SUMAGRAN

Sumatriptan (as succinate) 50 and 100 mg film coated tablets

What is in this leaflet

This leaflet answers some common questions about SUMAGRAN. It does not
contain all the information available on this medicine. It does not take the
place of talking to your pharmacist or doctor. All medicines have risks and
benefits. Your pharmacist or doctor has weighed the risks of you taking
SUMAGRAN against the benefits they expect it will have for you. If you have
any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine. You may want to read it again.

What SUMAGRAN is used for and how it works

Your SUMAGRAN tablets contain the active ingredient, sumatriptan succinate.
Sumatriptan belongs to a group of medicines known as serotonin agonists.

SUMAGRAN is used for the acute relief of migraine attacks, with or without
what is known as 'aura' or a forewarning of an attack. This may include visual
disturbances such as brilliant flickering lights or blurring of vision; or
sensory disturbances such as numbness or weakness of the limbs. SUMAGRAN is
only suitable in patients who have a stable, well-established pattern of
symptoms. It should not be used to prevent migraine attacks from occurring.

Migraine attacks are thought to be caused by the swelling of blood vessels
in the brain. Sumatriptan helps to relieve the symptoms of a migraine attack
by reducing the size of the blood vessels back to normal. SUMAGRAN tablets
help to relieve other symptoms that occur together with a migraine headache,
such as feeling sick and sensitivity to light and sound.

SUMAGRAN does not relieve the symptoms of other headaches that are not
migraine headaches.

Before you take SUMAGRAN

When you must not take it

  • Do not take SUMAGRAN if you are allergic to sumatriptan succinate,
    sulfur (e.g. sulfonamides) or any ingredients listed at the end of this
    leaflet


    Symptoms of an allergic reaction may include shortness of breath, wheezing
    or difficulty breathing; swelling of the face, lips, tongue or other parts
    of the body; rash, itching or hives on the skin.
  • Do not take SUMAGRAN if you have or have ever had:
    • Heart disease, or previous heart attack
    • Vascular problems (including a stroke or clot)
    • High blood pressure
    • Angina, including Prinzmetal's angina
    • Shortness of breath, pain or tightness in the chest, neck, jaw or
      upper arm
    • Liver failure
  • Do not take SUMAGRAN if you have taken monoamine oxidase inhibitors (MAOIs),
    a type of medicine used for depression within the last 14 days.


    Ask your pharmacist or doctor if you are unsure as to whether or not you are
    taking a MAOI
  • Do not take SUMAGRAN if you have taken any of the following other
    medicines used to treat migraines in the past 24 hours:
    • Other Sumatriptan containing medicines (eg. Imigran)
    • Other medicines belonging to the group of medicines known as the
      triptans or serotonin agonists (eg. naratriptan, rizatriptan)
    • Ergotamine containing preparations (eg. Cafergot) or derivatives of
      ergotamine (including methylsergide containing preparations (eg. Deseril)
  • Do not take SUMAGRAN if you are pregnant, plan to become pregnant or
    you are breastfeeding, without first discussing this with your doctor.


    Your pharmacist or doctor will assess the risks and benefits of taking
    SUMAGRAN if you are pregnant or breastfeeding.
  • Do not take SUMAGRAN after the expiry date (EXP) printed on
    the pack.


    If you take them after the expiry date has passed, they may not work as
    well.
  • Do not take SUMAGRAN if the packaging is torn or shows signs of
    tampering.

If you have not told your doctor about any of the above, tell them before
you take SUMAGRAN.

Before you take it

Tell your doctor if you are allergic to:

  • Any other medicines, foods, dyes or preservatives
  • Lactose, or if you are lactose intolerant
  • Any other medicines, especially any medicine that contains sulfur.

Tell your doctor if you have, or have ever had any other health
problems, especially the following:

  • Liver or kidney problems
  • A stroke
  • Epilepsy or fits
  • Brain tumour, or any other condition effecting the brain
  • Any problems with your heart, including irregular heart beats, or if you
    have a family history of heart problems
  • High blood pressure
  • High cholesterol
  • Angina or any other chest pain or tightness
  • Shortness of breath, pain of tightness in the chest, neck, jaw or upper
    arm

If you have not told your doctor about any of the above, tell them before
you take SUMAGRAN.

You must tell your doctor if you:

  • are over 65 or under 18 years of age
  • are taking a medicine for depression called a selective serotonin
    reuptake inhibitor (SSRI) or a serotonin noradrenaline reuptake inhibitor (SNRI)
  • have not had your headache diagnosed by a doctor as a migraine
  • think that this headache is different and worse than your usual migraine
  • have difficulty moving one side of your body when you have a "migraine"
    headache
  • have not responded to your first dose of SUMAGRAN.

Taking other medicines

Tell your doctor if you are taking any other medicines, or have taken any
other medicines in the past two weeks, including any that you buy without a
prescription from your pharmacy, supermarket or health shop.

Some medicines may affect how well other medicines work. Your pharmacist or
doctor has more information on medicines to be careful with or avoid while
taking SUMAGRAN.

How to take SUMAGRAN

Take your medicine as your doctor has told you. The label on the pack will
tell you how many tablets to take and how often you should take them. If you
do not understand what you should do, ask your doctor or pharmacist.

How much to take

The recommended starting dose for adults is 50 mg, however you may need to
have your dose of SUMAGRAN increased to 100 mg. Your doctor will tell you
which dose is right for you.

