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Dosage form: & nbspcoated tablets
Composition:1 tablet coated film contains:
Active substances:
Propiphenazone 200,000 mg
Caffeine 80,000 mg
Camilophin Chloride 25,000 mg
Mekloxamine citrate 20,000 mg
Ergotamine Tartrate 0.750 mg
Excipients: corn starch, lactose monohydrate, crospovidop, talc, magnesium stearate, gelatin, silicon dioxide colloid, tartaric acid, iron dye oxide red, titanium dioxide, macrogol 6000, polyacrylate dispersion, polysorbate 80, carmellose sodium.
Description:The tablets covered with a shell of round form, biconvex, dark pink color.
Pharmacotherapeutic group:protivomigrenoznoe means.
ATX: & nbsp
  • Ergotamine in combination with other drugs, excluding psycholeptics
  • Pharmacodynamics:Combined drug, has anti-migraine, antispasmodic and analgesic effect.
    Ergotamine is an ergot alkaloid; is a partial agonist of serotonin receptors, indiscriminately blocks 5-HTIA-ID receptors. For ergotamine, alpha-adrenergic blocking activity is combined with a pronounced direct vasoconstrictor effect on the smooth musculature of peripheral and cerebral vessels. In this regard, against the background of the action of ergotamine, a tonic effect on the peripheral and cerebral vessels predominates, which is of therapeutic importance in the management of migraine attacks.
    Propiphenazone has analgesic effect.
    Caffeine accelerates the absorption of ergotamine and enhances its therapeutic effect. Also caffeine has a tonic effect on the cerebral vessels.
    Camilophin exerts an antispasmodic effect, eliminating the initial vasospasm in the prodromal phase of a migraine attack.
    Meloxamine has anticholinergic, antihistaminic, moderately sedative and antiemetic effects.
    Pharmacokinetics:After ingestion, ergotamine is absorbed to a small extent from the gastrointestinal tract. Bioavailability is low due to intensive metabolism in the "primary passage" through the liver. The main metabolites are secreted through the intestines with bile. About 4% is excreted by the kidneys unchanged. The excretion of ergotamine is biphasic. The half-life (T1 / 2) in the final phase is 21 hours. Caffeine well absorbed in the intestine (including fat). T1 / 2 is about 5 hours. About 10% is excreted by the kidneys unchanged.
    After ingestion, about 25% of propiphenazone is metabolized by "primary passage" through the liver, the volume of distribution is 0.4 l / kg, the maximum concentration in the blood plasma is reached within 30-40 minutes, the maximum effect in 90 minutes, T1 / 2 - from 2,1 -2,4 hours, is excreted by the kidneys.
    T1 / 2 of meloxamine and camylophin - 1,5 - 2 hours, are excreted by the kidneys.
    Indications:Acute migraine attacks (including those accompanied by aura) and migraine-like headaches of vascular genesis.
    Contraindications:Hypersensitivity to the components of the drug, organic diseases of the cardiovascular system (including acute myocardial infarction, angina pectoris, severe atherosclerosis, paroxysmal tachycardia, frequent ventricular extrasystole, arterial hypertension), expressed obliterating peripheral vascular diseases, glaucoma, benign prostatic hyperplasia with a delay of urine, thyrotoxicosis, expressed hepatic and / or renal failure, sepsis, pregnancy and lactation, age younger than 15 years, lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the preparation contains lactose).
    Carefully:sleep disorders, anxiety disorders (agoraphobia, panic disorder), megacolon, elderly age, simultaneous reception of glucocorticosteroids; Migraine, accompanied by focal neurological disorders.
    Pregnancy and lactation:The use of Nomigren® is contraindicated in pregnancy (due to its effect of stimulating the uterus).
    It is not recommended to use the drug during lactation, as ergotamine and caffeine penetrate into breast milk in sufficient quantities (there is a risk of development of ergotism in the child). If you need to use the drug during lactation, breastfeeding should be discontinued.
