HISTERGAN Topical cream (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Histergan Cream. Lloyds Pharmacy Antihistamine Cream. Boots Skin Allergy Relief 2% w/w Cream. Vantage Antihistamine 2.0% w/w Cream. Careway Antihistamine 2% w/w Cream.
2. Qualitative and quantitative composition
Diphenhydramine Hydrochloride BP 2% w/w.
3. Pharmaceutical form
Topical cream.
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. Contraindications
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. ...
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 ...
4.5. Interaction with other medicinal products and other forms of interaction
None recorded.
4.6. Pregnancy and lactation
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 eczematous reactions have been reported, if this occurs, treatment should be discontinued. Reporting of suspected adverse reactions ...
4.9. Overdose
Accidental ingestion or excessive absorption may lead to dose related signs of diphenhydramine toxicity which includes drowsiness and sedation. Treatment is by gastric lavage and aspiration. In cases of ...
5.1. Pharmacodynamic properties
Diphenhydramine applied externally has anti-histaminic activity in conditions induced by allergic stimuli.
5.2. Pharmacokinetic properties
Diphenhydramine is a histamine H<sub>1</sub> receptor antagonist. External applications to largely intact skin results in minimal systemic absorption.
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Propyl hydroxybenzoate Liquid paraffin Emulsifying wax Deionised water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store between 4°C and 25°C.
6.5. Nature and contents of container
Tube 25g.
6.6. Special precautions for disposal and other handling
None stated.
7. Marketing authorization holder
Norma Chemicals Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF United Kingdom
8. Marketing authorization number(s)
PL 00386/5000R
9. Date of first authorization / renewal of the authorization
4 December 1989 / 13 June 1995
10. Date of revision of the text
18<sup>th</sup> October 2017
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