| 4.2. Posology and Method of Administration
The following text has been added:
It is important to shake the bottle for at least 10 seconds before use.
|
Child’s Age
|
How Much
|
How often (in 24 hours)
|
|
6 – 8 years
|
One 5 mL spoonful (large end)
|
4 times
|
|
8 – 10 years
|
One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end)
|
4 times
|
|
10 – 12 years
|
Two 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
- Do not give to children under the age of 6 years.
|
Children aged 12-16 years: Two - three 5mL spoonfuls (large end) up to 4 times a day
Adults and children over 16 years: Two - four 5mL spoonfuls (large end) up to 4 times a day.
4.4. Special Warnings and Special Precautions for Use
Text in red has been added:
· 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 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 reach and sight of children.
Excipients in the formulation
This product contains small amounts of tartrazine and carmoisine. These may cause allergic reactions.
4.5. Interactions with other medicinal products and other forms of interaction
The following text has been added:
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.
4.8. Undesirable Effects
The following text has been added:
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.
6.1. List of Excipients
Added excipients within pineapple flavour 545666E - tartrazine (E102) and carmoisine (E122)
6.4. Special Precautions for Storage
Text in red has been added:
Store below 25°C. Protect from light. Store in the original package.
6.5. Nature and Contents of Container
Text in red has been added:
Amber (Type III) glass bottle with capacity of 100ml, 125ml and 500ml
Closures: 1. Aluminium, wadded, roll-on, pilfer proof closure
2. HDPE, child resistant, tamper evident, EPE wadded closure
3. HDPE, tamper evident, EPE wadded closure.
Dosing device: 2.5/5ml double ended polypropylene spoon.
10. Date of (Partial) Revision of the Text
05 December 2011
|
