Land: Sydafrika
Språk: engelska
Källa: South African Health Products Regulatory Authority (SAHPRA)
Tramadol Hydrochloride & Paracetamol
Novagen Pharma (Pty) Ltd
See ingredients
TABLET
Each Film- coated Tablet contains: Tramadol Hydrochloride37,5 mg; Paracetamol 325,0 mg
Registered
2023-02-06
Page 1 of 11 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: MARTACET TRAMADOL HYDROCHLORIDE 37,5 MG AND PARACETAMOL 325 MG. SUGAR FREE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MARTACET. - KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. - IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR, PHARMACIST, NURSE OR OTHER HEALTHCARE PROVIDER. - MARTACET HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT SHARE YOUR MEDICINE WITH OTHER PEOPLE. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS. WHAT IS IN THIS LEAFLET: 1. What Martacet is and what it is used for 2. What you need to know before you use Martacet 3. How to use Martacet 4. Possible side effects 5. How to store Martacet 6. Contents of the pack and other information 1. WHAT MARTACET IS AND WHAT IT IS USED FOR Martacet contains tramadol and paracetamol. S5 Page 2 of 11 Tramadol is a painkiller belonging to the class of the opioids that acts on the central nervous system. It is used for the management of moderate to moderately severe pain. Paracetamol, the other active substance, has centrally acting analgesic effects. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MARTACET DO NOT TAKE MARTACET : • If you are allergic to tramadol, paracetamol, any of the other ingredients mentioned in section 6.1, or other opioids such as codeine. • If you are suffering from acute alcohol poisoning. • If you are taking sleeping pills, pain relievers or medicines that affect mood and emotions. • If you are also taking medicines such as tranylcypromine and moclobemide or have taken them in the last 14 days before treatment with Martacet which are used to treat depression. These medicines are used to treat depression and belong to a group called monoamine oxidase inhibitors (MAOIs). • If you have a severe liver disorder • Martacet must not be used for narcotic (an addictive substance) withdrawal treatment. • You should not take Martacet if you suffer from severe breathing problems. • You should not take Martacet if you are sufferin Läs hela dokumentet
Page 1 of 17 PROPOSED CLEAN PROFESSIONAL INFORMATION SCHEDULING STATUS S5 1. NAME OF THE MEDICINE Martacet 37,5 mg/ 325 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 37,5 mg tramadol hydrochloride and 325 mg paracetamol. Martacet is sugar free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Light yellow, oblong shaped biconvex film-coated tablets debossed with “I 03” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Martacet is indicated for the management of moderate to moderately severe pain in adults. Martacet is not recommended for minor pain that may be treated adequately through lesser means. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Page 2 of 17 POSOLOGY To be used in adults and children over 16 years of age. DO NOT EXCEED THE RECOMMENDED DOSE. ADULTS For the management of pain, the recommended dose of Martacet is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. As with all analgesic medicines, a titration period of several days with gradual dose increases at the initiation of Martacet therapy may be beneficial for some patients. Clinical studies with tramadol in patients with moderate to moderately severe chronic pain indicated that the tolerability of tramadol can be improved by starting at a lower dose with gradual upward titration to reach doses that provide sufficient pain relief. SPECIAL POPULATIONS RENAL IMPAIRMENT: For patients with creatinine clearance < 30 mL/min, the dosing interval of Martacet should be increased not to exceed 2 tablets every to 12 hours. METHOD OF ADMINISTRATION For Oral use Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed. 4.3 CONTRAINDICATIONS • Martacet is contraindicated in patients with a known hypersensitivity to tramadol, paracetamol, or any of the other ingredients mentioned in section 6.1 or other opioids such as codei Läs hela dokumentet