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BISOPROLOL 2.5 MG FILM-COATED TABLETS

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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
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 or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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.
In this leaflet:
1. What Bisoprolol is and what it is used for
2. Before you take Bisoprolol
3. How to take Bisoprolol
4. Possible side effects
5. How to store Bisoprolol
6. Further information
1.

WHAT BISOPROLOL IS AND WHAT IT IS USED FOR

Bisoprolol contains Bisoprolol fumarate, which belongs to the group of medicinal products that are known
as beta blockers.
Bisoprolol is used to treat:
 Stable heart failure. Bisoprolol is given as an additional treatment to other medications for heart
failure.
Heart failure occurs when the heart muscle is too weak to pump blood around the circulation adequately.
This results in breathlessness and swelling. Bisoprolol slows down the heart rate and makes the heart more
efficient at pumping blood around the body.
2.

BEFORE YOU TAKE BISOPROLOL

DO NOT take Bisoprolol if you:
 are allergic (hypersensitive) to bisoprolol fumarate or any of the other ingredients of Bisoprolol tablets
 have severe asthma or severe chronic lung disease
 have a slow heart rate (less than 60 beats per minute) or an irregular heart rate. Ask your doctor if you
are not sure
 have very low blood pressure
 have severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale
or blue)
 have heart failure that suddenly becomes worse and/ or may require hospital treatment
 have excess acid in the blood, a condition known as metabolic acidosis
 have untreated phaeochromocytoma, a rare tumour of the adrenal gland
Tell your doctor if you are not sure about any of the above: your doctor will be able to advise you.
Take special care with Bisoprolol
Talk to your doctor before taking Bisoprolol if you:














have asthma or chronic lung disease
have diabetes. Bisoprolol can hide the symptoms of low blood sugar
are fasting from solid food
are treated for hypersensitivity (allergic) reactions. Bisoprolol may make your allergy worse or often
difficult to treat.
have any heart problems
have any liver or kidney problems
have any problems with the circulation in your limbs
are going to be given a general anaesthetic during an operation – tell your doctor that you are taking
bisoprolol
are taking verapamil or diltiazem, medicines used to treat heart conditions. Concomitant use is not
recommended, see also “taking other medicines”
have (or have had) psoriasis (a recurring skin rash)
have phaeochromocytoma (tumour of the adrenal gland). Your doctor will need to treat this before
prescribing bisoprolol for you
have a thyroid problem. The tablets can hide symptoms of an overactive thyroid

Consult your doctor if one of the above warnings is applicable to you, or has been in the past.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. Certain medicines cannot be used at the same time,
while other drugs require specific changes (to the dose, for example).
Do not take the following medicines with Bisoprolol without special advice from your doctor:
 Medicines for controlling the blood pressure or medicines for heart problems (such as amiodarone,
amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine,
methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil)
 Medicines for depression e.g. imipramine, amitriptyline, moclobemide
 Medicines to treat mental illness e.g. phenothiazines such as levomepromazine
 Medicines used for anaesthesia during an operation (see also “Take special care with Bisoprolol”)
 Medicines used to treat epilepsy e.g. barbiturates such as phenobarbital
 Certain pain killers (for instance acetyl salicylic acid, diclofenac, indomethacin, ibuprofen, naproxen)
 Medicines for asthma or medicines used for a blocked nose
 Medicines used for certain eye disorders such as glaucoma (increased pressure in the eye) or used to
widen the pupil of the eye.
 Certain medicines to treat clinical shock (e.g. epinephrine, dobutamine, norepinephrine)
 Mefloquine, a medicine for malaria
All these drugs as well as bisoprolol may influence the blood pressure and/or heart function.
 Rifampicin for the treatment of infections
 medicines to treat severe headaches or migraines (ergotamine derivatives).
It is also especially important to speak with your doctor if you are taking:
 Insulin or other products for diabetes. The blood glucose reducing effect may be enhanced. Symptoms
of low blood glucose level can be masked.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Taking Bisoprolol with food and drink
Bisoprolol may be taken with or without food and should be swallowed whole with a drink of water.
Pregnancy and breast-feeding
Do not take bisoprolol if you are pregnant or may be pregnant. Bisoprolol may be harmful to the pregnancy
and/or the unborn child. There is an increased possibility of premature birth, miscarriage, low blood sugar
level and reduced heart rate of the child. The growth of the baby may also be affected.

