Land: Zuid-Afrika
Taal: Engels
Bron: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
TABLET
EACH TABLET CONTAINS ORPHENADRINE CITRATE 35,0 mg PARACETAMOL 450,0 mg
Registered
2001-09-08
ADCOCK INGRAM LTD UNIFLEX EACH TABLET CONTAINS PARACETAMOL 450 MG AND ORPHENADRINE CITRATE 35 MG Date of approval: 16 February 2024 M.D.T Page 1 of 10 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: UNIFLEX, EACH TABLET CONTAINS: PARACETAMOL 450 MG ORPHENADRINE CITRATE 35 MG SUGAR FREE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. UNIFLEX is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use UNIFLEX carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share UNIFLEX with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve after 10 days. WHAT IS IN THIS LEAFLET: 1. What UNIFLEX is and what it is used for 2. What you need to know before you take UNIFLEX 3. How to take UNIFLEX 4. Possible side effects 5. How to store UNIFLEX 6. Contents of the pack and other information S2 ADCOCK INGRAM LTD UNIFLEX EACH TABLET CONTAINS PARACETAMOL 450 MG AND ORPHENADRINE CITRATE 35 MG Date of approval: 16 February 2024 M.D.T Page 2 of 10 1. WHAT UNIFLEX IS AND WHAT IT IS USED FOR UNIFLEX contains paracetamol 450 mg and orphenadrine citrate 35 mg, which belongs to a group of medicine referred to as analgesic combinations. UNIFLEX is used for generalised pain and the relief of muscle spasm associated with acute painful musculo-skeletal conditions. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE UNIFLEX TABLETS DO NOT TAKE UNIFLEX If you are hypersensitive (allergic) to paracetamol and orphenadrine or any of the other ingredients of UNIFLEX (listed in section 6) If you suffer from the following: • severe liver function • enlarged prostate • achalasia (a failure of smooth muscle fibres to relax, which can cause the lower oesophageal sphincter to remain closed) • bladder neck obstruction • glaucoma (a condition in which the pressure of fluid in the eye is high. Lees het volledige document
ADCOCK INGRAM LTD UNIFLEX EACH TABLET CONTAINS PARACETAMOL 450 MG AND ORPHENADRINE CITRATE 35 MG Date of approval: 16 February 2024 M.D.T Page 1 of 12 PROFESSIONAL INFORMATION SCHEDULING STATUS: 1. NAME OF THE MEDICINE UNIFLEX 450 MG / 35 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains: Paracetamol 450 mg Orphenadrine citrate 35 mg Sugar free. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White, circular, biconvex tablets with a break bar on one face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS UNIFLEX tablets are indicated for generalized pain and the relief of muscle spasm associated with acute painful musculo-skeletal conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults: 2 tablets 3 times a day. DO NOT EXCEED THE RECOMMENDED DOSAGE S2 ADCOCK INGRAM LTD UNIFLEX EACH TABLET CONTAINS PARACETAMOL 450 MG AND ORPHENADRINE CITRATE 35 MG Date of approval: 16 February 2024 M.D.T Page 2 of 12 METHOD OF ADMINISTRATION Oral. 4.3. CONTRAINDICATIONS: Hypersensitivity to any of the ingredients. Severe liver function impairment. Prostatic enlargement, achalasia, bladder neck obstruction, glaucoma, myasthenia gravis, peptic ulcer or stenosing and pyloric or duodenal obstruction. Patients with porphyria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Dosages in excess of those recommended may cause severe liver damage. • Patients suffering from liver or kidney disease should take UNIFLEX under medical supervision. • Caution is recommended in patients on other central nervous system depression- producing medication as well as patients on anticholinergics or medication with anticholinergic properties. • Use with caution in patients with cardiac disease or arrhythmias, especially tachycardia. • Do not use continuously for more than 10 days without consulting your doctor. ADCOCK INGRAM LTD UNIFLEX EACH TABLET CONTAINS PARACETAMOL 450 MG AND ORPHENADRINE CITRATE 35 MG Date of approval: 16 February 2024 M.D.T Page 3 of 12 • Severe cutane Lees het volledige document