Histergan Cream 2% w/w

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE

Available from:

Norma Chemicals Limited

ATC code:

D04AA32

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Pharmaceutical form:

CREAM

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 2 percent weight/weight

Prescription type:

OTC

Therapeutic area:

ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.

Authorization status:

Authorised

Authorization date:

2006-04-18

Patient Information leaflet

Patient Information Leaflet
Histergan Cream
Diphenhydramine Hydrochloride
_Please read this leaflet carefully before using this medicine. If you
have any questions or are not sure about _
_anything, ask your doctor or pharmacist.. _
_ _
THIS LEAFLET CONTAINS THE FOLLOWING INFORMATION.
1.
What is Histergan Cream and what does it do?
2.
What should I know before using Histergan Cream?
3.
How do I use Histergan Cream?
4.
Does Histergan Cream have any side effects?
5.
How do I Store Histergan Cream?
6.
Further information.
1.
WHAT IS HISTERGAN CREAM AND WHAT DOES IT DO?
Histergan Cream is intended for the relief of minor discomforts due to
allergic conditions of the skin.
Such conditions include rashes and itches, stings and insect bites.
The active ingredient is
diphenhydramine hydrochloride which is an antihistamine; it works by
reducing the inflammatory
response to histamine, which is an agent responsible for causing the
pain associated with allergic
responses.
2.
WHAT SHOULD I KNOW BEFORE USING HISTERGAN CREAM
WHEN SHOULDN’T I USE HISTERGAN CREAM?
Do not use Histergan Cream if you are allergic to any of the
ingredients listed in SECTION 6 of this
leaflet. Do not apply to eczema, or conditions where the skin is
broken or producing any form of wet
discharge. Do not use the cream at the same time as using other
products that also contain
diphenhydramine. Histergan Cream is not suitable for children under
six years of age.
INFORMATION ABOUT SOME OF THE INGREDIENTS IN THIS MEDICINE:
This medicine contains propyl hydroxybenzoate which may cause allergic
reactions (possibly delayed).
WHAT ELSE SHOULD I BE AWARE OF BEFORE USING HISTERGAN CREAM?
Keep away from eyes, nose and mouth. Apply sparingly, avoiding
prolonged or repeated applications
especially to large areas. If burning or a rash develops or the
condition does not improve seek medical
advice immediately. You can remove the cream by washing with soap and
water if required.
WHAT SHOULD I DO IF I ACCIDENTALLY SWALLOW OR USE TOO MUCH HISTERGAN
CREAM?
Accidental swa

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAMES OF THE MEDICINAL PRODUCT 

Histergan Cream 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Diphenhydramine Hydrochloride BP 2% w/w 

3. 
PHARMACEUTICAL FORM 

Topical Cream 

CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Symptomatic treatment of allergic conditions e.g.:-  
Urticaria, pruritus, allergic rashes, stings and insect  bites. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Apply sparingly and infrequently (maximum twice daily) to the affected area. 
 Short term treatment only - not more than three days. 
 Not recommended for children under six years old. 

4.3 
CONTRA-INDICATIONS 

Known sensitivity to anti-histamines and benzoates. Do not apply to mucous membranes, 
eczematous conditions or where the skin is extensively broken or denuded, or in acute 
vesicular or exudative dermatoses. Do not use with any other product containing the same 
active ingredient. 

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Apply sparingly. Avoid prolonged use or repeated applications especially to large areas. If 
burning or rash develops, or if the condition persists, medical advice should be sought 
immediately. If necessary remove by washing with soap and water. Wash hands after use, 
unless they are being treated. 

4.5 
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION 

None recorded 

4.6 
PREGNANCY AND LACTATION 

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Not applicable when used as directed. Medicament should only be used in pregnancy when 
anticipated benefits exceed the risks. 

4.7 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

Not Applicable 

4.8 
UNDESIRABLE EFFECTS 

May give rise to sensitisation reaction and photosensitivity. Rarely