Sumarex™ Film Coated Tablets are indicated for the acute relief of migraine attacks, with or without aura.
Sumarex™ should only be used where there is a clear diagnosis of migraine.

Posology
Adults
Sumatriptan film-coated tablets are indicated for the acute intermittent treatment of migraine. They
should not be used prophylactically.

It is advisable that Sumatriptan film-coated tablets be given as early as possible after the onset of
migraine attack but it is equally effective at whatever stage of the attack it is administered.
The recommended dose of oral Sumatriptan film-coated tablets is a single 50 mg tablet. Some patients
may require 100 mg. 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 there is a minimum interval of two hours between the
two doses. No more than 300 mg should be taken in any 24 hour period.
Patients who do not respond to the prescribed dose of Sumatriptan film-coated tablets should not take a
second dose for the same attack. In these cases the attack can be treated with paracetamol,
acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Sumatriptan film-coated tablets may be
taken for subsequent attacks.
Sumatriptan film-coated tablets is recommended as monotherapy for the acute treatment of migraine
and should not be given concomitantly with ergotamine or derivatives of ergotamine (including
methysergide) (see section 4.3).
Paediatric population
The efficacy and safety of Sumatriptan film-coated 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 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 in children 10 to 17 years of age is not recommended (see section 5.1).
Elderly (Over 65 years of age)
Experience of the use of Sumatriptan film-coated tablets 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 Sumatriptan film-coated tablets in patients aged over 65 years is not
recommended.
Method of administration
The tablets should be swallowed whole with water.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or patients who have symptoms or signs consistent with ischaemic heart disease. Sumatriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). Sumatriptan should not be administered to patients with severe hepatic impairment. The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contraindicated. The concomitant administration of ergotamine or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine1 (5-HT1) receptor agonist with sumatriptan is contraindicated (see section 4.5). Concurrent administration of monoamine oxidase inhibitors and sumatriptan is contraindicated. Sumatriptan film-coated tablets must not be used within two weeks of discontinuation of therapy with monoamine oxidase inhibitors.

Sumatriptan film-coated tablets 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.
The recommended doses of sumatriptan should not be exceeded. As with other migraine therapies,
before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who
present atypical symptoms, care should be taken to exclude other potentially serious neurological
conditions.
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 which may be intense and involve the throat (see section 4.8). Where such symptoms are
thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given and
appropriate evaluation should be carried out.
Sumatriptan should not be given to patients with risk factors for ischaemic heart disease, including
those patients who are heavy smokers or users of nicotine substitution therapies, without prior
cardiovascular evaluation (see section 4.3). Special consideration should be given to postmenopausal
women and males over 40 with these risk factors. These evaluations however, may not identify every
patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients
without underlying cardiovascular disease.
Sumatriptan should be administered with caution to patients with mild controlled hypertension, since
transient increases in blood pressure and peripheral vascular resistance have been observed in a small
proportion of patients (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 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 section 4.5).
Sumatriptan should be administered with caution to patients with conditions which may affect
significantly the absorption, metabolism or excretion of drugs, e.g. impaired hepatic or renal function.
A 50mg dose should be considered in patients with hepatic impairment.

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).
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).
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose
malabsorption should not take this medicine as it contains lactose.

Studies in healthy subjects show that sumatriptan 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 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 ergotamine-containing
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 ergotamine-containing 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.
An interaction may occur between sumatriptan and monoamine oxidase inhibitors (MAOIs) and
concomitant administration 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 4.4).

Pregnancy : 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 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, embryofoetal 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.
Breastfeeding
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.

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 treatment with sumatriptan. This may influence the ability to drive
and to operate machinery.

