Product Summary

1.    Trade Name of the Medicinal Product

Disprol Paracetamol Suspension.

Disprol Paediatric

2.    Qualitative and Quantitative Composition

Active Ingredient    mg/5ml    Specification

Paracetamol    120    Ph Eur

3. Pharmaceutical Form

Suspension.

Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, pain in teething, sore throat, period pains, aches and pains. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness, feverish colds.

Symptomatic relief of reactions due to vaccination and immunisation.

4.2 Posology and method of administration

Posology

Paediatric population

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

Age	Dose
For post-vaccination fever for babies aged between 2 - 3 months	One 2.5 mL spoonful If necessary, after 4-6 hours, give a second 2.5 mL dose

4.3 Contra-indications

Hypersensitivity to paracetamol.

4.4 Special warnings and special precautions for use

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 non-cirrhotic alcoholic liver disease. Each 5 ml of suspension can provide up to 12 kcal and this should be taken into account when treating diabetic children.

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.

•    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.

The leaflet should contain the following statement:

•    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 Interactions with other Medicaments and other forms of Interaction

Drugs which induce hepatic microsomal enzymes such as alcohol, barbiturates and tricyclic antidepressants may increase the hepatotoxicity of paracetamol, particularly after overdosage. 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 daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

4.6. 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 contraindicate breast feeding.

4.7 Effects on Ability to Drive and Use Machines

None stated.

4.8 Undesirable Effects

Adverse effect of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Overdose

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g 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.

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 24 hours from ingestion should be discussed with the NPIS or a liver unit.

Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

5.2 Pharmacokinetic Properties

Paracetamol is absorbed rapidly and completely mainly from the small intestine producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T/ of approximately two hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

5.3 Preclinical Safety Data

No preclinical findings of relevance have been reported.

PHARMACEUTICAL PARTICULARS

6.1    List of Excipients

Hydrogenated glucose syrup, glycerol, carbomer, sodium hydroxide, methyl hydroxybenzoate, propyl hydroxybenzoate, citric acid, saccharin sodium, banana flavour, riboflavine sodium phosphate and water.

6.2    Incompatibilities

None stated.

6.3    Shelf Life

Two years.

Special precautions for storage

Store below 25°C.

Do not freeze.

Keep the bottle in the outer carton in order to protect from light.

6.5. Nature and contents of container

Disprol Paracetamol Suspension

A.    Amber glass bottle with child resistant polythene/polypropylene closure with expanded polythene wad or PVDC-faced pulpboard wad and tamper-evident band. 50 ml, 100 ml and 200 ml. (Pack given in bold is marketed). GSL - Up to and including 100 ml.

B.    Amber polyethylene terephthalate (PET) bottles with tamper evident/ CRC cap with expanded polythene wad or PVDC-faced pulpboard wad.

C.    Four-ply laminate sachet composed of paper, polythene, aluminium foil and Surlyn ionomer. Carton packs of 2, 6, 10 or 12 sachets.

GSL.

Disprol Paediatric

D.    100ml amber glass bottle with child resistant polythene/polypropylene cap with expanded polythene wad or PVDC-faced pulpboard wad.

E.    500ml or 1000ml amber glass bottles with aluminium roll-on pilfer-proof

closure with expanded polyethylene wad.

F.    5ml laminate sachet as in (C) above.

6.6    Instructions for Use, Handling and Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

Take the required dose using the enclosed spoon.

7.    MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 0063/0021.

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12/03/2009

10    DATE OF REVISION OF THE TEXT

03/11/2011