Summary of Product Characteristics (SmPC) - Ichthammol Glycerin B.P.C
1 NAME OF THE MEDICINAL PRODUCT
Ichthammol Glycerin BPC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ichthammol BPC 1973 10.0% w/w
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical bacteriostatic moisturiser
Viscous black liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of chronic eczema.
4.2. Posology and Method of Administration
Adults, the elderly and children under 12 years
To be applied topically 1-3 times daily.
Route of administration
Topical.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Do not apply to broken skin. For external use only. Keep out of the reach of children. Store at a temperature not exceeding 25◦ C in well closed containers.
4.5. Interactions with other Medicaments and other forms of Interaction
No significant interactions have been reported.
4.6 Fertility, pregnancy and lactation
No significant problems have been reported either with pregnant women or with nursing mothers who are breast feeding; however, as with many other medicines, its use especially in the first 3 months of pregnancy, is recommended only when the benefits outweigh any risks.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
Skin irritation 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 at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Overdosage is unlikely to present a significant risk as it is applied topically; however, should it occur then treatment includes induction of emesis followed by supportive therapy which may include gastric lavage.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Ichthammol has a slight bacteriostatic effect and acts in a similar manner to Coal Tar BP being used in the treatment of the less acute forms of eczema.
Glycerin is a humectant with emollient properties.
5.2. Pharmacokinetic Properties
Ichthammol is applied externally. There is little information available regarding its pharmacokinetics although it is probably not absorbed through intact skin.
5.3. Preclinical Safety Data
No relevant data.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Glycerol.
6.2. Incompatibilities
No significant major incompatibilities have been reported
6.3 Shelf life
5 years
6.4. Special Precautions for Storage
Store below 25oC.
6.5. Nature and Contents of Container
Dispensing pack
2 litre HDPE bottle, plastic screw cap with an aluminium foil lined EPE liner.
500 ml HDPE bottle with a wadless polypropylene screw cap.
Patient packs or OTC packs as appropriate
500 ml HDPE bottle with a wadless polypropylene screw cap.
200 ml amber glass bottle with a white Jay cap closure.
6.6 Special precautions for disposal
None stated
7. MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited,
Hani Wells Business Park,
Unit 7,
Hardicker Street,
Manchester,
M19 2RB
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 18374/0020
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
17th February 2005
10 DATE OF REVISION OF THE TEXT
25/01/2016