Страна: Малта
Език: английски
Източник: Medicines Authority
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th Km National Road Athens - Lamia 1, GR-145 64 Kifissia, Greece
M03BC51
ORPHENADRINE CITRATE 35 mg PARACETAMOL 450 mg
TABLET
ORPHENADRINE CITRATE 35 mg PARACETAMOL 450 mg
POM
MUSCLE RELAXANTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-05-25
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER UNIGESIC (35+450) MG/TAB TABLETS orphenadrine citrate and paracetamol 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 Unigesic is and what it is used for 2. What you need to know before you take Unigesic 3. How to take Unigesic 4. Possible side effects 5. How to store Unigesic 6. Contents of the pack and other information 1. WHAT UNIGESIC IS AND WHAT IT IS USED FOR Unigesic contains orphenadrine citrate that is a muscle relaxant and paracetamol that is an analgesic. Unigesic is used for: - Painful muscle disorders after injuries. - Muscle contractions caused by sudden movements of the body. - Sprains. - Extra-articular rheumatism accompanied by muscle spasm (inflammation of the connective tissues (fibrositis), inflammation of the muscles (myositis) and muscle pain (myalgia)). - Acute or chronic pain in the back (lumbar region). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE UNIGESIC DO NOT TAKE UNIGESIC - if you are allergic to orphenadrine citrate or paracetamol or any of the other ingredients of this medicine (listed in section 6). - if you have glaucoma. - if you have urinary retention e.g. prostatic hyperplasia or bladder obstruction. - if you suffer from a disease that causes muscle weakness (severe myasthenia (myasthenia Gravis)). - if you suffer from liver and kidney failure. - if you have stomach and bowel obstruction. - if you are breast-feeding. Unigesic is contraindicated in children under 12 years of age. WARNINGS AND PRECAUTIONS Talk t Прочетете целия документ
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Unigesic (35 + 450) mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 35 mg of orphenadrine citrate and 450 mg of paracetamol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets White, standard convex bisect two-layer tablets with a diameter of 12.0 mm ± 0.6%. The tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Unigesic is indicated for: • Painful post-traumatic muscle syndromes. • Muscle contractions caused by sudden body movements. • Sprains. • Extra-articular rheumatism accompanied by muscle spasm (fibrositis, myositis, myalgia). • Acute or chronic low back pain (lumbago). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ 1-2 tablets 3 times daily or as determined depending on the patient’s condition. _Elderly _ The dose in patients over 65 years of age should not exceed 3 tablets daily (105 mg orphenadrine citrate daily). The usual dose is ½-1 tablet 3 times daily (see section 4.4). _Paediatric population _ No data available. The safety and efficacy of Unigesic in children 0 to 12 years of age have not yet been established. Treatment duration The duration of treatment will generally vary to a maximum of 10 days, depending on the patient’s condition. Page 2 of 9 Method of administration The tablets can be divided into two equal doses. The tablets should be swallowed with a glass of water. The tablets can be taken with or without food. 4.3. CONTRAINDICATIONS Unigesic is contraindicated in: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Glaucoma, urinary retention (e.g. prostatic hyperplasia or bladder neck obstruction), severe myasthenia (myasthenia Gravis) or gastrointestinal obstruction, e.g. pyloric and duodenal stenosis, stenosing peptic ulcer, megaesophagus, due to the parasympatholytic action of orphenadrine. • Severe hepatic and severe renal i Прочетете целия документ