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IMIGRAN MIGRAINE RELIEF 50 MG FILM-COATED TABLETS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Imigran Migraine Relief, 50 mg, film-coated tablets.
2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

50 mg sumatriptan base (as the succinate salt).
For excipients, see Section 6.1.

3.

PHARMACEUTICAL FORM

Film-coated tablet.
Pink, film-coated, capsule shaped, biconvex tablets debossed with ‘GX ES3’ on one
side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Imigran Migraine Relief is indicated for the acute relief of migraine attacks, with or
without aura. Imigran Migraine Relief should only be used where there is a clear
diagnosis of migraine.

4.2

Posology and method of administration

Adults (18-65 years of age)
The recommended dose is a single 50 mg tablet that should be swallowed whole with
water. It is advisable that Imigran Migraine Relief be taken as soon as possible after
the onset of a migraine headache although it is effective at whatever stage of the
headache it is taken.
If there is a response to the first tablet but the symptoms recur, a second tablet may be
taken. However, this must be at least 2 hours after the first tablet. No more than two
50 mg tablets (total dose 100 mg) may be taken in any 24 hour period or to treat the
same attack.

If there is no response to the first tablet, a second tablet should not be taken for the
same attack.
Children and Adolescents (under 18 years of age)
Not to be used in children or adolescents under 18 years of age.
The safety and effectiveness of Imigran Migraine Relief in children have not been
established.
Elderly (over 65 years of age)
Not to be used in those over 65 years of age.
Experience of the use of Imigran Migraine Relief in patients over 65 years is limited.
4.3

Contraindications

Imigran Migraine Relief must not be used prophylactically.
Hypersensitivity to any component of the preparation or to sulphonamides.
Previous myocardial infarction, or those who have ischaemic heart disease, coronary
vasospasm (Prinzmetal’s angina), cardiac arrhythmias, peripheral vascular disease or
symptoms or signs consistent with ischaemic heart disease.
History of cerebrovascular accident (stroke) or transient ischaemic attack
(TIA / mini-stroke).
Known hypertension.
Hepatic or renal impairment.
History of seizures or other risk factors which lower the seizure threshold.
Concurrent treatment with the following medications is contra-indicated:


Ergotamine or derivatives of ergotamine (including methysergide) (see Section
4.5, Interactions).



Monoamine oxidase inhibitors (MAOIs). Imigran Migraine Relief must not be
used within 2 weeks of discontinuation of therapy with MAOIs.



Any 5-HT1 receptor agonist (triptan).

Imigran Migraine Relief is not to be used to treat the following rare variants of
migraine:



Hemiplegic migraine – migraine with aura including unilateral motor weakness.



Basilar migraine – migraine with aura symptoms originating from the brain stem
and/or both hemispheres such as double vision, difficulty in articulating words,
clumsy and unco-ordinated movements, tinnitus, reduced level of consciousness.



Ophthalmoplegic migraine – migraine headache with involvement of one or more
ocular cranial nerves resulting in weakness of the muscles controlling eye
movement.

4.4

Special warnings and precautions for use

Imigran Migraine Relief should only be used where a clear diagnosis of migraine has
been made by a doctor or a pharmacist. For pharmacy supply, patients should have an
established pattern of migraine (a history of five or more migraine attacks occurring
over a period of at least 1 year).
Imigran Migraine Relief should not be taken concomitantly with other migraine
therapies containing any triptan, ergotamine or derivative of ergotamine.
If a migraineur fails to respond to the first tablet of Imigran Migraine Relief, the
attack may be treated with simple analgesics. Further, the diagnosis of migraine
should be reconsidered with a doctor.
The recommended dose of Imigran Migraine Relief should not be exceeded.
Migraineurs whose typical headaches persist for longer than 24 hours should seek
advice from their doctor.
Migraineurs in whom the pattern of symptoms has changed, or whose attacks have
become more frequent, more persistent, or more severe, or who do not recover
completely between attacks, should seek advice from their doctor.
Anyone with atypical symptoms which include, but are not limited to, unilateral
motor weakness, double vision, clumsy and unco-ordinated movements, tinnitus,
reduced level of consciousness, seizure-like movements, or recent onset of rash with
headache should seek advice from their doctor.
Patients whose migraine symptoms appear for the first time after age 50 should seek
advice from their doctor as there may be a more serious underlying cause.
Migraineurs who experience four or more migraine attacks per month should be
referred to a doctor for ongoing management.
It should be noted that migraineurs may be at risk of certain cerebrovascular events
(e.g. cerebrovascular accident, transient ischaemic attack).

