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MIGRAINE RELIEF 342 MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN LYSINE

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Package leaflet: Information for the user

Migraine Relief Film-coated
Tablets
(ibuprofen lysine)

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as
described in this leaflet or as your doctor or
pharmacist has told you.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
• You must talk to a doctor if you do not feel
better or if you feel worse after 10 days.

What is in this leaflet

1. What Migraine Relief is and what it is used for.
2. What you need to know before you take
Migraine Relief.
3. How to take Migraine Relief.
4. Possible side effects.
5. How to store Migraine Relief.
6. Contents of the pack and other information.

1. What Migraine Relief is and what it
is used for
Migraine Relief contains the active substance
ibuprofen. It belongs to a group of medicines
known as non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs provide relief by changing
the body’s response to pain, swelling and high
temperature.
Migraine Relief tablets are used for the relief of
headaches and migraine pain.

2. What do you need to know before
you take Migraine Relief
Do not take Migraine Relief:

• if you are allergic to ibuprofen or any other
ingredients of this medicine (listed in
section 6)
• if you have had an allergic reaction such as a
worsening of asthma, nettle rash, itchy runny
nose or facial swelling to aspirin or other
NSAIDs
• if you have (or have had two or more episodes
of ) a stomach ulcer, perforation or bleeding
• if you have had gastrointestinal perforation or
bleeding when previously taking NSAIDs
• if you have severe liver or kidney disease or
have severe heart problems
• if you are taking other NSAID painkillers, or
aspirin with a daily dose above 75 mg, as
this will increase the risk of occurrence of
adverse effects
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Migraine Relief:

• if you have or have had asthma
• if you have kidney, heart, liver or bowel
problems
• if you have high blood pressure, high cholesterol
or previously have had a heart attack or stroke
• if you have a history of gastrointestinal
disease (such as ulcerative colitis,
Crohn’s disease)
• if you have Systemic Lupus Erythematosus (a
disease affecting the skin, joints and kidneys)
• if you are elderly
• if you are a smoker
• if you are in the first 6 months of pregnancy.
Anti-inflammatory/pain-killer medicines like
ibuprofen may be associated with a small
increased risk of heart attack (“myocardial
infarction”) or stroke, particularly when used at
high doses. Do not exceed the recommended
dose or duration of treatment (10 days).
You should discuss your treatment with your
doctor or pharmacist before taking Migraine
Relief if you:
• have heart problems including heart failure,
angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery
disease (poor circulation in the legs or feet
due to narrow or blocked arteries), or any kind
of stroke (including ‘mini-stroke’ or transient
ischaemic attack, ‘TIA’)
• have high blood pressure, diabetes, high
cholesterol, have a family history of heart
disease or stroke, or if you are a smoker
There is a risk of renal impairment in dehydrated
children and adolescents.

Description Ibuprofen Lysine 342 mg 8, 12, 16
Component Type LeafletInsert
Affiliate Item Code 830665
Superceded Affiliate Item Code 679136
TrackWise PR No. 830665
MA No. 04569/1453
Packing Site/Printer N/A
Supplier Code 50061021

Pharma Code 4761
SAP No. N/A
Vendor Job No. 275133
Trackwise Proof No. 1
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Other medicines and Migraine Relief

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Migraine Relief may affect or be affected by
some other medicines. For example:
• medicines that are anti-coagulants (i.e.
thin blood/prevent clotting e.g. aspirin/
acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, betablockers such as atenolol, angiotensin-II
receptor antagonists such as losartan)
Some other medicines may also affect or be
affected by treatment with Migraine Relief. You
should therefore always seek the advice of your
doctor or pharmacist before you use Migraine
Relief with other medicines.

