देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Teva B.V.
M02AA15
Diclofenac sodium
1 percent weight/weight
Gel
diclofenac
Not marketed
2020-08-25
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Motusol Rx 1 % w/w Gel diclofenac (as diclofenac diethylamine) For adults and adolescents aged 14 years and over READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. 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. You must talk to a doctor if you do not feel better or if you feel worse after 3 - 5 days. WHAT IS IN THIS LEAFLET 1. What Motusol Rx 1 % w/w Gel is and what it is used for 2. What you need to know before you use Motusol Rx 1 % w/w Gel 3. How to use Motusol Rx 1 % w/w Gel 4. Possible side effects 5. How to store Motusol Rx 1 % w/w Gel 6. Contents of the pack and other information 1. WHAT MOTUSOL RX 1 % W/W GEL IS AND WHAT IT IS USED FOR Motusol Rx 1 % w/w Gel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Motusol Rx 1 % w/w Gel is indicated in adults and adolescents aged 14 years and over. FOR ADULTS For the symptomatic treatment of pain: - in acute strains, sprains or contusions following blunt traumas - of the soft tissues close to the joint (e.g. bursae, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of knee and finger joints; - in epicondylitis (inflammation of the tendon insertions in the area of the elbow, also called tennis elbow or golfer elbow); - in acute muscular pain, e.g in the back area. FOR ADOLESCENTS AGED 14 YEARS AND OVER For short-term treatment. For local, symptomatic treatment of pain in acute strains, sprains or contusions following blunt trauma. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOTUSOL RX 1 % W/W GEL D पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 10 June 2021 CRN00C3SK Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Motusol Rx 1 % w/w gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of gel contains diclofenac as 11.6 mg of diclofenac diethylamine corresponding to 10 mg of diclofenac sodium Excipient(s) with known effect 1 g of gel contains 50 mg propylene glycol (E1520) and 1 mg fragance (contains 0.15 mg/g benzyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geranoil, d-limonene and linalool). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel White to almost white, homogeneous gel 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FOR ADULTS For the local symptomatic treatment of pain: - of acute strains, sprains or contusions following blunt traumas - of the soft tissues close to the joint (e.g. bursae, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of knee and finger joints - in epicondylitis; - in acute muscular pain, e.g in the back area. FOR ADOLESCENTS AGED 14 YEARS AND OVER For short-term treatment. For local, symptomatic treatment of pain in acute strains, sprains or contusions following blunt trauma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents aged 14 years or older:_ Depending on the size of the affected site to be treated, a cherry to walnut-sized quantity, corresponding to 1-4 g of gel (11.6 - 46.4 mg diclofenac diethylamine, corresponding to 10-40 mg diclofenac sodium) should be applied 3-4 times daily. This is sufficient to treat of an area of 400‑800 cm 2 . The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium). The duration of use depends on the symptoms and the underlying disease. Motusol Rx 1 % w/w Gelshould not be used longer than 1 week without medical advice. If symptoms worsen or do not improve after 3 - 5 days, a doctor should be consulted. Special patient groups पूरा दस्तावेज़ पढ़ें