Paracetamol 120mg/5ml Oral Suspension

Rosemont Pharmaceuticals Limited

Active ingredient
paracetamol

Legal Category
P: Pharmacy

SmPC Patient Leaflet

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This information is intended for use by health professionals

1. Name of the medicinal product

2. Qualitative and quantitative composition

Excipients with known effect:

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

Sucrose 3g/5ml

Sorbitol (E420)

Propylene Glycol (E1520)

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Oral Suspension

Off-white cream suspension

4. Clinical particulars

4.1 Therapeutic indications

For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period
pains, aches and pains.

For the reduction of fever and to be used as an adjunctive treatment to relieve symptoms of cold and flu.

4.2 Posology and method of administration

Posology

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

One 2.5 mL 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.

Age: 2 – 3 months Dose

Pain and other causes of fever - if your baby weighs over One 2.5 mL spoonful (small end).
4 kg and was born after 37 weeks
If necessary, after 4-6 hours, give a second 2.5 mL dose

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

• Leave at least 4 hours between doses

• Do not give more than 2 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 One 2.5 mL spoonful (small end) 4 times

6 – 24 months One 5 mL spoonful (large end) 4 times

2 – 4 years One 5.0 mL spoonful (large end) and one 2.5 mL 4 times
spoonful (small end)

4 – 8 years Two 5 mL spoonfuls (large end) 4 times

8 – 10 years Three 5 mL spoonfuls (large end) 4 times

10 - 12 years Four 5 mL spoonfuls (large end) 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

Method of administration

For oral administration only

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

4.3 Contraindications

Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.

Patients with severe hepatic dysfunction.

4.4 Special warnings and precautions for use

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.

• Contains paracetamol.

• Do not give with any other paracetamol-containing products.

• For oral use only.

• Never give more medicine than shown in the table.

• Always use the spoon supplied with the pack. Do not overfill the spoon.

• 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. Protect from light. Store in the original package.

• 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.

• If symptoms persist consult your doctor.

• Keep out of the sight and reach of children.

Excipients in the formulation

This product contains:

• Methyl and propyl hydroxybenzoates. These may cause allergic reactions (possibly delayed).

• Sucrose (3g per 5ml dose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

• Sorbitol. This medicine contains 782.25mg per 5ml dose. The additive effect of concomitantly administered products
containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral
use administered concomitantly.

Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

• Propylene Glycol. This medicine contains 144.8mg propylene glycol per 5ml dose. Co-administration with any substrate
for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.

While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may
reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating
patients should be considered on a case by case basis.

Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events
attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure
and liver dysfunction.

4.5 Interaction with other medicinal products and other forms of interaction

The hepatotoxicity of Paracetamol, particularly after overdosage, may be increased by drugs which induce liver
microsomal enzymes such as barbiturates, tricyclic antidepressants, and alcohol.

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 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.

Antivirals: Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).

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

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.

Breast-feeding

Paracetamol is excreted in breast milk but not in clinically significant quantities. Available published data do not
contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

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

Very rare cases of serious skin reactions have been reported.

Cases of acute pancreatitis have been reported. Paracetamol has been widely used and reports of adverse reactions
are rare, and are generally associated with overdosage.

Allergic reactions occur occasionally.

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.

Low 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.

Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except 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 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 10g or more of paracetamol. 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

a) Is on long term treatment wih carbamazepine, phenobarbital, 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 depleted 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 24h from ingestion should be discussed
with the NPIS or a liver unit.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides)

ATC Code: N02 BE01.

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting
prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by
blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to
inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical
stimulation.

Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulating centre to produce
peripheral vaso-dilation resulting in increased blood flow through the skin, sweating and heat loss. The central action
probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic properties

Oral absorption is rapid and almost complete, it may be decreased if Paracetamol is taken following a high carbohydrate
meal.

There is no significant protein binding with doses producing plasma concentrations of below 60mcg (µg)/ml, but may
reach moderate levels with high or toxic doses.

Approximately 90 - 95% of a dose is metabolised in the liver, primarily by conjugation with glucuronic acid, sulphuric acid
and cysteine. An intermediate metabolite, which may accumulate in overdosage after primary metabolic pathways
become saturated, is hepatotoxic and possibly nephrotoxic.

Half life is 1 to 4 hours; does not change with renal failure but may be prolonged in acute overdosage, in some forms of
hepatic disease, in the elderly, and in the neonate; may be somewhat shortened in children.

Time to peak concentration, 0.5 - 2 hours; peak plasma concentrations, 5 - 20mcg (µg)/ml (with doses up to 650mg);
time to peak effect, 1- 3 hours; duration of action, 3- 4 hours.

Elimination is by the renal route, as metabolites, primarily conjugates, 3% of a dose may be excreted unchanged.

Peak concentration of 10 - 15mcg(µg)/ml have been measured in breast milk, 1 - 2 hours following maternal ingestion of
a single 650mg dose. Half life in breast milk is 1.35 - 3.5 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

Propylene glycol

Methyl hydroxybenzoate

Propyl hydroxybenzoate

Xanthan gum

Sorbitol solution 70%

Sucrose

Mango flavour

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

24 months

6.4 Special precautions for storage

Store below 25°C. Protect from light. Store in the original package.

6.5 Nature and contents of container

Bottles: Amber (Type III) glass bottle

Closure: HDPE, child resistant, tamper evident, EPE wadded closure

Pack sizes: 100ml and 500ml

Dosing device: 2.5/5ml double ended polypropylene spoon.

6.6 Special precautions for disposal and other handling

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

7. Marketing authorisation holder

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text

 Report Side E!ect

Last updated on emc: 24 Oct 2019

Company contact details

Address
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE

Telephone
+44 (0)113 244 1400

Customer Care direct line

Out of Hours contact

WWW
http://www.rosemontpharma.com

Fax
+44 (0)113 245 3567

Out of Hours Telephone

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