Doroxib®

Patient Information

Doroxib^® contains celecoxib and belongs to a group of medicines called coxibs which are used to relieve pain and inflammation in a number of conditions.

What Doroxib^®is used for:

• Doroxib^® 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.
• Doroxib^® also provides short-term pain relief in conditions such as menstrual cramps or period pain, after surgery, muscle and joint injuries.

Tell your doctor or pharmacist before using Doroxib^®if:

• you are allergic to Doroxib^® or any of the other ingredients of this medicine.   
• you have had an allergic reaction to a group of medicines called “sulfonamides”                         
• you currently have an ulcer in your stomach or intestines, or bleeding in your stomach or intestines.
• as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain relieving medicine (NSAID) you have had asthma, nose polyps, severe nose congestion, or an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing.                                                                                                                    
• you are pregnant or breast-feeding
• you have severe liver disease or severe kidney disease                                                                 
• you have an inflammatory disease of the intestines such as ulcerative colitis or Crohn’s disease.
• you have heart failure, established ischaemic heart disease, or cerebrovascular disease.
• you have or have had problems with your blood circulation or if you have had surgery on the arteries of your legs.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

Who should not take Doroxib^®:

• 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.
• If you have or have had problems with your blood circulation.
• If you have or if your doctor has told you that severe heart or blood vessel disease affecting the circulation in your brain or limbs.
• If you have severe liver problems.
• If you have problems with your kidney function.
• If you are undergoing cardiac surgery called coronary artery bypass graft (CABG)
• If 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.
• If you are allergic to aspirin, NSAIDs, or other Coxib medicines and take Celebrex.
• If you have an allergy to celecoxib any of Doroxib`s ingredients, sulfonamides.

How to take your Doroxib^®:

• Follow all directions given to you by your doctor or pharmacist carefully. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
• Swallow the capsules whole with a full glass of water. Doroxib^® can be taken with or without food.
• Take your medicine at about the same time each day.
• If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of Doroxib^®

What to do if you forget to take a dose:

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 makeup for the dose you missed.

While taking your medicine:

• If you become pregnant while taking Doroxib^®, tell your doctor immediately.
• If you are about to start any new medicines, tell your doctor and pharmacist that you are taking Doroxib^®.
• Tell all doctors, dentists and pharmacists who are treating you that you are taking Doroxib^®.
• 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.
• If you feel dizzy or drowsy after taking Celebrex, do not drive or operate machinery until these effects wear off.

Call your doctor right away if you have:

• an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing - heart problems such as pain in the chest
• severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained stools, or vomiting blood
• a skin reaction such as rash, blistering or peeling of the skin
• liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow)).

What to do if you take too many capsules:

Immediately telephone your doctor or Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Doroxib^®. 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.

 Side effects:

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Very common: high blood pressure,
• Common: heart attack, fluid build up with swollen ankles, legs and/or hands, urinary infections, shortness of breath, sinusitis, blocked or runny nose, sore throat, coughs, colds, flu-like symptoms, dizziness, difficulty sleeping, vomiting, stomach ache, diarrhoea, indigestion, wind, Rash, itching, muscle stiffness, difficulty swallowing, headache, nausea,, painful joints, worsening of existing allergies, accidental injury Uncommon: stroke, heart failure, palpitations, fast heart rate, abnormalities in liver-related blood tests, abnormalities in kidney-related blood tests, anaemia, anxiety, depression, tiredness, drowsiness, tingling sensations, high levels of potassium in blood test results, nausea, fatigue, muscle weakness or palpitations, impaired or blurred vision, ringing in the ears, mouth pain and sores, difficulty hearing, constipation, burping, stomach inflammation, worsening of inflammation of the stomach or intestine, leg cramps, raised itchy rash, eye inflammation, difficulty breathing, kin discolouration, chest pain, face swelling.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed here.

You can also report side effects directly via the Yellow Card Scheme at: www.dorsapharma.com/ (ADR form)

By reporting side effects, you can help provide more information on the safety of this medicine.