MIGRALEVE ULTRA 50MG FILM-COATED TABLETS

Active substance: SUMATRIPTAN SUCCINATE

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ultra
50 mg Tablets
Sumatriptan
This medicine is used to relieve migraine attacks in those people who have
previously been diagnosed with migraine.
This medicine is for use by adults aged between 18 and 65 years.
Do not take this medicine:
There are some people who should not use this medicine. To find out if you
are one of them see section 2 c
If you have ever had a bad reaction to any of the ingredients. For the list of
ingredients see section 6 c
Speak to your doctor or pharmacist:
If you suffer from any of the conditions mentioned in section 2. See
section 2 c
If you are taking any other medicines see section 2 c
Follow the dosage instructions carefully. These are shown in the dosage
table. See Section 3 c
Now read this whole leaflet carefully before you use this medicine. Keep
the leaflet: you might need it again.

1 What this medicine is for

Migraleve Ultra is a medicine which is used to relieve migraine attacks (with
or without an aura), in those people who have been diagnosed with Migraine.
The tablets contain sumatriptan, which belongs to a group of medicines called
triptans (5-HT1 receptor agonists). The tablets are believed to work on the
imbalance of the body’s natural chemicals which have caused the blood vessels
in the head to temporarily swell. The tablets help to relieve the headache and
other symptoms of a migraine, such as feeling sick and sensitivity to light and
sound. They start to relieve the headache within about 30 minutes of taking them.
Migraleve Ultra is for use in adults between the age of 18 and 65 years.

!

If your headache normally lasts for longer than 24 hours.
If your pattern of symptoms has changed.
If your migraine attacks have become more frequent, are worse
than usual and last longer.
If you do not recover completely between attacks.
If you have four or more migraine attacks each month.
If you are over 50 and this is your first headache of this type.
If you have had a stroke.
If your migraine includes symptoms such as:
weakness on one side of your body
double vision
clumsy and uncoordinated movements
tinnitus (ringing in the ears)
reduced level of consciousness
seizure (fit)-like movements
a recent rash with a headache
If any of these bullet points apply to you now, or in the past, talk to a
doctor or pharmacist before taking Migraleve Ultra.

2 Before taking this medicine

This medicine is suitable for most adults, but a few people should not use it.
If you are in any doubt, talk to your doctor or pharmacist.

X Do not take this medicine...

If you have not been diagnosed with migraine by a doctor or
pharmacist.
To try and prevent a migraine attack - only take it when your
headache begins.
If you have ever had a bad reaction to triptans, sulphonamide
antibiotics or any of the ingredients in this medicine.
If you have heart problems including heart failure, a previous heart
attack, angina (chest pains) or irregular heart beat.
If you have had a stroke or a mini-stroke (also called a transient
ischaemic attack or TIA).
If you have high blood pressure or are being treated for it.
If you have kidney or liver disease.
If you have epilepsy or are prone to fits.
If you have circulation problems in your legs and have cramp-like
pains in your legs when you walk, or if your doctor has told you that
you suffer from peripheral vascular disease.

Talk to your doctor or pharmacist before taking this
medicine…

!

Talk to your doctor before taking Migraleve Ultra if
you are taking any of these medicines…

Antidepressants:
Monoamine Oxidase Inhibitors (drugs used to treat mood disorders)
- see Do not take this medicine section.
Tricyclic Antidepressants (drugs used to treat mood disorders
including doxepin and amitriptyline).

!
!

SSRI’s and SNRI’s.
Selective Serotonin Reuptake Inhibitors (SSRIs) (drugs used to treat
mood disorders including citalopram, fluoxetine, fluvoxamine,
paroxetine and sertraline).
Serotonin Noradrenaline Reuptake Inhibitors (SNRIs) (drugs used to
treat mood disorders including venlafaxine and duloxetine).
Combined oral contraceptives ("the pill").
St John’s Wort (hypericum perforatum) (a herbal medicine).

If you are pregnant or breast-feeding
If you are pregnant or could be pregnant, or you are breast-feeding, do
not take Migraleve Ultra unless you’ve agreed it with your doctor.

Driving and using machines

Either the symptoms of migraine or your medicine may make you
drowsy. If you are affected, do not drive or operate machinery.

!

Some of the ingredients can cause problems

!

Special warnings about this medicine

The tablets contain lactose. If you have been told by your doctor that
you are intolerant to some sugars, contact your doctor or pharmacist
before taking the tablets.

