Country: Մալթա
language: անգլերեն
source: Medicines Authority
ZINC OXIDE, LIDOCAINE HYDROCHLORIDE
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
C05AD01
ZINC OXIDE 6.6 % (W/W) LIDOCAINE HYDROCHLORIDE 0.7 % (W/W)
OINTMENT
ZINC OXIDE 6.6 % (W/W) LIDOCAINE HYDROCHLORIDE 0.7 % (W/W)
OTC
VASOPROTECTIVES
Suspended
2006-11-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Germoloids Ointment. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc oxide Ph. Eur. 6.6% w/w Lidocaine hydrochloride Ph. Eur. 0.7% w/w 3 PHARMACEUTICAL FORM Ointment for topical and rectal administration. 4 CLINICAL PARTICULARS 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 aged 12 years and over:_ _ _ Apply at least twice a day with a minimum of three to four hours between applications. Further applications can be made at any time of day and are particularly recommended after a bowel movement. Do not use more than four times in any 24-hour period. _External piles and pruritus ani:_ _ _ Apply to the affected area. _Internal piles:_ _ _ Gently insert applicator into the anal opening and expel a small amount of the ointment by squeezing the tube gently. _Children under 12 years: _ Only as directed by a doctor. _The elderly:_ Use as per adult directions. 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 topical preparations. 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. 4.8 UNDESIRABLE EFFECTS Very rarely increased irritation and read_full_document