Nomigren^® (Tablets) Instructions for Use

Marketing Authorization Holder

Bosnalijek, JSC (Bosnia And Herzegovina)

ATC Code

N02CA52 (Ergotamine in combination with other drugs, excluding psycholeptics)

Dosage Form

Nomigren®

Coated tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Coated tablets dark pink in color, round, biconvex.

Excipients: corn starch, lactose monohydrate, crospovidone, talc, magnesium stearate, gelatin, colloidal silicon dioxide, tartaric acid, red iron oxide dye, titanium dioxide, macrogol 6000, polyacrylate dispersion, polysorbate 80, sodium carboxymethylcellulose.

10 pcs. – polypropylene tubes (1) – cardboard packs.
20 pcs. – polypropylene tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antimigraine activity

Pharmacotherapeutic Group

Analgesics; antimigraine preparations; ergot alkaloids

Pharmacological Action

A combined drug. It has antimigraine, antispasmodic, and analgesic action.

Ergotamine is an ergot alkaloid; it is a partial agonist of serotonin receptors and non-selectively blocks 5-HT_1A-1D receptors. Ergotamine is characterized by alpha-adrenergic blocking activity combined with a pronounced direct vasoconstrictive effect on the smooth muscles of peripheral and cerebral vessels. Because of this, under the influence of ergotamine, the tonic effect on peripheral and cerebral vessels predominates, which has therapeutic significance in relieving migraine attacks.

Propyphenazone has an analgesic effect.

Caffeine accelerates the absorption of ergotamine and enhances its therapeutic effect. Caffeine also has a tonic effect on cerebral vessels.

Camylofin has an antispasmodic effect, eliminating the initial vasospasm in the prodromal phase of a migraine attack.

Meclozamine has anticholinergic, antihistamine, moderate sedative, and antiemetic effects.

Pharmacokinetics

After oral administration, ergotamine is poorly absorbed from the gastrointestinal tract. Bioavailability is low due to intensive metabolism during the first pass through the liver. The main metabolites are excreted through the intestine with bile. About 4% is excreted by the kidneys unchanged. The elimination of ergotamine is biphasic. T_1/2 in the terminal phase is 21 h.

After oral administration, about 25% of propyphenazone undergoes metabolism during the first pass through the liver. V_d is 0.4 l/kg, C_max in blood plasma is reached within 30-40 min, maximum effect – after 90 min. T_1/2 is 2.1-2.4 h, excreted by the kidneys.

Caffeine is well absorbed in the intestine (including the large intestine). T_1/2 is about 5 h. About 10% is excreted by the kidneys unchanged.

T_1/2 of meclozamine and camylofin is 1.5-2 h, excreted by the kidneys.

Indications

• Acute migraine attacks (including those accompanied by aura);
• Migraine-like headaches of vascular origin.

ICD codes

Dosage Regimen

Nomigren^® should be taken at the very beginning of an attack.

For the first dose, the recommended dose is 1-2 tablets (with water). If no improvement occurs within 30 minutes, take another 1-2 tablets.

The maximum daily dose is no more than 4 tablets, the maximum dose within 1 week is no more than 10 tablets.

The drug is not recommended for long-term use. In cases requiring long-term treatment, after 7 days of use, a break of 3-4 days should be taken.

Adverse Reactions

From the central nervous system: sleep disorders, increased excitability; with prolonged use, the development of habituation is possible.

From the cardiovascular system: transient tachycardia, ECG changes, increased blood pressure, heart pain, bradycardia, muscle pain, decreased pulsation in the extremities, paresthesia in the extremities (most of these effects are associated with increased peripheral vascular tone).

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

Other: leg weakness; rarely – peripheral edema, skin itching.

Contraindications

• Organic diseases of the cardiovascular system (including acute myocardial infarction, angina pectoris, severe atherosclerosis, paroxysmal tachycardia, frequent ventricular extrasystole, arterial hypertension);
• Obliterating diseases of peripheral vessels;
• Glaucoma;
• Benign prostatic hyperplasia with urinary retention;
• Thyrotoxicosis;
• Severe hepatic and/or renal impairment;
• Sepsis;
• Pregnancy;
• Lactation period;
• Lactose intolerance, lactase deficiency or glucose/galactose malabsorption syndrome (because the drug contains lactose);
• Children under 15 years of age;
• Hypersensitivity to the drug components.

With caution, the drug should be used for sleep disorders, anxiety disorders (agoraphobia, panic disorders), megacolon, in elderly patients, with simultaneous use of corticosteroids, and also for migraine accompanied by focal neurological disorders.

Use in Pregnancy and Lactation

The use of Nomigren^® is contraindicated during pregnancy (due to its uterus-stimulating effect).

The use of the drug during lactation is not recommended, as ergotamine and Caffeine pass into breast milk in sufficient quantities (there is a risk of ergotism in the child). If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Contraindicated in children and adolescents under 15 years of age.

Geriatric Use

With caution, the drug should be used in elderly patients.

Special Precautions

Do not use the drug to prevent a migraine attack!

Patients taking Nomigren^® should periodically monitor their blood picture.

With systematic use of drugs containing ergotamine, the patient should be warned about the need to strictly adhere to the prescribed doses to avoid the development of ergotism phenomena: peripheral vascular spasm – loss of sensation, paresthesia, a feeling of “tingling” in the extremities, pain in the lower extremities, cyanosis (especially of the fingers), a pronounced decrease in pulsation, as well as disorders from the central nervous system – dizziness, stupor, coma, convulsions.

If symptoms such as numbness of the fingertips of the hands or feet, heart pain, acceleration or deceleration of heart rate appear, the drug should be discontinued immediately and a doctor should be consulted.

Influence on the ability to drive vehicles and mechanisms

Nomigren^® may affect the psychophysical abilities of the patient, especially when taken simultaneously with alcohol or drugs that depress the central nervous system. Do not drive vehicles or work with potentially dangerous machinery for 2-3 hours after taking Nomigren^®.

Overdose

Symptoms: nausea, vomiting, general weakness, paresthesia, tinnitus, pain and cyanosis of the lower extremities (with decreased or complete absence of pulsation in the peripheral arteries), increased or decreased blood pressure, tachycardia, drowsiness, stupor, convulsions, anxiety.

Treatment: gastric lavage, if no more than 4 hours have passed since taking the drug, intake of activated charcoal, if necessary – symptomatic therapy.

Drug Interactions

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

Nomigren^® enhances the effect of ethanol and sedatives.

Alpha-adrenergic agonists, beta-blockers, and nicotine enhance the vasoconstrictive effect of the drug.

It should not be prescribed simultaneously with vasoconstrictors, as this can lead to life-threatening arterial hypertension.

When used concomitantly with serotonin agonists (including sumatriptan), the risk of prolonged vasospastic reactions increases.

When used concomitantly with macrolide antibiotics (including erythromycin), an increase in the plasma concentration of ergotamine is possible.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.