Patient leaflet - Bisoprolol 10 mg tablets
1. What Bisoprolol Tablets are and what they are used for
The full name of your medicine is Bisoprolol 5mg or 10mg Tablets, but within the leaflet it will be referred to as Bisoprolol Tablets.
The active substance in this medicine is Bisoprolol fumarate. Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers protect the heart against too much activity. This medicine works by affecting the body’s response to some nerve impulses, especially in the heart. As a result, Bisoprolol fumarate slows down the heart rate and makes the heart more efficient at pumping blood around the body. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s need.
Bisoprolol Tablets are used in combination with other medicines to treat stable heart failure.
Bisoprolol tablet are also used to treat high blood pressure (Hypertension) and angina pectoris (Chest pain caused by blockages in the arteries that supply the heart muscle)
2. What you need to know before you take Bisoprolol Tablets
DO NOT take Bisoprolol Tablets if you:
- are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6)
- have severe asthma
- have severe blood circulation problem in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue
- have an untreated phaeochromocytoma, a rare tumour of the adrenal gland
- have metabolic acidosis, which is a condition when there is too much acid in the blood
Do not take Bisoprolol 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.
Warnings and precautions
If you have any of the following conditions tell your doctor before taking Bisoprolol; he or she may want to take special care (for example give additional treatment or perform more frequent checks):
- strict fasting (fasting from solid food)
- certain heart disease such as disturbance in heart rhythm or severe chest pain at rest (Prinzmetal’s angina)
- history of a scaly skin rash (psoriasis)
- diabetes
- kidney or liver disease
- less severe blood circulation problem in your limbs
- less severe asthma or chronic lung disease
tumour of the adrenal gland (medulla)
(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.
- Anesthesia (for example for surgery) because this medicine may influence how your body react to this situation.
If you have chronic lung disease or less severe asthma please inform your doctor immediately if What is in this leaflet:
- 1. What Bisoprolol Tablets are and what they are 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.
you start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using Bisoprolol Tablets.
Children and adolescents
Bisoprolol Tablets is not recommended for use in children or adolescents
Other medicines and Bisoprolol Tablets
Tell your doctor if you are taking, having 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; 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. gliquidone, gliclazide, glibenclamide, 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.
Pregnancy and breast-feeding
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. He or she will decide whether you can take Bisoprolol during pregnancy.
Breast-feeding
It is not known whether bisoprolol fumarate passes into breast milk. Therefore, breast-feeding is not recommended during treatment with Bisoprolol Tablets. Driving and using machines
The ability to drive or operate machinery may be affected, depending on how well you tolerate the medicine. Be especially careful at the beginning of the treatment, when the dose is increased or when the medication is changed, and when combined with alcohol.
3. How to take Bisoprolol Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or your pharmacist if you are not sure.
Product: Bisoprolol 5mg & 10mg Tablets (Yiling)
P4118T Treatment with Bisoprolol Tablets requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase and when you stop treatment.
Take the tablet with some water in the morning, with or without food. Swallow the tablet/s whole with some water and do not crush or chew the tablet. The scored tablets can be divided into two equal doses. Treatment with Bisoprolol Tablets is usually prolonged. Adult:
Chest pain and high blood pressure:
Your doctor will start the treatment with lowest possible dose (5 mg). Your doctor will monitor you closely at the start of treatment.
Your doctor will increase your dose to obtain the best possible dosage for you.
The maximum recommended dose is 20 mg once per day.
Patient with kidney disease:
Patient with severe kidney disease should not exceed 10 mg of bisoprolol once daily. Please consult your doctor before starting to use this medicine. Patient with liver disease:
Patient with severe liver disease should not exceed 10 mg of bisoprolol once daily.
Please consult your doctor before starting to use this medicine.
Heart failure:
Before you start using bisoprolol fumarate tablet, you should already be taking other medicines for heart failure including any ACE inhibitor, a diuretic and (as an added option) a cardiac glycoside.
Adults including the elderly:
Treatment with Bisoprolol Tablets 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:
- 1.25mg bisoprolol fumarate once daily for a week
- 2.5mg bisoprolol fumarate once daily for a week
- 3.75mg bisoprolol fumarate once daily for a week
- 5mg bisoprolol fumarate once daily for four weeks
- 7.5mg bisoprolol fumarate once daily for four weeks
- 10mg bisoprolol fumarate once daily for maintenance (on-going) therapy.
