Skip to Content

BISOPROLOL 5MG FILM-COATED TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL FUMARATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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 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 TABLETS
Keep out of sight and reach of children
Do not use this medicine after the expiry date which is stated on the blister and the
carton after EXP. The expiry date refers to the last date of that month.
Do not throw away any medicines 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bisoprolol tablets contain
The active substance is bisoprolol hemifumarate.
Each Bisoprolol 2.5 mg film-coated tablets contains 2.5 mg of the active substance.
Each Bisoprolol 5 mg film-coated tablets contains 5 mg of the active substance.
Each Bisoprolol 10 mg film-coated tablets contains 10 mg of the active substance.
The other ingredients are:
Tablet core: Microcrystalline cellulose (PH –112), maize starch, crospovidone (type B), colloidal
anhydrous silica, magnesium stearate
Film coating (2.5mg tablets): Hypromellose, Macrogol 400 and Titanium dioxide (E1 71)
Film coating (5 mg tablets): Hypromellose, Macrogol 400, Titanium dioxide (E1 71), Ferric oxide
yellow E- 172
Film coating (10mg tablets): Hypromellose, Macrogol 400, Titanium dioxide (E171), Ferric oxide
yellow E-1 72, Ferric oxide red E-1 72
What Bisoprolol tablets looks like and the contents of the pack
The 2.5 mg tablets are white and heart-shaped with a break-line on both sides.
The 5 mg tablets are white -yellow, heart-shaped with a break-line on both sides.
The 10 mg tablets are pale to light orange, heart-shaped with a break-line on both
sides.
Each pack contains 20, 28, 30, 50, 56, 60, 90, or I00 tablets.
Not all pack sizes may be marketed.
2.5mg: PL 44041/0003,
5mg: PL 44041/0004
10mg: PL 44041/0005

To listen to or request a copy of this leaflet in
Braille, large print or audio please call,
020 33998960 (UK only)
Please be ready to give the following information:
Product name

Reference number

Bisoprolol 2.5 mg film-coated tablets

PL 44041/0003

Bisoprolol 5 mg film-coated tablets

PL 44041/0004

Bisoprolol 10 mg film-coated tablets

PL 44041/0005

Bisoprolol 2.5 mg film-coated tablets
Bisoprolol 5 mg film-coated tablets
Bisoprolol 10 mg film-coated tablets
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 tablets
3. How to take Bisoprolol tablets
4. Possible side effects
5. How to store Bisoprolol tablets
6. Contents of the pack and other information
1. WHAT BISOPROLOL IS AND WHAT IT IS USED FOR
Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work
by affecting the body's response to some nerve impulses, especially in the heart.
As a result, bisoprolol slows down the heart rate and makes the heart more efficient at
pumping blood around the body.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood
to supply the body's needs.
Bisoprolol is used to treat stable chronic heart failure. It is used in combination with
other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart
glycosides).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL
TABLETS
Do not take Bisoprolol tablets if you:
• are allergic (hypersensitive) to Bisoprolol or to any of the other ingredients (see
section 6 for list of ingredients)
• suffer from severe asthma or severe chronic obstructive lung disease
• suffer from 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
• suffer from untreated phaeochromocytoma, which is a rare tumour of the adrenal
gland
• suffer from metabolic acidosis, which is a condition when there is too much acid in
the blood.
• have one of the following heart problems:
- acute heart failure
- worsening heart failure requiring injection of medicines into a vein, that increase
the force of contraction of the heart
- slow heart rate
- low blood pressure
- certain heart conditions causing a very slow heart rate or irregular heartbeat
- cardiogenic shock, which is an acute serious heart condition causing low blood
pressure and circulatory failure.
Take special care and tell your doctor if you:
• suffer from less severe asthma or chronic lung disease
• suffer from diabetes
• are currently, or intend to partake in strict fasting while taking this medicine
• suffer from certain heart diseases such as disturbances in heart rhythm, or severe
chest pain at rest (Prinzmetal's angina)
• suffer from kidney or liver problems
• suffer from less severe blood circulation problems in your limbs
• have a history of a scaly skin rash (psoriasis)
• are being treated for tumour of the adrenal gland (phaeochromocytoma)
• have thyroid problems
• are going to have desensitization therapy (for example for the prevention of hay
fever), because Bisoprolol may make it more likely that you experience an allergic
reaction, or such reaction may be more severe
• are going to have anaesthesia (for example for surgery), because Bisoprolol may
influence how your body reacts to this situation.

This leaflet was last revised in January 2017
Marketing Authorization Holder:
NOUMED LIFE SCIENCES LIMITED
Noumed House, Shoppenhangers Road
Maidenhead, Berkshire, SL6 2RB, United Kingdom
Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk

