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FROVATRIPTAN 2.5MG FILM-COATED TABLETS

Active substance(s): FROVATRIPTAN

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Migard® 2.5mg Film-coated Tablets /
Frovatriptan 2.5mg Film-coated Tablets
(frovatriptan succinate)
This medicine is known by any of the above names but will be referred
to as Migard throughout this leaflet.
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 Migard is and what it is used for
2. What you need to know before you take Migard
3. How to take Migard
4. Possible side effects
5. How to store Migard
6. Contents of the pack and other information

1. WHAT MIGARD IS AND WHAT IT IS USED FOR
Migard contains frovatriptan, an anti-migraine treatment belonging to
the class of triptans (5-hydroxytryptamine (5HT 1 ) selective receptor
agonists).
Migard is a medicine for the treatment of the headache phase of a
migraine attack with or without aura (a temporary strange feeling
before a migraine, which varies from person to person but can affect,
for example, vision, smell, hearing).
Migard should not be used to prevent a migraine attack.
Migard is used to treat migraine attacks in adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIGARD
The diagnosis of migraine must have been clearly established by your
doctor.
Do not take Migard
• If you are allergic to frovatriptan or any of the other ingredients of
this medicine (listed in section 6).
• if you have had a heart attack, or suffer or have suffered from
certain cardiovascular diseases such as angina pectoris
(characterised by crushing pain in the chest which can extend into
the left arm), or circulation disorders of the legs or arms (especially
in the fingers and toes),
• if you have had a stroke or a transient ischaemic attack (TIA),
• if you have severely or moderately high blood pressure, or if your
blood pressure is not adequately controlled,
• if you have severe liver disease,
• in combination with certain other medicines also used in the
treatment of migraine (ergotamine and ergotamine derivatives
(including methysergide) or other triptans (5-hydroxytryptamine
(5HT 1 ) agonists).
Warning and precautions
Talk to your doctor before taking Migard:
if you are a patient at risk of coronary artery disease, including if:

you are a heavy smoker or a user of nicotine substitution therapy

you are a post-menopausal female or a male aged over 40 years
Stop taking Migard and talk to your doctor right away if you:

experience a feeling of tightness or pain in the chest, shortness
of breath and/or pain or discomfort in one or both arms, your
back, shoulders, neck, jaw, or upper part of the stomach; these
might be symptoms of a heart attack, which can occur when
taking triptans, even in patients with no history of cardio-vascular
disease (see also section 4).

have generalized skin rash and itching, rapid-onset swelling
(especially around the lips, eyes, or of the tongue), with possible
sudden difficulty in breathing and a fast heartbeat and thumping
heart. These are all symptoms and signs of allergy and wholebody hypersensitivity reaction (see also section 4).

Children and adolescents
Do not give this medicine to children and adolescents (under 18 years
of age) because the safety and efficacy of Migard have not been
established in these groups.
Other medicines and Migard
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without
a prescription.
You should not take this medicine at the same time as certain other
medicines used for the treatment of migraine:
• especially
ergotamine,
ergotamine
derivatives
(including
methysergide); you should allow at least 24 hours to elapse
between the discontinuation of these medicines and the
administration of Migard. Similarly, you should not take these
medicines within 24 hours following a dose of Migard.
• especially other triptans (5-HT 1 agonists, such as sumatriptan,
almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).
Unless otherwise directed by your doctor, you should not take this
medicine at the same time as monoamine oxidase inhibitor (MAOI)
medicines used in the treatment of depression (phenelzine,
isocarboxazid, tranylcypromine, moclobemide).
• you should also tell your doctor or pharmacist if you are taking oral
contraceptives or selective serotonin-reuptake inhibitors (citalopram,
fluoxetine, fluvoxamine, paroxetine, sertraline).
It is recommended that you do not take Migard at the same time as
taking St. John’s Wort (hypericum perforatum).
Concomitant use of Migard with the medicines listed above (especially
monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors
and hypericum perforatum) may also increase the risk of serotonin
syndrome (the symptoms of serotonin syndrome include: shivering,
sweating, agitation, trembling and abrupt contraction of muscles,
nausea, fever, confusion).
If you have any doubt about taking other medicines with Migard,
consult your doctor or pharmacist.
Migard with food and drink
Migard can be taken with food or on an empty stomach, always with an
adequate amount of water.
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 or pharmacist for advice
before taking this medicine.
Migard should not be used during pregnancy or when breast feeding,
unless you are told so by your doctor. In any case, you should not
breastfeed for 24 hours after taking Migard and during this time any
breast milk expressed should be discarded.
Driving and using machines
Migard and the migraine itself can cause drowsiness. If affected,
driving or operating machinery can be dangerous and should be
avoided.
Migard contains lactose
This product contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. HOW TO TAKE MIGARD
Always take this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
Take Migard as early as possible after the onset of the migraine
headache. Swallow one tablet whole with water.
If the first dose does not give you any relief, do not take a second
dose during the same attack. You can use Migard for any following
attacks.
If you obtain relief after the first dose, but later on suffer from the reappearance of a headache within 24 hours, you can take a second
dose provided that at least 2 hours have elapsed between the 2
doses.
Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.
Excessive use (repeated use over several consecutive days) of Migard
constitutes incorrect use of this medicine and may cause an increase
in side effects and lead to chronic daily headaches requiring the
temporary discontinuation of treatment. Consult your doctor if you start
having too frequent or daily headaches as you may be suffering from
medication overuse headache.

Use in children and adolescents
Migard should not be used in patients under 18 years of age.
Older people
As there is little experience in patients over 65 years, the use of Migard
is not recommended in patients in this age group.
If you take more Migard than you should
If you accidentally take an overdose of this medicine, tell your doctor or
pharmacist immediately or go to the emergency department of your
nearest hospital. Please remember to take the remaining tablets or this
leaflet with you.










