Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Teva B.V.
M02AA15
Diclofenac sodium
2 percent weight/weight
Gel
diclofenac
Marketed
2020-08-25
PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOTUSOL TM MAX 2 % W/W GEL diclofenac sodium 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 Max is and what it is used for 2. What you need to know before you use Motusol Max 3. How to use Motusol Max 4. Possible side effects 5. How to store Motusol Max 6. Contents of the pack and other information 1. WHAT MOTUSOL MAX IS AND WHAT IT IS USED FOR Motusol Max contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Motusol Max is indicated in adults and adolescents aged 14 years and over. FOR ADULTS AND ADOLESCENTS AGED 14 YEARS AND OVER For the local symptomatic treatment of pain in acutestrains, sprains or contusions following blunt trauma For adolescents aged 14 years and over the medicine is intended for short term treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOTUSOL MAX DO NOT USE MOTUSOL MAX: • if you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6. • if you have ever developed breathing problems (asthma, bronchospasm), hives, runny nose, or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal anti-inflammatory drugs (e.g. ibuprofen); • on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes; • in the Leggi il documento completo
Health Products Regulatory Authority 10 June 2021 CRN00C3SK Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Motusol Max 2 % w/w gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of gel contains diclofenac as 23.2 mg diclofenac diethylamine corresponding to 20 mg of diclofenac sodium. Excipient(s) with known effect 1 g of gel contains 54 mg of propylene glycol (E1520), 0.2 mg butylhydroxytoluene (E321) and 1 mg fragrance (contains 0.15 mg/g benzyl alchohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, 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 AND ADOLESCENTS AGED 14 YEARS AND OVER For local symptomatic treatment of pain in acute strains, sprains or contusions following blunt trauma. For adolescents aged 14 years and over the medicinal product is intended for short term treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents aged 14 years and over:_ Motusol Max 2 % w/w Gel is used 2 times a day (preferably morning and evening). Depending on the size of the affected site to be treated, cherry to walnut size quantity is required, corresponding to 1 -4 g of gel (23.2 - 92.8 mg diclofenac, diethylamine salt) corresponding to 20‑80 mg diclofenac sodium This is sufficient to treat of an area of 400 – 800 cm 2 . The maximum daily dose is 8 g of gel corresponding to 185.6 mg of diclofenac, diethylamine (corresponding to 160 mg diclofenac sodium). The duration of use depends on the symptoms and the underlying disease. Motusol Max 2 % w/w Gel should 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 _Elderly patients_: No special dose adjustment is required. Because of the potential undesirable effect profile, elderly people should be carefully monitored. _Patient with renal impair Leggi il documento completo