Germoloids cream

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Zinc oxide; Lidocaine hydrochloride

Disponible desde:

Bayer Plc

Código ATC:

C05AX04

Designación común internacional (DCI):

Zinc oxide; Lidocaine hydrochloride

Dosis:

66mg/1gram ; 7mg/1gram

formulario farmacéutico:

Rectal cream

Vía de administración:

Cutaneous; Rectal

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01070100; GTIN: 5010605829086 5010605829727

Información para el usuario

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PIL 190 x 120
Germoloids
Triple Action
Cream
Leaflet
UK
Cutter
Guides
Technical & Non Printing Items
BAYER ARTWORK PANEL
25/55g Pack
Packaging Site Approval:
ARTWORK
APPROVAL PANEL
Name:
Date:
Action:
Country Approval:
Name:
Date:
Action:
BAY437456
Main Text (body copy):
Height (based on lower case x):
7 pt
1.3 mm
FONT SIZE PANEL
02/11/20
OTH009060
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84349577
B
TR1985395
N/A
N/A
N/A
N/A
N/A
Famar Avlona 49km Greece [GR]
Generic Bayer
White Paper
1
LTH
Process Black
Colours
000000000
CREAM
CREAM FOR PILES
zinc oxide, 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 Cream is and what it is used for
2. What you need to know before you use Germoloids Cream
3. How to use Germoloids Cream
4. Possible side effects
5. How to store Germoloids Cream
6. Contents of the pack and other information
1. WHAT GERMOLOIDS
®
CREAM IS AND WHAT IT IS 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 external (outside the anus).
Germoloids Cream is used to relieve the symptoms of pain, swelling a

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Germoloids Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc oxide Ph. Eur.
6.6% w/w
Lidocaine hydrochloride Ph. Eur.
0.7% w/w
3
PHARMACEUTICAL FORM
Cream 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 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 cream
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 may occur at the site of application.
REP