Following administration, sumatriptan can be associated with transient symptoms
including chest pain and tightness that may be intense and involve the throat (see
Section 4.8, Undesirable effects). Typically, such symptoms develop within
30 minutes of treatment and last for less than 2 hours. Where such symptoms are
thought to indicate ischaemic heart disease, medical evaluation should be obtained
immediately and no further doses of Imigran Migraine Relief should be taken until
considered appropriate by a doctor.
Imigran Migraine Relief should not be used by migraineurs in whom unrecognised
cardiac disease is likely without a prior risk assessment by a doctor or pharmacist (see
Section 4.3, Contra-indications). Special consideration should be given to
post-menopausal women and men over 40. Risk factors for heart disease include
hypercholesterolaemia, regular smoking, marked obesity, diabetes or a family history
of early heart disease (father/brother developed heart disease before the age of 55,
mother/sister developed heart disease before the age of 65). Anyone who has three or
more of these risk factors is not suitable for pharmacy supply of sumatriptan. These
evaluations may not identify everyone who has cardiac disease and, in very rare cases,
serious cardiac events have occurred without underlying cardiovascular disease.
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
use of sumatriptan and an SSRI/SNRI is considered to be appropriate, migraineurs
should be warned to see their doctor if they develop symptoms of serotonin syndrome.
Undesirable effects may be more common during concomitant use of triptans and
herbal preparations containing St John’s wort (Hypericum perforatum).
Patients with known hypersensitivity to sulphonamides may exhibit an allergic
reaction following administration of sumatriptan. Reactions may range from
cutaneous hypersensitivity to anaphylaxis. Although evidence of cross-sensitivity is
limited, treatment with Imigran Migraine Relief is contraindicated in these patients
(see Section 4.3, Contra-indications).
Women with migraine who are taking the combined oral contraceptive have an
increased risk of stroke and should seek advice from their doctor if migraine attacks
started recently (within the last 3 months), migraine symptoms have worsened or they
have migraine with aura.
As with other acute migraine treatments, chronic daily headache/exacerbation of
headache have been reported with overuse of sumatriptan and this may necessitate a
drug withdrawal.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
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.

4.5

Interaction with other medicinal products and other forms of
interaction

Studies in healthy subjects show that sumatriptan does not interact with propranolol,
flunarizine, pizotifen or alcohol.
Sumatriptan has the potential to interact with MAOIs, ergotamine and derivatives of
ergotamine. The increased risk of coronary vasospasm is a theoretical possibility and
therefore concomitant administration with MAOIs and ergotamines is
contra-indicated (see Section 4.3, Contra-indications).
Prolonged vasospastic reactions have been reported with ergotamine. As these effects
may be additive, 24 hours should elapse before sumatriptan can be taken following
any ergotamine-containing preparation. Conversely, ergotamine-containing
preparations should not be taken until 6 hours have elapsed following sumatriptan
administration.
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 4.4, Special warnings and special precautions for use). There is a risk of
pharmacodynamic interaction between sumatriptan and tricyclic antidepressants.
Undesirable effects may be more common during concomitant use of triptans and
herbal preparations containing St John’s wort (Hypericum perforatum).
4.6

Pregnancy and lactation

Pregnancy
Imigran Migraine Relief is not to be used in pregnancy or when breastfeeding unless
on the advice of a doctor.
Post-marketing data from the use of sumatriptan during the first trimester in over
1,000 women are available. Although these data contain insufficient information to

draw definitive conclusions, they do not suggest 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, embryofoetal
viability might be affected in the rabbit (see Section 5.3, Preclinical safety data).
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

Effect on ability to drive and use machines

Drowsiness may occur as a result of migraine or its treatment with sumatriptan.
Caution is recommended when skilled tasks are to be performed 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) including
isolated reports.
Immune System Disorders
Very rare:

Hypersensitivity reactions ranging from
cutaneous hypersensitivity to anaphylaxis.

Nervous System Disorders
Common:

Dizziness, drowsiness, sensory disturbance
including paraesthesia and hypoaesthesia.

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 Contra-indications, Special
Warnings and special precautions for use).

