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.
4-CONTRAINDICATIONS
Do not take PAINEXA:
• If you are hypersensitive (allergic) to etoricoxib or any of
the other ingredients of PAINEXA (listed in section 2).
• If you have previously experienced any allergy to aspirin
or other non-steroidal anti-inflammatory medications,
including COX2 inhibitors.
• If you have an active stomach ulcer or bleeding in the
stomach or intestines.
• If you have serious liver disease.
• If you have serious kidney disease.
• If you have high blood pressure which is not adequately
controlled by treatment.
• If you are pregnant or breastfeeding.
• If you are under 16 years of age.
• If you have inflammatory bowel disease.
• If you are taking lithium (used to treat a certain type of
depression)
• If you are taking digoxin (a heart medication)
• If your doctor has diagnosed heart problems including
heart failure (moderate or severe
types), angina or if you have had a heart attack, bypass
surgery, narrow or blocked arteries of the extremities
(peripheral arterial disease), or any kind of stroke
(including mini-stroke, transient ischemic attack or TIA).
5-DOSAGE AND ADMINISTRATION
Always take this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure. Do not take more than the recommend-
ed dose for your condition.
PAINEXA should be taken once a day. You may take
PAINEXA with or without food.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once a day, increased
to a maximum of 60mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 60mg once a day, increased
to a maximum of 90 mg once a day if needed.
Ankylosing spondylitis
The recommended dose is 60 mg once a day, increased
to a maximum of 90mg once a day if needed.
Acute pain conditions
The recommended dose is 90 or 120 mg once daily,
limited to a maximum of 8 days treatment.
Gout
The recommended dose is 120 mg once a day which
should only be used for the acute painful period, limited to
a maximum of 8 days treatment.
For the treatment of menstrual pain
The recommended dose is 120 mg once a day which
should only be used for the acute painful period.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a
maximum of 3 days treatment.
-People with liver problems:
-If you have a mild liver disease: you should not take more
than 60 mg a day.
-If you have a moderate liver disease: you should not take
more than 30 mg a day.
-If you have severe liver disease: you should not use
PAINEXA.
-Children:
Safety and efficacy in children have not been
established., PAINEXA should not be given to children or
adolescents under 16 years old.
-Elderly:
No dose adjustment is necessary for elderly patients. As
with other medicines, caution should be exercised in
elderly patients
• If you take more PAINEXA than you should in the event
of overdosage, consult your doctor or pharmacist
• If you miss a dose, do not take a double dose to make
up for the forgotten individual doses, just resume your
usual schedule the following day.
6-WARNINGS AND PRECAUTIONS
Tell your doctor or pharmacist before taking etoricoxib:
• If you have a history of stomach bleeding or ulcers.
• If you are dehydrated, for example by a prolonged
period of vomiting or diarrhea.
• If you have a history of kidney disease; long term
administration may affect kidney function.
• If you have or have had liver disease; your physician
should monitor your liver enzymes.
• If you have a history of heart failure, heart attack, or
any other form of heart disease.
• If you have narrow or blocked arteries of the
extremities.
• If you have a history of high blood pressure.
• If you have swelling due to fluid retention.
• If you have a history of stroke or mini-stroke
• If you are elderly since you may be more likely to
develop certain side effects.
• If you are trying to become pregnant.
• If you have conditions which increase your risk of
coronary artery disease or atherosclerosis such as high
blood pressure, diabetes, high cholesterol or smoking.
Driving and using machinery
Dizziness and sleepiness have been reported in some
patients taking PAINEXA . Do not drive if you experience
dizziness or sleepiness. Do not use any tools or machines
if you experience dizziness or sleepiness.
Taking other medicines with PAINEXA
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
In particular if you are taking any of the following:
• Rifampicin (an antibiotic)
• Diuretics (water tablets)
• ACE inhibitors and angiotensin receptor blockers
(medicines used for high blood pressure and heart
failure)
• Lithium (a medicine used to treat a certain type of
depression)
• Digoxin (a heart medication)
• Birth control pills
• Methotrexate (a medicine used for suppressing the
immune system)
• Ciclosporin and tacrolimus
(medicines used for suppressing the
immune system)
• Furosemide (a water tablet)
• Hormone replacement therapy
• Aspirin: PAINEXA can be taken with
low-dose aspirin. If you are currently
taking low-dose aspirin for
prevention of heart attack or stroke,
you should not discontinue it without
consulting your doctor, because
PAINEXA cannot substitute aspirin for
this purpose.