Your SUMAGRAN tablet may take up to four hours to work. If the first
SUMAGRAN tablet helps your headache, but the headache comes back later
,
you may take another SUMAGRAN tablet. Do not take more than 300 mg of
SUMAGRAN in any twenty-four hours.
Six pink (50 mg strength) or three
white (100 mg strength) tablets contain 300 mg.

If the first SUMAGRAN tablet does not relieve or help your migraine
headache
, do not take another SUMAGRAN tablet for this same attack.
You may take something else for the pain but do not take medicine
containing ergotamine or dihydroergotamine or methysergide. If you are not
sure what to do, ask your doctor or pharmacist. They can tell you what you may
take.

If the first SUMAGRAN tablet does not relieve your migraine, you may use
Sumagran
tablets on another occasion to treat another migraine attack.

How to take it

SUMAGRAN tablets should be swallowed whole with a glass of water. Do not
crush or chew the tablets. It does not matter if you take SUMAGRAN before or
after food.

When to take it

It is best to take your SUMAGRAN tablet either when the migraine headache
begins or when other symptoms of the migraine headache begin. These symptoms
may include nausea (feeling sick), vomiting or your eyes becoming sensitive to
light.

If you take your first SUMAGRAN tablet during the migraine attack, and not
at the beginning as recommended, it may still work for you.

Do not take your SUMAGRAN tablet before the above symptoms occur.

While you are taking SUMAGRAN

Things you must do

Tell all doctors, dentists and pharmacists who treat you that you are
currently, or have recently taken SUMAGRAN.

If you are about to be started on any new medicine, remind your doctor that
you are currently, or have recently taken SUMAGRAN.

Tell your doctor if you are pregnant, plan to become pregnant or are
breastfeeding.

Things you must not do

Do not give SUMAGRAN to anyone else, even if they have the same condition
as you.

Do not use SUMAGRAN to treat any other medical complaints.

Do not use SUMAGRAN for any other headache that is not a migraine headache.
. SUMAGRAN only treats migraine headaches.

Do not take SUMAGRAN to try and prevent a migraine attack.

Things to be careful of

Be careful driving or operating machinery until you know how SUMAGRAN
affects you.

Drowsiness may occur as a result of a migraine or its treatment with SUMAGRAN.
It is therefore important that you are certain SUMAGRAN does not affect your
performance before you drive a car or operate machinery.

Side effects

Tell your doctor as soon as possible if you do not feel well while you
are taking SUMAGRAN.

Like all medicines, SUMAGRAN can have some unwanted effects. Sometimes they
are serious, most of the time they are not. You may need medical treatment if
you get some of the side effects.

Tell your doctor if you notice any of the following and they worry you:

  • flushing, dizziness or feelings of weakness
  • drowsiness or fatigue (tiredness)
  • nausea (feeling sick) or vomiting
  • feelings of tingling, warmth, cold, heaviness, pressure, or pain in
    different parts of the body
  • decreased feeling or sensitivity, especially in the skin.

These are generally mild adverse effects and may occur in a small number of
people.

Tell your doctor as soon as possible if you notice any of the following:

  • visual disturbances including flicking, double vision or changes in your
    vision
  • shaking, tremors or uncontrolled movement
  • changes in the speed of your heart rate (increase or decrease) or
    irregular heart beat.

These may be serious side effects. You may require urgent medical
attention. These side effects are rare.

Tell your doctor immediately or go to Accident and Emergency at your
nearest hospital if you notice any of the following:

  • pain, heaviness, pressure or tightness in any part of the body including
    the chest or throat
  • swelling of the face, lips or tongue which may cause difficulty in
    swallowing or breathing
  • wheezing
  • sudden or severe itching, skin rash or hives
  • fainting, seizures or fits

If you experience any of these side effects, you may have had a serious
allergic reaction to SUMAGRAN. You may need urgent medical attention or
hospitalisation. These side effects are very rare.

The list of side effects mentioned above is not complete. If you should
suffer from any of these side effects or any other undesired effect please
tell your pharmacist or doctor.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

Immediately contact your doctor or the National Poisons Information
Centre (0800 POISON or 0800 764 766) or go to the Emergency department at your
nearest hospital, if you think that you may have taken too much, or if anyone
else has taken SUMAGRAN by mistake. Do this even if there are no signs of
discomfort or poisoning. You may need urgent medical attention.
Take the
pack of SUMAGRAN with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Storage

Keep SUMAGRAN where children cannot reach it. A locked cupboard at
least one-and-a-half metres above the ground is a good place to store
medicines.

Keep your SUMAGRAN in a cool dry place where the temperature stays below
25°C.

Do not store SUMAGRAN or any other medicine in the bathroom or near a sink.
Do not leave SUMAGRAN in the car or on window sills. Heat and dampness
can destroy some medicines.

Disposal

If you do not take your SUMAGRAN tablet(s) or it has passed the expiry
date, ask your pharmacist what to do with the remaining medicine.

Product Description

What Sumagran tablets look like

SUMAGRAN 50mg tablets are pink, round, film coated tablets. They are
marked with "SU50" on one side and "G" on the other side.

SUMAGRAN 100mg tablets are white, round, film coated tablets. They are
marked with "SU100" on one side and "G" on the other side.

Each SUMAGRAN tablet contains the active ingredient, sumatriptan (as
succinate).

Each SUMAGRAN 50mg tablet also contains the ingredients lactose,
microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
titanium dioxide, polydextrose, hypromellose, glycerol triacetate,
polyethylene glycol, iron oxide red and iron oxide yellow.

Each SUMAGRAN 100mg tablet also contains the ingredients lactose,
microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
titanium dioxide, polydextrose, hypromellose, glycerol triacetate and
polyethylene glycol.


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