Ibuprofen 200mg/5ml Oral Suspension
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Ibuprofen 200 mg/5 ml Oral Suspension
Read all of this leaflet carefully before you start taking/giving this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ibuprofen 200 mg/5 ml Oral Suspension is and what it is used for
2. What you need to know before you give/take Ibuprofen 200 mg/5 ml Oral Suspension
3. How to give/take Ibuprofen 200 mg/5 ml Oral Suspension
4. Possible side effects
5. How to store Ibuprofen 200 mg/5 ml Oral Suspension
6. Contents of the pack and other information
1
What Ibuprofen 200mg/5ml Oral Suspension is and what it is used for
Ibuprofen 200 mg/5 ml Oral Suspension contains Ibuprofen as the active ingredient. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen 200 mg/5 ml Oral Suspension is given to children under 12 as a painkiller for relief of mild to moderate muscular pain, headache, teething pain and toothache. It also reduces the temperature in fever (e.g. colds, influenza and post-immunisation fever). For adults and children over 12 it can also be used for backache, migraines, neuralgia and relief from non-serious arthritic conditions.
2
What you need to know before you give/take Ibuprofen 200 mg/5 ml Oral Suspension
Do NOT give/take Ibuprofen 200 mg/5 ml Oral Suspension if you or your child:
• has an allergy or hypersensitivity to Ibuprofen or any of the other ingredients in this medicine (see Section 6 and Section 2: Important information about ingredients)
• has had an allergic reaction or wheezing e.g. an asthma attack, runny nose, skin reaction or swelling after taking aspirin or other non-steroidal anti-inflammatory painkillers
• has ever had a stomach ulcer or a history of bleeding into, or perforation of, the intestine especially after previous NSAID treatment
• is taking any other non-steroidal anti-inflammatory pain killers (NSAIDs)
• has ever had severe kidney, heart or liver problems
• is suffering from dehydration as there is a risk of renal impairment
• has an inherited intolerance to some sugars
• is less than 3 months old, except on the advice of a doctor
• suffers from a blood disorder
• are in the last three months of pregnancy
• are trying to conceive.
Warnings and precautions
Take special care and check with your doctor or pharmacist before taking this medicine if you are elderly or your child suffers from:
• high blood pressure, heart problems or a stroke because there is a small increased risk of heart
problems and stroke with ibuprofen
• kidney, liver or bowel problems
• lupus (SLE) or a mixed connective tissue disease
• a chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease
• asthma or allergic diseases of the lungs
• has chicken-pox
• has a disorder of porphyrin metabolism
Speak to your doctor or pharmacist before taking if you are trying to get pregnant. Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine, it is unlikely that ibuprofen, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
If any of these apply, ask for advice from a doctor or pharmacist before using this medicine.
Medicines such as Ibuprofen 200 mg/5 ml Oral Suspension may be associated with a small increased 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. If you have heart problems, previous stroke or if you think you or your child might be at risk of these conditions (for example if you or your child have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss the treatment with your doctor or pharmacist.
Drinking alcohol while taking Ibuprofen may increase your risk of certain side effects.
There is a risk of renal impairment in dehydrated children and adolescents.
Other medicines and Ibuprofen 200 mg/5 ml Oral Suspension
Tell your doctor or pharmacist if you or your child are taking, has recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you or your child are taking any of the following:
• Low-dose aspirin (up to 75 mg a day)
• Diuretics (drugs to help you pass water)
• Anticoagulants e.g. Warfarin and Heparin and Anti-platelet drugs such as Clopidogrel and Ticlopidine (drugs that thin the blood)
• Antihypertensives (drugs used to treat high blood pressure e.g. Captopril or Propranolol)
• Lithium, Phenytoin or Selective serotonin reuptake inhibitors (SSRI’s e.g. Fluoxetine -used to treat mood disorders)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)
• Zidovudine (used to treat HIV)
• Corticosteroids (anti-inflammatory drugs, such as prednisone)
• Cardiac glycosides (drugs used in the treatment of heart problems, such as Digoxin)
• Ciclosporin or Tacrolimus (used to suppress the body’s immune system)
• Quinolone antibiotics (used to treat a wide range of infections e.g. Ciprofloxacin)
• Probenecid and sulfinpyrazone (used to treat gout)
• Moclobemide (used to treat depression)
• Aminoglycosides (an antibiotic)
• Cholestyramine (used to reduce cholesterol)
• Baclofen (used to relax muscles)
• Sulphonylureas (used to treat diabetes)
• Ritonavir (used to treat HIV infection and AIDS)
• Bisphosphonates (used to prevent loss of bone mass)
• Oxpentifylline (used to treat poor circulation to arms and legs)
• Any other Ibuprofen preparations or NSAID painkillers, including those you can buy
without a prescription.
If you are not sure about any of the medicines your child is taking, ask your pharmacist for advice.
Pregnancy and breast-feeding
Ibuprofen should NOT be taken during the last 3 months of pregnancy, as it may be harmful to the unborn child. Pregnant women intending to use this product should seek medical advice before use as it should only be taken on doctor's advice during the first 6 months of pregnancy.
Only small amounts of ibuprofen and its break down products pass into breast milk. As no harmful effects to infants are known to date, it is not usually necessary to stop breast-feeding during shortterm use of ibuprofen at the recommended doses.
Ibuprofen 200 mg/5 ml Oral Suspension contains Maltitol (E965)
- Maltitol (E965) may have a mild laxative effect (caloric value 2.3 kcal/g). If you have been told that you or your child have an intolerance to some sugars, contact your doctor before taking/giving this medicine.
