DEFINAX 200 mg. 10 capsules

What Definax and what it is used
Definax is used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adults.
Definax belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), in particular subgroup known as cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, your body produces more thereof. Definaks works by reducing the production of prostaglandins, thereby reducing pain and inflammation.

2. What you need to know before taking Definax
Do not take Definax:
If you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6);
If you have had an allergic reaction to a group of medicines called "sulphonamides" (eg some antibiotics used to treat infections);
If you currently have an ulcer in the stomach or intestines, or bleeding in the stomach or intestines;
If after taking acetylsalicylic acid (aspirin) or other anti-inflammatory and analgesic drug (NSAID) you have had asthma, nasal polyps, severe nasal congestion, or allergic reaction such as an itchy skin rash, swelling of face, lips, tongue or throat, difficulty breathing or wheezing;
If you are pregnant. If there is a possibility to become pregnant during treatment you should discuss birth control methods with your doctor;
If you are breastfeeding;
If you have severe liver disease;
If you have severe kidney disease;
If you have inflammatory bowel disease such as ulcerative colitis or Crohn's disease;
If you have heart failure, established ischemic heart disease or cerebrovascular disease, eg you have had a heart attack, stroke or transient ischemic attack (temporary reduction of blood flow to the brain, also known as "mini-stroke"), angina or blockage of blood vessels to the heart or the brain;
If you have or have had problems with blood circulation (peripheral arterial disease) or if you have made operation of the arteries of the lower extremities.
Warnings and Precautions
Talk to your doctor before taking Definaks:
If you have ever had an ulcer or bleeding from the stomach or intestines;
If you are taking acetylsalicylic acid (even at low doses for the prevention of cardiovascular system);
If you are taking medicines that reduce blood clotting (eg warfarin);
If you are taking Definaks simultaneously with other non-aspirin NSAIDs, such as ibuprofen or diclofenac. Concomitant use of these drugs should be avoided;
If you smoke, have diabetes, high blood pressure or elevated cholesterol levels;
If your heart, liver or kidneys are not working well, your doctor may decide to conduct regular reviews;
If you have fluid retention (such as swollen ankles and feet);
If you're dehydrated, which may be due to fatigue, diarrhea or taking diuretics (used for drainage);
If you have severe allergic reactions or skin reactions to certain drugs;
If you feel unwell due to infection or think you have an infection as Definaks may mask fever or other signs of infection and inflammation;
If you are over 65 years your doctor may want you to carry out regular reviews.
As with other NSAIDs (eg, ibuprofen or diclofenac), this medicine can lead to high blood pressure and your doctor may wish periodically to monitor your blood pressure. Some cases of severe hepatic reactions, including acute liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant) have been reported with celecoxib.
Among the cases reported during the occurrence, most severe liver reactions occurred within one month after starting treatment.

Definaks can make conception more difficult. You should tell your doctor if you are planning to become pregnant or if you have problems getting pregnant (see "Pregnancy, breastfeeding and fertility").

Other medicines and Definaks
Some medicines can affect the way other medicines. Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines
Dextromethorphan (used for the treatment of cough);
ACE inhibitors or angiotensin II antagonists (used for high blood pressure and heart failure);
Diuretics (used to remove excess fluid in the body);
Fluconazole and rifampicin (used to treat fungal and bacterial infections);
Warfarin or other oral anticoagulants (means of "blood thinning" that reduce its clotting);
Lithium (used to treat certain types of depression);
Other medicines to treat depression, sleep disorders, high blood pressure or irregular heartbeat;
Neuroleptics (used to treat some mental disorders);
Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukemia);
Carbamazepine (used to treat epilepsy / seizures and some forms of pain or depression);
Barbiturates (used to treat epilepsy / seizures and some sleep disorders);
Cyclosporine and tacrolimus (used to suppress the immune system, for example after inserting the graft).
Definaks can be taken with low-dose acetylsalicylic acid. Ask your doctor for advice before taking both drugs together.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Definaks should not be taken by women who are pregnant or may become pregnant (ie women of childbearing potential not using adequate contraception) during treatment. If you become pregnant during treatment with Definaks should stop treatment and contact your doctor for alternative treatment.
Definaks can make conception more difficult (see section "Warnings and Precautions").
Definaks should not be used during breastfeeding.

