This information is intended for use by health professionals

1. Name of the medicinal product

Almus Paracetamol 120mg/5ml Oral Suspension or Paracetamol 120mg/5ml Oral Suspension

2. Qualitative and quantitative composition

Active ingredients

Per 5 ml

Paracetamol

120 mg

3. Pharmaceutical form

Oral Suspension

4. Clinical particulars
4.1 Therapeutic indications

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

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.

Babies over 2 months in age

For the relief of fever after vaccination at 2, 3 and 4 months

2.5 ml. This dose may be given up to 4 times a day at the time of vaccination. Don't give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist. Do not give to babies less than 2 months of age.

For other causes of pain and fever:

Child's age

How much

2-3 months

2.5 ml – usually once, if necessary, after 4-6 hours, a second 2.5 ml dose may be given

Do not give to babies less than 2 months of age. Only give if your baby weighs over 4 kg and was born after 37 weeks. Do not give more than 2 doses. Leave at least 4 hours between doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.

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

4 times

4-6 years

10 ml

4 times

Don't 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.

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 hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

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

Carmoisine (E122) may cause allergic reactions.

Very rare cases of serious skin reactions have been reported.

The labelling should contain the following statements:

Contains paracetamol.

Do not give anything else containing paracetamol while giving this medicine.

Give this medicine to your child to swallow.

Do not give more medicine than the label tells you to. If your child does not get better talk to your doctor.

Always use the syringe supplied with the pack.

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

Do not give if your child is between 2-3 months old and is taking this medicine for other causes of pain and fever and weighs less than 4 kg or was born before 37 weeks.

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 store above 25°C. Store in the original package. Keep the lid tightly closed.

Keep all medicines out of the sight and reach of children.

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

Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.

Never give more medicine than shown in the table.

Leaflet or combined label/leaflet:

Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.

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

Carmoisine (E122) may cause allergic reactions.

This medicine contains 0.8 g sorbitol and 1.3 g maltitol per 5 ml spoonful. This provides 5 kcal per 5 ml spoonful.

Don't give more than 4 times in any 24 hours.

Leave at least 4 hours between doses.

For the relief of fever after vaccination at 2, 3 and 4 months, if your baby still needs this medicine 2 days after receiving the vaccine talk to your doctor or pharmacist.

Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.

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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

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 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-acetylcystine 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 NPIS or a liver unit.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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 (E422)

Maltitol liquid (E965)

Dispersible cellulose (containing microcrystalline cellulose and sodium carboxymethylcellulose)

Hydroxyethyl cellulose

Methyl hydroxybenzoate (E218)

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

Strawberry flavour (L-125660) (containing propylene glycol)

Sugar flavour (511260) (containing propylene glycol)

Carmoisine edicol (E122)

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.

6.5 Nature and contents of container

70ml, 80ml, 90ml, 100ml amber PET bottle with a polypropylene child resistant closure with expanded polyethylene liner or polyethylene plug.

70ml, 80ml, 90ml, 100ml amber glass bottle with child resistant polypropylene closure with expanded polyethylene liner.

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)

PL 00014/0638

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 18 September 2002

10. Date of revision of the text

29th August 2019