ICHTHAMMOL GLYCERIN B.P.C

Active substance: ICHTHAMMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ichthammol Glycerin BPC

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ichthammol BPC. 1973 10.0% w/w

3.

PHARMACEUTICAL FORM
Glycerin

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.

Contra-indications
Sensitivity to the product has been reported and in such instances the
product is contraindicated.

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 25oC in well closed containers.

4.5.

Interactions with other Medicaments and other forms of Interaction
No significant interactions have been reported.

4.6.

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.

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
60 months.

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.

Instruction for Use/Handling
None.

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
17/02/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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