Номигрен

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Номигрен

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Treatment option: Fits

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Номигрен

Quick Facts

Property Description
Active Ingredients Ergotamine, Caffeine, Propyphenazone, Camylofin, Mecloxamine
Form Oral dosage form (Film-coated tablet)
Pharmacological Class Antimigraine Preparation, Analgesic Combination
Common Use Acute treatment of vascular headaches (e.g., migraine)
Origin Synthetic and semi-synthetic

What Type of Medicine Is Номигрен?

Номигрен is a unique multi-component fixed drug combination prescribed for the acute management of vascular headaches and is classified as an Antimigraine Preparation and Analgesic Combination. The medicinal entity is delivered as an oral dosage form, specifically a film-coated tablet, combining five distinct active compounds into one preparation. This formula is clinically recognized for its complex composition, which distinguishes it from simpler, single-agent treatments, often being designated as a prescription-only medicine (Rx).

Composition: The Five Active Ingredients

The unique complexity of the Номигрен formulation is its defining feature, incorporating five active ingredients: Ergotamine, Caffeine, Propyphenazone, Camylofin, and Mecloxamine. The key component, Ergotamine, is an ergot alkaloid known for its powerful vasoconstrictor activity. This core design is centered on targeting the vascular irregularities of a headache. The other components—the analgesic Propyphenazone, the stimulant Caffeine, and the spasmolytics Camylofin and Mecloxamine—are included to create a broad therapeutic profile that manages pain, vascular stability, and secondary tension.

General Purpose and Mechanism of Action

The overall purpose of Номигрен is to provide abortive treatment, meaning it is designed to be taken to interrupt an acute attack that has already begun, rather than serving a preventative role. The therapeutic goal involves combining ergotamine with multiple agents, including analgesics like Propyphenazone, to address acute migraine headaches. By combining vasoconstriction with direct pain signal reduction and spasmolytic effects, the medication targets the varied physiological aspects of a severe vascular headache simultaneously.

What side effects are possible with Номигрен?

Possible Side Effects and Safety Information

The official safety profile for this multi-component preparation, which includes the ergot alkaloid Ergotamine, is structured by regulatory documents based on the potential nature, frequency, and severity of adverse reactions, particularly those affecting the vascular system.

Frequency-Classified Adverse Reactions

Side effects documented in regulatory labeling are categorized by frequency. Common reactions often involve the gastrointestinal and nervous systems, including nausea, vomiting, paresthesias (numbness or tingling), and vertigo. Rare but serious events include cerebral ischemia and specific fibrotic complications.

Classification Examples of Documented Reactions
Common Nausea, Vomiting, Paresthesias, Weakness
Rare Cerebral Ischemia, Fibrotic thickening of heart valves

Serious Adverse Reactions and Safety Patterns

The most serious concern documented in official warnings is Ergotism, a condition of intense arterial vasoconstriction that can lead to peripheral vascular ischemia and, rarely, gangrene. Fibrotic thickening of the heart valves or other internal organs is associated with long-term continuous use.

The medication is contraindicated in several conditions and populations, including pregnancy, lactation, severe hepatic or renal impairment, and individuals with underlying conditions like uncontrolled hypertension or peripheral vascular disease. It is also contraindicated when co-administered with potent CYP 3A4 inhibitors due to the significantly increased risk of acute ergot toxicity.

Use is restricted to acute treatment only and should not be used for chronic daily administration due to the risks of serious systemic toxicity and the development of Medicine Overuse Headache.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory guidance for Номигрен overdose is determined by the potential toxic effects of its complex components, mandating immediate action due to the risk of severe, life-threatening outcomes.

Overdose is primarily associated with ergotism, which can present with signs of intense peripheral vasoconstriction. Clinically documented manifestations include numbness or tingling (paraesthesia) in the fingers and toes, severe muscle pain in the limbs, dizziness, and persistent nausea and vomiting. Other signs may involve changes in heart rate or blood pressure (tachycardia or bradycardia).

Severe outcomes may involve progression to conditions such as myocardial infarction, cerebral ischemia, cardiac arrhythmias, or, in the extremities, gangrene. Acute renal failure is also a documented risk, particularly in patients with pre-existing hepatic or renal impairment.

Immediate medical attention must be sought for any suspected overdose. Individuals must contact emergency services if they experience symptoms like severe limb pain, chest pain, or difficulty breathing, as these indicate a dangerous escalation. Management focuses on symptomatic and supportive treatment, often requiring hospitalisation for observation and continuous cardiovascular monitoring. Regulatory information confirms that no specific antidote is known for this overdose.

