BISOGAMMA 5 mg. 30 tablets

WHAT BISOGAMMA 5 CASES AND WHAT IT IS USED FOR?

Bisogamma 5 is a cardioselective beta-receptor blocker.

Bisogamma 5 is used for the treatment of:

- High blood pressure (essential hypertension);

- Chest pain due to poor circulation in the coronary arteries of the heart (coronary artery disease - angina pectoris).

 

2 WHAT YOU HAVE TO TYPE BEFORE YOU TAKE BISOGAMMA 5?

Bisogamma 5 should not be applied to cases of:

- Hypersensitivity (allergy) to bisoprolol hemifumarate or to any of the excipients Bisogamma 5;

hypersensitivity to beta-receptor blockers;

- Untreated heart muscle weakness (manifested heart failure);

- Shock;

- High-grade rhythm, conduction abnormalities of cardiac atria to the ventricles (AV-block II or III-nd grade);

- Syndrome sick sinus (sick sinus syndrome);

- Abnormal conduction between the sinus node and atrial cardiac block);

- Slow heart rate (bradycardia: resting pulse less than 50 beats per minute) predizapochvane 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);

- Final stages of peripheral vascular disorders and Raynaud's syndrome;

- Co-administration of MAO inhibitors (except MAO-B inhibitors);

- Untreated tumor nadbabrechnta gland (pheochromocytoma);

- 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 5 (exception - in intensive medicine).

 
In which case you can take Bisogamma ® 5 only after consultation with your doctor?

It will further be described certain conditions (shown) in which Bisogamma 5 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 statements are manifested and predi.Osobeno strict medical supervision is necessary when;

- Low-grade rhythm, conduction abnormalities of cardiac atria to the ventricles (AV-block I-st degree);

- Overt or already existing but previously undetected diabetes (manifest or latent diabetes mellitus), as it can cause severe drop in blood sugar (severe hypoglycemic conditions). Possible masking of hypoglycemic symptoms. You need regular blood sugar control.

- Longer strict diet (or fasting) and heavy exercise (possibly large decreases in blood sugar);

- Patients with tumor nadbabrechnta gland (pheochromocytoma). They Bisogamma 5 can be applied only after pre-treatment with alpha-receptor blockers.

 
- Angina Prinzmetal.

Appointment of beta-receptor blockers (eg. Bisogamma® 5) in patients with psoriasis (scaly patches) in personal or family history should be done after precise assessment of the benefit-risk.

Particular attention when taking Bisogamma ® 5 is needed when:

Liver and kidney - should be followed directions for dispensing the product. (See section "Dosage.")

Beta-receptor blockers can increase the sensitivity to allergens and cause severe anaphylactic reactions, i.e. 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 reaction.

The use of the medicinal product may mask clinical signs of hyperthyroidism - as tachycardia (rapid heartbeat). Abrupt discontinuation may be followed by a worsening of the symptoms of hyperthyroidism or cause acute thyrotoxic kriza.Ednovremennoto application Bisogamma 5 and medicines for anesthesia (anesthetic) may lead to a strong decrease in blood pressure. So before placing anesthesia, the anesthetist should be informed about the treatment Bisogamma 5.

Treatment of high blood pressure with this product requires regular medical supervision.

 

Interactions with other medicinal products

If Bisogamma 5 is used with other drugs should be observed for the occurrence of these interactions:

Decrease high blood pressure under the influence of Bisogamma 5 may be enhanced by other drugs also lower blood pressure (eg. ACE) inhibitors, diuretics, vasodilators substances (vasodilators), barbiturates, and tricyclic antidepressants fenotiazidi.

Concurrent use of Bisogamma 5 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 5 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 5 (except in intensive care , see "Contraindications").

Cardiodepressant properties Bisogamma 5 may potentiate the effects of antiarrhythmic drugs.

Concurrent use of Bisogamma 5 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 5 possible sharp rise in blood pressure. Clonidine can be stopped, a few days after completing treatment Bisogamma 5.

