Calprofen contains Ibuprofen which is an analgesic used for: the 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 he used in minor injuries such as sprains and strains. Calprofen also brings down a high temperature including post-immunisation fever.

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

Calprofen Oral Suspension is:

• for children from 3 months to 12 years
• colour and sugar free
• strawberry flavour

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Calprofen Oral Suspension Directions:

• Always read the full information in your own product
• Do not give to babies under 3 months unless recommended by your doctor

Calprofen Dosage for children from 3 months to 12 years:

For Pain and Fever Relief:

3 months - 6 months - weighing over 5 kg

• One small 2.5 ml spoonful 3 times a day
• Do not use for more than 24 hours

6 months - 1 year

• One small 2.5 ml spoonful
• 3 times a day

1 year - 2 years

• One small 2.5 ml spoonful
• 3 or 4 times a day

3 years - 7 years

• One large 5 ml spoonful
• 3 or 4 times a day

8 years - 12 years

• Two large 5 ml spoonful
• 3 or 4 times a day

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 aged 3 - 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:

• Babies and Children 3 months and over - weighing over 5 kg
• One small 2.5 ml spoonful up to twice a day
• If necessary, the second dose should be given 6 hours after the first one
• Do not give more than 2 doses in 24 hours
• If the fever is not reduced you should consult your doctor

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

Speak to your doctor as soon as possible if:

• your baby needs more than the dose recommended in your own leaflet
• the fever doesn't go away
• you are not sure of your child's illness or it is accompanied by a rash, breathing difficulties, diarrhoea, or excessive tiredness or lethargy. Do not give Calprofen until you get medical advice

If anyone has taken too much Calprofen: Contact a doctor or your nearest Accident and Emergency Department (Casualty), taking your leaflet and pack with you.

If you forget to give the medicine: Give the next dose when needed, provided that the last dose was taken at least 4 hours ago. Do not give a double dose.

Calprofen Oral Suspension contains the active ingredient: 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.

Before giving the Calprofen 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.

Do not give your child Calprofen if s/he:

• has ever had a bad reaction (e.g. asthma, runny nose, swelling of face, tongue and throat, rash) after taking Ibuprofen, any of the other ingredients, aspirin or non-steroidal anti-inflammatory (NSAID) painkillers.
• weighs less than 5kg
• is taking any other anti-inflammatory painkillers (NSAIDs) or aspirin with a daily dose above 75mg
• has (or has had two or more episodes of) a stomach ulcer, perforation or bleeding.
• 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.
• has any conditions which may put them at risk of heart problems e.g. suffers from diabetes, has high cholesterol.
• has asthma or allergic diseases of the lungs
• has or has previously had liver, kidney, heart or bowel problems.
• suffers from lupus (SLE) or a similar disease
• suffers from a chronic inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• is taking any other medicines including:
  • low-dose aspirin (up to 75 mg a day)
  • diuretics (drugs to help you pass water eg. 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 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 dugs (e.g. clopidogrel)
  • tacrolimus (a transplant drug)
  • any other ibuprofen preparations or NSAID painkillers, including those you can buy without a perception

If you are not sure about any of the medicines your child is taking, show your bottle or pack to your pharmacist

If any of these bullet point apply talk to a doctor or pharmacist

If adults take Calprofen: 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 doctors 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 in Calprofen 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.

Possible side-effects: Calprofen 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 (eg. 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 or heart 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 Calprofen and tell your doctor:

• unexplained stomach pains, indigestion, heartburn, feeling sick and/or vomiting.
• yellowing of the eyes and/or skin, which may be a sign of liver problems.
• severe sore threat with high fever
• unexplained bruising 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 your own leaflet or you are not sure about anything, talk to your doctor or pharmacist.