Ibuprofen 100 Mg/ 5 Ml Oral Suspension
Out of date information, search anotherThe name of your medicine is Ibuprofen 100mg/5ml Oral Suspension, but will be referred to as Ibuprofen suspension throughout the rest of this document
Read all of this leafet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ibuprofen suspension is and what it is used for
2. Before you take Ibuprofen suspension
3. How you take Ibuprofen suspension
4. Possible side effects
5. How to store Ibuprofen suspension
6. Further information
1. WHAT IBUPROFEN SUSPENSION IS AND WHAT IT IS USED FOR
Ibuprofen oral suspension contains 100 mg of the active ingredient ibuprofen in 5 ml.
Ibuprofen belongs to a group of drugs called non-steroidal anti-infammatory drugs (also known as NSAIDs), which relieve pain and reduce inflammation. Ibuprofen suspension is used to treat conditions affecting the joints and muscles such as swollen joints, frozen shoulder, low back pain, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis (inflammation of the spine), osteoarthritis and other disorders of the muscles, bones, and tendons.
Ibuprofen suspension can also be used:
- in soft tissue injuries such as sprains and strains
- to relieve mild to moderate pain in dysmenorrhoea (period pain), dental pain and pain after an operation
- to relieve mild to moderate pain due to headache; including migraine headache.
- Ibuprofen suspension can be used for the short-term treatment of pyrexia (fever) in children over one year of age.
2. BEFORE YOU TAKE IBUPROFEN SUSPENSION
Do not take Ibuprofen Suspension if you:
- are allergic (hypersensitive) to ibuprofen or any of the other ingredients in Ibuprofen suspension (see
list of ingredients in Section 6). An allergic reaction may include skin rash, itching, diffculty breathing or swelling of the face, lips, throat or tongue
- have had attacks of asthma, or an allergic reaction such as urticaria (nettle rash), angioedema (swelling of the face and throat) or rhinitis (inflammation of the lining of the nose) when you have taken aspirin, ibuprofen or any other NSAIDs (non-steroidal anti-inflammatory drugs)
- suffer from or have previously had stomach ulcers or stomach bleeding
- have suffered chronic indigestion
- have had severe heart failure, kidney failure or liver failure
- are in your last trimester of pregnancy.
Take special care with Ibuprofen suspension (and talk to your doctor) if you:
- are taking any other pain killers, NSAIDs or aspirin
- are taking steroids, SSRIs (medicines used to treat depression, anxiety or personality disorders),suffer from systemic lupus erythematosus or mixed connective tissue disease (a condition which causes joint pain, skin rashes and fever)
- suffer from asthma or have ever had asthma
- have had a disease of the digestive tract - you should report any digestive symptoms, (especially if you are elderly) particularly blood in your stools or vomit. If you develop an ulcer or have bleeding, you should stop treatment
- have had hypertension (high blood pressure) or heart failure
- have heart disease, peripheral arterial disease (a disease of the blood vessels), or cerebrovascular disease (a disease of the blood vessels in the brain)
- are at risk of heart disease because you have high blood pressure, high lipid levels, diabetes, or you smoke
- are trying to become pregnant
- have a kidney, heart or liver disorder.
Please note
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
♦ Pass blood in your faeces (stools/motions)
♦ Pass black tarry stools
♦ Vomit any blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience:
♦ Indigestion or heartburn
♦Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
Ibuprofen 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 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 you develop any skin reactions you should stop taking this medicine and contact your doctor immediately (see section 4 Possible side effects).
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including medicines obtained without a prescription. This is particularly true of the following as they may interact with
your Ibuprofen suspension.
- other painkillers (including aspirin)
- corticosteroids (drugs that reduce inflammation such as hydrocortisone)
- anticoagulants (blood thinners)
- cardiac glycosides (treatments for heart failure such as digoxin)
- lithium (a treatment for mental illness)
- methotrexate (used for rheumatoid arthritis and cancer)
- diuretics (water tablets)
- antihypertensives (drugs that reduce blood pressure)
- mifepristone (a drug used for abortion)
- quinolones (a type of antibiotic)
- ciclosporin and tacrolimus (a treatment to prevent rejection after a transplant)
- anti-platelet agents (used for circulatory problems and to prevent blood clots)
-SSRIs (selective serotonin reuptake inhibitors - antidepressants for anxiety and personality disorders)
-zidovudine (anti-viral treatment for HIV)
Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlopidine), some medicines that reduce high blood pressure (ACE-inhibitors such as catopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan), and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you take ibuprofen with other medicines.
It may still be all right for you to be given Ibuprofen suspension and your doctor will be able to decide what is suitable for you.
Taking Ibuprofen suspension with food and drink
Ibuprofen suspension should be taken by mouth, preferably with or after food.
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Pregnancy and breast-feeding
Do not take Ibuprofen oral suspension during your last trimester of pregnancy. You should not take Ibuprofen suspension while pregnant or breast-feeding unless your doctor has advised you to do so. Ask your doctor or pharmacist for advice before taking any medicine.
