CANDIPLAS Cream (2015)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Candiplas 2% w/w cream.

2. Qualitative and quantitative composition

Each 15g and 30g tube of cream contains miconazole nitrate 2% w/w. Excipients with known effect: chlorocresol and cetostearyl alcohol (quantity). Each 1g of Candiplas contains 1mg chlorocresol and ...

3. Pharmaceutical form

Cream. White, soft, homogeneous, smooth, odourless cream for topical application.

4.1. Therapeutic indications

For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.

4.2. Posology and method of administration

Posology Recommended dosage For all ages: Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Candiplas must not come into contact with the eyes. If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued. Candiplas contains chlorocresol which may cause ...

4.5. Interaction with other medicinal products and other forms of interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients ...

4.6. Pregnancy and lactation

Pregnancy In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, ...

4.7. Effects on ability to drive and use machines

Not relevant.

4.8. Undesirable effects

Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 below. ...

4.9. Overdose

Symptoms Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. Management Candiplas is intended for cutaneous use, not for oral use ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for dermatological/topical use (imidazole derivative) ATC code: D01AC02 Miconazole nitrate is an imidazole antifungal agent and may act by interfering ...

5.2. Pharmacokinetic properties

Absorption There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically. Distribution Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6.1. List of excipients

Candiplas also contains: Purified water Chlorocresol Cetomacrogol 1000 Cetostearyl alcohol White petrolatum Mineral oil Sodium biphosphate Phosphoric acid

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Lacquered pilfer proof collapsible aluminium tubes, crimped at bottom and sealed with a polypropylene screw cap containing 15g or 30g of cream, in a carton with a patient information leaflet. Not all pack ...

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

19935

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 13/03/1990 Date of renewal authorization: 14/09/2011

10. Date of revision of the text

12/2015

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