BELERGAMIN. 20 tablets
BELERGAMIN. 20 tablets
Content of a coated tablet in mg:
Belladonna Alkaloides 0,10Ergotamine tartrate 0.30Phenobarbital 20.0
wheat starch, lactose, gelatin, microcrystalline cellulose, talc, magnesium stearate, colloidal anhydrous silica, sucrose, opaluks, titanium dioxide, gum arabic, Macrogol 6000, glycerol.
PHARMACEUTICAL FORM AND Pharmacotherapeutic group
Belergamin be administered in the form of coated tablets.
In which cases can be applied Belergamin?
In the complex therapy: neuroses, neuro-vegetative disorders, Meniere's syndrome; kinetoses (sickness), migraine; neurodermatitis (skin illness and rash with itching), pruritus (itching), slow heart rate of different origins, including overdose of digitalis.
In which cases should not apply Belergamin?
- Not applicable in case of hypersensitivity to any component of the product;
- Thyrotoxicosis (thyroid disease);
- High blood pressure; angina (unstable and vasospastic type Prinzmetal);
- Myocardial infarction; acceleration or disturbance of the rhythmic activity of the heart;
- Peripheral vascular diseases elastic;
- Pregnancy and lactation;
- Severe liver and kidney disease;
- Narrow-angle glaucoma;
- An increase of prostate or other obstructions of the urinary tract;
- Sepsis ("blood poisoning" - blood infection with microorganisms).
PRECAUTIONS FOR USE
When Belergamin should be used with caution?
In men older c prostate enlargement use of the product leads to urinary obstruction and dysuria.
In mechanical obstacles along the gastrointestinal tract of different nature such as achalasia (esophageal spasms), duodenal pylorus, stenosis (narrowing), the adoption of Belergamin can lead to retention of gastrointestinal contents, flatulence (gas formation), 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, caution and rigorous assessment the benefit against the potential risk.
Belergamin be used with caution in patients with cardiovascular diseases especially cardiac arrhythmias, ischemic heart disease (coronary heart disease), congestive heart failure, mitral stenosis.
In patients with heart rhythm disorders medicinal product may result in acceleration of the heart. It is used with caution in sensitive to the action of ergotamine patients because of the risk of peripheral vascular spasm. In the course of treatment is necessary sick prone to vascular spasm be monitored for the possible occurrence of such symptoms.
Administration of a medicinal product may be observed visual disturbances - mydriasis (dilation of pupils) and cycloplegia (paralysis 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.
Prolonged treatment with high doses requires the precise 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).
Do not use during pregnancy and karmene.Upotrebata by the drivers and people working with machines, is undesirable and requires accurate assessment of the benefit / risk ratio.
What other drugs affect the Belergamin?
Not desirable 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 drugs tricyclic antidepressants, such combinations should be avoided. When co-administered with MAO inhibitors (certain drugs for depression) increases the risk of side effects. The presence of ergotamine in a 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 to treat migraine) with bromocriptine (used to treat Parkinson's disease), cabergoline (inhibits prolactin secretion), with drugs that constrict blood vessels (epinephrine, norepinephrine, phenylephrine) .It tell your doctor in case of any concomitant medicinal products in order to avoid any possible interaction between them and Belergamin.
METHOD AND DOSAGE:
The daily dose for treatment Belergamin be determined by the physician according to the severity of clinical symptoms and tolerability of the drug. The recommended daily dose is 3-4 times 1 tablet. In the absence of a satisfactory therapeutic effect, the daily dose may be increased to 6 tablets. Maximum weekly dose of ergotamine - 10 mg maximum daily dose of phenobarbital - 80 mg. Discontinuation should be a gradual reduction in dose. Does not apply to children under 14 years due to lack of data on therapeutic efficacy and safety.
What side effects may occur when applying Belergamin?
When drug administration can be observed: dry mouth, fatigue, drowsiness, visual disturbances - mydriasis (dilation of pupils) and cycloplegia (paralysis accommodative), glaucoma attack, decreased gastrointestinal motility (gastrointestinal motility ) and constipation, gastrointestinal discomfort (nausea, vomiting, colic), tachycardia (fast heart beat), retention (retention) of urine. Because of ergotamine can be observed localized edema (swelling of the face, fingers, feet), increased blood pressure, angina, peripheral vascular spasm, spasm of ocular vessels (impaired vision, constriction of the pupil), cerebral ischemia; caused by the presence of phenobarbital - agranulocytosis (disappearance of certain white blood cells), thrombocytopenia (reduced 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 administered in very high doses (intentional overdose or wrong)?
Overdose with drug observed psychomotor agitation, visual and auditory hallucinations, restlessness (atropine drunkenness), gradually manifestations of anxiety may be displaced by the events of the depression of the central nervous system (somnolence, coma) .In overdose of the drug product seek medical attention immediately.
Protected from light at a temperature below 25 ° C. Keep out of reach of children!
Two years from the date of proizvodstvo.Da not use after the expiry date!
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.