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CALAMINE OINTMENT BP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Calamine Ointment BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine BP 15% w/w

3

PHARMACEUTICAL FORM
Ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Calamine Ointment is used for symptomatic relief of itching in a variety of
minor skin disorders.

4.2

Posology and method of administration
For External Use Only.
Dosage:
Adults (including elderly) and children:
Apply evenly to the affected area one to three times daily until an
improvement occurs.

4.3

Contraindications
Hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use
Store at temperature below 25°C.
For external use only.

4.5

Interaction with other medicinal products and other forms of interaction
None stated.

4.6

Fertility, pregnancy and lactation
There is no evidence of hazard to suggest that this product cannot be used
during pregnancy and lactation.

4.7

Effects on ability to drive and use machines
None stated.

4.8

Undesirable effects
None stated.

4.9

Overdose
If accidentally ingested may cause nausea, vomiting and diarrhoea. Treat
symptomatically.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The Calamine exerts a mild astringent action on the skin.

5.2

Pharmacokinetic properties
None.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
White Soft Paraffin BP 85% w/w

6.2

Incompatibilities
None known.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
The product must be stored at a temperature below 25°C.

6.5

Nature and contents of container
Opaque containers and lids: 500g

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0045

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17 August 1984/ 29 November 1994

10

DATE OF REVISION OF THE TEXT
11/11/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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