Bisoprolol 10 mg film-coated Tablet

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.

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

• if you are allergic to bisoprolol or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe asthma
• if you suffer from 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 an untreated tumour of the adrenal gland (phaeochromocytoma)
• if you suffer from metabolic acidosis (a condition when there is too much acid in the blood)
• 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
  • low blood pressure
  • certain heart conditions causing a very slow heart rate or irregular heartbeat
  • cardiogenic shock, a serious heart condition causing low blood pressure and circulatory failure.

If you have any of the following conditions tell your doctor before taking Bisoprolol as they may want to take special care (e.g. 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)
• a tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder.

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

• desensitisation therapy (e.g. for the prevention of hay fever), because Bisoprolol may make it more likely that you experience an allergic reaction, or that such a reaction may be more severe
• anaesthesia (e.g. for surgery), because Bisoprolol may influence how your body reacts

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

Bisoprolol 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, including those obtained without a prescription. This includes herbal medicines.

Do not take the following medicines with Bisoprolol 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; 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 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 (e.g. during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (e.g. 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 characterised by a loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention or treatment of malaria
• medicines for depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide

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.

Pregnancy

There is a risk that use of Bisoprolol during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, tell your doctor. They will decide whether you can take Bisoprolol during pregnancy.

Breast-feeding

It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with Bisoprolol.

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 if the medication is changed, as well as in combination with alcohol.

If you accidentally take too many tablets, contact your doctor or nearest hospital department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of overdose may include: slowed heart rate, severe difficulty in breathing, feeling dizzy, or trembling (due to decreased blood sugar).

Take it as soon as you remember, unless it is time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

Treatment with Bisoprolol must not be stopped abruptly unless on your doctor’s advice otherwise your condition could become worse.

• allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness
• slowing of heart rate, slow or irregular heartbeat
• worsening of heart failure

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

• tiredness, feeling weak, dizziness
• headache
• feeling of coldness or numbness in hands or feet
• low blood pressure
• stomach problems such as nausea, vomiting, diarrhoea, or constipation

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

• sleep disturbances
• depression
• dizziness when standing up
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness
• cramps

Rare (may affect up to 1 in 1,000 people):

• hearing problems
• 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, runny nose
• impaired erection
• nightmares
• hallucinations
• fainting

Very rare (may affect up to 1 in 10,000 people):

• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.
• hair loss
• irritation and redness of the eye (conjunctivitis)

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 or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

• Each film coated tablet contains 5 mg or 10 mg of bisoprolol fumarate.
• The other ingredients are: maize starch, microcrystalline cellulose, crospovidone, anhydrous calcium hydrogen phosphate, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), macrogol 6000, dimeticone 350 and yellow iron oxide (E172). Bisoprolol 10mg Tablets also contain red iron oxide (E172)

• Bisoprolol 5 mg are ivory colour, round, biconvex, film-coated tablets with a break line on one side and embossed with “5” on the other side, diameter 7 mm.
• Bisoprolol 10 mg are light brown colour, round, biconvex, film-coated tablets with a break line on one side and embossed with “10” on the other side, diameter 7 mm.

Both strengths are available in blister packs of 28 tablets.

Product Licence Numbers:

Bisoprolol 5 mg Film-Coated Tablets: PL 11311/0725

Bisoprolol 10 mg Film-Coated Tablets: PL 11311/0726