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SUMATRIPTAN 100 MG FILM-COATED TABLETS

Active substance(s): SUMATRIPTAN SUCCINATE

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TEVA UK Ref:

Version:

231-30-63466-ZD LEA SUMATRIPTAN A/S TAB TUK
SUMATRIPTAN 50 mg
AND 100 mg TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Sumatriptan is and what it
is used for
2. What you need to know before
you take Sumatriptan
3. How to take Sumatriptan
4. Possible side effects
5. How to store Sumatriptan
6. Contents of the pack and other
information

1

WHAT SUMATRIPTAN IS
AND WHAT IT IS USED FOR

• Sumatriptan belongs to the group
of antimigraine preparations. The
active substance of Sumatriptan
Film-Coated Tablets is sumatriptan, a
5-HT¹ receptor agonist.
• Migraine headaches are thought
to result from the dilatation of
blood vessels. Sumatriptan
constricts these blood vessels,
thus relieving the migraine
headache.
• Sumatriptan is used to treat
migraine attacks with or without
aura (a warning sensation that
usually involves visual
distortions, such as light-flashes,
zigzag lines, stars, or waves).

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
SUMATRIPTAN

Do not take Sumatriptan
• if you are allergic (hypersensitive)
to sumatriptan or any of the other
ingredients of this medicine (listed
in section 6)
• if you have had a heart attack
• if you have any heart disease
• if you have symptoms that might
indicate heart disease, such as
temporary chest pain or a
sensation of pressure in your chest
• if you have a history of stroke or
transient ischaemic attack (TIA, a
minor form of stroke that lasts
less than 24 hrs)
• if you have blood circulation
problems in your legs that cause
cramp like pains when you walk
(called peripheral vascular disease)
• if you have significantly high
blood pressure, or if your blood
pressure is high despite
medication
• if you have severe liver problems
• if you use or have recently used
medicines containing ergotamine
or ergotamine derivatives
(including methysergide) or any
triptan or 5-HT¹ agonist (such as
naratriptan or zolmitriptan)
• if you use or have recently used
medicines to treat depression that
belong to the group known as
monoamine oxidase (MAO)
inhibitors.
If you think that you may have any
of these problems, or if you are in
any doubt at all, contact your doctor
before taking Sumatriptan.
Warnings and precautions
• Before you are prescribed
Sumatriptan your physician will
establish whether your headache
is caused by migraine and not by
any other condition.
Talk to your doctor or pharmacist
before taking Sumatriptan:
• if you know that you have
problems with your liver or
kidneys
• if you have been diagnosed with
epilepsy or any other disease
that reduces the threshold for
epileptic fits

