Nurofen for Children 100 mg soft chewable caps. 24

1. How should Nurofen for Children 100 mg be used?

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Nurofen for children 100 mg is for oral use.

The soft capsules should be chewed and then swallowed. No additional fluid intake is necessary.

This medicine is intended for short-term use only.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g., fever and pain) persist or worsen (see section 2).

Nurofen for Children 100 mg should not be used in children under 7 years of age or in children with a body weight under 20 kg.

The recommended dose is:

In children, ibuprofen is dosed according to body weight, usually with 5 to 10 mg/kg body weight as a single dose and up to 20 to 30 mg/kg body weight as a total daily dose.

Child's body weight (kg) Age (years) Single dose

Maximum

daily dose

20-29 7-9

200 mg ibuprofen (equivalent to

2 soft capsules)

600 mg ibuprofen (equivalent to

6 soft capsules)

30-40 10-12

300 mg ibuprofen (equivalent to

3 soft capsules)

900 mg ibuprofen (equivalent to

9 soft capsules)

Single doses should be administered approximately every 6-8 hours, if necessary (or

with a minimum interval of 6 hours between individual doses).

WARNING: Do not exceed the stated dosages.

If the use of this medicine is required for more than 3 days

or if the symptoms worsen, medical advice should be sought.

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What Nurofen for Children 100 mg contains

The active ingredient is ibuprofen. Each chewable soft capsule contains 100 mg of ibuprofen.

The other ingredients are: gelatin, purified water, glucose syrup, sucrose,

Fumaric acid (E297), sucralose, citric acid (E330), acesulfame potassium (E950), sodium edetate,

Glycerol, natural orange flavor, iron(III) oxide (E172), iron(III) hydroxide oxide (E172),

Titanium dioxide (E171), propylene glycol and HPMC 2910/hypromellose 3cP.

Processing aids: medium-chain triglycerides, soy lecithin and stearic acid

Nurofen for Children 100 mg must not be used in children,

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  who are allergic to the active substances or any of the other ingredients of this medicine listed in section 6;

  
  


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  who have previously suffered from allergic reactions such as asthma, runny nose, hives or swelling of the face, tongue, lips or throat after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);

  
  


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  who are allergic to peanuts or soy, as this medicine contains soy lecithin;

  
  


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  with existing or recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two separate episodes of proven ulcers or bleeding);

  
  


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  with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy;

  
  


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  with severe liver, heart or kidney dysfunction;

  
  


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  with cerebral hemorrhages (cerebrovascular hemorrhages) or other active bleeding;

  
  


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  with unexplained blood disorders;

  
  


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  who are severely dehydrated (caused by vomiting, diarrhea or insufficient fluid intake).

  
  

Do not take this medicine during the last 3 months of pregnancy.

This is a medecine available without a prescription.. Do not use long without medical advice. Read the instructions carefully. Keep this medicine out of the reach of children. Keep the manual as it contains important information. Ask for advice from your doctor or pharmacist. Consult your doctor if adverse reactions.

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