BISOPROLOL 2.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

5. how to store bisoprolol tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP’. The expiry date refers to the last date of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help to protect the environment.

6. contents of the pack and other informationthe active substance is bisoprolol fumarate.

Each Bisoprolol 1.25 mg Film-coated tablet contains 1.25 mg of the active substance.

Each Bisoprolol 2.5 mg Film-coated tablet contains 2.5 mg of the active substance.

Each Bisoprolol 3.75 mg Film-coated tablet contains 3.75 mg of the active substance.

Each Bisoprolol 5 mg Film-coated tablet contains 5 mg of the active substance.

Each Bisoprolol 7.5 mg Film-coated tablet contains 7.5 mg of the active substance.

Each Bisoprolol 10 mg Film-coated tablet contains 10 mg of the active substance.

The other ingredients are:

Tablet core: microcrystalline cellulose (PH –112), maize starch, crospovidone (type B), colloidal anhydrous silica and magnesium stearate.

Film coating (1.25 mg tablets and 2.5 mg tablets): hypromellose, macrogol 400 and titanium dioxide (E171).

Film coating (3.75 mg tablets, 5 mg tablets and 7.5 mg tablets): hypromellose, macrogol 400, titanium dioxide (E171) and ferric oxide yellow (E172).

Film coating (10 mg tablets): hypromellose, macrogol 400, titanium dioxide (E171), ferric oxide yellow (E172) and ferric oxide red (E172).

What Bisoprolol tablets looks like and the contents of the pack:

Bisoprolol 1.25 mg tablets are white, round and plain on both sides.

Bisoprolol 2.5 mg tablets are white and heart-shaped with a break-line on both sides.

Bisoprolol 3.75 mg tablets are off-white and heart-shaped with a break-line on both sides.

Bisoprolol 5 mg tablets are white-yellow, heart-shaped with a break-line on both sides.

Bisoprolol 7.5 mg tablets are pale yellow and heart-shaped with a break-line on both sides.

Bisoprolol 10 mg tablets are pale to light orange, heart-shaped with a break-line on both sides.

Each pack contains 20, 28, 30, 50, 56, 60, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:	Manufacturer:
Key Pharmaceuticals Ltd.	MEDREICH PLC
Galen House, 83 High Street,	Warwick House, Plane Tree Crescent,
Somersham, Cambridgeshire,	Feltham, TW13 7HF, UK
PE28 3JB, UK	E-mail :

This leaflet may be supplied in audio format for blind and partially sighted patients upon request.

This leaflet was last revised in October 2020.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisoprolol 1.25 mg Film-coated tablets

Bisoprolol 2.5 mg Film-coated tablets

Bisoprolol 3.75 mg Film-coated tablets

Bisoprolol 5 mg Film-coated tablets

Bisoprolol 7.5 mg Film-coated tablets Bisoprolol 10 mg Film-coated tablets bisoprolol fumarate

Your medicine is called Bisoprolol 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg or 10 mg Film-coated tablets, but it will be referred to as Bisoprolol tablets throughout this leaflet.

Read all of this 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 further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet

• 1. What Bisoprolol tablets are and what they are used for

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

3. How to take Bisoprolol tablets

4. Possible side effects

5. How to store Bisoprolol tablets

6. Contents of the pack and other information

1. What Bisoprolol tablets are and what they are used for

Bisoprolol tablets belong 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 or cardiac glycosides).

2. what you need to know before you take bisoprolol tablets are allergic (hypersensitive) to bisoprolol fumarate or to any of the other ingredients (see section 6 for list of ingredients)

• Suffer from severe asthma or severe chronic lung disease
• Suffer from 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
• Suffer from untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
• Suffer from metabolic acidosis, which is a condition when there is too much acid in the blood
• Have one of the following heart problems:

• – Acute heart failure

• – Worsening heart failure, requiring injection of medicines into a vein, which increases 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

• Suffer from low severity asthma or chronic lung disease
• Suffer from diabetes
• Are currently, or intend to partake in strict fasting while taking this medicine
• Suffer from certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal's an­gina)
• Suffer from kidney or liver problems
• Suffer from less severe blood circulation problems in your limbs
• Have a history of a scaly skin rash (psoriasis)
• Are being treated for a tumour of the adrenal gland (phaeochromocytoma)
• Have thyroid problems

This section is continued overleaf —»

• Are going to have desensitisation 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
• Are going to have anaesthesia (for example for surgery), because bisoprolol may influence how your body reacts to this situation

If you have chronic lung disease or low severity asthma, please inform your doctor immediately if you start to experience new difficulties in breathing, a cough, wheezing after exercise, etc, while taking Bisoprolol tablets.

