Bisoprolol 1.25 Mg Film-Coated Tablets
Uncommon (affects between I in 100 and I in 1,000 patients)
• breathing problems in patients with asthma or a chronic lung disease
• muscular weakness and cramps
• dizziness when standing up
• sleep problems
Rare (affects between I in 1,000 and I in 10,000 patients)
• certain blood test results for liver function or fat levels differing from normal
• reduced tear flow
• hearing problems
• allergic runny nose
• allergic reactions such as itching, flush and rash
• inflammation of the liver which can cause yellowing of the skin or whites of the eyes
• erection problems
Very rare (affects less than I in 10,000 patients)
• irritation and redness of the eye (conjunctivitis)
• hair loss
• appearance or worsening of scaly skin rash (psoriasis or psoriasis-like rash).
Tell your doctor or your pharmacist if any of the side effects get serious or if you notice any other unwanted or unexpected effects.
PACKAGE LEAFLET: INFORMATION FOR THE USER
1.25 mg film-coated tablets
2.5 mg film-coated tablets 3.75 mg film-coated tablets 5 mg film-coated tablets
7.5 mg film-coated tablets 10 mg film-coated tablets
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 it is used for
2. Before you take Bisoprolol tablets
3. How to take Bisoprolol tablets
4. Possible side effects
5. How to store Bisoprolol tablets
6. Further information
5. HOW TO STORE BISOPROLOL TABLETS
Keep out of 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.
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 tablets contain
The active substance is bisoprolol hemifumarate.
Each Bisoprolol 1.25 mg film-coated tablets contains 1.25 mg of the active substance. Each Bisoprolol 2.5 mg film-coated tablets contains 2.5 mg of the active substance. Each Bisoprolol 3.75 mg film-coated tablets contains 3.75 mg of the active substance. Each Bisoprolol 5 mg film-coated tablets contains 5 mg of the active substance.
Each Bisoprolol 7.5 mg film-coated tablets contains 7.5 mg of the active substance. Each Bisoprolol 10 mg film-coated tablets contains 10 mg of the active substance.
The other ingredients are:
Microcrystalline cellulose (PH - 112), maize starch, crospovidone (type B), colloidal anhydrous silica, magnesium stearate
Film coating (1.25mg tablets and 2.5mg tablets): Hypromellose, Macrogol 400 and Titanium dioxide (E171)
Film coating (3.75mg tablets, 5 mg tablets and 7.5mg tablets): Hypromellose, Macrogol 400, Titanium dioxide (E171), Ferric oxide yellow E-172 Film coating (10mg tablets): Hypromellose, Macrogol 400, Titanium dioxide (E171), Ferric oxide yellow E-172, Ferric oxide red E-172
What Bisoprolol tablets looks like and the contents of the pack
The 1.25 mg tablets are white, round and plain on both sides.
The 2.5 mg tablets are white and heart-shaped with a break-line on both sides.
The 3.75 mg tablets are off-white and heart-shaped with a break-line on both sides.
The 5 mg tablets are white - yellow, heart-shaped with a break-line on both sides.
The 7.5 mg tablets are pale yellow and heart-shaped with a break-line on both sides. The 10 mg tablets are pale to light orange, heart-shaped with a break-line on both sides. Each pack contains 20, 28, 30, 50, 56, 60, 90, or 100 tablets.
Not all pack sizes may be marketed.
1.25mg: PL 21880/0127, 2.5mg: PL 21880/0128, 3.75mg: PL 21880/0129, 5mg: PL 21880/0130, 7.5mg: PL 21880/0131,1 Omg: PL 21880/0132. Leaflet revised February 2015
Marketing Authorisation Holder and Manufacturer:
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : firstname.lastname@example.org
Bisoprolol 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.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs.
Bisoprolol is used to treat stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides).
• are allergic (hypersensitive) to Bisoprolol or to any of the other ingredients (see section 6 for list of ingredients)
• suffer from severe asthma or severe chronic lung disease
• 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
• suffer from untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
• suffer from metabolic acidosis, which is a condition when there is too much acid in the blood.
• 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.
