Package leaflet: Information for the user

SZ00000LT000

Bisoprolol Fumarate 1.25 mg, 2.5 mg, 3.75 mg and 7.5 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

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.

Bisoprolol fumarate is used to treat:

• 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.

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.

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 anaesthetic, let them know what medicines you are taking.

•    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.

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.

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.

•    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 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

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.

The usual dose is:

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).

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.

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).

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.

00000000

Continued on the next page >>

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.

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 Contents of the pack and other information

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.

Use in children and adolescents

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

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).

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.

4 Possible side effects

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

Side effects that could occur are:

What Bisoprolol fumarate contains

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 7.5 mg tablet contains 7.5 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).

The 3.75 mg and 7.5 mg tablets also contain iron oxide, yellow (E172).

What Bisoprolol fumarate looks like and contents of the pack

•    Bisoprolol Fumarate 1.25 mg Film-coated Tablets are white, round film-coated tablets encoded “BIS 1.25“ on one side.

•    Bisoprolol Fumarate 2.5 mg Film-coated Tablets are white, round film-coated tablets with a score (divides the tablet in two) encoded “BIS 2.5“ on one side.

•    Bisoprolol Fumarate 3.75 mg Film-coated Tablets are yellow-white, round film-coated tablets with a score (divides the tablet in three) encoded “BIS 3.75“ on one side.

•    Bisoprolol Fumarate 7.5 mg Film-coated Tablets are yellow, round film-coated tablets with a score (divides the tablet in three) encoded “BIS 7.5“ on one side.

Your tablets come in:

blister packs (OPA-Al-PVC/Al) of 7, 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 10x20 (only for1.25 mg tablets), 10x30 film-coated tablets.

HDPE bottles of 10, 20, 30, 50, 60, 100, 250, 500 film-coated tablets.

Very common, affects more than 1 per 10 users:

•    slow heart beat.

Common, affects 1 to 10 per 100 users:

•    tiredness, exhaustion

•    dizziness

•    headache

•    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

•    very low blood pressure (hypotension), particularly in patients with heart failure

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

•    diarrhoea

•    constipation.

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.

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1,39179 Barleben Germany

Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Germany

Uncommon, affects 1 to 10 per 1,000 users:

•    fall in blood pressure on standing up which may cause dizziness, light-headedness or fainting

•    sleep disturbances

•    depression

•    irregular heart beat

•    patients with asthma or a history of breathing problems may experience difficulty in breathing

•    muscular weakness and muscle cramps.

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.

ROWA Pharmaceuticals Limited Newtown, Bantry, Co. Cork Ireland

Lek Pharmaceuticals d.d Verovskova 57, 1526 Ljubljana Slovenia

Lek S.A

Ul. Domaniewska 50 C, 02-672 Warszawa Poland

Lek S.A

Ul Podlipie 16 C, 95 010 Strykow Poland

This leaflet was last revised in 02/2014.

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).

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

5 How to store Bisoprolol fumarate

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

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.

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.

Bottle:

For strength 1.25 mg: Do not store above 30°C.

For strengths 2.5 mg, 3.75 mg and 7.5 mg: This medicinal product does not require any special storage conditions.

After first opening: Do not store above 25°C.

00000000

SZ00000LT000