Kraj: Malta
Język: angielski
Źródło: Medicines Authority
ZINC OXIDE, LIDOCAINE HYDROCHLORIDE
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
C05AD01
ZINC OXIDE 283.5 mg LIDOCAINE HYDROCHLORIDE 13.2 mg
SUPPOSITORY
ZINC OXIDE 283.5 mg LIDOCAINE HYDROCHLORIDE 13.2 mg
OTC
VASOPROTECTIVES
Suspended
2006-11-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Germoloids Suppositories 2 QUALITATIVEAND QUANTITATIVE COMPOSITION Zinc oxide Ph. Eur. 283.5 mg Lidocaine hydrochloride Ph. Eur. 13.2 mg 3 PHARMACEUTICAL FORM Suppository for rectal administration. 4 CLINICALPARTICULARS 4.1 THERAPEUTIC INDICATIONS The symptomatic relief of pain, swelling, irritation and itching associated with haemorrhoids, and pruritus ani. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children 12 years and over:_ _ _ One suppository to be inserted into the rectum on retiring at night and in the morning, preferably after bowel movement. If necessary Germoloids Suppositories may be used at any time during the day with a minimum 3 - 4 hours between suppositories. Do not use more than 4 suppositories in any 24-hour period. _Children under 12 years: _ Only as directed by a doctor. _The elderly:_ The normal adult dose may be used. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Persons who continually suffer from haemorrhoids or who have severe haemorrhoids or who experience excessive bleeding, are advised to consult a doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known for suppositories. 4.6 PREGNANCY AND LACTATION There is a lack of definitive evidence of safety of the product in human pregnancy and lactation. However, lidocaine hydrochloride and zinc oxide have been in wide use for many years without apparent ill consequence. It is not necessary to contraindicate this product in pregnancy and lactation provided caution is exercised and the directions for use are followed. However, as with all medicines, the advice of a doctor should be sought. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8 UNDESIRABLE EFFECTS Very rarely increased irritation may occur at the site of application. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal produc Przeczytaj cały dokument