Germoloids ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zinc oxide; Lidocaine hydrochloride

Available from:

Bayer Plc

ATC code:

C05AX04

INN (International Name):

Zinc oxide; Lidocaine hydrochloride

Dosage:

66mg/1gram ; 7mg/1gram

Pharmaceutical form:

Rectal ointment

Administration route:

Rectal; Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01070100; GTIN: 5010605829062 5010605829079

Patient Information leaflet

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PIL 190 x 120
Germoloids
Triple Action
Ointment
Leaflet
UK
Cutter
Guides
Technical & Non Printing Items
BAYER ARTWORK PANEL
25/55ml Pack
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BAY437483
Main Text (body copy):
Height (based on lower case x):
7 pt
1.3 mm
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11/11/20
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84349607 84349615
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Famar Avlona 49km Greece [GR]
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OINTMENT
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 Ointment is and what it is used for
2. What you need to know before you use Germoloids Ointment
3. How to use Germoloids Ointment
4. Possible side effects
5. How to store Germoloids Ointment
6. Contents of the pack and other information
1. WHAT GERMOLOIDS
®
OINTMENT 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 Ointment is used to relieve the symptom

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Germoloids Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc oxide
6.6% w/w
Lidocaine hydrochloride
0.7% w/w
Excipients with known effect:
Propylene glycol 2% w/w
Lanolin 3.5% w/w
For the full list of excipients, see section 6.1
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