Celecoxib APOTEX

Contains the active ingredient celecoxib

Consumer Medicine Information

 

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.

The name of your medicine is Celecoxib APOTEX 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.

Celecoxib belongs to a group of medicines called Coxibs which are used to relieve pain and inflammation in a number of conditions.

There is no evidence that this medicine is addictive.

This medicine should not be used in children or adolescents under 18 years of age.

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 taking this medicine, tell your doctor if:

1.You have allergies to:

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.

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.

NSAIDs, which are related medicines, have been associated with reversible infertility in some women.

5.You drink large amounts of alcohol.

6.You are a smoker.

7.You are currently receiving or are planning to receive dental treatment.

8.You are planning to have surgery.

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 types of 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.

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

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.

Swallow the capsule whole with a glass of fluid.

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.

It does not matter if you take it before, with or after food.

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 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 think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, 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.

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.

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.

Be careful when driving or operating machinery until you know how this medicine affects you.

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 as soon as possible if you notice any of the following.

These may be serious side effects and you may need 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, flulike 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.

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.

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.

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.

100 mg capsules: opaque, white to off-white capsules imprinted with ‘CC’ and ‘100’ in black ink.

Blister pack of 60 capsules.

200 mg capsules: white to off-white capsules imprinted with ‘CC’ and ‘200’ in black ink.

Blister pack of 30 capsules.

* Not all strengths may be available.

Each capsule contains 100 mg or 200 mg of celecoxib as the active ingredient.

It also contains the following inactive ingredients:

lactose monohydrate

povidone

colloidal anhydrous silica

sodium lauryl sulfate

croscarmellose sodium and

magnesium stearate

The capsule shell contains:

gelatin

titanium dioxide

sodium lauryl sulfate

TekPrint SW-9008 Black Ink (Proprietary Ingredient # 2328)

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Celecoxib APOTEX 100 mg capsules blister pack: AUST R 212785

Celecoxib APOTEX 200 mg capsules blister pack: AUST R 212787

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

 

APO and APOTEX are registered trade marks of Apotex Inc.

 

This leaflet was last updated in December 2020.