País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
Dowelhurst Ltd
M02AA15
Diclofenac sodium
30mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13080100
PACKAGE LEAFLET: INFORMATION FOR THE USER SOLARAZE TM 3%, GEL Diclofenac Sodium 3% w/w WHAT IS IN THIS LEAFLET 1. WHAT SOLARAZE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLARAZE 3. HOW TO USE SOLARAZE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SOLARAZE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SOLARAZE IS AND WHAT IT IS USED FOR Solaraze is a non-steroidal anti-inflammatory dermatological gel. When applied to the skin, Solaraze gel is used to treat a skin problem known as actinic or solar keratosis that is caused by long-term sun exposure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLARAZE DO NOT USE SOLARAZE • If you are allergic to diclofenac or any of the ingredients of this medicine (listed in section 6). • If you have had an allergic reaction such as skin rash (nettle rash), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory agents. • If you are in the final 3 months of your pregnancy. WARNINGS AND PRECAUTIONS • The possibility of systemic side effects from application of Solaraze cannot be excluded if the product is used on large areas of skin and over a prolonged period. Consult your doctor if: - you have, or have had in the past, a stomach ulcer or bleeding from the stomach. - you have heart, liver or kidney problems. - you have any type of bleeding disorder or bruise very easily. • Avoid sun exposure, including tanning salons, when using Solaraze. If skin reactions occur, discontinue use. • Do not apply to skin wounds, infected skin or dermatitis. • Do not allow Solaraze to come into contact with your eyes or the inside of your nose or mouth and do not swallow it. If Solaraze has accidentally been swallowed, consult a doctor immediately. • Discontinue Solaraze and consult your doctor if you develop a wide-spread skin rash. • After applying products containing diclofenac on the skin you can use a permeable (non-occlusive) bandage. Do not use an airtight occlusive dressing. Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solaraze TM 3%, gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 30 mg diclofenac sodium (3% w/w). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel A clear, transparent, colourless or pale yellow gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of actinic keratosis (AK). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _USE IN ADULTS: _Solaraze is applied locally to the affected area twice daily, with the gel smoothed into the skin gently. The amount needed depends on the size of the affected area. Normally 0.5 grams (the size of a pea) of the gel is used on a 5 cm x 5 cm lesion site. The maximum daily amount of 8 grams of product allows simultaneous treatment of up to 200 cm² skin surface area. The usual duration of therapy is from 60 to 90 days. Maximum efficacy has been observed with treatment duration towards the upper end of this range. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. _ _ _USE IN THE ELDERLY:_ The usual adult dose may be used. _PAEDIATRIC POPULATION:_ AK is a condition not generally seen within the paediatric population and was not studied. Therefore, dosage recommendations and indications for the use of Solaraze have not been established for use in children. 4.3 CONTRAINDICATIONS Solaraze is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, macrogol monomethyl ether 350 and/ or sodium hyaluronate. Because of cross-reactions, the gel should not be used by patients who have experienced hypersensitivity reactions such as symptoms of asthma, allergic rhinitis or urticaria, to acetylsalicylic acid or other non-steroidal anti- inflammatory agents. The use of Solaraze is contraindicated during the third trimester of pregnancy (see Section 4.6). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The likelihood of systemic side effects occurring following t Leer el documento completo