PACKAGE LEAFLET: INFORMATION FOR THE USER

POM

6 mm
10 mm

This section is continued overleaf

50 mm

22 mm

58 mm

Children and adolescents
Bisoprolol is not recommended for use in children or adolescents
Other medicines and Bisoprolol
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Do not take the following medicines with Bisoprolol without special advice from your
doctor. However. do not stop taking these medicines without checking with your
doctor first:
• medicines used to treat irregular or abnormal heartbeat (called 'Class I
antiarrhythmic medicines' such as quinidine, disopyramide, lidocaine, phenytoin;
flecainide, propafenone)
• medicines used to treat high blood pressure, angina pectoris or irregular heartbeat
(called 'calcium antagonists' such as verapamil and diltiazem)
• medicines used to treat high blood pressure such as donidine, methyldopa,
moxonodine, rilmenidine.
Check with your doctor before taking the following medicines with Bisoprolol; your
doctor may need to check your condition more frequently:
• medicines used to treat high blood pressure or angina pectoris (called
dihydropyridine-type calcium antagonists such as felodipine and amlodipine)
• medicines used to treat irregular or abnormal heartbeat (called Class Ill
antiarrhythmic medicines such as amiodarone)
• Types of beta-blockers are applied locally (such as timolol eye drops for glaucoma
treatment)
• medicines used to treat for example Alzheimer's disease or glaucoma (called
parasympathomimetics such as tacrine or carbachol) or medicines that are used to
treat acute heart problems (called sympathomimetics such as isoprenaline and
dobutamine)
• Antidiabetic medicines including insulin
• Anaesthetic agents (for example during surgery)
• Digitalis, used to treat heart failure
• Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or
inflammation (for example ibuprofen or diclofenac)
• Any medicine, which can lower blood pressure as a desired or undesired effect such
as antihypertensives, certain medicines for depression (called tricyclic
antidepressants such as imipramine or amitriptyline). certain medicines used to treat
epilepsy or during anaesthesia (called barbiturates such as phenobarbital), or certain
medicines to treat mental illness characterized by a loss of contact with reality
(called phenothiazine such as levomepromazine)
• Mefloquine, used for prevention or treatment of malaria
• Depression treatment medicines called monoamine oxidase inhibitors (except
MAO-B inhibitors) such as moclobomide.
Pregnancy and breast-feeding
Pregnancy
There is a risk that use of Bisoprolol during pregnancy may harm the baby. If you are
pregnant or planning to become pregnant, tell your doctor. He or she will decide
whether you can take Bisoprolol during pregnancy.
Breast-feeding
It is not known whether Bisoprolol passes into human breast milk. Therefore,
breastfeeding is not recommended during therapy with Bisoprolol.
Driving and using machines
Your ability to drive or use machinery may be affected depending on how well you
tolerate the medicine. Be especially cautious at the start of treatment, when the dose is
increased or the medication is changed, as well as in combination with alcohol.
3. HOW TO TAKE BISOPROLOL TABLETS
Always take this medicine exactly as your doctor has told you. Ask your doctor or
pharmacist if you are not sure.
Treatment with this medicine requires regular monitoring by your doctor. This is particularly necessary at the start of treatment and during dose increase and when you stop
treatment.
Take the tablet with some water in the morning, with or without food. Do not crush or
chew the tablet.
The break line tablets can be divided into two equal doses.
Treatment with bisoprolol is usually long-term.
Dosage in adults including the elderly:
Treatment with Bisoprolol must be started at a low dose and increased gradually.
Your doctor will decide how to increase the dose, and this will normally be done in the
following way:
• 1.25 mg Bisoprolol (half of a 2.5mg tablets) once daily for the first week of treatment
• 2.5 mg Bisoprolol (one 2.5mg tablets) once daily for the second week of treatment
• 3.75 mg Bisoprolol (one and half 2.5mg tablets) once daily for the third week of
treatment

• 5 mg Bisoprolol (two 2.5mg or one 5mg tablet) once daily for the fourth, fifth, sixth
and seventh weeks of treatment
• 7.5 mg Bisoprolol (three 2.5mg tablets) once daily for the eighth, ninth, tenth and
eleventh week of treatment
• 10 mg Bisoprolol (one 10mg tablet) once daily from the twelfth week for maintenance
(on-going) therapy.
The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how well you tolerate the medicine, your doctor may also decide to
lengthen the time between dose increases. If your condition gets worse or you no longer
tolerate the drug, it may be necessary to reduce the dose again or to interrupt treatment.
In some patients a maintenance dose lower than 10mg bisoprolol may be sufficient.
Your doctor will tell you what to do.
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..
If you take more Bisoprolol than you should
If you have taken more tablets than you should, tell your doctor immediately. Your
doctor will decide what measures are necessary.
Symptoms of an overdose may include slowed heart rate, dizziness, low blood pressure,
severe difficulty in breathing. worsening of heart failure, or trembling (due to decreased
blood sugar).
If you forget to take a tablet
Do not take a double dose to make up for a forgotten dose. Take your usual dose the
next morning.
If you stop taking Bisoprolol
Never stop taking Bisoprolol unless told to by your doctor. Otherwise your condition
could become much worse.
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 tablets can cause side effects, although not everybody gets
them. Speak to a doctor immediately if a side effect is severe, occurred suddenly or
gets worse rapidly.
Serious Side Effects
The most serious side effects are related to the heart function:
• slowing of heart rate (may affect more than 1 in 10 people)
• worsening of heart failure (may affect up to 1 in 10 people)
• slow or irregular heartbeat (may affect up to 1 in 100 people)
If you feel dizzy or weak, or have breathing difficulties contact your doctor, pharmacist
or nearest hospital as soon as possible.
Other side effects include:
Common (affects between 1 in 10 and 1 in 100 patients)
• dizziness
• headache
• stomach or intestine problems such as nausea, vomiting, diarrhoea or constipation
• feeling of coldness in the hands or feet
• low blood pressure
• weakness or tiredness
Uncommon (affects between 1 in 100 and I in 1,000 patients)
• breathing problems in patients with asthma or a chronic lung disease
• muscular weakness and cramps
• dizziness when standing up
• sleep disturbances
• depression
Rare (affects between 1 in 1,000 and 1 in 10,000 patients)
• certain blood test results for liver function or fat levels differing from normal
• fainting
• reduced tear flow
• hearing problems
• allergic runny nose
• allergic reactions such as itching. flush and rash
• inflammation of the liver which can cause yellowing of the skin or whites of the eyes
• impaired erection
• nightmares
• hallucinations
Very rare (affects less than I in I0,000 patients)
• irritation and redness of the eye (conjunctivitis)
• hair loss
• appearance or worsening of scaly skin rash (psoriasis or psoriasis-like rash).
This section is continued overleaf

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.

Hide