MAXICLEAR

What it is

Maxiclear PSE Sinus & Anti-inflammatory Pain Relief capsules contain pseudoephedrine hydrochloride 30 mg and ibuprofen 200 mg. The capsules are light orange transparent, oval shape soft gelatin capsules containing clear to light orange transparent liquid.

Approved indications

— Relief of symptoms of sinus pain with sinus congestion occurring as a result of cold and flu, allergic rhinitis or sinusitis.

Dosing overview

The recommended dosage for adults and children over 12 years is 1 or 2 capsules with fluid every four to six hours when necessary, not exceeding 6 capsules in 24 hours. Maxiclear PSE Sinus & Anti-inflammatory Pain Relief should not be used for more than a few days at a time except on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.

Key safety warnings

Excessive use can increase the risk of heart attack, stroke or liver damage. Observational studies have indicated that NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use, and patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may be at greater risk. Ibuprofen may cause a severe allergic reaction, especially in patients allergic to aspirin, with symptoms including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash or blisters with or without pyrexia or erythema. Ibuprofen has very rarely been reported to cause Vanishing Bile Duct Syndrome, and patients should seek medical advice if they develop sudden onset abdominal pain or chronic abdominal pain associated with loss of appetite and/or new onset itching. Due to the pseudoephedrine component, this medicine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Contraindications

Maxiclear PSE Sinus & Anti-inflammatory Pain Relief is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to pseudoephedrine or ibuprofen (or any of the other ingredients in the product), other nonsteroidal anti-inflammatory drugs or other salicylates, with severe hypertension or coronary artery disease, and taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days. It is also contraindicated in patients with aspirin and other NSAID sensitive asthma, active gastrointestinal bleeding or peptic ulceration, renal impairment, heart failure, severe liver impairment, and undergoing treatment of perioperative pain in the setting of coronary artery bypass surgery (CABG). Use of ibuprofen is contraindicated during the third trimester of pregnancy. Maxiclear PSE Sinus & Anti-inflammatory Pain Relief should not be used for children under 12 years of age.

Regulatory history

Maxiclear PSE Sinus & Anti-inflammatory Pain Relief (ARTG 411971) was first listed on 2023-06-30 as a soft gelatin capsule blister pack.