Germoloids Suppositories

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 283.5 mg LIDOCAINE HYDROCHLORIDE 13.2 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

ZINC OXIDE 283.5 mg LIDOCAINE HYDROCHLORIDE 13.2 mg

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 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