Miotrol 2.5 Tablet 1 Strip

Miotrol contains Zolmitriptan and is indicated for the acute treatment of migraine attacks with or without aura in adults.

The recommended initial dose of Zolmitriptan is 2.5 mg.

• If the migraine does not improve within 2 hours, or returns after an initial improvement, a second dose may be taken at least 2 hours after the first dose.
• The maximum recommended single dose is 5 mg.
• The maximum total dose is 10 mg within any 24 hours.

Nasal Spray

For acute migraine, administer one 5 mg dose of Zolmitriptan nasal spray into one nostril.

• If the headache returns, a second dose may be administered after at least 2 hours.
• The maximum daily dose is 10 mg within 24 hours.
• Individual response to Zolmitriptan nasal spray may vary.
• A dose below 5 mg cannot be achieved with the nasal spray and requires an oral formulation.
• The choice of dose and route of administration should be determined according to the patient's clinical needs.
• The effectiveness of a second nasal-spray dose has not been established in placebo-controlled clinical trials.
• The safety of treating an average of more than four migraine attacks within 30 days has not been established.

Use Miotrol strictly according to the dosage and duration prescribed by a registered physician.

Contraindications

Miotrol is contraindicated in patients with:

• Ischemic coronary artery disease
• A history of stroke
• Concurrent or recent use of monoamine oxidase (MAO) inhibitors
• Known hypersensitivity to Zolmitriptan

Side Effects

The most commonly reported adverse effects include:

• Pain, pressure, or tightness in the neck, throat, or jaw
• Dizziness
• Paresthesia (tingling or abnormal sensations)
• Asthenia or weakness
• Drowsiness
• Warm or cold sensations
• Nausea
• Heaviness sensation
• Dry mouth

These effects are generally temporary. Consult your doctor if they persist, become severe, or cause significant discomfort.

Pregnancy & Lactation

Pregnancy: Zolmitriptan should be used during pregnancy only when the potential therapeutic benefit outweighs the potential risk to the fetus.

Lactation: It is not known whether Zolmitriptan is excreted into human breast milk. A healthcare professional should decide whether breastfeeding should be discontinued or treatment should be stopped, taking into consideration the importance of the medicine to the mother.

Precautions & Warnings

Rare cases of serious cardiovascular adverse reactions, including acute myocardial infarction, have been reported within several hours following administration of Zolmitriptan.

Patients may experience sensations of tightness, pain, or pressure in the chest, throat, neck, or jaw after taking Miotrol. Patients with cardiovascular risk factors should be appropriately evaluated before receiving Zolmitriptan.

Seek immediate medical attention if severe or persistent chest pain, difficulty breathing, or other serious cardiovascular symptoms occur.

Use in Special Populations

Pediatric Use: The safety and effectiveness of Zolmitriptan in patients below 18 years of age have not been established. Therefore, its use is not recommended in this age group.

Therapeutic Class

5-HT Agonists

Storage Conditions

Store below 30°C, protected from light and moisture. Keep the medicine out of the reach of children.