ZOLMITRIPTAN GRUNENTHAL

Posology The recommended dose of Zolmitriptan Grünenthal Nasal Spray to treat a migraine attack is 5 mg. Zolmitriptan Grünenthal Nasal Spray is administered as a single dose into one nostril. Zolmitriptan Grünenthal Nasal Spray provides particularly rapid onset of relief of migraine with the first signs of efficacy apparent within 15 minutes of dosing.

Zolmitriptan Grünenthal Nasal Spray provides an alternative non–oral formulation of zolmitriptan to that of Zomig oral tablets and orodispersible tablets. This formulation may also be beneficial where a non–oral route of treatment is either needed or preferred.

If symptoms persist or return within 24 hours a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose. Zolmitriptan Grünenthal Nasal Spray is effective whenever the nasal spray is administered during a migraine attack; although it is advisable that Zolmitriptan Grünenthal Nasal Spray is taken as early as possible after the onset of migraine headache.

In the event of recurrent attacks, it is recommended that the total intake of Zolmitriptan Grünenthal Nasal Spray in a 24 hour period should not exceed 10 mg. Zolmitriptan Grünenthal Nasal Spray is not indicated for prophylaxis of migraine.

Paediatric population (under 12 years of age) The safety and efficacy of Zolmitriptan Grünenthal Nasal Spray in children aged 12 years or under has not yet been established. Use of Zolmitriptan Grünenthal Nasal Spray in children is therefore not recommended.

Use in adolescents (from the age of 12 years) The recommended dose of Zolmitriptan Grünenthal Nasal to treat a migraine attack is 5 mg. It is advisable that Zolmitriptan Grünenthal Nasal is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage.

Elderly The safety and efficacy of Zolmitriptan Grünenthal Nasal Spray in individuals aged over 65 years have not been systematically evaluated. Hepatic Impairment The effect of hepatic disease on the pharmacokinetics of zolmitriptan nasal spray has not been evaluated.

2). 2). Method of administration For nasal inhalation.

Summary of the safety profile Zolmitriptan is well tolerated. Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment. Possible adverse reactions tend to occur within 4 hours of dosing and are no more frequent following repeated dosing.

Tabulated list of adverse reactions Adverse reactions are classified according to frequency and system organ class.

Frequency categories are defined according to the following convention:

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). The following undesirable effects have been reported following administration with zolmitriptan: System Organ Class Frequency Undesirable Effect Immune system disorders Rare Anaphylaxis/Anaphylactoid Reactions; Hypersensitivity reactions.

Nervous system disorder Common Abnormalities or disturbances of sensation; Dizziness; Headache; Hyperaesthesia; Paraesthesia; Somnolence; Warm sensation. Common Palpitations. Uncommon Tachycardia. Cardiac disorders Very rare Angina pectoris; Coronary vasospasm; Myocardial infarction.

Vascular disorders Uncommon Transient increases in systemic blood;pressure. Respiratory , thoracic and mediastinal disorders Common Epistaxis; Discomfort of nasal cavity. Gastrointestinal disorders Common Abdominal pain; Dry mouth; Nausea; Vomiting; Dysphagia.

Very rare Bloody diarrhoea; Gastrointestinal infarction or necrosis; Gastrointestinal ischaemic events; Ischaemic colitis; Splenic infarction. Skin and subcutaneous tissue disorders Rare Angioedema; Urticaria. Musculoskeletal and connective tissue disorders Common Muscle weakness; Myalgia.

Uncommon Polyuria; Increased urinary frequency. Renal and urinary disorders Very rare Urinary urgency. General disorders and administration site conditions Common Asthenia; Heaviness, tightness, pain or pressure in throat, neck, limbs or chest.

Paediatric population Data from multicentre, double-blind, randomised placebo-controlled, cross-over clinical trial involving 168 paediatric subjects (6 to 11 years) with migraine headache as well as post- marketing data support the adverse event profile.

The type and severity of adverse reactions were similar to those in adults. However, no statements can be made regarding the frequencies. No new safety issues have been identified from the completed paediatric trial for the age group investigated.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Zolmitriptan Grünenthal Nasal Spray should only be used where a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. There are no data on the use of Zolmitriptan Grünenthal Nasal Spray in hemiplegic or basilar migraine.

Migraineurs may be at risk of certain cerebrovascular events. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists. Zolmitriptan Grünenthal Nasal Spray should not be given to patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathways.

In very rare cases, as with other 5HT1B/1D agonists, coronary vasospasm, angina pectoris and myocardial infarction have been reported. 3). 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.

8) have been reported after the administration of Zolmitriptan Grünenthal Nasal Spray. If chest pain or symptoms consistent with ischaemic heart disease occur, no further doses of zolmitriptan should be taken until after appropriate medical evaluation has been carried out.

As with other 5HT 1B/1D agonists transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events.

As with other 5HT 1B/1D agonists, there have been rare reports of anaphylaxis/anaphylactoid reactions in patients receiving Zolmitriptan Grünenthal Nasal Spray. Prolonged use of any type of painkiller for headaches can make them worse.

If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Serotonin syndrome has been reported with combined use of triptans and serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin- norepinephrine reuptake inhibitors (SNRIs). Serotonin Syndrome is a potentially life- threatening condition and diagnosis is likely when (in presence of a serotonergic agent) one of the following is observed: • Spontaneous clonus • Inducible or ocular clonus with agitation or diaphoresis, • Tremor and hyperreflexia • Hypertonia and body temperature >38°C and inducible or ocular clonus.

5). Withdrawal of the serotonergic drugs usually brings about a rapid improvement. Treatment depends on the type and severity of the symptoms.

1 • Uncontrolled hypertension • Ischaemic heart disease • Coronary vasospasm/Prinzmetal’s angina • A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA) • Concomitant administration of Zolmitriptan Grünenthal Nasal Spray with ergotamine or ergotamine derivatives or other 5-HT1 receptor agonists.