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CALCOLD® SIXPLUS™ is especially formulated to provide symptomatic relief of flu, feverishness, feverish colds, runny nose and sneezing. It also treats mild to moderate pain in children aged 6 – 12 years, headache, sore throat and aches and pains.
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CalCold Six Plus is indicated for the treatment of mild to moderate pain in children aged 6 – 12 years, including teething pain, headache, sore throat, aches and pains and for the symptomatic relief of influenza, feverishness, feverish colds and associated symptoms of runny nose and sneezing.
CalCold Six Plus contains Paracetamol 120mg and Diphenhydramine hydrochloride 12.5mg in each 5 ml
CalCold Six Plus is indicated for the treatment of mild to moderate pain in children aged 6 – 12 years, including teething pain, headache, sore throat, aches and pains and for the symptomatic relief of influenza, feverishness, feverish colds and associated symptoms of runny nose and sneezing.
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For Oral Administration
Dosage:
Children under 6 years
CalCold Six Plus is contraindicated in children under the age of 6 years (see Section 4.3).
6 years – 12 years
10 ml - 20 ml three times daily
Not to be used for more than 3 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
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Contraindications
Hypersensitivity to paracetamol, diphenhydramine hydrochloride or any of the other constituents.
Large doses of anti-histamines may precipitate seizures in epileptics.
CalCold Six Plus should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or those patients who have received treatment with MAOIs within the last two weeks (see section 4.5).
Not to be used in children under the age of 6 years.
Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease.
Patients with hepatic or moderate to severe renal dysfunction or urinary retention should exercise caution when using this product.
Diphenhydramine should not be taken by patients with susceptibility to angle-closure glaucoma or symptomatic prostatic hypertrophy unless directed by a doctor.
Alcohol or other potential sedating medicines should not be used concurrently with CalCold Six Plus.
Patients with rare hereditary problems of fructose intolerance should not take this medicine. CalCold Six Plus contains Maltitol and Sorbitol which may have a mild laxative effect at high doses.
This product contains propylene glycol and may cause alcohol-like symptoms. Children should be supervised while on this medication.
This product may cause drowsiness. This product should not be used to sedate a child.
Warnings to appear on labelling:
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Do not take with any other cough and cold medicine.
Dose should not be repeated more frequently than four hour intervals.
Not more than 3 doses should be taken in 24 hours.
Dosage should not be continued for more than three days without consulting a doctor.
Special label warnings
Do not give with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if the child seems well.
Do not use to sedate a child.
Special leaflet warnings
Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicinal product.
Pregnancy and lactation
Safety in pregnancy has not been established. Pregnant or lactating patients should not take this medication unless it is considered essential by a doctor.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
Diphenhydramine hydrochloride crosses the placenta and is excreted in breast milk.
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Undesirable effects
Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Most reports of adverse reactions to paracetamol relate to overdosage with the drug.
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.
Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.
Adverse effects for diphenhydramine include:
Common side effects
• CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headache, psychomotor impairment
• Antimuscarinic effects: Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions
Rare side effects:
Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions, blood disorders and liver dysfunction.
Hypersensitivity reactions to diphenhydramine have been reported, in particular, skin rashes, erythema, urticaria and angiodema.
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