• if you know that you are allergic to
antibacterial medicines that
belong to the group of
sulphonamides
• if you have controlled high blood
pressure as is in a small number
of cases sumatriptan has been
seen to increase blood pressure
• if you are taking Selective
Serotonin Reuptake Inhibitors
(SSRI) or serotonin noradrenalin
reuptake inhibitors (SNRI).
Hyperreflexia and lack of
coordination has been observed
after concomitant use of Selective
Serotonin Reuptake Inhibitors and
sumatriptan
• if you experience pain and/or
tightness in the chest or throat.
These effects are usually short
lasting. If they however persist
and you are concerned, or they
become severe, contact your
doctor immediately for advice.
• if you experience chronic daily
headaches. Taking Sumatriptan
too often may result in
developing a chronic headache. In
such cases you should contact your
doctor as you may have to stop
taking Sumatriptan.
• if you are considered to be at risk
of developing heart disease (e.g.
diabetic, heavy smoker or
undergoing nicotine replacement
therapy), and particularly if you
are a post-menopausal woman or
a man over 40 years with these
risk factors, your doctor should
check your heart function before
prescribing Sumatriptan. In very
rare cases serious heart
conditions have occurred after
taking Sumatriptan, even if no
signs of any heart disease were
found. Contact your doctor for
advice if you have any concerns
• If you take herbal preparations
containing St John’s Wort
(Hypericum perforatum) with
sumatriptan, side effects may
become more common.
Other medicines and Sumatriptan
Certain medicines may influence the
effectiveness of Sumatriptan, and
Sumatriptan may influence the
effectiveness of other medicines.
Contact your doctor if you take:
• other medicines against migraine,
such as ergotamine or any triptan
or 5-HT¹ agonist (such as
naratriptan or zolmitriptan) or
similar medicines
• medicines to treat depression
(MAO inhibitors, serotonin
re-uptake inhibitors or serotonin
noradrenaline reuptake inhibitors).
Tell your doctor or pharmacist if you
are taking or have recently taken or
might take any other medicines.
Pregnancy, breast-feeding and
fertility
Pregnancy:
• Ask your doctor or pharmacist for
advice before taking this medicine
• There is only limited information
regarding the safety of
Sumatriptan in human pregnancy.
Up to now, these data do not
indicate that there is an increased
risk for malformations. It is
recommended that you do not
take Sumatriptan during
pregnancy, unless instructed by
your doctor to do so.
Breast-feeding:
• Ask your doctor or pharmacist for
advice about taking this medicine
whilst breast-feeding
• Sumatriptan is excreted into
breast milk. You can minimise the
exposure of your baby by
avoiding breast-feeding for
12 hours after administration of
Sumatriptan, during which time
any breast milk expressed should
be discarded.
Driving and using machines
• Migraine itself or its treatment
with Sumatriptan may cause
drowsiness. Do not drive or
operate machinery if you are
affected.
Sumatriptan contains the sugar
lactose. If you have been told by
your doctor that you have an
intolerance to some sugars, contact
your doctor before taking this
medicinal product.

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19 March 2014

TEVA UK Ref:

Version:

