QUALCOX is a nonsteroidal anti-inflammatory drug (NSAID).
Your health care provider has prescribed QUALCOX for you for one or more of the following medical conditions:

• Osteoarthritis – relieve pain
• Rheumatoid Arthritis – relieve joint pain and swelling
• Ankylosing Spondylitis – relieve pain
• Sprains, after orthopedic (bone and joint) surgery (NOT open-heart surgery), dental extraction – to relieve short-term pain (maximum use of 7 days).

What it does:
QUALCOX (celecoxib), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the type of prostaglandins (chemicals), produced by your body which cause joint swelling, redness and pain. At prescribed doses, QUALCOX does not affect the type of prostaglandins that helps maintain the protective layer of the stomach, and reduces the chances of bleeding from the stomach. QUALCOX, as a nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. QUALCOX can only relieve pain and reduce swelling as long as you continue to take it.

Before you use QUALCOX talk to your doctor or pharmacist if you have any of the following:

• Disease of the heart or blood vessels (also called cardiovascular disease, including uncontrolled high blood pressure, congestive heart failure, established ischemic heart disease, or peripheral arterial disease)
• Risk factors for cardiovascular disease (see above) such as high blood pressure, abnormally high levels of fat (cholesterol, triglycerides) in your blood
• Diabetes Mellitus or on a low sugar diet
• Atherosclerosis
• Poor circulation to your extremities
• Smoker or ex-smoker
• Kidney disease or urine problems
•  Previous ulcer or bleeding from the stomach or gut
• Previous bleeding in the brain
• Bleeding problems
• Family history of allergy to sulfonamide drugs
• Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
• Family history of asthma, nasal polyp, long-term swelling
• of the sinus (chronic sinusitis) or hives
• Gastrointestinal problems (problems with your stomach and/or intestine)
• Current pregnancy
• Any other medical problem Fertility may be decreased. The use of QUALCOX is not recommended in women who have difficulty conceiving.

Also, before taking this medication, tell your health care provider if you are planning to get pregnant.

a- Do not take QUALCOX if you:
Have any of the following medical conditions:

• Heart bypass surgery (planning to have or recently had)
• Severe, uncontrolled heart failure
• Allergy to celecoxib or any of the other ingredients in QUALCOX
• Allergy to sulfonamide drugs
• Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti- Inflammatory Drugs)
• Pregnancy of more than 28 weeks (in your third trimester)
• Currently breastfeeding (or planning to breastfeed)
• Ulcer (active)
• Bleeding from the stomach or gut (active)
• Bleeding in the brain or other bleeding disorders
• Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
• Liver disease (active or severe)
• Kidney disease (severe or worsening)
• High potassium in the blood

QUALCOX is NOT recommended for use in patients under 18 years of age since the safety and effectiveness of QUALCOX have NOT been established in these patients.

Patients who took a drug in the same class as QUALCOX after a type of heart surgery (coronary artery bypass grafting (CABG) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug.

b- Take special care with QUALCOX: 

c- Pregnancy & breast-feeding:

• Caution should be exercised in prescribing QUALCOX during the first and second trimesters of pregnancy.
• QUALCOX is CONTRAINDICATED for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition)
• QUALCOX is CONTRAINDICATED for use for Women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants
• The use of QUALCOX, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of QUALCOX should be considered.

d- Interactions with this medication:
Talk to your health care provider and pharmacist if you are taking any other medication (prescription or nonprescription) such as any of the following (NOT a complete list):

• Acetylsalicylic acid (ASA) or other NSAIDs (e.g. diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen)
• Antacids or proton pump inhibitors (omeprazole)
• Antidepressants [Selective serotonine receptor uptake inhibitor (SSRIs) (e.g. citalopram, paroxetine, fluoxetine, sertraline)]
• Blood pressure medications, such as ACE (angiotensin converting enzyme) inhibitors (e.g. enalapril, lisinopril, perindopril, ramipril), ARBs (angiotensin II receptor blockers) (e.g. candesartan, irbesartan, losartan, valsartan), beta blockers (e.g. metoprolol)
• Blood thinners (to prevent blood clots), such as warfarin, apixaban, rivaroxaban, dabigatran, ASA, clopidogrel
• Corticosteroids (including glucocorticoids)ne.g. prednisone
• Cyclosporin
• Digoxin
• Diuretics such as furosemide, hydrochlorothiazide
• Fluconazole
• Lithium
• Dextromethorphan (found in some cough medications)
• Tacrolimus

Using QUALCOX with a blood thinner such as warfarin increases the risk of bleeding, which can be fatal, especially in older patients. Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner for the prevention of having a heart attack or stroke while you are taking QUALCOX. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both QUALCOX and ASA than if you take QUALCOX alone.

Usual Adult dose:
18 years of age and older only:
 

Take QUALCOX only as directed by your health care provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much QUALCOX may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

If you will be using QUALCOX for more than 7 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

QUALCOX is NOT recommended for patients under 18 year of age since safety and effectiveness have NOT been established.

QUALCOX can be taken with or without food

a- If you take more QUALCOX then you should:
 

b- If you forget to take QUALCOX
Take the dose you missed as soon as you remember, then take the next dose at the scheduled time 

QUALCOX may cause some side effects, especially if used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.

QUALCOX may cause you to become drowsy or tired.

Be careful about driving or participating in activities that require you to be alert. If you become drowsy, dizzy or lightheaded after taking QUALCOX, do NOT drive or operate machinery.

QUALCOX may cause you to become more sensitive to sunlight. Any exposure to sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discoloration, or vision changes. If you have a reaction from the sun, check with your health care provider.

QUALCOX can cause abnormal laboratory test results. Your doctor will decide when to perform laboratory tests and will interpret the results. They may check kidney function, liver function, amount of blood cells and other functions.

Your doctor will decide when to measure the amount of your amniotic fluid during pregnancy.

Check with your health care provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms occur, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.

SERIOUS SIDE EFFECTS. HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect	STOP taking drug and get emergency medical attention IMMEDIATELY	STOP taking drug and talk to your health care provider
Bloody or black tarry stools
Shortness of breath, wheezing, any trouble breathing or chest tightness
Skin rash, hives, swelling or itching
Blurred vision or other visual disturbance
Sudden severe headache or worsening of headache, vomiting, dizziness, fainting, disturbance of vision or speech, or weakness or numbness in the face, arm or leg
Change in urine (amount or colour) (dark red or brown)
Pain or difficulty urinating
Feet or lower leg swelling; weight gain
Vomiting or persistent indigestion, nausea, stomach pain or diarrhea
Yellow discolouration of the skin or eyes with or without itchy skin
Malaise, fatigue, or loss of appetite
Headaches, stiff neck
Mental confusion or depression
Dizziness or light- headedness
Hearing problems
Pneumonitis (symptoms include trouble breathing, dry cough, tiredness)

This is NOT a complete list of side effects. If you develop any other symptoms while taking QUALCOX, see your health care provider.
 

• Keep out of the reach and sight of children.
• Do not use QUALCOX after the expiry date printed on the carton or blister.
• Blister: Store below 30°C. Store in the original package.