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IMIGRAN RECOVERY 50MG TABLETS

Active substance(s): SUMATRIPTAN SUCCINATE / SUMATRIPTAN SUCCINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Imigran Recovery, 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, triangular shaped, biconvex tablets debossed with
‘GS 1YM’ on one face and ‘50’ on the other.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Imigran Recovery is indicated for the acute relief of migraine attacks, with or
without aura. Imigran Recovery 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 Recovery 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.
Paediatric population (under 18 years of age)

The efficacy and safety of sumatriptan (film-coated) tablets/dispersible tablets in children
aged less than 10 years have not been established. No clinical data are available in this age
group.
The efficacy and safety of sumatriptan (film-coated) tablets/dispersible tablets in children 10
to 17 years of age have not been demonstrated in the clinical trials performed in this age
group. Therefore the use of Sumatriptan (film-coated) tablets/dispersible tablets in children 10
to 17 years of age is not recommended (see section 5.1).
Elderly (over 65 years of age)
Not to be used in those over 65 years of age.
Experience of the use of Imigran Recovery in patients over 65 years is limited.

4.3

Contraindications
Imigran Recovery 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,
Interaction with other medicinal products and other forms of interaction).
Monoamine oxidase inhibitors (MAOIs). Imigran Recovery must not be used within
2 weeks of discontinuation of therapy with MAOIs.
Any 5-HT1 receptor agonist (triptan).
Imigran Recovery 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 Recovery 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 Recovery 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 Recovery, the attack may
be treated with simple analgesics. Further, the diagnosis of migraine should be
reconsidered with a doctor.
The recommended dose of Imigran Recovery 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 Recovery should be taken until
considered appropriate by a doctor.
Imigran Recovery 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 Recovery 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.
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.
An interaction may occur between sumatriptan and MAOIs and concomitant
administration is contraindicated (see section 4.3).
There are limited data on an interaction with preparations containing ergotamine or
another triptan/5-HT1 receptor agonist. The increased risk of coronary vasospasm is a
theoretical possibility and concomitant administration is contraindicated (see
section 4.3).
The period of time that should elapse between the use of sumatriptan and ergotaminecontaining preparations or another triptan/5-HT1 receptor agonist is not known. This
will also depend on the doses and types of products used. The effects may be
additive. It is advised to wait at least 24 hours following the use of ergotaminecontaining preparations or another triptan/5-HT1 receptor agonist before
administering sumatriptan. Conversely, it is advised to wait at least 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.
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 precautions for use). There is a risk of
pharmacodynamic interaction between sumatriptan and tricyclic antidepressants.

4.6

Fertility, Pregnancy and lactation
Pregnancy

Imigran Recovery 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).
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 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:

Cardiac Disorders
Very rare:

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

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 (5HT1B/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.
A number of placebo-controlled clinical studies assessed the safety and efficacy of oral
sumatriptan in approximately 800 children and adolescent migraineurs aged 10 to 17 years.
These studies failed to demonstrate relevant differences in headache relief at 2 hours between
placebo and any sumatriptan dose. The undesirable effects profile of oral sumatriptan in
adolescents aged 10-17 years was similar to that reported from studies in the adult population.

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
Anhydrous calcium hydrogen phosphate
microcrystalline cellulose
sodium hydrogen carbonate
croscarmellose sodium
magnesium stearate
hypromellose (E 464)
titanium dioxide (E 171)
triacetin
iron oxide red (E 172).

6.2

Incompatibilities
None stated

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 30oC.

6.5

Nature and contents of container
Cardboard carton containing 2 tablets in an aluminium double foil blister pack.
Cardboard carton containing 2 tablets in an aluminium double foil blister pack
and a plastic carry case.

6.6

Special precautions for disposal
None stated

7

MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Ltd
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 00108/0331

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/12/2006

10

DATE OF REVISION OF THE TEXT
23/01/2015

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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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