BELERGAMIN table. 20 table
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.
BELERGAMIN table. 20 table
Content of a coated tablet in mg:
Belladonna Alkaloides 0,10 Ergotamine tartrate 0.30Phenobarbital 20.0
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 .
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.
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 ) .
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.