NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
CELEBREX®
celecoxib
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Celebrex. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Celebrex against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Celebrex is used for
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.
Celebrex contains celecoxib and belongs to a group of medicines called coxibs which are used to relieve pain and inflammation in a number of conditions.
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.
This medicine is only available with a doctor’s prescription.
Before you take Celebrex
When you must not take it
Do not take Celebrex if 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
have or have had problems with your blood circulation
have or if your doctor has told you that severe heart or blood vessel disease affecting the circulation in your brain or limbs.
have severe liver problems
Your doctor will decide if your condition is too severe to take this medicine.
have problems with your kidney function
are undergoing cardiac surgery called coronary artery bypass graft (CABG)
have had an attack of asthma, 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.
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.
have an allergy to:
celecoxib
any of the ingredients listed at the end of this leaflet
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).
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.
If you are allergic to sulfonamides or any of the capsule ingredients and take Celebrex, these symptoms may be severe.
Ask your doctor or pharmacist if any of this applies to you. Celebrex may not be suitable for you if any of the conditions below apply to you. You:
are already taking an NSAID
have an ulcer or gastric bleeding
have Irritable Bowel Disease
have heart failure
have had a heart attack, a “mini” stroke or stroke or blood vessel disease affecting circulation of blood to your brain or limbs, especially in the last 3 months.
Do not take Celebrex if 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.
Do not take Celebrex if the packaging is torn or shows signs of tampering.
If you are not sure if you should be taking Celebrex, talk to your doctor.
Before you start to take it
You must tell your doctor if you have any of the following health problems:
you currently have diabetes
high blood pressure
high cholesterol levels
heart failure or have a history of heart problems
stroke or a history of stroke
problems with the circulation in your limbs
you have any allergies to:
any other medicines
any other substances such as foods, dyes or preservatives.
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.
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.
you are breast-feeding or intend to breast-feed
Small amounts of celecoxib passes into breast milk, therefore taking Celebrex during breast-feeding should be discussed with your doctor.
you have any other health problems including:
liver or kidney problems
asthma, hives, itching, skin rash or a runny nose
high blood pressure
fluid retention or other medical conditions that can cause fluid retention
peptic ulcer (i.e. stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before
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.
you 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.
you drink large amounts of alcohol
you are a smoker
you currently have an infection.
If you are given Celebrex while you have an infection, it may hide some of the signs of an infection.
If you have not told your doctor or pharmacist about these things, tell them before you start taking Celebrex.
Taking other medicines
Tell your doctor or your pharmacist if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Celebrex may interfere with each other. 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 medicines 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 non-steroidal anti-inflammatory drugs (NSAIDs).
Your doctor may need to adjust the dosage of these medicines, or provide additional advice if you are also taking Celebrex.
How to 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 it
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 he/she can monitor your condition and treatment.
If you forget to take it
If 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 (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Celebrex. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much Celebrex, you may feel tired, drowsy, sick, vomit, and have stomach pain. You may also have difficulty breathing and feel faint.
While you are using Celebrex
Things you must 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 must 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.
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.
Like other medicines, Celebrex can cause some side effects. If they occur, most are likely to be minor and temporary.
Ask your doctor or pharmacist any questions you may have.
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, 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:
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.
These are serious side effects. You may need urgent medical attention.
Not all of these side effects have been reported with Celebrex but have been seen with similar medicines.
Other side effects not listed above may occur in some people.
Do not be alarmed by this list of possible side effects.
You may not get any of them.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
After taking Celebrex
Storage
Keep your capsules where young children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep Celebrex in a cool, dry place where the temperature stays at or below 25°C. Do not store it, or any other medicine, in the bathroom or near a sink. Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
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.
Disposal
If your doctor tells you to stop taking Celebrex or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it 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.
Celebrex 200 mg – opaque, white capsules with two gold bands marked 7767 and 200.
The 200 mg capsules come in blister packs of 10 and 30.
Ingredients
Active ingredient
Celebrex 100 mg – 100 mg celecoxib/capsule
Celebrex 200 mg – 200 mg celecoxib/capsule.
Other ingredients
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).
Celebrex does not contain sucrose, gluten, tartrazine or other azo dyes.
Supplier
Celebrex is supplied in Australia by:
Pfizer Australia Pty Ltd
SYDNEY NSW 2000.
Toll Free Number: 1800 675 229.
www.pfizer.com.au.
Australian Registration Number:
Celebrex 100 mg – AUST R 67901.
Celebrex 200 mg – AUST R 67902.
This document was last revised in January 2019.
® Registered Trademark.
© Copyright 2019.
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