Pregnancy, breastfeeding and
Fertility
Pregnant:
PAINEXA tablets should not be taken
during pregnancy. Tell your doctor if
you are pregnant. If you are
pregnant or think you could be
pregnant, or if you are planning to
become pregnant, do not take
PAINEXA. If you become pregnant,
stop taking the tablets and consult
your doctor.
Breastfeeding:
It is not known if PAINEXA is excreted
in human milk. If you are
breastfeeding, or planning to
breastfeed, you should not
breastfeed your baby. Consult your
doctor before taking PAINEXA.
Fertility:
PAINEXA: is not recommended in
women attempting to become
pregnant
7-ADVERSE REACTIONS
If you develop any of these signs you
should stop PAINEXA and talk to you
doctor immediately:
-Shortness of breath, chest pain, or
ankle swelling appear or if they get
worse.
-Yellowing of the skin and eyes
(jaundice) these are signs of liver
problems.
-Severe or continual stomach pain
or your stools become black.
-An allergic reaction which can
include skin problems such as ulcers
or blistering, or swelling of the face,
lips, tongue, or throat which may
cause difficulty in breathing.
The frequency of possible side
effects listed below is defined using
the following convention:
Very
common (affects more than 1 user in 10)
- Common (affects 1 to 10 users in 100)
- Uncommon (affects 1 to 10 users in 1000)
- Rare (affects 1 to 10 users in 10000)
- Very rare (affects less than 1 user in 10000).
The following side effects can occur during treatment with
PAINEXA
Very common (may affect up to 1 in 10 people)
- Stomach pain.
Common (may affect up to 1 in 10 people)
- Swelling of the legs and/or feet due to fluid retention
(oedema).
- Dizziness, headache.
- Palpitations (fast or irregular heartbeat), irregular heart
rhythm (arrhythmia).
- Increased blood pressure.
- Wheezing or shortness of breath (bronchospasms).
- Constipation, wind (excessive gas), gastritis
(inflammation of the lining of the stomach), heartburn,
diarrhea, indigestion (dyspepsia)/stomach discomfort,
nausea, being sick (vomiting), inflammation of the
esophagus, mouth ulcers.
- Changes in blood tests related to your liver.
- Bruising.
- Weakness and fatigue, flu-like illness.
Uncommon (may affect to 1 in 100 people)
Gastroenteritis (inflammation of the gastrointestinal tract
that involves both the stomach and small intestine/stom-
ach flu), upper respiratory infection, urinary tract infection.
- Changes in laboratory values (decreased number of
red blood cells, decreased number of white blood cells,
platelets decreased).
- Hypersensitivity (an allergic reaction including hives
which may be serious enough to require immediate
medical attention).
- Appetite increase or decrease, weight gain.
- Anxiety, depression, decrease in mental sharpness;
seeing, feeling or hearing things that are not there
(hallucinations).
- Taste alteration, inability to sleep, numbness or tingling,
sleepiness.
- Blurred vision, eye irritation and redness.
- Ringing in the ears, vertigo (sensation of spinning while
remaining still).
- Abnormal heart rhythm (atrial fibrillation), fast heart
rate, heart failure, feeling of tightness, pressure or
heaviness in the chest (angina pectoris), heart attack.
- Flushing, stroke, mini-stroke (transient ischemic attack),
severe increase in blood pressure, inflammation of the
blood vessels.
- Cough, breathlessness, nose bleed.
- Stomach or bowel bloating, changes in your bowel
habits, dry mouth, stomach ulcer, inflammation of the
stomach lining that can become serious and may lead to
bleeding, irritable bowel syndrome, inflammation of the
pancreas.
- Swelling of the face, skin rash or itchy skin, redness of
the skin.
- Muscle cramp/spasm, muscle pain/stiffness.
- High levels of potassium in your blood, changes in blood
or urine tests relating to your kidney, serious kidney
problems.
- Chest pain.
Rare (may affect up to 1 in 1000 people)
- Angioedema (an allergic reaction with swelling of the
face, lips, tongue and/or throat which may cause difficulty
in breathing or swallowing, which may be serious enough
to require immediate medical attention.
- Confusion, restlessness.
