Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking CELEBREX?
CELEBREX contains the active ingredient celecoxib. CELEBREX is used to relieve pain
and inflammation in a number of conditions such as osteoarthritis, rheumatoid arthritis,
ankylosing spondylitis, menstrual cramps or period pain and muscle and joint injuries.
For more information, see Section
1. Why am I taking CELEBREX? in the full CMI.
2. What should I know before I take CELEBREX?
Do not take if you have ever had an allergic reaction to celecoxib or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take CELEBREX? in the full CMI.
3. What if I am taking other medicines?
4. How do I take CELEBREX?
Swallow the capsules whole with a full glass of water.
CELEBREX can be taken with or without food.
5. What should I know while taking CELEBREX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking CELEBREX.
If you become pregnant while taking CELEBREX, tell your doctor immediately.
If you develop any skin rash (e.g. hives, spots) while being treated with CELEBREX,
contact your doctor immediately.
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Things you should not do
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Do not give CELEBREX to anyone else, even if they have the same symptoms or condition
as you.
Do not take CELEBREX to treat any other complaints unless your doctor tells you to.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep CELEBREX in a cool, dry place where the temperature stays at or below 25°C.
Do not store CELEBREX in the bathroom, near a sink or leave in the car on hot days.
Keep your capsules in their blister pack until it is time to take them.
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6. Are there any side effects?
Tell your doctor if you notice any of the following: Stomach pain, diarrhoea, indigestion, wind, swollen hands, ankles and feet, unexplained
weight gain, dizziness, sore throat, runny nose, sinusitis and upper respiratory tract
infection.
Tell your doctor immediately or go to the Accident and Emergency at your nearest hospital
if you notice any of the following: Signs of allergic reaction such as wheezing, swelling of the face, lips, mouth, tongue
or throat which may cause difficulty in swallowing or breathing; collapse or fainting,
shortness of breath or tiredness, irregular heartbeat, chest pain, swollen or sore
leg veins; severe stomach or throat pain, vomiting blood or black sticky bowel motions;
nausea, lethargy, itchiness, flu-like symptoms or yellowing of the skin or eyes (jaundice);
severe or persistent headache, fever, stiff neck, sensitivity to light and vomiting;
sudden severe headache, loss of consciousness, sudden tingling, numbness or paralysis
on one side the face, arm, leg or body, difficulty speaking, understanding, reading
or writing, loss of coordination or balance.
This is not a complete list of possible side effects.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
celecoxib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking CELEBREX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking CELEBREX.
Where to find information in this leaflet:
1. Why am I taking CELEBREX?
CELEBREX contains the active ingredient celecoxib. CELEBREX belongs to a group of medicines called coxibs which are used to relieve pain
and inflammation in a number of conditions.
CELEBREX is used to relieve the symptoms of joint pain, tenderness, swelling and stiffness
in:
osteoarthritis
rheumatoid arthritis
ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects,
but is not limited to, the spine.
CELEBREX also provides short-term pain relief in conditions such as:
menstrual cramps or period pain
after surgery
muscle and joint injuries.
Although CELEBREX can relieve the symptoms of pain and inflammation, it will not cure
your condition.
Your doctor, however, may have prescribed CELEBREX for another purpose.
Ask your doctor if you have any questions about why CELEBREX has been prescribed for
you.
CELEBREX is not recommended for use in children or adolescents under 18 years of age.
2. What should I know before I take CELEBREX?
Warnings
Do not take CELEBREX if:
you are allergic to celecoxib, sulfonamides, a group of medicines which include, for
example, certain antibiotics (if you are not sure if you are taking one of these medicines
ask your pharmacist), or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to these medicines may include:
asthma, wheezing or shortness of breath
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
hives, itching or skin rash
fainting
Always check the ingredients to make sure you can take this medicine.
If you are allergic to sulfonamides or any of the capsule ingredients and take CELEBREX,
these symptoms may be severe.
you suffer from chest pains or angina and they occur even when you are resting and
are becoming more frequent, severe, or lasting longer than usual
you have or have had problems with your blood circulation
you have or if your doctor has told you that you have severe heart or blood vessel
disease affecting the circulation in your brain or limbs
you have severe liver problems
Your doctor will decide if your condition is too severe to take this medicine.
you have problems with your kidney function
you are undergoing cardiac surgery called coronary artery bypass graft (CABG)
you have had an asthma attack, hives, itching, skin rash or a runny nose after taking
aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to treat
pain and inflammation), including other Coxib medicines
CELEBREX should not be used together with other NSAIDs
Many medicines used to treat headache, period pain and other aches and pains contain
aspirin or an NSAID.
