This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Frovex 2.5 mg film-coated tablets
Frovatriptan
Frovex 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists).
Frovex 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).
Frovex 2.5 mg tablets should not be used to prevent a migraine attack.
The diagnosis of migraine must have been clearly established by your doctor
In any of these cases ask for your doctor’s advice before taking Frovex.
In very rare cases a feeling of tightness or pain in the chest can occur when taking triptans, even in patients with no history of cardio-vascular disease. If this occurs contact your doctor and do not take an additional dose of this medicine.
Please tell your doctor or pharmacist if you are taking or have recently taken 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:
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).
It is recommended that you do not take Frovex 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).
Concomitant use of Frovex 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 Frovex 2.5 mg tablets, consult your doctor or pharmacist.
Frovex 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.
Ask your doctor or pharmacist for advice before taking any medicine.
Frovex 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 Frovex and during this time any breast milk expressed should be discarded.
Frovex 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.
Always take Frovex 2.5 mg tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.
Take Frovex 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 Frovex 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 Frovex 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.
Frovex should not be used in patients under 18 years of age.
As there is little experience in patients over 65 years, the use of Frovex 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 this product, ask your doctor or pharmacist.
Like all medicines, Frovex 2.5 mg tablets can cause side effects, although not everybody gets them.
A feeling of tightness or pains in the chest, sometimes intense and potentially extending to the throat, can occur within minutes of taking the medicine; if this occurs contact your doctor and do not take an additional dose of this medicine.
The side-effects reported during clinical studies with Frovex 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):
There have been cases of allergic reactions to Frovex, with skin rash and sometimes serious whole-body allergic-type reactions (anaphylaxis), with possible sudden difficulty in breathing, fast heart beat and palpitations. If this occurs, get medical help immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Do not use Frovex 2.5 mg tablets 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.
Bottle: keep the container tightly closed.
Keep out of the reach and sight of children.
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.
The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet.
The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.
Frovex 2.5 mg tablets are available in the form of round film-coated tablets, debossed with "m" on one side and "2.5" on the other.
Each blister pack contains 1, 2, 3, 4, 6 or 12 tablets.
Each child-proof bottle contains 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
or
This medicinal product is authorised in the Member States of the EEA under the following names:
France (RMS) : Tigreat
Austria : Frovamig
Hungary : Frovalon
Poland : Migren
Belgium : Frovatex
Iceland : Tigreat
Portugal : Dorlise
Czech Republic : Fromen
Ireland : Frovex
Slovakia : Frovamen
Estonia : Frovamig
Italy : Auradol
Slovenia : Frotan
Denmark : Tigreat
Latvia : Frovamig
Spain : Perlic
Finland : Tigreat
Lithuania : Frovamig
Sweden : Tigreat
Germany : Allegro
Luxembourg : Frovatex
The Netherlands : Fromirex
Greece : Migralin
Norway : Tigreat
United Kingdom : Fromig
This leaflet was last approved in June 2009.
Frovatriptan developed by Vernalis Ltd
Link to this document from your website:http://www.medicines.ie/medicine/7922/XPIL/Frovex/