COMBOGESIC

Posology For oral administration and short term use only (not more than 3 days). The patient should consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days. This medicine is for short-term use and is not recommended for use beyond 3 days.

4). Adults The usual dosage is one to two tablets taken every six hours, as required, up to a maximum of six tablets in 24 hours. Children under18 years This product is not recommended for children under 18 years. 4). The elderly are at increased risk of the serious consequences of adverse reactions.

If an NSAID is considered necessary, the lowest effective dose should be used for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy. 4) Method of administration This product is recommended to be taken with a full glass of water.

Clinical trials with this product have not indicated any other undesirable effects other than those for paracetamol alone or ibuprofen alone. Adverse reactions have been ranked under headings of frequency using the following convention: 1.

Very common (≥ 1/10); 2. Common (≥ 1/100, < 1/10); 3. Uncommon (≥ 1/1000, < 1/100); 4. Rare (≥ 1/10000, < 1/1000);

This medicine is for short-term use and is not recommended for use beyond 3 days. Hepatic Impairment The use of paracetamol at higher than recommended doses can lead to hepatotoxicity and even hepatic failure and death. Also, patients with impaired liver function or a history of liver disease, or who are on long term ibuprofen therapy or paracetamol treatment should have hepatic function monitored at regular intervals, as ibuprofen has been reported to have a minor and transient effect on liver enzymes.

Severe hepatic reactions, including jaundice and cases of fatal hepatitis, though rare, have been reported with ibuprofen as with other NSAIDs. g. ), ibuprofen should be discontinued. Both active drugs have been reported to cause hepatotoxicity and even hepatic failure, especially paracetamol.

Patients who regularly consume alcohol in excess of recommended amounts should not take this medicine. Dose reduction is recommended in patients showing signs of worsening hepatic function. 3). Renal Impairment Paracetamol can be used in patients with chronic renal disease without dosage adjustment.

There is minimal risk of paracetamol toxicity in patients with moderate to severe renal failure. However, for the ibuprofen component of this product - caution should be used when initiating treatment with ibuprofen in patients with dehydration.

The two major metabolites of ibuprofen are excreted mainly in the urine and impairment of renal function may result in their accumulation. The significance of this is unknown. NSAIDs have been reported to cause nephrotoxicity in various forms: interstitial nephritis, nephritic syndrome and renal failure.

Renal impairment from ibuprofen use is usually reversible. In patients with renal, cardiac or hepatic impairment, those taking diuretics and ACE Inhibitors, and the elderly, caution is required since the use of nonsteroidal anti-inflammatory drugs may result in deterioration of renal function.

The dose should be kept as low as possible and renal function should be monitored in these patients. 3). Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

Combination use of ACE inhibitors or angiotensin receptor antagonists, anti- inflammatory drugs and thiazide diuretics The use of an ACE inhibiting drug (ACE-inhibitor or angiotensin receptor antagonist), an anti-inflammatory drug (NSAID or COX-2 inhibitor) and thiazide diuretic at the same time increases the risk of renal impairment.

This includes use in fixed-combination products containing more than one class of drug. Combined use of these medications should be accompanied by increased monitoring of serum creatinine, particularly at the institution of the combination.

The combination of drugs from these three classes should be used with caution particularly in elderly patients or those with pre-existing renal impairment. Elderly No adjustment in labelled dosage is necessary for older patients who require paracetamol therapy.

Those who require therapy for longer than 10 days should consult their physician for condition monitoring; however, no reduction in recommended dosage is necessary. However, caution should be taken with regard to the use of ibuprofen as it should not be taken by adults over the age of 65 without consideration of co-morbidities and co-medications because of an increased risk of adverse effects, in particular heart failure, gastrointestinal ulceration and renal impairment.

Haematological Effects Blood dyscrasias have been rarely reported. Patients on long-term therapy with ibuprofen should have regular haematological monitoring. Coagulation Defects Like other NSAIDs, ibuprofen can inhibit platelet aggregation.

Ibuprofen has been shown to prolong bleeding time (but within the normal range), in normal subjects. Because this prolonged bleeding effect may be exaggerated in patients with underlying haemostatic defects, products containing ibuprofen should be used with caution in persons with intrinsic coagulation defects and those on anti-coagulation therapy.

Gastrointestinal Events Upper gastro-intestinal ulcers, gross bleeding or perforation have been described with NSAIDs. The risks increase with dose and duration of treatment, and are more common in patients over the age of 65 years.

Some patients will experience dyspepsia, heartburn, nausea, stomach pain or diarrhoea. These risks are minimal when this product is used at the prescribed dose for a few days. Products containing ibuprofen should be used with caution, and at the lowest effective dose for the shortest duration, in patients with a history of gastrointestinal haemorrhage or ulcer since their condition may be exacerbated.

Due to the ibuprofen component should be given with care to patients with a history of GI disease (ulcerative colitis, Chrohn’s disease) as well as in patients with porphyria and varicella. This product should be discontinued if there is any evidence of gastrointestinal bleeding.

The concurrent use of acetylsalicylic acid and NSAIDs also increases the risk of serious gastrointestinal adverse events. Cardiovascular Thrombotic Events Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

g. ≤ 1200 mg/day) is associated with an increased risk of arterial […]

1. • in patients with active alcoholism as chronic excessive alcohol ingestion may predispose patients to hepatotoxicity (due to the paracetamol component). • in patients who have experienced asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs.

• in patients with active or history of gastrointestinal bleeding or peptic ulceration. 6 ). 5).