- Liver problems (hepatitis).
- Low blood levels of sodium.
- Liver failure, yellowing of the skin and/or eyes (jaundice).
- Severe skin reactions.
8-STORAGE CONDITIONS
Store below 30°C in a dry place.
Protect from light and moisture. Keep out of reach of
children.
MANUFACTURER:
LIVEALTH BIOPHARMA PVT.LTD
PANCHMAHAL-389 350, GUARAT STATE, INDIA
MARKETING AUTHORIZATION HOLDER, PACKED BY:
Etoricoxib 90 mg film-coated tablets
Etoricoxib 120 mg film-coated tablets
1- FORM AND PRESENTATION
PAINEXA 90 mg: film coated tablets. Box of 30.
PAINEXA 120 mg: film coated tablet. Box of 10.
2-COMPOSITION
Each film coated tablet of PAINEXA 90 mg contains:
Etoricoxib 90 mg.
Each film coated tablet of PAINEXA 120 mg contains:
Etoricoxib 120 mg.
Inactive ingredients: Calcium Hydrogen Phosphate,
Croscarmellose Sodium, Microcrystalline Cellulose,
Magnesium Stearate, HPMC E 5 B, Diethyl Phthalate, PEG
6000, Titanium Dioxide, Isopropyl Alcohol, Methylene
Chloride.
3-THERAPEUTIC INDICATIONS
Pharmacotherapeutic group: Selective COX-2 inhibitors,
non-steroidal anti-inflammatory drugs (NSAIDS).
ATC code: M01AH05.
•PAINEXA 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.
•PAINEXA is also used for the short-term treatment of
moderate pain after dental surgery in people 16 years of
age and older.
Your doctor prescribes PAINEXA for one of the following
conditions:
• Relief of symptoms of osteoarthritis
• Relief of symptoms of rheumatoid arthritis
• Treatment of ankylosing spondylitis (inflammatory
disease of the spine and large joints)
• Short term relief of acute pain, treatment limited to a
maximum period of 8 days
• Treatment of moderate to severe acute pain after
dental surgery
• Treatment of menstrual pain
• Treatment of acute gout attacks (deposits of mineral
crystals in the joint)
4-CONTRAINDICATIONS
Do not take PAINEXA:
• If you are hypersensitive (allergic) to etoricoxib or any of
the other ingredients of PAINEXA (listed in section 2).
• If you have previously experienced any allergy to aspirin
or other non-steroidal anti-inflammatory medications,
including COX2 inhibitors.
• If you have an active stomach ulcer or bleeding in the
stomach or intestines.
• If you have serious liver disease.
• If you have serious kidney disease.
• If you have high blood pressure which is not adequately
controlled by treatment.
• If you are pregnant or breastfeeding.
• If you are under 16 years of age.
• If you have inflammatory bowel disease.
• If you are taking lithium (used to treat a certain type of
depression)
• If you are taking digoxin (a heart medication)
• If your doctor has diagnosed heart problems including
heart failure (moderate or severe
types), angina or if you have had a heart attack, bypass
surgery, narrow or blocked arteries of the extremities
(peripheral arterial disease), or any kind of stroke
(including mini-stroke, transient ischemic attack or TIA).
5-DOSAGE AND ADMINISTRATION
Always take this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure. Do not take more than the recommend-
ed dose for your condition.
PAINEXA should be taken once a day. You may take
PAINEXA with or without food.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once a day, increased
to a maximum of 60mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 60mg once a day, increased
to a maximum of 90 mg once a day if needed.
Ankylosing spondylitis
The recommended dose is 60 mg once a day, increased
to a maximum of 90mg once a day if needed.
Acute pain conditions
The recommended dose is 90 or 120 mg once daily,
limited to a maximum of 8 days treatment.
Gout
The recommended dose is 120 mg once a day which
should only be used for the acute painful period, limited to
a maximum of 8 days treatment.
For the treatment of menstrual pain
The recommended dose is 120 mg once a day which
should only be used for the acute painful period.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a
maximum of 3 days treatment.
-People with liver problems:
-If you have a mild liver disease: you should not take more
than 60 mg a day.
-If you have a moderate liver disease: you should not take
more than 30 mg a day.
-If you have severe liver disease: you should not use
PAINEXA.
-Children:
Safety and efficacy in children have not been
established., PAINEXA should not be given to children or
adolescents under 16 years old.
