Pack Copy Specification	Ibuprofen Oral Suspension Sachets - Leaflet
Marketing Authorisation number	PL 12063/0061

Paramed Ibuprofen for Children 100 mg/5 ml Oral Suspension Sachets Patient Information Leaflet

Read this leaflet carefully because it contains important information for you.

■    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

1.    WHAT THIS MEDICINE IS FOR

This medicine contains ibuprofen, which belongs to a group of medicines called Non-Steroidal AntiInflammatory 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 3 months

■    Mild to moderate pain including headache, sore throat, teething pain and toothache, cold and flu symptoms and minor aches and sprains.

2.    BEFORE YOU GIVE THIS MEDICINE

Do not give this medicine 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 aspirin with a daily dose above 75mg

■    are under 3 months or weigh less than 5 kg.

Talk to your doctor or pharmacist before giving this medicine 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 previously had, or are at risk of heart problems, high blood pressure or stroke. Medicines such as 'Ibuprofen for Children 100 mg/5 ml Oral Suspension Sachets' 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 your child has heart problems, previous stroke or think that you might be at risk of these conditions (for example if you or your child have high blood pressure, diabetes or high cholesterol) you should discuss your child's treatment with your doctor or pharmacist.

If your child is taking other medicines

Pack Copy Specification	Ibuprofen Oral Suspension Sachets - Leaflet
Marketing Authorisation number	PL 12063/0061

You must not give this medicine if they are taking certain other medicines - see section 2 'Do not give this medicine 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 as an anti-platelet agent medicine (i.e. 75mg or below daily) as taking ibuprofen may reduce the effect of the aspirin or cause stomach problems

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

■    two or more NSAID painkillers, including cyclooxygenase-2 selective inhibitors

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

■    antidepressants (e.g. fluoxetine)

■    corticosteroids (for skin problems and allergies e.g. cortisol)

■    methotrexate (a medicine for cancer)

■    cardiac glycosides (medicines used to treat heart failure e.g. digoxin)

■    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)

■    quinolone antibiotics (medicines used to treat bacterial infections e.g. ciprofloxacin).

There is a risk of renal impairment in dehydrated children.

Some other medicines may also affect or be affected by the treatment of Paramed Ibuprofen for Children 100 mg/5 ml Oral Suspension Sachets. You should therefore always seek the advice of your doctor or pharmacist before you use Paramed Ibuprofen for Children 100 mg/5 ml Oral Suspension Sachets with other medicines.

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.

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 Paramed Ibuprofen for Children 100 mg/5 ml Oral Suspension Sachets 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, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Pregnancy and Breast feeding

Do not take 'Ibuprofen for Children 100 mg/5 ml Oral Suspension Sachets' if you are in the last 3 months of pregnancy. Talk to your doctor before taking this medicine if you are in the first 6 months of pregnancy or are breastfeeding.

This ibuprofen suspension belongs to a group of medicines, which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally, will affect

Pack Copy Specification	Ibuprofen Oral Suspension Sachets - Leaflet
Marketing Authorisation number	PL 12063/0061

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 liquid 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 2g of liquid maltitol (equivalent to 4.7 kcal per 5ml of the medicine).

3. HOW TO GIVE THE MEDICINE

Massage the sachet to mix the contents. Give this medicine using the measuring spoon provided. For oral use. Do not give to a child weighing less than 5g:

Age	Dose
Children 7 to 12 years:	Two 5ml spoonfuls to be given 3 times a day.
Children 4 to 7 years:	One 7.5 ml (5 ml + 2.5 ml spoonfuls) to be given 3 times a day.
Children 1 to 4 years:	One 5 ml spoonful to be given 3 times a day.
Infants 6 months to 1 year:	One 2.5 ml spoonful to be given 3 to 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. Do not give to babies aged
under 3 months.
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.
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.
This medicine is intended for short-term use only. Please use it for the shortest time needed to relieve symptoms. Always use the lowest dose that relieves your symptoms. DO NOT EXCEED THE STATED DOSE

Talk to a doctor or pharmacist if your child's symptoms do not get better or get worse, or if new symptoms occur.

For children aged 3 - 5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist.

If in children aged from 6 months this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

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.

4. POSSIBLE SIDE EFFECTS

Most people take this medicine 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 your child is having an allergic reaction to this medicine:

Pack Copy Specification	Ibuprofen Oral Suspension Sachets - Leaflet
Marketing Authorisation number	PL 12063/0061

■    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 or perforation, mouth ulcers

■    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 ibuprofen 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 those listed below.

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).

If your child experiences any of these symptoms, or there are any other unusual symptoms or if you have concerns with you medicine, stop giving the medicine and see your doctor.

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 THE MEDICINE

Do not use after the expiry date shown on the pack.

Do not store above 25^oC. Store in the original container. Keep all medicines out of the reach and sight of children.

6.    FURTHER INFORMATION

What is in this medicine:

The active ingredient is: Ibuprofen 100mg/5ml

Pack Copy Specification	Ibuprofen Oral Suspension Sachets - Leaflet
Marketing Authorisation number	PL 12063/0061

The other ingredients are: Maltitol Liquid, Glycerol, Xanthan Gum, Sodium Benzoate, Sodium Cyclamate, Citric Acid, Orange Flavour, Acesulfame Potassium, Polysorbate 80, Disodium Edetate, Purified Water.

What this medicine looks like and contents of the pack:

This medicine is a white opaque smooth suspension available in sachets containing a 5ml dose which are packed into cartons containing 8 or 16 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, United Kingdom.

Date of revision: 11/2015

PL 12063/0061