Medine.co.uk

Calamine Lotion Bp

Document: spc-doc_PL 00014-5471R change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Calamine Lotion BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients    %    w/v

Calamine BP    15

Zinc Oxide Ph Eur    5

3 PHARMACEUTICAL FORM

Lotion

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of minor skin rashes and irritation.

Adults, children and elderly

To be applied when required to the affected area.

For topical application.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use Shake the bottle.

For external use only.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

May mask x-ray pictures under certain circumstances.

The safety of Calamine Lotion during pregnancy and lactation has not been established but used during these periods is not considered to constitute a hazard.

4.7 Effects on ability to drive and use machines

No adverse effects 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

If ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only.

PHARMACOLOGICAL PROPERTIES

5


5.1 Pharmacodynamic properties

Calamine has a mild astringent action on the skin.

5.2 Pharmacokinetic properties

None known.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Bentonite Glycerol Sodium Citrate Phenol

Water Purified

6.2    Incompatibilities

None stated.

6.3    Shelf life

36 months.

6.4    Special precautions for storage

None.

6.5    Nature and contents of container

A white flint glass bottle with an unlined polypropylene cap.

An amber glass bottle with vinyl seal faced compocork in thermoset plastic cap.

Alternative cap: Aluminium roll-on pilfer proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner.

Pack sizes: 200, 2000 millilitres.

6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

Trading as: BCM Almus

8    MARKETING AUTHORISATION NUMBER(S)

PL 00014/5471R

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 31 October 1984 Date of Last Renewal:    23 January 1996

10 DATE OF REVISION OF THE TEXT

December 2014