231-30-63466-ZD LEA SUMATRIPTAN A/S TAB TUK
HOW TO TAKE
SUMATRIPTAN

• Racing heart, slow heartbeat,
palpitations, irregular heartbeat,
and serious complications of the
Always take this medicine exactly as
coronary artery, heart attack,
your doctor or pharmacist has told
transient ischaemic ECG changes
you. Check with your doctor or
• Decrease in blood pressure, which
pharmacist if you are not sure.
is a disease characterised by signs
of paleness or a blue tinge to the
Sumatriptan must not be taken to
skin and/or pain of the fingers,
prevent migraine attacks, because it
toes, ears, nose or jaw in
is intended to treat migraine attacks.
response to cold or stress
Sumatriptan must be taken as soon
(Raynaud’s phenomenon)
as possible after the migraine
• Inflammation of the colon (part of
headache appears; however, it is
the intestine), which may present
equally effective when taken at a
as lower left-sided stomach-ache
later stage of the attack.
and bloody diarrhoea (ischaemic
The recommended dose for adults
colitis)
is 50 mg. For some patients 100 mg
• Diarrhoea
may be necessary. If Sumatriptan
does not bring immediate relief, it is • Pain in the joints
not beneficial to take more tablets for • Feeling anxious
this attack. Sumatriptan can be used • Neck stiffness
• Excessive sweating.
for your next attack. If, after your
first dose, your migraine goes away If you get any side effects talk to
your doctor or pharmacist. This
but then returns, you may take
another tablet, provided it is at least includes any possible side effects
not listed in this leaflet.
two hours since you took the first
tablet.
Reporting of side effects
If you get side effects, talk to your
Do not take more than 300 mg (six
doctor or pharmacist. This includes
50 mg tablets, or three 100 mg
any possible side effects not listed in
tablets) in 24 hours.
this leaflet.
Use in children and adolescents
You can also report side effects
The use of Sumatriptan in children,
directly via the Yellow Card Scheme
adolescents and patients over 65
at: www.mhra.gov.uk/yellowcard.
years is not recommended.
By reporting side effects you can
For patients with mild to moderate
help provide more information on
liver impairment low doses of
the safety of this medicine.
25-50 mg should be considered.
Method of administration
HOW TO STORE
Swallow the tablet whole with some
SUMATRIPTAN
water.
If you take more Sumatriptan than
Keep out of the sight and reach of
you should
children.
Overdose symptoms are the same
Do not use Sumatriptan after the
as those listed in section 4 ‘Possible
expiry date which is stated on the
side effects’. If you have taken too
carton. The expiry date refers to the
many tablets, contact a doctor or
last day of that month.
hospital.
This medicinal product does not
If you have any further questions on
require any special storage
the use of this medicine, ask your
conditions.
doctor or pharmacist.
Do not throw away any medicines
via wastewater or household waste.
POSSIBLE SIDE EFFECTS
Ask your pharmacist how to throw
away medicines you no longer use.
Like all medicines, this medicine can
These measures will help protect
cause side effects, although not
the environment.
everybody gets them. Contact your
doctor if you need to discuss these.
CONTENTS OF THE PACK
The following side effects are
AND OTHER INFORMATION
possible with the following
frequencies:
What Sumatriptan contains
Common: may affect up to 1 in 10
• The active substance is
people
sumatriptan. Each tablet contains
• Drowsiness, dizziness, tingling
50 mg/100 mg of sumatriptan (as
• Temporary increase in blood
succinate).
pressure (arising soon after
• The other ingredients are:
treatment), flushing
• Tablet core: lactose
• Feeling sick (nausea) or being sick
monohydrate, croscarmellose
(vomiting)
sodium, colloidal anhydrous
• Sensation of tension. This is
silica, microcrystalline cellulose
generally transient (temporary),
and magnesium stearate
but may be strong and may appear
• Tablet coating: hypromellose,
in any part of the body, including
lactose monohydrate, titanium
chest and throat, muscle pain
dioxide (E171), macrogol 3000
• Pain, sensation of heat or cold,
and glycerol triacetate. The
pressure or tightness. These
50 mg tablets also contain iron
symptoms may be strong and
oxides red, yellow and black
they may appear in any part of the
(E172).
body, including chest and throat
What Sumatriptan looks like and
• Shortness of breath
contents of the pack
• Feeling of weakness, tiredness.
• Sumatriptan 50 mg Film-Coated
Very rare: may affect up to 1 in
Tablets are peach to pink,
10,000 people
oblong-shaped film-coated tablets
• If you have a blood test to check
debossed “5” and “0” on one side
your liver function, Sumatriptan
with scoreline on each side.
may affect your results.
• The tablet can be divided into
Some patients may have the
equal doses.
following side effects but it is not
• Sumatriptan 100 mg Film-Coated
known (frequency cannot be
Tablets are white to off-white,
estimated from the available data)
oblong-shaped film-coated tablets
how often they occur.
debossed “100” on one side and
• Allergic reactions of the skin: A
plain on the other.
skin rash such as red spots or
The product is available in pack
hives (skin lumps).
sizes of 2, 3, 4, 6, 12, 18, 24, 30 and
Anaphylaxis (Strong allergic
50 tablets.
reactions such as swelling of
Not all pack sizes may be marketed.
eyelids, face or lips and sudden
Marketing Authorisation Holder and
wheeziness, fluttering or
Manufacturer
tightness in the chest).
The Marketing Authorisation Holder
If any strong allergic reaction
is TEVA UK Limited, Eastbourne,
appears, stop taking Sumatriptan
BN22 9AG.
and contact your doctor
The company responsible for
immediately.
manufacture is TEVA UK Limited,
• Nystagmus (involuntary back-and
Eastbourne, BN22 9AG.
forth-movement of the eyeball),
scotoma (dark spots in the field of The leaflet was last revised in
03/2014.
vision), tremor and dystonia
(involuntary muscle contractions). PL 00289/0588
Fits - usually in people with a
PL 00289/0589
history of epilepsy
• Visual disturbances (flickering,
dipoplia, reduced vision, loss of
vision including permanent
defect), although these may be
caused by the migraine attack
63466-ZD
itself

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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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