Summary of medicine characteristics - GALPAMOL FOR CHILDREN PARACETAMOL 120 MG / 5ML ORAL SUSPENSION., INFANTS & CHILDRENS PARACETAMOL SUSPENSION, PARACETAMOL 120 MG / 5ML ORAL SUSPENSION, GALPHARM CHILDRENS PARACETAMOL 120 MG / 5ML ORAL SUSPENSION, BOOTS PAIN RELIEF PARACETAMOL SUSPENSION 3
1 NAME OF THE MEDICINAL PRODUCT
Junior Paracetamol Suspension
Boots Pain Relief Paracetamol Suspension 3 Months Plus
Galpamol for Children Paracetamol 120mg/5ml Oral Suspension
Infant’s & Children’s Paracetamol Suspension
Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension
Galpharm Childrens Paracetamol 120mg/5ml Oral Suspension
Paracetamol 120mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 120 mg / 5 ml
Excipients with known effect:
Each 120mg/5ml dosage contains:
Sodium Methylparaben (E219) 8.750 mg
Sodium Propylparaben (E217) 1.000 mg
Strawberry Flavour D3694 8mg (containing 7mg Propylene Glycol)
Hydrogenated Glucose Syrup-consists of 260mg Sorbitol (E420) and 1,787.50mg Maltitol (E965)
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
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 oral administration. It is important to shake the bottle for at least 10 seconds before use.
For children aged 3 months to 12 years:
| 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 (5 ml + 2.5 ml) | 4 times |
| 4 – 8 years | 10 ml (5 ml + 5 ml) | 4 times |
| 8 – 10 years | 15 ml (5 ml + 5 ml + 5ml) | 4 times |
| 10 – 12 years | 20 ml (5 ml + 5 ml + 5 ml + 5 ml) | 4 times |
| Do not give more than 4 Leave at least 4 hours b Do not give this medi pharmacist | doses in any 24 hour period etween doses cine to your child for more than 3 days without speaking to your doctor or | |
Babies over 2 months in age
For the relief of fever after vaccination at 2, 3 and 4 months
2.5ml. This dose may be given up to 4 times a day 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.
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 renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Patients should be advised not to take other paracetamol containing products concurrently.
Paracetamol should be used with care in patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Patients should be advised not to take other paracetamol containing products concurrently. The label
should contain the following statements:
Contains paracetamol.
Do not give this medicine with any other paracetamol-containing product.
For 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.
Do not store above 25 DC. Store in the original package.
Keep out of the reach and sight of children.
Immediate medical advice should be sought in the event of an overdose, even if the child seems well (label).
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 (leaflet).
This medicine contains Sodium Methylparaben and Sodium Propylparaben which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per 120mg/5ml dosage, that is to say essentially ‘sodium-free’.
This medicine contains 7 mg propylene glycol in each 120 mg/5 ml dose which is equivalent to 28mg/20ml and 112mg/80ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
If you are pregnant or breast □ feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
This medicine contains 260 mg sorbitol in each 120 mg/5 ml dose which is equivalent to 1,040mg/20ml and 4,160mg/80ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicine also contains 1,787.50mg maltitol in each 120 mg/5 ml dose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.5. Interactions with other Medicaments and other forms of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone; and absorption reduced by colestyramine.
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.
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.
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 contra-indicate breast feeding.
4.7 Effects on ability to drive and use machines
None
4.8. Undesirable Effects
Undesirable effects with paracetamol are rare, however, hypersensitivity including skin rashes may occur. Very rare cases of serious skin reactions have been reported.
There have been a few reports of blood dyscrasias including thrombocytopenia, and agranulocytosis but these were not necessarily causally related to paracetamol.
Most reports of adverse reactions to paracetamol relate to overdosage with the drug.
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.
Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but apillary necrosis has been reported 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.
4.9 Overdose
Early symptoms of paracetamol overdosage include 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g of 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.
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. Any patient who has ingested around 7.5g or more of paracetamol in the preceding 2 hours should undergo gastric lavage. Administration of oral methionine or intravenous n-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
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
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 D3694 (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
Amber glass or PET bottles with polyethylene child resistant screw closures, containing 70, 100, 150 or 200 ml.
5ml unit dose foil laminate sachets sold individually or packed into cartons containing 4, 5, 8, 10, 12, 15, 16, 20, 24, 25, 48, 50, 70, 96 or 100.
6.6 Special precautions for disposal
Not applicable
7. MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0118
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 27/07/1995 / 23/02/2009