Calamine Lotion Bp
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
10
DATE OF REVISION OF THE TEXT
24/06/2016