-Elderly:
No dose adjustment is necessary for elderly patients. As
with other medicines, caution should be exercised in
elderly patients
• If you take more PAINEXA than you should in the event
of overdosage, consult your doctor or pharmacist
• If you miss a dose, do not take a double dose to make
up for the forgotten individual doses, just resume your
usual schedule the following day.
6-WARNINGS AND PRECAUTIONS
Tell your doctor or pharmacist before taking etoricoxib:
• If you have a history of stomach bleeding or ulcers.
• If you are dehydrated, for example by a prolonged
period of vomiting or diarrhea.
• If you have a history of kidney disease; long term
administration may affect kidney function.
• If you have or have had liver disease; your physician
should monitor your liver enzymes.
• If you have a history of heart failure, heart attack, or
any other form of heart disease.
• If you have narrow or blocked arteries of the
extremities.
• If you have a history of high blood pressure.
• If you have swelling due to fluid retention.
• If you have a history of stroke or mini-stroke
• If you are elderly since you may be more likely to
develop certain side effects.
• If you are trying to become pregnant.
• If you have conditions which increase your risk of
coronary artery disease or atherosclerosis such as high
blood pressure, diabetes, high cholesterol or smoking.
Driving and using machinery
Dizziness and sleepiness have been reported in some
patients taking PAINEXA . Do not drive if you experience
dizziness or sleepiness. Do not use any tools or machines
if you experience dizziness or sleepiness.
Taking other medicines with PAINEXA
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
In particular if you are taking any of the following:
• Rifampicin (an antibiotic)
• Diuretics (water tablets)
• ACE inhibitors and angiotensin receptor blockers
(medicines used for high blood pressure and heart
failure)
• Lithium (a medicine used to treat a certain type of
depression)
• Digoxin (a heart medication)
• Birth control pills
• Methotrexate (a medicine used for suppressing the
immune system)
• Ciclosporin and tacrolimus
(medicines used for suppressing the
immune system)
• Furosemide (a water tablet)
• Hormone replacement therapy
• Aspirin: PAINEXA can be taken with
low-dose aspirin. If you are currently
taking low-dose aspirin for
prevention of heart attack or stroke,
you should not discontinue it without
consulting your doctor, because
PAINEXA cannot substitute aspirin for
this purpose.
Pregnancy, breastfeeding and
Fertility
Pregnant:
PAINEXA tablets should not be taken
during pregnancy. Tell your doctor if
you are pregnant. If you are
pregnant or think you could be
pregnant, or if you are planning to
become pregnant, do not take
PAINEXA. If you become pregnant,
stop taking the tablets and consult
your doctor.
Breastfeeding:
It is not known if PAINEXA is excreted
in human milk. If you are
breastfeeding, or planning to
breastfeed, you should not
breastfeed your baby. Consult your
doctor before taking PAINEXA.
Fertility:
PAINEXA: is not recommended in
women attempting to become
pregnant
7-ADVERSE REACTIONS
If you develop any of these signs you
should stop PAINEXA and talk to you
doctor immediately:
-Shortness of breath, chest pain, or
ankle swelling appear or if they get
worse.
-Yellowing of the skin and eyes
(jaundice) these are signs of liver
problems.
-Severe or continual stomach pain
or your stools become black.
-An allergic reaction which can
include skin problems such as ulcers
or blistering, or swelling of the face,
lips, tongue, or throat which may
cause difficulty in breathing.
The frequency of possible side
effects listed below is defined using
the following convention:
Very
common (affects more than 1 user in 10)
- Common (affects 1 to 10 users in 100)
- Uncommon (affects 1 to 10 users in 1000)
- Rare (affects 1 to 10 users in 10000)
- Very rare (affects less than 1 user in 10000).
The following side effects can occur during treatment with
PAINEXA
Very common (may affect up to 1 in 10 people)
- Stomach pain.
Common (may affect up to 1 in 10 people)
- Swelling of the legs and/or feet due to fluid retention
(oedema).
- Dizziness, headache.
- Palpitations (fast or irregular heartbeat), irregular heart
rhythm (arrhythmia).
- Increased blood pressure.
- Wheezing or shortness of breath (bronchospasms).
