Paracetamol 120mg/5ml Oral Suspension – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol 120mg/5ml Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of the oral suspension contains Paracetamol 120mg

Excipients with known effect:

Maltitol liquid (E965) 1 ml

Sodium methyl parahydroxybenzoate (E219) 9 mg

Sodium propyl parahydroxybenzoate (E217) 1 mg

Strawberry flavour contains propylene glycol which amounts to 8mg of propylene glycol in 5ml see section 4.4

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral Suspension

White to off-white uniform suspension.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Paracetamol 120mg/5ml Oral Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and post-immunisation fever

4.2 Posology and method of administration

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

One 2.5ml spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Do not 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.

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

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

4.3 Contraindications

Paracetamol Oral Suspension is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other constituents listed in section 6.1.

4.4 Special warnings and precautions for use

Do not exceed the recommended dose. Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help straight away. Quick medical attention is critical for adults as well as children even if signs or symptoms are not noticed.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Chronic alcohol users should consult

a doctor before use.

Taking this product with other paracetamol-containing medicines could lead to overdose and should therefore be avoided.

Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

This product contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217). These may cause allergic reactions

(possibly delayed).

It also contains maltitol liquid (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The strawberry flavour contains propylene glycol in very small amounts of

8mg of propylene glycol in 5ml.

The label contains the following statements :

• Contains paracetamol.
• Do not give anything else containing paracetamol while giving this medicine.
• For oral use only.
• Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.
• 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 sight and reach of children.
• Talk to a doctor at once if your child takes too much of this medicine, even if they seem well .
• Shake the bottle for at least 10 seconds before use.

The leaflet contains the following statements:

• 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.

• Very rare cases of serious skin reactions have been reported.

  Symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away

Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

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.

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. Metabolism of paracetamol possibly accelerated by carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone (also isolated reports of hepatotoxicity).

Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4)

4.6 Fertility, Pregnancy and lactation

Fertility

There is no information relating to the effects of Paracetamol Oral Suspension on fertility (see section 5.3)

Pregnancy

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. When given to the mother in therapeutic doses (1 g single dose), paracetamol crosses the placenta into foetal circulation as early as 30 minutes after ingestion and is metabolised in the foetus by conjugation with sulfate and

increasingly with glutathione.

Breast-feeding

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 drug reactions (ADRs) identified during clinical trials and post marketing experience with paracetamol are listed below by System Organ

Class (SOC).

The frequencies are defined according to the following convention:

Very common ≥1/10

Common ≥1/100 to <1/10

Uncommon ≥1/1,000 to <1/100)

Rare ≥1/10,000 to <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data).

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2)

when incidence is unavailable, frequency category is listed as Not known.

¹ Reported following paracetamol use, but not necessarily causally related to the drug

²Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year

³ Reported after prolonged administration

⁴Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.

Description of selected adverse reactions

High anion gap metabolic acidosis

Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4).

Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

Very rare cases of serious skin reactions have been reported.

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.

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

Children who have ingested 75mg/kg or more of paracetamol in less than 1 hour should be referred to hospital. Administration of activated charcoal should be considered if paracetamol in excess of 150mg/kg is thought to have been ingested within the previous hour.

Liver damage is possible in adults and adolescents (≥12 years of age) who have taken 7.5g 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. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

1. a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.

Or

1. b) Regularly consumes ethanol in excess of recommended amounts.

Or

1. 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, hyperhidrosis, malaise, vomiting, anorexia and abdominal pain.

Liver damage may become apparent 12 to 48 hours after ingestion. This may include hepatomegaly, liver tenderness, jaundice, acute hepatic failure and hepatic necrosis. Abnormalities of glucose metabolism and metabolic acidosis may occur. Blood bilirubin, hepatic enzymes, INR, prothrombin time, blood phosphate and blood lactate may be increased. 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. Haemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency):

Haemolysis has been reported in patients with G6PD deficiency, with use of paracetamol in overdose.

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

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Non-Opioid Analgesic, Antipyretics (Anilides)

ATC CODE: N02B E01

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has weak anti-inflammatory effects. It is only a weak inhibitor of prostaglandin biosynthesis although there is some evidence to suggest it may be more effective against enzymes in the central nervous system than in the periphery. This may in part account for its activity profile.

5.2 Pharmacokinetic properties

Absorption

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are

reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses.

Distribution

Drug is widely distributed throughout most body fluids.

Biotransformation

Metabolism occurs almost entirely via hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected.

Children have less capacity for glucuronidation of the drug than do adults.

In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

Elimination

Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 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

Glycerol

Polysorbate 80

Xanthan gum

Maltitol liquid

Saccharin sodium

Citric acid monohydrate

Sodium methyl parahydroxybenzoate

Sodium propyl parahydroxybenzoate

Strawberry flavour (containing propylene glycol)

Purified water

6.2 Incompatibilities

None Known

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25ºC. Store the container in the outer carton. Discard after 2 months of first opening.

6.5 Nature and contents of container

Amber Type III Glass

Child Resistant Tamper Evident Cap- High density polypropylene cap with a polyethylene lining

A spoon with a 2.5 ml and 5 ml measure is supplied with all packs of this product; except 500ml pack size.

Pack sizes available: 100ml, 200ml, 500ml

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Crescent Pharma Limited

3&4 Quidhampton Business Units

Polhampton Lane

Overton

Hampshire

RG25 3ED

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 20416/0521 Legal status - P

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

22/11/2024

10 DATE OF REVISION OF THE TEXT

19/08/2026