Alaxan

Alaxan

 RELIEVES PAIN AND INFLAMMATION

Tablet

The combination of Paracetamol and Ibuprofen with a reasonable amount makes ALAXAN^®a fast and effective pain reliever.

COMPOSITION

Each tablet contains:

Ibuprofen ............................................................ 200 mg

Paracetamol ........................................................ 325 mg

 Lactose Monohydrate, Corn starch, Povidone, FDC Yellow # 6, Sodium Starch Glycolate, Syloid 244, Magnesium Stearate q.s.

INDICATIONS

• Relief of mild to moderate pain of musculoskeletal origin such as neck pain, shoulder pain, back pain, muscle strain of arms or legs, stiff neck, arthritis, rheumatism, bursitis, sprain, tendonitis.
• Relief of tension headache, dysmenorrhea, toothache, pain after tooth extraction and minor surgical operations.

DOSAGE AND INSTRUCTION FOR USE

Like other NSAIDs, the lowest effective dose of ibuprofen + paracetamol should be used for the shortest possible time.

Adult and children 12 years and older: Orally, 1 tablet every 6 hours as needed, or as directed by a doctor.

Do not take more than directed.

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

CONTRAINDICATIONS

You should not take this medicine if you are allergic to paracetamol, ibuprofen, aspirin, or other NSAIDs; if you have a history of stroke, heart attack, uncontrolled high blood pressure, or congestive heart failure; if you are pregnant or breastfeeding; active peptic ulcer; advanced kidney or liver disease; asthma or bronchospasm: bleeding disorder.

WARNINGS

• Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in peole allergic to aspirin. Symptoms may include:
• Hives (elevated, whitish or reddish patches on the skin with severe itching or pricking 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 blisters

If an allergic reaction occurs, stop use and seek medical help right away.

• Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
• Are 60 years old or older.
• Have had stomach ulcers or bleeding problems;
• Take an anticoagulant or steroid medicine;
• Take other medicines containing prescription or nonprescription NSAIDs (aspirin, naproxen, or others).
• Have 3 or more alcoholic drinks everyday while using this product;
• Take more or for a longer time than directed.

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

• Liver Warning: This product contains paracetamol. Severe liver damage may occur if you take:
• More than 4 g paracetamol in 24 hours, which is the maximum daily amount;
• With other medicines containing paracetamol (or acetaminophen);
• 3 or more alcoholic drinks everyday while using this product.

Do not use with any other medicine containing paracetamol (prescription or non-prescription). If you are not sure whether a medicine contains paracetamol, ask a doctor.

• Do not use this product:
• Right before or after heart surgery;
• If you have bronchospasm, angioedema, nasal polyps or allergic-type reactions after taking aspirin or other NSAIDs;
• Avoid long-term use in patients with anemia.

PRECAUTIONS

• If you develop signs and symptoms of liver abnormality (e.g., jaundice), stop taking this medicine and consult a doctor.
• When using this product, the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
• Do not use after the expiry date on the label.
• If you missed a dose, take the next dose if still needed for pain and/or fever or inflammation and the subsequent dose every 6 hours thereafter. Do not double the dose.
• Ask a doctor before use if you are:
• Having problems or serious side effects from taking pain relievers or fever reducers.
• Taking any other medicine;
• Under a doctor's care for any serious condition.
• Ask a doctor before use if:
• Stomach bleeding warning applies to you;
• You have a history of stomach problems, such as heartburn;
• You have high blood pressure, heart disease, liver cirrhosis, or kidney disease.
• You are taking a medicine to help reduce the amount of water in the body (diuretic).
• You are taking warfarin, a blood thinning medicine.
• Stop use and ask a doctor if:
• You experience any of the following signs of stomach bleeding:
• Feel faint
• Vomit blood
• Have bloody or black stools
• Any new symptoms appear
• Pregnancy and lactation:

If you are pregnant or breastfeeding, ask a doctor before use. It is especially important not to use 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.

