BISOPROLOL FUMARATE 2.5 MG FILM-COATED TABLETS

Active substance: BISOPROLOL FUMARATE

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Package leaflet: Information for the user

Bisoprolol Fumarate 1.25, 2.5 mg, 3.75 mg and 7.5 mg
Film-coated Tablets

SZ00000LT000

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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet.

What is in this leaflet:
1. What Bisoprolol fumarate is and what it is used for
2. What you need to know before you take Bisoprolol fumarate
3. How to take Bisoprolol fumarate
4. Possible side effects
5. How to store Bisoprolol fumarate
6. Contents of the pack and other information

1

Always tell your doctor if you are using or receiving any of the
following medicines in addition to Bisoprolol fumarate:
• 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).
• Sedatives and therapies for psychosis (a mental illness) e.g.
barbiturates (also used for epilepsy), phenothiazines (also
used for vomiting and nausea).
• Medicines for depression e.g. tricyclic antidepressants,
MAO-A inhibitors.
• Medicines used for anaesthesia during an operation (see also
section “Warnings and precautions”).
• Certain pain killers (for instance acetyl salicylic acid,
diclofenac, indomethacin, ibuprofen, naproxen).
• Medicines for asthma, blocked nose or certain eye disorders
such as glaucoma (increased pressure in the eye) or dilation
(widening) of the pupil.
• Certain medicines to treat shock (e. g. adrenaline,
dobutamine, noradrenaline).
• Mefloquine, a medicine for malaria.
• The antibiotic rifampicin.
• Ergotamine derivatives for migraine.
All these drugs as well as bisoprolol may influence the blood
pressure and/or heart function.

What Bisoprolol fumarate is and what it is
used for

Bisoprolol fumarate belongs to the group of medicinal products
that are indicated as beta blockers. They protect the heart from
too much activity.
Bisoprolol fumarate is used to treat:
• Heart failure causing breathlessness on exertion or fluid
retention. In this instance, Bisoprolol may be given as an
additional treatment to other medications for heart failure.

2

What you need to know before you take
Bisoprolol fumarate

Do not take Bisoprolol fumarate
• if you are allergic to bisoprolol fumarate or any of the other
ingredients of this medicine (listed in section 6).
• if you have a cardiogenic shock, a serious heart condition
causing a rapid, weak pulse; low blood pressure; cold,
clammy skin; weakness and fainting.
• if you have ever suffered from severe wheezing or severe
asthma, as they can affect your breathing.
• if you have a slow heart rate (less than 60 beats per minute).
Ask your doctor if you are not sure.
• if you have very low blood pressure.
• if you have severe blood circulation problems (which may
cause your fingers and toes to tingle or turn pale or blue).
• if you have certain serious heart rhythm problems.
• if you have heart failure which has just occurred or is not
stabilised and is requiring hospital treatment.
• if you have a condition in which there is an accumulation of
excessive acid in the body known as metabolic acidosis. Your
doctor will be able to advise you.
• if you suffer from a tumour of the adrenal glands known as
phaeochromocytoma which is untreated.

• Insulin or other products for diabetes. The blood glucose
reducing effect may be enhanced. Symptoms of low blood
glucose level can be masked.

Bisoprolol fumarate with alcohol
The dizziness and light-headedness that may be caused by
Bisoprolol fumarate can be made worse if you drink alcohol. If
this happens to you, you should avoid drinking alcohol.

Tell your doctor if you are not sure about any of the above.

