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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL17780/0892.
Bisoprolol film-coated tablets
Bisoprolol fumarate 1.25 mg tablets
Bisoprolol fumarate 2.5 mg tablets
Bisoprolol fumarate 3.75 mg tablets
Bisoprolol fumarate 5 mg tablets
Bisoprolol fumarate 7.5 mg tablets
Bisoprolol fumarate 10 mg tablets
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
The active substance is Bisoprolol fumarate. It belongs to a group of medicines called beta-blockers. These medicines work by affecting the body’s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body. At the same time, it reduces the amount of blood required by the heart, as well as its use of oxygen.
Bisoprolol fumarate is used to treat stable chronic heart failure. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. It is used in combination with other medicines suitable for this condition (such as ACE inhibitors, diuretics, and heart glycosides).
In addition, Bisoprolol fumarate 5 mg and 10 mg are used to treat high blood pressure (hypertension) and heart pain due to impaired perfusion of the coronary vessels (ischemic heart disease, angina pectoris).
Do not take Bisoprolol fumarate if you have one of the following heart problems:
Talk to your doctor about taking this medicine if you think that one of the conditions listed above applies to you.
Talk to your doctor or pharmacist before taking Bisoprolol fumarate if one of the following conditions applies to you. He or she may want to take special care (for example give additional treatment or perform more frequent checks):
In addition, tell your doctor if you are going to have:
If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties in breathing, coughing, wheezing after exercise, etc. when taking Bisoprolol fumarate.
Bisoprolol fumarate 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 fumarate without special advice from your doctor:
Check with your doctor before taking the following medicines with Bisoprolol fumarate; your doctor may need to check your condition more frequently:
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 fumarate 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 fumarate during pregnancy.
Breast-feeding
It is not known whether bisoprolol passes into human breast milk. Therefore, breast-feeding is not recommended during therapy with Bisoprolol fumarate.
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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Treatment with Bisoprolol fumarate requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increases and when you stop treatment.
Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet. The score line is not intended for breaking the tablet.
Treatment with Bisoprolol fumarate is usually long-term.
Adults including the elderly
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:
The maximum recommended daily dose is 10 mg bisoprolol.
In case bisoprolol 1.25 mg, 3.75 mg or 7.5 mg is not registered in your country, the dosages can be achieved by other bisoprolol products that are available.
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.
Adults including the elderly
Unless prescribed otherwise, the recommended dose is 5 mg bisoprolol daily. In cases of only slightly elevated blood pressure (diastolic blood pressure of up to 105 mmHg), treatment with 2.5 mg once daily may be sufficient, using other medicinal products with appropriate strength.
If the effect is insufficient, the dose can be increased to 10 mg bisoprolol daily.
Additional dose increases are justified only in exceptional cases.
The highest recommended dose is 20 mg once daily.
Adults including the elderly
Unless prescribed otherwise, the recommended dose is 5 mg bisoprolol daily.
If the effect is insufficient, the dose can be increased to 10 mg bisoprolol daily.
Additional dose increases are justified only in exceptional cases.
The highest recommended dose is 20 mg once daily.
Dosing in case of hepatic or renal impairment
In patients with mild to moderate hepatic or renal impairment, dosage adjustment is not normally necessary. In patients with severe renal impairment (creatinine clearance < 20 ml/min) and in patients with severe hepatic impairment, the daily dose should not exceed 10 mg bisoprolol fumarate.
If you have taken more Bisoprolol fumarate 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 fumarate unless your doctor tells you to do so. Otherwise your condition could become much worse.
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 your doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly.
If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.
Common (may affect up to 1 in 10 people):
*These symptoms particularly occur at the start of treatment. They are generally mild and usually disappear within 1 to 2 weeks after start of treatment.
Uncommon (may affect up to 1 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 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.
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 blister and the carton after EXP. The expiry date refers to the last date of that month.
For products packed in OPA/Alu/PVC100//Alu/ or OPA/Alu/PVC60//Alu blisters:
Store below 30 °C. Store in the original package in order to protect from moisture.
For product packed in white PVC/PVdC//Alu blisters:
Store below 25 °C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household 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 tablet contains 1.25 mg, 2.5 mg, 3.75 mg, 5 mg 7.5 mg or 10 mg bisoprolol fumarate.
The other ingredients are cellulose, microcrystalline (PH 102); starch, pregelatinised; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate.
Bisoprolol fumarate 3.75 mg, 5 mg, 7.5 mg and 10 mg tablets also contain iron oxide yellow (E172 ).
Bisoprolol fumarate 3.75 mg tablets and 10 mg tablets also contain iron oxide brown (E172).
Bisoprolol fumarate 1.25 mg tablets: White rounded tablets with 1.25 embossed and diameter 6 mm ± 0.3 mm.
Bisoprolol fumarate 2.5 mg tablets: White rounded tablets with 2.5 embossed, score line and diameter 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.
Bisoprolol fumarate 3.75 mg tablets: Off-white to light beige rounded tablets with 3.75 embossed and diameter 6 mm ± 0.3 mm.
Bisoprolol fumarate 5 mg tablets: Yellowish to light yellow rounded tablets with 5 embossed, score line and diameter 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.
Bisoprolol fumarate 7.5 mg tablets: Yellow to dark yellow rounded tablets with 7.5 embossed and with randomly distributed spots of colorant and diameter 6 mm ± 0.3 mm.
Bisoprolol fumarate 10 mg tablets: Ochre rounded tablets with 10 embossed, score line and with randomly distributed spots of colorants and diameter 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.
Pack sizes:
1.25 mg: 20, 28, 30, 60, 90 or 100 tablets
2.5 mg: 15, 28, 30, 60, 90 or 100 tablets
3.75 mg: 28, 30, 50, 90 or 100 tablets
5 mg: 28, 30, 50, 56, 60, 90 or 100 tablets
7.5 mg: 28, 30, 50, 56, 60 or 100 tablets
10 mg: 28, 30, 50, 56, 60, 90 or 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in April 2023.
ZV/706 89