Germoloids Ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ZINC OXIDE, LIDOCAINE HYDROCHLORIDE

Available from:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC code:

C05AD01

INN (International Name):

ZINC OXIDE 6.6 % (W/W) LIDOCAINE HYDROCHLORIDE 0.7 % (W/W)

Pharmaceutical form:

OINTMENT

Composition:

ZINC OXIDE 6.6 % (W/W) LIDOCAINE HYDROCHLORIDE 0.7 % (W/W)

Prescription type:

OTC

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Suspended

Authorization date:

2006-11-27

Summary of Product characteristics

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