Congescor 2.5mg Film-Coated Tablets
Package leaflet: Information for the user
Congescor 1.25 mg film-coated tablets and Congescor 2.5 mg film-coated tablets
Bisoprolol fumarate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or your pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Congescor is and what it is used for
2. What you need to know before you take Congescor
3. How to take Congescor
4. Possible side effects
5. How to store Congescor
6. Contents of the pack and other information
1. What Congescor is and what it is used for
The active substance in Congescor is bisoprolol. 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. Congescor 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).
2. What you need to know before you take Congescor Do not take Congescor
Do.not.take_Congescor.if.one.of_the.following_conditions.
applies.to.you:
■ allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What Congescor contains')
■ severe asthma
■ 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
■ untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
■ metabolic acidosis, which is a condition when there is too much acid in the blood.
Do_not_take_Congescor_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 Congescor; he or she may want to take special care (for example give additional treatment or perform more frequent checks):
■ diabetes
■ strict fasting
■ certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal's angina)
■ kidney or liver problems
■ less severe blood circulation problems in your limbs
■ chronic lung disease or less severe asthma.
■ history of a scaly skin rash (psoriasis)
■ tumour of the adrenal gland (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 Congescor may make it more likely that you experience an allergic reaction, or such reaction may be more severe
■ anaesthesia (for example for surgery), because Congescor may influence how your body reacts to this situation.
If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using Congescor.
Children and adolescents
Congescor is not recommended for use in children or adolescents.
Other medicines and Congescor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DonottakethefollowingmedicineswithCongescorwithout
specialadvicefromyourdoctor:
■ 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.
Checkwithyourdoctorbeforetakingthefollowing medicines with Congescor; your doctor may need to check yourconditionmorefrequently:
■ 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
■ 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 Congescor 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 Congescor during pregnancy.
Breast-feeding
It is not known whether bisoprolol passes into human breast milk. Therefore, breast-feeding is not recommended during therapy with Congescor.
Driving and using machines
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.
3. How to take Congescor
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Treatment with Congescor requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase, and when you stop treatment.
04604012 Till-Ver.6s