Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tramadol hydrochloride
Advanz Pharma
N02AX02
Tramadol hydrochloride
150mg
Modified-release tablet
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Caution - AMP level prescribing advised
BNF: 04070200; GTIN: 5021730020644
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 Tramulief SR is and what it is used for 2. What you need to know before you take Tramulief SR 3. How to take Tramulief SR Tablets 4. Possible side effects 5. How to store Tramulief SR 6. Contents of the pack and other information 1. WHAT TRAMULIEF SR IS AND WHAT IT IS USED FOR Tramadol, the active substance in Tramulief SR, is a pain killer belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the brain and spinal cord. Tramulief SR is used for the treatment of moderate to severe pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMULIEF SR DO NOT TAKE TRAMULIEF SR: - if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6); - in acute poisoning with alcohol, sleeping pills, pain relievers, or other psychotropic medicines (medicines that affect mood and emotions); - if you are also taking monoamine oxidase inhibitors (MAOIs) (certain medicines used for the treatment of depression) or have taken them in the last 14 days before treatment with Tramulief SR (see “Other medicines and Tramulief SR”); - if you are an epileptic and your fits are not adequately controlled by treatment; - as a substitute in drug withdrawal. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tramulief SR if: - you think that you are addicted to other pain relievers (opioids); - you suffer from consciousness disorders (i Read the complete document
OBJECT 1 TRAMULIEF SR 150MG TABLETS Summary of Product Characteristics Updated 26-Jul-2018 | ADVANZ Pharma • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Tramulief SR 150 mg prolonged-release tablets 2. Qualitative and quantitative composition One prolonged-release tablet contains 150 mg tramadol hydrochloride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet. Tramulief SR 150 mg prolonged-release tablets are off white, capsule shaped tablets, 14.3 mm long. 4. Clinical particulars 4.1 Therapeutic indications Treatment of moderate to severe pain. 4.2 Posology and method of administration Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. Unless otherwise prescribed, Tramulief SR prolonged-release tablets should be given as follows: Adults and adolescents older than 12 years: The usual initial Read the complete document