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BISOPROLOL FUMARATE 5 MG TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL FUMARATE (2:1)

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

181213/6

Colours Used

Customer

Calisto_Chanelle Medical UK

Black

Description

Bisoprolol Fumarate Lealfet

Keyline

Market

UK

Language

English

Size

156 x 550 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

6

Date

17-06-15

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Bisoprolol Fumarate 1.25 mg Tablets
Bisoprolol Fumarate 2.5 mg Tablets
Bisoprolol Fumarate 3.75 mg Tablets
Bisoprolol Fumarate 5 mg Tablets
Bisoprolol Fumarate 10 mg 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, please 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 Fumarate Tablets are and what they are used for
2. What you need to know before you take Bisoprolol Fumarate Tablets
3. How to take Bisoprolol Fumarate Tablets
4. Possible side effects
5. How to store Bisoprolol Fumarate Tablets
6. Contents of the pack and other information
1. What Bisoprolol Fumarate Tablets are and what they are used for

The active substance in this medicine is Bisoprolol Fumarate. Bisoprolol Fumarate 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).
!
In treatment of coronary heart disease and chest pain (angina pectoris) caused by shortage of oxygen
in the heart muscle.
!
In treatment of high blood pressure (hypertension).
2. What you need to know before you take Bisoprolol Fumarate Tablets
Do not take Bisoprolol Fumarate Tablets:

Do not take Bisoprolol Fumarate Tablets if one of the following conditions applies to you:
!
Allergic (hypersensitive) to bisoprolol fumarate or any of the other ingredients of Bisoprolol
Fumarate Tablets (See section 6 Contents of the pack and other information)
!
Severe asthma or severe chronic lung disease
!
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
!
Untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
!
Metabolic acidosis, which is a condition when there is too much acid in the blood.

Do not take Bisoprolol Fumarate Tablets if you 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.

Warnings and precautions:
If you have any of the following conditions tell your doctor before taking this medicine; he or she may want
to take special care (for example give additional treatment or perform more frequent checks):
!
Diabetes
!
Strict fasting
!
Certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (prinzmetal's
angina)
!
Kidney or liver problems
!
Less severe blood circulation problems in your limbs
!
Less severe asthma or chronic lung disease
!
History of a scaly skin rash (psoriasis)
!
A tumor of the adrenal gland (phaeochromacytoma) or if you are currently undergoing treatment for a
tumor of the adrenal gland.
!
Thyroid disorder
!
Psoriasis or a history of psoriasis
!
Thyroid problems
!
Taking other medicines (See section Other medicines and Bisoprolol).

Take special care with Bisoprolol Fumarate Tablets if you have Chronic Heart Failure and one of the
following conditions:
!
Insulin dependent diabetes
!
Severe kidney or liver disease
!
Heart condition known as restrictive cardiomyopathy where the blood flow to and from the heart is
slow
!
Inherited heart conditions
!
Problems with the heart valves
!
Heart attack within the last 3 months.

In addition, tell your doctor if you 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
!
Anaesthesia (for example for surgery), because this medicine may influence how your body reacts to
this situation
Other medicines and Bisoprolol Fumarate Tablets:
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Do not take the following medicines with Bisoprolol Fumarate without special advice from your
doctor:
!
If you have Chronic Heart failure certain medicines used to treat irregular or abnormal heartbeat
(e.g.Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide,
propafenone)
!
Certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (e.g.calcium
antagonists such as verapamil and diltiazem)
!
Certain medicines used to treat high blood pressure (e.g.clonidine, methyldopa, moxonodine,
rilmenidine).
However, do not stop taking these medicines without checking with your doctor first.

Check with your doctor before taking the following medicines with Bisoprolol Fumarate; your doctor
may need to check your condition more frequently:
!
If you have had high blood pressure or angina pectoris then certain medicines used to treat irregular or
abnormal heartbeat (e.g.Class I antiarrhythmic medicines)
!
Certain medicines used to treat high blood pressure or angina pectoris (e.g.dihydropyridine-type
calcium antagonists such as nifedipine, felodipine and amlodipine)
!
Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines
such as amiodarone)
!
Beta-blocking agents applied locally (such as timolol eye drops for glaucoma treatment)
!
Certain medicines used to treat for example Alzheimer's disease or glaucoma (parasympathomimetics
such as tacrine or carbachol) or medicines that are used to treat acute heart problems
(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)
!
Mefloquine, used for prevention or treatment of malaria.
!
Any medicine which can lower blood pressure as a desired effect such as antihypertensives, certain
medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain
medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain,
medicines to treat mental illness characterised by a loss of contact with reality (phenothiazines such as
levomepromazine)
!
Depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such
as moclobemide.
Taking Bisoprolol Fumarate Tablets with food and drink:
Bisoprolol Fumarate Tablets should be taken in the morning, before, with or after breakfast. They should be
swallowed whole with liquid and should not be chewed or crushed.
Avoid drinking excessive alcohol, since it may increase the blood pressure-lowering effect of Bisoprolol.
Avoid drinking alcohol altogether, if it makes you more dizzy or more light-headed than usual.
Pregnancy and breast-feeding:
There is a risk that use of Bisoprolol Fumarate Tablets 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 Fumarate Tablets during pregnancy.
It is not known whether Bisoprolol passes into human breast milk.
Therefore, breastfeeding is not recommended during therapy with Bisoprolol Fumarate Tablets.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

