البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
Diclofenac sodium
A Menarini Australia Pty Ltd
Medicine Registered
_Solaraze 3% Consumer Medicine Information _ SOLARAZE 3% GEL _DICLOFENAC SODIUM _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Solaraze. It does not contain all available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using Solaraze against the benefit it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT SOLARAZE IS USED FOR The name of your medicine is Solaraze. It contains the active ingredient diclofenac sodium. Diclofenac sodium belongs to a group called non-steroidal anti-inflammatory drugs (NSAIDs). Solaraze is used to manage the skin condition known as actinic or solar keratosis. BEFORE YOU USE SOLARAZE _WHEN YOU MUST NOT USE IT _ DO NOT USE SOLARAZE IF: • You are allergic to diclofenac sodium or any of the inactive ingredients listed at the end of this leaflet. • You are allergic to Aspirin or any other NSAID medicine. Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath, swelling of the face, lips or tongue, hives, itching or skin rash, fainting. • You are in the last trimester of pregnancy. • The tamper seal is broken. • The expiry date printed on the carton is passed. IF YOU ARE NOT SURE WHETHER YOU SHOULD START USING SOLARAZE, CONTACT YOUR DOCTOR. 1 _Solaraze 3% Consumer Medicine Information _ _BEFORE YOU START TO USE IT _ TELL YOUR DOCTOR OR PHARMACIST IF: • You have any allergies to any other اقرأ الوثيقة كاملة
SOLARAZE 3% GEL (DICLOFENAC SODIUM) NAME OF THE MEDICINE Solaraze (diclofenac sodium) Gel 3% contains the active ingredient, diclofenac sodium, in a clear, transparent, colourless to slightly yellow gel base. The chemical name for diclofenac sodium is: Sodium [o-(2,6-dichloranilino)phenyl]acetate Molecular weight: 318.13 CAS number: CAS-15307-79-6 DESCRIPTION Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in acetone, and partially insoluble in ether. _Active. _Diclofenac sodium _Inactive. _Sodium hyaluronate, benzyl alcohol, polyethylene glycol monomethyl ether (350) and purified water. PHARMACOLOGY Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in actinic keratoses is not known but may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E 2 (PGE 2 ) synthesis. Efficacy of the treatment has only been demonstrated in placebo-controlled studies. Comparative studies with topical 5-fluorouracil have not been conducted. The long term beneficial effects of Solaraze has not been proven. PHARMACOKINETICS Absorption: When Solaraze is applied topically, diclofenac is absorbed into the epidermis. In a study in patients with compromised skin (mainly atopic dermatitis and other dermatitic conditions) of the hands, arms or face, approximately 10% of the applied dose (2 grams of 3% gel over 100 cm 2 ) of diclofenac was absorbed systemically in both normal and compromised epidermis after seven days, with four times daily applications. After topical application of 2 g Solaraze three times daily for six days to the calf of the leg in healthy subjects, diclofenac could be detected in اقرأ الوثيقة كاملة