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SUMATRIPTAN TABLETS 50MG

Active substance: SUMATRIPTAN SUCCINATE

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PATIENT INFORMATION: LEAFLET FOR THE USER

SZ00000LT000

Sumatriptan 50mg Tablets
Sumatriptan 100mg Tablets
Sumatriptan
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, t alk 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 Tablet is and what it is used for
2. What you need to know before you take Sumatriptan
3. How to take Sumatriptan Tablets
4. Possible side effects
5. How to store Sumatriptan Tablets
6. Contents of the pack and other information

1

Children and adolescents
Sumatriptan is not recommended in children and
adolescents below the age of 18 years.

What Sumatriptan Tablet is and what it
is used for

Other medicines and Sumatriptan
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Sumatriptan, the active substance in sumatriptan, belongs
to a group of medicines called triptanes, which are used to
treat migraine headache.

An interaction means that medicines used at the same time
can influence the effect(s) and/or side effect(s) of each
other. The following comments may also apply to
medicines that you have used any time in the past or are to
use in the near future.

Migraine symptoms may be caused by the temporary
widening of blood vessels in the head. Sumatriptan is
believed to reduce the widening of these blood vessels.
This in turn helps to take away the headache and relieve
other symptoms of a migraine attack, such as feeling or
being sick (nausea or vomiting) and sensitivity to light and
sound.
Sumatriptan works only when a migraine attack has
started. It will not stop you from getting an attack.
You must not use sumatriptan to prevent a migraine attack.

2

What you need to know before you take
Sumatriptan Tablets

Do not take Sumatriptan
• if you are allergic to sumatriptan or any of the other
ingredients of this medicine(listed in section 6) (see also
“Warnings and precautions” if you are allergic to certain
antibiotics (sulphonamides).
• if you have or have ever had heart problems, including a
heart attack, angina (chest pain caused by exercise or
effort), Prinzmetal’s angina (chest pain which happens
at rest) or have experienced heart related symptoms
such as shortness of breath or pressure over the chest
• if you have problems with the blood circulation to your
hands and feet (peripheral vascular disease)
• if you have had a stroke/cerebral infarction, also
described as an “attack” or cerebral haemorrhage (CVA;
cerebrovascular accident)
• if you have had a temporary disturbance of the blood
supply to the brain that left little or no residual symptoms
(TIA)
• if you have severe liver function impairment
• if you have high blood pressure
• if you are taking drugs containing ergotamine or
ergotamine derivatives (migraine drugs such as
methysergide) or any triptan/5-HT1 receptor agonist.
These must not be taken at the same time as
Sumatriptan (see also “Other medicines and Sumatriptan”)
• if you are currently taking or stopped taking MAO
inhibitors (e.g. moclobemide for depression or selegiline
for Parkinson's disease) two weeks ago. See also
´Other medicines and Sumatriptan´ below.
Warnings and Precautions
Talk to your doctor before taking Sumatriptanif:
• you are a heavy user of tobacco or products containing
nicotine (patches or chewing gum), especially if you are
a woman past the menopause or a man over 40 years.
The doctor should examine you first.
• you have liver or kidney impairment. The doctor might
adjust the dose.
• you have ever suffered seizures/fits (convulsions) or
have a predisposition to seizures/fits (convulsions);
sumatriptan can cause seizures/fits. Sumatriptan might
increase the risk of seizures.
• you are allergic to certain antibiotics (sulphonamides).
You may experience an allergic reaction after taking
sumatriptan. Caution is advisable.