Driving and using machines
You need to know how you react to Definaks before driving or operating machinery. If you experience dizziness or fatigue after taking Definaks, do not drive or operate machinery until these effects disappear.

Important information about some of the ingredients of Definaks
Definaks contains lactose (a type of sugar).
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.

3. How to take Definax
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Since the risk of adverse reactions associated with heart problems may increase with increasing dose and duration of treatment, it is important to use the lowest dose that controls your pain and you should not use Definaks longer than necessary controlling the symptoms.
Contact your doctor if you feel any improvement within two weeks of starting treatment.

For osteoarthritis the usual dose is 200 mg daily, if necessary, can be increased by your doctor to a maximum of 400 mg.
The dose is usually:
One 200 mg capsule once a day;
One capsule of 100 mg twice daily.
For rheumatoid arthritis the usual dose is 200 mg daily (administered in two divided doses) in case of need can be increased by your doctor to a maximum of 400 mg (taken in two equal doses).
The dose is usually:
One capsule of 100 mg twice daily.
If you can not adjust the dose of this drug concentration, are available strengths of the same drug with which to reach the required dose for you. Please consult your doctor.

For ankylosing spondylitis the usual dose is 200 mg daily, if necessary, can be increased by your doctor to a maximum of 400 mg.
The dose is usually:
One 200 mg capsule once a day;
One capsule of 100 mg twice daily.
Maximum daily dose:
You should not take more than 400 mg per day (two capsules Definaks 200 mg hard capsules).

Kidney or liver problems: make sure your doctor knows if you have liver or kidney problems as you may need a lower dose.

Elderly patients, especially those weighing less than 50 kg: if you are aged over 65, and especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.

Use in children
Definaks is only for adults should not be used by children.
Method of administration
Definaks 200 mg hard capsules should be swallowed whole with a glass of water. The capsules can be taken at any time of day, with or without food. Try, however, to take each dose of Definaks 200 mg hard capsules at the same time each day.

If you take more dose Definax
You should not take more capsules than what you have been told by your doctor. If you take too many capsules, contact your doctor, pharmacist or hospital and take your medicine with you.

If you forget to take Definaks
If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up the missed dose.

If you stop taking Definax
Suddenly stopping your treatment with Definaks can lead to worsening of your symptoms. Do not stop taking Definaks unless your doctor has told you to do it. Your doctor may tell you to reduce the dose over several days before finally stopping.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist
The side effects listed below were observed in arthritis patients who took Definaks. Adverse reactions with an asterisk (*) and listed below have occurred with greater frequency than those occurring in patients receiving Definaks prevention of colon polyps. Patients in these trials were taking Definaks in high doses and for a long time.

