Skip to Content

MIGRAITAN 50MG TABLETS

Active substance(s): SUMATRIPTAN SUCCINATE

View full screen / Print PDF » Download PDF ⇩
Transcript
MIGRAITAN® 50mg FILM-COATED TABLETS
(Sumatriptan)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep the 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 is MIGRAITAN® and what is it used for
2. What you need to know before you take MIGRAITAN®
3. How to take MIGRAITAN®
4. Possible Side Effects
5. How to store MIGRAITAN®
6. Contents of the pack and other information

1. What is MIGRAITAN® and what is it used for
The name of your medicine is MIGRAITAN® 50mg Film-Coated Tablets.
The name is referred to as MIGRAITAN® in the entire leaflet.
• MIGRAITAN® is used to treat migraine. These tablets contain
Sumatriptan succinate as active substance, which belong to a group
of medicines called ‘triptans’ (5HT1-receptor agonists).
• Migraine symptoms may be caused by the temporary swelling of
blood vessels in the head due to a temporary imbalance in the body’s
chemicals. The tablets are believed to work on this imbalance and
reduce the swelling of these blood vessels. The tablets help to take away
the headache and other symptoms of a migraine attack such as feeling
sick (nausea) and sensitivity to light and sound.

2. What you need to know before you take MIGRAITAN®
Do not take MIGRAITAN®:
• if you are allergic to Sumatriptan or any of the other ingredients of
this medicine (listed in section 6).
• if you have or have ever had heart problems, including a heart attack,
angina (chest pain caused by exercise or effort), Prinzmental’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).

SAME SIZE ARTWORK
260 x 150 mm
Front

• 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 other triptans
(5 hydroxytriptamine (5HT1) receptor agonists, such as almotriptan,
eletriptan, frovatriptan, naratriptan, rizatriptan or zolmitriptan etc.).
These must not be taken at the same time as Sumatriptan (see also “Other
medicines and MIGRAITAN®”).
• if you are currently taking MAO inhibitors (e.g. moclobemide for depression
or selegiline for Parkinson’s disease). Sumatriptan must not be used
within two weeks of discontinuation of therapy with MAO inhibitors. See
also ´Other medicines and MIGRAITAN®´below.
Warnings and Precautions
Talk to your doctor or pharmacist before taking MIGRAITAN® if:
• you are diabetic, especially if you are a woman past the menopause or
a man over 40 years. The doctor should examine you first.
• 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); MIGRAITAN® can cause seizures/fits.
MIGRAITAN® might increase the risk of seizures.
• you are hypersensitive to certain antibiotics (sulphonamides). You may
experience an allergic reaction after taking MIGRAITAN®. Caution is
advisable.
• you use herbal products containing St John’s Wort (Hypericum perforatum).
Side effects may occur with greater frequency.
MIGRAITAN® 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 MIGRAITAN®.
After taking MIGRAITAN® 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.
Overuse of MIGRAITAN® may cause chronic, daily headache or worsened
headache. Ask your doctor if you think that this is the case for you. It may be
necessary to discontinue the treatment with MIGRAITAN® in order to correct
the problem.

260 mm

Other Medicines and MIGRAITAN®
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
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.
• medicines containing ergotamine (migraine drugs) or other triptans. These
must not be taken at the same time as MIGRAITAN® (see “Do not take
MIGRAITAN®”). After taking medicines containing ergotamine, 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 atleast 24 hours before taking
medicines containing other triptans.
• MAO inhibitors (e.g. moclobemide for depression or selegiline for
Parkinson’s disease). MIGRAITAN® must not be taken within two weeks
after stopping use of MAO inhibitors.
• Use of triptans with antidepressant drugs like Selective serotonin reuptake
inhibitors (SSRI) and Serotonin - nor epinephrine reuptake inhibitors (SNRI)
may cause serotonin syndrome (a combination of symptoms that may
include confusion, hallucination, restlessness, sweating, muscle spasms,
and tremors). If you experience these symptoms please tell your doctor.
• There is a risk that concomitant use of MIGRAITAN® and lithium (for
manic depressive (bipolar) disorders) may cause serotonin syndrome.
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
MIGRAITAN® should be used during the 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.
Breast-feeding
MIGRAITAN® passes in to breast milk. You are advised not to breast-feed
within 12 hours after taking Sumatriptan. Do not feed your child with milk
expressed during this period.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been

XXXXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

150 mm

24 mm

24 mm

3. How to take MIGRAITAN®
Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Dosage:
Adults:
The recommended dose is 50mg Sumatriptan. Some patients may need to
take a dose 100mg Sumatriptan.
Children under 18 and adults over 65
Do not take this medicine if you are under 18 or over 65 and have
migraine symptoms. Talk to your doctor.
Method of administration:
Swallow each tablet whole with a glass of water, preferably as soon as
possible after onset of the migraine attack.
Duration of treatment:
If symptoms are not reduced after the first dose, you may not take a second
dose for the same attack. 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 dose within 24 hours, provided you wait at least 2 hours
between doses.
You must not take more than 300mg of Sumatriptan in any 24-hour period.
The recommended dose must not be exceeded.
If you take more MIGRAITAN® Tablets than you should
Contact your doctor or nearest (A&E) immediately. Take your medicine in its
original packaging with you in order to enable the doctor to identify your
medication easily.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions: 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.

SAME SIZE ARTWORK
260 x 150 mm
Back

If you get any of these symptoms soon after using MIGRAITAN®,
don’t take anymore. Contact your doctor straight away.
Common (may affect up to 1 in 10 people)
• Feeling dizzy, drowsy or warm, sensory disturbance
• Transient increase in blood pressure soon after treatment. Flushing
• Breathlessness
• Feeling sick, Vomiting
• Feeling of heaviness, tightness, pain or pressure in any part of
the body including throat or chest. Myalgia.
• Feeling pain, sensation of heat or cold.
• Feeling of weak and fatigue
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
Not known (frequency cannot be estimated from the available data)
• Allergic/hypersensitivity reactions, varying from skin reactions to rare
cases of anaphylaxis (sharp fall in blood pressure, pallor, agitation, weak
and rapid pulse, clammy skin, impaired consciousness). If you think that
Sumatriptan is causing an allergic reaction, stop taking it and contact
your doctor straight away.
• Fits/seizures
• Tremor
• Dystonia
• 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.
• Slow heart beat, fast heart beat, irregular heart beat, palpitations.
• Reduced blood flow to the arms and legs and consequent pallor or blur
tinge to the fingers and toes.
• Angina (pain in the chest, often brought on by exercise), heart attack or
spasm of the blood vessels of the heart, transient ischaemic ECG changes.
If you notice chest pain or shortness of breath after taking Sumatriptan,
contact your doctor and do not take any more.
• Spasm of the blood vessels of the gut, which can cause damage to your
gut. You may notice stomach pain or bloody diarrhoea. If this happens,
contact your doctor and do not take any more MIGRAITAN®.
• Diarrhoea
• Fall in blood pressure
• Stiff neck
• Joint pain
• Anxiety
• Increased perspiration

Reporting of side effects
IIf 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 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 MIGRAITAN®
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date (EXP.) which is stated on the
carton. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Contents of the pack and other information
What MIGRAITAN® Film-coated Tablets contain:
• Each film-coated tablet contains 50mg of the active ingredient Sumatriptan
(as succinate)
• The other ingredients are lactose monohydrate, microcrystalline cellulose,
pregelatinised starch, croscarmellose sodium, magnesium stearate,
hypromellose, titanium dioxide (E171), purified talc, Macrogol, iron oxide
yellow E172 and iron oxide red E172.
What MIGRAITAN® Film-coated Tablets look like and contents of
pack
MIGRAITAN® 50mg Film-coated Tablets are peach coloured and capsule
shaped, biconvex film-coated tablets with “BL” embossing on one side and
plain on the other side.
Each pack of 50mg strength contains 2 tablets in blister strips.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
MIGRAITAN® 50mg Film-coated Tablets; PL 17907/0240
This leaflet was last revised in December 2014
To request a copy of this leaflet in braille, large print or audio format, please
contact the licence holder at the address (or telephone, fax, email) above.

V15 11-12-14 D0

XXXXXX

performed. Drowsiness may occur as a result of migraine or its treatment
with sumatriptan and this may influence the ability to drive and to operate
machinery.
MIGRAITAN® contains Lactose
• If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicinal product.

Expand view ⇕

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.

Hide