Calamine Lotion B.P.
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Oily Calamine Lotion BP 1980
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Arachis Oil BP 45.6% w/v Calamine BP 5.0% w/v
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM Lotion
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the relief of minor skin irritation and pruritus.
4.2 Posology and method of administration
Adults the elderly and children
The product should be applied to the skin. Repeat as required.
Shake the bottle well before applying the product.
Method of administration For topical application
4.3 Contraindications
Hypersensitivity to the active substances or to peanuts or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Oily Calamine Lotion B.P. 1980 contains arachis oil ( peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Oily Calamine Lotion B.P. 1980.
The product is for external use only. Keep out of the reach of children.
4.5 Interaction with other Medicinal Products and other Forms of Interaction
None known.
4.6 Fertility, pregnancy and lactation
No significant problems have been reported.
4.7 Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
None known. However, the product is preserved with phenonip, which contains a mixture of the esters of 4-hydroxybenzoic acid and phenoxyethanol: some patients may be hypersensitive to the preservative or other constituents of the product.
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
As the product is for topical use, the likelihood of overdosage due to ingestion is small; should it occur then treatment includes induction of emesis followed by supportive therapy accompanied by gastric lavage.
5. PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic Properties
Arachis oil is used topically as an emollient to soothe inflamed skin. Calamine has a mild astringent action on the skin.
5.2 Pharmacokinetic Properties
Arachis oil
Apart from the fact that it is absorbed through the skin to act as an emollient when applied topically, little is given in the literature concerning the Pharmacokinetic of arachis oil via this route of administration.
Calamine
Apart from the fact that it is a mild astringent when applied topically little is given in the literature concerning the pharmacokinetics of calamine via this route of administration.
5.3 Preclinical Safety Data
No relevant data.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Phenonip Wool fat Oleic acid
Calcium hydroxide solution
6.2 Incompatibilities
No significant incompatibilities have been reported..
6.3 Shelf Life
36 months.
6.4 Special Precautions for Storage
Store below 25 °C.
6.5 Nature and Contents of Container
Dispensing pack
500 ml amber glass bottle, plastic screw cap with an aluminium foil lined expanded polyethylene liner.
2 litre amber glass bottle, plastic screw cap with an aluminium foil lined
expanded
polyethylene liner.
Patient packs or OTC packs as apnronriate
500 ml amber glass bottle, plastic screw cap with an aluminium foil lined
expanded
polyethylene liner.
200 ml amber glass bottle with a white Jay cap closure.
6.6 Special precautions for disposal
None stated
7. MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd Hani Wells Business Park,
Unit 7,
Hardicker Street,
Manchester,
M19 2RB United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 18374/0034
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14th May 1986 / 14th April 1994
10 DATE OF REVISION OF THE TEXT
23/12/2015