- 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 Fertility, 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
- Administrative data
- 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
Benzalkonium chloride solution (equivalent to benzalkonium chloride 0.10g)
|Butylated hydroxyanisole compound (containing butylated hydroxyanisole (E320) 20%, propyl gallate 10% and citric acid 10%)||0.40|
|Methyl hydroxybenzoate (E218)||0.10|
|Propyl hydroxybenzoate (E216)||0.10|
Adults (including the elderly) and children.Dermatoses: Sufficient Timodine Cream should be applied to cover the lesion in a thin layer. It should then be massaged into the skin until the cream disappears. The treatment should be repeated three times a day until the lesion has healed. There is no indication that dosage need be modified for the elderly.Nappy rash: After removal of the soiled nappy, the affected area should be cleaned and dried, and a thin layer of Timodine Cream applied. The treatment should be repeated after every nappy change. In infants long-term continuous topical steroid therapy should be avoided since this can lead to adrenal suppression even without occlusion. A course of treatment should not normally exceed seven days.
The elderlyThe skin of the elderly is often relatively atrophic so that local and systemic side effects of hydrocortisone are more likely.
Patients with hepatic failureThe reduced metabolism of hydrocortisone in patients with hepatic failure increases the theoretical risk of adrenal suppression.
Paediatric populationAvoid prolonged use in children.Caution is required in dermatoses of infancy including nappy rash. Care should be taken as the nappy can act as an occlusive dressing and thus allow an increase in absorption of the steroid component of the cream.In infants, long-term continuous topical steroid therapy should be avoided since this can lead to adrenal suppression even without occlusion. A course of treatment should not normally exceed seven days.Use of hydrocortisone should be avoided in neonates. Any proposed use of hydrocortisone in neonates should be carefully assessed, as the high body surface area:weight ratio allows a proportionate increase in percutaneous absorption. Consideration should be given to the relative fragility of neonatal skin.
FertilityNo data available
PregnancyTopical 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.
LactationAlthough poorly absorbed, it is not known whether nystatin enters breast milk. Caution should be exercised when nystatin is prescribed for nursing mothers.Corticosteroids cross the placenta to varying degrees and may be distributed in small amounts in breast milk. Any topically applied hydrocortisone should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.
|System Organ Class||Frequency||Undesirable Effect|
|Endocrine disorders||Not known||• adrenal suppression (see Section 4.4 'Special warnings and precautions for use')|
|Immune system disorders||Not known||• hypersensitivity reactions1|
|Infections and infestations||Not known||• spread and worsening of untreated infection (see Section 4.4 'Special warnings and precautions for use')|
|Metabolism and nutrition disorders||Not known||• Cushing's syndrome (see Section 4.4 'Special warnings and precautions for use')|
|Skin and subcutaneous tissue disorder||Not known||• thinning of the skin2 (see Section 4.4 'Special warnings and precautions for use' and Section 4.9 'Overdose') • irreversible striae atrophicae (see Section 4.9 'Overdose') • telangiectasia (see Section 4.9 'Overdose') • contact dermatitis (see Section 4.4 'Special warnings and precautions for use') • perioral dermatitis • acne or worsening of acne • rosacea • mild depigmentation3 • hypertrichosis • contact sensitisation • purpura • loss of skin collagen and subcutaneous atrophy|
NystatinNystatin is a polyene antifungal antibiotic that interferes with the permeability of the cell membrane of sensitive fungi by binding to sterols, chiefly ergosterol. Nystatin is used for the prophylaxis and treatment of candidiasis of the skin and mucous membranes. It is both fungistatic and fungicidal against a wide range of yeasts and yeast-like fungi.
Dimeticone 350Dimeticones 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.
HydrocortisoneHydrocortisone is a mild, but effective anti-inflammatory agent.
Benzalkonium chloride solutionBenzalkonium chloride is a quaternary ammonium antiseptic with a broad spectrum of antibacterial activity.
NystatinNystatin is poorly absorbed.
Dimeticone 350Dimeticone is a silicone polymer that is not absorbed.
HydrocortisoneHydrocortisone is absorbed through the skin, metabolised in the liver, kidneys and most other body tissues. It is metabolised to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol, which are excreted in the urine mainly conjugated as glucuronides, together with a small proportion of unchanged hydrocortisone (<1%). Hydrocortisone is extensively bound to plasma proteins, >90%, and has a small volume of distribution, 0.31.kg-1. It has a short biological half-life of about 100 minutes and elimination is rapid, with about 90% of the absorbed dose excreted within 24 hours. Absorption through the skin is greatest where the skin is thin or raw, and from intertriginous areas; it is increased by occlusion.
Benzalkonium chloride solutionQuaternary ammonium salts, such as benzalkonium chloride, are poorly absorbed through the skin.
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