OLBAS MAX STRENGTH ALL-IN-ONE COLD AND FLU

Route of administration:

Oral. Swallow whole with water. Do not chew.

For all indications:

Adults, the elderly and children aged 16 years and over: Two capsules every 4 to 6 hours when necessary to a maximum of 8 capsules (4 doses) in 24 hours. Dosage should not be continued for longer than 3 days without consulting a doctor.

Children under 16 years:

Do not give to children under 16 years old.

The active ingredients are usually well tolerated in normal use. PARACETAMOL Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Very rare cases of serious skin reactions have been reported. 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, angioedema and Stevens Johnson syndrome, toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Gastrointestinal disorders Acute pancreatitis Metabolism and nutrition disorders High anion gap metabolic acidosis** * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

** Frequency “Not known” (cannot be estimated from the available data). 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. GUAIFENESIN The frequency of these events is unknown but considered likely to be rare.

Body System Undesirable effect Immune system disorders Allergic reactions, angioedema, anaphylactic reactions Respiratory, thoracic and mediastinal disorders Dyspnoea* Gastrointestinal disorders Nausea, vomiting, abdominal discomfort, Skin and subcutaneous disorders Rash, urticaria PHENYLEPHRINE HYDROCHLORIDE 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, irritability, restlessness, and excitability 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.

The frequency of these reactions is unknown but likely to be rare. g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions including cross- sensitivity with other sympathomimetics may occur. Renal and urinary disorders Dysuria.

Urinary retention. This is most likely to occur in men with an enlarged prostate. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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e. orally and topically (nasal, aural and eye preparations). Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Patients suffering from chronic cough or asthma should consult a physician before taking this product. Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.

Do not take with a cough suppressant. g. Raynaud's Phenomenon) Cardiovascular disease This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Concomitant use of other paracetamol-containing products should be avoided. If symptoms persist consult your doctor. Use with caution in patients with Raynaud’s Phenomenon and diabetes mellitus. Patients with prostatic hypertrophy may have increased difficulty with micturition.

Sympathomimetic-containing products should be used with great care in patients suffering from angina. Sympathomimetic-containing products may act as cerebral stimulants giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform convulsions.

Long term use of the product is not recommended. Do not take with alcohol. This medicine contains less than 1 mmol sodium (23 mg) per 2 capsules, that is to say essentially ‘sodium-free’. 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.

Special label warnings If you are taking medication or are under medical care, consult your doctor before using this medicine. CONTAINS PARACETAMOL Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Do not take with other flu, cold or decongestant products. Keep out of the sight and reach of children. Special leaflet warnings Talk to a doctor at once if you take too much of this medicine even if you feel well.

This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you. If you are taking medication or are under medical care, consult your doctor before using this medicine.

Hypersensitivity to paracetamol and /or any of the ingredients. 5). Use in patients with glaucoma or urinary retention. Use in patients who are currently receiving other sympathomimetic drugs. Phaeochromocytoma. Closed angle glaucoma. Avoid in patients with prostatic enlargement.