Bisoprolol Fumarate 2.5 mg film-coated tablets

Bisoprolol Fumarate 1.25mg and 2.5mg film coated Tablets are known as Bisoprolol Tablets in this leaflet.

• 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. 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.

1. What Bisoprolol Tablet 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

Do not take Bisoprolol Tablets if one of the following conditions applies to you:

Allergy (hypersensitive) to Bisoprolol or any of the other ingredients of this medicine (listed in section 6 What Bisoprolol Tablets contains')

• severe asthma
• 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 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.

If you have any of the following conditions tell your doctor before taking Bisoprolol Fumarate Tablets; 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
• chronic lung disease or less severe asthma
• history of a scaly skin rash (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• Thyroid disorder.

In addition, tell your doctor if you are going to have:

• desensitization therapy (for example for the prevention of hay fever), because Bisoprolol Tablets may make it more likely that you experience an allergic reaction, or such reaction may be more severe
• Anaesthesia (for example for surgery), because Bisoprolol Tablets may influence how your body reacts to this situation.

If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using Bisoprolol Fumarate Tablets.

Bisoprolol Tablets is not recommended for use in children or adolescents.

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 Tablets without special advice from your doctor:

• certain medicines used to treat irregular or abnormal heartbeat (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 (calcium antagonists such as verapamil and diltiazem)
• certain medicines used to treat high blood pressure such as 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 Tablets; your doctor may need to check your condition more frequently:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone)
• beta-blockers 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 and sulfonylureas (e.g. glibenclamide, gliquidone, gliclazide, glipizide, glimepiride or tolbutamide). Bisoprolol could increase the risk of severely low blood glucose levels when used with these medicines
• 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 (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 characterized by a loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention or treatment of malaria
• depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

There is a risk that use of Bisoprolol 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 Tablets during pregnancy.

It is not known whether Bisoprolol Tablets passes into human breast milk. Therefore, breastfeeding is not recommended during therapy with Bisoprolol Fumarate Tablets.

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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially 'sodium free'.

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 once daily for one week
• 2.5 mg bisoprolol once daily for one week
• 3.75 mg bisoprolol once daily for one week
• 5 mg bisoprolol once daily for four weeks
• 7.5 mg bisoprolol once daily for four weeks
• 10 mg bisoprolol once daily 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 10 mg 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 have taken more Bisoprolol 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, severe difficulty in breathing feeling dizzy, or trembling (due to decreased blood sugar).

Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.

Never stop taking Bisoprolol Tablets unless on your doctor's advice. Otherwise your condition could become much worse.

Bisoprolol Tablets 1.25mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg.
• The other ingredients are:

Tablet core: Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Magnesium Stearate Film coating: Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521), Ferric Oxide Yellow

Bisoprolol Tablets 2.5mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg.
• The other ingredients are:

Tablet core: Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Magnesium Stearate Film coating: Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521),

Bisoprolol Tablets 1.25mg film-coated tablets

Yellow, round, biconvex tablet, deep break mark on one side and debossed with “1.25” on other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Bisoprolol Tablets 2.5mg film-coated tablets

White to off white, round, biconvex tablet, deep break mark on one side and debossed with “2.5” on other side. The scored tablets can be divided into two equal doses.

The tablets are available in aluminium-PVC or aluminium- PVC/PVDC blister packs of 28's, 30's, 50's, 56's, 60's, 90's and 100 tablets. Not all pack sizes may be marketed.