With concomitant Bisogamma 5 and noradrenaline, adrenaline and other sympathomimetic active substances (eg .: contained in medicines against cough, nasal and eye drops) may increase blood pressure.

Concomitant administration of ergot derivatives (eg. Ergotaminsadarzhashti migraine drugs) and Bisogamma 5 can lead to increased distortions in the peripheral blood supply.

Monoamine oxidase inhibitors (MAOIs) should not be administered concurrently with 5 Bisogamma possible due to a large increase in blood pressure (see section "Contraindications").

Concurrent use of Bisogamma 5 and insulin or other medicines that lower blood sugar (eg. Oral antidiabetic agents). Their effect can be modified: boost, respectively. prolonged and may even be reduced.

Warning signs to reduce the amount of blood sugar (hypoglycemia) -uchesten heartbeat (tachycardia) shaking hands (tremor) - are masked or attenuated. Therefore required regular blood sugar.

Rifampicin may reduce the blood pressure lowering effect of Bisogamma 5.Deystvieto of Bisogamma 5 can be enhanced by cimetidine, hydralazine and alkohol.Pri patients with asthma or other chronic obstructive pulmonary disease is to be administered simultaneously bronchodilator therapy. Sometimes, patients with asthma, it may be necessary to increase the dose of the beta-2-Sympathomimetic (bronchodilator) medicines.

Coadministration of 5 Bisogamma and agents for anesthesia (anesthetic) may lead to greatly reduce blood pressure. Negative inotropic effect of the two aforementioned medicinal product can be enhanced.

So before placing anesthesia, the anesthetist should be informed about the treatment Bisogamma 5.

 

Please tell your doctor or pharmacist if you are taking / using or have recently adopted / implemented other medicines, including medicines obtained without a prescription.

 

When taking 5 Bisogamma is both food and drink

The blood pressure lowering effect of Bisogamma 5 can be intensified by alcohol.

 
Pregnancy and lactation

So far we have no clinical experience on the use of bizoprololov hemifumarate in pregnant women. Bisogamma 5 should be used during pregnancy only if the physician has determined that the benefits of a medicinal product for pregnant is significantly 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 and circulation of the child. If discontinuation is not possible, then 48-72 hours after birth, newborns should be monitored closely.

Passage of bisoprolol in human milk has not been studied. Since the active substance is found in the milk of experimental animals, infants should be well observed for beta-receptor response. In this case, breastfeeding is discontinued.

 

Driving and using machines

Due to the occurrence of different reactions in the body, can impair the ability to drive, operate machines when working outdoors. This is especially true at the beginning of treatment, increasing the dose, changing the drug and interaction with alcohol.

 

3 HOW TO TAKE BISOGAMMA 5?

When taking 5 Bisogamma always strictly follow the prescription given by your doctor. Please, if anything you are not sure, ask your doctor or pharmacist.

 
If it is not otherwise specified, the usual doses are:

Treatment should be initiated 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 (hypertension esenpialna)

Unless otherwise specified, the recommended dose is once daily 1 coated tablets Bisogamma  5 (5 mg bizoprololov hemifumarate).

In hypertension I-st degree (ESC GUIDELINE 2007; systolic pressure 140-159 mm Hg and / or diastolic blood pressure 90-99 mm Hg) may be sufficient treatment including half coated tablets Bisogamma 5 (respectively 2,5 mg bisoprolol fumarate) vednyzh day. When sufficient effect, the dose can be increased to 2 coated tablets Bisogamma 5 day (10 mg bizoprololov hemifumarate day). Further increase of the dose is appropriate only in exceptional cases.

Chest pain due to coronary heart disease - angina pectoris (impaired blood supply to the heart muskul1)

Unless otherwise specified, the recommended dose is once daily 1 coated tablets Bisogamma five (5 mg bizoprololov hemifumarate).

When sufficient effect, the dose may be increased to 2 coated tablets Bisogamma 5 day (10 mg bizoprololov hemifumarate day). Further increase of the dose is appropriate only in exceptional cases.

