BISOGAMMA 10 mg. 30 tablets

Ingredients:
Active ingredients:
One film-coated scored tablet contains 10 mg Bisoprolol fumarate
Excipients:
crospovidone, maize starch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, macrogol 6000, polysorbate 20, titanium dioxide, calcium carbonate, talc, ferric hydroxides (E 172), hypromellose (HPMC 5), hypromellose (HPMC 50)
 
 
Pharmaceutical form and content
Original packs of 30, 50 and 100 tablets
Cardioselective beta-blocker adrenergic receptors
 
 
Fields of application:
- High blood pressure (essential hypertension)
- Chest pain due to poor circulation in the coronary arteries of the heart (ischemic heart disease: angina pectoris)
 
Contraindications:
When you must not take Bisogamma10? Bisogamma10 should not be administered to: 
- Untreated heart muscle weakness (manifested heart failure)
- shock
  - High-grade beat conduction disorders of the heart atria to the ventricles (AV-block II and III degree)
- Syndrome sick sinus (sick sinus syndrome)
- Abnormal conduction between the sinus node and cardiac atrium - (sinoatrial block)
- Very slow heart beat (bradycardia: resting heart rate less than 50 beats per minute) before starting treatment
- Very low blood pressure (hypotension systolic pressure less than 90 mmHg)
- Increased acidity of the blood (acidosis)
- Propensity to bronchospasm (bronchial hyperreactivity, e. Obstructive airway disease, bronchial asthma)
- Co-administration of MAO inhibitors (except MAO-B inhibitors)
- Hypersensitivity to beta-receptor blockers, or any of the additional ingredients (excipients)
- Children (no therapeutic experience)
Intravenous administration of calcium antagonists of the verapamil group and diltiazem or other medicines for the treatment of cardiac arrhythmias (antiarrhythmic agents: eg. Disopyramide, quinidine, amiodarone) is contraindicated for patients who are treated with Bisogamma 10 (except in intensive care ) 
 
When you can take Bisogamma 10 only after further consultation with your doctor? 
It will further be described certain conditions (shown) in which Bisogamma10 can be applied only after further consultation with the doctor and especially great caution. Please talk about your doctor. The same applies if the following indications have occurred before.
Particularly close medical supervision is needed when:
- Low-grade rhythm and conduction disorders of the heart atria to the ventricles (AV-block Ist degree)
- Existing or previously undetected diabetes (manifest or latent Diabetes mellitus), as katomozhe cause severe drop in blood sugar (severe hypoglycemic conditions). Possible masking of hypoglycaemic-ing symptoms. You need regular blood sugar control.
- Longer strict diet (or fasting) and heavy exercise (possibly large decreases in blood sugar levels)
- Patients with tumor nadbabrechnta gland (pheochromocytoma); They Bisogamma 10 can only be used after prior treatment with alpha-receptor blockers.
- Angina Prinzmetal
Appointment of beta-receptor blockers (eg. Bisogamma® 10) in patients with scaly patches (psoriasis) in personal or family history should be done after precise assessment of risk-benefit ratio.
 
 
What has to be observed during pregnancy and lactation?
So far we have no clinical experience on the use of bisoprolol fumarate in pregnant women. Bisogamma®10 should be used during pregnancy only when the physician has decided that for the benefit of pregnant drug zanachitelno is greater than its risks for the child. Treatment with bisoprolol fumarate should be discontinued 48-72 hours before delivery because of the possibility of damage to the functions of the heart circulation of the child. If discontinuation is not possible, then 48-72 hours after birth, newborns should be monitored closely.
Passage of bisoprolol fumarate in human milk has not been studied. Since the active substance is found in the milk of experimental animals, infants should be closely observed for beta-receptor response. In this case, breastfeeding is discontinued.
 
What must be observed in children and adults?
Bisogamma® 10 should not be taken by children as far no therapeutic experience with detsa.Predpazni precautions for use and warnings
 
 
What precautions must be observed?
Disability liver and kidneys must follow the directions for dosing medicinal product (see section "Dosage") Beta-receptor blockers may increase sensitivity to allergens and result in severe anaphylactic reaction, ie to general acute allergic reaction of the body. It is therefore necessary to specify strictly the indications in patients with severe hypersensitivity reaction in history, and in patients who are on treatment to reduce or eliminate the tendency to allergic reaction (desensitization therapy). Warning - severe anaphylactic reaktsiya.Lechenieto high blood pressure with this product requires regular medical kontrol.Kakvo must observe when driving, operating machinery, and in the absence of reliable support? Due to the occurrence of different reactions in the body, can impair the ability to drive, operate machines and work without safe support. This is especially true at the start of treatment, during dose escalation and replacement of the product, and interaction with alcohol.
 