If you are allergic to aspirin, NSAIDs, or other Coxib medicines and take CELEBREX,
these symptoms may be severe.
the expiry date printed on the packaging has passed, even though the capsules may
look alright
If you take this medicine after the expiry date has passed, it may not work as well.
the packaging is torn or shows signs of tampering.
If you are not sure if you should be taking CELEBREX, talk to your doctor.
Check with your doctor or pharmacist if you:
are already taking an NSAID
have or have had gastric bleeding or an ulcer such as a peptic ulcer (i.e. stomach
or duodenal ulcer)
have irritable bowel disease
have heart failure or have a history of heart problems
have had a history of a heart attack, a "mini" stroke, stroke or blood vessel disease
affecting circulation of blood to your brain or limbs, especially in the last 3 months
are taking CELEBREX together with any medicines used to treat high blood pressure
and some other heart problems such as ACE inhibitors, angiotensin receptor antagonists,
beta blockers and diuretics (also called fluid or water tablets)
When taken together these medicines can cause kidney problems.
drink large amounts of alcohol
are a smoker
have any allergies to any other medicines or any other substances such as foods, preservatives
or dyes
currently have an infection
If you are given CELEBREX while you have an infection, it may hide some of the signs
of an infection.
have any other health problems including:
high blood pressure
high cholesterol levels
diabetes
problems with the circulation in your limbs
fluid retention or other medical conditions that can cause fluid retention
liver or kidney problems
asthma, hives, itching, skin rash or a runny nose
vomiting blood or material that looks like coffee grounds
bleeding from the rectum (back passage), have black sticky bowel motions (stools)
or bloody diarrhoea
bowel problems such as ulcerative colitis.
If you have not told your doctor or pharmacist about these things, tell them before
you start taking CELEBREX.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
NSAIDs, which are related medicines, have been associated with reversible infertility
in some women.
Use of NSAIDs in early pregnancy can increase the risk of spontaneous abortion.
There is no information on the use of CELEBREX during pregnancy.
CELEBREX may affect your developing baby if taken during pregnancy. Particular caution
should be exerted from the twentieth week of the pregnancy.
CELEBREX use is not recommended in pregnancy unless your doctor considers it essential.
If you are taking CELEBREX while pregnant, you may need to be closely monitored by
your doctor. Discuss any questions you may have with your doctor.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Small amounts of celecoxib passes into breast milk, therefore taking CELEBREX during
breast-feeding should be discussed with your doctor.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with CELEBREX and affect how it works. These include:
any medicines used to treat high blood pressure and some other heart problems such
as ACE inhibitors, angiotensin receptor antagonists, beta blockers or diuretics (also
called fluid or water tablets)
digoxin, a medicine used to treat abnormal heart beats and some other heart problems
fluconazole, an antifungal agent
lithium, a medicine used to treat some types of depression
warfarin or similar medicines including Eliquis (apixaban), Xarelto (rivaroxaban)
or Pradaxa (dabigatran), medicines used to stop blood clots
aspirin or salicylates, medicines used to treat pain
antacids, medicines used to treat indigestion
dextromethorphan, a medicine used to treat dry coughs
some medicines used to treat diabetes
methotrexate, a medicine used to treat arthritis and some cancers
cyclosporin, a medicine used to suppress the immune system
corticosteroids such as prednisolone, medicines that are used to reduce inflammation
certain medicines used to treat pain and inflammation called NSAIDs.
Your doctor may need to adjust the dosage of these medicines, or provide additional
advice if you are also taking CELEBREX.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect CELEBREX.
4. How do I take CELEBREX?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist
for help.
How much to take
Osteoarthritis
200 mg once daily or 100 mg twice daily.
Rheumatoid arthritis
100 mg twice daily.
Your doctor may increase the dose to 200 mg twice a day for a short period of time
if you have a flare up.
Ankylosing spondylitis
100 mg twice daily or 200 mg once daily.
Menstrual cramps or period pain
400 mg as a single dose on the first day and 200 mg twice daily on following days.
You may take CELEBREX for up to 5 days.
Muscle and joint injuries or after surgery
400 mg as a first dose followed by 200 mg once or twice daily as required. You may
take CELEBREX for up to 5 days.
How to take it
Swallow the capsules whole with a full glass of water. CELEBREX can be taken with
or without food.
When to take CELEBREX
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
If you need to take an antacid, take it at least 2 hours before or 2 hours after your
dose of CELEBREX
How long to take it
Depending on your condition, you may need CELEBREX for a few days or for longer periods.
CELEBREX will not cure your condition but should help control pain, swelling and stiffness.
Keep taking CELEBREX for as long as your doctor advises.
Do not exceed the dose recommended by your doctor.
