MIGRANAL NASAL

The solution in the vial was developed especially for intranasal administration and must not be injected. 5 mg) of MIGRANAL Nasal Spray should be administered in each nostril at the onset of the migraine headache. 0 mg) of MIGRANAL Nasal Spray per attack.

The following recommendations must be observed:

The maximum dose of MIGRANAL Nasal Spray allowed within 24 hours is 2 mg (= 4 sprays) and the maximum weekly dose is 8 mg (= 16 sprays). Following the treatment of a migraine attack with MIGRANAL Nasal Spray, an interval of at least 24 hours should be observed before treating any further attack with MIGRANAL Nasal Spray, Dihydergot injections, any ergotamine-containing preparations, sumatriptan or other agonists of the 5-hydroxytryptamine1(5-HT1) receptors.

The assembled nasal spray should be discarded after the treatment of a single migraine attack as described above (1 mg or 2 mg, respectively). Elderly MIGRANAL Nasal Spray is not recommended for use in patients aged over 65 years due to a lack of data on safety and efficacy.

2). 3). Paediatric population MIGRANAL Nasal Spray is not recommended for use in children aged below 16 years due to a lack of data on safety and efficacy. Method of administration Only prepare the nasal spray when you feel an attack of migraine starting.

Once the spray device is assembled, it should be used within 8 hours. 1. Pull back the blue seal by lifting up at the lip, but do not break the blue seal off the metal collar. 2. Tear off the whole cap and metal collar. The blue seal and metal collar should come off in one piece.

If the blue seal snaps off, continue to remove the metal collar but take extra care as the edges of the metal collar may be sharp. 3. Carefully remove the rubber stopper from the bottle. 4. Gently remove the plastic protective cap from the bottom of the pump unit.

5. Insert the nasal spray pump unit into the open bottle and turn the pump clockwise to tighten. 6. Holding the bottle upright, gently remove the blue protective cap from the top of the nozzle. 7. The pump unit must be primed before first use.

To do this hold the nasal spray upright and press down firmly on the pump 4 times. Do not worry if a small amount of medicine sprays out during the priming process, this is normal. 8. Holding the spray upright, insert the nozzle and spray once into each nostril.

The most frequently reported adverse reactions are rhinitis, nausea and vomiting, altered sense of taste, dose-dependent application-site reactions such as runny nose, nasal congestion, diarrhoea, pharyngitis, dizziness and flushing.

Frequencies are 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) and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

9) Respiratory, thoracic and mediastinal disorders Uncommon Nasal congestion, rhinitis Rare Pharyngitis, dyspnoea Not known Epistaxis Gastrointestinal disorders Uncommon Nausea, vomiting Rare Diarrhoea Not known Abdominal pain Skin and subcutaneous tissue disorders Rare Rash, face oedema, urticaria Musculoskeletal and connective tissue disorders Not known Muscular spasms General disorders and administration site conditions Uncommon Application site reactions Rare Chest pain In some patients who have taken Oral dihydroergotamine continuously over years ergotism can result.

The development of fibrotic changes, in particular of the pleura and the retroperitoneum have been observed. 4). 4). 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.

MIGRANAL

Nasal Spray is not intended for use as a prophylactic treatment for migraine nor should it be used continually in the long term due to the risk of serious side effects and complications of use. Dihydroergotamine can have serious side effects, called fibrosis, including retroperitoneal, cardiac, pulmonary and pleural fibrosis and ergotism (including severe cases of symptoms of constriction of peripheral blood vessels) with possible fatal outcome.

Patients with a history of drug induced fibrotic disorders such as retroperitoneal and pleural fibrosis should be monitored with caution. Prolonged use of dihydroergotamine or other ergot derivatives must be avoided because it may lead to drug dependence.

Chronic daily use of MIGRANAL Nasal Spray or its use in excess of the recommended doses should be avoided, since it may cause vasospasm. Chronic abuse of MIGRANAL Nasal Spray may cause rebound headache. If such a condition is suspected, the treatment should be discontinued.

In rare cases, vascular spasms may occur, particularly in the lower extremities. 9). g. numbness, tingling) in the fingers and toes, non-migraine-related nausea and vomiting, and symptoms of myocardial ischaemia and chest pain. Should signs of overdosage occur, treatment must be discontinued and patients should consult their physician at once.

Caution is recommended in patients with rhinitis, nasal congestion and allergic rhinitis as well as in patients with mild to moderate hepatic impairment, especially in patients with cholestatic hepatitis.

Note:

The solution contained in the amber glass vials is specially formulated for intranasal administration and must not be injected.

1. • Conditions predisposing to vasospastic reactions: coronary heart disease (in particular unstable or vasospastic angina), septic conditions, shock, obliterative vascular disease, peripheral vascular diseases such as Raynaud’s syndrome, past history of transitory ischaemic attack or cerebral injury as well as inadequately controlled hypertension.

• Temporal arteritis • Treatment of familial hemiplegic migraine. • Treatment of basilar migraine. 6). • Patients with severely impaired hepatic function. 5). 5).