Interactions with other drugs
What other drugs affect the Bisogamma® how Bisogamma® 10 and 10 affect the way other medicines?
_ Observe the following interactions between Bisogamma 10 and other drugs: decrease high blood pressure under the influence of Bisogamma®l 0 may be enhanced by other medicines also lower blood pressure (eg. ACE) inhibitors, diuretic drugs action (diuretics), vasodilator substances (vasodilators), barbiturates, and tricyclic antidepressants fenotiazidi.
Concurrent use of Bisogamma® 10 and calcium antagonists group of nifedipine may result in very low blood pressure and in some cases, weakness of the heart muscle (heart failure).
With concomitant Bisogamma 10 and calcium antagonists of the verapamil group and diltiazem or other medicines for the treatment of cardiac arrhythmias (antiarrhythmic agents: eg. Disopyramide, quinidine, amiodarone) requires careful monitoring of the patient, as it may lead to very low blood pressure (hypotension), slow heart beat (bradycardia) or other cardiac arrhythmias and / or weakness of the heart muscle (heart failure).
Intravenous administration of calcium antagonists of the verapamil group and diltiazem or other medicines for the treatment of cardiac arrhythmias (antiarrhythmic agents: eg. Disopyramide, quinidine, amiodarone) is contraindicated for patients who are treated with Bisogamma® 10 (except in intensive care , see "Contraindications").
Cardiodepressant properties Bisogamma® 10 may potentiate the effects of antiarrhythmic drugs.
Concurrent use of Bisogamma® 10 and reserpine, alpha-methyldopa, guanfacine, clonidine or cardiac glycosides (digitalis) can lead to very slow heart rate, respectively. by delaying conduction of the heart.
After abrupt discontinuation of clonidine with concomitant Bisogamma®l 0 possible sharp rise in blood pressure. Clonidine can be stopped, a few days after completing treatment Bisogamma®10.
With concomitant Bisogamma® 10 and noradrenaline, adrenaline and other sympathomimetic active substances (eg .: contained in medicines against cough, nasal and eye drops) may increase blood nalyagane.Ednovremennoto acceptance of ergot derivatives (eg. Ergotaminsadarzhashti migraine agents ) and Bisogamma® 10 can lead to increased distortions in the peripheral blood supply.
Monoaminooksizaznite inhibitors (MAOIs) should not be taken concomitantly with Bisogamma®10 possible because a large increase in blood pressure (see section "Contraindications")
Concurrent use of Bisogamma® 10 and insulin or other medicines that lower blood sugar (eg. Oral antidiabetic agents) their effect may be enhanced, respectively. Prolonged and can also be reduced. Warning signs to reduce the amount of blood sugar (hypoglycemia) - increased heart rate (tachycardia), tremor of the hands (tremor) - are masked or attenuated. Therefore required regular blood tests zahar.Rifampitsinat can reduce the blood pressure lowering effect of Bisogamma 10.Deystvieto of Bisogamma 10 can be enhanced by cimetidine, hydralazine and alcohol. 
Coadministration of Bisogamma 10 and medicaments for narcosis (drugs) may lead to a strong reduction of blood pressure. The negative inotropic action of the two above-mentioned drugs may be enhanced. So before placing anesthesia, the anesthetist should be informed about the treatment Bisogamma®10.Molya note that these figures apply to medicinal products which reception has ended recently.
 
 
Which bad habits, food and drink you should avoid?
The blood pressure lowering effect of Bisogamma 10 can be enhanced priupotreba alcohol. 
 
 
Dosage instructions, method and duration of use
The following instructions apply only in the event that your doctor has prescribed Bisogamma® 10 otherwise. Please adhere to the instructions for use, otherwise Bisogamma10 can not exert its therapeutic effect! 
 
 
How much and how often you should apply Bisogamma10? 
Generally, treatment should begin with low doses gradually, slowly increasing. Dosage must be determined individually for each case to be assessed on the basis of pulse rate and treatment success.
High blood pressure Gesenpialna hypertension)
Unless otherwise specified, the recommended dose is once daily tablet half Bisogamma10 (5 mg bisoprolol fumarate). 
When sufficient effect, the dose may be increased to 1 tablet daily Bisogamma10 (10 mg bisoprolol fumarate). Further in 
 
How long can be used Bisogamma 10?
The duration of use is not limited in time. It is determined by the type and severity of the disease. Dosing Bisogamma® 10 can not happen without a prescription. Premature interruption or completion of treatment can also be done without the opinion of a lekarya.Lechenieto Bisogamma10 should not be stopped abruptly. This should be done gradually (7-10 days), especially in patients with impaired blood supply to the coronary arteries of the heart (ischemic heart disease: angina pectoris) as an abrupt stopping the drug can lead to deterioration of пациента.Продължителността of treatment will be determined by your doctor. 
 
