Migard 2.5mg Film-Coated Tablets
Package leaflet: information for the user Migard™ 2.5 mg film-coated tablets
(frovatriptan succinate)
Your medicine is known as the above but will be referred to as Migard throughout the remainder of this leaflet.
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
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.
Migard contains frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HTi) 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.
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.
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).
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 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 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.
4. Possible side effects
Warning and precautions
T alk 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
T ell 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-HTi 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).
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.
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.