Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
Stephar (U.K.) Ltd
M01AB05
Diclofenac sodium
100mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
VOLTAROL ® SUPPOSITORIES 12.5, 25, 50 AND 100 MG (DICLOFENAC SODIUM) PATIENT INFORMATION LEAFLET WHAT YOU NEED TO KNOW ABOUT VOLTAROL SUPPOSITORIES Your doctor has decided that you need this medicine to help treat your condition. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE THESE SUPPOSITORIES. IT CONTAINS IMPORTANT INFORMATION. Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist. This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Voltarol Suppositories are, and what they are used for 2. Things to consider before you start to use Voltarol Suppositories 3. How to use Voltarol Suppositories 4. Possible side effects 5. How to store Voltarol Suppositories 6. Further information 1. WHAT VOLTAROL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Diclofenac sodium, the active ingredient in Voltarol Suppositories, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. • Voltarol Suppositories relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including: – Rheumatoid arthritis, osteoarthritis, acute gout, ankylosing spondylitis – Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures – Tendonitis, tenosynovitis, bursitis. • They are also used to treat pain and inflammation associated with dental and minor surgery. • In children aged 1 to 12 Voltarol Suppositories 12.5 and 25 mg are used to treat juvenile chronic arthritis. • In children aged over 6 they can also be used alone, or in combination with other painki Baca dokumen lengkapnya
1. NAME OF THE MEDICINAL PRODUCT Voltarol ® Suppositories 100mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium). Each suppository contains 100mg diclofenac sodium Ph.Eur. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppositories. 4. CLINICAL PARTICULARS _ _ 4.1 THERAPEUTIC INDICATIONS _ _ _Adults and Elderly_: Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis, (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery._ _ _ _ _Children_: Not indicated. 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 Special warnings and precautions for use). Not to be taken by mouth, as per rectal administration only. The suppositories should be inserted well into the rectum. It is recommended to insert the suppositories after passing stools. ADULTS: 75-150mg daily, in divided doses. 100mg suppositories may also be given as a once daily treatment, usually at night. Where necessary, therapy may be combined with 25mg or 50mg tablets or suppositories up to the maximum dose of 150mg per day. SPECIAL POPULATIONS ELDERLY Although the pharmacokinetics of Voltarol are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also se Baca dokumen lengkapnya