Overdose and other errors in use
 
What should I do if Bisogamma 10 adopted in very large doses (deliberate or accidental overdose)? 
A suspected overdose Bisogamma! 0, please tell your doctor immediately! It may take appropriate action depending on the severity of overdose / otravyaneto.Predoziraneto of Bisogamma®10 can lead to severely low blood pressure (severe hypotension), slow heart beat (bradycardia), heart failure, heart muscle weakness (heart failure) and shock. Additionally can occur breathing difficulties, bronchospasm, vomiting and loss of consciousness. 
Overdose should immediately stop taking Bisogamma 10. 
 
 
What should you do if you take a very small amount Bisogamma 10 or you forget a dose?
In this case, the next dose, do not take twice as much and take medicine as described in the guide dosing or as prescribed lekaryat.Kakvo must observe when interrupt shi earlier complete treatment Bisogamma 10? Please interrupt or end your treatment Bisogamma 10 without consulting beforehand with your doctor! 
Treatment with Bisogamma10 should not be stopped abruptly but gradually (about 7-10 days), especially in patients with impaired blood flow to the coronary arteries of the heart (coronary artery disease: angina pectoris) as an abrupt cessation of the drug product may result in deterioration of the patient. 
 
 
Undesirable effects
What side effects may occur when taking Bisogamma®10? Nervous sistemaPonyakoga can disturb the functions of the central nervous system: fatigue, dizziness, headache, depressive moods, confusion, increase the dose as appropriate in exceptional cases.
Chest pain due to poor circulation in the coronary arteries of the heart (ischemic heart disease: angina pectoris) Unless otherwise prescribed, the recommended dose is once daily tablet half Bisogamma®10 (5 mg bisoprolol fumarate) .if insufficient effect the dose may be increased to one tablet daily Bisogamma®10 (10 mg bisoprolol fumarate). Further increase of the dose is appropriate only in extreme sluchai.Dozirane in functional disturbances of the liver and babretsitePri patients with mild or moderate disturbances in the function of the liver and kidneys do not need a change in dosage. But in patients with advanced renal insufficiency (creatinine clearance <20 ml / min) and in patients with severe liver damage daily dose should not exceed 10 mg bisoprolol fumarate.
  eyes
Sometimes observed abnormal vision, inflammation of the conjunctiva (conjunctivitis) and decreased lacrimation (that must be observed when wearing contact lenses).
 
Cardiovascular system-
Treatment with Bisogamma®! 0 can sometimes lead to very low blood pressure, also when getting up from a lying position (orthostatic hypotension), slow heart beat (bradycardia), rhythm-conduction disorders of the heart atria to the ventricles (AV-conduction abnormalities) or strengthen the heart muscle weakness (heart failure), fluid accumulation in the legs (peripheral edema) or shortness of breath on exertion (display load) .Nablyudavano to strengthen the complaints in patients with peripheral vascularity disabilities - including patients with vascular cramps of toes and fingers (Raynaud's syndrome).
 
airways
In patients with a tendency to bronchospastic reactions (especially in obstructive respiratory diseases: asthma) can lead to shortness of breath as a result of increased resistance in the airways.
 
Gastrointestinal
Can sometimes be seen anorexia and gastrointestinal complaints (eg. Nausea, vomiting, constipation, diarrhea, pain and cramps in the abdomen).
 
Muscular and skeletal system (motor unit)
Sometimes it may appear muscle weakness, muscle cramps (eg. Cramps calves) or ad hoc joint disease (arthropathy) with involvement of one or more joints (mono or polyarthritis).
 
skin
There may be allergic reactions - such as redness, itching (pruritus), skin rashes under the action of light (photoallergic exanthema), very itchy rash (urticaria).
 
Genitourinary System
In isolated cases were observed impaired libido and potency. Exchange veshtestvataMozhe occur far unrecognized diabetes (latent diabetes mellitus), and a pre-existing diabetes (diabetes mellitus manifest) could deteriorate. After prolonged fasting or severe rigorous exercise and concomitant Bisogamma®10 may lead to new conditions with reduced blood sugar (hypoglycemic conditions). Possible masking of the warning symptoms of low blood sugar (hypoglycemia)-particularly increased heart rate (tachycardia) or shaking of the hands (tremor). Following treatment c Bisogamma 10, in rare cases can lead to increased blood fat levels (cholesterol, triglycerides).
The treatment of patients with overactive thyroid (hyperthyroidism) with Bisogamma! 0 may mask clinical signs of thyrotoxicosis (eg. Heartbeat, tremor) .In single cases observed increase in liver enzymes (transaminases: GOT, GTP) in the blood and liver inflammation (hepatitis) after treatment with 10 Bisogamma.