolol once daily for one week

• 3.75 mg bisoprolol once daily for one week

• 5 mg bisoprolol once daily for four weeks

• 7.5 mg bisoprolol once daily for four weeks

• 10 mg bisoprolol once daily for maintenance (on-going) therapy.

The maximum recommended daily dose is 10 mg bisoprolol.

Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. If your condition gets worse or you no longer tolerate the drug, it may be necessary to reduce the dose again or to interrupt treatment. In some patients a maintenance dose lower than 10 mg bisoprolol may be sufficient. Your doctor will tell you what to do. If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may become worse.

Renal or liver disease: The dosage should be increased very gradually and cautiously in patients with severe kidney or liver problems

Hypertension and angina

Adults and the elderly:The usual dose for adults is one tablet (10 mg) daily. Your doctor may decide to increase or decrease this dose.

Renal or liver disease: The dosage should not exceed 10 mg once daily in patients with severe kidney or liver problems.

If you take more Bisoprolol Orifarm than you should:

Contact your doctor or local emergency ward immediately. Take this leaflet and any tablets you still have with you. You may feel dizzy or extremely tired or notice tinnitus (ringing in you ears).

If you forget to take Bisoprolol Orifarm :

If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Bisoprolol Orifarm :

Do not stop treatment suddenly or change the recommended dose without talking to your doctor first. If you need to stop treatment, it must be done gradually, to avoid side effects.

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

4 Possible side effects

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

To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly.

The most serious side effects are related to the heart function:

• slowing of heart rate (may affect more than 1 in 10 people)

• worsening of heart failure (may affect up to 1 in 10 people)

• slow or irregular heartbeat (may affect up to 1 in 100 people)

If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.

Further side effects are listed below according to how frequently they may occur:

Common: may affect up to 1 in 10 people

• tiredness, feeling weak, dizziness, headache

• feeling of coldness or numbness in hands or feet

• low blood pressure • stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.

Uncommon: may affect up to 1 in 100 people

• sleep disturbances

• depression

• dizziness when standing up

• breathing problems in patients with asthma or chronic lung disease

• muscle weakness, muscle cramps.

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

• hearing problems

• allergic runny nose

• reduced tear flow

• inflammation of the liver which can cause yellowing of the skin or whites of the eyes

• certain blood test results for liver function or fat levels differing from normal

• allergy-like reactions such as itching, flush, rash

• impaired erection

• nightmares, hallucinations

• fainting

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

• irritation and redness of the eye (conjunctivitis)

• hair loss

• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects

If you get 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 national reporting system [to be completed nationally]. By reporting side effects, you can help provide more information on the safety of this medicine.

5 How to store Bisoprolol Orifarm

Keep out of the sight and reach of children

Do not use Bisoprolol Orifarm after the expiry date (EXP) which is stated on the blister and the carton. The expiry date refers to the last day of that month.This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Bisoprolol Orifarm contains

The active substance is bisoprolol fumarate

Each 1.25 mg tablet contains 1.25 mg bisoprolol fumarate.

Each 2.5 mg tablet contains 2.5 mg bisoprolol fumarate.

The other ingredients are microcrystalline cellulose, silica colloidal anhydrous, croscarmellose sodium, sodium starch glycolate (type A) and magnesium stearate.

What Bisoprolol Orifarm looks like and contents of the pack:

1.25 mg: Diameter 5 mm, white to off white round biconvex tablets.

2.5 mg: Diameter 6.5 mm, white to off white round biconvex tablets with a break line on one side.

Bisoprolol Orifarm 2.5 mg tablets only: The tablets can be divided into equal doses.

1.25: Pack sizes of 7, 10, 20, 21, 28, 30, 98 and 100 tablets.

2.5 mg: Pack sizes of 7, 10, 28, 30, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer:

Orifarm Generics A/S

Energivej 15

5260 Odense S

Denmark

This leaflet was last approved in: 05/2015