1-Active Ingredient:
-hyoscine-N-butylbromide
-Paracetamol
2-Concentration:
*film coated tablets:
-hyoscine-N-butylbromide 10 mg
-Paracetamol 500 mg
*suppositories
-hyoscine-N-butylbromide 10 mg
-Paracetamol 800 mg
3-Dosage form:
-tablets
-suppositories
4-Indication:
-paroxysmal pain in stomach or intestine diseases
-spastic pain
-functional disorder in biliary and urinary tracts and female genital organs
5-Side effect:
-allergic reaction with exanthema
-allergic platelet deficiency
-reduction in leucocytes
-reduction in granulocytes
-reduction in cellular blood elements
-spasms in the bronchial muscles in cases of bronchial asthma
6-Contraindication:
It should not be used when:
-known genetically determined glucose-6-phosphate dehydrogenase deficiency
-known hypersensitivity to paracetamol
7-Precautions:
It should be used with cautious in:
-hepatic dysfunction
-renal dysfunction
-Gilbert’s syndrome
*pregnancy and lactation:
-Available but limited preclinical data had shown no hazard but safety on human pregnancy and lactation has not been established yet
8-Dose:
*tablets:
-1 – 2 tablets three times daily
-the total daily dose should not exceed 6 tablets
*suppositories
- 1 suppository 3 to 4 times daily
-the total daily dose should not exceed 4 suppositories
* the tablets and suppositories are not suitable for children
9-Over dose:
*symptoms:
In case of sever paracetamol poisoning:
-circulatory collapse
-acute renal insufficiency
-icterus and hepatic coma
In case of chronic intoxication:
-hemolytic anemia
-cyanosis
-weakness
-dizziness
-paraesthesia
-tremor
-insomnia
-headache
-falling memory
-central nervous irritation
-delirium and convulsion
*therapy:
-the administration of the drug should be stopped immediately and medical advice sought
10-Storage:
-store at 25 C
-keep out of reach of children
11-Package:
-Film coated tablets: box of 20 tablets
-Suppositories: box of 5 suppositories
12-produced by:
-Chemical industries development
13-Price:
3.65 L.E
Tuesday, June 23, 2009
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