Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Pinewood Laboratories Ltd
M01AB; M01AB05
Diclofenac sodium
75 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances; diclofenac
Not marketed
1999-05-27
PATIENT INFORMATION LEAFLET DICLO 75 MG PROLONGED RELEASE TABLETS DICLOFENAC SODIUM 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Diclo tablets are and what they are used for 2. What you need to know before you take Diclo tablets 3. How to take Diclo tablets 4. Possible side effects 5. How to store Diclo tablets 6. Contents of the pack and other information 1. WHAT DICLO TABLETS ARE AND WHAT THEY ARE USED FOR Diclo tablets contain the active ingredient diclofenac sodium which is a non-steroidal anti- inflammatory drug (NSAID). It is used for the treatment of severe pain and inflammation of the following conditions: • osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (characterised by painful and stiff joints), spondylarthritis, psoriatic arthropathy, painful syndrome of the vertebral column, non-articular rheumatism • acute gout • frozen shoulder, back pain, tendonitis, bursitis (inflammation of the joints, commonly the knees and elbows) • bone fractures, sprains, strains, dislocations, dental or other minor surgery • painful menstruation (period pain). These tablets are prolonged-release which means they are designed to deliver a dose of a medication over an extended period. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLO TABLETS DO NOT TAKE DICLO TABLETS IF YOU: • are allergic to diclofenac sodium or any of the other ingredients of this medicine ( _listed in section 6 _ _and end of Section 2_ ) • are allergic to aspirin or any other NSAIDs (e.g. ibuprofen), seen as a red skin rash, wheezing, as Perskaitykite visą dokumentą
Health Products Regulatory Authority 02 December 2022 CRN00D6GP Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclo 75mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of Diclofenac Sodium in a prolonged release formulation. Excipients: each tablet contains lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Round, flat, two-layered pink and white coloured, prolonged release tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, psoriatic arthropathy, painful syndrome of the vertebral column, non-articular rheumatism - Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendonitis, tenosynovitis, bursitis; - Other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery; - Post-traumatic and post-operative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery. - Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis and menorrhagia. - Acute gout 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). For oral administration. The tablets should be swallowed whole with liquid, preferably with meals and must not be divided or chewed. Adults: The recommended initial daily dose is one or two tablets daily. The recommended maximum dose is 150mg. In milder cases, as well as for long-term therapy, 75mg is usually sufficient. Where the symptoms are most pronounced during the night or in the morning, Diclo 75mg prolonged release tablets should preferably be taken in the evening. _Elderly (patients aged 65 or above): _Although the pharmacokineti Perskaitykite visą dokumentą