Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
Mibe Pharma UK Ltd
M02AA15
Diclofenac sodium
30mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13080100; GTIN: 5060608410019
MIBE PHARMA UK LTD PACKAGE LEAFLET: INFORMATION FOR THE USER SOLACUTAN ® 3% GEL diclofenac sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT SOLACUTAN GEL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLACUTAN GEL 3. HOW TO USE SOLACUTAN GEL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SOLACUTAN GEL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SOLACUTAN GEL IS AND WHAT IT IS USED FOR Solacutan gel is a non-steroidal antiinflammatory dermatological gel. Solacutan gel is applied to the skin to treat a skin problem known as actinic or solar keratosis that is caused by long-term extensive sun exposure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLACUTAN GEL DO NOT USE SOLACUTAN GEL • if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6). • if you have ever experienced an allergic reaction such as skin rash (nettle rash), breathing problems (wheezing) or runny nose (allergic rhinitis) after taking aspirin or any other non- steroidal anti-inflammatory medicinal products. • if you are in the final 3 months of your pregnan- cy. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Solacutan gel. • The possibility of systemic adverse reactions following application of Solacutan gel cannot be excluded when the medicinal product is used on large areas of skin and for a prolonged period of time. Consult your doctor if you: – have, or have had in the past, a stomach ulcer or bleeding from the Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SOLACUTAN 3% GEL 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of gel contains 30 mg diclofenac sodium. Excipient with known effect: Each gram of gel contains 15 mg benzyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel Clear, transparent, colourless to yellowish 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of actinic keratoses (AKs). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: Solacutan gel should be applied to the affected skin areas twice daily and smoothed into the skin gently. The amount used depends on the size of the area to be treated. Usually 0.5 g of gel (about the size of a pea) is applied to a 5x5 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 treatment is 60 to 90 days. Maximum effect has been observed with treatment durations at the upper end of this time range. Complete healing of the lesion(s) or optimal therapeutic effect may not be seen for up to 30 days after completion of therapy. Elderly people: The normal dosage can be used. Children and adolescent: AK is a condition not generally seen within the paediatric population and was not studied. Therefore, dosage recommendations and indications for the use ofhave not been established for use in children and adolescent. Method of administration Cutaneous use 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Because of the potential for cross-reactions, the gel should not be used in patients who have experienced hypersensitivity reactions such as symptoms as asthma, allergic rhinitis or urticaria to 2-acetoxybenzoic acid (acetylsalicylic acid) or any other non-steroidal anti-inflammatory medicinal products (NSAIDs). The use of Solacutan gel is contraindicated in the third trimester of pregnancy (see section 4.6). 4.4 SPE Διαβάστε το πλήρες έγγραφο