ALAXAN FR Capsule

- used for the relief of mild to moderately severe pain of musculoskeletal origin such as muscle pain (myalgia), arthritis, rheumatism, sprain, strain, bursitis (inflammation of the fluid-filled sac or bursa that lies between a tendon and skin), tendonitis, backache and stiff neck.

- used for the relief of tension headache, dysmenorrhea, toothache, pain after tooth extraction and minor surgical operations.

- effective for fever reduction.

orally

Adults and children 12 years and older: 1 tablet or capsule every 6 hours as needed or as directed by a doctor.

Do not take longer than 10 days, unless directed by a doctor.

- If you are allergic to Paracetamol, Ibuprofen, Aspirin, and other NSAIDs. Ibuprofen, like other NSAIDs, may cause severe allergic reactions. Symptoms may include:

- Hives (elevated, whitish or reddish patches on the skin with severe itching or prickling sensations)

- Shock (anaphylactic)(a hypersensitivity reaction resulting in generalized skin lesions and itchiness, followed by low blood pressure and often accompanied by difficulty of breathing)

- Facial swelling

- Skin reddening

- Asthma (wheezing)

- Skin rash

- Skin blisters

- If you have or have ever had kidney disease.

- If you develop signs and symptoms of liver abnormality (e.g., jaundice), stop taking this medicine and consult a doctor.

- Right before or after heart surgery

- If you have a history of stroke, heart attack, uncontrolled high blood pressure, or congestive heart failure

- If you gave bronchospasm (constriction of air passages of the lung), angioedema (rapid swelling that occurs in the tissue just below the surface of the skin), nasal polyps or allergic-type reactions after taking Aspirin or other NSAID- containing product (e.g., Ibuprofen) during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Stomach ulceration and/or bleeding, indigestion, heartburn, nausea, vomiting, eating disorder (anorexia), diarrhea, constipation, mouth ulcers (stomatitis), flatulence, bloating, abdominal pain

Ibuprofen may cause harmful effects to the kidney and the liver.

dizziness, drowsiness, general feeling (malaise), lightheadedness, nervousness, headache, fatigue, mood swings (emotional lability), loss of sensation (paresthesia), hallucinations, dream abnormalities.

Ibuprofen may cause ringing in the ears (tinnitus), decreased hearing, loss of visual sharpness (amblyopia), inflammation or infection of the membrane lining the eyelids (conjunctivitis), inflammation of the optic nerve (optic neuritis), double vision (diplopia) , cataracts,

Skin rashes have been observed. There have been rare reports of Stevens-Johnson Syndrome, Lyell’s syndrome, erythema multiforme which are serious types of allergy and may occur without warning. Symptoms of these serious types of allergy include multiple skin lesions, itching, fever, and joint pains.

Allergic reactions manifested as a syndrome of abdominal pain, fever chills, nausea and vomiting have occasionally occurred.

Whole-body allergic reaction (anaphylaxis), constriction of air passages of the lung, dry mouth, gingival ulceration, and stuffy nose (rhinitis) have been reported.

fluid retention, increased blood pressure, low blood pressure, cerebrovascular accident (stroke) and palpitations.

- Aspirin decreases the amount of Ibuprofen in the blood, while Phenylbutazone, Indomethacin, Salicylates, and other NSAIDs (e.g., Mefenamic Acid, Naproxen, Diclofenac, Indomethacin, Ketoprofen) increase the risk of stomach and intestinal bleeding in patients receiving Ibuprofen.

- when taken with blood thinning (anticoagulant) medicines (e.g., Warfarin, Dicumarol) or together with thrombolytic agents (e.g., Streptokinase), Ibuprofen may cause stomach and intestinal bleeding.

- Ibuprofen increases the amount of lithium in the blood, interfering with lithium elimination in the kidney

- Ibuprofen may reduce the effect of diuretics such as Furosemide and Thiazide.

- Medicines which stimulate the enzymes responsible for the metabolic activation of Paracetamol such as medicines for convulsion (e.g., Phenobarbital) may increase susceptibility to the harmful effects to the liver.

If you are pregnant or breastfeeding unless advised by your doctor. It is especially important not to use an NSAIDs containing product (e.g., Ibuprofen) during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

- This medicine should be given with care to patients with kidney or liver disease including patients taking other drugs that affect the liver.

- Do not use with any other product containing Paracetamol, Ibuprofen or other NSAIDs. If you are taking cough and cold preparations, other fever reducers or pain relievers, check if they contain Paracetamol (or Actaminophen), Ibuprofen or other NSAIDs.

- Do not take more than the recommended dose or duration of treatment.

- This medicine may cause stomach bleeding.The chance is higher if you:

- Are 60 years old or older

- Have had stomach ulcersor bleeding problems

- Have a blood thinning (anticoagulation)(e.g., Warfarin) or steroid (e.g., Prednisone) drug

- Take other drugs containing an NSAIDs (e.g., Aspirin, Naproxen, or others)

- Have 3 or more alcoholic drinks every day while using this product

- Take more than the recommended dose or take more than the directed duration of treatment

- If stomach upset occurs, take this medicine with food or milk.

- Long term continuous use may increase the risk of heart attack or stroke.