Package leaflet: Information for the user Ibuprofen 100mg/5ml oral solution

Ibuprofen

Read all of this leaflet carefully before you start taking 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. Do not pass it on to others. It may harm them, even if their signs of illness 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 suspension is and what it is used for

2.    What you need to know before you take Ibuprofen suspension

3.    How to take Ibuprofen suspension

4.    Possible side effects

5.    How to store Ibuprofen suspension

6.    Contents of the pack and other 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-inflammatory 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.    What you need to know before you use Ibuprofen suspension

Do not take Ibuprofen suspension if you:

-    are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)

-    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 had severe heart failure, kidney failure or liver failure

-    have a condition which increase your tendency of bleeding

-    are in your last trimester of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofen suspension 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 that Crohn’s disease and ulcerative colitis- 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

-    are trying to become pregnant

-    there is a risk of kidney damage in dehydrated children and adolescents.

-    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.

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking this medicine if you:

-    have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).

-    have high blood pressure, diabetes or high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

If you develop any skin reactions you should stop taking this medicine and contact your doctor immediately (see section 4).

Other medicines and Ibuprofen Suspension Tell your doctor or pharmacist if you are taking, or have recently taken or might take 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)

-    antibiotics called quinolones such as ciprofloxacin

-    aminoglycosides (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)

-    cholestyramine (a drug used to lower cholesterol)

-    Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen)

-    medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)

-    voriconazole or fluconazole (anti-fungal drugs)

Ibuprofen suspension may affect or be affected by some other medicines. For example:

-    medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlopidine),

-    medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan),

Some other medicines may also affect or be affected by treatment with Ibuprofen suspension. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen suspension 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.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Ibuprofen 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.

Ibuprofen suspension contains liquid maltitol, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate and sodium

-    Sodium methyl and sodium propyl 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

Always take Ibuprofen suspension exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Ensure the bottle is thoroughly shaken before use. Take with or after food.

Adults

-    The recommended dose is 4 to 6 spoonfuls (5 ml) taken three times a day. Your doctor may choose to increase or decrease this depending on what you are being treated for. The maximum daily amount is 24 spoonfuls (2400 mg). Do not take more than this in one day.

Children

-    Not recommended for children weighing less than 7 kg.

-    The recommended dose 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 up to 40 mg/kg/day in 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 medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

-    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 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.

-    serious skin conditions including peeling, blistering, red spots, and swelling, and sensitivity to light.

-    ringing in the ears,

-    blood disorders include reduction in red and white blood cells and blood platelets. Signs may include: unexplained bruising or bleeding, sore throat, fever, mouth, ulcers, tiredness.

-    this medicine can sometimes cause kidney damage, abnormal liver function, liver inflammation, and jaundice (yellow skin and eyes).

Other side effects may include:

-    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,

-    burning sensation in the mouth or throat,

-    heart problems such as heart failure, high blood pressure, swelling and fluid retention.

Less commonly reported:

-    visual disturbances,

-    headaches,

-    pins and needles,

-    depression,

-    difficulty sleeping,

-    anxiety,

-    confusion,

-    hallucinations (seeing and hearing things that are not there),

-    hearing problems

-    vertigo (spinning sensation),

-    dizziness,

-    weakness,

-    tiredness,

-    sleepiness and generally feeling unwell.

Medicines such as Ibuprofen suspension may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Ibuprofen suspension has also been shown to sometimes worsen the symptoms of Crohn’s disease and ulcerative colitis. 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 use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. 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 suspension contains:

-    The active substance is ibuprofen. Per 5 ml of suspension contains 100 mg of 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 oral suspension.

An amber-coloured plastic bottle containing 500 ml Ibuprofen 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 05/2016.

Cipla