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ETORICOXIB MYLAN 90 MG FILM-COATED TABLETS

Active substance(s): ETORICOXIB / ETORICOXIB

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TBC

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

1. What Etoricoxib is and what it
is used for
Etoricoxib contains the active
substance etoricoxib which is one of
a group of medicines called selective
cyclooxygenase-2 (COX‑2) inhibitors. These
belong to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs):
• Etoricoxib helps to reduce the pain and
swelling (inflammation) in the joints and
muscles of people 16 years of age and
older with osteoarthritis, rheumatoid
arthritis, ankylosing spondylitis and gout
• Etoricoxib is also used for the short term
treatment of moderate pain after dental
surgery in people 16 years of age
and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It
results from the gradual breakdown of
cartilage that cushions the ends of the
bones. This causes swelling (inflammation),
pain, tenderness, stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term
inflammatory disease of the joints. It causes
pain, stiffness, swelling, and increasing loss
of movement in the joints it affects. It may
also cause inflammation in other areas of
the body.

What is gout?

Gout is a disease of sudden, recurring
attacks of very painful inflammation
and redness in the joints. It is caused by
deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory
disease of the spine and large joints.

2. What you need to know before
you take Etoricoxib
Do not take Etoricoxib:

• if you are allergic to etoricoxib or any of
the other ingredients of this medicine
(listed in section 6)
• if you are allergic to non-steroidal
anti-inflammatory drugs (NSAIDs),
including acetylsalicylic acid (aspirin) or
COX‑2 inhibitors (see section 4)
• if as a result of taking acetylsalicylic
acid or any other NSAIDs you have
experienced wheezing, chest tightness or
breathlessness, a runny or blocked nose
with pain in the face, swellings inside the
nose causing blockages (nose polyps), or
an allergic reaction such as an itchy skin
rash known as hives (urticaria) or swelling
of the face, lips, mouth, tongue or throat
which may cause difficulty in swallowing
or breathing
• if you currently have a stomach ulcer or
bleeding in your stomach or intestines
• if you have serious problems with your
liver or kidneys
• if you are pregnant or think you could
be pregnant or are breast-feeding (see
‘Pregnancy, breast-feeding and fertility’)
• if you are under 16 years of age
• if you have inflammatory bowel disease,
such as Crohn’s disease, ulcerative colitis,
or colitis
• if you have high blood pressure,
persistently over 140/90 mmHg, that is
not being controlled by treatment (check
with your doctor or nurse if you are not
sure whether your blood pressure is
adequately controlled)
• if you have been told by your doctor that
you have heart problems such as heart
failure (moderate or severe types), angina
(chest pain) or if you have had a heart
attack, bypass surgery, peripheral arterial
disease (poor circulation in legs or feet
due to narrow or blocked arteries), or
any kind of stroke (including mini‑stroke,
transient ischaemic attack (TIA)).
Etoricoxib may slightly increase your risk
of heart attack and stroke and this is why
it should not be used in those who have
already had heart problems or stroke.
If you think any of these are relevant to
you, do not take the tablets until you have
consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Etoricoxib if:
• you have a history of bleeding or ulcers in
your stomach or intestines
• you are taking acetylsalicylic acid (even at
low dose for heart protective purposes) or
other NSAIDs
• you are dehydrated, for example by
a prolonged bout of vomiting or diarrhoea
• you have swelling due to fluid retention
• you have a history of high blood pressure.
Etoricoxib can increase blood pressure in
some people, especially in high doses, and
your doctor will want to check your blood
pressure from time to time
• you have any other problems with your
heart, liver or kidneys
• you are being treated for an infection.
Etoricoxib can mask or hide a fever, which
is a sign of infection
• you use medicines to reduce blood
clotting (e.g. warfarin)

Description Etoricoxib 60 mg,30 mg,90 mg,120 mg 28,30,84,49,50,20,7,5,14,98,2,100,10

If you are not sure if any of the above
apply to you, talk to your doctor before
taking Etoricoxib to see if this medicine
is suitable for you.

During treatment

In the first month of treatment you are
at a higher risk of having serious skin
reactions. Stop taking Etoricoxib if you
get a skin rash, mouth lesions (damage
to the skin or gums) or any other signs
of an allergic reaction (see section 4 Possible side effects).
If you get signs of problems with your
liver such as a yellowing of the skin or
whites of the eyes, dark urine, pale stools
and generally feeling unwell, stop taking
Etoricoxib and talk to your doctor.

Children and adolescents

Do not give this medicine to children and
adolescents under 16 years of age.

