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BISOPROLOL 7.5 MG FILM-COATED TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL FUMARATE / BISOPROLOL FUMARATE

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Review - 1

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 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 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

Bisoprolol contains Bisoprolol fumarate, which belongs to the
group of medicinal products that are known as beta blockers.
This medicine protects the heart against too much activity. Heart
failure occurs when the heart muscle is too weak to pump blood
around the circulation adequately. This results in breathlessness
and swelling. Bisoprolol works by affecting the body’s response to
some nerve impulses especially in the heart. As a result, it slows
down the heart rate and makes the heart more efficient at pumping
blood around the body.
Bisoprolol is used to treat:
• stable heart failure. Bisoprolol is given as an additional
treatment to other medications for heart failure.
• angina pectoris (pains in the chest caused by blockages in
the arteries that supply the heart muscle)
• 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 fumarate or
any of the other ingredients of Bisoprolol tablets
• if you have severe asthma or severe chronic lung disease
• if you have a slow heart rate (less than 60 beats per minute)
or an irregular heart rate. Ask your doctor if you are not sure
• if you have very low blood pressure
• if you have 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
• if you have heart failure that suddenly becomes worse and/
or may require hospital treatment
• if you have a condition in which there is an accumulation of
excess acid in the blood, a condition known as metabolic
acidosis. Your doctor will be able to advise you.
• if you have untreated phaeochromocytoma, a rare tumour of
the adrenal gland







Consult your doctor if one of the above warnings is applicable to
you, or has been in the past.
Other medicines and Bisoprolol
Tell your doctor or pharmacist if you are taking, have recently
taken or might take 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, dobutamine,
isoprenaline, felodipine, flecainide, lidocaine, methyldopa,
moxonidine, nifedipine, phenytoin, propafenone, quinidine,
rilmenidine, verapamil)
• Medicines for depression e.g. tricyclic antidepressants such
as imipramine, amitriptyline, monoamine oxidase inhibitors
such as moclobemide
• Medicines to treat mental illness e.g. phenothiazines such as
levomepromazine
• Medicines used for anaesthesia during an operation (see
also “Warnings and precautions”)
• 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)
• Medicines used for prevention or treatment of malaria e.g.
mefloquine
• Medicines for Alzheimer’s Disease or glaucoma (known as
parasympathomimetics, such as tacrine or carbachol)
• Medicines known as sympathomimetics such as adrenaline
and noradrenaline which are used in the treatment of heart
attack and low blood pressure. Adrenaline is also used to
treat allergic reactions. Higher doses of adrenaline may be
necessary for treatment of allergic reactions if Bisoprolol is
being taken at the same time.
• Moxisylyte, which is used to treat circulatory problems like
Raynaud’s syndrome
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.

Tell your doctor if you are not sure about any of the above: your
doctor will be able to advise you.

Bisoprolol with food and drink
Bisoprolol may be taken with or without food and should be
swallowed whole with a drink of water.

Warnings and precautions
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 being treated for hypersensitivity (allergic) reactions.

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.
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

Always take Bisoprolol exactly as your doctor has told you. 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:
Stable chronic heart failure
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.
Adults and older people:
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.
Use in children:
Bisoprolol is not recommended for use in children.
Hypertension or angina pectoris
Adults:
The usual daily dose is 10 mg bisoprolol.
Depending on how well you respond to the medicine, your doctor
may decide to decrease the dose to 5 mg or he may decide to
increase it to 20 mg. The dose should not exceed 20 mg in one
day. Your doctor will tell you what to do. The label will also tell
you how many tablets to take and how often to take them. Your
pharmacist will help if you are unsure.
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.
Patients with kidney disease
Patients with severe kidney disease should not exceed 10 mg of
bisoprolol once daily. Please consult your doctor before starting to
use this medicine.
Patients with liver disease
Patients with severe liver disease should not exceed 10 mg of
bisoprolol once daily. Please consult your doctor before starting to
use this medicine.
Children under 12 years and adolescents
The use of Bisoprolol is not recommended as there is no
experience with this medicine in children under 12 years and
adolescents.

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Package Leaflet: Information for the user

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 “Other medicines and Bisoprolol”
have (or have had) psoriasis (a recurring skin rash)
have been treated for a condition called
‘phaeochromocytoma’ (a rare 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

Size: 280 x 360 mm

P15xxxxx
Bisoprolol Fumarate






P15xxxxx
Bisoprolol Fumarate

Bisoprolol fumarate - Leaflet - UK

Review - 1

Bisoprolol fumarate - Leaflet - UK

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, 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
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.






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 (may affect up to 1 in 10,000 people):
• Aggravation of the skin condition psoriasis or the appearance
of a similar dry, scaly rash
• Hair loss
• Itchiness or redness of the eye (conjunctivitis)
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: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of this
medicine.
5.

How to store Bisoprolol

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.

Keep this medicine out of the sight and reach of children.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Do not use this medicine 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.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
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 (may affect up to 1 in 10 people)
• Worsening of heart failure causing increased breathlessness
and / or retention of fluid
Not known (frequency cannot be estimated from the available
data)
• Worsening of symptoms of blockage of the main blood
vessels to the legs, especially at the start of treatment

Store below 25 °C. 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.

6.

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 revised in 11/2014

Contents of the pack and other 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

Common (may affect up to 1 in 10 people):
• Tiredness*, weakness
• Dizziness*
• Headache* (especially at the beginning of therapy; these are
generally mild and often disappear within 1-2 weeks)
• Feeling of coldness or numbness in hands or feet
• low blood pressure
• Feeling sick (nausea), being sick (vomiting)
• Diarrhoea
• Constipation

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.

* These symptoms especially occur at the beginning of treatment,
or if your dosage changes in patients with hypertension or angina
pectoris. They are generally mild and often disappear within 1 to 2
weeks.

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.

Rare (may affect up to 1 in 1,000 people):
• Nightmares
• Hallucinations (imagining things)
• Hearing problems
• Inflammation of the lining of the nose, causing a blocked,
runny nose with irritation
• Allergic reactions (itching, flushed appearance, rash)

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

Do not throw away any medicine via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

The following side-effects have also been reported:
Very common (may affect more than 1 in 10 people):
• Slow heart beat

Uncommon (may affect up to 1 in 100 people):
• Light-headedness
• Sleep disturbances
• Depression
• Worsening of irregular heart beat
• Breathing problems in patients with asthma or chronic lung
disease
• Muscle weakness, muscle cramps

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 1.25 mg film-coated tablets are white, circular, biconvex,
debossed with ‘P’ on one side and ‘1’ on the other side.

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 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 (for 1.25mg strength),
Cold form (Alu-Alu) blister with push through lidding foil (For
2.5mg, 3.75mg, 5mg, 7.5mg & 10mg strengths) 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

Font type: Helvetica TT
Font type: 8 pt.

Stable chronic heart failure and Hypertension or angina
pectoris
If you notice that the effect of Bisoprolol is too strong or not strong
enough, please consult your doctor or pharmacist.



Size: 280 x 360 mm

Older people
In general an adjustment of the dose is not needed.

Expand Transcript

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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