Ibuprofen 100mg/5ml Oral Suspension
Out of date information, search anotherPATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains important information.
This medicine is available without prescription for you to treat a mild illness in your child without a doctors help. Nevertheless you still need to use this medicine carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor or pharmacist if your child's symptoms worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you give this medicine
3. How to give the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
[] WHAT THIS MEDICINE IS FOR
Children's Ibuprofen 100mg/5ml Oral Suspension contains ibuprofen, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature.
This medicine is used to relieve:
• Fever (high temperature) including post immunisation fever at 2 months
• Mild to moderate pain including headache, sore throat, earache, teething pain and toothache, cold and flu symptoms and minor aches and sprains.
B
BEFORE YOU GIVE THIS MEDICINE
risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 days). If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist
If your child is taking other medicines:
You must not give this medicine if they are taking certain other medicines - see section 2 ‘Do not give Children's Ibuprofen 100mg/5ml Oral Suspension to children who:'. Talk to your pharmacist or doctor before you give this medicine if they are taking any regular medication, especially:
• aspirin at low dose (i.e. below 75mg daily) as taking ibuprofen may reduce the effect of the aspirin or cause stomach problems
• medicines for high blood pressure and water tablets (diuretics)
• medicines for thinning the blood (anti-coagulants and anti-platelet agents)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure)
• cyclosporin and tacrolimus (immunosuppressant medicines often used following organ transplants)
• mifepristone (a medicine used to terminate pregnancy - NSAIDs should not be used for 12 days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• guinolone antibiotics (medicines used to treat bacterial infections)
If you are an adult taking this medicine you should be aware of all the above factors and additionally you should talk to your doctor or pharmacist if you:
• are a smoker
• are elderly, as there may be an increased risk of side effects.
Do not give Children’s Ibuprofen 100mg/5ml Oral
Suspension to children who:
• have or have had a stomach ulcer, perforation or bleeding of the stomach
• are allergic to ibuprofen, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)
• have kidney or heart failure or severe liver failure
• are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
Talk to your doctor or pharmacist before giving
Children’s Ibuprofen 100mg/5ml Oral Suspension
to children who:
• have or have suffered from asthma, diabetes, high cholesterol or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn's disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) - an illness which affects your immune system. It causes joint pains, skin changes and problems with other parts of your body.
• have, have previously had, or are at risk of heart problems, high blood pressure or stroke. Medicines such as Children's Ibuprofen 100mg/5ml Oral Suspension may be associated with a small increased
Pregnancy and Breast feeding
Do not take Children's Ibuprofen 100mg/5ml Oral Suspension if you are in the last 3 months of pregnancy. Talk to your doctor before taking Children's Ibuprofen 100mg/5ml Oral Suspension if you are in the first 6 months of pregnancy or are breastfeeding.
Children's Ibuprofen 100mg/5ml Oral Suspension belongs to a group of medicines, which may impair fertility in women. This is reversible on stopping the medicine.
It is unlikely that the suspension, used occasionally, will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
Important information about some of the ingredients of this medicine:
This product contains liguid maltitol (E965). If you have been told by your doctor that your child may have an intolerance to some sugars, talk to your doctor before your child takes this medicinal product. May have a mild laxative effect. Each 5ml measure contains 1.375g of liguid maltitol (eguivalent to 3.2 kcal per 5ml of the medicine).
This product also contains sodium methylparahydroxybenzoate (E219) and sodium propylparahydroxybenzoate (E217). These ingredients may cause allergic reactions (possibly delayed).
