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The product code(s) for this leaflet is: PL 04416/0928.
Bisoprolol Fumarate 5mg and 10 mg film-coated tablets
Bisoprolol Fumarate 5mg and 10 mg film-coated tablets.
bisoprolol fumarate
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
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:
Tell your doctor if you are not sure about any of the above.
Talk to your doctor before taking Bisoprolol fumarate
There is so far no therapeutic experience of Bisoprolol fumarate treatment of heart failure in patients with the following diseases and conditions:
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 fumarate must not be discontinued abruptly unless for compelling reasons.
For patients with hypertension and angina pectoris, accompanying heart failure treatment should not be stopped abruptly. The dosage should be diminished slowly by a weekly halving of the dose.
Consult your physician if one of the above warnings is applicable to you, or has been in the past.
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).
Always tell your doctor if you are using or receiving any of the following medicines in addition to Bisoprolol fumarate:
All these drugs as well as Bisoprolol fumarate may influence the blood pressure and/or heart function.
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.
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.
This medicine 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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
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.
Adults
The dose is determined individually.
The recommended starting dose is 5 mg once daily.
The usual dose for adults is once daily 10 mg. Your doctor may decide to increase or decrease the dose.
The maximum dose is once daily 20 mg.
Severe kidney or severe liver function disorders
If you suffer from a severe kidney or severe liver function disorder the maximum dose is 10 mg per day.
Elderly
Normally no dosage adjustment is required. Your doctor will start therapy with the lowest possible dose.
Before you start using Bisoprolol fumarate, you are already using an ACE-inhibitor, diuretic or heart glycoside (heart/ blood pressure product).
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.
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 spoken an adjustment of the dose is not needed.
If you notice that the effect of Bisoprolol fumarate is too strong or not strong enough, please consult your doctor or pharmacist.
Place the tablet on a hard, flat surface with the scored side at the top.
Press with the thumb on the middle of the tablet and the tablet will break into two halves, press with the thumb in the middle of each half and you will have four parts.
Bisoprolol fumarate will usually be used long-term.
There is no experience with Bisoprolol fumarate in children and adolescents, therefore its use is not recommended in children.
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).
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly.
The most serious side effects are related to the heart function:
If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.
You should see a doctor straight away if you experience more severe allergic reactions, which may involve face, neck, tongue, mouth or throat swelling, or difficulty breathing.
Further side effects are listed below according to how frequently they may occur:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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 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 medicine does not require any special storage conditions.
Bottle: This medicine does not require any special storage conditions.
Storage conditions after first opening of the bottle:
Do not store above 25°C.
Do not throw away any medicines via wastewater or houshold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is bisoprolol fumarate.
Each film-coated tablet contains 5 mg of bisoprolol fumarate.
5mg film-coated tablets:
The other ingredients are: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172).
Each film-coated tablet contains 10 mg of bisoprolol fumarate.
10mg film-coated tablets:
The other ingredients are:
anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
The film-coated tablets are packed in OPA/Alu/PVC/Alu blisters and inserted in a carton, or are packed in a HDPE tablet bottle with PE cap.
Pack sizes:
Blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 10x30, 500 film-coated tablets
Bottle: 10, 20, 30, 50, 60, 100, 250, 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 06/2021
PL 04416/0928
PIL.0928.0018.0A