This information is intended for use by health professionals

1. Name of the medicinal product

Almus Paracetamol 250mg/5ml Oral Suspension or Boots Paracetamol 6 Years Plus 250mg/5ml Suspension.

2. Qualitative and quantitative composition

Active ingredients

Per 5 ml

Paracetamol

250 mg

Excipients:

Sorbitol solution (E420)

1.5 ml

Methyl hydroxybenzoate (E218)

7.5 mg

See section 4.4 for further information.

For a full list of excipients, see Section 6.1

3. Pharmaceutical form

Oral Suspension

An off-white, strawberry-flavoured, syrupy suspension.

4. Clinical particulars
4.1 Therapeutic indications

To relieve mild to moderate pain and reduce fever in many conditions including headache, toothache, feverishness, colds and influenza.

4.2 Posology and method of administration

For oral use only.

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

Child's Age

How Much

How Often (in 24 hours)

6-8 years

5 ml

4 times

8-10 years

7.5 ml

4 times

10-12 years

10 ml

4 times

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.

Do not give to children under the age of 6 years.

Children aged 12-16 years: 10-15 ml up to 4 times a day.

Adults and children over 16 years: 10-20 ml up to 4 times a day.

Elderly: Dosage may need to be reduced because of the longer elimination half life and reduced plasma clearance of paracetamol.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other ingredients.

4.4 Special warnings and precautions for use

Caution in patients with severely impaired liver or kidney function.

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 syringe supplied with the pack.

Do not give to children under 6 years of age.

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.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Leaflet or combined label/leaflet:

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.

This product contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.

Methyl hydroxybenzoate (E218) may cause allergic reactions (possibly delayed).

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 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.

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

Alcohol can increase the hepatotoxicity of paracetamol overdosage and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol.

Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic paracetamol levels by increasing first pass metabolism or clearance.

4.6 Fertility, pregnancy and lactation

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

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

No adverse effects known.

4.8 Undesirable effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

Very rare cases of serious skin reactions have been reported.

Very rarely there have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

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

Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe cases liver failure may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop with or without severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is likely in adults who have taken 10 g or more of paracetamol.

Ingestion of lower doses equivalent to 5g or more of paracetamol may lead to liver damage if the patient has risk factors. These include if:

• They are undergoing long-term treatment with drugs that induce liver enzymes

• They regularly consume ethanol in excess of advised amounts

• They are likely to be glutathione deplete e.g. as in cystic fibrosis, eating disorders, HIV infection, starvation, cachexia

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 7.5 g 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

ATC Code: N02BE01

Paracetamol is a peripherally acting analgesic with antipyretic activity.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol.

Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose dependent. The plasma elimination half life varies from about one to four hours.

5.3 Preclinical safety data

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

6. Pharmaceutical particulars
6.1 List of excipients

Sorbitol solution (E420)

Glycerol

Dispersible cellulose (containing microcrystalline cellulose and sodium carboxymethylcellulose)

Hydroxyethylcellulose

Acesulfame potassium

Methyl hydroxybenzoate (E218)

Strawberry flavour ABJH9 (containing benzyl alcohol, ethyl benzoate, propylene glycol)

Cream flavour ACP3P (containing propylene glycol)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months

6.4 Special precautions for storage

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

6.5 Nature and contents of container

70ml, 80ml, 90ml, 100ml, 120ml, 130ml, 140ml, 150ml, 200ml, 250ml 300ml amber PET bottle with polypropylene child resistant closure with expanded polyethylene liner or polyethylene plug.

Syringe composed of a natural polypropylene barrel and a polyethylene pigmented white plunger.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as BCM

8. Marketing authorisation number(s)

PL00014/0619

9. Date of first authorisation/renewal of the authorisation

27 November 2000

10. Date of revision of the text

03rd September 2019