The maximum recommended daily dose of bisoprolol fumarate is 10mg.
Depending on how well you tolerate the medicine, the doctor may also extend the time between dose increases. If your condition gets worse or if you no longer tolerate the drug, it may be necessary to lower the dose again or to stop treatment. In some patients a maintenance dose lower than 10mg bisoprolol fumarate may be sufficient. Your doctor will tell you what to do. If you have to stop the treatment entirely, your doctor will usually advice you to reduce the dose gradually, as otherwise your condition may become worse. Use in children
Bisoprolol tablet is not recommended for use in children. Elderly patient
In general adjustment of the dose is not needed. It is recommended to start with 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 Tablets than you should
If you take too much medicine, or if a child has swallowed the medicine by mistake, ask your doctor or hospital for assessing risk and advice. Take this leaflet and any tablets you still have with you. You may feel slow heartbeat, severe breathing difficulties, dizziness or tremor (due to decreased blood sugar).
If you forget to take Bisoprolol Tablets
Do not take a double dose to make up for a forgotten dose.
Take your usual dose the next morning.
If you stop taking Bisoprolol Tablets
Never stop taking Bisoprolol unless on your doctor’s advice. Otherwise your condition could become much worse.
If you have any further question on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. To prevent serious reaction, speak to a doctor IMMEDIATELY if a side effect is severe, occurs suddenly or gets worse rapidly.
The most serious side effects are related to the heart function:
slowing of heart rate (may affect more than 1 in 10 people)
- worsening of heart failure (may affect up to 1 in 10 people)
- slow or irregular heartbeat (may affect up to 1 in 100 people)
- Worsening of symptom of blockage of the main blood vessel to the legs, especially at the start of treatment (Frequency not stated).
If you feel dizzy or weak or have breathing difficulties, please contact your doctor as soon as possible. Further side effects are listed below according to how frequently they may occur:
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 or intestine problem such as nausea, vomiting, diarrhoea or constipation
Uncommon (may affect up to 1 in 100 people):
- Muscle weakness, muscle cramps
- Sleep disturbances
- Depression
- Breathing problems in patients with asthma or chronic lung disease
- Dizziness when standing up
Rare (may affect up to 1 in 1,000 people):
- Hearing problems
- Allergic runny nose (blocked or runny nose)
- Reduced tear flow (can be a problem if you wear contact lenses)
- Inflammation of liver which may cause yellowing of the skin or whites of the eyes
- Some blood test for liver function and fat content are different from normal value
- Impaired erection (reduced sexual performance)
- Nightmares or hallucinations
- Fainting
- Allergic reactions such as itching, redness and skin rash. 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.
Very rare (may affect up to 1 in 10,000 people):
- Irritation and redness of eye (conjunctivitis)
- Hair loss
- Appearance or worsening of scaly skin rash (psoriasis). Psoriasis like rash.
* if treated for high blood pressure or angina then these symptom occur especially at beginning of treatment, or if your dosage changes. They are generally mild or often disappear within 1 to 2 weeks.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect 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.
5. How to store Bisoprolol Tablets
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
DO NOT store above 25°C. Store in the original package.
DO NOT use this medicine after the expiry date which is stated on the carton and blister, after EXP. 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 to protect the environment.
6. Contents of the pack and other information
What Bisoprolol Tablets contain:
- The active substance is bisoprolol fumarate. The tablets contain 5mg and 10mg of bisoprolol fumarate respectively.
- 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 iron oxide yellow (E172). Bisoprolol 10mg Tablets also contain iron oxide red (E172).
What Bisoprolol Tablets look like and contents of the pack:
Bisoprolol 5mg tablets are round film-coated, ivory coloured tablets with a break-line on one side and ‘5’ embossed on the other.
Bisoprolol 10mg Tablets are round film-coated, light brown coloured tablets with a break-line on one side and ‘10’ embossed on the other.
Bisoprolol 5mg and 10mg Tablets are available in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Ltd., Key House,
Sarum Hill, Basingstoke, RG21 8SR, UK. This leaflet was last revised in October 2026.