Imigran Ftab 50mg Film-Coated Tablets

Section 6.1 Administrative change to update the excipient “Calcium Hydrogen Phosphate, anhydrous” in line with the Ph. Eur. to “Calcium Hydrogen Phosphate”

Section 4.4: Inclusion of warning statement for sodium
Section 5.1: The additional information was added to align to the GDS at this opportunity. The information „but does not alter cerebral blood flow,“ was added to the sentence regarding constriction of the carotid arterial circulation in animals.
SPC updated in line with QRD template

Section 4.8 (Undesirable effects)
o The following adverse reactions have been added under the General disorders and administration site conditions with a frequency “not known”:
o “Pain trauma activated”
o “Pain inflammation activated”
o The following adverse reactions have been added under the Gastrointestinal disorders with a frequency “not known”:
o “Dysphagia”

section 4.8 - update to reporting of suspected adverse reactions section

Section 6.5 – Added description of child resistant blister foil.

Changes to:

Section 4.2 - Posology and method of administration,
Section 4.4 - Special warnings and precautions for use,
Section 4.8 - Undesirable effects,
Section 5.1 - Pharmacodynamic properties

4.2       Posology and Method of Administration

Imigran Ftab is indicated for the acute intermittent treatment of migraine. Imigran Ftab should not be used prophylactically.

Imigran Ftab is recommended as monotherapy for the acute treatment of a migraine and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide) (see section 4.3)other acute migraine therapies. If a patient fails to respond to a single dose of Imigran Ftab there are no reasons, either on theoretical grounds or from limited clinical experience, to withhold products containing aspirin or non-steroidal anti-inflammatory drugs for further treatment of the attack.

It is advisable that Imigran Ftab 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 only:

The recommended adult dose of oral Imigran Ftab is a single 50 mg tablet. Some patients may require 100 mg.

If a patient does not respond to the first dose of Imigran Ftab, a second dose should not be taken for the same attack. Imigran Ftab 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 next 24 hours, provided that not more than 300 mg is taken in any 24 hour period. An interval of two hours should generally be allowed to elapse between doses.An interval of two hours should generally be allowed to elapse between doses.

The tablets should be swallowed whole with water. Patients with swallowing difficulties may choose to disperse a tablet in a small amount of water before administration. Imigran Ftab dispersed in water have a bitter taste.

Children and Adolescents (under 18 years of age)

Imigran Ftab fast disintegrating tablets are not recommended for use in children and adolescents due to insufficient data on safety and efficacy.have not been studied in adolescents or children (see Clinical Studies).

Elderly (over 65):

Experience of the use of Imigran Ftab in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population but, until further clinical data are available, the use of Imigran Ftab in patients aged over 65 years is not recommended.

Patients with Hepatic Impairment:

Impairment of hepatic function gives rise to an 80% increase in plasma sumatriptan levels after an oral dose of 100mg. The drug should therefore be used with extreme caution and at reduced dosage in these patients.

Patients with Renal Impairment:

There is no information on the effect of renal impairment.

Section 2

Statement regarding excipients updated to read: ‘For a full list of excipients, see section 6.1’

Section 6.6

Updated to read ‘Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product’

Section 8

PA number updated to new format, e.g. from PA 1077/8/6 to PA 1077/008/006

Section 9

Included the date of first authorisation and date of last renewal

Section 10

Section 4. 3

The following lines were  deleted “

Until further data are available the use of Imigran is contra-indicated in patients receiving concurrent treatment with certain antidepressants e.g. selective 5-HT reuptake inhibitors (see Interaction with other Medicinal Products and Other Forms of Interaction) and lithium.”

4.4       Special Warnings and Precautions for Use

Imigran Ftab should only be used where there is a clear diagnosis of migraine.

Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine.

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The concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.

Overuse of acute migraine treatments has been associated with the exacerbation of headache (Medication Overuse Headache, MOH) in susceptible patients. Withdrawal of the treatment may be necessary.

4.8       Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports. The data from clinical trials are estimates. It should be noted that the background rate in comparator groups was not taken into account. Post-marketing data refer to reporting rate rather than true frequency.

Clinical Trial Data:

Nervous System Disorders

Common:        Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia..

Vascular disorders

Common:        Transient increases in blood pressure arising soon after treatment. Flushing.

Respiratory, Thoracic and Mediastinal Disorders

Common:         Dyspnoea

Gastrointestinal Disorders

Common:        Nausea and vomiting occurred in some patients but the relationship to sumatriptan is not clear.

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10.       DATE OF (PARTIAL) REVISION OF THE TEXT

            June 2006July 2007

                       4.2......

Children and Adolescents (under 18 years of age)

Imigran Ftab fast disintegrating tablets have not been studied in adolescents or children (see Clinical Studies). ....................

4.4......

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs).

If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised (see Interactions).

The concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.

4.5...............There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs (see Warnings and Precautions)...........................

                4.8                   Undesirable effects

Adverse events are listed below by system organ class and frequency.  Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports. The data from clinical trials are estimates. It should be noted that the background rate in comparator groups was not taken into account. Post-marketing data refer to reporting rate rather than true frequency.

Clinical Trial Data:

Nervous System Disorders

Common:       Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

Vascular disorders

Common:       Transient increases in blood pressure arising soon after treatment.  Flushing.

Gastrointestinal Disorders

Common:       Nausea and vomiting occurred in some patients but the relationship to sumatriptan is not clear.

Musculoskeletal and Connective Tissue Disorders

The following symptom is usually transient and may be intense and can affect any part of the body including the chest and throat:

Common:                 Sensations of heaviness.

General Disorders and Administration Site Conditions

The following symptoms are usually transient and may be intense and can affect any part of the body including the chest and throat:

Common:       Pain, sensations of heat or cold,, pressure or tightness.

The following symptoms are mostly mild to moderate in intensity and transient:

Common:       Feelings of weakness, fatigue.

Investigations

Very rare:       Minor disturbances in liver function tests have occasionally been observed.

Post-Marketing Data:

Immune System Disorders

Very rare:       Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.

Nervous System Disorders

Very rare:                  Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures there are also reports in patients where no such predisposing factors are apparent. Tremor, dystonia, nystagmus, scotoma.

Eye disorders

Very rare:       Flickering, diplopia, reduced vision.         Loss of vision (usually transient). However, visual disorders may also occur during a migraine attack itself.

Cardiac disorders

Very rare:       Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see Section 4.3 Contraindications, Section 4.4 Special warnings and precautions).

Vascular disorders

Very rare:       Hypotension, Raynaud’s phenomenon.

Gastrointestinal Disorders

Very rare:       Ischaemic colitis.