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MIGARD 2.5MG FILM-COATED TABLETS

Active substance(s): FROVATRIPTAN / FROVATRIPTAN SUCCINATE MONOHYDRATE

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Package leaflet: information for the user

MIGARD 2.5 mg film-coated tablets
Frovatriptan
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 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of
triptans (5-hydroxytryptamine (5HT1) selective receptor agonists).
MIGARD 2.5 mg tablets 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 2.5 mg tablets 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
6.1).
- 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
(5HT1) 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 whole-body 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 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours
following a dose of MIGARD 2.5 mg tablets.
- especially other triptans (5-HT1 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 2.5 mg tablets 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 2.5 mg tablets, consult your
doctor or pharmacist.
MIGARD with food and drink
MIGARD 2.5 mg tablets 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 2.5 mg tablets 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 2.5 mg tablets 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 2.5 mg tablets 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 2.5 mg tablet for any following attacks.
If you obtain relief after the first dose, but later on suffer from the re-appearance 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 2.5 mg tablets 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 2.5 mg tablets 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, earorder, 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via 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 MIGARD
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers
to the last day of that month.
Do not store above 30°C.
Blister: store in the original package in order to protect from moisture.
Bottle: keep the bottle tightly closed in order to protect from moisture.
Keep this medicine out of the sight and reach of children.
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 to protect the environment.
6. Contents of the pack and other information
What MIGARD contains
The active substance is frovatriptan as succinate monohydrate.
Each tablet contains 2.5 mg of frovatriptan.
The other ingredients are:
Tablet core: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch
glycollate (type A), silica colloidal anhydrous.
Tablet coat: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464),
macrogol 3000, triacetin.
What MIGARD looks like and contents of the pack
MIGARD 2.5 mg film-coated tablets are available in the form of round film-coated tablets,
debossed with “m” on one side and “2.5” on the other.
MIGARD is packed in:
Child-proof HDPE bottle: 30 tablets per each bottle
PVC/PE/ACLAR/Aluminium blister: 1, 2, 3, 4, 6 or 12 tablets per each blister
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611, Luxembourg
Manufacturer:
Almac Pharma Services Limited
Almac House, 20 Seagoe Industrial Estate
Craigavon – County Armagh
Northern Ireland
BT63 5UA - United Kingdom
or
Berlin-Chemie AG
Glienicker Weg 125 – D-12489 Berlin, Germany
or
A.Menarini Manufacturing Logistics and services s.r.l.
Via Campo di Pile – L’Aquila (AQ), Italy
or
Laboratorios Menarini S.A.
Alfonso XII, 587, 08918 - Badalona (Barcelona), Spain
Marketed by:
A. Menarini Farmaceutica Internazionale SRL
This medicinal product is authorised in the Member States of the EEA under the following
names:
France (RMS)

Isimig

Austria

Eumitan

Hungary

Migard

Poland

Migard

Belgium

Migard

Iceland

Migard

Portugal

Migard

Czech Republic Recur

Ireland

Miguar

Slovakia

Migard

Estonia

Migard

Italy

Rilamig

Slovenia

Migard

Denmark

Migard

Latvia

Migard

Spain

Forvey

Finland

Migard

Lithuania

Migard

Sweden

Migard

Germany

Migard

Luxembourg Migard

The Netherlands

Migard

Greece

Pitunal

Norway

United Kingdom

Migard

Migard

This leaflet was last revised in 09/2014.
Frovatriptan developed by Vernalis Ltd

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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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