Midol Full Prescribing Information, Dosage & Side Effects - MIMS

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Midol Midol

ibuprofen

Manufacturer:

A. Menarini

Distributor:

Zuellig

SELECT Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Full Prescribing Info Contents Ibuprofen. Description Ibuprofen (Midol) is a white to off-white biconvex, film-coated tablet, plain on both sides. Each tablet contains Ibuprofen 200 mg. Action Non-Steroidal Anti-Inflammatory/Analgesic. 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, inflammation and fever resulting in relief of symptoms of inflammation (e.g., swelling, redness) and relief of pain and/or fever. Indications/Uses Ibuprofen (Midol) is used for the relief of minor aches and pains associated with the menstrual cycle like headache, muscular aches, back aches and menstrual cramps. Dosage/Direction for Use Ibuprofen (Midol) is for short term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If the patient has an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen. Adults and Children over 12 years old: Take 1 tablet every 4 to 6 hours while symptoms persist. If pain persists, 2 tablets may be taken, but do not exceed 6 tablets in 24 hours. Do not give Ibuprofen (Midol) to children under 12 years old, except under the advise and supervision of a doctor. Do not take for pain for more than 10 days unless directed by a doctor. If pain persists or gets worse, or if new symptoms occur, consult a doctor. What should the patient do if he/she misses a 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. Overdosage The patient may experience nausea, abdominal pain, 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. The patient should seek immediate medical advice in the event of an overdose, even if the patient feels well. What to do when the patient has taken more than the recommended dosage: If the patient has taken more than the recommended dosage, consult a doctor or contact a Poison Control Center right away. Contraindications If the patient has ever had an allergic reaction to ibuprofen, aspirin or other NSAIDs or to any of the other ingredients 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 are suffering from stomach ulcers, bleeding or 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 have ever had kidney disease. If the patient develops signs and symptoms of liver abnormality (e.g., jaundice), stop taking the medicine and consult a doctor. If the patient is pregnant of breastfeeding. Special Precautions Allergy Allert: Ibuprofen (Midol) 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: Ibuprofen (Midol) contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the patient: Is age 60 years old or older; Have 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. When should the patient 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 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 or stomach pain; 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, vomits blood, have bloody or black stools, have stomach pain that does not get better; Pain gets worse or lasts more than 10 days; Fever gets worse or lasts more than 3 days; Redness and swelling are present in the painful area; Any new symptoms appear. Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation for further information. Use In Pregnancy & Lactation If the patient is pregnant or breastfeeding, ask a doctor before use. It is especially important not to use Ibuprofen (Midol) 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. Adverse Reactions Undesirable effects from the use of Ibuprofen (Midol) are rare, but may occur. Tell a doctor if the patient experiences any undesirable effect. (See table.) Click on icon to see table/diagram/image 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. View ADR Reporting Link Drug Interactions 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 effects of diuretics such as furosemide and thiazide. Ibuprofen reduces methotrexate excretion from the body, thus increasing the risk of toxicity. Ibuprofen increases the amount of lithium in the blood (increased risk of 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. Storage Store at temperatures not exceeding 30°C. MIMS Class Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) ATC Classification M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products. Regulatory Classification Non-Rx Presentation/Packing Form Midol tab 200 mg Packing/Price 100's (P18/tab);200's (P18/tab)

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