Other medicines and Etoricoxib

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
In particular if you are taking any of the
following medicines, your doctor may
want to monitor you to check that your
medicines are working properly, once you
start taking Etoricoxib:
• medicines that thin your blood
(anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a drug used for
suppressing the immune system, and
often used in rheumatoid arthritis)
• ciclosporin or tacrolimus (medicines used
for suppressing the immune system)
• lithium (a medicine used to treat some
types of depression)
• medicines used to help control high
blood pressure and heart failure called
ACE inhibitors and angiotensin receptor
blockers, examples include enalapril and
ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and
irregular heart rhythm)
• minoxidil (a drug used to treat high
blood pressure)
• salbutamol tablets or oral solution (a
medicine for asthma)
• birth control pills (the combination may
increase your risk of side effects)
• hormone replacement therapy (the
combination may increase your risk of
side effects)
• acetylsalicylic acid (aspirin) or other
NSAIDs, the risk of stomach ulcers is
greater if you take etoricoxib with
these medicines
* etoricoxib can be taken with low‑dose
aspirin, used for prevention of heart
attacks or stroke. If you are currently
taking low‑dose aspirin to prevent heart
attacks or stroke, you should not stop
taking aspirin until you talk to your doctor
* do not take high doses of aspirin or
other anti-inflammatory medicines while
taking etoricoxib.

Etoricoxib with food

Etoricoxib may act quicker when taken
without food. This should be considered
when fast relief from pain or swelling
is needed.

Pregnancy, breast-feeding and fertility
Etoricoxib must not be taken during
pregnancy. If you are pregnant, think you
may be pregnant or are planning to have
a baby, do not take the tablets. If you
become pregnant, stop taking the tablets
and talk to your doctor. Ask your doctor or
pharmacist for advice before taking
this medicine.

It is not known if etoricoxib passes into
human milk. If you are breast-feeding, or
planning to breast‑feed, talk to your doctor
before taking this medicine. If you are
taking Etoricoxib, you must not breast‑feed.
Etoricoxib is not recommended in women
attempting to become pregnant.

Driving and using machines

Dizziness, vertigo (sensation of spinning
while remaining still) and sleepiness have
been reported in some patients
taking etoricoxib.
Do not drive or use any tools or machines if
you experience these side effects.

Etoricoxib contains lactose

If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3. How to take Etoricoxib
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Do not take more than the recommended
daily dose for your condition. Your doctor
will want to discuss your treatment from
time to time. It is important that you use
the lowest daily dose that controls your
pain and you should not take Etoricoxib
for longer than necessary. This is because
the risk of heart attacks and strokes might
increase after prolonged treatment,
especially with high doses.
Take Etoricoxib by mouth once a day. This
medicine can be taken with or without food.
Etoricoxib may act quicker when taken
without food. Take this medicine without
food if you need fast relief from the pain
or swelling.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg
(equivalent to one 30 mg tablet) once
a day, increase to a maximum of 60 mg
(equivalent to two 30 mg tablets or
equivalent to one 60 mg tablet) once a day
if needed.
Rheumatoid arthritis
The recommended dose is 60 mg
(equivalent to two tablets of 30 mg) once
a day, increased to a maximum of 90 mg
once a day if needed.
Ankylosing spondylitis
The recommended dose is 60 mg
(equivalent to two tablets of 30 mg) once
a day, increased to a maximum of 90 mg
once a day if needed.
Acute pain conditions
Etoricoxib should be used only for the
period of time you have pain.
Gout
The recommended dose is 120 mg
(equivalent to four 30 mg tablets,
equivalent to two 60 mg tablets or

Date: 13 Jan 2017

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 999429

SAP No. n/a

Colours

Black

Non-Print
Colours

Codes
area

Superceded Affiliate Item Code n/a
TrackWise PR No. 999429

Vendor Job No. 292077
Trackwise Proof No. 7

MA No. n/a

Client Market UK

Packing Site/Printer n/a

Keyline/Drawing No. n/a

Supplier Code TBC

Barcode Info n/a

TBC

Etoricoxib 30 mg
Film‑coated Tablets
Etoricoxib 60 mg
Film‑coated Tablets
Etoricoxib 90 mg
Film‑coated Tablets
Etoricoxib 120 mg
Film‑coated Tablets

• y ou are a woman trying to
become pregnant
• you are elderly (i.e. over 65 years
of age)
• you have diabetes, high cholesterol or
are a smoker. These can increase your
risk of heart disease.

