INSTRUCTION
for usage of medicinal product
TRAMALGIN (Tramalginum)

Main characteristic: International and chemical name: Tramadol; (_) - trans-2- [(dimethylamino) methyl]-1-(3-metoxyphenyl) cyclogexanole hydrochloride;
main physical-chemical properties: solid gelatinous capsules with green opaque lid and whit opaque corps. Content of capsules - powder of white colour.
Content: tramadol hydrochloride - 0,05 g
excipients (magnesium stearate, milk sugar) - enough for achieving of tablet with the mass of capsule's content- 0,3 g
Form of output: Capsules
Pharmacological group: Analgesic of central action.
Pharmacological properties: Tramalgin is an analgesic medicinal product of central action. It influences to opioidal receptors of CNS and decreases pain sensitivity. Analgesic effect develops in 15 - 30 min after administration of the medicine inside and lasts till 5 hours. Tramalgin also has some sedative and anti-coughing effect.
Pharmacokinetics: After administration inside Tramadol is quickly and almost fully absorbed from alimentary canal. Maximal concentration in blood plasma is achieved in 2 hours after administration inside. It is excreted with urine (90) and excrement (10).
Indications for administration: Capsule of "Tramalgin" is used in case acute and chronic ache of strong and average intensity of different etiology: before and after operation periods, trauma, burns, tumor disease, infarct of myocardium, bout of kidney's and bilious' colic, acute pancreatitis, neuralgia, in case of carrying of painful therapeutic and diagnostics procedure and etc.
Way of administration and dosage: Dose for adults and children over 14 - one capsule (50 mg of tramalgin) per each administration with small amount of liquid. In case of absence of satisfactiry effect receiving of this dose can be repeated in 30-60 min. Maximal dose per twenty-four-hours period - 400 mg (8 receiving per twenty-four-hours period). In order to avoid accustoming to tramalgin do not use the drug lingering way.
Side effects: Tramalgin is endured good enough not causing in therapeutic doses depressed breath, not influencing greatly on blood circulation and alimentary canal. Some patients might have high perspiration, dizziness, heavy head, avidity in mouth, sickness, vomit, tiredness, drowsiness, confused conscious, mioz. High arterial pressure could be reduced.
Contraindications: Pregnancy, women's lactation period, age before 14, increased individual sensitivity to narcotic analgesics and tramadol increased, acute alcohol intoxication.
Interaction with other drugs: Tramadol shouldn't be prescribed to patients, who use inhibitors Mono Amin Oxidasum. In simultaneous using medicines, influencing on central nervous system (tranquilizers, antidepressants, sedative and soporific remedies) synergic effect as increasing of analgesic and sedative action is possible.
Overdose: Convulsions, depressing of breath. Naloxon is the specific antidote.
Particularities of administration: It should be carefully administrated under breach of function of kidneys and liver. Under prolonged administration the possibility of development of drug dependence is not excluded. During treatment the activity, requiring increased attention, acute psychical and motor reactions should be excluded.
Conditions and shelf-life: It is kept in dry place, away from direct sunlight, administration only by doctor's prescription. Shelf-life - 2 years.
Conditions of output: By prescription.
Packing: 6 or 12 capsules in contour cell packages. 30, 50 and 100 capsules in polymer containers.
Manufacturer: SC "Concern Stirol"
Address: 84610, Ukraine, Donetsk region, Gorlovka, Gorlovskoi divisii str., 10
Adress in Internet: http://pharm.stirol.net
E-mail:support