Summary of Product Characteristics (SmPC) - Calamine lotion BP
1 NAME OF THE MEDICINAL PRODUCT
Calamine Lotion BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine 15.0% w/v
Zinc Oxide 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 relief of the symptoms of mild sunburn and other minor skin conditions.
4.2. Posology and Method of Administration
Topical. Applied directly to the skin.
Recommended dose and dosage schedule
The product is suitable for use by adults, children and the elderly. Apply gently with a pad of cotton wool to the affected parts as required.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
4.4. Special Warnings and Precautions for Use
Shake the bottle.
For external use only.
Keep all medicines away from children.
4.5. Interactions with other Medicaments and other forms of Interaction
May mask x-ray pictures under certain circumstances.
4.6. Pregnancy and Lactation
No evidence has been found as to the safety of the product when used during pregnancy and lactation. However, the product has been used for many years without any apparent ill effects.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
Occasional hypersensitivity or irritant 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
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 action of the skin and is used as a dusting powder, cream, lotion or ointment in a variety of skin conditions.
Zinc oxide has a mildly antiseptic action and is a mild astringent, it has soothing and protective properties.
5.2. Pharmacokinetic Properties
No information available.
5.3. Preclinical Safety Data
None.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Bentonite
Sodium Citrate
Glycerol
Phenol
Purified Water
6.2. Incompatibilities
None known.
6.3 Shelf life
100ml: 36 months unopened
200ml: 36 months unopened
6.4. Special Precautions for Storage
Store below 25°C.
6.5 Nature and contents of container
100ml: Glass bottle with polypropylene white 28mm cap with tamper evident band and EPE Saranex liner 200ml: Glass bottle with polypropylene white 28mm cap with tamper evident band and EPE Saranex liner
6.6. Instruction for Use/Handling and Disposal
None.
7. MARKETING AUTHORISATION HOLDER
L.C.M. Limited.,
Linthwaite Laboratories,
Huddersfield,
HD7 5QH,
England.
8. MARKETING AUTHORISATION NUMBER
PL 12965/0003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
25/8/1993 / 15/03/2001
10 DATE OF REVISION OF THE TEXT
07/11/2016