    Dosing and Administration:Inside.
    Nomigen® should be taken at the beginning of the attack.
    For the first dose, the recommended dose is 1-2 tablets inside, washed down with water, if no improvement occurs after 30 minutes, 1-2 more pills should be taken. The maximum daily dose is not more than 4 tablets, the maximum dose for 1 week is not more than 10 tablets.
    The drug is not recommended to be used for a long time: after 7 days of use in cases requiring longer treatment, take a break for 3-4 days.
    Side effects:From the central nervous system (CNS): sleep disorders,
    increased excitability; with prolonged use it is possible to develop addiction.
    From the cardiovascular system: transient tachycardia, changes in the ECG, increased blood pressure (BP), pain in the heart, bradycardia, muscle pain, decreased pulsations in the limbs, paresthesia in the extremities (most of these effects are associated with an increase in the tone of peripheral vessels).
    From the digestive system: nausea, vomiting; rarely diarrhea.
    Other: weakness in the legs; rarely - peripheral edema, itchy skin.
    Overdose:Symptoms: nausea, vomiting, general weakness, paresthesia, tinnitus, pain and cyanosis of the lower extremities (with a decrease or total absence of pulsation in the peripheral arteries), increased or decreased blood pressure, tachycardia, drowsiness, stupor, convulsions, anxiety.
    Treatment: gastric lavage, if not more than 4 hours after taking the drug, taking activated charcoal, if necessary - performing symptomatic therapy.
    Interaction:Amantadine, quinidine and tricyclic antidepressants potentiate the effect of the drug.
    Nomigen® enhances the effect of ethanol and sedatives.
    Alpha-adrenostimulators, beta-blockers and nicotine intensify the vasoconstrictive effect of the drug.
    It is not possible to appoint simultaneously with vasoconstrictive agents, t. can lead to life-threatening hypertension.
    With simultaneous use with agonists, serotonin (including with sumatriptan) is increased. risk of prolonged vasospastic reactions.
    With the simultaneous use with antibiotics of the group of macrodides (including with erythromycin), an increase in the concentration of ergotamine in the blood plasma is possible.
    Special instructions:Do not use the drug to prevent a migraine attack!
    Patients taking Nomigren® should periodically monitor the blood picture.
    With a systematic use of ergotamine-containing medications, the patient should be advised to strictly adhere to prescribed doses in order to avoid the development of ergotism: spasm of peripheral vessels - loss of sensation, paresthesia, tingling sensation in the limbs, pain in the lower extremities, cyanosis (especially fingers) a decrease in pulsation, as well as violations from the side of the central nervous system - dizziness, stupor, coma, convulsions.
    When there are such symptoms as numbness of the fingertips of the hands or feet, pain in the heart,acceleration or slowing of the heart rate, taking the drug should be stopped immediately and consult a doctor.
    Effect on the ability to drive transp. cf. and fur:Nomigen® may affect the psychophysical capabilities of the patient, especially when taken concomitantly with alcohol or drugs depressing the central nervous system. Do not drive vehicles and work with potentially dangerous mechanisms for 2-3 hours after taking Nomigren®.
    Form release / dosage:The tablets are coated.
    Packaging:For 10 or 20 tablets, coated in a white propylene tube, sealed with a white plastic lid with the control of the first opening. Each tube together with the instruction for use is placed in a cardboard box.
    Storage conditions:At a temperature not higher than + 25 ° ะก.
    Keep out of the reach of children.
    Shelf life:2 years.
    Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001304/10
    Date of registration:24.02.2010
    The owner of the registration certificate:Boznalek, AOBoznalek, AO Bosnia and Herzegovina
    Manufacturer: & nbsp
    BOSNALIJEK, d.d. Bosnia and Herzegovina
    Representation: & nbspBOSNALEK AO BOSNALEK AO Bosnia and Herzegovina
    Information update date: & nbsp2016-02-09
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