To reduce the risk of side effects, do not
take Migraine Relief with:

• o
 ther NSAID containing products including
COX-2 inhibitors (e.g. aspirin, ibuprofen)
• corticosteroids
• quinolone antibiotics
• drugs prescribed to stimulate your heart (e.g.
glycosides) or treat high blood pressure
• drugs prescribed to help you pass water
(diuretics)
• drugs prescribed for the temporary
suppression of your immune system (e.g.
methotrexate, cyclosporine, tacrolimus)
• drugs prescribed for mania and depression
(e.g. lithium or selective serotonin reuptake
inhibitors)
• drugs prescribed for pregnancy termination
(e.g. mifepristone)
• drugs prescribed for HIV treatment (e.g.
zidovudine).

Low dose aspirin

Do not take this medicine if you are taking
aspirin at doses of above 75 mg daily. If you are
on low-dose aspirin (up to 75 mg daily) speak
to your doctor or pharmacist before you take
Migraine Relief.

Pregnancy, breast-feeding and fertility

Do not take in the last 3 months of pregnancy.
If you are in the first 6 months of pregnancy or
if you are breast-feeding ask your doctor or
pharmacist for advice before taking this
medicine.
Migraine Relief tablets belong to a group
of medicines which may impair fertility in
women. This effect is reversible on stopping
the medicine. It is unlikely that Migraine Relief,
used occasionally, will affect your chances
of becoming pregnant, however, tell your
doctor before taking this medicine if you have
problems becoming pregnant.

Driving and using machinery

This medicine has no effect on driving or the
ability to use machinery at the recommended
doses and duration of treatment.

3. How to take Migraine Relief
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
told you. Check with your doctor or pharmacist
if you are not sure.
The product is for short term use only. You
should take the lowest dose for the shortest
time necessary to relieve your symptoms. Do
not take for longer than 10 days unless your
doctor tells you to. If you do not get better, or
get worse, talk to your doctor. They will tell you
if it is safe to carry on taking the medicine.

Adults, the elderly and children aged
12 years or older:

Take 1 or 2 tablets with water, up to three times
a day as required. Leave at least four hours
between doses. Do not take more than 6 tablets
in 24 hours.

Use in children

Migraine Relief is not recommended for use in
children under 12 years.
If in children aged from 12 years and in
adolescents this medicinal product is required
for more than 3 days, or if symptoms worsen a
doctor should be consulted.
Migraine Relief tablets are swallowed whole
with plenty of water. Do not chew the tablets.
Patients with sensitive stomachs should take
Migraine Relief tablets during a meal.

If you take more Migraine Relief than you
should

You may experience nausea, vomiting, stomach
pain or diarrhoea. Ringing in the ears, headache,

Date: 29 FEB 2016
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vomiting blood and blood in stools are also
possible. More serious poisoning can lead
to drowsiness, and sometimes excitation,
disorientation, coma or convulsions. You should
seek immediate medical advice in the event of
an overdose, even if you feel well.

If you forget to take Migraine Relief

Simply refer to the directions above on how to
take the medicine and do not take more than is
advised.
Do not take a double dose to make up for a
forgotten dose.
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.

If you think you have any of the following
side effects or symptoms, stop taking
this medicine and seek immediate
medical help:

• intestinal bleeding with bright red faeces
(stools/motions), black tarry stools, vomiting
blood or dark particles that look like coffee
grounds (very rare: may affect up to 1 in
10,000 people)
• serious allergic reaction (very rare: may affect
up to 1 in 10,000 people), symptoms include:
* difficulties in breathing or unexplained
wheezing
* dizziness or faster heartbeat
* swelling of your face, tongue or throat
• Stevens Johnson Syndrome - a rare skin
condition with severe blisters and bleeding in
the lips, eyes, mouth, nose and genitals (very
rare: may affect up to 1 in 10,000 people)
• heart failure (frequency not known)
• severe condition of the skin that may affect
the mouth and other parts of the body (very
rare: may affect up to 1 in 10,000 people)
• severe skin disease that starts with painful
red areas, then large blisters and ends with
peeling of layers of skin. This is accompanied
by fever and chills, aching muscles and
generally feeling unwell (very rare: may affect
up to 1 in 10,000 people).
• aseptic meningitis (infection around the brain
or spinal cord with the following symptoms:
fever, nausea, vomiting, headache, stiff neck
and extreme sensitivity to bright light) (very
rare: may affect up to 1 in 10,000 people)
particularly in patients with pre-existing
autoimmune disorders such as systemic
lupus erythematosus and mixed connective
tissue disease
• small increased risk of heart attack
(“myocardial infarction”) or stroke. Any risk
is more likely with high doses or prolonged
treatment (see section 2 “Warnings and
precautions”)

