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THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 165 Fax: +44 (0)1159 592 565 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 01/08/2008

SPC	Calamine Lotion BP (Boots Company PLC)

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Calamine Lotion BP

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients	% w/v
Calamine BP	15
Zinc Oxide Ph Eur	5

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3. PHARMACEUTICAL FORM

Lotion

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of minor skin rashes and irritation.

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4.2 Posology and method of administration

Adults, children and elderly

To be applied when required to the affected area.

For topical application.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

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4.4 Special warnings and precautions for use

Shake the bottle.

For external use only.

Keep all medicines out of the reach of children.

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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

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4.6 Pregnancy and lactation

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

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4.7 Effects on ability to drive and use machines

No adverse effects known.

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4.8 Undesirable effects

Occasional hypersensitivity or irritant reactions.

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4.9 Overdose

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

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Calamine has a mild astringent action on the skin.

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5.2 Pharmacokinetic properties

None known.

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5.3 Preclinical safety data

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

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