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Package leaflet: Information for the user

Bisoprolol Fumarate 2.5 mg film-coated tablets Bisoprolol Fumarate 3.75 mg film-coated tablets Bisoprolol Fumarate 5 mg film-coated tablets Bisoprolol Fumarate 7.5 mg film-coated tablets Bisoprolol Fumarate 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 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. What Bisoprolol Fumarate is and what it is used for

Bisoprolol Fumarate contains Bisoprolol fumarate, which belongs to the group of medicinal products that are known as beta blockers.

Bisoprolol Fumarate is used to treat:

• Stable heart failure. Bisoprolol is given as an additional treatment to other medications for heart failure.

Heart failure occurs when the heart muscle is too weak to pump blood around the circulation adequately. This results in breathlessness and swelling. Bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body.

2. What you need to know before you take Bisoprolol Fumarate

Do not take Bisoprolol Fumarate if you:

•    are allergic to active substance or any of the other ingredients of this medicine (listed in section 6).

• have severe asthma or severe chronic lung disease

• have a slow or irregular heart rate. Ask your doctor if you are not sure

•    have very low blood pressure

•    have severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)

•    have heart failure that suddenly becomes worse and/ or may require hospital treatment

•    have excess acid in the blood, a condition known as metabolic acidosis

•    have untreated phaeochromocytoma, a rare tumour of the adrenal gland

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

Warnings and precautions

Talk to your doctor before taking Bisoprolol Fumarate 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 treated for hypersensitivity (allergic) reactions. 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 “taking other medicines”

•    have (or have had) psoriasis (a recurring skin rash)

•    have phaeochromocytoma (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

Consult your doctor 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 or have recently taken or might take any other medicines. 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 Fumarate 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, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil)

•    Medicines for depression e.g. imipramine, amitriptyline, moclobemide

•    Medicines to treat mental illness e.g. phenothiazines such as levomepromazine

•    Medicines used for anaesthesia during an operation (see also “Take special care with Bisoprolol Fumarate ”)

•    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. adrenaline, dobutamine, noradrenaline)

•    Mefloquine, a medicine for malaria

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.

Bisoprolol Fumarate with food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

Do not take bisoprolol if you are pregnant or may be pregnant. 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.

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 Fumarate

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before you start using Bisoprolol Fumarate you should already be taking other medicines for heart failure including an ACE-inhibitor, a diuretic and (as an added option) a cardiac glycoside.

•    Your doctor will tell you how many tablets to take.

•    You should take Bisoprolol Fumarate 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 Fumarate will be increased gradually until the dose that is suitable for you has been found:

Adults and elderly: the recommended 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 Fumarate.

Children

Bisoprolol Fumarate is not recommended for use in children.

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 tablet can be divided into equal halves

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, 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 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. The dose of bisoprolol 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. 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 Fumarate and see your doctor immediately if the following symptoms occur:

Common effects

•    Worsening of heart failure causing increased breathlessness and / or retention of fluid

Frequency not stated

•    Worsening of symptoms of blockage of the main blood vessels to the legs, especially at the start of treatment

The following side-effects have also been reported:

Very Common: may affect more than 1 in 10 people

•    Slow heart beat

Common: may affect up to 1 in 10 people

•    Tiredness, weakness

•    Dizziness

•    Headache

•    Feeling of coldness or numbness in hands or feet

•    low blood pressure

•    Feeling sick (nausea), being sick (vomiting)

•    Diarrhoea

•    Constipation

Uncommon: may affect up to 1 in 100 people

•    Light-headedness

•    Sleep disturbances

•    Depression

•    Irregular heart beat

•    Breathing problems in patients with asthma or chronic lung disease

•    Muscle weakness, muscle cramps

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 runny nose with irritation

•    Allergic reactions (itching, flushed appearance, rash)

•    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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. How to store Bisoprolol Fumarate

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

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.

Do not use Bisoprolol Fumarate after the expiry date which is stated on the carton/ bottle after EXP. The expiry date refers to the last day 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 protect the environment.

6. Contents of the pack and other information

What Bisoprolol Fumarate contains

-    The active substance is bisoprolol fumarate. Each tablet contains 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 Fumarate looks like and contents of the pack

Bisoprolol Fumarate 2.5 mg film-coated tablets are white, circular, biconvex, debossed with 'P' and breakline on one side and '2' on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 3.75 mg film-coated tablets are white, circular, biconvex, debossed with 'P' and breakline on one side and '3' on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 5 mg film-coated tablets are white, circular, biconvex, debossed with 'P' and breakline on one side and '5' on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 7.5 mg film-coated tablets are white, circular, biconvex, debossed with 'P' and breakline on one side and '7' on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate 10 mg film-coated tablets are white, circular, biconvex, debossed with 'P' and breakline on one side and '10' on the other side. The tablet can be divided into equal doses.

Bisoprolol Fumarate film-coated tablets are available in cold form Polyamide /Aluminum/ PVC/ -Aluminum blisters and HDPE bottle packs.

Pack sizes:

Blister pack: 20, 28, 30, 50, 90, 100 film-coated tablets Bottle pack: 30, 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This leaflet was last revised in 05/2016.