Document: leaflet MAH GENERIC_PL 42357-0008 change

• leaflet MAH GENERIC_PL 21880-0127
• leaflet MAH GENERIC_PL 42357-0008

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PHARMACEUTICALS

Package Leaflet: Information for the user

Bisoprolol 1.25 mg film-coated tablets Bisoprolol 2.5 mg film-coated tablets Bisoprolol 3.75 mg film-coated tablets Bisoprolol 5 mg film-coated tablets Bisoprolol 7.5 mg film-coated tablets Bisoprolol 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 is and what it is used for

2.    What you need to know before you take Bisoprolol

3.    How to take Bisoprolol

4.    Possible side effects

5.    How to store Bisoprolol

6.    Contents of the pack and other information

1. What Bisoprolol is and what it is used for

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

This medicine protects the heart against too much activity. Heart failure occurs when the heart muscle is too weak to pump blood around the circulation adequately. This results in breathlessness and swelling. Bisoprolol works by affecting the body’s response to some nerve impulses especially in the heart. As a result, it slows down the heart rate and makes the heart more efficient at pumping blood around the body.

Bisoprolol is used to treat:

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

•    angina pectoris (pains in the chest caused by blockages in the arteries that supply the heart muscle)

•    hypertension (high blood pressure)

2. What you need to know before you take Bisoprolol

DO NOT take Bisoprolol:

•    if you are allergic (hypersensitive) to bisoprolol fumarate or any of the other ingredients of Bisoprolol tablets

•    if you have severe asthma or severe chronic lung disease

•    if you have a slow heart rate (less than 60 beats per minute) or an irregular heart rate. Ask your doctor if you are not sure

•    if you have very low blood pressure

•    if you have 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

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

•    if you have a condition in which there is an accumulation of excess acid in the blood, a condition known as metabolic acidosis. Your doctor will be able to advise you.

•    if you 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 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 being 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 “Other medicines and Bisoprolol”

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

have been treated for a condition called

‘phaeochromocytoma’ (a rare 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 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 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, dobutamine, isoprenaline, felodipine, flecainide, lidocaine, methyldopa, moxonidine, nifedipine, phenytoin, propafenone, quinidine, rilmenidine, verapamil)

•    Medicines for depression e.g. tricyclic antidepressants such as imipramine, amitriptyline, monoamine oxidase inhibitors such as moclobemide

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

•    Medicines used for anaesthesia during an operation (see also “Warnings and precautions”)

•    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. epinephrine, dobutamine, norepinephrine)

•    Medicines used for prevention or treatment of malaria e.g. mefloquine

•    Medicines for Alzheimer’s Disease or glaucoma (known as parasympathomimetics, such as tacrine or carbachol)

•    Medicines known as sympathomimetics such as adrenaline and noradrenaline which are used in the treatment of heart attack and low blood pressure. Adrenaline is also used to treat allergic reactions. Higher doses of adrenaline may be necessary for treatment of allergic reactions if Bisoprolol is being taken at the same time.

•    Moxisylyte, which is used to treat circulatory problems like Raynaud’s syndrome

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 with food and drink

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

Pregnancy and breast-feeding

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

Always take Bisoprolol exactly as your doctor 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 Bisoprolol 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 will be increased gradually until the dose that is suitable for you has been found:

Stable chronic heart failure

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

Adults and older people:

The usual 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.

Use in children:

Bisoprolol is not recommended for use in children.

Hypertension or angina pectoris

Adults:

The usual daily dose is 10 mg bisoprolol.

Depending on how well you respond to the medicine, your doctor may decide to decrease the dose to 5 mg or he may decide to increase it to 20 mg. The dose should not exceed 20 mg in one day. Your doctor will tell you what to do. The label will also tell you how many tablets to take and how often to take them. Your pharmacist will help if you are unsure.

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.

Patients with kidney disease

Patients with severe kidney disease should not exceed 10 mg of bisoprolol once daily. Please consult your doctor before starting to use this medicine.

