Timodine Intertrigo Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timodine Intertrigo Relief.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Active ingredient |
% w/w |
Specification |
|
Nystatin |
3.00 |
BP |
|
Dimeticone 350 |
10.00 |
BP |
|
Hydrocortisone |
0.50 |
Ph Eur |
|
Benzalkonium chloride solution (equivalent to benzalkonium chloride 0.10 g) |
0.20 |
BP |
(a) An overage of 15% is added at manufacture. The 3% w/w is approximate only to achieve an activity of nystatin in the final formulation of 100,000 IU/g.
(b) An overage of 8% is added at manufacture.
3 PHARMACEUTICAL FORM
Cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Intertrigo.
4.2 Posology and method of administration
For topical application to the skin.
Apply a finger-tip full of Timodine Intertrigo Relief three times a day to the sore area and rub gently in until the cream disappears.
Do not use the cream for more than seven days. If symptoms persist consult your doctor.
Not to be used on children under 10.
There is no indication that dosage need be modified for the elderly.
4.3 Contraindications
Sensitivity to benzalkonium chloride and nystatin or any of the other ingredients.
4.4 Special warnings and precautions for use
Do not use on the face.
Keep away from the eyes.
For external use only.
Keep out of reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6
Pregnancy and lactation
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human
beings has not been established. However, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.
There is no information about effects on lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
If signs of hypersensitivity appear, application should stop immediately. Exacerbation of symptoms may occur. Dermatitis, probably contact, has been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Tel: Freephone 0808 100 3352. Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
No special procedures are likely to be needed.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Nystatin
Nystatin is used for the prophylaxis and treatment of candidiasis of the skin and mucous membranes. It is an antifungal antibiotic which is both fungistatic and fungicidal against a wide range of yeasts and yeast-like fungi.
Dimeticone
Dimeticones and other silicones are water-repellent and have a low surface tension. They are used in topical barrier preparations for protecting the skin against water-soluble irritants.
Hydrocortisone
Hydrocortisone is a mild, but effective anti-inflammatory agent. Benzalkonium chloride
Benzalkonium chloride is a quaternary ammonium antiseptic with a broad spectrum of antibacterial activity.
5.2 Pharmacokinetic properties
Nystatin
Nystatin is not absorbed through the skin.
Dimeticone
Dimeticone is a silicone polymer that is not absorbed.
Hydrocortisone
Hydrocortisone is absorbed through the skin, metabolised in the liver and excreted in the urine. It has a short biological half-life of about 100 minutes and its metabolites are also excreted in the urine.
Benzalkonium chloride
Quaternary ammonium salts, such as benzalkonium chloride, are poorly absorbed through the skin.
5.3 Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
6.1 List of excipients
Dibutyl phthalate, glyceryl monostearate SE, stearic acid, cetostearyl alcohol, cellulose nitrate, butylated hydroxyanisole compound, sodium metabisulphite, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbic acid and pure water.
6.2 Incompatibilities
None known.
6.3 Shelf life
Two years.
6.4 Special precautions for storage
Store below 15°C.
6.5 Nature and contents of container
Collapsible aluminium tubes with diaphragm and an internal lacquer coating of araldite resin. Pack size - 15 g.
6.6 Special precautions for disposal
For topical application to the skin.
MARKETING AUTHORISATION HOLDER
7
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
8 MARKETING AUTHORISATION NUMBER(S)
PL 16853/0104
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/02/2010
10 DATE OF REVISION OF THE TEXT
19/01/2015