BELERGAMIN table. 20 table

INGREDIENTS:
Content of a coated tablet in mg:
Drugs :
Belladonna Alkaloides 0,10 Ergotamine tartrate 0.30Phenobarbital 20.0
Excipients:
wheat starch , lactose , gelatin , microcrystalline cellulose , talc, magnesium stearate, colloidal silicon dioxide , anhydrous sucrose opaluks , titanium dioxide, gum arabic , Macrogol 6000 , glycerol .
PHARMACEUTICAL FORM AND Pharmacotherapeutic group
Belergamin is applied in the form of coated tablets .
INDICATIONS:
In which cases can be applied Belergamin ?
In the complex therapy of : neuroses, neuro- vegetative disorders , Meniere's syndrome , kinetoses ( sickness ) , migraine , neurodermatitis (skin illness with itching and hives) , pruritus ( itching), slow heart rate of different origin, including overdose of digitalis.
CONTRAINDICATIONS :
In which cases should be applied Belergamin ?
- Do not apply in case of hypersensitivity to any component of the product ;
- Thyrotoxicosis ( thyroid disease ) ;
- High blood pressure, angina ( unstable and vasospastic type Prinzmetal);
- MI , during acceleration or distortion of the rhythmic activity of the heart ;
- Elastic peripheral vascular disease ;
- Pregnancy and lactation;
- Severe liver and kidney disease ;
- Narrow-angle glaucoma ;
- For prostate enlargement or other obstructions of the urinary tract ;
- Sepsis ( " septicemia " - bloodstream infection by micro-organisms ) .
PRECAUTIONS FOR USE:
When Belergamin should be used with caution ?
In adult males c prostate enlargement using the product lead to urinary obstruction and dysuria .
In mechanical obstacles along the gastrointestinal tract of various kinds such as achalasia ( esophageal spasms ) - duodenal pylorus stenosis (narrowing ) , the adoption of Belergamin can lead to retention of gastrointestinal contents, flatulence (gas ) and intoxication.
The application of this product in gastroesophageal reflux disease (GERD ) , intestinal atony , paralytic ileus ( bowel obstruction ) , myasthenia gravis (a disease marked by muscle weakness) , severe pruritus (itching ), particularly associated with liver disease requires caution and rigorous assessment the benefit to the potential risk .
Belergamin be used with caution in patients with cardiovascular disease, particularly cardiac arrhythmias , ischemic heart disease ( coronary heart disease ), congestive heart failure , mitral stenosis.
In patients with heart rhythm disorders medicinal product may lead to an acceleration of the heart . It is used with caution in sensitive to the action of ergotamine patients because of the risk of peripheral vascular spasms . In the course of therapy patients prone to vascular spasms be monitored for the possible occurrence of such symptoms.
Administration of the drug can be observed visual disturbances - mydriasis ( pupil expansion ) and cycloplegia ( paralysis of accommodative ) . The product should be used with caution in patients with glaucoma (increase of the intraocular pressure) at elevated temperature in individuals with xerostomia ( dry mouth ) . No data on therapeutic efficacy and safety of this product in children.
Long-term treatment with high doses requires precise refinement of dietary intake phenobarbital, because of the risk of developing tolerance and drug dependence.
Caution should be exercised in patients with a history of drug abuse or drug dependence , and in patients with bronchial astma.Poradi content of wheat starch to be used with caution in patients with celiac disease ( gluten intolerance ) .
SPECIAL WARNINGS :
The product is not administered during pregnancy and karmene.Upotrebata by the drivers and people working with machinery is undesirable and requires an accurate assessment of the benefit / risk ratio .
DRUG INTERACTIONS :
What other drugs affect the action of Belergamin ?
It is desirable for the combination of alcohol or narcotic analgesics with Belergamin because it contains phenobarbital . The latter can reduce the effects of estrogen preparations , oral contraceptives , corticosteroids, antipyrine , some antibiotics and sulfonamides , oral anticoagulants ( anti-clotting drugs ) and dr.Nalichieto atropine in medicine increases toxicity of digitalis glycosides , and the effects of the ' anti-Parkinsonian agents and tricyclic antidepressants , and therefore these combinations should be avoided. Coadministration of MAO inhibitors ( certain drugs for depression ) increases the risk of side effects. Ergotamine in the presence of drug combination makes it undesirable to macrolide antibiotics , beta-blockers ( propranolol ) , and drugs that inhibit the metabolism of ergot - antiviral drugs from the group of protease inhibitors, such as (ritonavir); with triptans (drugs for the treatment of migraine ) , with bromocriptine (used to treat Parkinson's disease) , cabergoline ( inhibits prolactin secretion ) with drugs that constrict blood vessels ( epinephrine, norepinephrine , phenylephrine ) . should inform your doctor in case of any concomitant other drugs in order to avoid any possible interaction between them and Belergamin .
METHOD AND DOSAGE:
The daily dose for treatment Belergamin be determined by a physician depending on the severity of the clinical symptomatology and tolerance for the drug product. The recommended daily dose is 3-4 times 1 tablet . In the absence of a satisfactory therapeutic effect in the daily dose may be increased to 6 tablets. Maximum weekly dose of ergotamine - 10 mg maximum daily dose of phenobarbital - 80 mg . Discontinuation of therapy should be to gradually reduce the dose. Does not apply to children under 14 years due to lack of data on therapeutic efficacy and safety.
SIDE EFFECTS :
What side effects may occur when applying Belergamin ?
When drug administration can be observed : dry mouth, fatigue , drowsiness , visual disturbances - mydriasis ( pupil expansion ) and cycloplegia ( paralysis of accommodative ) , glaucoma attack, decreased gastrointestinal motility ( gastrointestinal motility ) and constipation, gastrointestinal distress (nausea, vomiting , colic ) , tachycardia (rapid heartbeat) , retention ( retention ) of urine. Due to the presence of ergotamine may occur localized edema ( facial , fingers , feet ) , increased blood pressure , angina pectoris, peripheral vascular spasms , spasms of ocular vessels ( visual disturbance , constriction of the pupil ) , cerebral ischemia , caused by the presence of phenobarbital - agranulocytosis (disappearance of certain white blood cells) , thrombocytopenia (decreased platelet count ) , exfoliative dermatitis syndrome, Stevens - Johnson ( severe skin reaction) , liver failure, dizziness, irritability. Are possible hypersensitivity reactions (itching , rash ) .
OVERDOSE :
What to do if Belergamin was administered in very high doses ( intentional overdose or wrong ) ?
Overdose of drug was observed psychomotor agitation, visual and auditory hallucinations , restlessness ( atropine drunkenness ) , gradually manifestations of arousal may be displaced by acts of depression of the central nervous system ( somnolence, coma) . In case of drug overdose product seek medical attention immediately .
Storage Instructions :
Protected from light at a temperature below 25 ° C. Keep out of reach of children !
SHELF LIFE :
Two years from the date of proizvodstvo.Da not use after the expiry date !
DATA PACKAGE :
The product is packed in 20 / twenty / tablets in blister packs solid PVC / aluminum foil. A blister is placed in a cardboard box along with a leaflet with instructions for use.