AMIGRAINE ADCO

Ergotamine Tartrate 1 mg + Caffeine 100 mg + Analgin (Metamizole) 300 mg
30 Film-Coated Tablets

►Medical Description

AMIGRAINE ADCO is an oral combination medicine formulated for the acute symptomatic treatment of migraine attacks and associated headache pain. Each film-coated tablet contains ergotamine tartrate 1 mg, caffeine 100 mg, and Analgin (metamizole/dipyrone) 300 mg.

The combination provides complementary pharmacological actions. Ergotamine is an ergot alkaloid with activity at serotonin and other vascular receptors and produces constriction of cranial blood vessels; it is intended for use during the early stages of a migraine attack. Caffeine has cranial vasoconstrictive activity and is combined with ergotamine to enhance its effect. Metamizole (Analgin) is a non-opioid analgesic with analgesic and antipyretic properties and contributes to relief of the pain component of the attack.

►Indications & Potential Therapeutic Use

AMIGRAINE ADCO may be used, under appropriate medical direction, for the acute treatment of migraine attacks, particularly when treatment is initiated early in the attack.

Ergotamine-containing preparations are specifically indicated for aborting vascular headache such as migraine, and ergot derivatives tend to be most effective when administered during the early phase of an attack.

►How the Ingredients Work

• Ergotamine Tartrate 1 mg: An ergot derivative that acts on serotonin and other vascular receptors and produces vasoconstriction of cranial blood vessels, contributing to termination of migraine-associated vascular headache.
• Caffeine 100 mg: Produces cranial vasoconstrictive effects and may enhance the therapeutic effect of ergotamine, allowing the ergotamine component to be used at a lower dose.
• Analgin (Metamizole) 300 mg: A non-opioid analgesic that contributes to reduction of headache pain. Metamizole has analgesic and antipyretic activity and relatively limited anti-inflammatory activity compared with conventional NSAIDs.

►Important Dosage & Administration Considerations

Use only according to the prescribing information provided with the specific AMIGRAINE ADCO product and the directions of a physician or pharmacist.

Because ergotamine has a narrow therapeutic range and excessive exposure can cause serious vasospastic toxicity, ergotamine-containing products must not be taken more frequently or at higher doses than recommended. Official ergotamine/caffeine labeling advises administration at the beginning of a migraine attack and specifies strict maximum single-attack and weekly limits.

AMIGRAINE ADCO should not be used as routine daily treatment for recurrent headaches. Frequent use of acute headache medicines can also contribute to medication-overuse headache.

►Contraindications & Major Precautions

Because AMIGRAINE ADCO contains ergotamine, particular caution is required in patients with:

• Peripheral vascular disease or circulatory disorders
• Coronary artery disease or other significant cardiovascular disease
• Uncontrolled or significant hypertension
• Impaired hepatic or renal function
• Sepsis
• Pregnancy or possible pregnancy
• Hypersensitivity to any component of the product

Ergotamine is contraindicated in these settings because of its potent vasoconstrictive effects and potential for ischemic complications.

►Important Drug Interactions

Ergotamine has clinically important drug interactions. Concomitant administration with potent CYP3A4 inhibitors can markedly increase ergotamine exposure and may result in severe vasospasm, peripheral ischemia, cerebral ischemia, or other manifestations of ergot toxicity.

Particular attention is required with drugs such as clarithromycin, erythromycin, certain HIV protease inhibitors, ketoconazole, itraconazole, and other potent CYP3A4 inhibitors. The interaction list is not exhaustive, so a complete medication review should be performed before use.

• Important Metamizole (Analgin) Safety Information

Metamizole is associated with a rare but potentially life-threatening adverse reaction called agranulocytosis, characterized by a severe reduction in granulocytes/neutrophils and an increased susceptibility to serious infections.

Patients taking metamizole should seek urgent medical attention if they develop symptoms suggestive of agranulocytosis, particularly:

• Fever
• Chills
• Sore throat
• Painful mouth, nasal, throat, genital, or anal ulcers

Treatment should be discontinued while urgent medical assessment and an appropriate blood-cell evaluation are performed when agranulocytosis is suspected. This reaction can occur at any time during treatment or shortly after discontinuation and is not necessarily related to dose.

►Possible Adverse Effects

Depending on individual sensitivity and dosage, adverse effects may include:

Ergotamine-related: nausea, vomiting, abdominal discomfort, dizziness, tingling or numbness of the extremities, muscle pain, peripheral vasospasm, changes in heart rate, and—in excessive exposure or susceptible patients—serious ischemic complications.

Caffeine-related: nervousness, restlessness, insomnia, tremor, palpitations, or gastrointestinal discomfort, particularly in caffeine-sensitive individuals.

Metamizole-related: allergic or hypersensitivity reactions, hypotension in susceptible individuals, and rarely agranulocytosis, which can be life-threatening.

►Pregnancy & Breastfeeding

AMIGRAINE ADCO should not be used during pregnancy unless specifically determined appropriate by a qualified physician. Ergotamine-containing medicines are contraindicated during pregnancy because of potential fetal harm and their vascular effects.

Women who are pregnant, planning pregnancy, or breastfeeding should consult a physician before using this medicine.

►Patient Counseling

Patients should:

• Use AMIGRAINE ADCO only for migraine attacks for which it has been prescribed.
• Follow the prescribed dose strictly and never exceed the recommended maximum.
• Avoid combining it with other ergotamine-containing medicines.
• Inform their doctor or pharmacist about all prescription medicines, OTC medicines, and supplements they use.
• Seek immediate medical attention for severe chest pain, marked weakness, cold/numb or painful fingers or toes, or other symptoms suggestive of significant vasospasm.
• Seek urgent medical attention for fever, chills, sore throat, or painful mucosal ulcers while taking or shortly after taking the product because these may indicate metamizole-associated agranulocytosis.

►Storage

Store according to the specific manufacturer's packaging and product leaflet, protected from excessive heat and moisture and kept out of reach of children.

Patient / Medical Disclaimer

This information is provided for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. AMIGRAINE ADCO contains ergotamine and metamizole, both of which have important safety considerations and drug interactions. Do not start, stop, or change the dose of this medicine without consulting a qualified physician or pharmacist. Always refer to the official product leaflet and locally approved prescribing information for the most accurate dosage, contraindications, and precautions.