- Constipation, wind (excessive gas), gastritis
(inflammation of the lining of the stomach), heartburn,
diarrhea, indigestion (dyspepsia)/stomach discomfort,
nausea, being sick (vomiting), inflammation of the
esophagus, mouth ulcers.
- Changes in blood tests related to your liver.
- Bruising.
- Weakness and fatigue, flu-like illness.
Uncommon (may affect to 1 in 100 people)
Gastroenteritis (inflammation of the gastrointestinal tract
that involves both the stomach and small intestine/stom-
ach flu), upper respiratory infection, urinary tract infection.
- Changes in laboratory values (decreased number of
red blood cells, decreased number of white blood cells,
platelets decreased).
- Hypersensitivity (an allergic reaction including hives
which may be serious enough to require immediate
medical attention).
- Appetite increase or decrease, weight gain.
- Anxiety, depression, decrease in mental sharpness;
seeing, feeling or hearing things that are not there
(hallucinations).
- Taste alteration, inability to sleep, numbness or tingling,
sleepiness.
- Blurred vision, eye irritation and redness.
- Ringing in the ears, vertigo (sensation of spinning while
remaining still).
- Abnormal heart rhythm (atrial fibrillation), fast heart
rate, heart failure, feeling of tightness, pressure or
heaviness in the chest (angina pectoris), heart attack.
- Flushing, stroke, mini-stroke (transient ischemic attack),
severe increase in blood pressure, inflammation of the
blood vessels.
- Cough, breathlessness, nose bleed.
- Stomach or bowel bloating, changes in your bowel
habits, dry mouth, stomach ulcer, inflammation of the
stomach lining that can become serious and may lead to
bleeding, irritable bowel syndrome, inflammation of the
pancreas.
- Swelling of the face, skin rash or itchy skin, redness of
the skin.
- Muscle cramp/spasm, muscle pain/stiffness.
- High levels of potassium in your blood, changes in blood
or urine tests relating to your kidney, serious kidney
problems.
- Chest pain.
Rare (may affect up to 1 in 1000 people)
- Angioedema (an allergic reaction with swelling of the
face, lips, tongue and/or throat which may cause difficulty
in breathing or swallowing, which may be serious enough
to require immediate medical attention.
- Confusion, restlessness.
- Liver problems (hepatitis).
- Low blood levels of sodium.
- Liver failure, yellowing of the skin and/or eyes (jaundice).
- Severe skin reactions.
8-STORAGE CONDITIONS
Store below 30°C in a dry place.
Protect from light and moisture. Keep out of reach of
children.
MANUFACTURER:
LIVEALTH BIOPHARMA PVT.LTD
PANCHMAHAL-389 350, GUARAT STATE, INDIA
MARKETING AUTHORIZATION HOLDER, PACKED BY:
Date of Revision: June 23, 2025
1- FORM AND PRESENTATION
PAINEXA 90 mg: film coated tablets. Box of 30.
PAINEXA 120 mg: film coated tablet. Box of 10.
2-COMPOSITION
Each film coated tablet of PAINEXA 90 mg contains:
Etoricoxib 90 mg.
Each film coated tablet of PAINEXA 120 mg contains:
Etoricoxib 120 mg.
Inactive ingredients: Calcium Hydrogen Phosphate,
Croscarmellose Sodium, Microcrystalline Cellulose,
Magnesium Stearate, HPMC E 5 B, Diethyl Phthalate, PEG
6000, Titanium Dioxide, Isopropyl Alcohol, Methylene
Chloride.
3-THERAPEUTIC INDICATIONS
Pharmacotherapeutic group: Selective COX-2 inhibitors,
non-steroidal anti-inflammatory drugs (NSAIDS).
ATC code: M01AH05.
•PAINEXA 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.
•PAINEXA is also used for the short-term treatment of
moderate pain after dental surgery in people 16 years of
age and older.
Your doctor prescribes PAINEXA for one of the following
conditions:
• Relief of symptoms of osteoarthritis
• Relief of symptoms of rheumatoid arthritis
• Treatment of ankylosing spondylitis (inflammatory
disease of the spine and large joints)
• Short term relief of acute pain, treatment limited to a
maximum period of 8 days
• Treatment of moderate to severe acute pain after
dental surgery
• Treatment of menstrual pain
• Treatment of acute gout attacks (deposits of mineral
crystals in the joint)
This is a medicine:
- A medicine is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who dispensed the
medicine.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicines out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
PI040/01
