Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRAMADOL HYDROCHLORIDE
APEX PHARMACY MARKETING SDN. BHD.
TRAMADOL HYDROCHLORIDE
100Capsule Capsules
DELORBIS PHARMACEUTICALS LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ TRAMOX CAPSULE Tramadol hydrochloride 50mg 1 WHAT IS IN THIS LEAFLET: 1. What Tramox capsule is used for 2. How Tramox capsule works 3. Before you use Tramox capsule 4. How to use Tramox capsule 5. While you are using it 6. Side effects 7. Storage and Disposal of Tramox capsule 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT TRAMOX CAPSULE IS USED FOR Tramadol hydrochloride is the active substance in Tramox capsule. It is a painkiller belonging to the class of opioids that acts on the central nervous system (nervous system consisting of brain and spinal cord). Tramox capsule is used for the treatment of moderate to severe pain. HOW TRAMOX CAPSULE WORKS Tramox capsule relieves pain by acting on specific nerve cells of the spinal cord and brain. BEFORE YOU USE TRAMOX CAPSULE - _When you must not use it_ Do not take Tramox capsule if you have any of the following medical conditions: • if you are allergic (hypersensitive) to Tramadol hydrochloride or any of the other ingredients of Tramox capsule • 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 treatment of depression) or have taken them in the last 14 days before treatment with Tramox capsule (see “ _Taking other _ _medicines_ ”); Do not take Tramox if: ‐ you are less than 12 years old ‐ you have slow or shallow breathing, or other breathing problems ‐ you are pregnant ‐ you are breastfeeding - _Before you start to use it _ Tell your doctor or pharmacist: • if you think that you are addicted to other pain relievers (opioids); • if you suffer from consciousness disorders (if you feel that you are going to faint); • if you are in a state of shock; • if you suffer from increased pressure in the brain (possibly after a head injury or brain disease Прочитајте комплетан документ
COMPOSITION Tramadol hydrochloride 50mg PRODUCT DESCRIPTION Buff, hard gelatine capsule, size 3, containing white to off-white granular powder. PHARMACODYNAMICS Tramadol hydrochloride is a centrally acting analgesic. It is non selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms which may contribute to its analgesic effect are inhibitor of neuronal reuptake of noradrenaline and enhancement of serotonin release. PHARMACOKINETICS After oral administration, tramadol is almost completely absorbed. Mean absolute bioavailability is approximately 70% following a single dose and increases to approximately 90% at steady state. Plasma protein binding of tramadol is approximately 20%. When C14 labelled tramadol was administered to humans, approximately 90% was excreted via the kidneys with the remaining 10% appearing in the faeces. Tramadol has a linear pharmacokinetic profile within the therapeutic dosage range. The half life of the terminal elimination phase (t½β) was 6.0±1.5 h in young volunteers. Tramadol pharmacokinetics show little age dependence in volunteers up to the age of 75 years. In volunteers aged over 75 years, t½β was 7.0±1.6 h on oral administration. Following a single oral dose administration of tramadol 100mg as capsules or tablets to young healthy volunteers, plasma concentrations were detectable within approximately 15-45 minutes with a mean Cmax of 280 to 308 mcg/L and Tmax of 1.6 to 2h. Tramadol is metabolized by the cytochrome P450 iso-enzyme CYP2D6. It undergoes biotransformation to a number of metabolites mainly by means of N- and O-demethylation. O- desmethyl tramadol appears to be the most pharmacologically active metabolite, showing analgesic activity in rodents. As humans excrete a higher percentage of unchanged tramadol than animals it is believed that the contribution made by this metabolite to analgesic activity is likely to be less in humans than animals. In humans the plasma concentration of this metabolite is abo Прочитајте комплетан документ