It is not known if bisoprolol is excreted in the breast milk and therefore it is not recommended while
breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These tablets may make you feel tired, drowsy or dizzy. If you suffer from these side effects, do not
operate vehicles and/or machines. Be aware of the possibility of these effects, particularly at the beginning
of the treatment, with changes in medication and with use in combination with alcohol.
3.

HOW TO TAKE BISOPROLOL

Before you start using Bisoprolol you should already be taking other medicines for heart failure including
an ACE-inhibitor, a diuretic and (as an added option) a cardiac glycoside.
Always take Bisoprolol exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.




Your doctor will tell you how many tablets to take.
You should take Bisoprolol in the morning, before, with or after breakfast.
Swallow the tablet/s with some water and do not chew or crush them.

The dose of Bisoprolol will be increased gradually until the dose that is suitable for you has been found:
Adults and elderly: the usual dose is
1.25 mg once daily for 1 week. If this is well tolerated, the dose may be increased to:
2.5 mg once daily during the next week. If this is well tolerated, the dose may be increased to:
3.75 mg once daily during the next week. If this is well tolerated, the dose may be increased to:
5 mg once daily during the next 4 weeks. If this is well tolerated, the dose may be increased to:
7.5 mg once daily during the next 4 weeks. If this is well tolerated, the dose may be increased to:
10 mg once daily as a maintenance dose.
Maximum dose: once daily 10 mg.
The doctor will determine the most suitable dose for you based on your tolerance to bisoprolol and side
effects.
Your heart rate and blood pressure will be monitored closely as the dose is increased.
Patients with liver or kidney problems:
Your doctor will take extra care when adjusting the dose of Bisoprolol.
Children:
Bisoprolol is not recommended for use in children.
If you notice that the effect of Bisoprolol is too strong or not strong enough, please consult your doctor or
pharmacist.
Duration of the treatment
Bisoprolol will usually be used long-term.
If you take more Bisoprolol than you should
If you have accidentally taken more than the prescribed dose, tell your doctor/pharmacist immediately.
Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken.
Symptoms of overdose may include dizziness, light-headedness, fatigue, breathlessness and/or wheezing.
Also, there may be reduced heart rate, reduced blood pressure, insufficient action of the heart and a low
blood glucose level (which may involve feelings of hunger, sweating and palpitations).

If you forget to take Bisoprolol
Do not take a double dose to make up for a forgotten dose. Take the normal dose as soon as you remember
and then carry on with the usual dose the next day.
If you stop taking Bisoprolol
Treatment with Bisoprolol must not be stopped abruptly. If you suddenly stop taking this medicine your
condition may get worse. The dose of bisoprolol must be reduced gradually over a few weeks as advised
by your doctor.
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 can cause side effects, although not everybody gets them.
Side effects can occur with the following frequencies:
very common:
affects more than 1 user in 10
common:
affects 1 to 10 users in 100
uncommon:
affects 1 to 10 users in 1,000
rare:
affects 1 to 10 users in 10,000
very rare:
affects less than 1 user in 10,000
not known:
frequency cannot be estimated from the available data
The following side effects are important and will require immediate action if you experience them. You
should stop taking Bisoprolol and see your doctor immediately if the following symptoms occur:
Common effects
 Worsening of heart failure causing increased breathlessness and / or retention of fluid
Frequency not stated
 Worsening of symptoms of blockage of the main blood vessels to the legs, especially at the start of
treatment
The following side-effects have also been reported:
Very Common:
 Slow heart beat
Common:
 Tiredness, weakness
 Dizziness
 Headache (especially at the beginning of therapy; these are generally mild and often disappear within 12 weeks)
 Feeling of coldness or numbness in hands or feet
 low blood pressure
 Feeling sick (nausea), being sick (vomiting)
 Diarrhoea
 Constipation
Uncommon:
 Light-headedness
 Sleep disturbances
 Depression
 Irregular heart beat
 Breathing problems in patients with asthma or chronic lung disease
 Muscle weakness, muscle cramps

