Calamine Lotion B.P.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calamine Lotion B.P.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Calamine BP |
15.0% w/v |
|
Zinc Oxide BP |
5.0% w/v |
|
Liquefied Phenol BP |
0.5% w/v |
|
Glycerol BP |
5.0% w/v |
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM Lotion.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the relief of minor skin rashes and irritation.
4.2 Posology and method of administration
For topical application. Applied directly to the skin.
Adults, older people and children Apply to the affected area as required
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Shake the bottle before use.
For external use only.
Keep all medicines out of the sight and reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No significant interactions are known
May mask x-ray pictures under certain circumstances.
4.6 Fertility, pregnancy and lactation
The safety of Calamine Lotion during pregnancy and lactation has not been established. No significant problems have been reported, but use during these periods is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Occasional hypersensitivity or irritation reactions.
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
Overdosage with calamine is very unlikely, if ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Calamine has astringent, antipruritic and mild antiseptic activity.
Zinc oxide is mildly astringent and forms a soothing and protective application.
Phenol is an antiseptic and disinfectant.
Glycerol is an osmotic agent with lubricating and moisturising properties.
5.2 Pharmacokinetic Properties
There is no evidence that calamine is absorbed through the skin.
No information is available on the absorption of zinc oxide through the skin. Zinc and its salts are poorly absorbed from the gastrointestinal tract. Zinc is widely distributed throughout the body and is excreted in the faeces with only traces in the urine.
Phenol is absorbed through the skin. It is metabolised to phenylglucuronide and phenyl sulphate and small amounts are oxidised to catechol and quinol which are mainly conjugated. The metabolites are excreted in the urine and on oxidation to quinones they may tint the urine green.
No information is available on the absorption of glycerol through the skin. Glycerol, taken orally, is readily absorbed from the gastrointestinal tract. It is extensively metabolised in the liver. It may be used in the synthesis of lipids, metabolised to glucose or glycogen, or oxidised to carbon dioxide and water.
It may also be excreted unchanged in the urine.
5.3 Pre-clinical Safety Data
No relevant data.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Bentonite B.P.
Sodium Citrate B.P.
Water (Potable) HSE
6.2 Incompatibilities
None stated
6.3
Shelf-Life
36 months.
6.4 Special Precautions for Storage
Store below 25oC.
6.5 Nature and Contents of Container
200 ml amber glass bottle with a white ‘J’ cap closure.
100 ml amber glass bottle with a white ‘J’ cap closure.
2 litre white polythene bottle with a white plastic screw cap with an EPE liner faced with aluminium.
500 ml white polythene bottle with a white plastic screw cap with an EPE liner faced with aluminium.
6.6 Special precautions for disposal
No special instructions.
7. MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited Hani Wells Business Park Unit 7
Hardicker Street Manchester M19 2RB United Kingdom.
8. MARKETING AUTHORISATION NUMBER
PL 18374/0033
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/04/2005
10 DATE OF REVISION OF THE TEXT
27/05/2015