• medicines containing ergotamine (migraine drugs,
including methysergide) and triptans/5-HT1 receptor
agonists. These must not be taken at the same time as
Sumatriptan (see “Do not take Sumatriptan”). After
taking medicines containing ergotamine or another
triptan/5-HT1 receptor agonist, you are advised to wait
at least 24 hours before taking Sumatriptan. After taking
Sumatriptan you are advised to wait at least 6 hours
before taking medicines containing ergotamine and at
least 24 hours before taking another triptan/5-HT1
receptor agonist.
• MAO inhibitors (e.g. moclobemide for depression or
selegiline for Parkinson's disease). Sumatriptan must
not be taken at the same time as or within two weeks
after stopping use of MAO inhibitors.
• medicines for depression and other mental conditions
called SSRIs and SNRIs. Side effects may occur.
• lithium (for manic/depressive (bipolar) disorders)
• Herbal products containing St John´s wort (Hypericum
perforatum). Side effects may occur with greater
frequency.
Please note that the above medicines may be known to
you by other names, often the brand names. In this section
only the active ingredient or therapeutic group of the
medicine is given, and not the brand name. Always
thoroughly check the pack and information leaflet of the
medicines you are already using for the active ingredient or
therapeutic group of that medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine
During pregnancy, sumatriptan must only be taken
following consultation with your doctor. Sumatriptan should
be used during pregnancy only if the potential benefit to
the mother outweighs the potential risk to the unborn child
and no other appropriate treatment option is available.
Sumatriptan passes into breast milk. You are advised not to
breastfeed within 12 hours after taking Sumatriptan. Do not
feed your child with milk expressed during this period.
Driving and using machines
Migraine itsself as well as using sumatriptan can cause
drowsiness, dizziness and weakness which may adversely
affect your speed of reaction. Wait until you have found out
how you react to sumatriptan before you drive or use
machines.
Sumatriptan contains 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

Sumatriptan must only be used if a diagnosis of “migraine”
has been clearly established in your case and other factors
have been excluded. Certain forms of migraine cannot be
treated with sumatriptan.

How to take Sumatriptan Tablets

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

After taking Sumatriptan you may feel pain in your chest
and a feeling of pressure for a short time. This can be quite
intensive and may radiate up towards your throat. In very
rare cases this may be caused by effects on your heart.
Therefore, if the symptoms do not disappear, contact your
doctor.

The recommended dose is:
Adults:
The usual dose is 50 mg sumatriptan in the event of a
migraine attack. Some patients may need to take a dose of
100 mg sumatriptan.

If you take Sumatriptan too often, your headache may
become worse. In this case, your doctor might recommend
you stop taking sumatriptan.

The tablet can be divided into equal doses.
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Older people (over 65 years of age)
Sumatriptan is not recommended for this age group.
Patients with liver impairment:
Your doctor may prescribe you low doses of ½ - 1 tablet
Sumatriptan 50 mg.
Method of administration:
Take the tablet with water, preferably as soon as possible
after onset of the migraine attack. The sumatriptan
substance has a bitter taste. The bitter taste is masked with
the aid of a grapefruit flavour.
Duration of treatment:
If symptoms are not reduced after the first dose, you must
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, such as
ibuprofen.
In the event of a subsequent attack, Sumatriptan can be
taken again.
If, after the first dose, your symptoms are reduced, but then
return, you may take a second or third dose, provided that
there is a minimum interval of 2 hours between the two
doses. You must not take more than 300 mg of Sumatriptan
in any 24-hour period.
The recommended dose must not be exceeded.
If you take more Sumatriptan than you should
When you take too much of Sumatriptan, immediately
contact your doctor or pharmacist. Side effects such as
those mentioned under “Possible side effects” may occur.
If you forget to take Sumatriptan
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

• Minor disturbances in liver function tests
• Feeling anxious
• Excessive sweating
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme: 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 Tablets

Keep out of the sight and reach of children.
Do not use Sumatriptan after the expiry date which is
stated on the carton and blister after EXP. The expiry date
refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Medicines should not be disposed off via wastewater or
household waste. Ask your pharmacist how to dispose off
medicines no longer required. These measures will help to
protect the environment.

