Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Diclofenac epolamine
IBSA Farmaceutici Italia S.r.l
M02AA15
Diclofenac epolamine
Medicated plaster
diclofenac
Not marketed
2022-10-28
PACKAGE LEAFLET: INFORMATION FOR THE USER DICLOFENAC 140 MG MEDICATED PLASTER diclofenac sodium (as diclofenac epolamine) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Diclofenac 140 mg Medicated Plaster is and what it is used for 2. What you need to know before you use Diclofenac 140 mg Medicated Plaster 3. How to use Diclofenac 140 mg Medicated Plaster 4. Possible side effects 5. How to store Diclofenac 140 mg Medicated Plaster 6. Contents of the pack and other information 1. WHAT DICLOFENAC 140 MG MEDICATED PLASTER IS AND WHAT IT IS USED FOR Diclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. Diclofenac 140 mg medicated plaster is used to relieve the pain and inflammation of tennis elbow, golfer’s elbow and a sprained ankle in adolescents from 16 years of age and adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOFENAC 140 MG MEDICATED PLASTER DO NOT USE DICLOFENAC 140 MG MEDICATED PLASTER: • if you are allergic to diclofenac, acetylsalicylic acid (aspirin) or any other NSAID • if you are allergic to any of the other ingredients of this medicine (listed in section 6) • if you have asthma, breathing problems, skin rash or a runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs • if you are entering or are already beyond your 6 th month of pregnancy • if you currently have a stomach ulcer (peptic ulcer) • if you have any damaged skin including weeping or infected areas, eczema, bur Lue koko asiakirja
Health Products Regulatory Authority 13 January 2023 CRN00DCQQ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac 140 mg medicated plaster 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 140 cm 2 (10 cm x 14 cm) of medicated plaster contains a total of 180 mg of diclofenac epolamine corresponding to 140 mg of diclofenac sodium (1% w/w). Excipients with known effect: methyl parahydroxybenzoate (E218): 14 mg propyl parahydroxybenzoate (E216): 7 mg propylene glycol: 420 mg Dalin PH perfume containing amyl cinnamal, amylcinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamal, cinnamyl alcohol, citronellol, d‐Limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptine carbonate Referred to amount per plaster. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated plaster. White to pale yellow paste spread as a uniform layer onto unwoven support. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local symptomatic treatment of pain in epicondylitis and ankle sprain in adolescents from 16 years of age and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cutaneous use only _Posology_ Adults and adolescents 16 years and older Symptomatic treatment of ankle sprains: 1 application a day Symptomatic treatment of epicondylitis: 1 application morning and evening. _Duration of administration_ Diclofenac is to be used for as short as possible depending on the indication: Symptomatic treatment of ankle sprains: 3 days Symptomatic treatment of epicondylitis: max. 14 days. If there is no improvement, during the recommended duration of treatment or symptoms worsen, a doctor should be consulted. _Elderly_ This medication should be used with caution in elderly patients who are more prone to adverse events. See also Section 4.4. _Children and adolescents below 16 years_ There are insufficient data on efficacy and safety available for children and adolescents below 16 years Lue koko asiakirja