- 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 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
- 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
PL 00079/0706, PL 44673/0028Should not be used in patients with known hypersensitivity to any of the ingredients
PL 44673/0031Hospital users should follow local procedures and policies for using topical products on in-patients.
FertilityThere are no data on the use of topical Oilatum Cream on human fertility
PregnancyThere are no data on the use of topical Oilatum Cream in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to WSP-LLP is low.
LactationIt is not known if Oilatum 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.
Skin and Subcutaneous Tissue DisordersRare: Application site reactions including application site erythema, rash, pain, pruritus, skin burning sensation.
Immune System DisordersRare: Application site hypersensitivity reactions including application site dermatitis.
Reporting of suspected adverse reactionsReporting 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 at:www.mhra.gov.uk/yellowcard.
Symptoms and signsThe product is intended for topical use only. Ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Excessive topical application should cause no untoward effects other than greasy skin.
TreatmentIn case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.
PL 44673/003130 Months
PL 00079/0706, PL 44673/0028Three years.
PL 44673/0031Do not store above 25 °C
PL 00079/0706, PL 44673/0028Store below 25 °C
PL 44673/0031350ml and 500ml pump pack: High density polyethylene bottle fitted with a mechanical pump dispenser (polyethylene/ polypropylene components).1000ml, 1050ml, 1100ml 1150ml pump pack: polypropylene container and lid, fitted with a mechanical pump dispenser (polypropylene components), utilising a follower plate (HDPE).Not all pack sizes may be marketed.
PL 00079/0706, PL 44673/0028Internally lacquered, membrane sealed aluminium tube fitted with a polypropylene screw cap and packed into a carton. Pack size 40g and 80g. Internally lacquered, membrane sealed aluminium tube fitted with a polyethylene screw cap and packed into a carton. Pack size 30g and 50g. Laminate tubes with polypropylene caps packed into cartons. Pack sizes 100g and 150g And 25g, 50g & 150g in a high density polyethylene tube. Not all pack sizes may be marketed.
PL 44673/0031GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,trading as Stiefel 980 Great West Road Brentford Middlesex TW8 9GSUnited Kingdom
PL 00079/0706, PL 44673/0028Beecham Group plc,980 Great West RoadBrentford, MiddlesexTW8 9GSUnited KingdomGlaxoSmithKline Consumer Healthcare (UK) Trading Limited980 Great West RoadBrentfordMiddlesexTW8 9GSUnited Kingdom
PL 00079/0706, PL 44673/002807/12/2010
GlaxoSmithKline Consumer Healthcare
980 Great West Road, Brentford, Middlesex, TW8 9GS
0800 783 8881
0800 783 8881