Germoloids suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lidocaine hydrochloride; Zinc oxide

Available from:

Bayer Plc

ATC code:

C05AX04

INN (International Name):

Lidocaine hydrochloride; Zinc oxide

Dosage:

13.2mg ; 283.5mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01070100; GTIN: 5010605829093 5010605829109

Patient Information leaflet

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PIL 210 x 148 Delpharm Huningue
Germoloids
Triple Action
Suppositories
Leaflet
UK
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Guides
Technical & Non Printing Items
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12/24CT Pack
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16/11/20
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SUPPOSITORIES
zinc oxide and lidocaine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet._ See section 4._
•
You must contact a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1. What Germoloids Suppositories are and what they are used for
2. What you need to know before you use Germoloids Suppositories
3. How to use Germoloids Suppositories
4. Possible side effects
5. How to store Germoloids Suppositories
6. Contents of the pack and other information
1. WHAT GERMOLOIDS
® SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Haemorrhoids (also known as piles) are swollen or enlarged blood
vessels, which can cause
discomfort, itching and bleeding, particularly after a bowel movement.
They may be either
internal (inside the anus) or externa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Germoloids Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc oxide Ph. Eur. 283.5 mg
Lidocaine hydrochloride Ph. Eur. 13.2 mg
3
PHARMACEUTICAL FORM
Suppository for 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 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
product i