Nomigren Bosnalek (ergotamine tartrate) coated tablets №10

Description

Nomigren Bosnalek composition
active substances: ergotamine tartrate, mecloxamine citrate, camilofin hydrochloride, propifenazone, caffeine;
1 film-coated tablet contains ergotamine tartrate 0.75 mg, mecloxamine citrate 20 mg, camilofin hydrochloride 25 mg, propifenazone 200 mg, caffeine 80 mg;
excipients: corn starch, lactose, monohydrate; crospovidone, talc, magnesium stearate, gelatin, colloidal anhydrous silica, tartaric acid, iron oxide red (E 172), titanium dioxide (E 171), polyacrylate dispersion 30%, macrogol 6000, polysorbate 80, carmellose sodium.

Dosage form
Film-coated tablets.

Pharmacological properties
The active substances of Nomigren Bosnalek act synergistically and comprehensively on migraine pain and accompanying symptoms.
Ergotamine tartrate is an ergot alkaloid that stimulates smooth muscle and causes vasoconstriction of cerebral and peripheral blood vessels, resulting in reduced cerebral edema.
Mecloxamine citrate has a mild sedative, antiemetic and antihistamine effect.
Camilofin hydrochloride acts as an antispasmodic, eliminating the initial vasospasm in the prodromal phase of a migraine attack.
Propifenazone has an analgesic effect.
Caffeine increases the absorption of ergotamine and enhances its therapeutic effect.
When taken orally, the active substances of Nomigren Bosnalek are quickly and completely absorbed from the digestive tract.

Indication
Prevention or cessation of vascular headache (migraine, cluster headache), namely:

• migraine: cessation of pain.
• cluster headache: cessation and short-term prevention.

Contraindication:

• hypersensitivity to any components of the drug;
• leukopenia;
• prostate adenoma;
• gastric ulcer;
• mechanical stenoses of the gastrointestinal tract;
• megacolon;
• tachyarrhythmias;
• severe cerebral sclerosis;
• vascular stenosis;
• angina pectoris;
• coronary heart disease;
• arterial hypertension;
• peripheral circulatory disorders;
• temporal arteritis;
• stroke;
• state of increased excitement;
• sleep disorders;
• narrow-angle glaucoma;
• genetically determined glucose-6-phosphate dehydrogenase deficiency (manifested as hemolytic anemia);
• acute hepatic porphyria;
• kidney and liver diseases;
• sepsis;
• hyperthyroidism;
• malnutrition or eating disorders;
• hemiplegic or basilar migraine;
• concomitant treatment with CYP3A4 inhibitors, including macrolides, HIV proteases or reverse transcriptase inhibitors and antifungals;
• concomitant treatment with vasoconstrictors, including ergot alkaloids, sumatriptan and other 5HT1-receptor agonists;
• age over 65 years.

Children
Do not apply.

Use during pregnancy or breastfeeding
There is a risk of exposure to the fetus. Contraindicated in pregnant women and women planning a pregnancy.
Ergotamine and caffeine pass into breast milk. The use of the drug Nomigren Bosnalek during breastfeeding is contraindicated.

Method of application and dosage
Nomigren Bosnalek is recommended for oral use in the initial (prodromal) stages of the attack. Unless otherwise prescribed by a doctor, the drug should be used to stop a migraine attack (depending on the severity of the manifestations):

• Severe migraine.
  1-2 tablets at the beginning of a headache attack, if necessary – another 1 tablet 30 minutes after the first and every half hour if necessary, a maximum of 4 tablets per day. It is recommended to use the drug no more than 2 times a week with an interval between doses of at least 4 days. The maximum weekly dose should not exceed 10 tablets. No more than 2 therapeutic courses for 1 month are recommended.
• Moderate migraine.
  1 tablet at the beginning of the attack. The maximum daily dose is 4 tablets. The total weekly dose should not exceed 10 tablets.
• Cessation and short-term prevention of cluster headache.
  For cessation and short-term prevention of seizures in patients with regular attacks.
  Apply a dose of 4-5 tablets (3-4 mg in terms of ergotamine) per day, divided into several doses, for 3 weeks. Take 30-60 minutes before the expected attack.
• Carrying out short-term prophylaxis for patients with nocturnal attacks of pain.
  1-2 tablets (1-2 mg in terms of ergotamine) at bedtime.

Overdose should be avoided to prevent adverse reactions. To do this, it is important not to exceed the recommended maximum weekly dose of no more than 10 tablets.

