Pharmacy Own

What it is

Pharmacy Own Ibuprofen + Paracetamol is an oval soft gelatin capsule containing 200 mg of ibuprofen and 500 mg of paracetamol. Each capsule is opaque white on one side and opaque light brown on the other, imprinted with "IP" in black.

Approved indications

Pharmacy Own Ibuprofen + Paracetamol is indicated for temporary relief of acute (short term) pain and/or inflammation associated with: — Headache — Migraine headache — Tension headache — Sinus pain — Toothache — Dental procedures — Backache — Muscular aches and pains — Period pain — Sore throat — Tennis elbow — Rheumatic pain and arthritis — Aches and pains associated with colds and flu It also reduces fever.

Dosing overview

For adults under 65 and children from 12 years, the recommended dose is 1 capsule every 8 hours as necessary, with a maximum of 3 capsules in 24 hours. Pharmacy Own Ibuprofen + Paracetamol should not be used for more than 3 days at a time (or not more than 2 days at a time for adolescents aged 12 to 17 years).

Key safety warnings

The hazard of paracetamol overdose is greater in patients with noncirrhotic alcoholic liver disease, and immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious 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; patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk. Clinical trial data suggest that the use of ibuprofen, particularly at high doses (2400 mg daily) may be associated with an increased risk of arterial thrombotic events such as myocardial infarction or stroke. Gastrointestinal (GI) bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Severe cutaneous adverse reactions (SCARs), exfoliative dermatitis, Stevens-Johnson syndrome (SJS), Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP), which can be life threatening or fatal, have been reported in association with the use of ibuprofen and paracetamol.

Contraindications

Pharmacy Own Ibuprofen + Paracetamol is contraindicated in patients with known hypersensitivity to ibuprofen, paracetamol or any constituent; a history of hypersensitivity reactions (such as bronchospasm, angioedema, rhinitis or urticaria) associated with aspirin or other anti-inflammatory or analgesic drugs; a history of or existing gastrointestinal ulceration, perforation or bleed; impaired hepatic function, impaired renal function or heart failure; asthma; pregnancy; conditions that predispose to renal failure; concomitant use with ibuprofen or other NSAID containing products or aspirin; concomitant use with other paracetamol containing products; and in patients aged 65 years and over and children under 12 years.

Regulatory history

Pharmacy Own Ibuprofen + Paracetamol was first registered on the ARTG on 12 March 2020 as a liquid capsule blister pack (ARTG 331060).