Prescribing information

Migsun 85 mg/500 mg film-coated tablets (sumatriptan/ naproxen sodium)

Prescribing Information for Migsun

For more detailed information, please refer to the product Summary of Product Characteristics (SmPC) before prescribing.

Presentations: Film-coated tablets containing 119 mg sumatriptan succinate corresponding to 85 mg sumatriptan and 500 mg naproxen sodium corresponding to 457 mg naproxen.

Indications: For the acute treatment of the headache phase of migraine attacks with or without aura where treatment with a mono-entity product has been insufficient. For adults only. Use in elderly patients (over 65 years of age) is not recommended.

Dosage and Administration: One tablet taken as soon as possible after the onset of migraine headache. Tablets should be swallowed whole with water and may be taken with or without food.

If the patient does not respond to the first dose of Migsun, a second dose should not be given for the same migraine headache. If the patient has responded to the first dose but the symptoms recur, a second dose may be given provided that there is a minimum interval of two hours between doses. The maximum recommended dosage in a 24-hour period is two tablets taken at least two hours apart. The safety of treating an average of more than five migraine headaches in a 30-day period has not been established.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Severe cardiac failure, history of myocardial infarction or ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease. History of ischaemic stroke or transient ischemic attack. Previous hypersensitivity reactions in response to ibuprofen, aspirin or other NSAIDs. History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active acute peptic ulcer or gastrointestinal bleeding or recurring previous episodes. Moderate and severe hypertension and mild uncontrolled hypertension. Severe renal impairment. Moderate and severe hepatic impairment. Concomitant use of ergotamine, or derivatives of ergotamine or any triptan/5-hydroxytryptamine1 receptor agonist. Concomitant use of reversible or irreversible monoamine oxidase inhibitors. Within 2 weeks of discontinuation of therapy with MAOIs. Pregnancy (last trimester).

Precautions and Warnings for Use: Only to be administered where there is a clear diagnosis of migraine. Migsun is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Before treating with Migsun, care should be taken to exclude potentially serious neurological conditions if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for sumatriptan use. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.

Common Side Effects: Sumatriptan: Dizziness, tingling, drowsiness, sensory disturbance, transient increases in blood pressure, flushing, dyspnoea, nausea and vomiting, myalgia, fatigue. The following side effects are usually transient and may affect any part of the body including the chest and throat: pain, sensations of heat or cold, pressure or tightness. Naproxen sodium: headache, dizziness, light-headedness, visual disturbances, tinnitus, hearing disorders, worsening of heart failure, upper abdominal pain, heartburn, nausea, constipation, stomatitis, diarrhoea, vomiting, dyspepsia, pruritus, skin, rashes, urticaria, increased sweating, purpura, ecchymosis, tiredness. Prescribers should refer to the SmPC (section 4.8) in relation to other adverse effects.

Legal Category: POM

Pack Contents: 9 x film-coated tablets

Marketing Authorisation and Holder:

PA1327/022/001

Orion Corporation, Orionintie 1, FI-02200, Espoo, Finland

Ireland Distributor: Orion Pharma Ireland (Ltd) C/o Allphar Services, 4045 Kingswood Rd Citywest Business Park D24V06K

Date of Preparation: January 2025

Additional information is available in the SmPC or upon request from: Medical Information Orion Pharma Ireland +353 1 4688482 or email ie.medicalinformation@orionpharma.com