Summary of Product Characteristics (SmPC) - Panadol Baby and Infant suspension
1 NAME OF THE MEDICINAL PRODUCT
Panadol Baby and Infant Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml spoonful of suspension contains Paracetamol Ph.Eur. 120mg
(Paracetamol Ph.Eur. 2.40% w/v)
3 PHARMACEUTICAL FORM
Aqueous suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Panadol Baby and Infant Suspension is recommended for the relief of pains of teething, toothache and sore throats and for reducing the feverishness often associated with colds and 'flu' and childhood infections such as chicken pox, whooping cough, measles and mumps.
4.2 Posology and method of administration
This product is intended for use in children.
It is important to shake the bottle for at least 10 seconds before use.
| Age | Dose | ||||
2 – 3 months
| One 2.5 mL spoonful (small end) If necessary, after 4-6 hours, give a second 2.5 mL spoonful | ||||
| |||||
- Leave at least 4 hours between doses
- If further doses are needed, 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 spoonful (small end) | 4 times | |||||
| 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 | |||||
| |||||||
Method of administration
Panadol Baby and Infant Suspension is for oral administration only.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents
4.4 Special warnings and precautions for use
Contains paracetamol. Do not use with any other paracetamol-containing products.
Underlying liver disease increases the risk or paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
Do not exceed the recommended dose.
Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (refer also to section 4.9).
Use with caution in patients with glutathione depletion due to metabolic deficiencies.
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.
If symptoms persist, medical advice must be sought.
Keep out of the sight and reach of children.
If your baby was born prematurely, and is less than 3 months old, consult your doctor prior to use.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
The label should contain the following statements:
- Contains paracetamol.
- Do not give anything else containing paracetamol while giving this medicineFor oral use only.
- Never give more medicine than shown in the table.
- 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.
Keep out of the reach and sight 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 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.
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
This product is intended for use in children.
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy if clinically needed, however, as with any medicine it should be used at the lowest effective dose for the shortest possible time.
Paracetamol is excreted in breast milk but not in a clinically significant amount in recommended dosages. Available published data do not contraindicate breast feeding.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class and frequency.
The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).
Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data.
Post marketing data
| Body System | Undesirable effect | Frequency |
| Blood and lymphatic system disorders | Thrombocytopenia Agranulocytosis | Very rare |
| Immune system disorders | Anaphylaxis Cutaneous hypersensitivity reactions including, among others, skin rashes and angiodema. Very rare cases of serious skin reactions have been reported. | Very rare |
| Metabolism and nutrition disorders | High anion gap metabolic acidosis* | Not known |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm** | Very rare |
| Hepatobiliary disorders | Hepatic dysfunction | Very rare |
* 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.
** There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
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
- Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
- Regularly consumes ethanol in excess of recommended amounts. Or
Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis,
HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdose 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
Paracetamol has analgesic and antipyretic actions. It is only a weak inhibitor of prostaglandin biosynthesis, although there is some evidence to suggest that it may be more effective against enzymes in the CNS than those in the periphery. This fact may partly account for its ability to reduce fever (a central action) and to induce analgesia.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma generally reaches a peak in 20-30 minutes; plasma half-life is 1-4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids. Plasma binding is variable. Excretion is almost exclusively renal in the form of conjugates.
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
Malic acid, maltitol liquid, strawberry flavour L10055, nipasept sodium, hexacol carmoisine supra E122, xanthan gum, sorbitol solution, sorbitol powder, citric acid, purified water.
6.2 Incompatibilities
None
6.3 Shelf life
36 months
6.4 Special precautions for storage
To be stored below 30ºC
Do not freeze
6.5 Nature and contents of container
25ml, 100ml, 200ml and 1000ml amber glass bottles fitted with white clic-loc closures with PVC faced pulpboard wads or black bakelite screw caps
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Haleon UK Trading Limited
The Heights
Weybridge
Surrey
KT13 0NY
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0088
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/10/1990 / 09/06/2005
10 DATE OF REVISION OF THE TEXT
03/02/2025