Your pharmacist will have checked the points listed below to make
sure this medicine is right for you.
If you are a man over 40, or a woman who has had the menopause
If you are very overweight
If you are a regular smoker (more than 10 cigarettes a day)
If you have diabetes
If you have high cholesterol
If you have a close relative who developed early heart disease either your father or brother developed heart disease before the
age of 55, or your mother or sister developed heart disease before
the age of 65.
If three or more of the points apply to you, you may be at higher risk of
heart disease - see your doctor without taking Migraleve Ultra. If you are not
sure, your doctor or pharmacist can help.
Prolonged use of any type of painkiller for headaches can make them
worse. If your headaches are daily or very frequent or getting worse you
should contact your doctor.

turn over c

0000

2. Insert and check barcode

Migraleve Ultra - Sumatriptan

1. Remove cutting form

Section 1 What this medicine is for
Section 2 Before taking this medicine
Do not take this medicine.
Talk to your doctor or pharmacist before taking this medicine.
Talk to your doctor or pharmacist before taking Migraleve Ultra
if you are taking any of these medicines.
If you are pregnant or breast-feeding.
Driving and using machines.
Some of the ingredients may cause problems.
Special warnings about this medicine.
Section 3 How to take this medicine
Dosing Information.
Special warnings whilst taking Migraleve Ultra.
If anyone takes too much of this medicine.
If you forget to take the medicine.
Section 4 Possible Side-Effects
If you experience any of the following, stop using the medicine
and seek immediate medical help.

If you have been told by your doctor that you have one of the rare
types of migraine known as hemiplegic, basilar or
ophthalmoplegic migraine.
If you are taking any of the following medicines:
Ergotamine or derivatives of ergotamine (drugs which are also used
to treat migraines such as methysergide).
Triptans (5-HT1 receptor agonist) (drugs which are also used to
treat migraines such as zolmitriptan, rizatriptan and naratriptan or
any other sumatriptan containing products).
Monoamine Oxidase Inhibitors (MAOI’s) (drugs used to treat mood
disorders) either now or within the past 2 weeks.
If any of these apply to you, get advice from a doctor or pharmacist
without using Migraleve Ultra.

If you experience any of the effects stop using the medicine and
talk to your doctor.
Other effects which may occur include.
Section 5 Storing this medicine
Section 6 Further Information
What’s in this medicine?
What the medicine looks like.
Section 7 Information on Migraine

3. Bleeds and trapping to add if necessary

3 How to take this medicine
Leaflet

Check the table below to see how much medicine to take.
For oral use only.
Do not use more than the stated dose shown in the table.
Swallow the tablet whole with a drink of water.

i
1 DH

i

Children and Adolescents under the age of 18 years

Migraleve Ultra should not be taken by children and adolescents under
the age of 18 years. Contact your doctor.

Adults aged 18 to 65 years

Age
Adults aged 18
to 65 years

!

If anyone takes too much of this medicine

!

If you forget to take the medicine

Dose

07.01.2009

Take one tablet as soon as possible at the first signs
of a migraine headache.
If your symptoms start to come back you can take a
second tablet after 2 hours.
You must leave at least 2 hours after the first tablet.

Don’t take more than two tablets in 24 hours.
Don’t take more than two tablets for the same attack.
If the first tablet does not provide any relief: Don’t take a second tablet.

Adults over the age of 65 years

!
None

None

None

None

130mm x 323mm

i

Special Warnings whilst taking Migraleve Ultra

Migraleve Ultra should not be taken by adults over the age of 65 years.
Contact your doctor.

None

None

None

None

Migraleve Ultra is only to relieve migraine symptoms. Don’t take it to
try to prevent an attack. Don’t take them until you are sure it is a
migraine and not just a headache.
If you do not get relief from the pain whilst taking these tablets it may
mean that you do not have a migraine and you should talk to your
doctor or pharmacist.
If you are taking antidepressants called SSRI’s or SNRI’s whilst taking
this medicine it can make some side-effects more likely. If you
experience weakness and/or lack of coordination, talk to your doctor.
If you are not sure if you are taking an SSRI or SNRI, talk to your
doctor or pharmacist.

If you are on the combined pill whilst taking this medicine there is an
increased risk of stroke. If your migraines have only begun within the
last 3 months or your symptoms have worsened or you have migraine
with an aura (attacks that start with disturbed vision or a change in
sensation such as ‘pins and needles’), you should contact your doctor.
Sometimes you can develop chest pain or tightness that may involve
the throat. These effects usually occur within 30 minutes, are not
usually troublesome and do not last too long, they can however be
intense. If they last for more than 2 hours or are very severe you
should contact your doctor straight away. You should not take any
more Migraleve Ultra.
If anyone takes too many Migraleve Ultra tablets, contact your doctor or
nearest Accident and Emergency department (Casualty) taking this
leaflet with you.

