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Leaflet:information for user

Panadol Baby 120mg/5ml Oral Suspension

Please read right through this leaflet before you start using this medicine.
This medicine is available without prescription, but you still need to use Panadol Baby
suspension carefully to get the best results from it.
Keep this leaflet, you may need to read it again.
If you have any further questions, ask your pharmacist.
You must contact a doctor if symptoms worsen or do not improve after 3 days.
If any of the side effects get serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Panadol Baby is and what it is used for
2. Before you give Panadol Baby to the child
3. How should you give Panadol Baby to the child
4. Possible side effects
5. How to store Panadol Baby
6. Further information

1. What Panadol Baby is and what it is used for


Panadol Baby is an opaque, pink liquid with an odour of strawberry, with no sugar or
alcohol, which contains paracetamol, an analgesic (a pain killer that reduces aches and shivers)
and antipyretic (it reduces temperature when a child has a fever). Panadol Baby suspension
relieves the pain of teething, toothache and sore throats and reduces the fever often associated
with colds and flu and childhood infections such as chicken pox, whooping cough, measles and
mumps. This medicine does not irritate the stomach and it is easy to take.
2. Before you give Panadol Baby

Do not give Panadol Baby to the child if the child is allergic to paracetamol or any of its
other ingredients
Please very cautious with Panadol baby if:
-

the child suffers from liver or kidney problems


the child has a known intolerance to some sugars, contact your doctor before use as

this product contains maltitol syrup and sorbitol


-

the child is taking any prescribed drugs or is under the care of a doctor

Panadol baby is not recommended for babies under 3 months except under medical
advice.
If symptoms do not improve, consult your doctor.
Panadol baby should not be given more than 3 days without the doctors
recommendation.
Keep out the medicine of the reach and sight of children.

Taking other medicines


Please tell your doctor or pharmacist if your child has been taking any other medicines,
including medicines obtained without a prescription.
Effects of other drugs may be altered or these medicines may alter the effects of Panadol
Baby, if they are co-administered. In this case, your doctor may change your treatment or dosage
instructions.
Do not use with Panadol Baby with other drugs containing acetaminophen.
Tell your doctor if the child has been taking one of the following medications:
Warfarin or other coumarin (used to thin blood);
Metoclopramide or domperidone used to treat nausea or vomiting;
Cholestyramine (for the treatment of hypercholesterolemia);
Barbiturates (sleeping pills);
Tricyclic antidepressants;
Anticonvulsants.

Pregnancy and lactation

Not applicable, since the product is intended for pediatric use in children aged 2 months to 12
years.
The effect of this medicine on the management of motor vehicles and machinery
operation
Paracetamol does not affect your ability to drive a car and operate machinery.

Important information about ingredients of Panadol Baby


Panadol Baby contains maltitol (E965) and sorbitol liquid (E420). If your doctor has warned you
that you have rare hereditary problems of fructose intolerance you should not use this medicine.
Each 5 ml suspension contains 666.5 mg of sorbitol.
Sodium methylparaben (E219), Sodium ethylparaben (E215), Sodium propylparaben (E217)
may cause delayed allergic reactions.
Consult your doctor before using this medicine.
3. How to use Panadol Baby
Shake the bottle before use.
Administration method
Weight

Age

Dose

6-8 kg

3 - 6 months

4,0

8-10 kg

6 - 12 months

5,0

10-13 kg

1 - 2 months

7,0

13-15 kg

2- 3 months

9,0

15-21 kg

3- 6 months

10,0

21-29 kg

6- 9 months

14,0

29-42 kg

9- 12 months

20,0

6-8 kg

3 - 6 months

4,0

8-10 kg

6 - 12 months

5,0

10-13 kg

1 - 2 months

7,0

13-15 kg

2- 3 months

9,0

15-21 kg

3- 6 months

10,0

21-29 kg

6- 9 months

14,0

29-42 kg

9- 12 months

20,0

Locate the required dose in the table above, depending on the child's weight.
Alternatively, if you are unsure about your child's weight, you can be guided by age.
Use the dosing syringe, insert it into the glass and extract the suspension according to the correct
dosage indicators.
If you need more than 8 ml, repeat the procedure. After use, the syringe should be
flushed in hot water and dried.
The dose can be repeated every 4 hours if necessary
Leave at least 4 hours between doses
Do not use more than 4 doses per 24 hours.
You should not use Panadol Baby more than 3 times without the doctors
recommendation.
If you give too much to the child
Immediate medical advice should be sought in the event of overdosage because of the
risk of irreversible liver damage.

If you forget to use from Panadol Baby.


If you miss a dose at the right time do not worry. Take the next dose immediately, and
after 4-6 hours resume the routine.
If you have any further questions regarding this medicine, ask your doctor or your
pharmacist.

4. Possible side effects

Like all medicines, Panadol Baby can cause side effects, although not everybody gets
them.
Stop using this medicine and tell your doctor immediately if you see these very rare, but
possible reactions:
-

the child experiences allergic reactions such as skin rash or itching, sometimes with

breathing problems or swelling of the lips, tongue, throat or face.


-

the child experiences a skin rash or peeling, or mouth ulcers.


the child has previously experienced breathing problems with aspirin or non-steroidal
anti-inflammatories and experiences a similar reaction with this product.
the child experiences unexpected bruising or bleeding.
if the child previously had difficulty breathing while taking acetylsalicylic
acid(aspirin) or other nonsteroidal anti-inflammatory drug (NSAIDs) and now has the
same reaction

5. How to store Panadol Baby


Keep out of the reach and sight of children.
Do not use Panadol Baby after the expiry date stated on the label (after EXP). The
expiry date relates to the last day of that month.
Does not require any special storage
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures
will help protect the environment.
6. Further information
What does Panadol Baby contains:
The active substance of Panadol Baby is paracetamol. Each 5 ml of oral suspension containing
120 mg of paracetamol.
Other Ingredients: Hexacol Carmoisine Supra (E122), Malic Acid, Keltrol F (Xanthan Gum),
Maltitol Syrup, Strawberry Flavour L10055, Sorbitol Liquid (Crystallising), Sodium
methylparaben (E219), Sodium ethylparaben (E215), Sodium propylparaben (E217), Sorbitol
Powder, Citric Acid, Purified Water.
What Panadol Baby looks like and contents of the pack

Panadol Baby is an opaque, pink liquid with an odour of strawberry, with small white

crystals.
Each bottle contains either 100 ml or 300ml.
The pack contains a double-ended measuring spoon to measure the dose correctly.
Not all pack sizes may be marketed.

Marketing authorisation holder


GlaxoSmithKline Consumer Healthcare
GlaxoSmithKline Export LTD.
Brentford, TW8 9GS, United Kingdom
Producer
Farmaclair
440, Avenue du General de Gaulle
14200, Herouville Saint-Clair, France

This leaflet was revised in November 2013