Vascular Disorders
Common:

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

Very rare:

Hypotension, Raynaud’s phenomenon.

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.

Very rare:

Ischaemic colitis.

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.

4.9

Overdose

In the event of an overdose, medical advice should be sought immediately.
There have been some reports of overdosage with Imigran Migraine Relief. Doses in
excess of 400 mg orally were not associated with side effects other than those
mentioned in Section 4.8, Undesirable 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 Imigran Migraine Relief.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics: Selective 5-HT1 receptor agonists.
ATC code: N02CC01
Sumatriptan has been demonstrated to be a specific and selective
5-hydroxytryptamine-1 (5-HT1B/D) receptor agonist with no effect on other 5-HT
receptor (5-HT2-5-HT7) subtypes. The vascular 5-HT1B receptor is found
predominantly in cranial blood vessels and mediates vasoconstriction. In animals,
sumatriptan selectively constricts the carotid arterial circulation but does not alter
cerebral blood flow. The carotid arterial circulation supplies blood to the extracranial
and intracranial tissues such as the meninges and dilatation of and/or oedema
formation in these vessels is thought to be the underlying mechanism of migraine in
man.
In addition, evidence from animal studies suggests that sumatriptan inhibits trigeminal
nerve activity. Both these actions (cranial vasoconstriction and inhibition of
trigeminal nerve activity) may contribute to the anti-migraine action of sumatriptan in
humans.
Sumatriptan relieves headache and other symptoms of migraine including nausea, and
sensitivity to light and sound. Clinical response for relief of migraine headache
begins around 30 minutes following a 50 mg oral dose.
Sumatriptan remains effective in treating menstrual migraine i.e. migraine without
aura that occurs between 3 days prior and up to 5 days post onset of menstruation.
Sumatriptan should be taken as soon as possible after the onset of a migraine
headache.

5.2

Pharmacokinetic properties

Following oral administration, sumatriptan is rapidly absorbed, 70% of maximum
concentration occurring at 45 minutes. After a 50 mg dose, the mean maximum
plasma concentration is 32 ng/ml. Mean absolute oral bioavailability is 14% partly
due to presystemic metabolism and partly due to incomplete absorption.
Plasma protein binding is low (14-21%), mean volume of distribution is 170 litres.
The major metabolite, the indole acetic acid analogue of sumatriptan is mainly
excreted in the urine, where it is present as a free acid and the glucuronide conjugate.
It has no known 5-HT1 or 5-HT2 activity. Minor metabolites have not been identified.
The elimination phase half-life is approximately 2 hours, although there is an
indication of a longer terminal phase. Mean total plasma clearance is approximately
1160 ml/min and the mean renal plasma clearance is approximately 260 ml/min.
Non-renal clearance accounts for about 80% of the total clearance. Sumatriptan is
eliminated primarily by oxidative metabolism mediated by monoamine oxidase A.
The pharmacokinetics of oral sumatriptan do not appear to be significantly affected by
migraine attacks.

5.3

Preclinical safety data

Sumatriptan was devoid of genotoxic and carcinogenic activity in in vitro systems and
animal studies.
In a rat fertility study, oral doses of sumatriptan resulting in plasma levels
approximately 200 times those seen in man after a 100 mg oral dose were associated
with a reduction in the success of insemination.
This effect did not occur during a subcutaneous study where maximum plasma levels
achieved approximately 150 times those in man by the oral route.
In rabbits, embryolethality, without marked teratogenic defects, was seen. The
relevance for humans of these findings is unknown.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
hypromellose (E464), titanium dioxide (E171), triacetin and iron oxide (E172).
6.2

Incompatibilities

Not applicable.
6.3.

Shelf life

36 months
6.4

Special precautions for storage

Do not store above 30ºC.
6.5

Nature and contents of container

Aluminium double foil blister packs in a cardboard carton, containing 2 tablets.
Cardboard carton containing 2 tablets in an aluminium double foil blister pack and a
plastic carry case.

6.6

Special precautions for disposal
None

7.

MARKETING AUTHORISATION HOLDER

SmithKline Beecham (SWG) Limited
980 Great West Road
Brentford, TW8 9GS, U.K.
Trading as:
GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8.

MARKETING AUTHORISATION NUMBER
PL 00071/0455

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/04/2006

10

DATE OF REVISION OF THE TEXT
21/05/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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