Adverse events are listed below by system organ class and frequency [4]. Frequencies are defined as:
very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000
to <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). Some of
the symptoms reported as undesirable effects may be associated symptoms of migraine.
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 it is unclear if this is
related to sumatriptan or the underlying condition.
Musculoskeletal and Connective Tissue Disorders
Common: Sensations of heaviness (usually transient and may be intense and can affect
any part of the body including the chest and throat).
Myalgia.
General Disorders and Administration Site Conditions
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).
Investigations
Very rare: Minor disturbances in liver function tests have occasionally been observed.
Post-Marketing Data
Immune System Disorders
Not known: Hypersensitivity reactions ranging from cutaneous hypersensitivity to
anaphylaxis.
Nervous System Disorders
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
Not known: Hypotension, Raynaud's phenomenon.
Gastrointestinal Disorders
Not known: Ischaemic colitis
Diarrhoea.
Musculoskeletal, Connective Tissue and Bone Disorders
Not known: Neck stiffness.
Arthralgia.
Psychiatric disorders
Not known: Anxiety.
Skin and subcutaneous tissue disorders
Not known: Hyperhidrosis.
To reports any side effect(s):
• Saudi Arabia
-The National Pharmacovigilance and Drug Safety Centre (NPC) Fax: +966-
11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340. Toll free
phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Doses in excess of 400mg orally were not associated with side effects other than those mentioned.
If overdosage occurs, the patient should be monitored for at least ten hours and standard supportive
treatment applied as required.
It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of
Sumarex.

Pharmacotherapeutic group: Analgesics: Selective 5-HT1 receptor agonists.
ATC code: N02CC01
Sumatriptan has been demonstrated to be a specific and selective 5-Hydroxytryptamine1 (5HT1D)
receptor agonist with no effect on other 5HT receptor (5-HT2-5-HT7) subtypes. The vascular 5-
HT1D 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 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 in an attack.
Clinical response begins around 30 minutes following a 100mg oral dose.
Although the recommended dose of oral sumatriptan is 50mg, migraine attacks vary in severity both
within and between patients. Doses of 25-100mg have shown greater efficacy than placebo in clinical
trials, but 25mg is statistically significantly less effective than 50 and 100mg.

A number of placebo-controlled clinical studies assessed the safety and efficacy of oral sumatriptan
standard tablets in over 650 child and adolescent migraineurs aged 10 - 17 years. These studies failed
to demonstrate a statistically significant difference in headache relief at 2 hours between placebo and
any sumatriptan dose. The undesirable effects profile of oral sumatriptan in children and adolescents
aged 10 - 17 years was similar to that reported from studies in the adult population.

Following oral administration, sumatriptan is rapidly absorbed, 70% of maximum concentration
occurring at 45 minutes. After 100mg dose, the maximum plasma concentration is 54ng/ml. Mean
absolute oral bioavailability is 14% partly due to presystemic metabolism and partly due to incomplete
absorption. The elimination phase half-life is approximately 2 hours, although there is an indication of
a longer terminal phase. Plasma protein binding is low (14-21%), mean volume of distribution is 170
litres. Mean total plasma clearance is approximately 1160ml/min and the mean renal plasma clearance
is approximately 260ml/min. Non-renal clearance accounts for about 80% of the total clearance.
Sumatriptan is eliminated primarily by oxidative metabolism mediated by monoamine oxidase A.
Special patient populations
Hepatic Impairment
Sumatriptan pharmacokinetics after an oral dose (50 mg) and a subcutaneous dose (6 mg) were studied
in 8 patients with mild to moderate hepatic impairment matched for sex, age, and weight with 8
healthy subjects. Following an oral dose, sumatriptan plasma exposure (AUC and Cmax) almost
doubled (increased approximately 80%) in patients with mild to moderate hepatic impairment
compared to the control subjects with normal hepatic function. There was no difference between the
patients with hepatic impairment and control subjects after the s.c. dose. This indicates that mild to
moderate hepatic impairment reduces presystemic clearance and increases the bioavailability and
exposure to sumatriptan compared to healthy subjects.
Following oral administration, pre-systemic clearance is reduced in patients with mild to moderate
hepatic impairment and systemic exposure is almost doubled.
The pharmacokinetics in patients with severe hepatic impairment have not been studied (see Section
4.3 Contraindications and Section 4.4 Warnings and Precautions).
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 5HT1 or 5HT2 activity. Minor metabolites have not been identified. The pharmacokinetics of oral Sumatriptan
do not appear to be significantly affected by migraine attacks.
In a pilot study, no significant differences were found in the pharmacokinetic parameters between the
elderly and young healthy volunteers.

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.

The other ingredients are:
 Lactose Monohydrate
 Microcrystalline Cellulose Type PH102
 Croscarmellose Sodium
 Magnesium Stearate
 Opadry II White -32K280000
 Purified Water

Not applicable.

24 Months

Do not store above 30 °C.
Keep out of reach and sight of children.

Immediate Container: Alu-Alu Blister pack
Secondary Container: Carton & PIL

No special requirements.