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ADVIL NIGHTTIME is a brand name for Ibuprofen, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
Ibuprofen is contraindicated for patients with active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system. Both ibuprofen and diphenhydramine have been associated with hypersensitivity.
Patients who are hypersensitive to these drugs or to any ingredient in the formulation or component of the container should not use this product. For a complete listing, see Dosage Forms, Composition and Packaging Section of the product monograph.
The potential for cross-reactivity between different NSAIDs must be kept in mind. Ibuprofen containing products should not be used in patients with the complete or partial syndrome of nasal polyps, or in whom asthma, anaphylaxis, urticaria, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti-inflammatory agents.
Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse effects. Do not use Advil Nighttime during the last 3 months of pregnancy [17].
Ibuprofen should not be used right before or after heart surgery Significant hepatic impairment or active liver disease. Severely impaired or deteriorating renal function (creatinine clearance <30 mL/min). Individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored.
Advil Nighttime is not recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive side effects. Children with kidney disease and children who have suffered significant fluid loss due to vomiting, diarrhea or lack of fluid intake, should not be given ibuprofen.
Ibuprofen is contraindicated in patients with systemic lupus erythematosus, as an anaphylaxis-like reaction with fever may occur, particularly when ibuprofen has been administered previously. Ibuprofen should not be used in the presence of known hyperkalemia (also see Warnings and Precautions - Renal section).
Ibuprofen should not be used during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus, and prolonged parturition. Haleon Canada ULC Page 5 of 46 Children and adolescents (see Indications) WARNINGS AND PRECAUTIONS General As with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ibuprofen in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Ibuprofen is NOT recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions. (See Drug Interactions – Drug/Drug Interactions – Acetylsalicylic acid (ASA) or other NSAIDs) Patients who suffer from sleeplessness without pain and pain that does not cause sleeplessness should not take this product.
Patients with glaucoma, chronic lung disease (emphysema or chronic bronchitis), or difficulty in urination due to prostate enlargement or bladder neck problems should not take this product unless directed by a physician [126]. Serious Warnings and Precautions Causes sedation or sleepiness.
Not for daytime use. Caution in patients prone to gastrointestinal tract irritation (See Warnings and Precautions, Gastrointestinal and Drug Interactions, Coumarin-type anticoagulants). Use with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention (See WARNINGS AND PRECAUTIONS, Cardiovascular and Fluid and Electrolyte Balance; and DRUG INTERACTIONS, Antihypertensives).
Patients at greatest risk of renal toxicity are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly (See WARNINGS AND PRECAUTIONS, Renal). If urinary symptoms, hematuria and cystitis occur, the drug should be stopped immediately (See WARNINGS AND PRECAUTIONS, Genitourinary).
Risk in Pregnancy: Caution should be exercised in prescribing Advil products during the first and second trimesters of pregnancy or breastfeeding. Use of NSAIDS at approximately 20 weeks of gestation or later may cause oligohydramnios, and renal dysfunction including renal failure (See Oligohydramnios/Neonatal Renal Impairment, Pregnant Women and Breast-feeding).
Ibuprofen is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see CONTRAINDICATIONS). Haleon Canada ULC Page 6 of 46 If symptoms of acute pain and sleeplessness caused by pain do not improve within 5 days or are accompanied by fever, patients should stop use and consult a physician.
Carcinogenesis and Mutagenesis Not applicable.
Cardiovascular Ibuprofen:
Congestive heart failure in patients with marginal cardiac function, elevated blood pressure and palpitations. Long term continuous use may increase the risk of heart attack or stroke [136].
Diphenhydramine:
Vasconstrictive effects have been noted [17]. Dependence/Tolerance A combination of butorphanol and diphenhydramine is being increasingly used as a drug of abuse. Diphenhydramine dependence has been documented in case reports involving mentally ill patients [17].
Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use this drug (See CONTRAINDICATIONS). Endocrine and Metabolism Patients with thyroid disease should not take this drug unless directed by a physician.
Fluid and Electrolyte Balance Fluid retention and oedema have been observed in patients treated with ibuprofen. Therefore, as with many other NSAIDs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind.
Advil Nighttime should be used with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention. With nonsteroidal […]