Patients with liver disease

Patients with severe liver disease should not exceed 10 mg of bisoprolol once daily. Please consult your doctor before starting to use this medicine.

Children under 12 years and adolescents

The use of Bisoprolol is not recommended as there is no

experience with this medicine in children under 12 years and

adolescents.

Pharmacode position can change as per Supplier’s m/c requirement & additional small pharma code may appear on the front/back panel

Older people

In general an adjustment of the dose is not needed.

Stable chronic heart failure and Hypertension or angina pectoris

If you notice that the effect of Bisoprolol is too strong or not strong enough, please consult your doctor or pharmacist.

Duration of the treatment

Bisoprolol will usually be used long-term.

If you take more Bisoprolol 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

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

Treatment with Bisoprolol 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.

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 and see your doctor immediately if the following symptoms occur:

Common effects (may affect up to 1 in 10 people)

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

Not known (frequency cannot be estimated from the available data)

•    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* (especially at the beginning of therapy; these are generally mild and often disappear within 1-2 weeks)

Feeling of coldness or numbness in hands or feet low blood pressure

Feeling sick (nausea), being sick (vomiting)

Diarrhoea Constipation

* These symptoms especially occur at the beginning of treatment, or if your dosage changes in patients with hypertension or angina pectoris. They are generally mild and often disappear within 1 to 2 weeks.

Uncommon (may affect up to 1 in 100 people):

•    Light-headedness

•    Sleep disturbances

•    Depression

•    Worsening of 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 blocked, 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. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the 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

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 this medicine after the expiry date which is stated on the carton and blister/ bottle after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicine 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.

Contents of the pack and other information

What Bisoprolol contains

- The active substance is bisoprolol fumarate. Each tablet contains 1.25 mg, 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 looks like and contents of the pack

Bisoprolol 1.25 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ on one side and ‘1’ on the other side.

Bisoprolol 2.5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one side and ‘2’ on the other side. The tablet can be divided into equal halves.

Bisoprolol 3.75 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one side and ‘3’ on the other side. The tablet can be divided into equal halves.

Bisoprolol 5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one side and ‘5’ on the other side. The tablet can be divided into equal halves.

Bisoprolol 7.5 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one side and ‘7’ on the other side. The tablet can be divided into equal halves.

Bisoprolol 10 mg film-coated tablets are white, circular, biconvex, debossed with ‘P’ and score line on one side and ‘10’ on the other side. The tablet can be divided into equal halves.

Bisoprolol film-coated tablets are available in cold form Aluminum -Aluminum blisters with peelable lidding foil (for 1.25mg strength), Cold form (Alu-Alu) blister with push through lidding foil (For 2.5mg, 3.75mg, 5mg, 7.5mg & 10mg strengths) and HDPE bottle packs.

Pack sizes:

Bisoprolol 1.25 mg film-coated tablets:

Blister pack: 1, 10, 20, 28, 30 film-coated tablets Bottle pack: 30, 500 film-coated tablets

Bisoprolol 2.5 mg film-coated tablets:

Blister pack: 10, 14, 28, 30, 100 film-coated tablets Bottle pack: 30, 500 film-coated tablets

Bisoprolol 3.75 mg film-coated tablets:

Blister pack: 10, 28, 30, 56, 100 film-coated tablets Bottle pack: 30, 500 film-coated tablets

Bisoprolol 5 mg film-coated tablets:

Blister pack: 7, 10, 28, 30, 50, 56, 100 film-coated tablets Bottle pack: 30, 500 film-coated tablets

Bisoprolol 7.5 mg film-coated tablets:

Blister pack: 10, 28, 30, 100 film-coated tablets Bottle pack: 30, 500 film-coated tablets

Bisoprolol 10 mg film-coated tablets:

Blister pack: 10, 28, 30, 56, 90, 100 film-coated tablets Bottle pack: 30, 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland

Manufacturer

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

Hal Far, Birzebbugia, BBG 3000 Malta

This leaflet was last revised in 11/2014

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10 mm