Contains the active ingredient celecoxib
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about celecoxib. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Celecoxib. It contains the active ingredient celecoxib.
It is used to treat:
osteoarthritis,
rheumatoid arthritis
ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine.
Celecoxib also provides short term pain relief in conditions such as:
menstrual cramps or period pain
after surgery
muscle and joint injuries.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Celecoxib belongs to a group of medicines called NSAIDs which are used to relieve pain and inflammation in a number of conditions.
There is no evidence that this medication is addictive.
Use in children
This medicine should not be used in children or adolescents under 18 years of age.
Before you take this medicine
When you must not take it
Do not take this medicine if you have or have had any of the following:
severe heart disease
blood vessel disease affecting the circulation in your brain or limbs
severe liver problems
recently undergone a coronary artery bypass graft
peptic ulceration or gastric intestinal bleeding
severe kidney problems
an attack of asthma, hives, itching, skin rash or a runny nose after taking Aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including other Coxib medicines.
You are taking any other NSAIDs
You are hypersensitive to, or have had an allergic reaction to, celecoxib, any of the ingredients listed at the end of this leaflet or sulfonamides, a group of medicines which include certain antibiotics (if you are not sure if you are taking one of these medicines ask your doctor or pharmacist).
Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You have or have had any medical conditions, especially the following:
diabetes
high blood pressure or fluid retention
high cholesterol levels
heart failure
history of heart problems or stroke
circulation problems in your limbs
liver or kidney problems
asthma, hives, itching, skin rash or runny nose
peptic ulcer
vomiting blood or material that looks like coffee grounds
bleeding from the rectum, have black sticky bowel motions or bloody diarrhoea
low blood count
inflammatory bowel disease
infection.
3.You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
NSAIDs, which are related medicines, have been associated with reversible infertility in some women.
4.You are currently breastfeeding or you plan to breastfeed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
5.You drink large amounts of alcohol
7.You are planning to have surgery.
8.You are currently receiving or are planning to receive dental treatment.
9.You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with celecoxib. These include:
medicines 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)
frusemide and thalizides, types of diuretics
aspirin
metoprolol, a beta-blocker used for heart conditions, high blood pressure and migraines
fluconazole, an antifungal agent
lithium, a medicine used to treat some mood disorders
warfarin, apixaban, dabigatran, and rivaroxaban, medicines used to stop blood clots
rifampicin, an antibiotic
carbamazepine, a medicine used for epilepsy
barbiturates, a class of medicines that cause sedation
cyclosporin, an immune suppressant
antacids, medicines used to treat indigestion
dextromethorphan, a cough suppressant
medicines used to treat pain and inflammation called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or (cortico) steroids.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with celecoxib.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Osteoarthritis
The recommended dose is 200 mg once daily or 100 mg twice daily.
Rheumatoid arthritis
The recommended dose is 100 mg twice daily.
Ankylosing spondylitis
The maximum recommended dose is 200 mg once daily or 100 mg twice daily.
Menstrual cramps or period pain
The recommended dose is 400 mg as a single dose on the first day and 200 mg once daily on the following days. The maximum recommended treatment duration is 5 days.
Muscle and joint injuries or after surgery
The recommended dose is 400 mg as a first dose followed by 200 mg once or twice daily as required for up to 5 days.
How to take it
Swallow the capsule whole with a glass of fluid.
When to take it
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
This medicine can be taken with or without food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough of this medicine to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or go to the Accident and Emergency department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Signs of an overdose with celecoxib may include:
nausea and/or vomiting
headache
drowsiness/tiredness
difficulty in breathing
impaired consciousness
kidney failure.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breastfeeding or are planning to breastfeed
you are about to have any blood tests
you are going to have surgery or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Things you must not do
Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor tells you to.
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects you.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking celecoxib or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following.
stomach pain, diarrhoea, indigestion, wind, nausea
back pain, swollen hands, ankles and feet, unexplained weight gain
dizziness
sore throat, runny nose, sinusitis, upper respiratory tract infection
skin rash
difficulty sleeping.
Tell your doctor immediately if you notice any of the following.
These may be serious side effects and you may need urgent medical attention.
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
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
worsening epilepsy.
Other side effects not listed above may occur in some patients.
Allergic reactions
If you think you are having an allergic reaction to celecoxib, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
fainting
hay fever-like symptoms.
Storage and disposal
Storage
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
Product description
What APO-Celecoxib looks like
APO-Celecoxib 100 mg capsules: Opaque, white capsules with 2 blue bands and marked "100" on the body.
Blister pack: 60 capsules.
APO-Celecoxib 200 mg capsules: Opaque, white capsules with 2 gold bands and marked "200" on the body.
Blister pack: 30 capsules.
* Not all strengths, pack types and/or pack sizes may be available.
Ingredients
Each capsule contains 100 mg or 200 mg of celecoxib as the active ingredient.
It also contains the following inactive ingredients:
lactose
sodium lauryl sulphate
croscarmellose sodium
povidone
magnesium stearate.
In addition, each capsule shell contains the following inactive ingredients:
gelatin
titanium dioxide
sodium lauryl sulfate
TekPrint TM SB-6018 Blue Ink (ARTG 2653) [for 100 mg capsules]
TekPrint TM SB-3002 Gold Ink (ARTG 3426) [for 200 mg capsules].
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
