GALPHARM

For oral use after dissolving the contents of the sachet in a standard mug of hot, but not boiling water (250 ml). Allow to cool to a drinkable temperature.

Adults, the elderly and children aged 12 years and over:

One sachet every four hours as required. Do not take more than 4 sachets (4 doses) in any 24 hour period. Do not give to children under 12 years old.

The active ingredients are usually well tolerated in normal use. PARACETAMOL Adverse effects of paracetamol are rare but hypersensitivity including skin rashes may occur. There have been reports of blood dyscasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Very rare cases of serious skin reactions have been reported. GUAIFENESIN Gastrointestinal discomfort has occasionally been reported with guaifenesin.

PHENYLEPHRINE HYDROCHLORIDE Phenylephrine hydrochloride may elevate blood pressure with headache, dizziness, vomiting, diarrhoea and insomnia, and rarely palpitations, tachycardia or reflex bradycardia, tingling and coolness of the skin.

There have been rare reports of allergic reactions. 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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4. 1. 3 PHARMACEUTICAL FORM Powder for oral solution. Sachets containing the drug product, an off-white powder. 1 Therapeutic indications For the short term symptomatic relief of the symptoms of colds and influenza, including aches and pains, headache, nasal congestion, tickly sore throat and chesty coughs.

2 Posology and method of administration For oral use after dissolving the contents of the sachet in a standard mug of hot, but not boiling water (250 ml). Allow to cool to a drinkable temperature.

Adults, the elderly and children aged 12 years and over:

One sachet every four hours as required. Do not take more than 4 sachets (4 doses) in any 24 hour period. Do not give to children under 12 years old. 3 Contraindications Hypersensitivity to any of the ingredients. Severe heart disease and cardiovascular disorders.

Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis. Use in patients with glaucoma or urinary retention.

5). 4 Special warnings and precautions for use This product is not suitable for long term use. 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.

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. 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. e. orally and topically (nasal, aural and eye preparations).

Sympathomimetic-containing products may act as cerebral stimulants giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform convulsions. Contains a source of phenylalanine equivalent to 20 mg per sachet. May be harmful to people with phenylketonuria.

This medicinal product contains 117 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet. Special label warnings If you are taking medication or are under medical care, consult your doctor before using this medicine.

Do not take with other cold, flu or decongestant products. Do not exceed the stated dose. If symptoms persist or worsen, consult your doctor. Keep all medicines out of the reach and sight of children. Contains paracetamol. Do not take with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Special leaflet warnings Contains paracetamol. Do not take with any other paracetamol-containing products. 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.

If you are taking medication or are under medical care, consult your doctor before using this medicine. Do not take with other cold, flu or decongestant products.

Hypersensitivity to any of the ingredients. Severe heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis.

Use in patients with glaucoma or urinary retention. 5).