Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Astellas Pharma Co. Ltd
M02AA15
DICLOFENAC SODIUM
4 %w/w
Cutaneous Spray Solution
Product subject to prescription which may be renewed (B)
Antiinflammatory preparations, non-steroids for topical use
Authorised
2008-10-03
Difene Spray Gel 4% Vol.-1 1.3.1 1/5 PACKAGE LEAFLET: INFORMATION FOR THE USER DIFENE SPRAY GEL 4%W/W CUTANEOUS SPRAY, SOLUTION 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, please 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 Difene Spray Gel is and what it is used for 2. What you need to know before you use Difene Spray Gel 3. How to use Difene Spray Gel 4. Possible side effects 5. How to store Difene Spray Gel 6. Content of the pack and other information 1. WHAT DIFENE SPRAY GEL IS AND WHAT IT IS USED FOR Difene Spray Gel contains the active substance diclofenac sodium, which belongs to the group of non- steroidal anti-inflammatory drugs (NSAID). Difene Spray Gel is used to relieve the acute pain and swelling affecting small or medium-sized joints and surrounding tissues. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFENE SPRAY GEL DO NOT USE DIFENE SPRAY GEL If you are allergic (hypersensitive) to diclofenac sodium, peanut, soya or any of the other ingredients of Difene Spray Gel (listed in section 6). If you have ever had an allergic reaction to aspirin (acetylsalicylic acid) or any other NSAID such as ibuprofen with difficulty in breathing, skin rash and runny nose. In the last three months of pregnancy Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difene Spray Gel 4% w/w Cutaneous Spray, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1g of solution contains 40 mg of diclofenac sodium. Excipients with known effects: 150 mg propylene glycol (E1520) / gram solution 100 mg Soybean lecithin / gram solution For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray, solution. A golden-yellow, transparent solution, which turns to a gel-like consistency after administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Sufficient solution of Difene Spray Gel should be sprayed onto the skin of the affected site. Depending on the size of area to be treated 4-5 pump strokes (0.8-1.0 g of spray containing 32-40 mg of diclofenac sodium) should be applied 3 times daily in regular intervals. A maximum single dose of 1.0 g of the product should not be exceeded. The maximum daily dose is 15 pump strokes (3.0 g of spray containing 120 mg of diclofenac sodium). Difene Spray Gel should be massaged gently into the skin. After this the hands should be washed unless they are the site to be treated. After application some minutes for drying should be allowed before dressing or binding the treated area. The treatment may be discontinued when the symptoms (pain and swelling) have subsided. Treatment should not be continued beyond 7-8 days without review. The patient is requested to consult the doctor if no improvement is seen after 3 days. _Older people_ The posology is the same as for adults. _Paedi Baca dokumen lengkap