Instruction for use: Nomigren

Trade name of the drug – Nomigren

Dosage Form: tablets

Active substance: Propyphenazonum + Coffeinum + Kamilophini chloridum + Mecloxamini citras + Ergotamini tartras

ATX

N02CA52 Ergotamine in combination with other drugs, except psycholeptics

Pharmacotherapeutic group: antimigraine solution [myotropic antispasmodics in combination] antimigraine solution [alpha-blockers in combination]

The nosological classification (ICD-10)

G43 Migraine: The pain at migraine, hemiplegic migraine, migraine headache, migraine attack, continuous headache, hemicranias

G43.1 Migraine with aura [classical migraine]: basilar migraine; Migraine with aura

G43.9 Migraine, unspecified: Migraine; Acute migraine attack

G44.1 Vascular headache, not elsewhere classified: Arteriogipotonichesky option headaches; Pain vasogenic; Vasomotor headache; Headache vascular genesis; Headache vascular origin

Composition (per tablet): active substance:

propyphenazone 200 mg

caffeine 80 mg

kamilofina chloride 25 mg

mekloksamina citrate 20 mg

ergotamine tartrate 0,75 mg

Excipients: corn starch; lactose monohydrate; crospovidone; talc; magnesium stearate; gelatin; colloidal silicon dioxide; wine acid; iron oxide red dye; titanium dioxide; macrogol 6000; polyacrylate dispersion; polysorbate 80; carmellose sodium

Description: Tablets, film-coated, round shaped, biconvex, dark pink.

Pharmacological effect of Nomigren

Pharmachologic effect – analgesic, antispasmodic, antimigraine.

Pharmacodynamics

Combined preparation has protivomigrenoznoe, antispasmodic and analgesic effect.

Ergotamine - ergot alkaloid; It is a partial agonist of serotonin receptors indiscriminately blocking 5-HT1A-1D-receptors. For typical ergotamine alpha adrenoceptor blocking activity, combined with a strong vasoconstrictor action directly on the smooth muscle of peripheral and cerebral vessels. In this regard, the predominant background action ergotamine tonic effect on the peripheral and cerebral vessels, which has therapeutic value in relieving migraine attacks.

Propyphenazone has analgesic effect.

Caffeine accelerates absorption of ergotamine and enhances its therapeutic effect. Also, caffeine has a tonic effect on the brain vessels.

Kamilofin has antispasmodic action, eliminating initial vasospasm in the prodromal phase of a migraine attack.

Mekloksamin has anticholinergic, antihistamine, mildly sedative and antiemetic effect.

Pharmacokinetics

After ingestion of ergotamine in a small degree absorbed from the gastrointestinal tract.

Bioavailability is low due to intensive metabolism during the initial passage through the liver.

The main metabolites are excreted through the intestine with bile. About 4% is excreted by the kidneys unchanged. Withdrawal of ergotamine is biphasic. T1 / 2 in the terminal phase - 21 hours.

Caffeine is well absorbed in the intestine (including the large). T1 / 2 is about 5 hours. About 10% excreted by the kidneys unchanged.

After oral administration around 25% propyphenazone metabolized during the initial passage through the liver, Vd is 0.4 L / kg, Cmax plasma levels reached within 30-40 minutes, the maximal effect - 90 min, T1 / 2 - 2.1 -2.4 hours excreted by the kidneys.

T1 / 2 and mekloksamina kamilofina - 1.5-2 hours, the kidneys.

Indications for Nomigren

Acute attacks of migraine (including accompanied by aura) and migraine headaches of vascular origin.

Contraindications for Nomigren

Hypersensitivity to the drug;

organic CVD (including acute myocardial infarction, angina, marked atherosclerosis, paroxysmal tachycardia, frequent ventricular premature beats, hypertension);

expressed obliterating peripheral vascular disease;

glaucoma;

Benign prostatic hyperplasia with urinary retention;

hyperthyroidism;

severe hepatic and / or renal failure;

sepsis;

lactose intolerance, lactase deficiency or glucose-galactose malabsorption (product contains lactose);

pregnancy;

lactation;

age under 15 years old.

