NOT MARKETED

100 mg/5 ml Oral Suspension

■    This medicine brings down high temperature (also called fever) and relieves pain such as muscular pain, headache, earache, dental pain, backache and symptoms of cold and flu.

■    The medicine is OK for most babies over 3 months, children and adults.

■    The active ingredient in this medicine is Ibuprofen which is a non-steroidal anti-inflammatory (NSAID) painkiller.

■    Follow the dosage instructions carefully. Children of different ages need different amounts. These are shown

in the table. See section 3 C

■    Speak to your doctor if anything in this list applies:

■    If a child suffers from any of the conditions mentioned in section 2. See section 2 C

■    If a child is taking aspirin at doses of above 75 mg a day.

See section 2 c

■    If a child is taking any other medicines. See section 2 C

■    If a child is not getting better, or needs more medicine than shown in the table. See section 3 C

■    If a child gets a rash, breathing problems, diarrhoea or gets very tired. See section 3 c

■    If the symptoms persist or worsen. See section 3 C

■    Do not use this product and speak to your doctor if you are trying to get pregnant, suspect you are pregnant, are pregnant or are breast-feeding. See section 2 c

Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

1 What the medicine is for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory painkillers (NSAIDs).

The Ibuprofen in Calprofen 100 mg/ 5 ml Oral Suspension is used as an analgesic for relief of mild to moderate muscular pain, symptomatic relief of headache, earache, dental pain, backache and relieves the symptoms of cold and flu.

It can also be used in minor injuries such as sprains and strains. Calprofen 100 mg/ 5 ml Oral Suspension also brings down a high temperature including post-immunisation fever.

2 Before giving the medicine to your child

This product is suitable for most people but a few people should not use it. If you are in any doubt you should contact your doctor or pharmacist.

x Do not give your child this medicine...

■    If s/he has had a bad reaction (e.g. asthma, runny nose, swelling of face, tongue and throat, rash) after taking Ibuprofen, any of the other ingredients (see section 6), aspirin or non-steroidal anti-inflammatory (NSAIDs) painkillers.

■    If s/he weighs less than 5 kg.

■    If s/he is taking any other anti-inflammatory painkillers (NSAIDs) or aspirin with a daily dose above 75 mg.

■    If s/he has (or has had two or more episodes of) a stomach ulcer, perforation or bleeding.

■    If s/he has severe kidney, heart or liver failure.

If any of these apply, get advice from a doctor or pharmacist without using Calprofen.

Talk to your doctor or pharmacist.

■    If your child has or has previously had high blood pressure, heart problems or a stroke because there is a small increased risk of heart problems with Ibuprofen.

■    If your child has any conditions which may put them at risk of heart problems e.g. suffers from diabetes, has high cholesterol.

■    If your child has asthma or allergic diseases of the lungs.

■    If your child has or has previously had liver, kidney, heart or bowel problems, or is dehydrated.

■    If your child suffers from lupus (SLE) or a similar disease.

■    If your child suffers from a chronic inflammatory bowel disease such as Crohn's disease or ulcerative colitis.

■    If your child is taking any other medicines including:

■    low-dose aspirin (up to 75 mg a day)

■    diuretics (drugs to help you pass water e.g. bendroflumethiazide)

■    anticoagulants (drugs that thin the blood, such as warfarin)

■    antihypertensives (drugs used to treat high blood pressure, such as verapamil or propranolol)

lithium (used to treat mood disorders)

■    methotrexate (used to treat arthritis, some types of cancer and psoriasis)

■    zidovudine (used to treat HIV)

corticosteroids (a type of anti-inflammatory drugs, e.g. hydrocortisone)

■    cardiac glycosides (drugs used in the treatment of heart failure and arrhythmias (abnormal heart rhythm e.g. digoxin).

■    ciclosporin (used to suppress the body’s immune system e.g. following a transplant).

■    mifepristone (used for termination of pregnancy).

■    quinolone antibiotics (used to treat a wide range of infections e.g. ciprofloxacin).

■    SSRI antidepressants (e.g. fluoxetine).

■    antiplatelet drugs (e.g. clopidogrel).

■    tacrolimus (a transplant drug).

■    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, show the bottle or pack to your pharmacist.

If any of these bullet points apply, talk to a doctor or pharmacist.

HL If adults take this medicine:

The above warnings and information apply and in addition the following:

■    Ibuprofen belongs to a group of medicines which may impair fertility in women. The 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.

■    You should only take this product on a doctor's advice during the first 6 months of pregnancy.

■    Do NOT take Calprofen if you are in the last 3 months of pregnancy due to potential harm to the unborn child.

■    Speak to your doctor or pharmacist before using this product if you are elderly or are a smoker.

