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VALDERMA CREAM

Active substance(s): CHLOROCRESOL / POTASSIUM HYDROXYQUINOLINE SULPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Valderma Cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION % w/w 0.2 0.2

Potassium Hydroxyquinoline Sulphate Chlorocresol

(equivalent to 0.125% w/w of 8-hydroxyquinoline base)

3.

PHARMACEUTICAL FORM Cream

4 4.1.

CLINICAL PARTICULARS Therapeutic indications For the treatment of all common minor skin troubles, for example spots and pimples.

4.2.

Posology and Method of Administration For topical application to the skin. Adults and Children: Wash the affected area with warm water and a gentle soap. Rub in the cream. There is no indication that dosage need be modified for the elderly. The product may be applied freely two or three times a day to the affected area of the skin.

4.3.

Contra-indications

Known allergy to the product or any of its constituents.

4.4.

Special Warnings and Special Precautions for Use Treatment should be terminated if irritation develops. In the event of any irritation of sensitive skin, wash with luke-warm water. Product labelling If symptoms persist, consult your doctor. Keep out of the reach of children. For external use only.

4.5. Interactions with other Medicinal Products and other Forms of Interaction None known.

4.6.

Pregnancy and Lactation There is inadequate evidence of safety of the active ingredients in human pregnancy, but the drug has been in wide use without apparent ill consequence. Significant percutaneous absorption of 8-hydroxyquinolines has been demonstrated but there is however no evidence from animal data of any adverse reactions occurring to the foetus. Avoid in pregnancy if a safer alternative is known, although safety in pregnancy is likely.

4.7.

Effects on ability to Drive and Use Machines None known.

4.8.

Undesirable Effects None known.

4.9.

Overdose

It is unlikely that a sufficient volume of cream could be ingested to cause any medical problems. In the event of accidental eye contact, wash with lukewarm water.

5

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties Chlorocresol at the concentration present in Valderma is bacteriostatic towards a wide range of Gram positive and Gram negative bacteria; the activity against the Gram positive bacteria is particularly complemented by the presence of potassium hydroxyquinoline sulphate. The latter also confers anti-fungal activity to the cream.

5.2.

Pharmacokinetic Properties No formal pharmacokinetic studies have been conducted on Valderma. The literature indicates that both active constituents are capable of being absorbed by the transdermal route. Chlorocresol is absorbed through mucous membranes and is metabolised principally to its glucuronide, which is excreted in the urine and percutaneous absorption of hydroxyquinoline is also known to occur. As the content of chlorocresol in the finished product is 0.2% w/w it is unlikely that significant systemic levels will be achieved. Similarly the content of potassium hydroxyquinoline sulphate is also 0.2% w/w and, as other dermatological preparations in the market contain up to 0.5% w/w it is unlikely that systemic absorption would create any problem.

5.3.

Preclinical Safety Data None given.

6

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients

Hard paraffin Stearic acid Technical white oil Cetostearyl alcohol Cetyl ester wax (synthetic spermaceti) Urea Sodium lauryl sulphate Sodium hydroxide Geraniol Purified water

6.2.

Incompatibilities None known.

6.3.

Shelf Life 3 years.

6.4.

Special Precautions for Storage Store below 25C.

6.5.

Nature and Contents of Container Collapsible aluminium tube with a diaphragm and a screw cap. Pack sizes 15g, 30g, 45g, 60g.

6.6

Special precautions for disposal None.

7.

MARKETING AUTHORISATION HOLDER William Ransom & Son plc T/A Ransom Consumer Healthcare Stepfield, Witham,

Essex, CM8 3AG United Kingdom

8.

MARKETING AUTHORISATION NUMBER(S) PL 01252/0066

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 31st May 2002

10.

DATE OF (PARTIAL) REVISION OF THE TEXT December 2004

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Source: Medicines and Healthcare Products Regulatory Agency

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