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Active substance(s): BISOPROLOL FUMARATE

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Package leaflet: information for the user

Bisoprolol 5mg and 10mg Tablets
Bisoprolol fumarate
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 any of the side effects talk to your doctor or 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 is and what it is used for
2. What you need to know before you take Bisoprolol
3. How to take Bisoprolol
4. Possible side effects.
5. How to store Bisoprolol
6. Contents of the pack and other information

1. What Bisoprolol is and what it is used for
The name of this medicine is Bisoprolol 5mg Tablets or Bisoprolol 10mg Tablets referred to as Bisoprolol throughout this leaflet.
Bisoprolol belongs to a group of medicines commonly called ‘beta-blockers’ which work by blocking the transmission of certain nerve
impulses. Bisoprolol is used to help treat:

angina pectoris (chest pain)

hypertension (high blood pressure).

2. What you need to know before you take Bisoprolol
Do not take Bisoprolol if you:

are allergic (hypersensitive) to bisoprolol or any of the other ingredients in this medicine (listed in Section 6)

are in acute heart failure or if you require injection of inotropic drugs (drugs which increase the force of contraction of the heart)

have had cardiogenic shock (a condition in which your heart is unable to pump enough blood to your body)

suffer from heart block

suffer from low heart rate or your heart rate is abnormal because of a condition known as sick sinus syndrome

have very poor circulation or Raynaud’s Syndrome

have unusually low blood pressure

have a tumour of the adrenal gland (phaeochromocytoma)

suffer from severe asthma or have severe breathing difficulties

suffer from metabolic acidosis (a disorder of the metabolism which causes the blood to become acidic)
Do not take Bisoprolol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bisoprolol.
Warnings and precautions
Check with your doctor or pharmacist before taking your medicine if any of the following apply to you. You may need to be given a
different dose or a different medicine if:

you suffer from heart failure (the treatment of heart failure is very different)

you suffer from asthma or any other lung disease

you have diabetes mellitus (sugar diabetes)

you have a history of allergies, including any for which you are undergoing desensitising treatment

you have first degree heart block

you suffer chest pain at rest

you have poor circulation

you have psoriasis (a type of rash)

you have an overactive thyroid

you have a tumour of the adrenal gland (phaeochromocytoma) which is being treated with drugs

you have kidney or liver disease

you are pregnant, might become pregnant or are breast-feeding

you are fasting
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Bisoprolol.
Other medicines and Bisoprolol
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained
without a prescription or herbal medicines. This is because Bisoprolol can affect the way some other medicines work. Also some other
medicines can affect the way Bisoprolol works.
Please tell your doctor or pharmacist if you are taking any of the following:

medication to treat heart disease or high blood pressure

medication for irregular heartbeat

medication for angina or poor blood circulation

medication for epilepsy, depression or mental illness

medication for migraine such as clonidine

medication for diabetes such as insulin or oral diabetic drugs

cough medicines

eye or nose drops
moxisylyte used to treat erectile dysfunction
mefloquine used as an anti-malarial drug
anaesthetics agent (for example during surgery)
non–steriodal anti-inflammary medicines (NSAIDs) used to treat arthritis, pain or inflammation(for example ibuprofen or diclofenac)

Tests and operations
If you are going to have an operation or any form of surgery (even at the dentist) please inform your doctor and ensure that the
anaesthetist or dentist and other relevant medical personnel know that you are taking Bisoprolol.
Pregnancy, breast-feeding and fertility
Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. Adverse effects
(e.g. hypoglycaemia and bradycardia) may occur in the foetus and newborn infant.
Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, the
uteroplacental blood flow and the foetal growth should be monitored. In case of harmful effects on pregnancy or the foetus
alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and
bradycardia are generally to be expected within the first 3 days.
It is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended during administration of
Driving and using machines
You may find that your reactions are impaired when taking Bisoprolol, particularly during the first few weeks of your treatment, during
changes to your medication or if you have also drunk alcohol. Therefore it is very important that you do not drive or use any tools or
machines if you are affected.

Always take Bisoprolol exactly as your doctor has told you. The doctor, depending on your needs and the condition being treated, will
decide the dose of Bisoprolol. You should check with your doctor or pharmacist if you are not sure. Check with your doctor or
pharmacist if you are not sure.
Taking this medicine

Swallow the tablets whole with a glass of water

If you have the impression that the effect of Bisoprolol is too strong or too weak, talk to your doctor or pharmacist.
How much to take – adults and older people

The usual dose is either two 5mg tablets or one 10mg tablet (10mg) daily.

Your doctor may decide to increase or decrease this dose.

The dose should not exceed 20mg in one day.

Do not stop taking this medicine except on your doctor’s advice. In some cases, it may be necessary to stop taking your medicine
Patients with severe liver or kidney problems

Your doctor may decide to decrease the usual adult dose.

The dose should not exceed 10mg in one day.
Children (less than 18 years of age)

Do not give to children aged less than 18 years.
If you take more Bisoprolol than you should

If you take more Bisoprolol than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Bisoprolol

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose

Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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

skin rash, itching, swollen or lumpy skin, swollen face, lips, tongue or throat, difficulty breathing

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

feeling of coldness or numbness in the fingers or toes,

tiredness, exhaustion, dizziness or headache

stomach or intestine problems such as nausea, vomiting, diarrhoea or constipation

worsening of heart failure

low blood pressure

Uncommon: may affect up to 1 in 100 people

interference with the normal heart rate, worsening of heart failure, low blood pressure upon standing up
muscle weakness and cramps
sleep disturbances, depression
breathing problems in patients with asthma or chronic lung disease

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

nightmares, hallucinations

skin reactions (itching, flushing, rash)

increased liver enzymes (yellowing of your skin or the whites of your eyes)

increased blood levels of some fats

an inability to achieve or maintain an erection in men (impotence)

hearing loss, runny nose or dry eyes.


reduced tear flow

hearing disorders

allergic rhinitis
Very rare: may affect up to 1 in 10,000 people
 red itching inflammation in the eye (conjunctivitis)
 worsening of psoriasis or the development of a psoriasis-like rash, alopecia (hair loss)
 chest pain
Side effects more usual in heart failure patients:

tiredness, exhaustion, dizziness or headache
These side effects at the beginning are usually mild and disappear after 1 -2 weeks of treatment.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 the Yellow Card Scheme at or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children
Do not store above 30°C.
Do not use Bisoprolol after the expiry date which is stated on the carton after EXP. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no
longer required which will help protect the environment.

What Bisoprolol contains

The drug substance is Bisoprolol fumarate

Each film-coated tablet contains either 5mg or 10mg of the drug substance as bisoprolol fumarate.

The other ingredients are maize starch, microcrystalline cellulose, crospovidone, anhydrous calcium hydrogen phosphate,
magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), macrogol, dimeticone and iron oxide yellow
(E172) .
What Bisoprolol Tablets look like and contents of the pack

Bisoprolol 5mg Tablets are ivory, film-coated tablets with a scoreline.

Bisoprolol 10mg Tablets are ivory, film-coated tablets with a scoreline.
Bisoprolol is only available from your pharmacist on prescription in pack sizes of 28 tablets.
MA Holder: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park, Liverpool L30 1RD, UK
Date leaflet last revised: September 2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.