Imigran Ftab 100mg Film-Coated Tablets

Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat and arms. These symptoms may mimic angina pectoris but, in patients in whom cardiac investigations have been performed, they have only rarely been found to have been the result of coronary vasospasm. Although rare, the vasospasm may result in arrhythmia including ventricular fibrillation/ischaemia or myocardial infarction. If the patient experiences symptoms which are severe or persistent or are consistent with angina, further doses should not be taken until appropriate investigations have been carried out to check for the possibility of ischaemic changes.

There have been a number of fatalities from ventricular fibrillation and myocardial infarction.

Sumatriptan should be administered with caution to patients with controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.

Sumatriptan should be administered with caution to patients with conditions, which may affect significantly the absorption, metabolism or excretion of the drug, e.g. impaired hepatic or renal function.

Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan. Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross sensitivity is, limited, however, caution should be exercised before using sumatriptan in these patients.

Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St. John’s wort (Hypericum perforatum).

Sumatriptan should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold, as seizures have been reported in association with sumatriptan (see section 4.8).

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 (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

The recommended dose of Imigran Ftab should not be exceeded.

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.

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.

4.5       Interaction with other medicaments and other forms of interaction

There is no evidence of interactionsStudies in healthy subjects show that Imigran does not interact with propranolol, flunarizine, pizotifen or alcohol.

There are limited data on an interaction with preparations containing ergotamine or another triptan/5-HT₁ receptor agonistcontaining preparations. The increased risk of coronary vasospasm is a theoretical possibility and concomitant administration is contra-indicated (see section 4.3).

The period of time that should elapse between the use of sumatriptan and ergotamine containing preparations or another triptan/5-HT₁ receptor agonist is not known. This will also depend on the doses and type of ergotamine containing products used. The effects may be additive. It is advised to wait at least 24 hours following the use of ergotamine containing preparations or another triptan/5-HT₁ receptor agonist before administering sumatriptan. Conversely, it is advised to wait at least six 6 hours following use of sumatriptan before administering an ergotamine containing product and at least 24 hours before administering another triptan/5-HT₁ receptor agonist.(see Contra-indications).

An interaction may occur between sumatriptan and MAOIs and concomitant administration is contraindicatedThere is a risk of CNS toxicity when both MAOI’s and SSRI’s are given with Imigran; hence concomitantant use is contraindicated (see section 4.3)

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 section 4.4Warnings and Precautions).

4.6       Pregnancy and Lactation

Pregnancy:

Post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women are available. Although these data contain insufficient information to draw definitive conclusions, they do not point to an increased risk of congenital defects. Experience with the use of sumatriptan in the second and third trimester is limited.

Evaluation of experimental animal studies does not indicate direct teratogenic effects or harmful effects on peri- and postnatal development. However, embryo-foetal viability might be affected in the rabbit (see section 5.3). Administration of sumatriptan should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.Caution should be exercised by considering the expected benefit to the mother against possible risk to the foetus

Post-marketing data from multiple prospective pregnancy registries have documented the pregnancy outcomes in over 1,000 women exposed to sumatriptan. Although there is insufficient information to draw definitive conclusions, the findings have not detected an increase in the frequency of birth defects nor a consistent pattern of birth defects, amongst women exposed to sumatriptan compared with general population.

Lactation:

It has been demonstrated that following subcutaneous administration sumatriptan is excreted into breast milk. Infant exposure can be minimised by avoiding breast-feeding for 12 hours after treatment, during which time any breast milk expressed should be discarded.

4.7       Effects on the ability to drive and operate machinery

No studies on the effects on the ability to drive and use machines have been performed. Drowsiness may occur as a result of migraine or its treatment with Imigran Ftab. This may influence the ability to drive and to operate machinery.Caution is recommended in patients performing skilled tasks, e.g. driving or operating machinery.

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) , not known (cannot be estimated from the available data).  Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.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:

Immune system disorders

Not known:                   Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis.

Nervous System system Disorders disorders

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

Not known:                   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

Not known:                   Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself.

Cardiac disorders

Not known:                   Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see sections 4.3 and 4.4).

Vascular disorders

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

Not known:                   Hypotension, Raynaud’s phenomenon.

Respiratory, Thoracic thoracic and Mediastinal mediastinal Disordersdisorders

Common:                      Dyspnoea

Gastrointestinal Disorders

Common:                      Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying conditionbut the relationship to sumatriptan is not clear.

Not known:                   Ischaemic colitis.

Not known:                   Diarrhoea.

Musculoskeletal and Connective connective Tissue tissue Disordersdisorders

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 (usually transient and may be intense and can affect any part of the body including the chest and throat). Myalgia..

Not known:                   Neck stiffness.

Not known:                   Arthralgia.

General Disorders disorders and Administration administration Site site Conditionsconditions

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 (these events are usually transient and may be intense and can affect any part of the body including the chest and throat); feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient).

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.

Psychiatric disorders

Not known:                   Anxiety.

Skin and subcutaneous tissue disorders

Not known:                   Hyperhidrosis.

Post-Marketing Data: