HISTERGAN Topical cream Ref.[27732] Active ingredients: Diphenhydramine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Norma Chemicals Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF United Kingdom

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. 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. 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

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard.

6.2. Incompatibilities

Not applicable.

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