Further information overleaf _|
|cj HOW TO GIVE THIS MEDICINE
Check the seal is not broken before first use. Shake thoroughly to mix the contents. Give this medicine using the measuring spoon provided. For oral use. Do not give to a child weighing less than 5kg:
|
Age |
Dose |
|
Children over 7 years: |
Two 5ml spoonfuls to be given 3 times a day. |
|
Children 4 to 7 years: |
One 5ml spoonful plus one 2.5ml spoonful (7.5ml) to be given 3 times a day |
|
Children 1 to 4 years: |
One 5ml spoonful to be given 3 times a day. |
|
Infants 6 months to 1 year: |
One 2.5ml spoonful to be given 3-4 times a day. |
|
If your child's symptoms persist for more than 3 days, or if new symptoms occur, talk to your doctor. | |
|
Babies 3 to 6 months: |
One 2.5ml spoonful to be given 3 times a day. |
|
Do not give to babies aged 3 to 6 months for more than 24 hours. | |
|
Doses should usually be given every 6-8 hours, preferably with or after food. Do not give more often than every 4 hours. Do not exceed 4 doses in any 24 hour period. | |
|
Do not give to children under 3 months except for post-immunisation fever: one 2.5ml spoonful may be given followed by one further 2.5ml spoonful 6 hours later if necessary. No more than 2 doses should be given in 24 hours. If fever is not reduced, talk to your doctor. | |
|
For short-term use only. DO NOT EXCEED THE STATED DOSE | |
If your child takes too much medicine: Talk to a doctor straight away or go to your nearest hospital casualty department. Take the carton, this leaflet and any remaining medicine with you.
[] POSSIBLE SIDE EFFECTS
Most people take Children's Ibuprofen 100mg/5ml Oral Suspension without any problems, but it can have side effects, like all medicines. To reduce the chance of side effects, especially in the elderly, use the lowest effective dose for the shortest possible time.
STOP GIVING the medicine and contact your doctor immediately if your child develops any of the following symptoms at any time while taking this medicine: Allergic reactions:
The following reactions may mean you are having an allergic reaction to this medicine:
• asthma, worsening of asthma, unexplained wheezing or shortness of breath
• swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse
• also, there may be skin reaction (including hives, rash and itching) - very rarely these can be severe with blistering and peeling skin
Stomach and bowel problems including:
• stomach discomfort or pain, nausea, indigestion or
|_ heartburn, stomach ulcer _ _ _
t
• stomach bleeding which can result in vomit with blood or dark particles (like coffee grounds), black tarry stools or blood passed in your stools
• worsening of bowel problems (ulcerative colitis or Crohn's disease)
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion Heart and circulation effects: Medicines such as Children's Ibuprofen 100mg/5ml Oral Suspension may be associated with a small increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke.
Other side effects that may occur include:
Other stomach and intestine effects including:
• diarrhoea, flatulence, constipation and vomiting.
Liver problems that might be indicated by yellowing of the skin and eyes (jaundice) and/or pale coloured stools and dark urine
Kidney problems that might be indicated by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs) - very rarely kidney failure Nervous system problems including headache and aseptic meningitis (which can have symptoms such as severe headache, stiff neck, disorientation, fever and eye sensitivity to light in those with existing auto-immune disorders such as lupus).
Reporting of side effects
If you or your child 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
FI STORING THE MEDICINE
Do not use after the expiry date shown on the pack. Do not store above 25°C. Store in the original container. Keep all medicines out of the reach and sight of children.
Q FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Ibuprofen 100mg/5ml The other ingredients are: Sodium Methylparahydroxybenzoate (E219), Sodium Propylparahydroxybenzoate (E217), Citric Acid Anhydrous, Saccharin Sodium, Sodium Benzoate, (E211), Dispersible Cellulose, Juicy Orange Flavour, Polysorbate 80, Liguid Maltitol (E965), Xanthan Gum, Purified Water
What this medicine looks like and contents of the pack: Children's Ibuprofen 100mg/5ml Oral Suspension is a white opague smooth suspension available in a bottle containing 150ml or 200ml of suspension. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Galpharm Healthcare Ltd, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom. Manufacturer: Galpharm International Limited,
Elmhirst Park, Middle Field Road, Barnsley,
South Yorkshire, S75 4LS, United Kingdom.
Text revised: August 2013. 0000000000 4004275 _j