You should only take this medicine as required following the dosage
instructions above carefully. Do not take a double dose.

4 Possible side-effects

Migraleve Ultra tablets can have side-effects, like all medicines, although these
don’t affect everyone and are usually mild.

If you experience any of the following, stop using the
medicine and seek immediate medical help:
Very rare: (affect less than 1 in 10,000 people)
Allergic reactions: Signs of allergy include rash (such as hives); wheezing;
breathlessness; swollen eyelids, face or lips; complete collapse.
Seizures/ fits.
Pain in the lower left side of your stomach and bloody diarrhoea.
Heart problems, including heart attack and heart pains.

If you experience any of the effects stop using the
medicine and talk to your doctor:
Very rare: (affect less than 1 in 10,000 people)
Bad circulation which is shown by pale, blue-tinged skin and/or pain in
your fingers, toes, ears, nose or jaw in response to cold or stress.

Common: (affect less than 1 in 10 people)
Heaviness, pressure, tightness or pain in the chest, throat or other parts of
the body, or feelings of tingling or warmth. These effects usually develop
within 30 minutes of treatment, and are not usually troublesome. They
may be intense, but they do not last long. If these effects continue for
more than two hours, or are particularly severe (especially the chest pain),
tell your doctor straight away.

Other effects which may occur include:

Very rare: (affect less than 1 in 10,000 people)
Visual disturbances - although this is often part of the migraine attack itself.
Heart beat may go faster, slower or change rhythm.
Neck stiffness.
Liver function changes. If you have a blood test to check your liver
function tell your doctor or nurse that you are taking Migraleve Ultra.
Heart function changes. If you have an ECG to check your heart function
tell your doctor or nurse that you are taking Migraleve Ultra.
Common: (affect less than 1 in 10 people)
Tingling, dizziness, drowsiness, flushing.
Feeling sick, sickness.
Feeling faint as your blood pressure may go up and down.
Feeling weak or heavy.
Side-effects which occur but it is unknown how often:
Diarrhoea.
Pain in your joints.
Anxiety.
Excessive sweating.
If you experience any side-effects not included in this leaflet or are not sure
about anything, talk to your doctor or pharmacist.

5 Storing this medicine

Keep the product out of the reach and sight of children.
There are no special storage precautions for these tablets.
Do not use your medicine if the pack is damaged, or after the expiry date on
the packaging.

6 Further Information

What’s in this medicine?

The active ingredient in Migraleve Ultra is: 50 mg Sumatriptan base (as
sumatriptan succinate).
Other ingredients are: Lactose monohydrate, croscarmellose sodium,
microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate,
hypromellose (E464), titanium dioxide (E171), lactose monohydrate,
macrogol, glycerol triacetate, iron oxide red (E172), iron oxide yellow (E172)
and iron oxide black (E172).

What the medicine looks like

Migralve Ultra are peach coloured, scored oblong shaped film coated tablets
marked with “5” and “0”. They are available in packs of 2 tablets.
The Marketing Authorisation Licence holder and distrubuter:
McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufactured by: TEVA UK Limited, Eastbourne, BN22 9AG, England.
This leaflet was revised December 2008.
McNeil Products Limited is a licensee of the registered trade mark Migraleve.

7 Information on migraine

Most migraine attacks occur for no apparent reason. However, something
may trigger migraine attacks in some people. Triggers can be all sorts of
things. For example:
Diet. Dieting too fast, irregular meals, cheese, chocolate, red wines, citrus fruits.
Environmental. Smoking and smoky rooms, glaring light, VDU screens
or flickering TV sets, loud noises, strong smells.
Psychological. Stress, anxiety, anger, tiredness, etc.
Other. Periods (menstruation), shift work, different sleep patterns, the
menopause, some medicines e.g the Pill.
It may help if you keep a migraine diary. Note down when and where
each migraine attack started, what you were doing, and what you had
eaten that day. A pattern may emerge, and it may be possible to avoid
one or more things that may trigger your migraine attacks.
Further sources of help and information:
Migraine Action Association: 27 East Street, Leicester, LE1 6NB.
Migraine Trust: 2nd Floor, 55-56 Russell Square, London, WC1B 4HP. Tel:
020 7436 1336.
PRODIGY; Patient Information Leaflets & Self-help Contacts.

06-0133

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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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