SUVEXX

Posology Adults Suvexx is indicated for the acute treatment of migraine and it should not be used prophylactically. The recommended dose of sumatriptan/naproxen should not be exceeded. It is advisable that sumatriptan/naproxen be given as early as possible after the onset of migraine headache, but it is effective when administered at any stage of the headache phase.

The recommended dosage for adults is one tablet of sumatriptan/naproxen 85 mg/457 mg. If the patient does not respond to the first dose of sumatriptan/naproxen, a second dose should not be taken for the same attack. 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 the two doses.

The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart. The safety of treating an average of more than 5 migraine attacks in a 30-day period has not been established. Paediatric population The efficacy and safety of sumatriptan/naproxen in children aged less than 18 years have not been established.

Elderly (Over 65 years of age) Sumatriptan/naproxen has not been studied in geriatric patients and its use in this population is not recommended. Elderly patients are more likely to have age- associated decreased hepatic and renal function.

Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of sumatriptan/naproxen has not been studied. 3). Sumatriptan/naproxen is not recommended in patients with mild hepatic impairment (Child Pugh A). If there is a need to use sumatriptan/naproxen in patients with mild hepatic impairment, only one dose should be used within a 24-hour period and patient should be monitored during treatment.

Renal Impairment The effect of renal impairment on the pharmacokinetics of sumatriptan/naproxen has not been studied. 3). In patients with mild or moderate renal impairment, only one dose should be administered within a 24-hour period and renal function should be monitored during treatment.

Method of administration Oral use. Suvexx tablets should be swallowed whole with water. Tablets should not be split, crushed, or chewed as this can affect the optimised rate of drug absorption. Suvexx tablets may be administered with or without food.

Summary of safety profile Since Suvexx contains both sumatriptan succinate and naproxen sodium, the same pattern of adverse reactions reported for these individual components may occur with the combination product. Serious cardiac events, including some that have been fatal, have occurred following the use of 5-HT1 agonists, such as sumatriptan.

These events are very rare and most have been reported in patients with risk factors predictive of coronary artery disease (CAD). 4). The most common adverse reactions encountered with NSAIDs, such as naproxen, are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe.

Fatalities have occurred particularly in the elderly. Most commonly reported adverse reactions in adults with sumatriptan/naproxen in clinical trials (incidence ≥ 2%) were: dizziness, somnolence, paresthesia, nausea, dry mouth, dyspepsia, chest discomfort.

No new safety findings were identified during sumatriptan/naproxen treatment compared to the established safety profile for the individual substances. Tabulated list of adverse reactions Frequencies have been defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Sumatriptan Organ system Common Rare Very rare Not known Immune system disorders Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis Psychiatric disorders Anxiety Nervous system disorders Dizziness, tingling, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia Seizures*, tremor, dystonia, nystagmus, scotoma Eye disorders Flickering, diplopia, reduced vision.

4) Vascular disorders Transient increases in blood pressure arising soon after treatment. flushing Hypotension, Raynaud's syndrome Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Nausea and vomiting*** Ischaemic colitis, diarrhoea, dysphagia Skin and subcutaneous tissue disorders Hyperhidrosis Musculoskeletal and connective tissue disorders Myalgia Neck stiffness, arthralgia Reproductive system and breast disorders Breast pain General disorders and administration site conditions Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and Pain trauma activated, pain inflammation activated Organ system Common Rare Very rare Not known may be intense and affect any part of the body including the chest and throat).

Sumatriptan/naproxen should only be used where there is a clear diagnosis of migraine. Sumatriptan/naproxen is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. g. stroke, TIA) if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for sumatriptan use.

2, and gastrointestinal and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events. According to International Headache Society (IHS), regular intake of acute or symptomatic migraine medication for more than 9 days a month and more than 3 months may predispose to medication overuse headache (MOH).

It usually, but not invariably, resolves after the overuse is stopped. Cardiovascular and cerebrovascular effects Sumatriptan Sumatriptan, a component of Suvexx, can cause coronary artery vasospasm. 3). Sumatriptan/naproxen is not recommended in patients with family history or risk factors predictive of coronary artery disease.

8). Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given and an appropriate evaluation should be carried out. 3). Special consideration should be given to postmenopausal women and males over 40 with these risk factors.

These evaluations however, may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease. 3). Naproxen Naproxen sodium, a component of Suvexx, is a non-steroidal anti-inflammatory drug (NSAID).

Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

1 Sumatriptan/naproxen is contraindicated in patients with • 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 (TIA), because these patients are at a higher risk of ischaemic stroke.

g. nasal polyps, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti- inflammatory/analgesic drugs (NSAIDs). These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients.

73m2) • moderate and severe hepatic impairment. g. g. 5). 5). 6).