How to take it

this medicine

• Shake the bottle before each use.
• Give this medicine to your child by mouth with or after food.
• Use the spoon provided to measure 2.5ml or 5ml.

Children from 8 – 12 years

Two 5ml spoonfuls three or four times a day.

Children from 3 – 7 years

One 5ml spoonful three or four times a day.

Children from 1 – 2 years

One 2.5ml spoonful three or four times a day.

Infants from 6 – 12 months

One 2.5ml spoonful three times a day.

Children under 6 months

Do not give to children under 6 months unless your doctor tells you to.

For fever following vaccination

• One 2.5ml spoonful. Repeat after 6 hours if necessary.
• Do not give more than 2 doses in 24 hours.

• If the high temperature is not reduced see your doctor. DO NOT EXCEED THE STATED DOSE. If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

If you give too much

If you have given more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital straight away to get an opinion of the risk and advice on action to be taken. Take the pack with you to show which medicine your child has swallowed. The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

If you forget a dose

Give the next dose as soon as you remember. Do not give a double dose. You can then carry on with the normal dose at the correct time. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

4. Possible side effects

Like all medicines, Care Ibuprofen for Children Oral Suspension can cause side effects, although not everybody gets them. Important side effects If you think your child has any of the following serious side effects or symptoms, STOP TAKING this medicine immediately and see a doctor as soon as possible.

• Fast heartbeat.

• • • •

Low blood pressure (causing light headedness). Severe shock. Unexplained wheezing or shortness of breath. Allergic reactions including rashes or itching, bruising, blistering or peeling and swelling of the face, lips, tongue, throat or difficulty in swallowing.

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Blood in the faeces (stools/motions).
• Pass black tarry stools.
• Vomit any blood or dark particles that look like coffee grounds.
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using this medicine if you develop these symptoms and seek medical attention immediately. See also section 2.
• Liver, kidney problems or difficulty urinating. Care Ibuprofen for Children Oral Suspension, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness. Other possible side effects
• Feeling sick.
• Indigestion or heartburn.

• Stomach pain or other stomach problems.
• Worsening of the symptoms of asthma, inflammation of the colon and crohn's disease.
• General swelling.
• High blood pressure.
• Heart failure. Rarely
• Headache.
• Dizziness.
• Hearing disturbance.
• Diarrhoea.
• Wind.
• Constipation.
• Being sick. Very Rarely
• Stomach ulcers, bleeding or swelling of the stomach lining.
• Meningitis.
• Kidney damage (look for passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling particularly of the legs).
• Liver problems (look for yellowing of the skin and eyes, pale stools/motions and dark urine).
• Blood cell disorders whose symptoms include fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, bruising or a purple skin rash. Not Known
• a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• In exceptional cases, serious infections of the skin and soft tissues have occurred during chickenpox (varicella).
• Skin becomes sensitive to light. Medicines such as Ibuprofen for Children may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report

Possible side effects

directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storing this medicine

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month. Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment.

6. Further information What is in the medicine

The active ingredient per 5ml is: ibuprofen 100mg. The other ingredients are: sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate(E217), citric acid anhydrous(E330), saccharin sodium(E954), sodium benzoate (E211), dispersible cellulose, juicy orange flavour, polysorbate 80 (E433), maltitol liquid (which contains maltitol and sorbitol), xanthan gum (E415) and purified water.

What the medicine looks like

Ibuprofen for Children is a white cloudy suspension. It is supplied in 100ml bottles.

Marketing authorisation holder and manufacturer

Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK. This leaflet was last revised in December 2023

92767232212 GB

REVERSE FACE TOP

• This medicine contains 275mg sorbitol in each 5ml dose. Sorbitol is a source of fructose. If your doctor has told you that your child has an intolerance to some sugars or if they have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before your child receives this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• Sodium Methyl Parahydroxybenzoate (E219) and Sodium Propyl Parahydroxybenzoate (E217) may cause allergic reactions (possibly delayed).
• Sodium Benzoate (E211): This medicine contains 5mg Sodium Benzoate in each 5ml dose.
• This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'.