BISOPROLOL 5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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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.

The name of your medicine is ‚Bisoprolol 5mg film-coated Tablets or Bisoprolol 10mg film-coated Tablets‘ but it will be referred as ‚Bisoprolol Tablets‘ throughout the leaflet.

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

The active ingredient in Bisoprolol Tablets is Bisoprolol fumarate.

Bisoprolol belongs to a group of drugs called beta-blockers. These medicines protect heart against too much activity.

It may be used to treat angina pectoris (pains in the chest caused by blockages in the arteries leading to the heart) or hypertension (high blood pressure).

2. what you need to know before you take bisoprolol tablets

DO NOT take Bisoprolol Tablets if one of the following applies to you:

• Allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (are allergic (hypersensitive) to Bisoprolol or any of the other ingredients of Bisoprolol Tablets (See Section “What Bisoprolol Tablets contain”)
• severe asthma
• 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 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

If you have any of the following conditions tell your doctor before taking Bisoprolol; 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
• chronic lung disease or less severe asthma

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 Bisoprolol may influence how your body reacts to this situation.

If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using Bisoprolol.

Children and adolescents

Bisoprolol is not recommended for use in children or adolescents

Other medicines and Bisoprolol Tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines , have recently taken or might take other medicines.

Do not take the following medicines with Bisoprolol 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; 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-blockers 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)
• 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

Pregnancy

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

Breast-feeding

It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding 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. Please 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.

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3. how to take bisoprolol tablets

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

Treatment with Bisoprolol 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 scored tablets can be divided into two equal doses. Treatment with Bisoprolol is usually long-term.

Adults including the elderly:

Treatment with bisoprolol must be started at a low dose and increased gradually.

The maximum daily dose is 10mg.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.

If you take more Bisoprolol Tablets than you should

If you have taken more bisoprolol tablets than you should, tell your doctor immediately. Your doctor will decide what measures are necessary. Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing, feeling dizzy, or trembling (due to decreased blood sugar).

If you forget to take Bisoprolol Tablets

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

Treatment with Bisoprolol Tablets must not be stopped abruptly unless on your doctor’s advice. 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.

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, diarrhea, or constipation.
• Sleep disturbances
• Depression
• Dizziness when standing up
• Breathing problems in patients with asthma or chronic lung disease.
• Muscle weakness, cramps
• 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
• Appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.
• Hair loss
• Irritation and redness of the eye (conjunctivitis)

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store bisoprolol tablets

• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Bisoprolol after the expiry date (EXP) which is stated on the blister and the carton. The expiry date refers to the last date of that month.
• Do not throw away any medicines via wastewater or household waste.

6. contents of the pack and other information

What Bisoprolol Tablets contain

The inactive ingredients are: maize starch, microcrystalline cellulose, crospovidone, anhydrous calcium hydrogen phosphate, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), macrogol 6000, dimeticone 350 and yellow iron oxide (E172).

Bisoprolol 10mg Tablets also contain red iron oxide (E172)

What Bisoprolol Tablet looks like and contents of the pack

Bisoprolol 5mg Tablets are round, biconvex, film-coated tablets with break line on one side and embossed with “5” on the other side, diameter 7 mm, ivory colour.

Bisoprolol 10mg Tablets are round, biconvex, film-coated tablets with break line on one side and embossed with “10” on the other side, diameter 7 mm, light brown colour.

They are each available in blister packs of 28 tablets.

Marketing Authorisation Holder

Name and address: RxFarma, Colonial Way, Watford, Hertfordshire, WD24 4YR, United Kingdom.

Manufacturer

Name and address: Rx Farma Limited, Unit 3 Colonial Way, Watford, Hertfordshire, WD24 4YR, United Kingdom.

Bisoprolol 5mg Film coated Tablets; PL 36722/0069

Bisoprolol 10mg Film-coated Tablets; PL 36722/0070

This leaflet was last revised in September 2021

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.