Medicol Advance/Medicol Advance 400

Ibuprofen.

Each softgel capsule contains: Ibuprofen 200 mg or 400 mg.
This product contains ibuprofen which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Like other NSAIDs, ibuprofen works by changing the body's chemical response to pain, swelling and fever resulting in relief of symptoms of inflammation (e.g., swelling, redness) and relief of pain and/or fever.
Ibuprofen given as a softgel capsule is absorbed more rapidly by the body compared to an ordinary tablet.

Medicol Advance: For the relief of headache.
For the relief of toothache, muscular aches, minor arthritis pain, backache, minor aches and pains associated with the common cold, and pain of menstrual cramps (dysmenorrhea).
For fever reduction.
Medicol Advance 400: For the relief of headache including migraine, neuralgia (painful disorder of the nerves).
For the relief of muscular aches including sprains and strains, backache including low back pain, minor aches and pains associated with the common cold, menstrual cramps (dysmenorrhea), dental pain and pain after surgery.
For the relief of inflammation from arthritis and non-serious arthritic conditions.
Also for fever reduction.

Medicol Advance: Like other NSAIDs, the lowest effective dose of ibuprofen should be used for the shortest possible time.
This medicine is given orally (by mouth).
Adults and Children 12 years and older: 1 softgel capsule with a glassful of water every 4 to 6 hours as needed, or, as directed by a doctor.
Children under 12 years old: Consult a doctor before use.
Do not take more than directed.
Do not exceed 6 softgel capsules in 24 hours, unless directed by a doctor.
Do not take longer than 10 days, unless directed by a doctor.
Missed Dose: If the patient misses a dose, take the next dose if still needed for pain and/or fever or inflammation and the subsequent dose every 4 to 6 hours thereafter.
Do not double the dose.
Medicol Advance 400: Like other NSAIDs, the lowest effective dose of Ibuprofen should be used for the shortest possible time.
This medicine is given orally and may be taken with food or milk if stomach upset occurs.
Adults and children 12 years old and above: One softgel capsule up to 3 times a day, as needed.
Leave at least 4 hours between each dose. Alternatively, the patient may take one softgel capsule every 8 hours, as needed.
Or, as prescribed by a doctor.
Do not take more than 3 softgel capsules (1,200 mg) in each 24-hour period.
Do not take this medicine continuously for more than 10 days unless directed by a doctor.
Missed Dose: If the patient misses a dose, take the next dose if still needed for pain and/or fever or inflammation and the subsequent dose at least 4 hours thereafter without exceeding 3 softgel capsules in 24 hours.
Do not double the dose.

The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, fatigue (lethargy) and drowsiness. Other symptoms include headache, ringing in the ears (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 the patient has taken more than the recommended dosage, consult a doctor or contact a Poison Control Center right away.

Medicol Advance: If the patient has ever had an allergic reaction to ibuprofen, aspirin or other NSAIDs or to any ingredient in the medicine.
If the patient has bronchospasm (constriction of air passages of the lungs), 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 NSAIDs.
If the patient is taking aspirin or other NSAIDs, lithium or methotrexate.
If the patient has had or is suffering from stomach ulcers, bleeding or other stomach problems.
Right before or after heart surgery.
If the patient has a history of stroke, heart attack, uncontrolled high blood pressure, or congestive heart failure.
If the patient has or has ever had kidney disease.
If the patient develop signs and symptoms of liver abnormality (e.g., jaundice), stop taking this medicine and consult a doctor.
If the patient is pregnant or breastfeeding.
Medicol Advance 400: If the patient has ever had an allergic reaction to Ibuprofen or to any ingredient in the medicine.
If the patient is taking Aspirin or other NSAIDs, Lithium or Methotrexate.
If the patient has bronchospasm (constriction of air passages of the lungs), 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 NSAIDs.
If the patient has had or is suffering from stomach ulcers, bleeding or other stomach problems.
If the patient has a history of stroke, heart attack, uncontrolled high blood pressure or congestive heart failure.
If the patient has or has ever had kidney disease.
If the patient develop signs and symptoms of liver abnormality (e.g., jaundice), stop taking this medicine and consult a doctor.
Right before or after surgery.
If the patient is pregnant or breastfeeding.

Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people 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 rash; 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 change is higher if the patient: Is age 60 years or older; Has had stomach ulcers or bleeding problems; Take a blood thinning (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.
When using this product the risk of heart attack or stroke may increase if the patient uses more than directed or for longer than directed.
Consult a Doctor: Ask a doctor before use if the patient is: Having problems or serious side effects from taking pain relievers or fever reducers; Taking any other product that contains ibuprofen; Taking other medicines; Under a doctor's care for any serious condition; 60 years old or older.
Ask a doctor before use if: Stomach bleeding warning applies to the patient; The patient has a history of stomach problems such as heartburn, upset stomach, stomach pain, Crohn's disease (inflammation of the digestive system) or ulcerative colitis (ulcers in the lining of the rectum and colon); The patient has liver or kidney problems; The patient has heart problems, previous stroke or might be at risk of these conditions (e.g., high blood pressure, high cholesterol, diabetes or if the patient is a smoker; Suffer from asthma; Suffer from systemic lupus erythematosus (SLE) or other auto-immune diseases.
Stop use and ask a doctor if: The patient experiences any of the following signs of stomach bleeding: Feel faint; Vomit blood; Have blood or black stools; Have stomach pain that does not get better.
An allergic reaction occurs.
Any new symptoms appear.
Paint gets worse or lasts more than 10 days.
Fever gets worse or lasts more than 3 days.
Redness and swelling is present in the painful area.
Any new symptoms appear.

If the patient is pregnant or breastfeeding, as 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.

Undesirable effects from the use of ibuprofen are rare, but they may occur. Tell the doctor if the patient experiences any undesirable effect.
Central Nervous System: Dizziness, drowsiness, general ill feeling (malaise), lightheadedness, nervousness, headache, fatigue, mood swings (emotional lability), loss of sensation (paresthesia), hallucinations, and dream abnormalities.
Gastrointestinal: Stomach ulceration and/or bleeding, indigestion, heartburn, nausea, vomiting, eating disorder (anorexia), diarrhea, constipation, mouth ulcers (stomatitis), flatulence, bloating, and abdominal pain.
Kidneys: Blood in the urine, kidney damage and kidney failure.
Liver: Abnormal liver function tests, jaundice, inflammation of the liver and liver failure.
Blood: Blood does not clot properly, anemia and low white blood cell count.
Cardiovascular: Fluid retention, increased blood pressure, low blood pressure, cerebrovascular accident (stroke), and palpitations.
Special senses: Ringing in the ears (tinnitus), decreased hearing, loss of visual sharpness (amblyopia), inflammation or infection of the membrane lining of the eyelids (conjunctivitis), inflammation of the optic nerve (optic neuritis), double vision (diplopia) and cataracts.
Skin: Skin rashes; symptoms of serious allergies (e.g., Stevens-Johnson Syndrome, Lyell's syndrome, and erythema multiforme) which include multiple skin lesions, itch, fever, and joint pains.
Allergic reactions manifested as a syndrome of abdominal pain, fever, chills, nausea and vomiting. Whole-body allergic reaction (anaphylaxis), constriction of air passages of the lungs, dry mouth, gingival ulceration, and stuffy nose (rhinitis) have also been reported.

Blood concentrations of ibuprofen may be decreased when given together with aspirin.
Phenylbutazone, indomethacin, salicylates, and other NSAIDs (e.g., mefenamic acid, naproxen, diclofenac, 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.
Corticosteroids (e.g., prednisone, prednisolone), selective serotonin reuptake inhibitors (SSRIs) [e.g., citalopram, escitalopram, sertraline] may increase the risk of stomach bleeding with ibuprofen.
Ibuprofen may cause acute reduction in kidney function and blood pressure response to ACE inhibitors (e.g., captopril, enalapril, ramipril, imidapril, fosinopril, lisinopril).
Ibuprofen should not be used 8-12 days after mifepristone use because it can reduce the effect of mifepristone.
Ibuprofen may reduce the effect of diuretics such as furosemide and thiazide.
Ibuprofen reduces methotrexate excretion from the body, thus increasing the risk of methotrexate toxicity.
Ibuprofen increases the amount of lithium in the blood (increased risk of lithium toxicity) probably by reducing excretion of lithium.
Ibuprofen may increase the plasma concentration of cardiac glycosides (e.g., digitalis), worsen cardiac failure and reduce renal function.
Ibuprofen may enhance the effect of phenytoin, an antiepileptic medicine.
There is an increased risk of nephrotoxicity (kidney damage) when ciclosporin or tacrolimus are given together with ibuprofen.
Ginkgo biloba may enhance the risk of bleeding when given with ibuprofen.
Medicol Advance 400: An increased risk of blood problems such as bleeding into a joint (hemarthrosis) and bruising (hematoma) may result when ibuprofen is given with antiviral medicines such as zidovudine.
A possible increased risk of convulsions may occur when ibuprofen is taken with quinolones (e.g., ofloxacin, levofloxacin, norfloxacin, ciprofloxacin, sparfloxacin, moxifloxacin).

Store at temperatures not exceeding 25°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

Non-Rx