This information is intended for use by health professionals

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 Interaction with other medicinal products and other forms of interaction

May mask x-ray pictures under certain circumstances.

4.6 Fertility, 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 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

L.C.M. Limited.,

Linthwaite Laboratories,

Huddersfield,

HD7 5QH,

England.

8. Marketing authorisation number(s)

PL 12965/0003

9. Date of first authorisation/renewal of the authorisation

25/8/1993 / 15/03/2001

10. Date of revision of the text

07/11/2016