SIDE EFFECTS

ibuprofen+paracetamol, when taken within the recommended dose and duration of treatment, has a low incidence of side effects,

Ibuprofen: Ibuprofen shares the same side effects as other NSAIDs. Ibuprofen may cause stomach and intestinal side effects such as ulceration and/or bleeding; other side effects are indigestion, heartburn, nausea, vomiting, anorexia, diarrhea, constipation, mouth ulcers, flatulence, bloating and abdominal pain.

Ibuprofen may also cause harmful effects to the kidneys and the liver.

There have been occasional reports of side effects involving the blood and blood-forming tissues.

There have also been occasional reports of dizziness, drowsiness, malaise, lightheadedness, nervousness, headache, fatigue, emotional lability, paresthesia, hallucinations, and dream abnormalities.

Ibuprofen may cause side effects involving the ears and eyes such as tinnitus, decreased hearing, amblyopia, conjunctivitis, optic neuritis, diplopia and cataracts.

Skin rashes have been observed.

There have been rare reports of Stevens-Johnson syndrome, Lyell's syndrome and 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 lungs, dry mouth, gingival ulceration, and stuffy nose (rhinitis) have also been reported.

Other side effects are fluid retention, increased blood pressure, low blood pressure, stroke, and palpitations.

Paracetamol: Paracetamol, when taken within the recommended dose and duration of treatment, has a low incident of side effects. Skin rashes and minor stomach and intestinal disturbances have been reported.

OVERDOSE AND TREATMENT

Overdosage of paracetamol usually involves 4 phases with the following signs and symptoms:

Eating disorder, nausea, vomiting, malaise, and excessive sweating

Right upper abdominal pain or tenderness, liver enlargement which may be characterized by abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentrations, prolongation of prothrombin time, and occasionally decreased urine output

Eating disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and possibly kidney failure

Recovery or progression to fatal complete liver failure

The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, fatigue (lethargy) and drowsiness. Other symptoms include headache, tinnitus, central nervous system depression, and convulsions. Excessive acidity of the blood (metabolic acidosis), coma, acute kidney failure and absence of spontaneous breathing (apnea) may rarely occur.

If you have taken more than the recommended dosage, consult a doctor or contact a Medical Center right away. Quick medical attention is important for adults as well as for children even if you do not notice any signs or symptoms.

Treatment includes using of gastric lavage. N-acetylcysteine is the effective antidote if treatment is started within 10 to 12 hours after overdose: however it may be of some benefit if treatment is started within 24 hours.

DRUG INTERACTIONS

Aspirin decreases the amount of ibuprofen in the blood, while phenylbutazone, indomethacine, salicylates, and other NSAIDs (e.g., mefenamic acid, naproxen, diclofenac; ketoprofen) increase the risk of stomach and intestinal bleeding in patients receiving ibuprofen.

Ibuprofen increases the amount of lithium in the blood (increased risk of toxicity) probably by reducing excretion of lithium.

Ibuprofen may cause acute reduction of kidney function and blood pressure response to ACE inhibitors (e.g., captopril, enalapril, ramipril, imidapril, fosinopril, lisinopril). Ibuprofen may reduce the effect of diuretics such as furosemide and thiazide. When taken with anticoagulants (e.g., warfarin, dicumarol), or together with thrombolytic agents (e.g., streptokinase), ibuprofen may cause stomach and intestinal bleeding.

An increase in the International Normalized Ratio (INR), which may serve as a sign of increased risk for bleeding, may be observed when using paracetamol and warfarin at the same time. Paracetamol increases the anticoagulation effect of warfarin.

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.

PRESENTATIONS

Boxes of 5 blisters x 20 press-thru tablets Boxes of 25 strips x 4 tablets

KEEP OUT OF REACH OF CHILDREN
READ THE PACKAGE INSERT CAREFULLY BEFORE USE
FOR MORE INFORMATION, PLEASE ASK FOR DOCTOR'S ADVICE

Manufactured by
UNITED PHARMA VIETNAM, INC.
ISO 9001:2000, WHO-GMP, GLP, GSP
Commune 2, Binh Chanh, HCMC, Vietnam
Tel: 08-38100800
°Registered trademark of Therapharma, Inc.

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