If you stop taking Migard
No special precautions are necessary when stopping the drug.



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.
Stop taking Migard and tell your doctor right away if you experience
any of the following symptoms:

a feeling of tightness or pain in the chest, shortness of breath
and/or pain or discomfort in one or both arms, your back,
shoulders, neck, jaw, or upper part of the stomach; these might
be symptoms of a heart attack (myocardial infarction), which can
occur when taking triptans, even in patients with no history of
cardio-vascular disease;

have generalized skin rash and itching, rapid-onset swelling
(especially around the lips, eyes, or of the tongue and mucosa),
with possible sudden difficulty in breathing and a fast heartbeat
and thumping heart. These are all symptoms and signs of allergy
and whole-body hypersensitivity reaction (hypersensitivity
reactions, angioedema, anaphylaxis).
The side-effects reported with Migard were temporary, generally mild
to moderate and disappeared spontaneously. Some symptoms
reported may be caused by the migraine itself.
The following side-effects were commonly observed (estimated
frequency is more than 1 person out of 100 and less than 1 person out
of 10):
• nausea (feeling sick), dry mouth, digestion problems, stomach pain,
• fatigue, chest discomfort (sensation of slight heaviness, pressure or
tightness in the chest),
• headache, dizziness, sensation of pins and needles, most frequently
in the arms and legs, reduction or disturbance of the sensations of
touch, extreme sleepiness,
• hot flushes,
• tightness in the throat,
• sight disturbances,
• increased sweating.
The following were uncommonly observed (estimated frequency is
more than 1 person out of 1000 and less than 1 person out of 100):
• altered sense of taste, trembling, poor concentration, lethargy,
increased sensation of touch, drowsiness, involuntary muscle
contractions,
• diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach
discomfort, bloated stomach,
• awareness of heart beat (palpitations), fast heart beat, high blood
pressure, chest pain (intense tightness or feeling of pressure in the
chest),
• feeling hot, reduced tolerance of heat and cold, pain, weakness,
thirst, sluggishness, increased energy, generally feeling unwell,
sensation of spinning,
• anxiety, inability to sleep, confusion, nervousness, agitation,
depression, loss of sense of personal identity,
• coldness in the hands and feet,
• irritation of the nose, inflamed sinus, sore throat and/or voice box,
• muscle stiffness, muscle and bone pain, pain in the hands and feet,
back pain, painful joints,
• eye pain, eye irritation, painful oversensitivity to light,
• itchiness,
• ringing in the ears, earache,
• dehydration,
• passing urine frequently, production of large amounts of urine.
The following were rare (estimated frequency is more than 1 person
out of 10,000 and less than 1 person out of 1000):
• muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia),
movement problems,







constipation, burping, heartburn, irritable bowel syndrome, lip
blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in
the stomach or upper part of the small intestine, pain in the salivary
gland, inflammation of the mouth, toothache,
fever,
loss of memory, abnormal dreams, personality disorder,
nosebleed, hiccups, overbreathing, breathing disorder, irritation in
the throat,
night blindness,
skin reddening, sensation of hairs standing on end, purplish spots or
patches on skin and mucous surfaces of the body, hives,
slow heart beat,
ear discomfort, eardisorder, ear itchiness, sensitive hearing,
increase in bilirubin (a substance produced by the liver) in the blood,
decrease of calcium in the blood, abnormal urine analysis,
low sugar in the blood,
passing urine frequently at night, pain in the kidneys,
self-inflicted injury (eg bite or bruising),
swollen lymph nodes,
breast pain or discomfort.

Although the frequency cannot be estimated from the available data,
the following events were
also reported:
• allergic reactions (hypersensitivity) including generalized skin rash
and itching, rapid-onset swelling (especially around the lips, eyes, or
of the tongue), with possible sudden difficulty in breathing, that can
be associated with fast heartbeat and thumping heart (anaphylaxis),
• heart attack (myocardial infarction),
• chest discomfort or pain that is caused by a temporary spasm
(constriction) in your coronary arteries (the blood vessels that bring
oxygen and nutrients to your heart, i.e. coronary artery spasm).
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly on the Yellow Card Scheme website:
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 MIGARD
Keep out of the sight and reach of children.
Store in the original package in order to protect from moisture.
Do not store above 30°C.
Do not use this product after the expiry date printed on the carton. The
expiry date refers to the last day of that month.
Leave your tablets in the blister pack and only remove them when
required or when it is time for you to take your medicine.
If you notice that your tablets have become discoloured or show any
other signs of deterioration, speak to your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Migard contains and looks like
Each film coated tablet contains 2.5 mg frovatriptan (as succinate
monohydrate).
Each tablet also contains: Anhydrous lactose, microcrystalline
cellulose, magnesium stearate, sodium starch glycollate, silica colloidal
anhydrous.
Film coating: OPADRY white OY-L-28906: titanium dioxide (E171),
anhydrous lactose, hypromellose (E464), macrogol, triacetin.
Migard tablets are round, biconvex, white, film-coated tablets,
debossed with ‘m’ on one side and ‘2.5’ on the other.
Migard tablets are supplied in blister packs of either two or six.
Manufactured by Menarini Manufacturing Logistics and Services Srl,
Campo Di Pile – L’Aquila, Italy. Procured from within the EU by the
Product Licence holder : Caseview (PL) Ltd., 20 Alliance Court,
Alliance Road, London W3 0RB. Repackaged by: OPD Laboratories
Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
PL 13826/1636

POM

Migard
Leaflet revision date (ref) 27/01/2016
Migard is a registered trademark of Vernalis Developement Limited.
To request a copy of this leaflet in Braille, large print or audio please
call 01923 332 796.

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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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