Your risk of developing heart or blood vessel diseases (e.g., heart attack) may increase
with dose and duration of use even if you don't have a history of heart or blood vessel
disease.
If you need to take CELEBREX for a long time see your doctor for regular check-ups
so that they can monitor your condition and treatment.
If you forget to take CELEBREX
CELEBREX should be used regularly at the same time each day. If you miss your dose at the usual time, and it is almost time for your next dose,
skip the dose you missed and take your next dose when you are meant to. Otherwise,
take it as soon as you remember, then go back to taking your capsules as you would
normally.
Do not take a double dose to make up for the dose you missed.
If you take too much CELEBREX
If you think that you or anyone else may have taken too much CELEBREX, urgent medical
attention may be needed.
Symptoms of an overdose may include:
feeling tired
drowsiness
feeling sick
vomiting
stomach pain
difficulty breathing
feeling faint
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking CELEBREX?
Things you should do
If you become pregnant while taking CELEBREX, tell your doctor immediately.
If you are about to start any new medicines, tell your doctor and pharmacist that
you are taking CELEBREX.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
CELEBREX.
If you develop any skin rash (e.g. hives, spots) while being treated with CELEBREX,
contact your doctor immediately.
The onset of these events, if they occur, can occur at any time, but most often occur
in the first month of treatment.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
Things you should not do
Do not give CELEBREX to anyone else, even if they have the same symptoms or condition
as you.
Do not take CELEBREX to treat any other complaints unless your doctor tells you to.
Drinking alcohol
Tell your doctor if you drink large amounts of alcohol.
Looking after your medicine
Store below 25°C
Keep your capsules in their blister pack until it is time to take them. If you take
the capsules out of their container they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Check with your doctor as soon as possible if you have any problems while taking CELEBREX,
even if you do not think the problems are connected with the medicine or are not listed
in this leaflet.
Do not be alarmed by this list of possible side effects.
You may not get any of them.
Less serious side effects
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Less serious side effects
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What to do
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stomach pain, diarrhoea, indigestion, wind
swollen hands, ankles and feet, unexplained weight gain
dizziness
sore throat, runny nose, sinusitis, upper respiratory tract infection.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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skin rash, including hives, raised red, itchy spots
blistering and bleeding in the lips, eyes, mouth, nose and genitals
swelling, blistering or peeling of the skin, which may be accompanied by fever, chills,
headache, sore throat, diarrhoea, aching joints and muscles
muscles weakness
other signs of allergic reaction such as wheezing, swelling of the face, lips, mouth,
tongue or throat which may cause difficulty in swallowing or breathing
collapse or fainting, shortness of breath or tiredness, irregular heartbeat, chest
pain, swollen or sore leg veins
severe stomach or throat pain, vomiting blood or black sticky bowel motions
bleeding or bruising more than usual, reddish or purple blotches under the skin
nausea, lethargy, itchiness, flu-like symptoms or yellowing of the skin or eyes (jaundice)
signs of anaemia such as tiredness, being short of breath and looking pale
loss or deterioration of hearing
confusion
redness, irritation or watering of the eye(s)
experience sensations with any of the senses (sight, sound, touch, taste or feel)
which may not be real
severe or persistent headache, fever, stiff neck, sensitivity to light and vomiting
sudden severe headache, loss of consciousness, sudden tingling, numbness or paralysis
on one side the face, arm, leg or body, difficulty speaking, understanding, reading
or writing, loss of coordination or balance.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention.
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Not all of these side effects have been reported with CELEBREX but have been seen
with similar medicines.
Tell your doctor if you notice anything else that is making you feel unwell, even
if it is not on this list.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What CELEBREX contains
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Active ingredient
(main ingredient)
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celecoxib 100 mg or 200 mg
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Other ingredients
(inactive ingredients)
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lactose monohydrate
sodium lauryl sulfate
povidone
croscarmellose sodium
magnesium stearate
gelatin
titanium dioxide
iron oxide yellow CI 77492 (200 mg capsule)
indigo carmine CI 73015 (100 mg capsule).
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Potential allergens
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CELEBREX 100 mg contains sugars as lactose.
CELEBREX 200 mg contains lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What CELEBREX looks like
CELEBREX 100 mg - opaque, white capsules with two blue bands marked 7767 and 100.
The 100 mg capsules come in blister packs of 60 (AUST R 67901).
CELEBREX 200 mg - opaque, white capsules with two gold bands marked 7767 and 200.
The 200 mg capsules come in blister packs of 30 (AUST R 67902).
Who distributes CELEBREX
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in June 2024.
CELEBREX® is a Viatris company trade mark
CELEBREX_cmi\Jun24/01