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TEVA SUMATRIPTAN 50 MG FILM-COATED TABLETS

Active substance(s): SUMATRIPTAN SUCCINATE

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ZINC Ref:

EBNUK1363a LEA SUMATRIPTAN A/S TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
380 mm
120 mm
N/A
N/A

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

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 cramps 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.

4

18 September 2017
PANTONE® GREEN C

Colours Used:

SUMATRIPTAN 50 mg
AND 100 mg TABLETS

1

Version:

BLACK
CUTTER

• 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.

3

HOW TO TAKE SUMATRIPTAN

Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

Sumatriptan must not be taken to prevent
migraine attacks, because it is intended to
Talk to your doctor or pharmacist before treat migraine attacks. Sumatriptan must
taking Sumatriptan:
be taken as soon as possible after the
• if you know that you have problems
migraine headache appears; however, it is
with your liver or kidneys;
equally effective when taken at a later
• if you have been diagnosed with
stage of the attack.
epilepsy or any other disease that
The recommended dose for adults is 50 mg.
reduces the threshold for epileptic
For some patients 100 mg may be
fits;
necessary. If Sumatriptan does not bring
• if you know that you are allergic to
immediate relief, it is not beneficial to take
antibacterial medicines that belong
more tablets for this attack. Sumatriptan
to the group of sulphonamides;
can be used for your next attack. If, after
• if you have controlled high blood
your first dose, your migraine goes away
pressure as is in a small number of
cases sumatriptan has been seen to but then returns, you may take another
tablet, provided it is at least two hours
increase blood pressure;
since you took the first tablet.

ZINC Ref:

EBNUK1363a LEA SUMATRIPTAN A/S TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
380 mm
120 mm
N/A
N/A

Version:

BLACK
CUTTER

Do not take more than 300 mg (six 50 mg
tablets, or three 100 mg tablets) in 24
hours.

You can also report side effects
directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the
safety of this medicine.

5

HOW TO STORE SUMATRIPTAN

Keep out of the sight and reach of
children.

Do not use Sumatriptan after the expiry
Method of administration
Swallow the tablet whole with some water. date which is stated on the carton. The
expiry date refers to the last day of that
If you take more Sumatriptan than you
month.
should
Overdose symptoms are the same as those This medicinal product does not require
listed in section 4 ’Possible side effects’. If any special storage conditions.
you have taken too many tablets, contact a
Do not throw away any medicines via
doctor or hospital.
wastewater or household waste. Ask your
pharmacist how to throw away medicines
If you have any further questions on the
you no longer use.These measures will
use of this medicine, ask your doctor or
help protect the environment.
pharmacist.

4

POSSIBLE SIDE EFFECTS

18 September 2017
PANTONE® GREEN C

Colours Used:

Use in children and adolescents
The use of Sumatriptan in children,
adolescents and patients over 65 years is
not recommended.
For patients with mild to moderate liver
impairment low doses of 25-50 mg should
be considered.

4

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

Like all medicines, this medicine can cause
What Sumatriptan contains
side effects, although not everybody gets
• The active substance is sumatriptan.
them. Contact your doctor if you need to
Each tablet contains 50 mg/100 mg of
discuss these.
sumatriptan (as succinate).
The following side effects are possible
• The other ingredients are:
with the following frequencies:
• Tablet core: lactose monohydrate,
croscarmellose sodium, colloidal
Common: may affect up to 1 in 10 people
anhydrous silica, microcrystalline
• Drowsiness, dizziness, tingling
cellulose and magnesium stearate
• Temporary increase in blood pressure
• Tablet coating: hypromellose, lactose
(arising soon after treatment), flushing
monohydrate, titanium dioxide (E171),
• Feeling sick (nausea) or being sick
macrogol 3000 and glycerol
(vomiting)
triacetate. The 50 mg tablets also
• Sensation of tension. This is generally
contain iron oxides red, yellow and
transient (temporary), but may be
black (E172).
strong and may appear in any part of
the body, including chest and throat, What Sumatriptan looks like and contents
muscle pain
of the pack
• Pain, sensation of heat or cold,
• Sumatriptan 50 mg Film-coated
pressure or tightness. These
Tablets are peach to pink,
symptoms may be strong and they
oblong-shaped film-coated tablets
may appear in any part of the body,
debossed “5” and “0” on one side
including chest and throat
with scoreline on each side.
• Shortness of breath
• The tablet can be divided into equal
• Feeling of weakness, tiredness
doses.
• Sumatriptan 100 mg Film-coated
Very rare: may affect up to 1 in 10,000
Tablets are white to off-white,
people
oblong-shaped film-coated tablets
• If you have a blood test to check your
debossed “100” on one side and plain
liver function, Sumatriptan may affect
on the other.
your results.
The product is available in pack sizes of 2,
Some patients may have the following
3, 4, 6, 12, 18, 24, 30 and 50 tablets.
side effects but it is not known
(frequency cannot be estimated from
Not all pack sizes may be marketed.
the available data) how often they
Marketing Authorisation Holder and
occur:
Manufacturer
• Allergic reactions of the skin: A skin
rash such as red spots or hives (skin The Marketing Authorisation Holder is
lumps).
TEVA UK Limited, Eastbourne, BN22 9AG
Anaphylaxis (Strong allergic
reactions such as swelling of eyelids, The company responsible for manufacture
face or lips and sudden wheeziness,
is TEVA Pharmaceutical Works Private
fluttering or tightness in the chest).
Limited Company, H-4042 Debrecen, Pallagi
If any strong allergic reaction
str. 13, Hungary
appears, stop taking Sumatriptan and
The leaflet was last revised in 09/2017.
contact your doctor immediately.
• Nystagmus (involuntary back- and
PL 00289/0588
forth-movement of the eyeball),
PL 00289/0589
scotoma (dark spots in the field of
vision), tremor and dystonia
(involuntary muscle contractions).
Fits - usually in people with a history
of epilepsy.
• Visual disturbances (flickering,
dipoplia, reduced vision, loss of
vision including permanent defect),
although these may be caused by the
migraine attack itself.
• Racing heart, slow heartbeat,
palpitations, irregular heartbeat, and
serious complications of the
coronary artery, heart attack,
transient ischaemic ECG changes.
• Decrease in blood pressure, which is
a disease characterised by signs of
paleness or a blue tinge to the skin
and/or pain of the fingers, toes, ears,
nose or jaw in response to cold or
stress (Raynaud’s phenomenon).
• Inflammation of the colon (part of the
intestine), which may present as
lower left-sided stomach-ache and
bloody diarrhoea (ischaemic colitis).
• Diarrhoea
• Pain in the joints
• Feeling anxious
• Neck stiffness
• Excessive sweating
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.
Reporting of side effects
If you get side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet.
EBNUK1363a

+ Expand Transcript

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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