Package leaflet: Information for the patient

Mylatrip 2.5 mg Film-coated Tablets

(frovatriptan)

1.    What Mylatrip is and what it is used for

2.    What you need to know before you take Mylatrip

3.    How to take Mylatrip

4.    Possible side effects

5.    How to store Mylatrip

6.    Contents of the pack and other information

1.    What Mylatrip is and what it is used for

Mylatrip contains the active ingredient frovatriptan which belongs to a group of medicines called triptans.

Mylatrip is used to treat migraine headache in adults.

•    Migraine symptoms may be caused by the widening of blood vessels in the head. Mylatrip is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound.

•    Mylatrip works only when a migraine headache has started. You should not take Mylatrip to prevent migraines occuring.

2.    What you need to know before you take Mylatrip

Do not take Mylatrip

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

•    if you have moderately high or very high blood pressure or mild high blood pressure that is not being treated.

•    if you have or have had heart disease, a heart attack, angina (chest pain as a result of lack of oxygen in the heart muscle) or other signs of coronary heart disease such as breathlessness, extreme tiredness or ankle swelling.

•    if you have peripheral vascular disease (narrowing of the vessels that carry blood to the legs and arms)

•    if you have had a stroke or if you have had the symptoms of a stroke, which only lasted a short time and from which you made a complete recovery (transient ischaemic attack).

•    if you are taking medicines containing ergotamine or medicines similar to ergotamine to treat migraine (including methysergide) or other triptans (see "Other medicines and Mylatrip" for further information).

•    if you have severe problems with your liver. Warnings and precautions

Talk to your doctor or pharmacist before taking Mylatrip if:

•    you are at a higher risk of heart disease for example if you are a heavy smoker or you use nicotine replacement therapy. Your doctor should make additional checks especially if you are a woman after menopause or a man older than 40 years old.

•    you have unusual forms of migraine caused by brain or eye problems

•    you are taking herbal medicines containing St John's wort (side effects may be more frequent)

During treatment

If you get a serious allergic reaction when taking Mylatrip such as flushing of the skin, nettle rash, swelling of the mouth, lips, tongue or throat causing difficulty breathing or swallowing, feeling sick (nausea) or being sick (vomiting), collapse or unconsciousness stop taking this medicine and contact your doctor or go immediately to the nearest hospital emergency department (see section 4 'Possible side effects').

When taking Mylatrip, you may notice pain or a feeling of tightness in your chest and throat. If these symptoms do not pass quickly, stop taking frovatriptan and tell your doctor immediately.

If you have frequent or daily headaches while taking this medicine, stop taking Mylatrip and contact your doctor. Using painkillers to treat headaches for longer than normal can make the headaches worse.

Children and adolescents Mylatrip should not be given to children and adolescents under the age of 18 as it is not known how this medicine may affect them.

Other medicines and Mylatrip

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, inform your doctor if you are taking:

•    Triptans other than frovatriptan (such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan). Do not take these medicines at the same time as Mylatrip. After taking Mylatrip, leave 24 hours before taking other triptans as this may result in high blood pressure, narrowing of the blood vessels of the heart or serotonin syndrome, a potentially life threatening drug reaction (see section 4 'Possible side effects').

•    Ergotamine or medicines similar to ergotamine (used to treat migraines including methysergide and methylergometrine). Do not take these medicines at the same time as Mylatrip as this may also result in high blood pressure, narrowing of the veins of the heart or serotonin syndrome. Wait at least 24 hours after taking Mylatrip before taking these medicines or similarly, wait at least 24 hours after taking these medicines before taking Mylatrip.

•    Medicines for depression called selective serotonin re-uptake inhibitors (SSRIs) such as fluoxetine, citalopram, fluvoxamine, paroxetine or sertraline) as this may result in high blood pressure, narrowing of the blood vessels of the heart or serotonin syndrome.

•    St John's wort (Hypericum perforatum), a herbal remedy used to treat depression, as this may result in serotonin syndrome.

•    Medicines used to treat depression called monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, isacarboxazid and tranylcypromine as these may cause high blood pressure or serotonin syndrome.

•    Oral contraceptives as these may increase the amount of frovatriptan in your body.

Pregnancy and breast-feeding

Pregnancy

Mylatrip is not recommended in pregnant women and in women of child bearing age who do not use contraception unless clearly necessary as it is not known if it is safe to use.

Breast-feeding

Frovatriptan may be present in breast milk. Breast-feeding is not recommended unless necessary, in which case avoid breast-feeding for 24 hours after taking Mylatrip.

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.

Driving and using machines This medicine and the migraine itself may make you feel drowsy. Do not drive or operate machinery if you feel drowsy, are affected by a migraine attack or after taking Mylatrip.

Mylatrip 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.