Overdose
Symptoms: nausea, vomiting, diarrhea, weakness, feeling cold, pain, tingling or cyanosis of the extremities; convulsions; muscle numbness, tinnitus, severe headache, dizziness, chest pain, hypertension or hypotension, tachycardia, difficulty breathing, drowsiness, confusion, stupor, convulsions, shock, weak pulse.
In case of systematic (chronic) overdose of the drug, symptoms and complications associated with exposure to the components of the drug, namely ergotamine (ergotism) and / or caffeine (caffeinism) may occur.
Ergotism is defined as intense arterial vasoconstriction, with signs and symptoms of peripheral vascular ischemia of the extremities, such as numbness, tingling and pain in the extremities, cyanosis, lack of peripheral pulse and, if left untreated, can lead to gangrene. In addition, ergotism may also include signs and symptoms of vascular ischemia of other tissues (renal or cerebral vasospasm). In most cases, ergotism is associated with chronic intoxication and / or overdose. The toxic effect at a dose of ergotamine 15 mg lasts 24 hours, and at a dose of 40 mg – several days.
Caffeine can occur with high doses of caffeine (250-700 mg). Manifested by agitation or depression, anxiety, anxiety, which sometimes leads to panic, sleep disturbances, dilated pupils, incoordination, redness and dryness of the skin, strong thirst, muscle twitching, nausea, gastrointestinal disorders, arrhythmia, aggravation. Occasionally, poisoning is possible psychosis of the type of white fever (delirium). Exit from intoxication is often accompanied by throbbing headache, dizziness, heart pain, tinnitus, blurred vision, insomnia. Caffeine, like other sympathomimetics, has the potential to cause drug-induced hyperthermia.
Treatment: gastric lavage no later than 4 hours after taking the drug with activated charcoal and magnesium sulfate.
If vasoconstriction persists, vasodilators should be used, but with caution so as not to exacerbate pre-existing hypotension. Heparin or dextran can be administered intravenously to reduce the risk of thrombosis. If necessary, the patient should be warmed, but not too much. It is necessary to monitor lung ventilation, eliminate hypotension, control seizures.
If there are signs of caffeine intoxication, it is necessary to limit the use of foods, beverages and medicines containing methylxanthines. Regular coffee and carbonated drinks are replaced by decaffeinated. Patients should be informed about which foods, beverages, and medicines contain methylxanthines (caffeine). Gradual withdrawal of caffeine allows to avoid the expressed withdrawal syndrome, at a headache to appoint analgesics. Full rest is recommended.

Side effects
Are found out mainly at long treatment and at use of large doses of Nomigren Bosnalek.

• From the immune system: hypersensitivity reactions in the form of urticaria or redness of the skin, mucous membranes of the eyes and nasopharynx. In case of such side effects, you should immediately stop using the drug and consult a doctor.
• Anaphylactic shock is manifested by the following symptoms: cold sweat, dizziness, nausea, paleness, shortness of breath, swelling of the face, itching, heart failure.
• From the central nervous system: paresthesia (eg, tingling sensation), hypoaesthesia (eg, numbness), weakness, dizziness, depression, insomnia, limited movement, medical headache, drowsiness, hallucinations, convulsions.
• On the part of the visual organs: blurred vision as a result of accommodation disorders; the appearance of moving green stars (“flies”) in the field of view, which may indicate the development of glaucoma.
• From the organs of hearing and labyrinth: vertigo, ringing in the ears.
• Respiratory, thoracic and mediastinal disorders: shortness of breath. Cases of pleuropulmonary fibrosis have been reported.
• From the cardiovascular system: myocardial ischemia, cyanosis, cold sensation in the extremities, gangrene, weak pulse, pain in the heart, changes in the ECG, transient tachycardia or bradycardia, hypertension, peripheral vasoconstriction; in isolated cases – tinnitus, heart attack, endocardial fibrosis.
• From the digestive tract: nausea and vomiting (not related to migraine), epigastric pain, dry mouth, abdominal pain, diarrhea. Cases of retroperitoneal fibrosis and intestinal ischemia.
• From the skin and subcutaneous tissue: localized edema, itching, rash, redness of the skin, swelling of the face.
• From the musculoskeletal system: pain in the muscles of the back and extremities, myalgia, cramps in the muscles of the lower extremities.
• Common disorders: muscle weakness.

Expiration date
2 years.

Storage conditions
Keep Nomigren Bosnalek out of the reach of children at a temperature not exceeding 25 ºC.