3. How to give/take Ibuprofen 200 mg/5 ml Oral Suspension
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Shake the bottle well before measuring the dose. A measuring device is provided to ensure accuracy.
If in children aged from 6 months and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. For infants aged 3 - 5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist.
This medicine should NOT be given if your child weighs less than 5 kg. The usual daily dose in children is 20 - 30 mg per kg of bodyweight in divided doses. Leave at least 4 hours between doses. For oral and short term use only.
WARNING: DO NOT EXCEED THE STATED DOSE
|
Babies under 3 months |
Do not give except on the advice of a doctor |
|
3-6 months (weighing more than 5 kg) |
1.25 ml dose (50 mg) taken up to 3 times in 24 hours |
|
6 - 12 months (weighing 8-10 kg) |
1.25 ml dose (50 mg) taken up to 3 to 4 times in 24 hours |
|
1 - 4 years (weighing 10-15 kg) |
2.5 ml dose (100 mg) taken up to 3 times in 24 hours |
|
4 - 7 years (weighing 15-20 kg) |
3.75 ml dose (150 mg) taken up to 3 times in 24 hours |
|
7 - 12 years (weighing 20-40 kg) |
5 ml dose (200 mg) taken up to 3 times in 24 hours |
|
Over 12 years |
5 ml to 10ml dose (200 mg - 400 mg) taken 3 times in 24 hours. Do not give more than 30 mls (1200 mg) in any 24 hours. |
Post-immunisation fever: One 1.25 ml, followed by another 1.25 ml six hours later if necessary. Not more than 2 doses should be given in 24 hours. If fever is not reduced, consult a doctor.
If you forget to give/take Ibuprofen 200 mg/5 ml Oral Suspension
If you forget to give/take a dose, give/take it as soon as you remember, unless it is almost time for the next dose. Never give a double dose to make up for the missed dose.
If you give/take more Ibuprofen 200 mg/5 ml Oral Suspension than you should
If you or your child takes a lot more than the stated dose (an overdose), you should contact a doctor immediately, or go to the nearest hospital casualty department, and take the bottle with you if you can.
4. Possible side effects
Like all medicines, this medicine can cause side-effects, although not everybody gets them. The most common side-effect is irritation of the stomach which can cause problems in some patients.
If any of the following occur, stop giving/taking the medicine and seek immediate medical help:
• Passing blood in the stools (faeces/motions)
• Passing black tarry stools
• Vomiting blood or dark particles that look like coffee grounds
• Unexplained wheezing, shortness of breath, skin rash (which may be severe and include blister or peeling of the skin), itching or bruising, light-headedness, racing of the heart or fluid retention e.g. swollen ankles, not passing enough water
• Stiff neck, headache, nausea, vomiting, fever and disorientation
• Swelling of the face
If any of the following occur, stop giving/taking the medicine and tell your doctor:
• If you or your child’s skin start to turn red or they develop a varied skin reaction or their skin starts to blister or peel, this is very rare.
• Unexplained stomach pain, indigestion, heartburn, feeling sick and/or vomiting
• Yellowing of the eyes and/or skin
• Severe sore throat with high fever or unexplained bleeding, bruising and tiredness
Other unusual effects may include the following:
Uncommon:
• Headache, dizziness, sleeplessness, agitation, irritability or tiredness
• Visual disturbances Rare:
• Flatulence, diarrhoea or constipation
• Ringing in the ears (tinnitus)
• Kidney damage, increased blood uric acid levels Very Rare:
• Occasionally hypersensitivity reactions may occur which can cause skin rashes as well as asthma attacks, swelling of the tongue and breathlessness
• Liver problems may occur with Ibuprofen
• Passing less urine than normal, increased proteins in the blood (detected by tests)
• Crohn’s disease or ulcerative colitis or other stomach problems may be exacerbated
• Ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment.
• Depression or psychotic reactions
• Hair loss
• High blood pressure.
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 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.
5. How to store Ibuprofen 200 mg/5 ml Oral Suspension
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the bottle. The expiry date refers to the last day of that month. Do not store above 25 °C. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ibuprofen 200 mg/5 ml Oral Suspension contains The active ingredient is Ibuprofen 200 mg per 5 ml.
The other ingredients are: Glycerol (E422), Xanthan Gum, Maltitol (E965), Polysorbate 80, Saccharin Sodium (E954), Citric Acid Monohydrate, Sodium benzoate (E211), Magnesium Aluminium Silicate, Purified Water and Strawberry Flavour (contains Propylene glycol).
What Ibuprofen 200 mg/5 ml Oral Suspension looks like and contents of the pack
Ibuprofen 200 mg/5 ml Oral Suspension is a colour-free, white oral suspension.
This medicine comes in amber glass bottles containing: 60 ml, 80ml 100 ml, 150 ml or 200 ml, with a child-resistant closure. Not all pack sizes may be marketed. A double ended spoon with measures of 1.25ml, 2.5ml and 5ml is provided. This medicine should be used within 3 months of first opening.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd,
Ballymacarbry,
Clonmel,
Co. Tipperary, Ireland.
This medicinal product is authorised in the Member States of the EEA under the following names:
FI: Burana 40mg/ml Oraalisuspenio
LT: IbuViva Forte 200mg/5ml geriamoji suspensija
PL Number: PL 04917/0100
This leaflet was last revised in June 2014
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