6

Contents of the pack and other
information

What Sumatriptan contains
• The active substance is sumatriptan.
Each tablet contains 50 mg sumatriptan (as sumatriptan
succinate).
Each tablet contains 100 mg sumatriptan (as
sumatriptan succinate).

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

The other ingredients are: Ammonium methacrylate
copolymer type A, carmellose sodium (E466),
microcrystalline cellulose (E450), croscarmellose sodium
(E468), lactose monohydrate, magnesium stearate
(E470b), flavouring (grapefruit).

Some of the symptoms reported as undesirable effects may
be associated symptoms of migraine.

The 50mg tablet also contains red iron oxide (E172) and
yellow iron oxide (E172)

Allergic reaction: get doctor’s help straight away
The following side effects have occurred but their exact
frequency is not known.
• The signs of allergy include rash, hives (itchy rash);
wheezing; swollen eyelids, face or lips; complete
collapse.

What Sumatriptan looks like and contents of the pack
Sumatriptan 50 mg tablets are pink, biconvex, oblong
tablets with a break-line on both sides.
The tablet can be divided into equal halves.

If you get any of these symptoms soon after using
Sumatriptan:
Do not use Sumatriptan any more. Contact a doctor
straight away.
The side effects are listed by the following frequency:
Common: may affect up to 1 in 10 people
• Feeling of heaviness or sensations of heat or cold,
pressure or tightness.These effects may be intense,
affect any part of the body including the chest and throat
but generally pass quickly.
• Feeling dizzy
• Feeling sleepy
Feeling of unusual sensations, including numbness or
tingling
• Temporary increase in blood pressure, soon after intake
• Hot flushes
• Breathlessness
• Feeling sick and vomiting. This may be due to the
migraine itself.
• Aching muscles
• Pain
• Feeling of weakness or tiredness. These effects are
mostly mild to moderate in intensity and pass quickly.

Sumatriptan 100 mg tablets are white/off-white, biconvex,
oblong tablets with a break-line on both sides.
The tablet can be divided into equal halves.
Sumatriptan 50 mg tablets are available in packs of
2, 3, 4, 6, 8, 12, 18, 20, 24, 30, 50 and 100 tablets.
Sumatriptan 100 mg tablets are available in packs of
2, 3, 4, 6, 12, 18, 19, 20, 24 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR.
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179
Barleben, Germany or
Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork,
Ireland or
Tillomed Laboratories Ltd., 3 Howard Road, Eaton Socon,
St. Neots, Cambridgeshire, PE19 3ET, UK.
This leaflet was last revised in 02/2015.

Uncommon: may affect up to 1 in 100 people
• Somnolence
Very rare: may affect up to 1 in 10,000 people
• Disturbances in liver function tests
Frequency not known: frequency cannot be estimated
from the available data
• Allergic reactions of all degrees of severity varying from
skin reactions to allergic shock
• Temporary disturbances of the blood circulation of the
heart, spasms of the blood vessels of the heart, chest
pain, heart attack
• Slow heart beat, fast heart beat, irregular heart beat,
palpitations
• Fits/seizures
• Tremor, tremor of the eyes
• Visual field disturbances
• Muscle tone disturbances
• Impaired vision, e.g. double vision, flickering and
sometimes loss of vision with permanent impairment.
Visual disturbances can also occur as a result of the
migraine attack itself.
• Fall in blood pressure, reduced blood flow to the arms
and legs and consequent pallor and blue tinge to the
fingers and toes
• Spasms of the blood vessels of the gut, which can
cause damage to your gut. You may notice stomach
pain or bloody diarrhoea.
• Diarrhoea
• Stiff neck, pain in the joints

SZ00000LT000

Artwork Proof Box
Ref: V024: SPC & PIL update product & MHRA + National Phase
Proof no.
005.1

Date prepared:
02/06/2015

Colours:
Black
Dimensions: 145 x 340 mm

Font size:
6.5pt
Fonts:
Helvetica

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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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