Warnings and precautions
Talk to your doctor before taking Bisoprolol fumarate
• if you suffer from wheezing or difficulty breathing (asthma).
Bronchodilating therapy should be given concomitantly. A
higher dose of beta2-stimulants may be needed.
• if you have diabetes. The tablets can hide the symptoms of
low blood sugar (such as accelerated heart beat rate,
palpitations or sweating).
• if you are fasting from solid food.
• if you are treated for hypersensitivity (allergic) reactions.
Bisoprolol may increase the hypersensitivity to the
substances you are allergic to and increase the severity of
the hypersensitivity reactions. Treatment with adrenaline then
may not have the desired result. A higher dose of adrenaline
(epinephrine) may be needed.
• with 1st degree heart block (conduction disorder in the heart).
• if you suffer from Prinzmetalʼs angina which is a type of chest
pain caused by spasm of the coronary arteries that supply the
heart muscle.
• if you have any problems with the circulation to the
extremities of the body such as hands and feet.
• in case of surgery involving an anaesthetic: If you consult a
doctor, attend hospital or the dentist for surgery involving
anaesthetic, let them know what medicines you are taking.
• if you suffer (or have suffered) from psoriasis (a recurrent skin
disorder involving scaling and dry skin rash).
• if you suffer from phaeochromocytoma (tumour of the adrenal
marrow). Your doctor will need to treat this before prescribing
bisoprolol for you.
• if you have a thyroid problem. The tablets can hide symptoms
of an overactive thyroid.
There is so far no therapeutic experience of bisoprolol treatment
of heart failure in patients with the following diseases and
conditions:
• diabetes mellitus treated with insulin (type I).
• severe kidney disease.
• severe liver disease.
• certain heart diseases.
• heart attack within 3 months.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant, or are planning to have a baby, ask your doctor for
advice before taking this medicine. 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. Therefore, bisoprolol should not
be taken during pregnancy.

It is not known if bisoprolol is excreted in the breast milk and
therefore it is not recommended while breast-feeding.
Driving and using machines
No studies on the effects on the ability to drive and use
machines have been performed.

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.

Bisoprolol fumarate contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.

3

How to take Bisoprolol fumarate

Always take this medicine exactly as your doctor or pharmacist
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 this medicine in the morning, before, with or after breakfast.
Swallow the tablet(s) with some water and do not chew or crush
them.
The usual dose is:

Heart failure (reduced pumping strength of the heart)
Before you start using Bisoprolol fumarate, you are already
using an ACE-inhibitor, diuretic or heart glycoside (heart/blood
pressure product).

The dose will be increased gradually until the dose that is
suitable for you has been found:

Treatment of heart failure with Bisoprolol fumarate requires
regular medical monitoring. This is absolutely necessary,
particularly at the beginning of treatment, and upon stopping
treatment.

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.

Treatment with Bisoprolol must not be discontinued abruptly
unless for compelling reasons.
Consult your physician if one of the above warnings is
applicable to you, or has been in the past.

Other medicines and Bisoprolol fumarate
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines. This includes
medicines obtained without a prescription. Certain medicines
cannot be used at the same time, while other drugs require
specific changes (in the dose, for example).

Maximum dose is once daily 10 mg.
The doctor will determine the optimum dose for you amongst
others based on possible side effects.

draft: 44017213, 44017212,
44017214, 44017215
laetus code:
mat.no.:

Continued on the next page >>

Artwork Proof Box
Ref: V022 - Extension of shelf life of bottles to 3 years
Proof no.
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Date prepared:
07/02/2013

Colours:
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Dimensions: 165 x 420 mm

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6

After the very first dose of 1.25 mg the doctor will check your
blood pressure, heart rate and heart function disorders.

Liver or kidney function disorders:
The doctor will be extra careful with the increasing of the dose.

What Bisoprolol fumarate contains
The active substance is bisoprolol fumarate.
Each 1.25 mg tablet contains 1.25 mg bisoprolol fumarate.
Each 2.5 mg tablet contains 2.5 mg bisoprolol fumarate.
Each 3.75 mg tablet contains 3.75 mg bisoprolol fumarate.
Each 7.5 mg tablet contains 7.5 mg bisoprolol fumarate.

Elderly:
Normally an adjustment of the dose is not needed.

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.

The other ingredients are:
calcium hydrogen phosphate, anhydrous
cellulose, microcrystalline
maize starch, pregelatinised
croscarmellose sodium
silica, colloidal anhydrous
magnesium stearate
lactose monohydrate
hypromellose
macrogol 4000
titanium dioxide (E171).

Use in children and adolescents
There is no experience with Bisoprolol fumarate in children and
adolescents, therefore its use is not recommended in children.

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, 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).

The 3.75 mg and 7.5 mg tablets also contain iron oxide, yellow
(E172).

