BISOPROLOL FUMARATE 5 MG FILM-COATED TABLETS

Active substance: BISOPROLOL FUMARATE

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Package leaflet: Information for the user

SZ00000LT000

Bisoprolol Fumarate 5 mg and 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 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

For patients with hypertension and angina pectoris,
accompanying heart failure treatment should not be stopped
abruptly. The dosage should be diminished slowly by a
weekly halving of the dose.

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.

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).
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.

Bisoprolol fumarate is used to treat:
• high blood pressure.
• angina pectoris (heart pain).
• 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.
Tell your doctor if you are not sure about any of the above.

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

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 Prinzmetal’s 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 anaesthetics, let them know what medicines
you are taking.
• in combination with calcium antagonists, such as
verapamil and diltiazem. Concomitant use is not
recommended, see also section “Other medicines and
Bisoprolol fumarate”.
• 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.

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.

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

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.

draft: 44017216, 44017217,
44034280, 44034258
laetus code: 0000
mat.no.: 00000000

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.
Treatment with Bisoprolol must not be discontinued abruptly
unless for compelling reasons.

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.

Continued on the next page >>

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Elevated blood pressure/angina pectoris
Adults
The dose is determined individually. The recommended
starting dose is 5 mg once daily. The usual dose for adults
is once daily 10 mg. Your doctor may decide to increase or
decrease the dose. The maximum dose is once daily
20 mg.

Uncommon, affects 1 to 10 per 1,000 users:
• exhaustion. In the treatment of heart failure this side
effect occurs commonly
• fall in blood pressure on standing up which may cause
dizziness, light-headedness or fainting
• sleep disturbances
• depression
• slow heart beat. In the treatment of heart failure this side
effect occurs very commonly
• irregular heart beat
• worsening of pre-existing heart failure. In the treatment of
heart failure this side effect occurs commonly
• patients with asthma or a history of breathing problems
may experience difficulty in breathing
• muscular weakness and muscle cramps.

Severe kidney or severe liver function disorders
If you suffer from a severe kidney or severe liver function
disorder the maximum dose is 10 mg per day.

Elderly
Normally no dosage adjustment is required. Your doctor will
start therapy with the lowest possible dose.

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).

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.

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

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

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.
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.

5

How to store Bisoprolol fumarate

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.

Press with the thumb on the middle of
the tablet and the tablet will break into
two halves, press with the thumb in
the middle of each half and you will
have four parts.

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.

Duration of the treatment
Bisoprolol fumarate will usually be used long-term.

Bottle: This medicinal product does not require any special
storage conditions.
After first opening: Do not store above 25ºC.

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

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.

6

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).

Contents of the pack and other
information

What Bisoprolol fumarate contains
The active substance is bisoprolol fumarate.
Each 5 mg tablet contains 5 mg bisoprolol fumarate.
Each 10 mg tablet contains 10 mg bisoprolol fumarate.

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); iron oxide, yellow
(E172).

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.

The 10 mg tablets also contain iron oxide, red (E172).

What Bisoprolol fumarate looks like and contents of the
pack
• Bisoprolol Fumarate 5 mg Film-coated Tablets are yellow,
round film-coated tablets with a cross score (divides the
tablet in four) encoded “BIS 5” on one side.
• Bisoprolol Fumarate 10 mg Film-coated Tablets are
apricot, round film-coated tablets with a cross score
(divides the tablet in four) encoded "BIS 10" on one side.
Your tablets come in:
blister packs (OPA-Al-PVC/Al) of 7, 10, 14, 20, 28, 30,
50, 56, 60, 90, 98, 100, 10 x 30, 500 film-coated tablets.
HDPE bottles of 10, 20, 30, 50, 60, 100, 250, 500
film-coated tablets.

Possible side effects

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

Side effects that could occur are:
Very common, affects more than 1 per 10 users:
• slow heart beat. In the treatment of hypertension or
angina pectoris this side effect occurs uncommonly.

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.

Common, affects 1 to 10 per 100 users:
• exhaustion. In the treatment of hypertension or angina
pectoris this side effect occurs uncommonly
• dizziness, tiredness and headache (especially at the
beginning of therapy in patients with hypertension and
angina pectoris; symptoms are generally mild and often
disappear within 1-2 weeks)
• 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. In the treatment of
hypertension or angina pectoris this side effect occurs
uncommonly
• very low blood pressure (hypotension) particularly in
patients with heart failure
• feeling sick (nausea), being sick (vomiting)
• diarrhoea
• constipation.

draft: 44017216, 44017217,
44034280, 44034258
laetus code: 0000
mat.no.: 00000000

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

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

Place the tablet on a hard, flat surface
with the scored side at the top.

4

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).

Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179
Barleben, Germany or Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany or ROWA
Pharmaceuticals Limited, Newtown, Bantry, Co. Cork,
Ireland or Lek Pharmaceuticals d.d, Verovskova 57, 1526
Ljubljana, Slovenia or Lek S.A, Ul. Domaniewska 50 C,
02-672 Warszawa, Poland or Lek S.A, Ul Podlipie 16 C, 95
010 Strykow, Poland.
This leaflet was last revised in 02/2014.

00000000
SZ00000LT000

Artwork Proof Box
Ref: V025G - CEP update deletion of API manufacturer
Proof no.
011.0

Date prepared:
20/02/2014

Colours:
Black
Dimensions: 165 x 420 mm

Font size:
7.5pt
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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