Precautions: sleep disturbances; anxiety disorders (agoraphobia, panic disorder); megacolon; elderly age; concomitant use of corticosteroids; migraine, accompanied by focal neurological disorders.

Pregnancy and breast-feeding

Application Nomigren® drug is contraindicated during pregnancy (due to its stimulating effect of the uterus).

Do not use during lactation since ergotamine and caffeine passes into breast milk in sufficient quantities (of the risk of ergotism in the child). If necessary, use during lactation should stop breastfeeding.

Side effect

CNS: sleep disturbance, irritability; long-term use may develop addiction.

From the CCC: transient tachycardia, ECG changes, increased blood pressure, heart pain, bradycardia, muscle pain, reduction of pulsation in the extremities, paresthesias in extremities (most of these effects related to increased peripheral vascular tone).

From the digestive system: nausea, vomiting; rarely - diarrhea.

Other: weakness in the legs; rarely - peripheral edema, pruritus.

Interaction

Amantadine, quinidine and tricyclic antidepressants potentiate the effect of the drug.

Nomigren enhances the effect of ethanol and sedatives.

Adrenostimulyatorov Alpha, beta-blockers and nicotine increase the vasoconstrictor effect of the drug.

You cannot assign both a vasoconstrictor, because it can lead to life-threatening hypertension. In an application with serotonin agonists (including with sumatriptan) increases the risk of prolonged vasospastic reactions.

In an application with macrolide antibiotics (including erythromycin) may increase the concentration of ergotamine in plasma.

Dosage and Administration

Inside, with water. Nomigren should be taken early in the attack. For the first receiving the recommended dose - 1-2 tablets if after 30 minutes improvement does not occur, you should take another 1-2 Table.. The maximum daily dose - Table 4 max, the maximum dose for 1 week -. Table 10 max.The drug is not recommended for a long time: after 7 days of treatment in cases requiring longer treatment make a break for 3-4 days.

Overdose

Symptoms include nausea, vomiting, weakness, paraesthesia, tinnitus, pain and cyanosis of the lower limbs (with a decrease or complete absence of pulsation in the peripheral arteries), increased or decreased blood pressure, tachycardia, somnolence, stupor, convulsions, anxiety.

Treatment: gastric lavage, if passed no more than 4 hours after taking the drug, the appointment of activated charcoal, if necessary - symptomatic therapy.

Special Instructions

Do not use the drug for prevention of migraine attack!

Patients taking Nomigren need to periodically monitor the blood picture.

The systematic admission containing ergotamine drugs should warn patients about the need to adhere strictly to the assigned dose to prevent the development of phenomena of ergotism: a spasm of peripheral vessels - numbness, paresthesia, tingling in the extremities, pain in the lower extremities, cyanosis (especially toes), a pronounced decrease in pulsation as well as disorders of the central nervous system - dizziness, stupor, coma, convulsions.

When symptoms such as numbness in the fingertips of hands or feet, pain in the heart, heart rate acceleration or deceleration, the drug should be discontinued immediately and seek medical advice.

Effects on ability to drive vehicles and other mechanisms. Nomigren® may affect psychophysical abilities of the patient, particularly when taken with alcohol or drugs, oppressive central nervous system. It is impossible to drive and work with potentially dangerous machinery for 2-3 hours after taking the drug Nomigren.

Release Form

Coated tablets. 10 or Table 20. in a white polypropylene tube, corked white plastic lid with a control of the first opening. Each tube is placed in a cardboard box.

Manufacturer

Bosnalek JSC. Sarajevo, Str. Yukicheva, 53, Bosnia and Herzegovina.

Claims directed to consumers in the Russian Federation representative address: 119435, Moscow, Big Savvinsky lane, 11..

Storage conditions of Nomigren

The temperature is not above 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use beyond the expiration date printed on the package.

Conditions of supply of pharmacies

On prescription.