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Numark Calamine Lotion Bp

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Calamine Lotion BP Superdrug Calamine Lotion BP Sainsbury’s Calamine Lotion BP Tesco Calamine Lotion BP Morrisons Calamine Lotion BP Numark Calamine Lotion BP Wilko Calamine Lotion

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Calamine BP Zinc Oxide BP

3.    PHARMACEUTICAL FORM

Topical suspension

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Use as a mild astringent, cooling lotion for minor skin irritations and sunburn. Administered by application to skin.

4.2    Posology and method of administration

For children, adults and the elderly apply with cotton wool to the affected area as required.

4.3


Contraindications

Known hypersensitivity to any of the ingredients

4.4 Special warnings and precautions for use

Shake bottle well.

For external use only.

Do not use on broken skin.

4.5    Interaction with other medicinal products and other forms of interaction

May mask x-ray pictures under certain circumstances.

4.6    Pregnancy and lactation

Acceptable for use in pregnancy and lactation.

4.7    Effects on ability to drive and use machines

None.

4.8 Undesirable effects

None known

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 at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

If accidentally ingested treat symptomatically.

Overdose is considered unlikely with this product. However, if large quantities have been ingested, vomiting, inflammation of mucous membranes of the mouth and

stomach, weakness, mental confusion, cold sweats, depression of pulse and leg cramps may occur.

Where phenol has been swallowed it may be necessary to empty the stomach by aspiration and lavage.

Castor oil or olive oil may be added to the water to dissolve the phenol and delay absorption: 50ml of oil may be left in the stomach.

The patient should be kept warm and pulmonary oedema, systemic acidosis, respiratory failure and circulatory failure should be treated symptomatically. Respiration may have to be assisted.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Calamine has a mild astringent on the skin and is used to relieve the discomfort of dermatitis.

Calamine lotion cools the skin by evaporation and is useful for allaying the pain and swelling of sunburn.

Zinc oxide is applied externally as a mild astringent for the skin and protective application in eczema and as a protective for slight excoriations.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

None available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Bentonite BP Sodium Citrate BP Liquefied Phenol BP Glycerol BP Purified Water

6.2    Incompatibilities

None known.

6.3    Shelf life

36 months in unopened bottle.

6.4    Special precautions for storage

None.

6.5    Nature and contents of container

White or amber glass bottle with tamper evident screw cap. 100 ml, 150 ml, 200 ml, 500 ml.

6.6    Instructions for use/handling

Shake well before use

7.    MARKETING AUTHORISATION HOLDER

Bell, Sons & Co (Druggists) Ltd

Gifford House

Slaidbum Crescent

Southport

Merseyside

PR9 9AL

8.    MARKETING AUTHORISATION NUMBER

PL 03105/0011

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20/04/2009

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DATE OF REVISION OF THE TEXT

24/06/2016