PANADOL Baby syrup 120mg/5ml 100ml
PANADOL BABY syrup 120 mg / 5 ml 100 ml
Leaflet: user information
PANADOL Baby 120 mg/5 ml oral suspension
Paracetamol
PANADOL Baby 120 mg/5 ml oral suspension
Paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What PANADOL Baby is and what it is used for
2. What you need to know before using PANADOL Baby
3. How to take PANADOL Baby
4. Possible side effects
5. How to store PANADOL Baby
6. Contents of the package and additional information
1. What PANADOL Baby is and what it is used for
PANADOL Baby suspension is intended for children aged 1 month to 12 years. To relieve mild to moderate pain and reduce fever in teething, toothache, sore throat and ear pain; for pain and fever after vaccinations/immunizations, as well as to relieve the symptoms of colds and flu.
How does PANADOL Baby suspension work?
PANADOL Baby suspension has a pleasant strawberry taste, does not contain sugar and alcohol. The active substance is paracetamol - an analgesic (pain reliever) and antipyretic (lowers the temperature). PANADOL Baby suspension does not irritate the stomach and is easy to dose.
2. What you need to know before using PANADOL Baby
Do not give PANADOL Baby suspension to children who are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Check before taking this medicine, IMPORTANT!
Warnings and precautions
Remember: PANADOL Baby contains paracetamol.
Taking too much paracetamol can cause serious liver damage.
Do not use this medicinal product if your child is taking prescription or over-the-counter medicines that contain paracetamol for pain, fever, cold and flu symptoms, or sleeping pills.
Do not take more than the recommended dose as this can seriously damage the liver.
Do not take with other medicines containing paracetamol.
Important information about some of the ingredients of PANADOL Baby:
The suspension contains as excipients:
- azo dye azorubin (E 122) - May cause allergic reactions.
- parahydroxybenzoates: sodium methyl parahydroxybenzoate (E219), sodium
ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) - May cause allergic reactions (may be delayed type).
- sorbitol (E420) - each dose of 5 ml contains 666.5 mg of sorbitol - If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
- maltitol (E965) - If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
Talk to your doctor or pharmacist before giving PANADOL Baby Suspension if
- the child has kidney or liver disease; the child is malnourished or underweight;
- You may need to avoid using it altogether or reduce the amount of paracetamol you give.
- taking warfarin and similar medicines used to thin the blood; have had a breathing problem when using this or a similar medicine in the past; - have a severe infection, are severely malnourished or severely underweight, as this may increase the risk of metabolic acidosis.
Signs of metabolic acidosis include:
- deep, rapid, difficult breathing;
- urges to vomit, vomiting;
- loss of appetite;
Tell your doctor right away if you have any combination of these symptoms. If symptoms do not improve, you should seek medical attention. Pregnancy and breastfeeding
Not applicable — the drug is intended for use in pediatrics, for the treatment of children from 1 month to 12 years.
3. How to take PANADOL Baby
The suspension is for oral use.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your GP or pharmacist.
Shake before use.
A graduated measuring spoon (2.5 - 5 ml) or pipette (0.5 - 8 ml) is included in the package, which make it easier to measure the exact dose. Do not exceed the recommended dose.
Always give the lowest effective dose to relieve your child's symptoms and always use the product for the shortest possible treatment period.
Do not give more than 60 mg/kg in single doses of 10-15 mg/kg over a 24-hour period.
For children aged 1 to 3 months:
In case of a reaction after vaccination:
A single dose of 10-15 mg/kg for symptomatic relief of fever after vaccination. If a second dose is required, allow at least 4 hours between doses. If the temperature persists even after taking a second dose of PANADOL Baby suspension, a doctor should be consulted.
At temperature:
If the temperature does not decrease for more than 24 hours (after taking 4 doses), a doctor should be consulted in order to take preliminary measures to diagnose a possible more serious infection.
To facilitate dosing, you can use the following table:
Dosage of paracetamol in children
Weight Dosage
4 kg 2 ml
5-6 kg 3 ml
7-9 kg 4 ml
10-12 kg 6 ml
13-15 kg
8 ml
16-19 kg 10 ml
20-25 kg 12 ml
26-31 kg 16 ml
32-42 kg 20 ml
Measure the recommended dosage listed in the table above based on the child's weight. Use the pipette provided in the package. Draw a suspension from the bottle to the appropriate line on the scale. Repeat if a dose greater than 8 ml is required. After use, the pipette should be washed with warm water and dried, it is not necessary to sterilize it.
This dose can be repeated every 4 hours if necessary. Do not give more than 4 doses in a 24-hour period. Do not give at intervals shorter than 4 hours.
Not recommended for infants under 1 month.
PANADOL Baby suspension should not be given for more than 3 days without consulting a doctor. If the child's condition does not improve, seek advice from your doctor.
If your child has taken more than the required dose of PANADOL Baby suspension
Do not exceed the indicated dose. Taking too much can damage the liver. If you think the child has taken more than recommended
seek medical attention even if you feel well and have no symptoms because of the risk of liver failure.
If you forget to give PANADOL Baby suspension
Give the required dose when you remember. Do not give a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions may occur, e.g. skin rash. Although rare, changes in the blood count are possible.
Stop taking the medicine and consult your doctor immediately if you observe an allergic reaction such as a skin rash or itching, sometimes with breathing problems or the appearance of swelling of the lips, tongue, throat or face; if a skin rash or peeling occurs, or mouth ulcers, if your child has had breathing problems while using non-steroidal anti-inflammatory drugs or a similar reaction with this product; when unexplained bruising or unexpected bleeding occurs.
These reactions are very rare.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St., Sofia 1303, BULGARIA
tel.: (+359 2) 8903417
e-mail: bda@bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store PANADOL Baby
Keep out of the reach of children. To be stored at a temperature below 25°C. Do not freeze. Keep away from direct light.
Do not use this medicine after the expiry date which is stated on the carton. The initially opened package can be used within 1 month.
Do not dispose of medicines with household waste or down the drain. Ask your pharmacist how to dispose of unnecessary medicines and help protect the environment.
6. Contents of the package and additional information
What PANADOL Baby suspension contains
- The active substance is: paracetamol
Each dose of 5 ml contains 120 mg of paracetamol (1 ml contains 24 mg).
- The other ingredients (excipients) are: malic acid, azorubin (E 122), xanthan gum, maltitol (E965), sorbitol (E420), sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E2I7), citric acid, strawberry flavored essence (L10055) and water.
What PANADOL Baby looks like and what it contains
PANADOL Baby is a thick transparent suspension with a pink color.
The package contains a dark glass bottle of 100 ml, 200 ml or 300 ml with a white cap, with
protection against opening the bottle by children.
The package also includes a 5 ml plastic measuring spoon graduated to 2.5 ml or
clear, plastic pipette with a blue, polyester plunger with an externally graduated scale of po
0.5 ml to 8 ml.
Marketing Authorization Holder and Manufacturer
The holder of the authorization is:
GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland
Manufacturer: Farmaclair, France
Date of last revision of the leaflet August 2018
