PANADOL BABY&INFANT SUSP 120MG/5ML 100ML

ATC code: N02BE01 

Active substances: Paracetamolum

Vendor, principal: Glaxosmithkline Consumer Healt. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PANADOL 120MG/5ML 100ML

Package leaflet: Information for the user Panadol, 120mg/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.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet

1.   What Panadol is and what it is used for
2.   What you need to know before you use Panadol
3.   How to take Panadol
4.   Possible side effects
5.   How to store Panadol
6.   Contents of the pack and other information

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

Panadol suspension contains paracetamol - analgesic and antipyretic.
Panadol is used for short-term treatment of mild to moderate pain and/or fever in children at the age of 2 months to 12 years.
The medicine is indicated for alleviation of pain during teething, toothache and sore throat and to lower fever incidental to viral diseases and after vaccinations.

2.   What you need to know before you use Panadol

Do not use Panadol suspension:

if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Taking excess amount of paracetamol may cause severe hepatic impairment.
Do not give this medicine to a child, if the child is already taking another prescription or non-prescription drug that contains paracetamol to combat pain or fever, cold or influenza or sleep disorders. Always check the labelling.
Before giving Panadol, consult your doctor if:
-   your child has liver or kidney disease;
-   your child is underweight or malnourished;
-   you take Panadol and regularly drink alcohol.
In the above cases, you should avoid using this medicine or take lower doses of paracetamol.
Before giving your child Panadol, consult your doctor or pharmacist if:
-   if your child has problems with liver, including hepatitis (and Gilbert’s syndrome).
-   if your child has asthma.
-   if your child is hypersensitive to acetyl salicylic acid and NSAIDs.
-   if your child has rare hereditary problems of fructose intolerance.
-   if your child has glucose-6-phosphate dehydrogenase (G6PD) deficiency.
-   if your child has a condition predisposing to abnormal destruction of red blood cells (haemolytic anaemia).
-   if your child has long-term eating disorders.
-   if your child has lost a lot of fluid and is dehydrated, e.g. conditions like vomiting, diarrhoea, profuse sweating, etc.
-   if your child has severe infection that may increase the risk of metabolic acidosis.
Signs of metabolic acidosis:
-   deep, rapid, difficult breathing;
-   feeling unwell (nausea), feeling sick    (vomiting);
-   loss of appetite.
If you get a combination of these symptoms, contact your doctor immediately.
If you experience no relief of symptoms, please consult with your doctor.

Other medicines and Panadol

Before using Panadol, tell your doctor or pharmacist if you use or your child uses the following medicines:
-   Warfarin or other similar medicines used to thin blood.
-   Metoclopramide or Domperidone, used to treat nausea and vomiting.
-   Cholestyramine, which is used to lower high blood cholesterol level.
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Panadol contains azorubine (E122) and sodium methyl, sodium ethyl and sodium propyl hydroxy benzoate (E219, E215, E217). These substances may cause allergic reactions, possibly delayed.
Contains sorbitol (E420) and maltitol (E965). If you have been told by your doctor, that your child has intolerance to some sugars, contact your doctor before giving the medicine to your child.
5 millilitres of Panadol oral suspension contains 570.5 mg sorbitol (E 420).

3.   How to take Panadol

Always give Panadol suspension to your child exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Do not exceed the recommended dose.
Always use the lowest dose that ensures alleviation of your child’s symptoms.
Do not give the medication more frequently than in every 4 hours.
Panadol suspension is for oral administration.
Shake the bottle well before using the medicine.
Use the measuring spoon supplied with the product.

Dosing in children:

Age Single dose - number of measuring spoons (5 mL) 2 - 3 months 0.5 measuring spoon 3 months to 1 years 0.5-1 measuring spoon 1 to 6 years 1-2 measuring spoons 6 to 12 years 2-4 measuring spoons

If necessary, repeat the dose in every 4-6 hours, but not more frequently than at 4 hour intervals.
Do not give more than 60 mg/kg divided into single doses of 10-15 mg/kg over the period of 24 hours.

Children from 2 to 3 months:

To relieve symptoms of vaccination related reaction use as a single dose of 0.5 measuring spoon (60 mg). If fever persists after the second dose, consult with your doctor. In other indications, only under the supervision of a doctor.
If your child was born prematurely and is less than 3 months old, consult with a doctor before using Panadol.
Do not give Panadol to your child for more than 3 days without consulting with your doctor.
Not recommended for children under 2 months.

If you give your child more Panadol than you should

In case of paracetamol overdose, consult your doctor immediately due to the risk of hepatic impairment, even if the child does not develop any symptoms. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you forget to give Panadol

Give the dose to your child as soon as you remember it.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.   Possible side effects

Like all medicines, Panadol suspension can cause side effects, although not everybody gets them.

Stop giving this medicine and contact your doctor immediately:

-   if after taking Panadol suspension, your child experienced allergic reaction in the form of rash or itching and may involve difficulty in breathing, swelling of lips, tongue, throat or face.
-   if after taking Panadol suspension, your child developed rash or flaking of the skin or ulcers in mouth.
-   if your child has previously experienced difficulty in breathing after taking aspirin or other non-steroid antiinflammatory drugs and the same occurs after taking Panadol suspension.
-   if your child is susceptible to infections (e.g. influenza/cold), or experiences fever and ulcers in mouth and pharynx (these may indicate lack of white cells called neutrophils (neutropenia) or leukocytes (leukopenia)).
-   if after taking Panadol suspension, your child experiences unexplained bruising or bleeding (these may indicate lack of platelets (thrombocytopenia)).
-   if your child experiences vomiting, sudden weight loss, loss of appetite and/or yellowing of the skin and the whites of the eyes. These may indicate liver disorders.
Such side effects are rare.
There have been very rare reports of serious skin reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5.   How to store Panadol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not freeze.
Shelf life of the medicine after first opening is 1 month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information

What Panadol suspension contains

-   The active substance is paracetamol. Each 5 mL dose contains 120 mg of paracetamol.
-   Excipients are malic acid, maltitol syrup (E965), sodium ethyl hydroxy benzoate (E215), sodium propyl hydroxy benzoate (E217), sodium methyl hydroxy benzoate (E219), colouring agent (azorubine E122), xanthan gum, sorbitol solution (crystallising), sorbitol (E420), citric acid anhydrous, strawberry flavour L10055 (contains propylene glycol (E1520)), purified water.

What Panadol looks like and contents of the pack

Opaque, pink, viscous strawberry-flavoured suspension.
Amber yellow glass bottle with child resistant cap contains 100 mL or 300 mL oral suspension and 5 mL measuring spoon, also marked for 2.5 mL dose.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited 980 Great West Road, Brentford Middlesex, TW8 9GS United Kingdom
Manufacturer: Farmaclair, 440 Avenue du General de Gaulle, 14200 Herouville Saint-Clair, France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Eesti OÜ,
Löötsa 8a,
11415 Tallinn Phone: +372 6676 900

This leaflet was last revised in August 2016.