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MYLATRIP 2.5 MG FILM-COATED TABLETS

Active substance(s): FROVATRIPTAN SUCCINATE

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Package leaflet: Information for the patient

Mylatrip 2.5 mg
Film-coated Tablets
(frovatriptan)

TBC

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• K
 eep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet

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.
• M
 igraine 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.
• M
 ylatrip 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.
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’).

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.

TBC

Warnings and precautions

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.

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

TBC

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:

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

• E ach 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 Komárom, Mylan utca 1
Hungary
670264

This leaflet was last revised in October 2015

TBC

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
• W
 arm 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

 onstipation, belching, heartburn, irritable bowel
• C
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
• L oss of memory, abnormal dreams, changes to
your personality
• N
 osebleed, hiccups, very quick shallow breathing
(hyperventilation), other breathing problems,
sore throat
• Night blindness
• S kin reddening, sensation of hairs standing on
end, purplish spots or patches on skin and mucous
surfaces of the body, hives
• S low heart beat
• E ar 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
• L ow sugar in the blood
• P
 assing urine frequently at night, pain in
the kidneys
• Self inflicted injury (bite)
• S wollen lymph nodes
• Breast tenderness

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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