Ibucine Paediatric Suspension

This medicine contains Ibuprofen which belongs to a group of medicines called non - steroidal anti - inflammatory drugs (NSAIDs). Ibucine Paediatric Suspension is indicated for the management of mild to moderate pain and inflammation. Ibucine Paediatric Suspension is also used to reduce fever. Ibucine Paediatric Suspension is used in the management of mild to moderate pain and infl ammation in dysmenorrhoea, migraine, post - operative pain, dental pain, musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis and rheumatoid arthritis including juvenile rheumatoid arthritis, peri - articular disorders such as bursitis, and tensosynovitis, and soft tissue disorder such as pains and sprains.

Ibucine Paediatric Suspension is not recommended for children under 1 year of age or in those weighing less than 7 kg. However, some children should not be given this medicine or you should seek the advice of their pharmacist or doctor first.

Do not give:

• If your child is under 1 year old, or weighs less than 7 kg
• If your child has a stomach ulcer, perforation or bleeding, or has had one twice or more in the past
• If your child has had perforation or a bleeding stomach after taking a non - steroidal anti - inflammatory medicine (your child may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in their stools or passed black tarry stools)
• If your child is allergic to ibuprofen or any other ingredients in the product, aspirin or other non - steroidal anti - inflammatory medicines (your child has ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)
• If your child has severe heart, kidney or liver failure
• If your child is taking aspirin, or other non - steroidal anti - inflammatory medicines

Other important information

Risk of heart attack or stroke: Anti - inflammatory/pain - killer medicines like ibuprofen may be associated with a small increased risk of heart attack o r stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment. Ibucine Paediatric Suspension should be used with caution in the elderly. Care is required in those receiving oral anti - coagulants, lithium, meth otrexate and cardiac glycosides.

Shake the container before use.

Children:

Juvenile Rheumatoid Arthritis

- 20 mg/kg of body mass daily in divided doses with up to 40 mg/kg being given daily if necessary.

Pain:

- 5 mg/kg of body mass. A second dose of 5 mg/kg may be given after 2 hours if pain is not controlled, thereafter 5 mg/kg every 4 - 6 hours. If pain persists for more than 7 days, consult your physician.

Fever:

- 5 mg/kg of body mass every 4 - 6 hours. If fever persists more than three days consult your doctor.

Age Daily Dosage Body Mass

• 1 - 2 years 2,5ml 3 – 4 times daily 7 - 12 kg
• 3 - 7 years 2,5 - 5ml 3 – 4 times daily 14 - 23 kg
• 8 - 12 years 10 ml 3 - 4 times daily 25 - 40 kg

Give the lowest amount for the shortest possible time to relieve the symptoms.

If you give more than you should: If you have given more than you should, or if children have taken the medicine by accident always contact a doctor or nearest hospital to get an opinion on the risk and advice on action to be taken. The symptoms can include epigastric pain and nausea. Ga stric lavage will remove any unabsorbed Ibucine Paediatric Suspension, if recently taken and electrolites may be corrected by intravenous infusions, if necessary.

Most people will not have problems, but some may get some. If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:

• Your child is sick and it contains blood or dark particles that look like coffee grounds
• Pass blood in their stools or pass black tarry stools
• Tiredness or severe exhaustion, changes in the blood which may cause unusual bruising or unexplained bleeding and an increase in the number of infections that they get (e.g. sore throats, mouth ulcers, flu - like symptoms including fever)
• Stomach problems including pain, indigestion or heartburn
• Unexplained wheezing (asthma), worsening of existing asthma, difficulty in breathing, swelling of the face, tongue, neck or throat, fast heart rate, feeling faint or dizzy or collapse (severe allergic reactions)
• Allergic skin reactions such as itchy, red, raised rash (which can sometimes be severe and include peeling, blistering and lesions of the skin)
• Meningitis (e.g. stiff neck, fever, disorientation)
• High blood pressure, heart failure, (your child may be tired, have difficulty breathing or swollen legs)
• A small increased risk of heart attack or stroke if you take large amounts for a long time
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)
• Swellings or ulcers of the stomach
• Kidney problems, which may lead to kidney failure (your child may pass more or less urine , have blood in the urine or cloudy urine, or feel breathless, very tired or weak, have no appetite, or have swollen ankles)
• When your child experience visual disturbances, such as blurred vision, changes in visual colour perception

If your child gets any of the following side effects see your pharmacist or doctor:

• Uncommon, feeling sick or rarely, being sick
• Uncommon, headache
• Rarely, diarrhoea, constipation and wind, and very rarely, and very rarely, worsening of colitis or Crohn's disease
• Frequency not known, swellings or ulcers of the mouth lining, fluid retention, which may cause swelling of the limbs

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 side effects directly via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications. http//www.sahpra.org.za/publications/index/8 By reporting side effects you can help provide more information on the safety of this medicine.

Store in a well closed container Store at or below 25 0C. KEEP OUT OF THE REACH OF CHILDREN.