Dosage in functional disturbances of the liver and kidneys

In patients with mild or moderate disturbances in the function of the liver and kidneys no alteration 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 bizoprololov hemifumarate.

Elderly

Generally not a change in dosage.

 
Directions

Coated tablets should be taken if possible in the morning on an empty stomach or with breakfast, with plenty of fluids, without chewing.

 

Duration of dosing

The duration of use is not limited in time. It is determined by the type and severity of the disease.

 
Dosing Bisogamma 5 can not be done without a doctor appointment. Interruption or premature discontinuation of treatment should also not be made without first seeking medical opinion.

Treatment c Bisogamma 5 should not be abruptly interrupted. Discontinuation of therapy should be gradual (7-10 days), especially in patients with coronary heart disease -angina pectoris (impaired blood supply to the heart muscle) as an abrupt stopping the drug can lead to deterioration of patient.

 
The duration of treatment is determined by the doctor.

 
If you take a large amount Bisogamma 5 than was necessary:

A suspected overdose Bisogamma  5, please tell your doctor immediately! It may take appropriate action depending on the severity of the overdose / otravyaneto.Predoziraneto of Bisogamma 5 can lead to severely low blood pressure (severe hypotension), slow heart beat (bradycardia), heart failure, heart muscle weakness (cardiac failure) and shock. Additionally can occur breathing difficulties, bronchospasm, vomiting and loss of consciousness.

 
Overdose should immediately stop taking Bisogamma 5.

If you forget to take Bisogamma 5:

In this case, the next dose, do not take twice as much, and administered drugs as described in the guide dosing or as prescribed by the physician.

 
If you stop taking Bisogamma 5:

Please do not interrupt or stop treatment with 5 Bisogamma without prior consulting with your doctor!

Treatment with Bisogamma 5 should not be stopped abruptly but gradually (about 7-10 days), especially in patients with coronary heart disease - angina (impaired blood supply to the heart muscle) as an abrupt cessation of drug can lead to deterioration of the patient.

 

4 What side effects are possible?

Like all medicines, Bisogamma® 5 can show adverse reactions that occur at each patsient.Pri assessment of adverse events following data are used for the frequency of their occurrence:

Very common: More than 1 in 10 patients treated

Common: rto-less than 1 in 10 but more than 1 in 100 patients treated

Uncommon: less than 1 in 100 but more than 1 in 1000 patients treated

Rare: less than 1 in 1,000 but more than 1 in 10,000 patients treated

Very rare: less than 1 in 10,000 patients treated, incl. single cases

Significant side effects or symptoms that need to be addressed or taken in case occur to you:

If at you is a person any of the following side effects, please stop taking Bisogamma 5 and consult your doctor as soon as possible.

 

Nervous System Disorders

Common: CNS disorders such as fatigue, dizziness, headache, depressive moods, confusion, dreams nightmares or increased dreaming, sleep disturbances and hallucinations. Sensory disturbances such as numbness and cold feeling in extremities (paresthesia).

 

Eye disorders

Uncommon: abnormal vision, inflammation of the conjunctiva (conjunctivitis) and decreased lacrimation (that must be observed when wearing contact lenses).

 
Cardiac and vascular disorders

Common: severe drop in 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 increased cardiovascular muscle weakness (heart failure), fluid accumulation in the legs (peripheral edema) or shortness of breath on exertion (dyspnea under load).

Observed strengthening of complaints in patients with peripheral vascularity disabilities - including patients with vascular cramps toes and fingers (Raynaud's syndrome).

Registered only one case of intolerance to beta-blocker (bisoprolol and carvedilol) in anthracycline-induced cardiomyopathy.

 
Respiratory, thoracic and mediastinal disorders

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 disorders

Common: anorexia, and gastrointestinal complaints (eg. Nausea, vomiting, constipation, diarrhea, pain and cramps in the abdomen).

 

Disorders of the musculoskeletal system and connective tissue

Common: muscle weakness, muscle cramps (eg. Calf cramps) .Many rare disease of the joints (arthropathy) with involvement of one or more joints (mono-or polyarthritis).