Therapeutic Uses of Номигрен

What Номигрен treats: Main Uses and Benefits

This medication is intended for the acute, supportive management of specific, severe symptom patterns associated with vascular headaches. The core therapeutic approach is indicated as therapy to assist with the management of acute vascular headache, such as migraine.

The medication is generally used for the abortive treatment of conditions characterized by severe migraine attacks. This approach is commonly applied in scenarios where patients experience intense, throbbing pain that is resistant to other common pain management options. It addresses symptom clusters involving primary vascular pain, associated secondary discomfort, and muscular tension.

Key Information: Management of Acute Headache Attacks

Focus Conditions Symptom Clusters Addressed Therapeutic Benefit
Acute migraine attacks and severe vascular headaches. Intense, pulsatile pain and secondary tension. Supportive assistance to interrupt an episode and improve day-to-day comfort.

Regulatory References

  1. NIH DailyMed overview for Ergotamine Tartrate and Caffeine

Eligibility and Restrictions for Use

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults for the acute management of vascular headaches.
Populations for whom use is contraindicated Patients with Peripheral Vascular Disease, Coronary Heart Disease, or Uncontrolled Hypertension. Impaired Hepatic or Renal Function. Sepsis. Known Hypersensitivity to any component.
Pregnancy and lactation eligibility status Pregnancy is a contraindication (Category X). Use during Lactation is generally contraindicated.

Age-Related Eligibility Rules

Age Group Regulatory Status
Pediatric Population Safety and efficacy have not been established.
Geriatric Population No information is available on the effects; use is often advised to be approached with caution or avoided.

Eligibility-Context Constraints

The medicine is strictly contraindicated for use with Triptans and with strong CYP3A4 Inhibitors (e.g., specific macrolide antibiotics or HIV protease inhibitors) due to the serious risk of acute ergot toxicity and vasospasm.


Connection to the overall eligibility profile:

Official government documentation defines the primary eligible population as adults without significant vascular or organ dysfunction. The majority of constraints are absolute prohibitions, or contraindications, which strictly exclude patients based on pre-existing cardiovascular disease, severe liver or kidney impairment, or reproductive status, emphasizing the systemic risks of the medicine's components.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information classifies specific drug combinations as contraindicated due to the risk of severe interaction effects, primarily driven by the ergotamine component.

Contraindicated Combinations

Co-administration with potent CYP 3A4 inhibitors is strictly prohibited, as the resulting pharmacokinetic interaction significantly impairs the metabolic clearance of ergotamine. This increases systemic exposure and elevates the risk of acute ergot toxicity (ergotism). This group includes HIV protease inhibitors (e.g., ritonavir) and certain macrolide antibiotics (e.g., erythromycin) and azole antifungals (e.g., ketoconazole).

Similarly, other 5-HT₁ Receptor Agonists (Triptans) are contraindicated. This is based on a pharmacodynamic interaction risk of additive or synergistic vasoconstrictive effects, which can lead to prolonged vasospasm.

Administration Restrictions and Population Notes

Regulatory documents mandate a 24-hour separation interval between the administration of this medicine and any triptan. Combining with other peripheral or central vasoconstrictors is also officially prohibited due to the risk of additive hypertensive effects. For non-medicinal substances, the official labeling advises against co-consumption with grapefruit juice, which acts as a CYP 3A4 inhibitor.

Patients with severe hepatic or renal impairment face an elevated risk of accumulation and toxicity due to impaired drug clearance, which represents a population-specific interaction consideration noted in official documents.

Mechanism of Action

Selective Activation of 5- HT Receptors

The drug functions as a selective agonist, meaning it activates specific 5- HT (serotonin) receptor subtypes (5- HT1B/1D) located on cranial blood vessels and nerve endings. This targeted engagement with the body's natural signaling molecules initiates specific downstream effects within targeted neurovascular pathways.


Modulating Cranial Blood Vessel Tone

Activation of the 5- HT1B receptors in the walls of the intracranial arteries and dural vessels causes vasoconstriction, or a narrowing of the vessels. This action results in vasoconstriction of the intracranial arteries.


Inhibiting Neurogenic Signaling

The drug's action on 5- HT1D receptors found on the trigeminal nerve terminals limits the release of potent vasoactive neuropeptides, such as Calcitonin Gene-Related Peptide ( CGRP). Suppression of these neuropeptides modifies the activity within the neurogenic signaling pathway, altering downstream events related to local inflammation and sensitization.

Dosage and Administration Information

How to Use Номигрен: Official Administration Guidelines

Номигрен (an Ergotamine-containing oral combination) is prescribed exclusively for acute, intermittent use and is not intended for the chronic, daily prevention of vascular headaches. Its official administration is structured by standardized limits on dose and frequency defined for Ergotamine Tartrate and Caffeine combination products.


