ALGOXIB 200 mg. 30 capsules

What Algoxib and what it is used
Algoxib is used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
Algoxib belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), particularly the subset known as cyclooxygenase-2 (COX-2) inhibitors. Your body produces substances called prostaglandins (hormone-like substances) that can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis your body produces more of these substances. Algoksib works by reducing the production of prostaglandins, thereby reducing pain and inflammation.

2. What you need to know before taking Algoxib
Your doctor has prescribed Algoxib. The following information will help you achieve the best results from treatment with Algoxib. If you have further questions, please ask your doctor or pharmacist.

Do not take Algoxib if:
you are allergic to celecoxib or any of the other ingredients of this medicine (listed in Section 6.1);
you have had an allergic reaction to a group of medicines called "sulphonamides" (eg. some antibiotics used to treat infections);
have a stomach ulcer or intestine, bleeding from the stomach or intestines;
you had asthma, nasal polyps or severe nasal congestion, or allergic reaction such as an itchy skin rash, swelling of face, lips, tongue or throat, difficulty or wheezing after taking aspirin or another anti-inflammatory or analgesic (NSAID) medicine ;
You are pregnant. If it is possible to become pregnant during treatment you should discuss contraception with your doctor;
breast feeding;
have severe liver disease;
have severe kidney disease;
have inflammatory bowel disease such as ulcerative colitis or Crohn's disease;
have heart problems, such as heart failure, established coronary artery disease, or cerebrovascular disease, e. You have had a heart attack, stroke or transient ischemic stroke (transient ischemic attack, also called "mini-stroke"), angina, or blockage of blood vessels to the heart or brain;
You have had problems with blood circulation (peripheral arterial disease) or you have experienced arterial operation of your limbs.
Warnings and Precautions
Talk to your doctor before taking Algoksib if:
you had an ulcer or bleeding in the stomach or intestines (Algoksib Do not take if you have an ulcer or bleeding in the stomach or intestines.);
taking acetylsalicylic acid (even at low doses to prevent heart);
taking medicines to reduce blood clotting (eg. warfarin);
Algoksib taking at the same time with other NSAIDs such as ibuprofen or diclofenac. Concomitant use of these drugs should be avoided;
smoke, have diabetes, high blood pressure or high cholesterol;
have heart, liver or kidney problems, your doctor may order regular reviews;
holding liquids (swollen ankles or feet);
you are dehydrated, for instance due to sickness, diarrhea or the use of diuretics (used to treat fluid from the body);
you have had a serious allergic reaction or a serious skin reaction to any medicine;
feel ill due to an infection or think you may have an infection, Algoksib may mask fever or other signs of infection and inflammation;
you are aged over 65, your doctor may do regular reviews.
As with other NSAIDs (eg., Ibuprofen or diclofenac), this medicine can increase blood pressure, so your doctor can measure your blood pressure regularly. In celecoxib have been reported cases of severe liver reactions, including severe liver inflammation, liver damage, liver failure (some fatal or requiring liver transplant). Most severe liver reactions occurred one month after starting treatment.

Other medicines and Algoxib
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 in the treatment of cough);
ACE inhibitors or angiotensin II antagonists (used for high blood pressure and heart failure);
Diuretics (used to treat fluid retention of the body);
Fluconazole and rifampicin (used in the treatment of fungal and bacterial infections);
Warfarin or other oral anticoagulants (anticoagulants are agents that reduce blood clotting);
Lithium (used in the treatment of certain types of depression);
Other medicines to treat depression, sleep disorders, high blood pressure or irregular heart beat;
Neuroleptics (used for the treatment of certain psychiatric disorders);
Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and leukemia);
Carbamazepine (used to treat epilepsy / convulsions and certain forms of pain);
Barbiturates (used to treat epilepsy / seizures and some sleep disorders);
Cyclosporin or tacrolimus (used to suppress the immune system, eg. After transplantation.
Algoksib can be taken with low-dose aspirin (75 mg or less daily dose). Ask your doctor for advice before taking both drugs together.

Pregnancy, lactation and fertility
Algoksib should not be used 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 Algoksib you should stop treatment and contact your doctor for alternative treatment. Algoksib should not be used during breastfeeding.
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.

Driving and using machines
Before driving or operating machinery, you should know how you react to taking Algoksib. If you experience dizziness or fatigue after taking Algoksib, do not drive or operate machinery until you are feeling well again.

Algoksib contains lactose monohydrate
Algoksib 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 Algoxib
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist. If you think or feel that the effect of Algoksib is too strong or too weak, talk to your doctor or pharmacist.
The dose of your treatment will be determined by your doctor. You should be treated with the lowest dose that controls pain and you should not use Algoksib more than necessary. This is recommended because the risk of heart problems may increase with prolonged treatment, especially with high doses.
Algoksib 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 the capsules at the same time of day.
Contact your doctor if your symptoms do not improve within two weeks of starting treatment.

Recommended dosage:
In osteoarthritis the usual dose is 200 mg once daily. If necessary, this dose may be increased to a maximum of 400 mg.
Usual dose:
one 200 mg capsule once a day, or
one capsule of 100 mg twice daily.
In rheumatoid arthritis the usual dose every day in 200 mg (two divided doses), if necessary, your doctor may increase it up to 400 mg (two divided doses).
Usual dose:
one capsule of 100 mg twice daily;
A dose of 200 mg (taken as one capsule of 100 mg twice a day) can be achieved with 200 mg capsules Algoksib. Please consult your doctor.
In ankylosing spondylitis the usual dose every day is 200 mg, and if necessary, your doctor may increase it up to 400 mg.
Usual dose:
one 200 mg capsule once a day, or
one capsule of 100 mg twice daily.
Kidney or liver problems: make sure your doctor knows if you have kidney or liver 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 monitor you more often.