Ibuprofen suspension may make it more difficult for you to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Driving and using machines
Ibuprofen may cause dizziness, sleepiness, visual disturbances or headaches. If you have any of these symptoms, do not drive or operate machinery.
Important information about some of the ingredients of Ibuprofen Suspension
- Sodium methyl (E219) and sodium propyl (E217) parahydroxybenzoate may cause allergic reactions which could possibly be delayed.
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- This medicine contains 0.48 mmol of sodium per 5 ml. To be taken into consideration by patients on a controlled sodium diet.
3. HOW YOU TAKE IBUPROFEN SUSPENSION
Dosage
Always take Ibuprofen suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Take with or after food.
Adults
-The usual dose for adults is 1200 mg to 1800 mg daily in 3 or 4 divided doses, The maximum dose is 2400 mg per day.
Children
-Not recommended for children weighing less than 7 kg.
-The usual dose for children with fever or pain is 20 mg/kg of bodyweight in divided doses.
-Children 1-2 years: One 2.5 ml spoonful (50 mg) to be taken three to four times in 24 hours.
-Children 3- 7 years: One 5 ml spoonful (100 mg) to be taken three to four times in 24 hours.
-Children 8-12 years: Two 5 ml spoonfuls (200 mg) three to four times in 24 hours.
-For juvenile rheumatoid arthritis the usual daily dosage is 30-40 mg/kg/day in three to four divided doses.
If Ibuprofen suspension is being used to treat fever it should not be used long term and should not be given to children under one year of age.
Elderly
-The elderly are more susceptible to side effects from Ibuprofen so the lowest effective dose should be taken. -Elderly patients should be monitored regularly during the treatment to check that there is no bleeding in the stomach or gut.
If you take more Ibuprofen suspension than you should
If you, or a child you are giving this medicine to, have accidentally taken more than the stated dose, you must contact your doctor or local casualty department as soon as possible. Symptoms of an overdose include nausea (feeling sick), vomiting (being sick), stomach pains, stomach bleeding, diarrhea, headaches, drowsiness, dizziness, feeling excitable, disorientation, fainting, fits and coma. If you are asthmatic your condition may get worse.
If you forgot to take Ibuprofen suspension
If you have forgotten to take your medicine, take it as soon as you remember unless it is almost time for your next dose. Do not take a double-dose to make up for the one you missed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuprofen can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Stop taking ibuprofen and tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, skin peeling, skin rash or itching (especially affecting your whole body).
The following side effects have been reported:
Nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, constipation, flatulence (wind), inflammation and ulcers of the digestive tract stomach or gut rarely leading to bleeding and perforation, hypersensitivity (allergic) reactions such as asthma, worsening asthma, breathlessness, skin disorders including itchiness, nettle rash, bleeding into the skin, and swelling of the face and hands.
Occasionally bleeding of the stomach or intestines may occur (signs of this are blood in your vomit or passing black stools, indigestion or heartburn). If you notice any of these symptoms or if you notice an increased tendency to bleed or bruise easily stop taking the tablets and tell your doctor straight away.
Heart problems such as heart failure, high blood pressure, swelling and fluid retention.
Less commonly reported:
Serious skin conditions including peeling, blistering, red spots, and swelling, and sensitivity to light.
Ibuprofen can sometimes cause kidney damage, abnormal liver function, liver inflammation, and jaundice (yellow skin and eyes).
Visual disturbances, headaches, pins and needles, depression, confusion, hallucinations (seeing and hearing things that are not there), ringing in the ears, vertigo (spinning sensation), dizziness, weakness, tiredness, sleepiness and generally feeling unwell.
If you have systemic lupus erythematosus (your doctor would have told you if you have this), you may get side effects such as a stiff neck, headaches, nausea (feeling sick), vomiting (being sick), fever or disorientation.
Blood disorders include reduction in red and white blood cells and blood platelets.
Medicines such as Ibuprofen suspension may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
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 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 SUSPENSION
Keep this medicine out of the sight and reach of children Do not store above 25°C.
Keep container in the outer carton to protect from light.
Do not take this medicine after the expiry date shown on the label.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Ibuprofen suspension contains:
The active substance is Ibuprofen.
The other ingredients are: sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), xanthan gum, carboxymethylcellulose sodium, microcrystalline cellulose, liquid maltitol (E965), citric acid monohydrate, sodium citrate, sodium benzoate, saccharin sodium, Polysorbate 80, Natural Orange Flavour, Orange Sweet No 1 Flavour (which contains propylene glycol), and purified water.
What Ibuprofen suspension looks like and contents of the pack
Ibuprofen suspension is a white coloured, orange flavoured suspension.
An amber-coloured plastic bottle containing 500 ml Ibuprofen oral suspension sealed with a child resistant cap. Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom.
This leaflet was last revised in 09/2014.