Official Use Protocol

The approved route of administration is oral, delivered as a film-coated tablet. To align with its purpose as abortive therapy, the medication is administered as early as possible following the onset of an acute headache episode. Tablets are intended to be swallowed whole with water.


Standard Labeled Dosing and Limits

Feature Guideline for Acute Treatment Restriction/Constraint
Initial Dose Two tablets are taken at the first sign of the attack. Must be followed by a minimum interval.
Subsequent Dose One tablet may be taken after a minimum interval of 30 minutes. Only if initial dose did not provide sufficient effect.
Maximum Dose per Attack Must not exceed a total of six tablets. Strict per-episode limit.
Maximum Dose per Week Must not exceed a total of ten tablets. Critical limit for a seven-day period.

Population and Duration Constraints

The usage framework prohibits chronic daily or prophylactic use. For special populations, the safety and efficacy have not been established in pediatric patients. The maximum dose limits must not be exceeded; this procedural rule is essential to conform to the defined usage protocol and avoid consequences associated with overconsumption.

Recent Clinical Evidence

Research evidence / Overview of studies for Номигрен

Evidence for the Acute Treatment of Migraine Attacks

Research exploring the use of Номигрен's core components for acute headache relief primarily focuses on conditions characterized by acute or disruptive episodes like migraine. The evidence base is largely historical, relying on older Randomized Controlled Trials (RCTs) that compared two-drug combinations, specifically ergotamine and caffeine, against a placebo or alternative preparations studied at the time. These studies were applied in research contexts involving fluctuating or unstable symptoms in adult populations.

The trials generally focused on measuring outcomes describing episodic or acute changes, such as the achievement of a pre-defined endpoint on a pain severity scale two hours after taking the medication. Studies monitored how quickly the patient-reported outcomes describing perceived discomfort evolved in the observed populations. Findings describe patterns observed in the studies related to outcomes related to physical discomfort and included measurements of outcomes reflecting daily functioning or activity level in the short-term.

It is important to understand that the primary research does not focus on the entire five-component fixed dose formula of Номигрен. Instead, the evidence base for this specific combination is largely inferred from the well-established historical data on its primary active ingredients. Therefore, comparative evidence is lacking for the specific combination against newer, commonly used migraine therapies.


Study Endpoints: What Researchers Measured

In the research that was studied for acute migraine, the main goal was to track how the medication influenced the severity and duration of an attack. Studies monitored high-level endpoints such as the score reduction of pain at set intervals. Researchers also examined outcomes related to systemic or functional imbalance by tracking associated symptoms, including nausea, sensitivity to light (photophobia), and sensitivity to sound (phonophobia).


⏳ Long-Term Evidence and Follow-up

Research exploring short-term symptom changes generally uses limited follow-up durations, with primary outcomes being measured over intervals like 2, 6, or 24 hours. Long-term effects are not fully established regarding the use of ergotamine-containing formulations over extended periods, such as months or years. Studies do not provide sufficient data to describe whether sustained usage influences the frequency or severity of future attacks.

Key Studies & References

  1. Ergotamine/Caffeine - StatPearls - NCBI Bookshelf (Used for historical context, efficacy, and monitoring/safety limitations for ergotamine)

Frequently Asked Questions (FAQ)

Common questions about Номигрен (FAQ)

Q: How quickly does Номигрен usually start working?

A: Official administration guidelines state that this abortive therapy should be taken as early as possible after the onset of a vascular headache attack. The formal regulatory documents typically do not provide a specific time frame for when a patient should expect to feel the effect.

Q: Does Номигрен interact with common over-the-counter pain relievers?

A: Official product information provides warnings about combining this medicine with specific prescription drug classes, such as CYP 3A4 inhibitors and triptans. Official documentation advises caution when using the medicine alongside any other medications, including common over-the-counter pain relievers, due to the potential for additive vasoconstrictive effects.

Q: Is Номигрен officially approved for tension headaches?

A: Official labeling indicates the medication is specifically indicated for the acute treatment of vascular headaches, such as migraine. Regulatory warnings advise that the medicine should not be taken for other types of headaches.

Q: Does Номигрен have any warnings related to driving or operating machinery?

A: The official safety information notes possible nervous system effects, including dizziness, vertigo, and unusual tiredness. Regulatory warnings mention the potential for these documented effects to interfere with the ability to perform tasks requiring full alertness, such as driving or operating heavy machinery.

Q: Are headaches that worsen after taking Номигрен a known issue?

A: Official safety patterns documented for this class of medicine include the risk of developing a condition known as Medicine Overuse Headache. This is a safety concern associated with frequent or prolonged administration, where the medication itself contributes to an increase in headache frequency over time.

