Frovex

Package leaflet: information for the user

FROVEX 2.5 mg film-coated tablets

Frovatriptan

1. What FROVEX is and what it is used for

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.

FROVEX is used to treat migraine attacks in adults.

2. What you need to know before you take FROVEX

The diagnosis of migraine must have been clearly established by your doctor

3. How to take FROVEX

Always take this medicine exactly as your doctor has told you. 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.

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 FROVEX 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 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):

• 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, ear disorder, 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).

5. How to store FROVEX

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

This medicinal product is authorised in the Member States of the EEA under the following names:

France (RMS) Tigreat

Austria Frovamig

Belgium Frovatex

Czech Republic Fromen

Germany Allegro

Greece Migralin

The Netherlands Fromirex

Hungary Frovalon

Iceland Tigreat

Ireland Frovex

Italy Auradol

Latvia Frovamig

Luxembourg Frovatex

Poland Migren

Portugal Dorlise

Slovakia Frovamen

Slovenia Frotan

Spain Perlic