Bisoprolol 10 Mg Film-Coated Tablets.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bisoprolol 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.
- 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 symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Bisoprolol is and what they are used for
2. Before you take Bisoprolol
3. How to take Bisoprolol
4. Possible side effects
5. How to store Bisoprolol
6. Further information
1. What Bisoprolol is and what they are used for
Bisoprolol belongs to a group of medicines called beta-blockers. These medicines protect the heart against too much activity.
Bisoprolol may be used to treat angina pectoris (pains in the chest caused by blockages in the arteries that supply the heart muscle) or hypertension (high blood pressure).
2. 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.
• have severe asthma or severe chronic lung disease.
• have a slow heart rate (less than 60 beats per minute) or an 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 that may require hospital treatment
• 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.
• have untreated phaeochromocytoma, a rare tumour of the adrenal gland.
• Tell your doctor if you are not sure about any of the above.
Take Special Care with Bisoprolol
Talk to your doctor before taking Bisoprolol if you:
• have liver or kidney problems.
• have diabetes. Bisoprolol tablets can hide the symptoms of low blood sugar.
• have (or have had) psoriasis (as recurring skin rash)
• Are being treated for hypersensitivity (allergic) reactions. Bisoprolol may make your condition worse or more difficult to treat.
• have been treated for a condition called ‘phaeochromocytoma’ (a rare tumour of the adrenal gland).
• have a thyroid problem. The tablets can hide symptoms of an overactive thyroid.
• have asthma or chronic lung disease.
• are fasting from solid food.
• Have any heart problems
• have any problems with the circulation to your hands and feet.
• consult a doctor, attend hospital or the dentist for surgery involving an anaesthetic, let them know what medicines you are taking.
Taking other medicines:
Please, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is particularly important to mention any of the following drugs as their action may be affected:
• Medicines used for controlling blood pressure or medicines used for the treatment of heart problems, such as: amlodipine, amiodarone, clonidine, diltiazem, disopyramide, digoxin, dobutamine, isoprenaline, methyldopa, moxonidine, nifedipine, quinidine, rilmenidine, verapamil and beta blocking agents.
• Medicines for the treatment of depression and mental disorders such as tricyclic antidepressants, phenothiazines, monoamine oxidase inhibitors and barbiturates.
• Medicines used as anaesthetics during an operation.
• Certain pain killers (for instance acetyl salicylic acid, diclofenac, indomethacin, ibuprofen, naproxen)
• Medicine used for diabetes.
• Medicines used for malaria e.g. mefloquine.
• Medicines used for migraine e.g. ergotamine.
• Medicines for asthma.
• Medicines for a blocked nose.
• Medicines for glaucoma (increased pressure in the eye).
• Medicines used to dilate (widen) the pupil of the eye.
• Medicines known as corticosteroids used to treat inflammation of the joints and organs.
• Certain medicines to treat clinical shock (e.g. epinephrine, dobutamine, norepinephrine)
• Rifampicin for the treatment of infections.
• Medicines for Alzheimer’ s Disease.
All these medicines may influence your blood pressure and/or heart function.
With insulin and other medicines used for diabetes, Bisoprolol may mask the symptoms of a low blood sugar.
Taking Bisoprolol with food and drink
Bisoprolol may be taken with or without food and should be swallowed whole with a drink of water.
The dizziness and light-headedness that may be caused by Bisoprolol can be made worse if you drink alcohol. If this happens to you, you should avoid drinking alcohol.
Pregnancy and breastfeeding
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. 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 breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicinal product.
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. You should check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with water. The tablets should not be chewed.
Your doctor will tell you your correct dosage and will usually start with the lowest dose (5 mg). The maximum recommended dose of 20 mg. The tablets should be taken at about the same time each day.
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.
Elderly patients
In general an adjustment of the dose is not needed. It is recommended to start with the lowest possible dose.
If you notice that the Bisoprolol dose is too strong or does not work well enough, please consult your doctor or pharmacist.
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, 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
If you forgot to take a tablet, take it if you remember within 12 hours of your usual time. If more than 12 hours have passed, you should not take the missed tablet but should take your next tablet at the normal time when it is due.
If you stop taking Bisoprolol
Treatment with Bisoprolol must not be stopped abruptly, particularly if you have had angina or a heart attack. If you suddenly stop the use of Bisoprolol your condition may get worse or your blood pressure may start to rise again. Instead, it must be reduced gradually over one or two weeks as advised by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Bisoprolol tablets 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 tablets and see your doctor immediately if the following symptoms occur:
Uncommon side effects (affecting fewer than 1 in 100 people):
• 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:
Common side effects (affecting fewer than 1 in 10 people):
• cold hands and/or feet
• numbness of hands and/or feet
• low blood pressure
• feeling sick, vomiting, diarrhoea, constipation
• tiredness*
• dizziness*
• headache*.
Uncommon side effects (affecting fewer than 1 in 100 people)
• slow heart beat
• worsening of irregular heart beat
• sleep disorders
• depression
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps
• feeling weak.
Rare side effects (affecting fewer than 1 in 1,000 people)
• changes in blood test results
• reduced tear flow (can be a problem if you wear contact lenses)
• hearing disorders
• blocked, runny nose
• 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
• hypersensitivity reactions such as itching, redness and skin rash
• reduced sexual performance
• nightmares
• hallucinations
• fainting.
Very rare side effects (affecting fewer than 1 in 10,000 people):
• inflammation of the eye (conjunctivitis)
• aggravation of the skin condition psoriasis or the appearance of a similar dry, scaly rash
• hair loss.
* these symptoms are especially occur at the beginning of treatment, or if your dosage changes. They are generally mild and often disappear within 1 to 2 weeks.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Bisoprolol
Keep out of the reach and sight of children.
Store in the original package in order to protect from light.
Do not use Bisoprolol after the expiry date which is stated on the carton/ bottle after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Bisoprolol contains
- The active substance is bisoprolol fumarate.
Each 5 mg film-coated tablet contains 5 mg of bisoprolol fumarate equivalent to 4.24 mg bisoprolol. Each 10 mg film-coated tablet contains 10 mg of bisoprolol fumarate equivalent to 8.48 mg bisoprolol.
- 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, iron oxide yellow (E172).
What Bisoprolol looks like and contents of the pack Film-coated tablet.
Bisoprolol 5 mg film-coated tablets
Yellow coloured, circular, biconvex, film-coated tablets debossed with ‘I and score line’ on one side and ‘11’ on the other side. The tablet can be divided into equal halves.
Bisoprolol 10 mg film-coated tablets
Yellow coloured, circular, biconvex, film-coated tablets debossed with ‘I and score line’ on one side and ‘13’ on the other side. The tablet can be divided into equal halves.
Bisoprolol film-coated tablets are available in -Polyamide/Aluminium/PVC/Paper/Polyester/Aluminium blisters and HDPE container with PP closure containing silica gel sachet.
Pack sizes:
Blister pack: 20, 28, 30, 50, 56, 60, 90, 100 film-coated tablets HDPE container 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 06/2014