Frovatriptan 2.5 mg film coated tablets

Frovatriptan 2.5 mg Film-coated Tablets

Frovatriptan 2.5 mg Film-coated Tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5-HT1) selective receptor agonists). It 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 attack, which varies from person to person but can affect, for example, vision, smell, hearing).

Frovatriptan 2.5 mg Film-coated Tablets should not be used to prevent migraine attacks. Frovatriptan 2.5 mg Film-coated Tablets is used to treat migraine attacks in adults.

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

Do not take Frovatriptan 2.5 mg Film-coated Tablets:

• if you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6).
• 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 (5-HT₁) agonists).

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Frovatriptan 2.5 mg Film-coated 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 Frovatriptan 2.5 mg Film-coated Tablets 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 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 Frovatriptan 2.5 mg Film-coated 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine 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 Frovatriptan 2.5 mg Film-coated Tablets were temporary, generally mild to moderate and spontaneously disappeared. Some symptoms reported may be caused by the migraine itself.

The following side effects were commonly observed (may affect up to 1 in 10 people):

• 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 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 effects were uncommonly observed (may affect up to 1 in 100 people):

• 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 heartbeat ( palpitations), fast heartbeat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),
• feeling hot, reduced tolerance to 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 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 effects were rare (may affect up to 1 in 1,000 people):

• muscle spasms, 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 salivary gland, inflammation of the mouth, toothache,
• fever,
• loss of memory, abnormal dreams, personality disorder,
• nosebleeds, hiccups, over breathing, 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 heartbeat,
• ear discomfort, ear disorder, ear itchiness, sensitive hearing,
• increased in bilirubin (a substance produced by the liver) in the blood, decreased 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 (e.g. 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).

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the blister and on the outer carton after EXP.

The expiry date refers to the last day of that month.

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 protect the environment.