Available composition

 

V-TRAM-50

Each hard gelatin capsule contains: Tramadol hydrochloride 50 mg

PHARMACOLOGICAL CLASSIFICATION:

Analgesic

MECHANISM OF ACTION

Tramadol and its O-desmethyl metabolite (M1) are selective, weak OP3-receptor agonists. Opiate receptors are coupled with G-protein receptors and function as both positive and negative regulators of synaptic transmission via G-proteins that activate effector proteins. As the effector system is adenylate cyclase and cAMP located at the inner surface of the plasma membrane, opioids decrease intracellular cAMP by inhibiting adenylate cyclase. Subsequently, the release of nociceptive neurotransmitters such as substance P, GABA, dopamine, acetylcholine and noradrenaline is inhibited. The analgesic properties of Tramadol can be attributed to norepinephrine and serotonin reuptake blockade in the CNS, which inhibits pain transmission in the spinal cord.

PHARMACOKINETICS

Tramadol is readily absorbed following oral administration but is subjected to first pass metabolism. Tramadol is metabolized by N-and o-demethylation and glucronidation or sulfation in the liver. The metabolite o-desmethylationis pharmacologically active. Tramadol is excreted mainly in the urine predominantly as metabolites. Tramadol is widely distributed, crosses in placenta, and appear in small amount in breast milk. The elimination half life following oral administration is about 6 hours.

Tramadol hydrochloride is an opioid analgesic. It also has noradrenergic and serotonergic properties that may contribute to its analgesic activity. Tramadol is used for moderate to severe pain.

Paient information:

The name of your medicine is V-TRAM-50. Before taking V-TRAM-50, please read this leaflet carefully. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same

known hypersensitivity to tramadol or any excipients acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs patients who are taking MAO inhibitors or who have taken them within the last 14 days Known hypersensitivity to opioids. Patients with unrolled epilepsy or epilepsy not adequately controlled by treatment. If you are pregnant or if you are breast-feeding. If you have severe kidney disease.

You should avoid alcohol during treatment with V-TRAM-50

Do not drive or operate any tools or machines may make you drowsy or dizzy Taking other medicinesPlease inform your doctor or pharmacist

Please inform your doctor or pharmacist. Some medicines may interfere with V-TRAM-50. These include:Carbamazepine, coumarin derivatives, serotonin reuptake inhibitors, tricyclic anti-depressants, quinidine, phenothiazines or anti-psychotics, some antibiotics. How to take V-TRAM-50You should usually swallow one capsule twice a day every morning and evening. Swallow the capsule whole, not divided or chewed, with sufficient liquid, before, with, or after food.The recommended dosage of V-TRAM-50 is either:Two V-TRAM- 50 mg capsule(s) twice a day (morning and evening). Do not take more than eight of the 50 mg capsules per day.

If you forget to take a dose, it is important to take another as soon as possible. Then go on as before.

In case of over dose do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department.

Serotonin Syndrome may result from interaction of tramadol with other medicines which increase serotonin effects, for example, the SSRI antidepressants. skin rash (red spots or patches), itching hives, skin lumps,swelling or puffiness of the eyelids, face or lips,chest tightness, wheezing or pain in the chest,heart palpitations, faintness or collapse,hallucinations,convulsions.

Keep V-TRAM-50 capsules where children cannot reach or see them. Keep in a cool, dry place. Do not store above 30°C.Do not use your capsules after the expiry date printed on the pack.