What Bisoprolol fumarate looks like and contents of the
pack
• Bisoprolol Fumarate 1.25 mg Film-coated Tablets are white,
round film-coated tablets encoded “BIS 1.25“ on one side.
• Bisoprolol Fumarate 2.5 mg Film-coated Tablets are white,
round film-coated tablets with a score (divides the tablet in
two) encoded “BIS 2.5“ on one side.
• Bisoprolol Fumarate 3.75 mg Film-coated Tablets are
yellow-white, round film-coated tablets with a score (divides
the tablet in three) encoded “BIS 3.75“ on one side.
• Bisoprolol Fumarate 7.5 mg Film-coated Tablets are yellow,
round film-coated tablets with a score (divides the tablet in
three) encoded “BIS 7.5“ on one side.

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. Instead, it must be reduced gradually over a few
weeks as advised by your doctor.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4

Contents of the pack and other information

Your tablets come in:
blister packs (OPA-Al-PVC/Al) of 7, 10, 20, 28, 30, 50, 56, 60,
90, 98, 100, 10 x 20 (only for 1.25 mg tablets), 10 x 30
film-coated tablets.

Possible side effects

HDPE bottles of 10, 20, 30, 50, 60, 100, 250, 500 film-coated
tablets.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Side effects that could occur are:

Very common, affects more than 1 per 10 users:
• slow heart beat.

Common, affects 1 to 10 per 100 users:
• tiredness, exhaustion
• dizziness
• headache
• feeling of coldness or numbness in the extremities (fingers or
toes, ears and nose); more frequent occurrence of a
cramp-like pain in the legs when walking
• worsening of pre-existing heart failure
• very low blood pressure (hypotension), particularly in patients
with heart failure
• feeling sick (nausea), being sick (vomiting)
• diarrhoea
• constipation.

Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany
or

Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen,
Germany
or

Uncommon, affects 1 to 10 per 1,000 users:
• fall in blood pressure on standing up which may cause
dizziness, light-headedness or fainting
• sleep disturbances
• depression
• irregular heart beat
• patients with asthma or a history of breathing problems may
experience difficulty in breathing
• muscular weakness and muscle cramps.

HEXAL AG,
Industriestrasse 25, 83607 Holzkirchen,
Germany
or

ROWA Pharmaceuticals Limited,
Newtown, Bantry, Co. Cork,
Ireland
or

Rare, affects 1 to 10 per 10,000 users:
• nightmares
• hallucinations (imagining things)
• syncope
• hearing impairment
• inflammation of the lining of the nose, causing a runny nose
with irritation
• allergic reactions (such as itching, flushed appearance, rash)
• dry eyes from reduced tear flow (which 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)
• increased levels of blood lipids (triglycerides) and liver
enzymes.

Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia
or

Lek S.A.,
Ul. Domaniewska 50 C, 02-672 Warszawa,
Poland.
This leaflet was last revised in 01/2013.

Very rare, affects less than 1 per 10,000 users:
• chest pain
• aggravation of the skin condition psoriasis or cause a similar
dry, scaly rash and hair loss
• itchiness or redness of the eye (conjunctivitis).
If you get any of the side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in this
leaflet.

5

How to store Bisoprolol fumarate

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

Do not use this medicine after the expiry date which is stated on
the packaging after “EXP”. The first two numbers match the
month, the last numbers the year. The expiry date refers to the
last day of that month.
Do not use the medicine packed in bottles after 6 months after
first opening of the bottle.
Blister: This medicinal product does not require any special
storage conditions.

Bottle for strength 1.25 mg: Do not store above 30ºC.
Bottle for strengths 2.5 mg, 3.75 mg and 7.5 mg: This medicinal
product does not require any special storage conditions.
Bottles for all strengths after first opening: Do not store above
25ºC.

draft: 44017213, 44017212,
44017214, 44017215
laetus code:
mat.no.:

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

00000000
SZ00000LT000

Artwork Proof Box
Ref: V022 - Extension of shelf life of bottles to 3 years
Proof no.
008.0

Date prepared:
07/02/2013

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
7pt
Fonts:
Helvetica

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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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