COLDREX HOTREM LEMON

For oral administration, dissolved in hot water.

Dosage:

Adults (including elderly) and children aged 12 years and over: One sachet in a tumbler full of hot water to be taken every four to six hours up to four times a day.

Children:

Not recommended for children under 12 years of age. Coldrex HotRem Lem PL 02855/0272 Do not take continuously for more than 5 days without medical advice.

Paracetamol Adverse events 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.

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.

Body System Undesirable effect Coldrex HotRem Lem PL 02855/0272 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 and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm * Hepatobiliary disorders Hepatic dysfunction Metabolism and nutrition High anion gap metabolic acidosis Coldrex HotRem Lem PL 02855/0272 * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

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, 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.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. 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).

Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 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 Coldrex HotRem Lem PL 02855/0272 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.

Concomitant use of other flu, cold or decongestant medicines, or other paracetamol- containing medicines should be avoided. Consult your doctor if you are taking warfarin. Do not exceed the stated dose. If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products. Patient Information Leaflet Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

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

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