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Panadol Baby And Infant Suspension

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Document: leaflet MAH BRAND_PL 00071-0355 change

Panadol Baby & Infant Suspension

Paracetamol

Please read this leaflet carefully before you start to give Panadol Baby & Infant Suspension. If you have any questions, or if you do not understand anything, ask your doctor or pharmacist. Keep this leaflet, you may want to read it again.

What is in the pack?

Panadol Baby & Infant Suspension

The bottle contains 25, 100, 200 or 1000 ml. *

What is in Panadol Baby & Infant Suspension?

Each 5 ml dose contains Paracetamol Ph Eur 120 mg.

The suspension also contains: malic acid, xanthan gum, maltitol liquid, sorbitol solution, sorbitol powder, citric acid, nipasept sodium, water, colour carmoisine (E122) and strawberry flavour.

What does Panadol Baby & Infant Suspension do?

Panadol Baby & Infant Suspension contains paracetamol which is an analgesic (pain killer) and antipyretic (helps to reduce body temperature when you have a fever).

What is Panadol Baby & Infant Suspension used for?

Panadol Baby & Infant Suspension relieves the pain of teething, toothache and sore throats and reduces the feverishness often associated with colds and ‘flu’ and childhood infections such as chicken pox, whooping cough, measles and mumps. It is suitable for babies and children from 3 months to 12 years of age.

Check before you give this suspension

IMPORTANT:

   Do not give with any other paracetamol-containing products.

Panadol Baby & Infant Suspension should not be given:

•    if your child is sensitive to paracetamol or to any of the other ingredients listed above.

•    if your child suffers from an inherited sugar absorption problem, as each dose contains up to 0.8 mg of sorbitol.

only marketed pack sizes will be printed

Please see your doctor before you give Panadol Baby and Infant Suspension:

   if your child has liver or kidney disease, including alcoholic liver disease.

•    If your child is currently taking any medicines

•    if your child is taking anti-coagulants (drugs to thin the blood e.g. warfarin) and you need to give them a painkiller on a daily basis over a long period. However, you can give occasional doses of Panadol Baby and Infant Suspension.

Always use the spoon supplied with this pack. Do not overfill the spoon. Shake the bottle for at least 10 seconds before use.

Age

Dose

2 - 3 months

•    Weighs over 4 kg

•    Was not premature (not born before 37 weeks)

One 2.5 mL spoonful (small end)

If necessary, after 4-6 hours, give a second 2.5 mL spoonful

•    Do not give to babies less than 2 months of age

•    Do not give more than 2 doses

•    Leave at least 4 hours between doses

•    If further doses are needed, talk to your doctor or pharmacist

Child’s Age

How Much

How often (in 24 hours)

3 - 6 months

One 2.5 mL spoonful (small end)

4 times

6 - 24 months

One 5 mL spoonful (large end)

4 times

2 - 4 years

One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end)

4 times

4 - 8 years

Two 5 mL spoonfuls (large end)

4 times

8 - 10 years

Three 5 mL spoonfuls (large end)

4 times

10 - 12 years

Four 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

If your baby was born prematurely, and is less than 3 months old, consult your doctor before use.

For Oral Use only.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

What should you do if your child has too much Panadol Baby & Infant Suspension?

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.

Will Panadol Baby & Infant Suspension suit your child?

Like all medicines, Panadol Baby & Infant Suspension can have side effects, but not everybody gets them. A small number of people have had side effects.

Stop taking the medicine and tell your doctor immediately if you experience:

   Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath

   Skin rash or peeling, or mouth ulcers

   Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin.

•    Unexplained bruising or bleeding

   Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

If you do get any side effects, even those not mentioned on this leaflet, tell your doctor or pharmacist.

Who makes Panadol Baby and Infant Suspension?

The product licence holder is GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is Farmaclair, 440 Avenue du General de Gaulle, 14200 Herouville Saint Clair, France.

Further Information

Shake bottle before use. Store below 30°C. Do not freeze.

Do not use this medicine after the “EXP” date shown on the pack.

Keep out of the reach and sight of children.

Leaflet prepared: August 2011 GSK GlaxoSmithKline (logo)

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

Panadol is a registered trade mark of the GlaxoSmithKline group of companies.