Document: spc-doc_PL 16028-0119 change

• spc-doc_PL 16028-0118
• spc-doc_PL 16028-0119

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Junior Paracetamol Suspension

Infant’s & Children’s Paracetamol Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol BP 120 mg/ 5 ml

3    PHARMACEUTICAL FORM

Oral Suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For relief of mild to moderate pain including teething pain, and for pyrexia.

4.2.    Posology and Method of Administration

For oral administration. It is important to shake the bottle for at least 10 seconds before use.

For children aged 3 months to 12 years:

Child’s Age	How Much	How often (in 24 hours)
3 - 6 months	2.5 ml	4 times
6 - 24 months	5 ml	4 times
2 - 4 years	7.5 ml (5 ml + 2.5 ml)	4 times
4 - 8 years	10 ml (5 ml + 5 ml)	4 times
8 - 10 years	15 ml (5 ml + 5 ml + 5ml)	4 times
10 - 12 years	20 ml (5 ml + 5 ml + 5 ml + 5 ml)	4 times
•    Do not give more t •    Leave at least 4 hoi •    Do not give this m	ian 4 doses in any 24 hour period ars between doses edicine to your child for more than 3 days without speaking to

4.3 Contraindications

Contra-indicated in patients with a known hypersensitivity to paracetamol or any of the other constituents.

4.4 Special warnings and precautions for use

Paracetamol should be used with care in patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Patients should be advised not to take other paracetamol containing products concurrently.

The label should contain the following statements:

•    Contains paracetamol.

•    Do not give this medicine with any other paracetamol-containing product.

•    For oral use only.

•    Never give more medicine than shown in the table.

•    Do not overfill the spoon.

•    Always use the spoon supplied with the pack.

•    Do not give to babies less than 2 months of age

•    For infants 2-3 months no more than 2 doses should be given.

•    Do not give more than 4 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.

•    As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

•    Do not store above 25°C. Store in the original package.

•    Keep out of the reach and sight of children.

•    Immediate medical advice should be sought in the event of an overdose, even if the child seems well (label).

•    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 (leaflet).

4.5. Interactions with other Medicaments 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.

4.6 Fertility, Pregnancy and lactation

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 contra-indicate breast feeding.

4.7 Effects on ability to drive and use machines

None

4.8. Undesirable Effects

Undesirable effects with paracetamol are rare, however, hypersensitivity including skin rashes may occur. Very rare cases of serious skin reactions have been reported.

There have been a few 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 apillary necrosis has been reported after prolonged administration.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Early symptoms of paracetamol overdosage include 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, 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. Any patient who has ingested around 7.5g or more of paracetamol in the preceding 2 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 has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about 1 to 4 hours.

5.3 Preclinical safety data

None stated

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glycerol; Dispersible Cellulose; Sodium Methylparaben; Sodium Propylparaben; Citric Acid Anhydrous; Saccharin Sodium; Strawberry Flavour D3694 (containing    Propylene    Glycol);    Acesulphame    K;    Carmine

Extract P4011 (containing    Carmine,    Glycerine,    Potassium    Hydroxide);

Hydrogenated Glucose Syrup; Xanthan Gum; Purified Water.

6.2 Incompatibilities

None

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store at or below 25 °C. Do not refrigerate. Protect from light.

6.5 Nature and contents of container

Amber glass or PET bottles with polyethylene child resistant screw closures, containing 70, 100, 150 or 200 ml.

5ml unit dose foil laminate sachets sold individually or packed into cartons containing 4, 5, 8, 10, 12, 15, 16, 20, 24, 25, 48, 50, 70, 96 or 100.

6.6 Special precautions for disposal

Not applicable

MARKETING AUTHORISATION HOLDER

Galpharm Healthcare Limited

Wrafton

Braunton

Devon

EX33 2DL

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16028/0119

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/07/1995 / 23/02/2009

10 DATE OF REVISION OF THE TEXT

08/03/2016