Take special care and tell your doctor if you:
• suffer from less severe asthma or chronic lung disease
• suffer from diabetes
• are currently, or intend to partake in strict fasting while taking this medicine
• suffer from certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)
• suffer from kidney or liver problems
• suffer from less severe blood circulation problems in your limbs
This section is continued overleaf —>
• have a history of a scaly skin rash (psoriasis)
• are being treated for tumour of the adrenal gland (phaeochromocytoma)
• have thyroid problems
• are going to have desensitization therapy (for example for the prevention of hay fever), because Bisoprolol may make it more likely that you experience an allergic reaction, or such reaction may be more severe
• are going to have anaesthesia (for example for surgery), because Bisoprolol may influence how your body reacts to this situation.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take the following medicines with Bisoprolol without special advice from your doctor. However, do not stop taking these medicines without checking with your doctor first:
• medicines used to treat irregular or abnormal heartbeat (called ‘Class I antiarrhythmic medicines’ such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)
• medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (called ‘calcium antagonists’ such as verapamil and diltiazem)
• medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine, rilmenidine.
Check with your doctor before taking the following medicines with Bisoprolol; your doctor may need to check your condition more frequently:
• medicines used to treat high blood pressure or angina pectoris (called dihydropyridine-type calcium antagonists such as felodipine and amlodipine)
• medicines used to treat irregular or abnormal heartbeat (called Class III antiarrhythmic medicines such as amiodarone)
• Types of beta-blockers are applied locally ( such as timolol eye drops for glaucoma treatment)
• medicines used to treat for example Alzheimer’s disease or glaucoma (called parasympathomimetics such as tacrine or carbachol) or medicines that are used to treat acute heart problems (called sympathomimetics such as isoprenaline and dobutamine)
• Antidiabetic medicines including insulin
• Anaesthetics (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 (called tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (called barbiturates such as phenobarbital), or certain medicines to treat mental illness characterized by a loss of contact with reality (called 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.
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.
It is not known whether Bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during therapy with Bisoprolol.
Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. 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. Ask your doctor or pharmacist if you are not sure.
Treatment with this medicine requires regular monitoring by your doctor. This is particularly necessary at the start of treatment and during dose increase.
Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.
Treatment with this medicine is usually long-term.
Dosage in 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:
• 1.25 mg Bisoprolol once daily for the first week of treatment
• 2.5 mg Bisoprolol once daily for the second week of treatment
• 3.75 mg Bisoprolol once daily for the third week of treatment
• 5 mg Bisoprolol once daily for the fourth, fifth, sixth and seventh weeks of treatment
• 7.5 mg Bisoprolol once daily for the eighth, ninth, tenth and eleventh week of treatment
• 10 mg Bisoprolol once daily from the twelfth week for maintenance (on-going) therapy.
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.
The maximum recommended daily dose is 10 mg.
Bisoprolol is not recommended for use in children.
If you take more Bisoprolol than you should
If you have taken more 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, dizziness, low blood pressure, severe difficulty in breathing, worsening of heart failure, or trembling (due to decreased blood sugar).
If you forget to take a tablet
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
Never stop taking Bisoprolol unless told to by your doctor. Otherwise your condition could become much worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Bisoprolol tablets can cause side effects, although not everybody gets them. 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:
• slowing of heart rate
• worsening of heart failure
• irregular heartbeat
If you feel dizzy or weak, or have breathing difficulties contact your doctor, pharmacist or nearest hospital IMMEDIATELY
Common (affects between I in 10 and I in 100 patients)
• stomach or intestine problems such as nausea, vomiting, diarrhoea or constipation
• feeling of coldness in the hands or feet
• low blood pressure
• weakness or tiredness
This section is continued overleaf —»
Font type & size
Futura MD BT (8 pt)
RA artwork code
Title: Art Work Approval Form
Bisoprolol Tablets - S/L - Eng - PIL
Printed on 56 - 60 GSM Maplitho Paper.
MEDREICH PLC, UK
Reason for Issue
a) pharmacode re-positioned at the bottom as per machine requirement and accordingly size changed.) (oldcode: 1214260-V1)
2 - Pantone Red 032 C & Black
260 x 310 mm (open size) 130 x 38 mm (Folded Size)
Related FG Codes
1302628 / 29 / 31 / 32
/ 33 & 34
No. of Folds (only for PIL)
Artwork made to
121XXXX-V1 (WOA) Layout No.: NA
Format No.: CO-QA005-F03-02
WIN/192.168.1.33/pdc/Artworks/Medreich/Bisoprolol/PIL/Bisoprolol Tablets - SL - Eng - PIL_121XXXX-V1.ai Internal Approval issued on CD issued on