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Care Ibuprofen for Children Oral Suspension

(Ibuprofen 100mg/5ml)

Important information about Ibuprofen for Children

•    This medicine reduces fever and relieves mild to moderate pain in infants and children between 6 months and 12 years old.

•    Follow the dosage instructions carefully. Children of different ages need different amounts. See section 3.

Do not give....

•    For longer than 3 days.

•    To infants under 6 months old.

•    To anyone who is allergic to the ingredients. See section 6.

•    To anyone who is allergic to aspirin.

Talk to your doctor....

•    If your child is taking or is allergic to any other painkiller.

•    If your child has asthma.

Now read the rest of the leaflet before you use this medicine. It includes other information which might be especially important for you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need any more information or advice.

•    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.

1.    What the medicine is for

This medicine contains Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAIDs).

It has pain relieving and anti-inflammatory properties and also acts to bring down high temperature.

The medicine reduces fever including high temperature caused by vaccinations.

It also relieves mild to moderate pain such as headache, sore throat, teething pains and toothache, cold and flu symptoms, minor aches and sprains.

2.    Before you use this medicine

Warning

Anti-inflammatory/pain-killer medicines like Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly when used at high doses and/or prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 days). If your child has heart problems, previous stroke or you think that they might be at risk of these conditions (for example have high blood pressure, diabetes or high cholesterol) you should discuss their treatment with your doctor or pharmacist.

There is a risk of renal impairment in dehydrated children.

Do not use the medicine if your child has....

•    An allergy to any of the ingredients listed in section 6.

>    An allergy to aspirin.

>    A history of breathing problems, runny nose or rashes particularly after taking aspirin or other anti-inflammatory medicines.

« A stomach ulcer or a history of stomach ulcers.

« Stomach bleeding or perforation, related to previous NSAIDs treatment.

>    Severe heart, kidney or liver failure.

>    Or the child is under 6 months old.

•    Do not give this medicine with any other NSAID painkillers or aspirin with a daily dose above 75mg.

A Talk to your doctor or pharmacist if your child has....

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

• Kidney or liver problems, as a lower dose than normal may be needed.

• A history of asthma, allergies, high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke.

• Lupus, an allergic condition which causes joint pain, skin rashes and fever.

• Bowel problems, colitis or Crohn's disease.

A Talk to your doctor or pharmacist if your child is taking....

• Aspirin or any other anti-inflammatory medicines as the risk of side effects may be increased if used with Ibuprofen.

• Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine). • Some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan).

• Diuretics which help remove fluids from the body. • Antibiotics for infection.

• Steroids for inflammation.

• SSRIs for depression.

• Cardiac glycosides for heart problems.

• Methotrexate, for cancer treatment.

• Ciclosporin or tacrolimus to prevent transplant rejection.

• Mifepristone for termination of pregnancy.

• Zidovudine for the treatment of HIV and AIDS. • Lithium for manic depression.

Some other medicines may also affect or be affected by the treatment of Ibuprofen for Children. You should therefore always seek the advice of your doctor or pharmacist before /ou give/use Ibuprofen for Children with other medicines.

A Can adults take this medicine?

This product is intended for children aged between 6 months and 12 years.

If vou are an adult taking this product vou should be aware of all the factors and the following information:

• Do not take if you are in the last three months of pregnancy.

Falk to your doctor or pharmacist before taking f:

•    You are in the first six months of pregnancy.

•    You are trying to get pregnant.

•    You are elderly.

•    You are a smoker.

buprofen may impair fertility if used when :rying to become pregnant. This effect is 'eversed when you stop taking the medicine.

buprofen appears in breast milk in small amounts, but such small amounts are unlikely :o affect breast-fed infants.

Driving and using machines....

This medicine may rarely cause dizziness and aeadaches. If you are affected do not drive or operate machinery.

A Important information about some of the ingredients

• This medicine contains maltitol and sorbitol.

If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicine.

• It also contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).

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3. How to use this medicine

•    Shake the bottle before each use.

•    Give this medicine to your child by mouth with or after food.

•    Use the spoon provided to measure 2.5ml or 5ml.

Children from 8 -12 years

Two 5ml spoonfuls three or four times a day.

Children from 3 - 7 years

One 5ml spoonful three or four times a day.

Children from 1 - 2 years

One 2.5ml spoonful three or four times a day.

Infants from 6-12 months

One 2.5ml spoonful three times a day.

□ Children under 6 months

Do not give to children under 6 months unless your doctor tells you to.

O For fever following vaccination

•    One 2.5ml spoonful. Repeat after 6 hours if necessary.

•    Do not give more than 2 doses in 24 hours.

•    If the high temperature is not reduced see your doctor.

DO NOT EXCEED THE STATED DOSE.

If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

If you give too much

If you accidentally give too much, see a doctor straight away. Take the pack with you to show which medicine your child has swallowed.

If you forget a dose

Give the next dose as soon as you remember. Do not give a double dose. You can then carry on with the normal dose at the correct time.

4. Possible side effects

Like all medicines, Ibuprofen for Children can have side effects, although these don't affect everyone.

Important side effects

If you think your child has any of the following serious side effects or symptoms, STOP TAKING this medicine immediately and see a doctor as soon as possible.

•    Fast heart beat.

•    Low blood pressure (causing light headedness).

•    Severe shock.

•    Unexplained wheezing or shortness of breath

•    Allergic reactions including rashes or itching, bruising, blistering or peeling and swelling of the face, lips, tongue, throat or difficulty in swallowing.

•    Blood in the faeces (stools/motions).

•    Pass black tarry stools.

•    Vomit any blood or dark particles that look like coffee grounds.

Other possible side effects

•    Feeling sick.

•    Indigestion or heartburn.

•    Stomach pain or other stomach problems.

•    Worsening of the symptoms of asthma, inflammation of the colon and crohn's disease.

•    General swelling.

•    High blood pressure.

•    Heart failure.

Rarely

•    Fleadache.

•    Dizziness.

•    Flearing disturbance.

•    Diarrhoea.

•    Wind.

•    Constipation.

•    Being sick.

Very Rarely

•    Stomach ulcers, bleeding or swelling of the stomach lining.

•    Meningitis.

•    Kidney damage (look for passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling particularly of the legs).

•    Liver problems (look for yellowing of the skin and eyes, pale stools/motions and dark urine).

•    Blood cell disorders whose symptoms include fever, sore throat, mouth ulcers, flulike symptoms, severe exhaustion, unexplained bleeding, bruising ora purple skin rash.

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

If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

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.    Storing this medicine

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25°C.

•    Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.

•    Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of any unused medicine. These measures will help to protect the environment.

6.    Further information

What is in the medicine

The active ingredient per5ml is: ibuprofen 10Omg

The other ingredients are:

sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate, citric acid anhydrous, saccharin sodium, sodium benzoate (E211), dispersible cellulose, juicy orange flavour, polysorbate 80 (E433), maltitol liquid (which contains maltitol and sorbitol), xanthan gum (E415) and purified water.

What the medicine looks like

Ibuprofen for Children is a white cloudy suspension.

It is supplied in 100ml bottles.

Marketing authorisation holder and manufacturer

Thornton and Ross Ltd., Huddersfield,

HD7 5QH, UK.

This leaflet was last revised in February 2016

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