TBC

TBC

Package leaflet:
Information for the patient

1

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Page Count

1/2

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equivalent to one 120 mg tablet) once
a day (maximum daily dose) which should
only be used for the acute painful period,
limited to a maximum of 8 days treatment.
Pain following dental surgery
The recommended dose is 90 mg
(equivalent to three tablets of 30 mg or
equivalent to one 90 mg tablet) once
daily (maximum daily dose), limited to
a maximum of 3 days treatment. Talk to
your doctor if you still have pain after
taking Etoricoxib.

People with liver problems:

• If you have mild liver disease, you should
not take more than 60 mg (equivalent
to two 30 mg tablets, equivalent to one
60 mg tablet) a day
• If you have moderate liver disease, you
should not take more than 30 mg a day.

Use in children and adolescents

Etoricoxib should not be taken by children
or adolescents under 16 years of age.

If you take more Etoricoxib than
you should

You should never take more tablets than
the doctor recommends. You may have
problems with your stomach or intestines,
heart or kidneys. If you do take too many
Etoricoxib tablets, you should immediately
talk to your doctor or go to the nearest
hospital emergency department, taking the
pack with you.

If you forget to take Etoricoxib

It is important to take Etoricoxib as your
doctor has prescribed. If you miss a dose,
just resume your usual schedule the
following day. 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 develop any of these signs you
should stop taking Etoricoxib and
immediately talk to your doctor or go
to your nearest hospital emergency
department (see also section 2, ‘What
you need to know before you
take Etoricoxib’):

• a n allergic reaction such as a rash, hives,
itching or swelling of the face, lips,
mouth, tongue or throat which may cause
difficulty in breathing or swallowing
• shortness of breath, severe chest pains,
severe headaches with increasing
confusion or blurred vision with ankle
swelling. These may be signs you have
dangerously high blood pressure
• yellowing of the skin and eyes, dark urine,
tiredness, fever, feeling sick (nausea),
weakness, drowsiness and stomach pain.
These may be signs of serious
liver problems
• severe or continual stomach pain, black
tar‑like stools or bloodstained stools,
being sick (vomiting) which may contain
blood, bloated stomach, loss of appetite
or feeling sick (nausea). These may be
signs of serious problems with your
stomach, intestine or pancreas
• a serious skin condition with severe
blisters and bleeding in the lips, eyes,
mouth and nose (Stevens-Johnson
syndrome) or severe skin reactions which
start as painful red areas then large
blisters and ends with peeling of layers of
skin. This may be accompanied by fever
and chills, aching muscles and generally
feeling unwell (toxic epidermal necrolysis)
• an increase in the number of infections
which you may see as fevers, severe chills,
sore throat or mouth ulcers. These may
indicate you have a low number of white
blood cells
• an abnormally or dangerously fast
heart beat
• sudden collapse, numbness or weakness
in the arms or legs, headache, dizziness
and confusion, disturbances in vision,
difficulty swallowing, slurred, mixed up
or loss of speech. These may be signs of
a stroke or mini stroke caused by a clot
or bleed affecting blood supply to part of
the brain
• heavy or pressing sensation on your chest
with chest pain and shortness of breath
on exercise (these may be signs you
have angina)
• sudden chest pain which may spread
to the neck or arm, with a shortness of
breath and clammy feeling. These may be
signs of a heart attack or other problems
with your heart
• a reduction in the working of the heart,
which may cause tiredness, weakness
and/or fluid retention such as swelling of
the legs and ankles, difficulty breathing
including coughing up frothy or
watery phlegm
• producing little or no urine, cloudy urine
or blood in the urine, pain when passing
urine or lower back pain. These may be
signs of serious problems with
your kidney.
Other possible side effects include

Very common (may affect more than
1 in 10 people):
• stomach pain.

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

• dry socket (inflammation and pain after
tooth extraction)
• swelling of the legs and/or feet due to
fluid retention (oedema)
• dizziness, headache
• fast or irregular heartbeat (palpitations),
irregular heart rhythm (arrhythmia),
• increased blood pressure (hypertension)
• constipation, wind (excessive gas),
gastritis (inflammation of the lining of
the stomach), heartburn, diarrhoea,
indigestion (dyspepsia)/stomach
discomfort, feeling sick (nausea), being
sick (vomiting), inflammation of the
food pipe
• changes in blood tests related to your liver
• bruising
• weakness and tiredness, flu‑like illness.

