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BISOPROLOL 10MG FILM-COATED TABLETS

Active substance(s): BISOPROLOL FUMARATE

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If any of the above listed side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Reporting of 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: http://www.mhra.gov.uk/yellowcard.
By reporting side affects you can help provide more information on the safety of Sertraline
tablets.

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

5. How to store Bisoprolol tablets
Keep 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 no longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Bisoprolol tablets contain:
The 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, magnesium stearate.
Film coating (1.25 mg tablets and 2.5 mg tablets): Hypromellose, Macrogol 400 and
Titanium dioxide (E1 71).
Film coating (3. 75 mg tablets, 5 mg tablets and 7.5 mg tablets): Hypromellose, Macrogol
400, Titanium dioxide (E171), Ferric oxide yellow (E172).
Film coating (10 mg tablets): Hypromellose, Macrogol 400, Titanium dioxide (E171), Ferric
oxide yellow (E172) , 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:
Key Pharmaceuticals Ltd.
Galen House, 83 High Street
Somersham, Cambridgeshire, PE28 3JB UK
Manufacturer:
MEDREICH LIMITED
Survey No. 4/3, Avalahalli
Anjanapura Post, Off Kanakpura Road
Bangalore - 560 062, INDIA.
This leaflet may be supplied in audio format for blind and partially sighted patients upon request.
This leaflet was last revised in March 2017.

6 mm

PC No.
15 mm

121XXXX-V1

50 mm

19.5 mm

60.5 mm

bisoprolol fumarate
Your medicine is called Bisoprolol 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 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 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).
2. What you need to know before you take Bisoprolol tablets
Do not take Bisoprolol tablets if you:
• are allergic (hypersensitive) to bisoprolol 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, 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
Take special care and tell your doctor, if you:
suffer from less severe 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 tumour of the adrenal gland (phaeochromocytoma)
• have thyroid problems

• 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
• are going to have anaesthesia (for example for surgery), because bisoprolol may influence
how your body reacts to this situation
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, propafenone)
• Medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (called
'calcium antagonists' such as verapamil and diltiazem)
• Medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine,
rilmenidine
Check with your doctor before taking the following medicines with Bisoprolol
tablets; your doctor may need to check 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 for example 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 and dobutamine)
• Antidiabetic medicines including insulin
• Anaesthetics (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 (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 characterized 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. He or she will decide whether
you can take Bisoprolol tablets during pregnancy.
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. 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 and during dose increase.
Take the tablet with some water in the morning, with or without food. Do not crush or chew
the tablet.
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:
• 1.25 mg Bisoprolol once daily for the first week of treatment
• 2.5 mg Bisoprolol once daily for the second week of treatment
• 3.75 mg Bisoprolol once daily for the third week of treatment
• 5 mg Bisoprolol once daily for the fourth, fifth, sixth and seventh weeks of treatment
121XXXX-V1

• 7.5 mg Bisoprolol once daily for the eighth, ninth, tenth and eleventh week of treatment
• 10 mg Bisoprolol once daily from the twelfth 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, as otherwise your condition may become worse. The maximum recommended
daily dose is 10 mg.
Children
Bisoprolol is 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 slowed 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, occurred suddenly or gets worse
rapidly.
Serious Side Effects
The most serious side effects are related to the heart function:
• Slowing of heart rate
• Worsening of heart failure
• Irregular heartbeat
If you feel dizzy or weak, or have breathing difficulties contact your doctor, pharmacist or
nearest hospital IMMEDIATELY.
Other side effects include:
Common (affects between 1 in 10 and 1 in 100 patients)
• Dizziness
• Headache
• Stomach or intestine problems such as nausea, vomiting, diarrhoea or constipation
• Feeling of coldness in the hands or feet
• Low blood pressure
• Weakness or tiredness
Uncommon (affects between 1 in 100 and 1 in 1,000 patients)
• Breathing problems in patients with asthma or a chronic lung disease
• Muscular weakness and cramps
• Dizziness when standing up
• Sleep problems
• Depression
Rare (affects between 1 in 1,000 and 1 in 10,000 patients)
• 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, flush and rash
• Inflammation of the liver which can cause yellowing of the skin or whites of the eyes
• Erection problems
• Nightmares
• Hallucinations
Very rare (affects less than 1 in 10,000 patients)
• Irritation and redness of the eye (conjunctivitis)
• Hair loss
• Appearance or worsening of scaly skin rash (psoriasis or psoriasis-like rash)

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