Product image of Gynergène Caféiné (Ergotamine Tartrate, Caffeine) supplied by GNH India

Gynergène Caféiné

Active Ingredient:
Ergotamine Tartrate, Caffeine
Origin:
EU

Gynergène Caféiné (Ergotamine Tartrate, Caffeine)

Gynergène Caféiné is an oral tablet that combines ergotamine tartrate and caffeine, formulated as a prescription medication in the European Union. The product delivers a standard dose of ergotamine tartrate together with caffeine to target acute migraine attacks and associated headache symptoms. As an ergot alkaloid with a central nervous system stimulant, it is intended for patients who need rapid relief from migraine discomfort.

Manufacturer / TM Owner

Amdipharm Limited

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Indications & Clinical Uses

Gynergène Caféiné is indicated for the acute treatment of migraine episodes in adults.

  • Alleviation of moderate to severe migraine headache pain, including throbbing or pulsating sensations.
  • Decrease of accompanying migraine symptoms such as nausea, vomiting, photophobia, and phonophobia.
  • Shortening of the overall duration of an acute migraine attack when taken at onset.
  • Option for patients who have not responded to or cannot use triptan medications.
  • Use as a rescue therapy for breakthrough migraine episodes despite preventive treatment.

Side Effects

The safety profile of Gynergène Caféiné includes both frequent, less severe reactions and rare, potentially serious events.

Common

  • Nausea or stomach discomfort.
  • Dizziness or light‑headed feeling.
  • Tingling, numbness, or paresthesia in the fingers or toes.
  • Mild flushing, warmth, or feeling of pressure.
  • Transient worsening of headache if the medication is not taken promptly.

Serious

  • Severe vasoconstriction that may cause chest pain, cardiac ischemia, or peripheral ischemic events.
  • Allergic reactions including rash, itching, swelling of the face, lips, or tongue, and difficulty breathing.
  • Persistent vomiting, severe dehydration, or hypertensive crisis requiring medical attention.

Precautions & Warnings

Before prescribing Gynergène Caféiné, clinicians should evaluate several precautionary factors to ensure safe use.

  • Evaluate cardiovascular disease; ergotamine may worsen coronary, peripheral, or cerebrovascular conditions.
  • Check for hypertension or uncontrolled high blood pressure.
  • Use cautiously in patients with liver or kidney impairment.
  • Avoid during pregnancy or lactation unless benefits clearly outweigh risks.
  • Do not prescribe to individuals with known ergot allergy or previous ergotism.
  • Limit frequency to prevent medication‑overuse headache.

Avoid Interactions

Gynergène Caféiné can interact with several medicines; awareness of these interactions helps prevent adverse effects.

Avoid

  • Monoamine oxidase inhibitors (MAOIs) – risk of severe hypertension.
  • Ergot derivatives (e.g., dihydroergotamine) – additive vasoconstriction.
  • Certain antihypertensives (e.g., beta‑blockers) – may reduce therapeutic effect.

Use with caution

  • CYP3A4 inhibitors (e.g., erythromycin, ketoconazole) – may increase ergotamine levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine) – may reduce efficacy.
  • Other serotonergic agents (e.g., triptans, SSRIs) – potential for serotonin syndrome.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) – may increase risk of gastrointestinal irritation.

Frequently Asked Questions

Gynergène Caféiné contains ergotamine tartrate and caffeine as its active pharmaceutical ingredients, formulated in an oral tablet.

Ergotamine acts as an agonist at serotonin 5‑HT1B and 5‑HT1D receptors, causing constriction of cranial blood vessels, which helps reduce migraine headache intensity.

Caffeine blocks adenosine receptors and can enhance the analgesic effect of ergotamine, leading to faster and more effective relief of migraine symptoms.

No, Gynergène Caféiné is a prescription‑only medication (Rx) and must be prescribed by a qualified healthcare professional.

Safety data are limited; the medication should be avoided during pregnancy and breastfeeding unless the potential benefit clearly outweighs the risk.

Common adverse reactions include nausea, stomach discomfort, dizziness, tingling or numbness in extremities, mild flushing, and temporary worsening of headache if not taken promptly.

Serious events may include severe chest pain or signs of cardiac ischemia, allergic reactions such as facial swelling or difficulty breathing, persistent vomiting, dehydration, or a hypertensive crisis.

Patients with coronary artery disease, uncontrolled hypertension, peripheral vascular disease, or a history of stroke should not use Gynergène Caféiné due to its vasoconstrictive properties.

Concurrent use with other ergot derivatives or serotonergic agents (e.g., triptans, SSRIs) can increase the risk of vasospasm or serotonin syndrome and should be avoided or closely monitored.

To reduce the risk of medication‑overuse headache, the tablet is generally limited to a few doses per month, as directed by a healthcare provider.

Avoid combining with MAO inhibitors, other ergot drugs, and certain antihypertensives. Use caution with CYP3A4 inhibitors or inducers, other serotonergic agents, and NSAIDs.

Ergotamine and caffeine are not classified as controlled substances, but frequent use may lead to medication‑overuse headache, emphasizing the need for proper medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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