1. Name Of The Medicinal Product
CalCold Six Plus
2. Qualitative And Quantitative Composition
CalCold Six Plus contains Paracetamol 120mg and Diphenhydramine hydrochloride 12.5mg in each 5 ml. For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Oral Solution.
Clear, alcohol-free, strawberry flavour solution.
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
For Oral Administration
6 years – 12 years
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• Do not give more than 3 doses in any 24 hour period.
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It is important to shake the bottle for at least 10 seconds before use.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 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.
4.4 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.
For oral use only.
Do not give more than 3 doses in any 24 hour period
Leave at least 4 hours between doses
Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist
Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
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.
Shake the bottle for at least 10 seconds before use.
Do not overfill the spoon.
Always use the spoon supplied with the pack.
Never give more medicine than is shown in the table.
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.
The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.
CNS Depressants: Diphenhydramine may potentiate the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.
Antimuscarinic Drugs: may have an additive muscarinic action with other drugs such as atropine and some antidepressants.
MAOI's: Not to be used in patients taking MAOI's or within 14 days of stopping treatment as there is a risk of serotonin syndrome.
4.6 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.
4.7 Effects On Ability To Drive And Use Machines
May cause drowsiness, dizziness or blurred vision. If affected do not drive or operate machinery. Avoid alcoholic drink.
4.8 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.
4.9 Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors:
If the patient
a) is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b) regularly consumes ethanol in excess of recommended amounts.
Or
c) is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Symptoms of diphenhydramine overdose include drowsiness, hyperpyrexia and anticholinergic effects. In children, CNS excitation, including hallucinations and convulsions may appear; with larger doses, coma or cardiovascular collapse may follow.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the National Poisons Information Service (NPIS) or a liver unit.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol (ATC Code: NO2B E01) is an antipyretic analgesic with a mechanism of action that is not fully elucidated. Diphenhydramine hydrochloride (ATC Code: RO6A A02) is an antihistamine with anti-cholinergic, anti-emetic, anti-allergic and sedative effects.
5.2 Pharmacokinetic Properties
Paracetamol and diphenhydramine hydrochloride are both readily absorbed from the gastrointestinal tract. Both are widely distributed throughout the body, metabolised in the liver and excreted in the urine. As CalCold Six Plus is an oral solution, the active ingredients are absorbed rapidly following ingestion.
5.3 Preclinical Safety Data
Paracetamol and diphenhydramine hydrochloride are well established drug substances whose preclinical profiles have been investigated and are thoroughly established.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Propylene Glycol
Polyethylene Glycol 4000
Benzoic Acid (E210)
Glycerol
Liquid Sorbitol 70%
Liquid Maltitol (Lycassin 80/55)
Strawberry Flavour
Base Sugar 555049E
Sodium Cyclamate
Saccharin Sodium
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25ºC. Keep bottle in the outer carton.
6.5 Nature And Contents Of Container
Pharmaceutical grade III amber glass bottles with pilfer proof screw caps.
Pack sizes: 100ml, 150ml, 200ml.
All pack sizes may not be marketed.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
Administrative Data
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0145
9. Date Of First Authorisation/Renewal Of The Authorisation
12 January 2007
10. Date Of Revision Of The Text
6th June 2011
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