Zolmsolan 2.5 mg 6 orodispersible films

Zolmsolan 2.5 mg 6 orodispersible films

Composition:

Each film contains:
Zolmitriptan — 2.5 mg.
Excipients: polyvinyl alcohol, polyethylene glycol, starch, glycerol, sucrose, menthol oil, simethicone.

Product Description:

Zolmitriptan is a selective 5HT1B/1D receptor agonist that induces vasoconstriction and inhibits trigeminal nerve activity by reducing the release of calcitonin gene‑related peptide, vasoactive intestinal peptide, and substance P.
Clinical studies show onset of effect within 1 hour, with peak efficacy between 2–4 hours.
Effective for migraine with or without aura, including menstrual migraine.

Indications for Use:

Relief of migraine attacks with or without aura.

Method of Administration and Dosage:

• Place the film on the tongue with dry hands.
• Recommended dose: 2.5 mg (1 film) at onset of migraine.
• If symptoms recur within 24 hours, a second dose may be taken, not earlier than 2 hours after the first.
• Maximum daily dose: 10 mg (no more than 2 doses per day).
• If no effect after the first dose, repeat administration during the same attack is unlikely to help.
• For subsequent attacks, 5 mg may be used if 2.5 mg is insufficient.
• Not indicated for migraine prophylaxis.

Contraindications:

• Hypersensitivity to any component.
• Hemiplegic, basilar, or ophthalmoplegic migraine.
• Uncontrolled hypertension.
• Ischemic heart disease, coronary vasospasm/Prinzmetal’s angina.
• Wolff–Parkinson–White syndrome or arrhythmias with accessory conduction pathways.
• Peripheral arterial disease.
• History of cerebrovascular accident (stroke or TIA).
• Severe renal failure (CrCl < 15 ml/min).
• Concomitant use with other 5HT1B/1D agonists, ergotamine or derivatives within 24 hours.
• Concomitant use with MAO‑A inhibitors or within 14 days of discontinuation.
• Lactose intolerance, lactase deficiency, glucose‑galactose malabsorption.
• Pregnancy.
• Children under 18 years.
• Elderly patients over 65 years (safety not established).

Precautions:

• Use only in clearly diagnosed migraine.
• Exclude other serious neurological conditions in atypical cases.
• Not indicated for hemiplegic, basilar, or ophthalmoplegic migraine.
• Cerebrovascular events, including stroke, have been reported with triptans.
• Caution in hepatic/renal impairment, epilepsy, glaucoma, prostatic hypertrophy, COPD.
• Avoid alcohol and sedatives during treatment.

Adverse Reactions / Side Effects:

• Nervous system: common — sensory disturbances, dizziness, hyperesthesia, paresthesia, drowsiness, sensations of heat or cold, vertigo.
• Cardiovascular system: common — palpitations.
• Gastrointestinal system: common — abdominal pain, nausea, vomiting, dry mouth.
• Musculoskeletal system: common — muscle weakness, myalgia.

Pregnancy and Lactation:

Contraindicated during pregnancy.
During lactation, use only under medical advice.

Storage Conditions:

Store at temperatures not exceeding 30 °C, in a dry place, protected from light.

Packaging:

Carton box containing 6 orally soluble films and a leaflet.