OTRICAPS BLOCKED NOSE AND SINUSITIS RELIEF

Adults (including elderly) and children aged 16 years and over: 2 capsules every 4 to 6 hours as required, but no more than 12 capsules in any 24 hours. Do not take continuously for more than 7 days without medical advice Do not exceed the stated dose.

Use the lowest amount needed to achieve benefit for the shortest duration of treatment. Not recommended for children under the age of 16 years.

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.

The frequency of these adverse events is not known (cannot be estimated from available data). Paracetamol Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol.

Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema Very rare cases of serious skin reactions have been reported. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

** There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. Caffeine Adverse reactions identified through post-marketing use with caffeine are listed below.

The frequency of these reactions is unknown. Body System Undesirable effect Central Nervous system excitability, dizziness and headache Psychiatric disorders Nervousness, insomnia, restlessness, anxiety and irritability Cardiac disorders Palpitations Gastrointestinal disorders Gastrointestinal disturbances When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.

Phenylephrine The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events. Body System Undesirable effect Psychiatric disorders Nervousness Nervous system disorders Headache, dizziness, insomnia Cardiac disorders Increased blood pressure Gastrointestinal disorders Nausea, vomiting, diarrhoea Adverse reactions identified during post-marketing use are listed below.

Contains paracetamol. Patients should be advised not to take other paracetamol-containing products concurrently. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

Concomitant use of other decongestants or cold and flu medicines should be avoided. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Underlying liver disease increases the risk of paracetamol-related liver damage.

Medical advice should be sought before using this product in patients with these conditions: • Medical advice should be sought before taking this medicine in patients with: glutathione depletion due to metabolic deficiencies. g. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions). g. coffee, tea and some canned drinks) should be avoided while taking this product.

Keep out of the sight and reach of children Do not exceed the stated dose If symptoms persist consult your doctor If you are under the care of your doctor or receiving prescribed medicines consult your doctor before taking this product.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Special Label Warnings Do not take with any other paracetamol-containing products.

Concomitant use of other sympathomimetic decongestants Phaeochromocytoma Closed angle glaucoma Known hypersensitivity to paracetamol or any of the other ingredients. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease.

5).