This information is intended for use by health professionals

1. Name of the medicinal product

Care Infant Paracetamol 120mg/5ml Suspension

2. Qualitative and quantitative composition

Paracetamol BP 120 mg/5 ml

3. Pharmaceutical form

Suspension for oral administration

4. Clinical particulars
4.1 Therapeutic indications

For relief of mild to moderate pain including teething pain, and for pyrexia.

4.2 Posology and method of administration

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

2.5ml. 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 4 kg and was born after 37 weeks

2.5 ml

If necessary, after 4-6 hours, give a second 2.5ml 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.

Children aged 3 months – 6 years:

Child's Age

How Much

How often (in 24 hours)

3–6 months

2.5 ml

4 times

6–24 months

5ml

4 times

2–4 years

7.5ml (5ml + 2.5ml)

4 times

4–6 years

10ml (5ml + 5ml)

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.

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

Elderly patients

No specific dose adjustment is necessary.

4.3 Contraindications

Contra-indicated in patients with a known hypersensitivity to paracetamol or any of the other constituents.

4.4 Special warnings and precautions for use

Paracetamol should be used with care in patients with:

• Severe hepatic and/or severe renal impairment

• Chronic alcohol consumption

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

The label should contain the following statements:

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

• For oral use only.

• Do not take more medicine than the label tells you to. If you do 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 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 (label).

• 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 (leaflet)

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 anti-coagulant 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.

The metabolism of Paracetamol is possibly accelerated by carbamazepine, fosphenytoin, phenobarbital, phenytoin and primidone (there have been isolated reports of hepatotoxicity.

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. Patients should follow the advice of their doctor regarding its use.

Breast-feeding

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contra-indicate breast feeding.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

In this section frequencies of undesirable effects are defined as follows: 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).

Blood and lymphatic system disorders

Not known: Blood dyscrasias including thrombocytopenia, agranulocytosis.

Immune system disorders

Not known: Hypersensitivity reactions (including skin rashes)

Skin and subcutaneous tissue disorders

Very rare cases of serious skin reactions have been reported.

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

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 with 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 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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half life varies from about 1 to 4 hours.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

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

Dispersible Cellulose

Sodium Methylparaben

Sodium Propylparaben

Citric Acid Anhydrous

Saccharin Sodium

Strawberry Flavour (containing Propylene Glycol)

Acesulphame K

Carmine Extract P4011 (containing Carmine)

Glycerine

Potassium Hydroxide

Hydrogenated Glucose Syrup

Xanthan Gum

Purified Water

6.2 Incompatibilities

None

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store at or below 25°C. Do not refrigerate. Protect from light.

6.5 Nature and contents of container

100ml: PET bottles with polyethylene child resistant screw closures.

A 5ml graduated syringe with a 2.5 & 5ml measure is supplied. The barrel is clear natural polypropylene. The plunger is white high density polyethylene.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Thornton and Ross Limited

Linthwaite Laboratories

Huddersfield

HD7 5DH

United Kingdom

8. Marketing authorisation number(s)

PL 00240/0133

9. Date of first authorisation/renewal of the authorisation

30/06/2004

10. Date of revision of the text

15/08/2019