Q: Is Номигрен something you take regularly, or only when needed?

A: Regulatory guidelines explicitly state that this medication is intended only for acute, intermittent use to interrupt a headache attack that has already begun. It is not approved or intended for chronic daily administration or to prevent future headaches.

Q: Can Номигрен be taken by people with high blood pressure?

A: Official labeling strictly lists uncontrolled hypertension as a contraindication for using the medicine. Due to the vasoconstrictive nature of the active components, official safety information indicates that the medicine's use warrants careful consideration, even in individuals with high blood pressure that may be considered mild or controlled.

Q: Do any official studies discuss the long-term use of Номигрен?

A: Official documentation notes that while the initial research measured outcomes over short intervals (e.g., 2 to 24 hours), long-term effects are not fully established. Safety warnings advise that chronic use has been associated with the risk of fibrotic complications, such as thickening of internal organ tissues.

Q: Can Номигрен cause stomach upset or nausea?

A: The official safety profile for the medicine documents gastrointestinal reactions as common side effects. These documented reactions include stomach upset, nausea, and vomiting.

Q: Does caffeine in Номигрен affect sleep?

A: The formulation contains caffeine, a known central nervous system (CNS) stimulant. Regulatory side effect profiles note systemic stimulation effects such as nervousness, anxiety, or tremors, which may be related to sleep disruption.

Q: What kind of precautions are mentioned for older adults using Номигрен?

A: Formal studies on the safety and efficacy of the medication in the geriatric population (individuals over 65) are limited. However, regulatory documents note that the vasoconstrictive effects on blood circulation may be more pronounced or likely in older adults.

Q: How does Номигрен's purpose differ from triptan medicines?

A: Both this medicine and triptans act on specific serotonin receptors to cause the narrowing of blood vessels. Due to their shared action of vasoconstriction, official documents prohibit taking the two types of medicines together due to the risk of additive or synergistic side effects.

Q: Can Номигрен affect a person's mood or energy levels?

A: The safety profile documented in regulatory sources includes side effects related to energy and mood, such as unusual tiredness, weakness, nervousness, and anxiety.

Q: Is Номигрен described as having a risk of rebound headaches?

A: The risk of developing what patients commonly refer to as a 'rebound headache' is addressed in official documents using the technical term Medicine Overuse Headache (MOH). This is a known safety concern associated with frequent or prolonged administration of the acute pain medication.

Q: Why is Номигрен recommended to be taken at the start of a headache?

A: The medicine is explicitly designed as abortive therapy, meaning its purpose is to interrupt the headache process as early as possible. Taking it at the start of an attack is intended to stabilize the blood vessel irregularity before the headache is fully established.

Q: What does 'ergot alkaloid' mean in simple terms, related to this drug?

A: Ergot alkaloids are compounds that were originally derived from certain types of fungi. This component is key to the medication’s action, as it works on the blood vessels to cause vasoconstriction (narrowing) of cranial arteries.

Q: Are there different versions or strengths of Номигрен available?

A: The official regulatory documentation defines this medication as a fixed-dose combination product. This means the standard tablet form contains a specific, defined amount of each of the five active ingredients.

Q: What are the general expectations for relief when using Номигрен?

A: The therapeutic goal of the medication is described as providing abortive treatment to interrupt an acute attack. Research studies referenced in official sources typically measured outcomes such as the reduction of pain severity at set time intervals, such as two hours after administration.

Q: Is it possible to develop a dependency on Номигрен?

A: Official safety information indicates that if the medicine is taken in excess of the recommended limits or for a long period of time, it may become habit-forming. This term is used by regulatory bodies to describe the potential for dependence linked to serious unwanted effects.

Q: Are there specific instructions for what to do if an allergic reaction occurs?

A: Official safety warnings indicate that signs of an allergic reaction, such as a rash, hives, swelling of the face or throat, or trouble breathing, should be immediately reported to a physician.

Q: Does the use of Номигрен require regular monitoring by a doctor?

A: Regulatory guidance indicates that monitoring a patient's progress at regular visits by a healthcare provider is an important step to assess the effectiveness and safety of continued use.

How should Номигрен be stored and disposed of?

Storage and Disposal of Номигрен

Nomigraine tablets must be stored according to specific regulatory requirements to maintain product stability and ensure safety.

Required Storage Conditions

Storage Requirement Specification
Temperature Store below 25°C.
Protection Must be protected from light and moisture.
Container Keep in the original container.
Child Safety Store out of the sight and reach of children.

Disposal Instructions

Any unused or expired Nomigraine product must be discarded strictly in accordance with local requirements. The product should not be disposed of in general household waste, as mandated by official labeling, to comply with environmental protection procedures.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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