1.25 mg, 2.5 mg, 5 mg, 10 mg film-coated tablets
bisoprolol fumarate
1. What Bisomyl is and what it is used for
This medicine contains the active substance bisoprolol fumarate which belongs to a group of medicines called beta-blockers . Bisoprolol is used with other medicines to treat stable heart failure.
Heart failure occurs when the heart muscle is too weak to pump around the blood in the circulation efficiently enough. This results in shortness of breath and swelling.
Bisoprolol attenuates pulse one and makes the heart pump around the blood in the body more efficiently.
Bisoprolol fumarate contained in Bisomyl may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you take Bisomyl
Do not take Bisomyl:
If you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
• if you have severe asthma
• if you have a slow or irregular heartbeat. Ask your doctor if you are unsure
• if you have very low blood pressure
• if you have severe circulatory problems (which can cause tingling in the fingers and toes or make them pale or blue)
• if you have heart failure that suddenly worsens and/or may require hospitalization
• if you have too much acid in your blood, a condition called metabolic acidosis
• if you have untreated pheochromocytoma, a rare adrenal tumor
Warnings and cautions
Talk to your doctor or pharmacist before taking Bisomyl if you:
• have asthma or chronic lung disease
• have diabetes. Bisoprolol may mask the symptoms of low blood sugar.
• fasting (if you do not eat solid food)
• have heart problems
• have liver or kidney problems
• has problems with circulation in the arms and legs
• if you are taking verapamil or diltiazem, which are medicines for heart problems. Concomitant treatment is not recommended, see also “Other medicines and Bisomyl”.
• have or have had psoriasis (a recurring skin disease)
• has pheochromocytoma (an unusual tumor of the adrenal glands). Your doctor will need to treat it before prescribing bisoprolol to you
• have thyroid problems. The tablets may mask symptoms of an overactive thyroid gland.
During treatment
Talk to your doctor or pharmacist if you:
- to be anesthetized (for example before an operation) – tell your doctor that you are taking bisoprolol
- treated for hypersensitivity reactions (allergic reactions). Bisoprolol may worsen your allergy or make it harder to treat
- have chronic lung disease or less severe asthma , contact your doctor immediately if you experience new symptoms such as difficulty breathing, coughing, wheezing after exercise, etc. when taking bisoprolol.
- experience worsening of symptoms of decreased blood circulation to the legs, especially at the beginning of treatment.
Children and young people
No information is available on the treatment of children and adolescents.
Other drugs and Bisomyl
Tell your doctor or pharmacist if you are already taking or using any of the following as they may affect your medicine:
• medicines used to treat blood pressure or medicines used to treat heart problems (eg amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, quinidine, quinidine, quinidine)
• antidepressants, such as imipramine, amitriptyline, moclobemide
• medicines for mental illness, such as phenothiazines such as levomepromazine
• medicines used for anesthesia during operations (see also “Warnings and Precautions”)
• medicines for epilepsy, such as barbiturates such as phenobarbital
• some painkillers (eg acetylsalicylic acid , diclofenac , indomethacin, ibuprofen , naproxen )
• medicines for asthma and medicines for nasal congestion
• drug against certain eye diseases as glaucoma (increased pressure in the eye) or used to widen the pupil a
• certain shock medicines (eg adrenaline, dobutamine, norepinephrine )
• mefloquine, a medicine for malaria
• all medicines that, like bisoprolol, may affect blood pressure and/or heart function
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Fertility, pregnancy, and lactation:
Bisomyl can be harmful to pregnancy and / or the baby (increased risk of premature birth, miscarriage, growth retardation, low blood sugar and decreased heart rate in the baby).
Therefore, do not take this medicine if you are pregnant.
It is not known whether bisoprolol is excreted in human milk. Therefore, breast-feeding is not recommended during treatment with this medicine.
There is no information on the effects of bisoprolol on fertility.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Bisoprolol sometimes causes dizziness and fatigue (see “Possible side effects”). If you experience these side effects , do not drive or use machines. These side effects are likely to occur at the beginning of treatment or if you change the amount of bisoprolol you take.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Bisomyl tablets contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
Only 5 mg and 10 mg tablets:
Bisomyl tablets contain para-orange
Paraorange (E110) can cause allergic reactions.
3. How to take Bisomyl
Before you start taking Bisomyl, you should be treated with other heart failure medications including ACE inhibitors , a diuretic , and maybe even a cardiac glycoside.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
Treatment with bisoprolol must be initiated at a low dose and gradually increased. Your doctor will decide how to increase your dose and it will usually be done as follows:
• 1.25 mg bisoprolol once daily for one week
• 2.5 mg bisoprolol once daily for one week
• 3.75 mg bisoprolol once daily for one week
• 5 mg bisoprolol once daily for four weeks
7.5 mg bisoprolol once daily for four weeks
• 10 mg bisoprolol once daily as maintenance treatment
The highest recommended daily dose is 10 mg bisoprolol.
