ACLEXA 200 mg. 30 capsules
Aclexa is used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
Aclexa belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and in particular a subset 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 of them. Aclexa works by reducing the production of prostaglandins, thereby reducing pain and inflammation.
2. What you need to know before taking Aclexa
Aclexa has been prescribed by your doctor. The following information will help you get the best results with Aclexa. If you have any further questions, ask your doctor or pharmacist.
Do not take Aclexa:
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 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 the face, lips, tongue or throat, difficulty breathing or wheezing ;
if you are pregnant. If it is possible to become pregnant during treatment, you should discuss contraception 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 coronary artery disease or cerebrovascular disease, e. you 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 brain;
if you have or have had problems with blood circulation (peripheral arterial disease) or if you have received surgery on the arteries of the lower extremities.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Aclexa:
if you have previously had an ulcer or bleeding in the stomach or intestines (Do not take Aclexa, if you currently have an ulcer or bleeding in the stomach or intestines);
if you are taking acetylsalicylic acid (even at low dose for cardiac prophylaxis);
if you are taking medication to reduce blood clotting (eg. warfarin);
if you use Aclexa with other NSAIDs containing aspirin, for example. ibuprofen or diclofenac. Use of these medicines together should be avoided;
if you smoke, have diabetes, have high blood pressure or elevated cholesterol levels;
if your heart, liver or kidneys are not working well, your doctor may wish to carry out regular reviews;
if you have fluid retention (such as swollen ankles or feet);
if you are dehydrated, due, for example, vomiting, diarrhea, or the use of diuretics (used for drainage);
if you have had a serious allergic reaction or a serious skin reaction to any medicines;
if you feel unwell due to infection or think you have an infection as Aclexa may mask fever or other signs of infection and inflammation;
if you are over 65, your doctor may want you to make periodic reviews.
As with other NSAIDs (eg. Ibuprofen or diclofenac), this medicine may lead to increases in blood pressure and your doctor may wish periodically to monitor your blood pressure.
Some cases of acute hepatic reactions, incl. 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.
Aclexa may make it more difficult pregnancy. You should tell your doctor if you are planning to become pregnant, or if you have fertility problems (see. Section "Pregnancy and lactation").
Other medicines and Aclexa:
Some medicines can affect the way other medicines work. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription:
Dextromethorphan (used for the treatment of cough);
ACE inhibitors or angiotensin II-antagonists (used for high blood pressure and heart failure);
Diuretics (used for drainage);
Fluconazole and rifampicin (used to treat fungal and bacterial infections);
Warfarin or other oral anticoagulants ("blood-thinning" agents that reduce blood clotting);
Lithium (used for the treatment of certain types of depression);
Other medicines to treat depression, sleep disorders, high blood pressure or irregular heartbeat;
Neuroleptics (used for the treatment of certain mental disorders);
Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and leukemia);
Carbamazepine (used to treat epilepsy / convulsions and certain forms of pain or depression);
Barbiturates (used to treat epilepsy / seizures and some sleep disorders);
Cyclosporine and tacrolimus (used to suppress the immune system, e. Post-transplant).
Aclexa may be administered with low-dose aspirin (75 mg or less / day). Consult your doctor before taking both drugs together.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Aclexa 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 Aclexa should discontinue treatment and contact your doctor for alternative treatment.
Aclexa should not be used during breastfeeding.
Aclexa may make it more difficult pregnancy (see. Point Warnings and Precautions).
Driving and using machines
You need to know how you react to Aclexa before driving or operating machinery. If you experience dizziness or fatigue after taking Aclexa, do not drive or operate machinery until these effects do not disappear.
Aclexa contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Aclexa
Always take Aclexa exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
If you think or feel that the effect of Aclexa is too strong or too weak, talk to your doctor or pharmacist.
Your doctor will tell you what dose you should take. 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 Aclexa longer than is necessary for controlling the symptoms.
Aclexa capsules should be swallowed whole with water. The capsules can be taken at any time of day, with or without food. Try, however, to take each dose Aclexa at the same time each day.
Contact your doctor if you feel any improvement within two weeks of starting treatment.
The recommended dose is:
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 capsule of 200 mg once daily; or
one capsule of 100 mg twice daily.
In rheumatoid arthritis, 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 capsule of 100 mg twice daily.
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 capsule of 200 mg once daily; or
one capsule of 100 mg twice daily.
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 years, and especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.
Use in children: Aclexa is for adults only, should not be used by children.
Maximum daily dose:
You should not take more than 400 mg per day (4 capsules Aclexa 100 mg or 2 capsules Aclexa 200 mg).
If you take more dose Aclexa
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 Aclexa
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 Aclexa
Suddenly stopping your treatment with Aclexa can lead to worsening of your symptoms. Do not stop taking Aclexa 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Aclexa can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
Adverse reactions listed below were observed in arthritis patients who received Aclexa. Adverse reactions with an asterisk (*) and listed below have occurred with greater frequency than those occurring in patients taking Aclexa prevention of colon polyps. Patients in these trials were taking Aclexa in high doses and for a long time.
If anything of the following, stop taking Aclexa and tell your doctor:
If you have:
allergic reaction 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 up to 1 in 10 people:
* Heart attack;
Fluid retention with swelling of the ankles, legs and / or arms;
Urinary tract infections;
Shortness of breath *, sinusitis (inflammation of the sinuses, sinus infection, blocked or painful sinuses), blocked or runny nose, sore throat, cough, colds, flu-like symptoms;
Dizziness, trouble sleeping;
* Vomiting, stomach pain, diarrhea, indigestion, flatulence
* Difficulty swallowing;
Uncommon: may affect up to 1 in 100 people:
Heart failure, palpitations (awareness of heartbeats), increased heart rate;
Worsening of high blood pressure;
Changes in laboratory tests reflecting liver function;
Changes in laboratory tests that reflect kidney function;
Anaemia (changes in red blood cells that can cause fatigue and shortness of breath;
Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles);
High levels of potassium in the laboratory blood tests (can cause nausea (feeling sick), 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;
Cramps (cramps) of the lower limbs;
Convex itchy rash (urticaria).
Rare: may affect 1 in 1,000 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 (which 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;
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 intestine, nausea (feeling sick);
Serious skin conditions such as syndrome 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 (feeling sick), 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 pain when breathing or collapse;
Meningitis (inflammation of the coverings of the brain and spinal cord);
Worsening of epilepsy (possible more frequent and / or severe seizures);
Inflammation of blood vessels (can cause fever, pain, purple spots on the skin);
Blockage of an 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);
Impaired sense of smell;
Discoloration of the skin (hematoma), muscle pain and weakness, painful joints;
Low sodium levels from blood samples (can cause loss of appetite, headache, nausea (feeling sick), muscle cramps and weakness).
In clinical trials, not associated with arthritis or other arthritic conditions, wherein Aclexa is administered in doses of 400 mg / day to 3 years, the following side effects:
Common: affects 1 to 10 in 100 people:
Heart problems: angina (chest pain);
Stomach problems: irritable bowel syndrome (can include stomach pain, diarrhea, indigestion, gas);
Kidney stones (which can cause pain in the stomach or back, blood in the urine), difficulty urinating;
Uncommon: affects 1 to 10 of 1000:
Deep vein thrombosis (blood clot 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 (infection of the chest (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 ulcers;
Excessive urination at night, bleeding from hemorrhoids, often defecating;
Fatty lumps on the skin or elsewhere, ganglion (harmless swelling in or around joints and tendons in the hands or feet), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain;
High levels of sodium blood tests.