Children: Algoksib is for adults only and is not intended for use in children.

Maximum daily dose:
You should not take more than 400 mg (4 capsules Algoksib of 100 mg or 2 capsules Algoksib 200 mg) per day.

If you take more dose Algoxib
You should not take more capsules than you. If you accidentally swallow too much capsules, report it immediately to your doctor or visit a hospital, taking your medicine.

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

If you stop taking Algoxib
Abrupt discontinuation of Algoxib can lead to worsening of your symptoms. Do not stop taking Algoksib, unless your doctor has told you. Your doctor may advise you to reduce your dose over a few days before you stop it completely.

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.

Stop taking Algoksib immediately and contact your doctor if you develop any of these symptoms:
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 pains or signs of bleeding from the stomach or intestine, 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 or the whites of the eyes become yellowish)).
The following adverse reactions were observed in arthritis patients who took Algoksib. Side effects marked with an asterisk (*) are listed below in a higher frequency, which occurs in patients receiving Algoksib prevention of colon polyps.

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, swelling of ankles, legs and / or arms;
Urinary tract infections;
Feeling short 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;
* Vomiting (nausea), stomach pain, diarrhea, indigestion, flatulence
Rash, itching;
Increased muscle tension (hardening);
* Difficulty swallowing;
Worsen existing allergy.
Uncommon: may affect up to 1 in 100 people:
* Stroke;
Heart failure, palpitations (awareness of heart beat), rapid heart beat;
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;
High levels of potassium in blood tests (can cause nausea, fatigue, muscle weakness or palpitations);
Impaired or blurred vision, tinnitus, pain and mouth ulcers, hearing loss;
Constipation, flatulence, stomach inflammation (indigestion, stomach pain or nausea), worsening of inflammation of the stomach or intestines;
Leg cramps;
convex itchy rash (hives).
Rare: may affect up to 1 in 1000 people:
Ulcers (bleeding) of the stomach, esophagus or intestine; or perforation of the bowel (may cause abdominal pain, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the esophagus (may cause difficulty in swallowing), inflammation of the pancreas (can lead to abdominal pain) ;
Decreased number of white blood cells (which protect the body from infection) and platelets (increased risk of bleeding and bruising);
Difficulty coordinating muscle movements;
Confusion, changes in taste;
Sensitivity to light;
Hair loss.
Not known: frequency can not be estimated from available data:
Brain hemorrhage 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 from the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the small intestine or colon, nausea;
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 exanthematous pustulosis (red swollen areas with very small pustules);
Delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen glands, and changes in laboratory tests (eg. Liver, blood);
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, fever or tingling;
Kidney problems (possible renal failure, nephritis);
Clot in a blood vessel in the lungs. Symptoms may include sudden shortness of breath, pain when breathing or collapse;
Irregular heartbeat;
Meningitis (inflammation of the membrane around the brain and spinal cord);
Hallucinations (seeing, hearing or feeling things that are not);
Worsening of epilepsy (possible more frequent and / or severe seizures);
Inflamed blood vessels (can cause fever, aches, purple spots on the skin);
Occlusion of the artery or vein in the eye, leading to partial or complete loss of vision, al or complete loss of vision, inflammation of the conjunctiva, bleeding from the eye;
Reduced red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nosebleeds and increased risk of infections);
Chest pain;
Impaired olfactory sensations;
Skin discoloration (bruising), muscle pain and weakness, pain in the joints;
Menstrual irregularities;
Headache, flushing;
Low sodium levels in laboratory studies (can cause loss of appetite, headache, nausea, cramps and muscle weakness).
The following adverse reactions have been observed in clinical trials that are not associated with arthritis or other arthritic condition in which Algoksib taken in doses of 400 mg daily for up to three years:
Heart problems: angina (chest pain);
Stomach problems: irritable bowel syndrome (can include stomach pain, diarrhea, indigestion, gas);
Kidney stones (which may lead to pain in the abdomen or back, blood in the urine), difficulty urinating;
Weight gain.
Uncommon: may affect up to 1 in 100 people:
Deep vein thrombosis (a blood clot, usually in the lower extremities that can cause pain, swelling or redness of the calf or breathing problems);
Stomach problems: stomach infection (which can cause ulceration and perforation of the stomach and intestines);
Fracture of the lower limbs;
Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing));
Bleeding in the eye, causing blurred or impaired vision, dizziness due to problems with the inner ear, redness, inflammation or bleeding gums, mouth sores;
Excessive urination at night, bleeding piles / haemorrhoids, frequent bowel movement;
Fatty deposits in the skin or elsewhere ganglionovi cysts (benign entity on or around joints and tendons in the hands or feet), difficulty with speech, unusual or very heavy bleeding from the vagina, pain in the chest;
High levels of sodium in laboratory blood tests.
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet. You can also report adverse reactions directly by Drug Agency Street. "Damyan Gruev" № 8, 1303 Sofia, website: www.bda.bg. As reported side effects, you can do your bit to obtain more information on the safety of this medicine.

5. How to store Algoxib
Do not store above 30 ° C. Store in the original package to protect from moisture.
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
These measures will help to protect the environment.