PSORIDERM Cream (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
1. Name of the medicinal product
Psoriderm Cream.
2. Qualitative and quantitative composition
Distilled coal tar 6.0% w/w <u>Excipients with known effect:</u> 1g of cream contains 50 mg of propylene glycol (E 1520). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Buff coloured Cream.
4.1. Therapeutic indications
For the topical treatment of sub-acute and chronic psoriasis, including psoriasis of the scalp and flexures.
4.2. Posology and method of administration
For adults, children and the elderly Apply to the affected area once or twice daily, or as recommended by the physician. Wash hands after use.
4.3. Contraindications
Not to be used for acute, sore or pustular psoriasis or in the presence of infection. Not to be used in cases of sensitivity to any of the ingredients.
4.4. Special warnings and precautions for use
Keep away from the eyes, mucous membranes, genital or rectal areas. Avoid cuts and grazes or infected skin. Propylene glycol may cause skin irritation. Replace cap after use. Avoid spillage. Instruct patients ...
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
No special precautions.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Local side-effects do not normally occur. In rare cases of skin irritation, acne-like eruptions or photosensitivity, discontinue treatment. Rarely, Psoriderm Cream may stain skin, hair or fabric. Reporting ...
4.9. Overdose
There are no known toxic effects resulting from excessive use of Psoriderm Cream.
5.1. Pharmacodynamic properties
Coal tar has been used dermatologically for hundreds of years and has been shown to be safe and effective in the treatment of scaly scalp conditions such as psoriasis. The British Pharmacopoeia contains ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6.1. List of excipients
Lecithin Stearic acid Isopropyl palmitate Propylene glycol (E1520) Trolamine Phenoxyethanol Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months in unopened container.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
225 ml amber glass JAR with black bakelite SCREWCAP incorporating a Steran liner. This is supplied as an original pack (OP).
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts SG4 7QR, UK
8. Marketing authorization number(s)
PL 00173/5000R
9. Date of first authorization / renewal of the authorization
18 September 1990 / 16 February 2006
10. Date of revision of the text
27/01/2020
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