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PARACETAMOL & PROMETHAZINE SUSPENSION

Active substance(s): PARACETAMOL / PROMETHAZINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Paracetamol & Promethazine Suspension.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 120mg/5ml
Promethazine Hydrochloride 1.5mg/5ml

3

PHARMACEUTICAL FORM
Oral Suspension

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of mild to moderate pain including headache, toothache, sore throat,
aches and pains. For the symptomatic relief of influenza, feverishness, feverish colds.
For the reduction of nasal irritation and watery discharge. For the relief of the
symptoms of chickenpox.

4.2

Posology and method of administration
Children aged two - five years: 10ml
Children aged six -twelve years: 20ml
To be given up to four times daily.

Dose should not be repeated more frequently than four hour intervals, and no more
than 4 doses should be taken in any 24 hour period.
Do not give to children under two years, except on the advice of a doctor.

4.3

Contraindications
Contraindicated in hepatic disease or viral hepatitis and in severe renal impairment.
Hypersensitivity to paracetamol or any of the other constituents.

4.4

Special warnings and precautions for use
Do not give to children under two years, except on the advice of a doctor. If
symptoms persist, dosage should not be continued for more than three days without
consulting a doctor. Do not exceed the recommended dose. An overdose is
dangerous - medical attention should be sought immediately.
Care is advised in the administration of paracetamol to patients with severe renal or
severe hepatic impairment. The hazard of overdose is greater in those with noncirrhotic alcoholic disease.
Do not give with any other paracetamol containing products.
Keep out of the reach of children.
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.

4.5

Interaction with other medicinal products and other forms of interaction
Hepatic enzyme inducers and/or hepatotoxic medications increase the risk of
hepatotoxicity with single toxic or prolonged use or high doses of Paracetamol. Antiinflammatory analgesics, NSAIDs or aspirin taken at high dose levels in combination
with Paracetamol for prolonged periods may increase the risk of analgesic
nephropathy and/or adverse renal effects. Alcohol potentiates the sedative effect of

Promethazine and increases the risk of hepatotoxicity with Paracetamol at single toxic
or with prolonged use. Hypnotics and anxiolytics are potentiated by Promethazine.
The speed of absorption of paracetamol may be increased by Metoclopramide or
Domperidone, and absorption reduced by cholestyramine.
The anticoagulant 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.

4.6

Pregnancy and lactation
Not applicable. This product is not intended for adult use.
However, epidemiological studies in human pregnancy have shown no ill effects due
to paracetamol used in the recommended dosage, but patients should follow medical
advice regarding its use.
Paracetamol is excreted in breast milk, but not in a clinically significant amount.
Available published data do not contraindicate breast feeding.

4.7

Effects on ability to drive and use machines
This preparation may cause drowsiness. Children are advised not to ride bicycles if
affected.

4.8

Undesirable effects
Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may
occur. There have been a few reports of blood dyscrasias including
thrombocytopaenia and agranulocytosis, but these were not necessarily causally
related to Paracetamol.
Paradoxical reactions characterised by hyperexcitability and nightmares have been
reported in children receiving single doses of Promethazine between 75 and 125mg.
The concentration of Promethazine in Paracetamol and Promethazine Suspension is
1.5mg/5ml.

4.9

Overdose
Immediate medical advice should be sought in the event of an overdose, even if the
child seems well.
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting,
anorexia and abdominal pain. Liver damage may become apparent 12 to 24 hours
after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may
occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma
and death. Acute renal failure with acute tubular necrosis may develop even in the
absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been
reported. Liver damage is possible in adults who have taken 10g or more of
paracetamol. It is considered that excess quantities of a toxic metabolite (usually
adequately detoxified by glutathione when normal doses of paracetamol are ingested)
become irreversibly bound to liver tissue.
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 and any patient who has ingested around
7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage.
Administration of oral methionine or intravenous N-acetylcysteine, which may have a
beneficial effect up to at least 48 hours after the overdose, may be required. General
supportive measures must be available.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Paracetamol:
The mechanism of analgesic action has not been fully determined but may be caused
by inhibition of prostaglandin synthesis in the CNS system and through a peripheral
action by blocking pain impulse generation.
The antipyretic actions may be produced by the drug’s action on the hypothalamic
heat-regulation centre to produce peripheral vasodilation, resulting in increased
cutaneous blood flow, sweating and heat loss.
Promethazine:
Promethazine acts as a CNS depressant possibly by reduction of stimuli to the brain
stem reticulary system.

5.2

Pharmacokinetic properties
Paracetamol:
Rapid and almost complete; may be decreased if taken after a high
Absorption:
carbohydrate meal.
Protein binding: Not significant with doses producing plasma concentration of less
than 60 micrograms per ml; may reach moderate concentration with high or toxic
doses.
Metabolism: 90-95% is metabolised in the liver, primarily by conjugation with
glucuronic acid, sulphuric acid and cysteine. An intermediate metabolite which may
accumulate in overdose after primary metabolic pathways have become saturated, is
hepatotoxic and possibly nephrotoxic.
1 - 4 hours, possibly somewhat shortened in children. Not effected
Half life:
by renal failure but may be prolonged in acute overdose and in some forms of hepatic
disease.
Route of elimination: Via hepatic metabolism, followed by renal excretion of
metabolites, primarily conjugates. Approximately 3% may be eliminated unchanged.
Promethazine:
Absorption:

Rapidly absorbed when taken orally.

Plasma binding: Very high
Metabolism: Subject to extensive first pass metabolism; major reactions appear to
be sulphoxidation and glucuronic acid conjugation.
Half life:

4 hours

Route of elimination:
unchanged material.

5.3

Hepatic; principally as sulphoxide. Only about 2% as the

Preclinical safety data
There are no preclinical data of relevance to the prescriber additional to that included
in other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Carbomer
Maltitol Solution
Saccharin sodium
Sodium Methylhydroxybenzoate
Sodium Propylhydroxybenzoate
Sodium Cyclamate
Potassium Sorbate
Blackcurrant Flavour 500013E
Vanilla Flavour
Ascorbic Acid
Concentrated Sodium Hydroxide Solution
Purified Water

6.2

Incompatibilities
None stated.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Keep container in outer carton.

6.5

Nature and contents of container
Cartoned amber glass bottles with polypropylene child resistant caps containing
25ml or 140ml of product.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
AYRTON SAUNDERS LIMITED
NORTH WAY
WALWORTH INDUSTRAIL ESTATE
ANDOVER
SP10 5AZ
UNITED KINGDOM

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0145

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
3 November 2000

10

DATE OF REVISION OF THE TEXT

11

DOSIMETRY (IF APPLICABLE)

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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