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The product code(s) for this leaflet is: PL 16239/0017.
Migard
MIGARD 2.5 mg film-coated tablets
Frovatriptan
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
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.
The diagnosis of migraine must have been clearly established by your doctor
Talk to your doctor before taking MIGARD:
if you are a patient at risk of coronary artery disease, including if:
Stop taking MIGARD and talk to your doctor right away if you:
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.
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:
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 abrubt 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 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.
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.
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.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
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.
MIGARD should not be used in patients under 18 years of age.
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 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.
No special precautions are necessary when stopping the drug.
If you have any further questions on the use of thismedicine, 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:
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):
The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):
The following were rare (estimated frequency is more than 1 person out of 10,000 and less than 1 person out of 1000):
Although the frequency cannot be estimated from the available data, the following events were also reported:
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
Store in the original package 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.
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.
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:
PVC/PE/PVDC/Aluminium blister: 1, 2, 3, 4, 6 or 12 tablets per each blister
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
or
or
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
Belgium, Estonia, Finland, Hungary, Latvia, Lithuania, Luxembourg, Portugal, The Netherlands, United Kingdom (Northern Ireland): Migard
Greece: Pitunal
Italy: Rilamig
Spain: Forvey
This leaflet was last revised in May 2021.
Frovatriptan developed by Vernalis Ltd