Uncommon (may affect up to 1 in
100 people):

• appetite increases or decreases,
weight gain
• anxiety, depression, decreases in mental
sharpness; seeing, feeling or hearing
things that are not there (hallucinations)
• changes in taste, inability to sleep,
numbness or tingling of the hands or feet,
reduced skin sensitivity, sleepiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of
spinning while remaining still)
• changes in the electrical activity of
the heart
• flushing, inflammation of the
blood vessels
• cough, nose bleed
• changes in your bowel habits, dry mouth,
irritable bowel syndrome
• muscle cramp or spasm, muscle pain
or stiffness
• high levels of potassium in your blood,
changes in blood or urine tests relating to
your kidneys.

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

• confusion, restlessness
• low blood levels of sodium.

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 Etoricoxib
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 pack after EXP.
The expiry date refers to the last day of
that month.
Store in the original container in order to
protect from moisture.
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 Etoricoxib contains

The active substance is etoricoxib. Each
film‑coated tablet contains 30, 60, 90 or
120 mg of etoricoxib.
The other ingredients are:
Core:
Anhydrous calcium hydrogen phosphate,
microcrystalline cellulose, croscarmellose
sodium, colloidal anhydrous silica,
magnesium stearate
Coating:
30 mg: Hypromellose, lactose monohydrate,
titanium dioxide (E171), triacetin, carnauba
wax, Brilliant blue FCF (E133), iron oxide
black (E172), iron oxide yellow (E172).
60 mg: Hypromellose, lactose monohydrate,
titanium dioxide (E171), triacetin, iron
oxide yellow (E172), Indigo carmine (E132),
carnauba wax.
90 mg: Hypromellose, lactose monohydrate,
titanium dioxide (E171), triacetin,
carnauba wax.
120 mg: Hypromellose, lactose
monohydrate, titanium dioxide (E171),
triacetin, Indigo carmine (E132), iron oxide
yellow (E172), carnauba wax.

What Etoricoxib looks like and contents
of the pack
30 mg Tablets: Blue green, film‑coated,
round tablet with ‘E’ on one side and ‘30’ on
the other side.
60 mg Tablets: Green, film‑coated, round
tablet with ‘E’ on one side and ‘60’ on the
other side.
90 mg Tablets: White, film‑coated, round
tablet with ‘E’ on one side and ‘90’ on the
other side.
120 mg Tablets: Pale green, film‑coated,
round tablet with ‘E’ on one side and ‘120’
on the other side.
Pack sizes:
30 mg:
Blister strips containing 2, 5, 7, 14, 20, 28,
49, 98 tablets; unit dose containing 28 or
Calendar blister containing 28 tablets.
60 mg:
Blister strips containing 2, 5, 7, 10, 14, 20,
28, 30, 49, 50, 84, 98, 100 tablets; unit dose
containing 5, 28, 50, 100 or Calendar blister
containing 28 tablets.
90 mg:
Blister strips containing 2, 5, 7, 10, 14, 20,
28, 30, 49, 50, 84, 98, 100 tablets; unit dose
containing 5, 7, 28, 50, 100 or Calendar
blister containing 28 tablets.
120 mg:
Blister strips containing 2, 5, 7, 10, 14, 20,
28, 30, 49, 50, 84, 98, 100 tablets; unit dose
containing 5, 7, 28, 50, 100 or Calendar
blister containing 28 tablets.
All strengths:
Plastic bottles with screw cap containing
28 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

Mylan Hungary Kft, Mylan utca 1, Komarom,
H‑2900 Hungary.
Generics [UK] Ltd, Station close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
Mylan B.V, Dieselweg 25, 3752 LB
Bunschoten, The Netherlands.
McDermott Laboratories Limited trading
as Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13,
Ireland.
This leaflet was last revised in
November 2016

• chest or throat infection
• discomfort or a burning pain when
passing water. This may be a sign you
have a urinary tract infection
• tiredness, shortness of breath, coldness in
your hands and feet and pale skin. These
may be signs of a low number of red
blood cells
• unexplained bruising or bleeding more
frequently or for longer than normal.
These may be signs of a low number
of platelets

CODE No.: MH/DRUGS/25/NKD/89

Description Etoricoxib 60 mg,30 mg,90 mg,120 mg 28,30,84,49,50,20,7,5,14,98,2,100,10

Date: 13 Jan 2017

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 999429

SAP No. n/a

Colours

Black

Non-Print
Colours

Codes
area

Superceded Affiliate Item Code n/a
TrackWise PR No. 999429

Vendor Job No. 292077
Trackwise Proof No. 7

MA No. n/a

Client Market UK

Packing Site/Printer n/a

Keyline/Drawing No. n/a

Supplier Code TBC

Barcode Info n/a

1

999429

Time: 11:40
Page Count

2/2

Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 130 x 600mm

Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

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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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