Rare:
 Nightmares
 Hallucinations (imagining things)
 Hearing problems
 Inflammation of the lining of the nose, causing a runny nose with irritation
 Allergic reactions (itching, flushed appearance, rash)
 Dry eyes from reduced tear flow (can be very troublesome if you use contact lenses)
 Inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite and sometimes jaundice
with yellowing of the whites of the eyes and skin and dark urine
 Reduced sexual performance (potency disorder)
 Change in blood test results
 Fainting
Very Rare:
 Aggravation of the skin condition psoriasis or the appearance of a similar dry, scaly rash
 Hair loss
 Itchiness or redness of the eye (conjunctivitis)
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.
5.

HOW TO STORE BISOPROLOL

Keep out of the reach and sight of children.
Store below 25 ºC. Store in the original package in order to protect from light.
[HDPE bottle of 500 tablets]
Use within 6 months after first opening the HDPE bottle.
Do not use Bisoprolol after the expiry date which is stated on the carton and blister/ bottle 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. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Bisoprolol contains
The active substance is bisoprolol fumarate. Each tablet contains 1.25 mg, 2.5 mg, 3.75 mg, 5 mg,
7.5 mg or 10 mg bisoprolol fumarate.
The other ingredients are: Cellulose microcrystalline, calcium hydrogen phosphate anhydrous, silica
colloidal anhydrous, crospovidone (Type A), magnesium stearate.
Tablet coat: Hypromellose 6cP (E464), Titanium Dioxide (E171), Macrogol 400
What Bisoprolol looks like and contents of the pack
Bisoprolol 1.25 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ on one side and ‘1’
on the other side.
Bisoprolol 2.5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one
side and ‘2’ on the other side. The tablet can be divided into equal halves.
Bisoprolol 3.75 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on
one side and ‘3’ on the other side. The tablet can be divided into equal halves.

Bisoprolol 5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one
side and ‘5’ on the other side. The tablet can be divided into equal halves.
Bisoprolol 7.5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one
side and ‘7’ on the other side. The tablet can be divided into equal halves.
Bisoprolol 10 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one
side and ‘10’ on the other side. The tablet can be divided into equal halves.
Bisoprolol film-coated tablets are available in cold form Aluminum-Aluminum blisters with peelable
lidding foil and HDPE bottle packs.
Pack sizes:
Bisoprolol 1.25 mg film-coated tablets:
Blister pack: 1, 10, 20, 28, 30 film-coated tablets
Bottle pack: 30, 500 film-coated tablets
Bisoprolol 2.5 mg film-coated tablets:
Blister pack: 10, 14, 28, 30, 100 film-coated tablets
Bottle pack: 30, 500 film-coated tablets
Bisoprolol 3.75 mg film-coated tablets:
Blister pack: 10, 28, 30, 56, 100 film-coated tablets
Bottle pack: 30, 500 film-coated tablets
Bisoprolol 5 mg film-coated tablets:
Blister pack: 7, 10, 28, 30, 50, 56, 100 film-coated tablets
Bottle pack: 30, 500 film-coated tablets
Bisoprolol 7.5 mg film-coated tablets:
Blister pack: 10, 28, 30, 100 film-coated tablets
Bottle pack: 30, 500 film-coated tablets
Bisoprolol 10 mg film-coated tablets:
Blister pack: 10, 28, 30, 56, 90, 100 film-coated tablets
Bottle pack: 30, 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
This leaflet was last approved in

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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.

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