Children and adolescents

Bisoprolol tablets are not recommended for use in children or adolescents.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take the following medicines with Bisoprolol tablets without special advice from your doctor. However, do not stop taking these medicines without checking with your doctor first:

• Medicines used to treat irregular or abnormal heartbeat (called ‚Class I antiarrhythmic medicines‘, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide or propafenone)
• Medicines used to treat high blood pressure, angina pectoris or an irregular heartbeat (called ‚calcium antagonists‘, such as verapamil or diltiazem)
• Medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine or rilmenidine

Check with your doctor before taking the following medicines with Bisoprolol tablets, your doctor may need to check on your condition more frequently:

• Medicines used to treat high blood pressure or angina pectoris (called ‘dihydropyridine-type calcium antagonists’, such as felodipine and amlodipine)
• Medicines used to treat irregular or abnormal heartbeat (called ‘Class III antiarrhythmic medicines’, such as amiodarone)
• Types of beta-blockers that are applied locally (such as timolol eye drops for glaucoma treatment)
• Medicines used to treat conditions such as Alzheimer's disease or glaucoma (called ‘parasympatho­mimetics’, such as tacrine or carbachol) or medicines that are used to treat acute heart problems (called ‘sympathomimetics’ such as isoprenaline or dobutamine)
• Antidiabetic medicines including insulin
• Anaesthetics (for example during surgery)
• Digoxin, 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 (called ‘tricyclic antidepressants’, such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (called ‘barbiturates’, such as phenobarbital) , or certain medicines to treat mental illness characterised by a loss of contact with reality (called ‘phenothiazines’ such as levomepromazine)
• 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

There is a risk that use of Bisoprolol tablets during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, tell your doctor. They will decide whether you can take Bisoprolol tablets during pregnancy.

It is not known whether bisoprolol passes into human breast milk. Therefore, breast-feeding is not recommended during therapy with Bisoprolol.

Driving and using machines

Your ability to drive or use 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, as well as in combination with alcohol.

3. how to take bisoprolol tablets

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

Treatment with this medicine requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase and when you stop treatment.

Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.

The tablets with a break-line can be divided into two equal doses.

Treatment with this medicine is usually long-term.

Dosage in adults including the elderly:

Treatment with Bisoprolol tablets 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:

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• 1.25 mg once daily for the first week of treatment
• 2.5 mg once daily for the second week of treatment
• 3.75 mg once daily for the third week of treatment
• 5 mg once daily for the fourth, fifth, sixth and seventh weeks of treatment
• 7.5 mg once daily for the eighth, ninth, tenth and eleventh week of treatment
• 10 mg once daily from the twelth week for maintenance (on-going) therapy

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.

Your doctor will tell you what to do.

In some patients a maintenance dose lower than 10 mg bisoprolol may be sufficient.

If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, otherwise your condition may become worse. The maximum recommended daily dose is 10 mg.

Children

Bisoprolol tablets are not recommended for use in children.

If you take more Bisoprolol tablets than you should

If you have taken more tablets than you should, tell your doctor immediately. Your doctor will decide what measures are necessary.

Symptoms of an overdose may include slowing of heart rate, dizziness, low blood pressure, severe difficulty in breathing, worsening of heart failure, or trembling (due to decreased blood sugar).

If you forget to take a tablet

Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.

If you stop taking Bisoprolol tablets

Never stop taking Bisoprolol tablets unless told to by your doctor. Otherwise your condition could become much worse.

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 tablets can cause side effects, although not everybody gets them. Speak to a doctor immediately if a side effect is severe, has occurred suddenly or rapidly gets worse.

Serious side effects

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 contact your doctor, pharmacist or nearest hospital IMMEDIATELY.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Stomach or intestine problems such as nausea, vomiting, diarrhoea or constipation
• Feeling of coldness or numbness in the hands or feet
• Low blood pressure
• Weakness or tiredness

Uncommon (may affect up to 1 in 100 people)

• Breathing problems in patients with asthma or a chronic lung disease
• Muscular weakness and cramps
• Dizziness when standing up
• Sleep problems
• Depression

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

• Certain blood test results for liver function or fat levels differing from normal
• Fainting
• Reduced tear flow
• Hearing problems
• Allergic runny nose
• Allergic reactions such as itching, redness and skin rash. You should see a doctor straight away if you experience more severe allergic reactions, which may involve face, neck, tongue, mouth or throat swelling, or difficulty breathing
• Inflammation of the liver which can cause yellowing of the skin or whites of the eyes
• Erection problems
• Nightmares
• Hallucinations

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

• Irritation and redness of the eye (conjunctivitis)