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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU Telephone: +44 (0)1992 467 272 Fax: +44 (0)1992 479 292 Medical Information e-mail: medicalinformationuk@merck.com 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: 04/04/2011

SPC	Diprobase Ointment

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
11 LEGAL CATEGORY

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1. NAME OF THE MEDICINAL PRODUCT

Diprobase Ointment

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

No pharmacologically active components

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3. PHARMACEUTICAL FORM

Ointment

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Diprobase Ointment is an emollient, moisturising and protective ointment for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Diprobase Ointment is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.

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4.2 Posology and method of administration

Adults and Children :

The ointment should be thinly applied to cover the affected area completely, massaging gently and thoroughly into the skin. Frequency of application should be established by the physician. Generally, Diprobase Ointment can be used as often as required.

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4.3 Contraindications

Hypersensitivity to any of the components of the ointment is a contraindication to its use.

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4.4 Special warnings and precautions for use

None stated.

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4.5 Interaction with other medicinal products and other forms of interaction

None stated.

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4.6 Pregnancy and lactation

None stated.

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4.7 Effects on ability to drive and use machines

None stated.

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4.8 Undesirable effects

Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use.

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4.9 Overdose

None stated.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Diprobase Ointment contains no active ingredients and has no pharmacological action. The ingredients have an emollient action on dry or chapped skin.

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5.2 Pharmacokinetic properties

Not applicable due to topical administration and direct action on the skin.

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