Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CELECOXIB SANDOZ. 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 CELECOXIB SANDOZ against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Read this leaflet carefully before you start CELECOXIB SANDOZ and keep it with the medicine. You may need to read it again.
What CELECOXIB SANDOZ is used for
CELECOXIB SANDOZ is used to relieve the symptoms of joint pain, tenderness, swelling and stiffness in:
- rheumatoid arthritis and
- ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine.
CELECOXIB SANDOZ also provides short-term pain relief in conditions such as:
- menstrual cramps or period pain
- after surgery
- muscle and joint injuries.
CELECOXIB SANDOZ belongs to a group of medicines called Coxibs which are used to relieve pain and inflammation in a number of conditions.
Although CELECOXIB SANDOZ can relieve the symptoms of pain and inflammation, it will not cure your condition.
Your doctor, however, may have prescribed CELECOXIB SANDOZ for another purpose.
Ask your doctor if you have any questions about why CELECOXIB SANDOZ has been prescribed for you.
CELECOXIB SANDOZ 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 CELECOXIB SANDOZ
When you must not take it
Do not take CELECOXIB SANDOZ if:
- you suffer from chest pains or angina and they occur even when you are resting and are becoming more frequent, severe, or lasting for longer than usual
- you have or have had problems with your blood circulation
- 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 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 use CELECOXIB SANDOZ, these symptoms may be severe.
- you have an allergy to:
– CELECOXIB SANDOZ
– 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
If you are allergic to sulfonamides or any of the capsule ingredients and take CELECOXIB SANDOZ, these symptoms may be severe.
Ask your doctor or pharmacist if any of this applies to you. CELECOXIB SANDOZ may not be suitable for you if any of the conditions below apply to you.
- you are already taking an NSAID
- you have an ulcer or gastric bleeding
- you have Irritable Bowel Disease
- you have heart failure
- you 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 CELECOXIB SANDOZ 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 CELECOXIB SANDOZ if the packaging is torn or shows signs of tampering.
If you are not sure if you should be taking CELECOXIB SANDOZ, talk to your doctor.
Before you start to take it
You must tell your doctor if:
- you currently have diabetes, high blood pressure, high cholesterol levels, heart failure or have a history of heart problems or stroke, or 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
Related medicines, NSAIDs, 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 CELECOXIB SANDOZ during pregnancy.
CELECOXIB SANDOZ may affect your developing baby if taken during pregnancy.
CELECOXIB SANDOZ use is not recommended in pregnancy unless your doctor considers it essential. If you are taking CELECOXIB SANDOZ 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
CELECOXIB SANDOZ passes into breast milk in small amounts, therefore, the use of CELECOXIB SANDOZ during breastfeeding 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 or 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 CELECOXIB SANDOZ together with any medicines used to treat high blood pressure and some other heart problems such as ACE inhibitors, angiotensin receptor antagonists 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 CELECOXIB SANDOZ 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 CELECOXIB SANDOZ.
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 CELECOXIB SANDOZ 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 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 (rivaroxaba
n) or Pradaxa (dabigatran), a medicine 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, medicine used to suppress the immune system
- certain medicines used to treat pain and inflammation called non-steroidal anti-inflammatories (NSAIDs) or (cortico) steroids.
Your doctor may need to adjust the dosage of these medicines, or provide additional advice if you are also taking CELECOXIB SANDOZ.
How to take CELECOXIB SANDOZ
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How much to take
200mg once daily or 100mg twice daily.
100mg twice daily or 200mg twice daily.
100mg twice daily or 200mg once daily.
Menstrual cramps or period pain
200mg twice daily, you may take CELECOXIB SANDOZ for up to 5 days.
Muscle and joint injuries or after surgery
200mg once or twice daily as required. You may take CELECOXIB SANDOZ for up to 5 days.
How to take it
Swallow the capsules whole with a glass of fluid. CELECOXIB SANDOZ can be taken with or without food.
How long to take it
Depending on your condition, you may need CELECOXIB SANDOZ for a few days or for longer periods.
CELECOXIB SANDOZ will not cure your condition but should help control pain, swelling and stiffness.
Keep taking CELECOXIB SANDOZ for as long as your doctor advises.
Do not exceed the dosage recommended by your doctor.
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 CELECOXIB SANDOZ. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much CELECOXIB SANDOZ, you may feel tired, drowsy, sick, vomit, and have stomach pain. You may also have difficulty breathing and feel faint.
While you are taking it
Things you must do
If you become pregnant while taking CELECOXIB SANDOZ, tell your doctor immediately.
If you are about to start any new medicines, tell your doctor and pharmacist that you are taking CELECOXIB SANDOZ.
Tell all doctors, dentists and pharmacists who are treating you that you are taking CELECOXIB SANDOZ.
If you develop any skin rash (e.g. hives, spots) while being treated with CELECOXIB SANDOZ, 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 CELECOXIB SANDOZ to anyone else, even if they have the same symptoms or condition as you.
Do not use CELECOXIB SANDOZ to treat any other complaints unless your doctor tells you to.
Check with your doctor as soon as possible if you have any problems while taking CELECOXIB SANDOZ, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, CELECOXIB SANDOZ 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
- sore throat, runny nose, sinusitis, upper respiratory tract infection.
Tell your doctor immediately 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
- 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 of 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 CELECOXIB SANDOZ 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 CELECOXIB SANDOZ
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 CELECOXIB SANDOZ in a cool, dry place where the temperature stays at or below 30°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.
If your doctor tells you to stop taking CELECOXIB SANDOZ, or the capsules have passed their expiry date, ask your pharmacist what to do with any left over.
What it looks like
- CELECOXIB SANDOZ 100mg – opaque, white and blue capsules.
The 100mg capsules come in blister packs of 60.
- CELECOXIB SANDOZ 200mg – opaque, white and orange capsules.
The 200mg capsules come in blister packs of 30.
The active ingredient in CELECOXIB SANDOZ is celecoxib.
- CELECOXIB SANDOZ 100mg – 100mg celecoxib/capsule
- CELECOXIB SANDOZ 200mg – 200mg celecoxib/capsule
- Lactose monohydrate
- sodium lauryl sulfate
- cellulose – microcrystalline
- silica – colloidal anhydrous
- talc – purified
- magnesium stearate
- titanium dioxide
- indigo carmine – / 100mg
- iron oxide red / 200mg
- iron oxide yellow / 200mg
- CELECOXIB SANDOZ does not contain sucrose, gluten, tartrazine or other azo dyes.
CELECOXIB SANDOZ is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park NSW 2113
Tel: 1800 634 500
Australian Registration Number:
CELECOXIB SANDOZ 100mg – AUST R 210630
CELECOXIB SANDOZ 200mg – AUST R 210632
This document was prepared December 2018.
Published by MIMS January 2019