3. How to take Mylatrip

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

The recommended dose is 2.5 mg to treat a migraine attack. Take this medicine as soon as possible after you start to get a headache. Do not take this medicine before you start to have a headache.

If the symptoms of migraine return within 24 hours, you may take a second dose of Mylatrip. The second dose should not be taken within 2 hours of your first dose.

You should not take more than 2 doses of Mylatrip a day. The maximum daily dose is 5 mg Mylatrip in 24 hours.

The tablets should be swallowed whole and with water. You can take this medicine with or without food as it does not affect the way the medicine works.

Use in older patients (over 65 years)

The use of Mylatrip is not recommended.

Patients with liver problems

Do not take Mylatrip if you have serious liver problems (see section 2 'Do not take Mylatrip').

If you take more Mylatrip than you should

Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you.

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.

Contact your doctor immediately or go to your nearest hospital emergency department if you get the following:

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

•    Burning stomach pain, usually immediately or 1 to 2 hours after eating. This may be a sign of an ulcer in the stomach or upper part of the small intestine

Not known (frequency cannot be estimated from the available data):

•    Serious allergic reactions such as flushing of the skin, nettle rash, swelling of the mouth, lips, tongue or throat causing difficulty breathing or swallowing, feeling sick (nausea) or being sick (vomiting), collapse or unconsciousness

•    Sudden chest pain that may spread to the neck or arms with a clammy feeling or a shortness of breath. These may be signs of a heart attack (myocardial infarction)

•    A pressing, tight or heavy sensation on your chest with chest pain that lasts for a short period of time. These may be signs of a temporary narrowing of the blood vessels of the heart (coronary artery spasm)

Other possible side effects include:

Common (may affect up to 1 in 10 people):

•    Dizziness, headache, abnormal or lack of feeling when touching, tingling, pins and needles in the fingers or toes, sleepiness

•    Warm sensation (flushing)

•    Problems with your sight

•    Increased sweating

•    Stomach pain, feeling sick (nausea), indigestion problems, dry mouth

•    Tiredness, chest discomfort, tightness in the throat

Uncommon side effects (may affect up to 1 in 100 people)

•    Change in sense of taste, trembling, poor concentration, lethargy, increased sensitivity to touching, twitching muscles

•    Diarrhoea, difficulty in swallowing, wind, stomach upset, bloated stomach

•    Fast heartbeat that feels like a thumping in your chest (palpitations), increased heart beat, chest pain

•    Coldness in feet and hands

•    Feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, general feeling of being unwell

•    Foggy head or feeling lightheaded, with a sensation of spinning when sitting or standing (vertigo)

•    Anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of

personal identity

•    Runny or stuffy nose, possibly with pain or tenderness in the face, sore throat

•    Muscle or joint stiffness, muscle or joint pain, pain in the hands and feet, back pain

•    Pain in the eye, eye irritation, painful oversensitivity to light

•    Itchiness

•    Ringing in the ears, earache

•    Dehydration

•    Passing abnormally large amounts of urine; urinating more frequently

•    Increase in blood pressure

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

•    An increase or decrease in muscle tone, delay in reflexes, movement problems

•    Constipation, belching, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the food pipe, blisters in the mouth, pain in the salivary gland, redness, irritation or swelling of the mouth, toothache

•    Fever

•    Loss of memory, abnormal dreams, changes to your personality

•    Nosebleed, hiccups, very quick shallow breathing (hyperventilation), other breathing problems, sore 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, earache, ear itchiness, sensitive hearing

•    Increase in bilirubin (a substance produced in the liver) in the blood or a decrease of calcium in the blood which can be seen in a blood test, abnormal urine test results

•    Low sugar in the blood

•    Passing urine frequently at night, pain in the kidneys

•    Self inflicted injury (bite)

•    Swollen lymph nodes

•    Breast tenderness Reporting of side effects

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Mylatrip

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 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.

6.    Contents of the pack and other information

What Mylatrip contains

•    Each film-coated tablet contains 2.5 mg of frovatriptan as frovatriptan succinate.

•    The other ingredients are:

*    Tablet core: anhydrous lactose (see section 2 'Mylatrip contains lactose'), microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate and colloidal anhydrous silica

*    Film-coating: hypromellose, titanium dioxide (E 171), macrogol 8000, macrogol 400.

What Mylatrip looks like and contents of the pack

The tablets are white to off white, film-coated, round tablets with two sides that curve out marked with "M" on one side of the tablet and "FR" over "2.5" on the other side.

Mylatrip is available in blister packs containing 2, 6 and 12 film-coated tablets and in perforated blister packs containing 2 x 1, 6 x 1 and 12 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan

Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturers

Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road,

Dublin 13

Ireland

Mylan Hungary Kft

H-2900 Komarom, Mylan utca 1

Hungary

670264

This leaflet was last revised in October 2015