Package leaflet: Information for the patient

Frovatriptan Mylan 2.5 mg film-coated tablets

frovatriptan
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Frovatriptan Mylan is and what it is used for
What you need to know before taking Frovatriptan Mylan
How to take Frovatriptan Mylan
Possible side effects
How to store Frovatriptan Mylan
Contents of the pack and other information

1. What Frovatriptan Mylan is and what it is used for

Frovatriptan Mylan contains the active substance frovatriptan, which belongs to a group of medicines called triptans.
Frovatriptan Mylan is used to treat migraine in adults.

2. What you need to know before taking Frovatriptan Mylan

Do not take Frovatriptan Mylan

if you are allergic to frovatriptan or to any of the other excipients of this medicine (listed in section 6)
if you have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Frovatriptan Mylan if:
During treatment
If you experience a severe allergic reaction while taking Frovatriptan Mylan, such as skin redness,
hives, swelling of the mouth, lips, tongue or throat causing difficulty breathing or swallowing, nausea or
vomiting, collapse or unconsciousness, stop taking this medicine and contact your doctor or go
immediately to the Emergency Room of the nearest hospital (see section 4 “Possible unwanted
effects”).
While taking Frovatriptan Mylan, you may experience pain or a feeling of pressure in the chest or throat. If
these symptoms do not quickly go away, stop taking Frovatriptan Mylan and inform your doctor
immediately.
If you develop frequent or daily headaches while taking this medicine, stop taking Frovatriptan
Mylan and contact your doctor. The prolonged use of painkillers to treat headaches may worsen the headaches.
Children and adolescents
Frovatriptan Mylan must not be given to children and adolescents under 18 years of age, as it is unknown how this medicine affects them.
Other medicines and Frovatriptan Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
In particular, inform your doctor if you are taking:

Medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, isocarboxazid or tranylcypromine, as these may cause high blood pressure or serotonin syndrome.
Oral contraceptives, as they may increase the amount of frovatriptan in your body.

Driving and using machines
This medicine and migraine itself may cause drowsiness. Do not drive or operate machinery if you feel drowsy, are experiencing a migraine attack, or after taking Frovatriptan Mylan.
Frovatriptan Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Frovatriptan Mylan

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately or go to the nearest Emergency Room if you experience any of the following
reactions:
Rare (may affect up to 1 in 1,000 people)

Burning stomach pain, usually occurring right after eating or 1 to 2 hours later. This may be a sign of a stomach or upper small intestine ulcer.

Frequency not known (frequency cannot be estimated from the available data)

Severe allergic reactions such as skin redness, hives, swelling of the mouth, lips, tongue or throat, causing difficulty breathing or swallowing, nausea or vomiting, collapse or loss of consciousness
Sudden chest pain that may spread to the neck or arms, accompanied by a sensation of cold, clammy skin or shortness of breath. These may be signs of a heart attack (myocardial infarction)
A feeling of pressure, tightness or heaviness in the chest with chest pain lasting for a short time. These may be signs of a temporary narrowing of the heart's blood vessels (coronary artery spasm).

Other possible side effects include:
Common (may affect up to 1 in 10 people)

Dizziness; headache, abnormal or absent touch sensation, tingling, pins and needles in the fingers of the hands or feet, drowsiness
Feeling of warmth (hot flushes)
Vision disorders
Increased sweating
Stomach pain, nausea, indigestion, dry mouth
Fatigue; chest heaviness or discomfort, throat tightness

Uncommon (may affect up to 1 in 100 people)

Altered taste sensation, tremor, difficulty concentrating, lethargy, increased sensitivity to touch, muscle contractions
Diarrhea, difficulty swallowing, abdominal bloating, stomach discomfort, stomach swelling
Rapid heartbeat felt as pounding in the chest (palpitations), increased heart rate, chest pain
Feeling of coldness in hands and feet
Feeling of warmth, reduced tolerance to heat and cold, pain, weakness, thirst, fatigue, excess energy, general feeling of malaise
Clouded or light-headed feeling, with dizziness when sitting or standing up (vertigo)
Anxiety, insomnia, confusion, nervousness, agitation, depression, loss of sense of personal identity
Stuffy or runny nose, sometimes with facial pain and tenderness, sore throat
Muscle or joint stiffness, muscle or joint pain, pain in hands and feet, back pain
Eye pain, eye irritation, painful sensitivity to light (photophobia)
Itching
Ringing in the ears (tinnitus), earache
Dehydration
Increased urine production; more frequent urination
Increased blood pressure

Rare (may affect up to 1 in 1,000 people)

Increased or decreased muscle tone, delayed reflexes, movement disorders
Constipation, belching, heartburn, irritable bowel syndrome, blistering on the lips, lip pain, esophageal spasm, blistering in the mouth, pain in the salivary glands, redness, irritation or swelling of the mouth, toothache
Fever
Memory loss, abnormal dreams, personality changes
Nosebleeds, hiccups, very rapid and shallow breathing (hyperventilation), other breathing problems, sore throat
Night blindness
Skin redness, goosebump-like sensation, purple spots or skin rashes, hives
Slow heart rate
Ear discomfort, disturbances and itching, sensitivity to sound
Increased bilirubin (a substance produced in the liver) in the blood or decreased calcium in the blood, which may be observed in blood tests; abnormal urine test results
Low blood sugar levels
Need to urinate frequently during the night, kidney pain
Self-harming behaviors (e.g. biting)
Swollen lymph nodes
Breast pain

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Frovatriptan Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Frovatriptan Mylan contains

Each film-coated tablet contains 2.5 mg of frovatriptan as frovatriptan succinate.
The other components are:
- Tablet core: anhydrous lactose (see section 2 “Frovatriptan Mylan contains lactose”), microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silica.
- Coating: hypromellose, titanium dioxide (E171), macrogol 8000, macrogol 400.

Description of the appearance of Frovatriptan Mylan and pack contents
The tablets are round, film-coated, white to almost white, with convex surfaces, marked with an “M” on one side and “FR” above “2.5” on the other side.
Frovatriptan Mylan is available in blisters containing 2, 6 or 12 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer responsible for batch release
McDermott Lab. Limited trading as Gerard Lab.
35/36 Baldoyle Ind. Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft Komarom,
Mylan utca 1, Komarom 2900, Hungary
Generics (UK) Ltd,
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Denmark: Frovamyl 2.5 mg filmovertrukket tablet
France: Frovatriptan Mylan 2,5 mg, comprimé pelliculé
Italy: Frovatriptan Mylan 2.5 mg compressa rivestita con film
United Kingdom: Mylatrip 2.5 mg film-coated tablets