For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory. Light Liquid Paraffin and White Soft Paraffin Cream

Transcription

1 For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory OILATUM CREAM / KIDS CREAM Light Liquid Paraffin and White Soft Paraffin Cream QUALITATIVE AND QUANTITATIVE COMPOSITION Light Liquid Paraffin IP White Soft Paraffin IP 6.0% w/w 15.0% w/w Benzyl alcohol IP (as preservative) 0.5% w/w in a cream base q.s. PHARMACEUTICAL FORM Cream CLINICAL PARTICULARS Therapeutic Indications OILATUM CREAM / KIDS CREAM is indicated for the treatment of contact dermatitis, atopic eczema, senile pruritus, ichthyosis and related dry skin conditions. Posology and Method of Administration For topical use only OILATUM CREAM / KIDS CREAM may be used as frequently as necessary. Adults, adolescents and children Apply OILATUM CREAM / KIDS CREAM to the skin as required and smooth into the skin in the direction of hair growth.

2 Elderly No dosage adjustment is necessary. Renal impairment No dosage adjustment is necessary. Systemic exposure to OILATUM CREAM / KIDS CREAM is expected to be low following topical administration because percutaneous absorption of OILATUM CREAM / KIDS CREAM is very low (see Pharmacokinetics Properties). Hepatic impairment No dosage adjustment is necessary. Systemic exposure to OILATUM CREAM / KIDS CREAM is expected to be low following topical administration because percutaneous absorption of OILATUM CREAM / KIDS CREAM is very low (see Pharmacokinetics Properties). Contraindications No contraindications identified. Special Warnings and Special Precautions for Use OILATUM CREAM / KIDS CREAM should be used with caution in patients with a known sensitivity or allergy to white soft paraffin or light liquid paraffin or to any of the excipients in the preparation. Interaction with Other Medicaments and Other Forms of Interaction No drug interaction studies have been conducted with topical OILATUM CREAM / KIDS CREAM. Considering the low level of systemic absorption, drug interactions are unlikely to occur.

3 Pregnancy and Lactation Fertility There are no data on the use of topical OILATUM CREAM / KIDS CREAM on human fertility. Pregnancy There are no data on the use of topical OILATUM CREAM / KIDS CREAM in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to OILATUM CREAM / KIDS CREAM is low. Lactation It is not known if OILATUM CREAM / KIDS CREAM is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding. Effects on Ability to Drive and Use Machines There have been no studies to investigate the effect of OILATUM CREAM / KIDS CREAM on driving performance or the ability to operate machinery. No effects are anticipated based on the adverse event profile. Undesirable Effects Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common ( 1/10), common ( 1/100 and <1/10), uncommon ( 1/1,000 and <1/100), rare ( 1/10,000 and <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). Post-marketing data Skin and Subcutaneous Tissue Disorders Rare: Application site reactions including application site erythema, rash, pain, pruritus, skin burning sensation. Immune System Disorders Rare: Application site hypersensitivity reactions including application site dermatitis

4 Overdose Symptoms and signs The product is intended for topical use only. Ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Treatment In case of ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available. PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Pharmacotherapeutic Group: Dermatologicals, other emollients and protectives (ATC code : D02AX ) Mechanism of action White soft paraffin and light liquid paraffin are emollients widely used in the treatment of eczema and related dry skin conditions. Pharmacodynamic effects White soft paraffin and light liquid paraffin exert an emollient effect by forming an occlusive film on the stratum corneum. Pharmacokinetic Properties There have been no studies to investigate the pharmacokinetics of topically applied OILATUM CREAM / KIDS CREAM. White Soft Paraffin and Light Liquid Paraffin are chemically and biologically inert. Penetration of the skin of mineral oil hydrocarbons does not go beyond the stratum corneum, and therefore systemic uptake of OILATUM CREAM / KIDS CREAM is considered to be minimal (<1%).

5 Preclinical Safety Data Genotoxicity and carcinogenicity studies have not been conducted with OILATUM CREAM / KIDS CREAM formulations. Studies in which refined mineral oils were applied topically to the skins of mice, rats or rabbits, over periods of time ranging from 90 days to lifetime exposure have shown that white mineral oil does not produce tumours in any internal organ or at the site of application. Repeat dose studies using mice, rats and rabbits showed that after 90 days or lifetime application of mineral oil, no histopathological changes to any internal organs or to the skin could be recognized that could be attributable to the chemical. When administered orally over a prolonged period, white mineral oils induced pathological changes in the livers and mesenteric nodes of experimental animals. PHARMACEUTICAL PARTICULARS List of Excipients PEG 1000 Monostearate, Cetostearyl Alcohol, Citric Acid Anhydrous, Potassium Sorbate, PVP- K 30 (Plasdone K29/32), Benzyl Alcohol, Glycerin and Purified Water. Incompatibilities No data available. Shelf Life 24 months The expiry date is indicated on the label and packaging. Special Precautions for Storage Store at temperature below 25ºC. Do not freeze. Keep out of reach of children.

6 Nature and Specification of Container Lami Tube with screw cap packed in a carton. Instructions for Use / Handling For external use only. Refer section Posology and Method of Administration for information. No other special requirements. For further information please contact: Stiefel India Private Limited, Registered office : 401 & 402, A Wing, 4th Floor, Floral Deck Plaza, Opp. Rolta Bhavan, Central MIDC Road, Andheri ( E ), Mumbai OILATUM is a trademark of the GlaxoSmithKline group of companies Version OLC/PI/IN/2013/01 dated 02 September 2013 Adapted from GDS Version 01 dated 24 September 2012