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BISOPROLOL FUMARATE 7.5MG FILM-COATED TABLETS

Active substance: BISOPROLOL FUMARATE

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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 Fumarate is and what it is used for
2. Before you take Bisoprolol Fumarate
3. How to take Bisoprolol Fumarate
4. Possible side effects
5. How to store Bisoprolol Fumarate
6. Further information
1. WHAT BISOPROLOL FUMARATE IS AND WHAT IT IS USED
FOR
Bisoprolol Fumarate contains Bisoprolol fumarate, which belongs to
the group of medicinal products that are known as beta blockers.
Bisoprolol Fumarate 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 FUMARATE
Do not take Bisoprolol Fumarate if you:
• are allergic (hypersensitive) to bisoprolol fumarate or any of the
other ingredients of Bisoprolol Fumarate
• have severe asthma or severe chronic lung disease
• have a slow or 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 Fumarate
Talk to your doctor before taking Bisoprolol Fumarate 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).

P150

P150

Bisoprolol Fumarate

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisoprolol Fumarate 2.5 mg film-coated tablets
Bisoprolol Fumarate 3.75 mg film-coated tablets
Bisoprolol Fumarate 5 mg film-coated tablets
Bisoprolol Fumarate 7.5 mg film-coated tablets
Bisoprolol Fumarate 10 mg film-coated tablets
Bisoprolol fumarate

Black

Bisoprolol Fumarate

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Do not take the following medicines with Bisoprolol Fumarate
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 Fumarate ”)
• 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. adrenaline,
dobutamine, noradrenaline)
• 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 Fumarate with food and drink
Bisoprolol Fumarate 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 Fumarate 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.
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this 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 FUMARATE
Before you start using Bisoprolol Fumarate 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 Fumarate 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 Fumarate 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 Fumarate 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 Fumarate.





Children
Bisoprolol Fumarate is not recommended for use in children.

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 you notice that the effect of Bisoprolol Fumarate is too strong or
not strong enough, please consult your doctor or pharmacist.
Duration of the treatment
Bisoprolol Fumarate will usually be used long-term.
If you take more Bisoprolol Fumarate 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, lightheadedness, 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 Fumarate
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 Fumarate
Treatment with Bisoprolol Fumarate 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 Fumarate 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
Fumarate 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
• 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

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 FUMARATE
Keep out of the reach and sight of children.
Store below 25ºC.
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 Fumarate after the expiry date which is
stated on the carton/ 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. OTHER INFORMATION
What Bisoprolol Fumarate contains
- The active substance is bisoprolol fumarate. Each tablet
contains 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 Fumarate looks like and contents of the pack
Bisoprolol Fumarate 2.5 mg film-coated tablets are white, circular,
biconvex, debossed with `P' and breakline on one side and `2' on
the other side. The tablet can be divided into equal halves.
Bisoprolol Fumarate 3.75 mg film-coated tablets are white, circular,
biconvex, debossed with `P' and breakline on one side and `3' on
the other side.
Bisoprolol Fumarate 5 mg film-coated tablets are white, circular,
biconvex, debossed with `P' and breakline on one side and `5' on
the other side. The tablet can be divided into equal halves.
Bisoprolol Fumarate 7.5 mg film-coated tablets are white, circular,
biconvex, debossed with `P' and breakline on one side and `7' on
the other side. The tablet can be divided into equal halves.
Bisoprolol Fumarate 10 mg film-coated tablets are white, circular,
biconvex, debossed with `P' and breakline on one side and `10' on
the other side. The tablet can be divided into equal halves.
Bisoprolol Fumarate film-coated tablets are available in cold form
Polyamide /Aluminum/ PVC/ –Aluminum blisters and HDPE bottle
packs.
Pack sizes:
Blister pack: 20, 28, 30, 50, 90, 100 film-coated tablets
Bottle pack: 30, 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 09/2014.

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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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