IMIGRAN Nasal spray, solution Ref.[7805] Active ingredients: Sumatriptan

Imigran Nasal Spray should not be used prophylactically. The recommended dose of Imigran should not be exceeded.

Imigran is recommended as monotherapy for the acute treatment of a migraine attack and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide) (see section 4.3).

It is advisable that Imigran be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered.

Adults (18 years of age and over)

The optimal dose of Imigran Nasal Spray is 20 mg for administration into one nostril. However, due to inter/intra patient variability of both the migraine attacks and the absorption of sumatriptan, 10 mg may be effective in some patients.

If a patient does not respond to the first dose of Imigran, a second dose should not be taken for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Imigran may be taken for subsequent attacks.

If the patient has responded to the first dose but the symptoms recur, a second dose may be given in the following 24 hours, provided that there is a minimum interval of 2 hours between the two doses.

No more than two doses of Imigran 20 mg Nasal Spray should be taken in any 24-hour period.

Adolescents (12–17 years of age)

Use of sumatriptan in adolescents should be on the recommendation of a specialist or physician who has significant experience in treating migraine, taking into account local guidance.

The recommended dose of Imigran Nasal Spray is 10 mg for administration into one nostril.

If a patient does not respond to the first dose of Imigran, a second dose should not be taken for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs.

Imigran may be taken for subsequent attacks.

If the patient has responded to the first dose but the symptoms recur, a second dose may be given in the following 24 hours, provided that there is a minimum interval of 2 hours between the two doses.

No more than two doses of Imigran 10 mg Nasal Spray should be taken in any 24-hour period.

Children (under 12 years of age)

Imigran Nasal Spray is not recommended for use in children under 12 years of age due to insufficient data on safety and efficacy.

Elderly (over 65)

There is no experience of the use of Imigran Nasal Spray in patients over 65. The pharmacokinetics in elderly patients have not been sufficiently studied. Therefore the use of sumatriptan is not recommended until further data are available.

Single doses of sumatriptan up to 40 mg intranasally, in excess of 16 mg subcutaneously and 400 mg orally have not been associated with side effects other than those mentioned.

In clinical studies volunteers have received 20 mg of sumatriptan by the intranasal route three times a day for a period of 4 days without significant adverse effects.

If overdosage occurs, the patient should be monitored for at least 10 hours and standard supportive treatment applied as required. It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.

3 years.

Do not store above 30°C. Do not freeze.

Imigran Nasal Spray should be kept in the sealed blister, preferably in the box, to protect from light.

The container consists of a type I Ph.Eur. glass vial with rubber stopper and applicator.

Imigran 10 mg Nasal Spray: unit dose spray device containing 0.1mL solution.

Pack contains 1, 2, 4, 6, 12, or 18 sprays.

Not all pack sizes may be marketed.

No special requirements.