Some of the ingredients can cause problems

■    Sodium methylhydroxybenzoate (E219) and sodium propylhydroxybenzoate (E217) may cause allergic reactions which could possibly be delayed.

■    This product contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

■    Maltitol may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol.

3 How to use this medicine

Check the information below to see how much medicine to use.

■    Always shake the bottle thoroughly before use.

■    Do not use more medicine than shown in the instructions below.

■    Do not overfill the spoon.

There is a double ended measuring spoon in the pack, which is to be used to measure doses of 2.5 ml and 5 ml.

turn over C

Hj^ Babies under 3 months

Do not give to babies under 3 months. Consult your doctor.

$ Children from 3 months to 12 years For Pain and Fever Relief:

■ Doses should usually be given every 6 - 8 hours. Leave at

least 4 hours between doses.

■    Short term use only:

-    Do not give to babies from 3 months to under 6 months for more than 24 hours.

-    Do not give to children aged 6 months or over for more than 3 days.

■    If symptoms persist or worsen consult your doctor.

For Post-Immunisation Fever:

If necessary, the second dose should be given 6 hours after the first one.

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

■    Do not give to a child under 3 months unless recommended by your doctor.

■    If the fever is not reduced you should consult your doctor.

Speak to your doctor

■ If your baby needs more than the dose shown in the table, or if the fever doesn't go away, speak to your doctor as soon as possible.

■    If you are not sure of your child's illness or it is accompanied by a rash, breathing difficulties, diarrhoea or excessive tiredness or lethargy, speak to your doctor straight away.

Do not give Calprofen until you get medical advice.

riL If anyone has taken too much

If anyone has taken too much of this product, contact a doctor or

your nearest Accident and Emergency Department (Casualty),

taking this leaflet and pack with you.

If you forget to give the medicine

If you forget a dose, give the next dose when needed,

provided that the last dose was taken at least 4 hours ago.

Do not take a double dose.

4 Possible side-effects

Calprofen 100 mg/5 ml Oral Suspension can have side-effects, like all medicines, although these don’t affect everyone and are usually mild. The most common side-effect is irritation of the stomach which can cause problems (e.g. indigestion, heartburn) in some patients.

If your child experiences any of the following, stop giving the medicine and seek immediate medical help:

■    blood in the faeces (stools/motions).

■    black tarry stools.

■    vomiting blood or dark particles that look like ground coffee.

■    unexplained wheezing, shortness of breath, skin rash (which may be severe and include blistering or peeling of the skin), itching or bruising, lightheadedness or racing heart or fluid retention e.g. swollen ankles or decreased levels of urine passed.

■    stiff neck, headache, nausea, vomiting, fever and disorientation.

If your child experiences any of the following, stop giving this medicine and tell your doctor:

■    unexplained stomach pain, indigestion, heartburn, feeling sick and/or vomiting.

■    yellowing of the eyes and/or skin, which may be a sign of liver problems.

■    severe sore throat with high fever.

■    unexplained bruising, bleeding or tiredness or getting more infections (such as colds) than usual.

Other effects which may occur are listed below:

Uncommon:

■    Headache.

Rare:

■    Diarrhoea, wind or constipation. If any of these become troublesome or last more than a few days, tell your doctor.

Very rare:

■    Kidney problems may occur with Ibuprofen.

■    Stroke or heart problems may occur with Ibuprofen but this is very unlikely at the doses given to children.

■    Worsening of colitis and Crohn's disease.

Other effects reported include:

■    High blood pressure.

If your child experiences any side-effects not included in this leaflet or you are not sure about anything, talk to your doctor or pharmacist.

5    Storing this medicine

Do not take your medicine after the expiry date shown on the bottle.

Do not store above 25°C.

Keep all medicines out of the reach and sight of children.

6    Further Information

What’s in this medicine?

The active ingredient is: Ibuprofen 100 mg per 5 ml.

Other ingredients are: Glycerol (E422), xanthan gum, maltitol (E965), polysorbate 80, saccharin sodium (E954), citric acid monohydrate, sodium methylhydroxybenzoate (E219), sodium propylhydroxybenzoate (E217), purified water. The flavouring is strawberry.

What the medicine looks like

Calprofen 100 mg/5 ml Oral Suspension is awhitish liquid, available in 100 ml and 200 ml bottles, not all packs may be marketed. It contains 100 mg ofthe active ingredient Ibuprofen in every 5 ml of medicine. The Product Licence holder is McNeil Products Ltd,

Maidenhead, Berkshire, SL6 3UG, UK.

The manufacturer is Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

This leaflet was revised December 2013.

For further information please contact: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Calprofen is a registered trade mark.

13-0142

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