Depending on how well you tolerate the medicine, your doctor may also decide to extend the time between dose increases. If the condition worsens or if you can no longer tolerate the medicine, it may be necessary to reduce the dose again or to stop the treatment. For some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient.
Your doctor will tell you what to do.
Kidney or liver disease
Your doctor will be extra careful to set a dose of Bisomyl.
Use for children and adolescents
The use of Bisomyl is not recommended as experience in treating children and adolescents with this medicine is insufficient.
Older
Normally no dose adjustment is required. Starting with the lowest possible dose is recommended.
Talk to your doctor or pharmacist if you notice that a dose of Bisomyl is too strong or does not work well enough.
Method of administration
• The tablets should be taken in the morning
• Swallow the tablets whole with a glass of water
• The tablets should not be chewed
• 2.5 mg, 5 mg, and 10 mg tablets can be divided into equal doses. 1.25 mg tablets should not be broken.
If you forget to take Bisomyl
Do not take a double dose to make up for a forgotten dose. Take the next dose at the right time. Contact your doctor if you miss several doses.
If you stop taking Bisomyl
If you suddenly stop taking Bisomyl, it is likely that you will get side effects . Your doctor will reduce the dose slowly over 2 weeks.
If you have any further questions 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 everybody gets them.
The following side effects are important and require immediate action if you experience them. You should stop taking Bisomyl and see a doctor immediately if the following symptoms occur:
Very common (may affect more than 1 user in 10)
• slow heartbeat
Common (may affect up to 1 in 10 people)
• worsening of heart failure which causes difficulty breathing and/or fluid retention.
Uncommon (may affect up to 1 in 100 people)
• worsening of irregular heartbeat
• depression
• respiratory problems in patients with asthma or chronic lung disease
Rare (may affect up to 1 in 1,000 people)
• liver inflammation ( hepatitis ) that provides abdominal pain, loss of appetite, and sometimes yellow jaundice with the eyes and skin and dark urine
If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.
The following side effects have also been reported:
Common a (may affect up to 1 in 10 users)
• cold hands and/or feet
Numbness in hands and/or feet
• low blood pressure
• nausea, vomiting, diarrhea, constipation
• fatigue
• headache
Uncommon a (may affect up to 1 in 100 people)
• difficulty sleeping
• dizziness when traveling to a standing position
• muscle weakness, muscle cramps
Rare (may affect up to 1 in 1,000 people)
• changes in laboratory values for blood tests
• reduced tear flow (may be a problem if you wear contact lenses)
• hearing problems
• stuffy, runny nose
• allergic reactions such as itching, redness, and rash
• impaired sexual ability
• nightmares
• hallucinations
• fainting
Very rare (may affect up to 1 in 10,000 people)
• eye inflammation ( conjunctivitis )
Worsening of the skin disease psoriasis or the appearance of similar dry rashes with flaky skin
• hair loss
Reporting of side effects
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bisomyl
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 carton and can or blister after EXP. The expiration date is the last day of the specified month.
Blister packs: Do not store above 30 ° C.
Jars: This medicine does not require any special storage instructions.
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. Contents of the packaging and other information
Content declaration
Each film-coated tablet contains 1.25 mg, 2.5 mg, 5 mg or 10 mg of the active substance bisoprolol fumarate.
Other ingredients are:
Tablet core:
microcrystalline cellulose, butyl hydroxy anisole, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate, croscarmellose sodium, yellow iron oxide (E172) (only 2.5 mg and 5 mg tablets), red iron oxide (E172) (only 2.5 and 10 mg tablets).
Film coating:
Titanium dioxide (E171), polydextrose (E1200), hypromellose (E464), quinoline yellow, macrogol, yellow iron oxide (E172) (only 10 mg tablets), indigo carmine (E132) (only 5 mg tablets), para-orange (E110) (only 5 mg and 10 mg tablets) (see section 2, “Bisomyl contains:”)
What the medicine looks like and the contents of the pack
1.25 mg tablet:
White, oval, biconvex film-coated tablets, debossed with ‘BL’ and ‘1’ on one side of the tablet and ‘M’ on the other.
2.5 mg tablet:
White, oval, biconvex film-coated tablets with a score line, debossed with ‘BL’ and ‘2’ on each side of the score line on one side of the tablet and ‘M’ on the other side of the tablet.
5 mg tablet:
Pale yellow, oval, biconvex film-coated tablets with a score line, debossed with ‘BL’ and ‘4’ on each side of the score line on one side of the tablet and ‘M’ on the other side of the tablet.
10 mg tablet:
Slightly orange, oval, biconvex film-coated tablets with a score line and embossed with ‘BL’ and ‘6’ on each side of the score line on one side of the tablet and ‘M’ on the other side of the tablet.
Bisomyl is available in blister packs containing 10, 20, 28, 30, 50, 56, 84, 98 and 100 film-coated tablets and in cans containing 10, 28, 30, 50, 56, 84, 98, 100, 500 and 1000 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer:
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1 TL, UK
Mylan Hungary Kft., H-2900, Komárom, Mylan útca.1, Hungary