181213/6

Colours Used

Customer

Calisto_Chanelle Medical UK

Black

Description

Bisoprolol Fumarate Lealfet

Keyline

Market

UK

Language

English

Size

156 x 550 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

6

Date

17-06-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

Driving and using machines:
Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine.
Please 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 Fumarate Tablets
Always take Bisoprolol Fumarate Tablets exactly as your doctor has told you. You should check with your
doctor or your pharmacist if you are not sure. Bisoprolol Fumarate Tablets should be taken in the morning,
before, with or after breakfast. Swallow the tablet/s whole with some water and do not chew or crush them.
This treatment should be initiated by a specialist in cardiology or internal medicine.
Children: Bisoprolol Fumarate Tablets are not recommended for use in children.
Adults and the Elderly:
Hypertension or angina pectoris
The maximum daily dose is 20mg once a day.
Stable chronic heart failure
The treatment should be managed by a doctor experienced in treating chronic heart failure.
The maximum recommended dose is 10mg once daily.
Renal or liver disease:
Patients with hypertension or angina pectoris: The dosage should not exceed 10 mg once daily in patients
with severe kidney or liver problems.
If you take more Bisoprolol Fumarate Tablets than you should:
Contact your doctor or local emergency ward immediately. Take this leaflet and any tablets you still have
with you. Your doctor will decide what measures are necessary.
The most common signs of an overdose may include slowed heart rate, severe difficulty in breathing feeling
dizzy, or trembling (due to decreased blood sugar).
If you forget to take Bisoprolol Fumarate Tablets:
If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Bisoprolol Fumarate Tablets:
Do not stop treatment suddenly or change the recommended dose without talking to your doctor first. If
you need to stop treatment, it must be done gradually, to avoid side effects.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly or
gets worse rapidly. The most serious side effects are related to the heart function:
!
Slowing of heart rate (affects more than 1 person in 10)
!
Worsening of heart failure (affects less than 1 person in 10)
!
Slow or irregular heartbeat (affects less than 1 person in 100)
If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.
Further side effects are listed below according to how frequently they may occur:
Very common:

> 10%

Common:

> 1% and <10%

Uncommon:

> 0.1% and <1%

Rare:

> 0.01% and <0.1%

Very rare:

<0.01%

Very Common:
!
Slow heart rate (in patients with chronic heart failure).

Common:
!
Tiredness*,
!
Feeling weak (in patients with chronic heart failure)
!
Dizziness*, headache*
!
Feeling of coldness or numbness in hands or feet
!
Low blood pressure
!
Stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.
!
Worsening of pre-existing heart failure (in patients with chronic heart failure).
* These symptoms occur at the beginning of therapy in patients with hypertension or angina pectoris.
They are usually mild and disappear within 1-2 weeks.

Uncommon:
!
Sleep disturbances
!
Depression
!
Breathing problems in patients with asthma or chronic lung disease
!
Muscle weakness and muscle cramps.
!
Worsening of pre-existing heart failure or slow heart rate (in patients with hypertension or angina
pectoris)
!
Feeling weak (in patients with hypertension or angina pectoris)
!
Changes in the normal heart rate
!
Dizziness when standing up.

Rare:
!
Hearing problems
!
Allergic runny nose
!
Reduced tear flow
!
Inflammation of the liver which can cause yellowing of the skin or whites of the eyes
!
Certain blood test results for liver function or fat levels differing from normal
!
Allergy-like reactions such as itching, flush, rash
!
Impaired erection
!
Nightmares, hallucinations
!
Fainting
!
Allergic runny nose with sneezing and itching.

Very rare:
!
Irritation and redness of the eye (conjunctivitis)
!
Hair loss
!
Appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website 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 Fumarate Tablets
Keep out of the sight and reach of children.
Do not use Bisoprolol Fumarate Tablets after the expiry date which is stated on the blister and the carton.
The expiry date refers to the last day of that month. This medicinal product does not require any special
storage conditions.
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. Contents of the pack and other information
What Bisoprolol Fumarate Tablets contain:
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 5 mg tablet contains 5 mg bisoprolol fumarate.
Each 10 mg tablet contains 10 mg bisoprolol fumarate.
The other ingredients are microcrystalline cellulose, silica colloidal anhydrous, croscarmellose sodium,
sodium starch glycollate (type A) and magnesium stearate.
What Bisoprolol Fumarate Tablets look like and contents of the pack:
1.25 mg: White to off white round biconvex tablets.
2.5 mg: White to off white round biconvex tablets with a break line on one side.
3.75 mg: White to off white round biconvex tablets.
5 mg: White to off white round biconvex tablets with a break line on one side.
10 mg: White to off white round biconvex tablets with a break line on one side.
Bisoprolol Fumarate 2.5 mg, 5 mg and 10 mg Tablets only: The tablet can be divided into equal halves.
Pack sizes of 20, 21, 28, 30, 50, 56, 60, 90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Chanelle Medical U.K. Limited, United Kingdom.
Manufacturer:
Chanelle Medical, Loughrea, Co Galway, Ireland
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom : Bisoprolol Fumarate Tablets
Italy : Bisoprololo Mylan Generics
Portugal : Bisoprolol Anova
This leaflet was last revised in June 2015.

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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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