Section 4.8

Text and table updated

The following definitions apply to the incidence of the undesirable effects:

Very common (≥1/10); common (≥1/100 < 1/10); uncommon (≥1/1,000 < 1/100); rare (≥1/10,000 < 1/1,000); very rare (<1/10,000).

The following undesirable effects have been reported following administration with zolmitriptan:

Table 1           Table of Adverse Drug Reactions

Section 5.1

Additional text

Pharmacotherapeutic group: Selective serotonin (5HT₁) agonists.
ATC code: N02CC03

Section 5.2

Additional text

Paragraph 8 – additional text at end

(see section 4.5 for precautions regarding ergotamine use).

Paragraph 10 – additional text at end

(see section 4.4 for warnings and precautions regarding concomitant use with SSRIs).

Section 10

New revision date of text: 3 June 2011

^{1 ZOMIG NASAL SPRAY only}

As with other 5HT _1B/1D agonists, there have been rare reports of hypersensitivity reactions, including anaphylaxis/anaphylactoid reactions, urticaria and angioedema.

²As with other acute migraine treatments, including 5HT _1B/1D agonists, there have been rare reports of headache.

³In very rare cases, as with other 5HT _1B/1D agonists, angina pectoris, myocardial infarction have been reported.

⁴As with other 5HT _1B/1D agonists very rare reports of gastrointestinal ischaemic events including ischaemic colitis, gastrointestinal infarction or necrosis, which may present as bloody diarrhoea or abdominal pain, have been received.

⁵As with other 5HT _1B/1D agonists, transient increases in systemic blood pressure, very rarely associated with significant clinical events, have been reported.  

Section 4.4

Additional information, last paragraph in section 4.4.

Serotonin Syndrome has been reported with combined use of triptans, and Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs). Serotonin Syndrome is a potentially life-threatening condition, and it may include signs and symptoms such as: mental status changes (e.g. agitation, hallucinations, coma), autonomic instability, (e.g. tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, in-coordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Careful observation of the patient is advised, if concomitant treatment with Zomig and an SSRI or SNRI is clinically warranted, particularly during treatment initiation and dosage increases (See section 4.5).  

Section 4.5

Additional information to 6^th paragraph.

However, Serotonin Syndrome has been reported during combined use of triptans, and SSRIs (e.g. fluoxetine, paroxetine, sertraline) and SNRIs (e.g. venlafaxine, duloxetine) (See section 4.4).

Section 10

New revision date of text: 28 January 2008

Section 4.2

Additional new text regarding children and adolescents:

Zomig is not indicated for prophylaxis of migraine.

Use in children (under 12 years of age)

Safety and efficacy of Zomig Nasal Spray in paediatric patients have not been evaluated. Use of Zomig Nasal Spray in children is therefore not recommended.

Adolescents (12-17 years of age)

Safety and efficacy of Zomig Nasal Spray in adolescents have not been evaluated. Use of Zomig Nasal Spray in adolescents is therefore not recommended.

Section 5.1

Additional new text (last paragraph)

One controlled clinical trial in 696 adolescents with migraine failed to demonstrate superiority of zolmitriptan tablets at doses of 2.5 mg, 5 mg and 10 mg over placebo. Efficacy was not demonstrated.

Section 10