Stop taking the medicine and tell your
doctor if you experience:

• indigestion or heartburn (uncommon: may
affect up to 1 in 100 people)
• pains in your stomach (abdomen) or other
abnormal stomach symptoms (uncommon:
may affect up to 1 in 100 people).

Not known (frequency cannot be estimated
from the available data):
• excessive fluid in the body
• high blood pressure
• worsening of colitis (inflammation of the
colon, symptoms include diarrhoea, usually
with blood and mucus, stomach pain,
fever) and worsening of Crohn’s disease (an
inflammatory disease that can affect any part
of the gastrointestinal tract with the following
symptoms: pain, fever, diarrhoea and loss
of weight)
• purple or red-brown spots visible through
the skin.
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
Website: 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 Migraine Relief
Keep this medicine out of the sight and reach
of children.
Do not use Migraine Relief after the expiry
date which is stated on the blister, carton after
‘EXP’. The expiry date refers to the last day of
that month.
This medicine does not require any special
storage conditions.
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 Migraine Relief contains:

The active substance is ibuprofen. Each tablet
contains 342 mg of ibuprofen lysine (equivalent
to 200 mg of ibuprofen).
The other ingredients of a tablet are cellulose,
microcrystalline; silica, colloidal anhydrous;
crospovidone; povidone; magnesium stearate;
talc (E553b). The tablet coating contains
polyvinyl alcohol, hydrolysed; titanium dioxide
(E171); macrogol; talc (E553b). The printing
ink contains shellac; iron oxide black (E172);
ammonium hydroxide (E527).

What Migraine Relief looks like and
contents of the pack

White to off-white, film-coated, round, biconvex,
bevelled edge tablet imprinted with “M” over
“IL1” in black ink on one side of the tablet and
blank on the other side.
Migraine Relief is available in blister packs of 8,
12, 16 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

Tell your doctor if you experience any of the
below side effects:

Manufacturer

Uncommon (may affect up to 1 in 100 people):
• nausea,
• headache,
• skin rash, allergies with itching and nettle
rash.

Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

Rare (may affect up to 1 in 1,000 people)
• diarrhoea, wind, constipation, vomiting.
Very rare (may affect up to 1 in 10,000 people):
• stomach and intestinal ulcers, sore mouth,
inflammation of the stomach
• reduction in the number of red blood cells,
white blood cells and platelets. Symptoms
include: fever, sore throat, mouth ulcers,
flu-like symptoms, severe exhaustion,
unexplained bleeding or bruising
• signs of kidney problems such as acute
kidney disease where you pass little or
no urine (drowsiness, nausea, vomiting,
breathlessness)
• liver disorders.

Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft, H-2900 Komarom, Mylan
utca 1, Hungary.

This leaflet was last revised in:
February 2016

830665
50061021

Description Ibuprofen Lysine 342 mg 8, 12, 16
Component Type LeafletInsert
Affiliate Item Code 830665
Superceded Affiliate Item Code 679136
TrackWise PR No. 830665
MA No. 04569/1453
Packing Site/Printer N/A
Supplier Code 50061021

Pharma Code 4761
SAP No. N/A
Vendor Job No. 275133
Trackwise Proof No. 1
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 29 FEB 2016
No. of colours
Colours

1

Time: 15:31
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 X 480 MM

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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