If something happens of the following cheese intake Definaks and tell your doctor:
If you have:
Allergic reactions such as skin rash, swelling of the face, wheezing or difficulty breathing;
Heart problems, such as chest pain;
Severe stomach pain or signs of bleeding from the stomach or intestines, such as passing a black or bloody stools, or vomiting blood;
Skin reactions such as rash, blistering or peeling skin;
Liver failure (symptoms may include nausea, diarrhea, jaundice (your skin and whites of the eyes look yellow)).
Very common: may affect more than 1 in 10 people:
High blood pressure*.
Common: may affect 1 to 10 in 100 people:
Heart attack*;
Fluid retention, swelling of ankles, legs and / or arms;
Urinary tract infections;
* Shortness of breath, sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore throat, cough, cold, flu-like symptoms;
Dizziness, trouble sleeping;
* Nausea, stomach pain, diarrhea, indigestion, flatulence
Rash, itching;
Muscle stiffness;
* Difficulty swallowing;
Worsening of existing allergies.
Uncommon: may affect 1 in 100 people:
* Stroke;
Heart failure, palpitations (awareness of heartbeats), increased heart rate;
Worsening of high blood pressure;
Changes in laboratory studies reflecting the function of the liver;
Changes in laboratory tests that reflect kidney function;
Anaemia (changes in red blood cells that may cause fatigue and breathlessness);
Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles);
High levels of potassium in the laboratory blood tests (may cause nausea, fatigue, muscle weakness or palpitations);
Decreased or blurred vision, noise (ringing) in the ears, pain and sores in the mouth, hearing loss *;
Constipation, hiccups, inflammation of the stomach (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestines;
Muscle cramps (cramps) of the lower limbs;
Convex itchy rash (urticaria).
Rare: may affect 1 to 10 in 10,000 people:
Ulcers (bleeding) in the stomach, esophagus or intestine; or rupture of the intestine (can cause stomach pain, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the gullet (can cause difficulty in swallowing), inflammation of the pancreas (can lead to stomach pain) ;
Reduced number of white blood cells that help protect the body from infection) and platelets (increased risk of bleeding or bruising);
Difficulties in coordinating muscle movements;
Confusion, change in taste perception;
Increased sensitivity to light;
Hair loss.
Not known: from the available data can not be estimated:
Bleeding in the brain, causing death;
Serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash, swelling of face, lips, mouth, tongue or throat, wheezing or difficulty breathing; difficulty swallowing;
Bleeding in the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the small or large intestines, nausea;
Serious skin conditions such as Stevens-Johnson, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalized exanthemous pustulosis (red swollen area with numerous small pustules);
Delayed allergic reaction to possible symptoms such as rash, facial swelling, fever, swollen glands and abnormal laboratory tests (eg, liver, blood cells (eosinophilia, increased number of a type of white blood cell));
Liver failure, liver damage and severe liver inflammation (sometimes fatal or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, light stools, bleeding easily, itching or chills;
Kidney problems (possible kidney failure, inflammation of the kidneys);
Blood clot in the blood vessels of the lungs. Symptoms may include sudden zapahtyanost, sharp pains when you breathe or collapse;
Irregular heartbeat;
Meningitis (inflammation of the lining of the brain and spinal cord);
Hallucinations;
Worsening of epilepsy (possible more frequent / or severe seizures);
Inflammation of blood vessels (can cause fever, pain, purple spots on the skin);
Occlusion of the artery or vein in the eye, leading to partial or complete loss of vision, inflammation of the conjunctiva, bleeding in the eye;
Reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nosebleeds and increased risk of infections);
Chest pain;
Impaired sense of smell;
Discoloration of the skin (hematoma), muscle pain and weakness, painful joints;
Menstrual disorders;
Headache, flushing;
Low sodium levels in blood tests (can cause loss of appetite, headache, nausea, swelling of the lower extremities and weakness).
In clinical trials, not associated with arthritis or other arthritic conditions, wherein Definaks is administered in doses of 400 mg / day to 3 years, the following additional adverse events:
Common: may affect 1 to 10 people:
Heart problems: angina (chest pain);
Stomach problems: irritable bowel syndrome (can include stomach ache, diarrhea, indigestion, gas);
Kidney stones (which can cause pain in the stomach or back, blood in the urine), difficulty urinating;
Increased weight.
Uncommon: may affect 1 to 10 of 1000:
Deep vein thrombosis (blood clotted usually in the leg, which can cause pain, swelling or redness of the calf or breathing problems);
Stomach problems: stomach infection (which can cause inflammation or ulceration of the stomach and intestines);
Fracture of lower limb;
Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing));
Floating particles in the eye, causing blurred or decreased vision, dizziness, due to the problems of the inner ear, painful, inflamed or bleeding gums, mouth sores;
Excessive urination at night, bleeding from hemorrhoids often bowel movement;