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CALPROFEN IBUPROFEN SUSPENSION

Active substance(s): IBUPROFEN

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If adults take this medicine:

Do not give your child 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 Ibuprofen 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.

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 (see section 6), aspirin or
non-steroidal anti-inflammatory (NSAID) 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®.


Ibuprofen
Suspension

Some of the ingredients can cause problems

Talk to your doctor or pharmacist…


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
■ 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
■ If a child is taking aspirin at doses of above 75 mg a day.
See section 2
■ If a child is taking any other medicines. See section 2
■ If a child is not getting better, or needs more medicine than shown in
the table. See section 3
■ If a child gets a rash, breathing problems, diarrhoea or gets very tired.
See section 3
■ If the symptoms persist or worsen. See section 3
■ 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
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® 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® 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.

Babies under 3 months

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.

Children from 3 months to 12 years

4 Possible side-effects

For Pain and Fever Relief:
Age
Dose
3 months - 6 months
2.5 ml 3 times a day.
■ weighing over 5 kg
Do not use for more than 24 hours
6 months - 1 year
2.5 ml 3 times a day
1 year - 2 years
2.5 ml 3 or 4 times a day
3 years - 7 years
5 ml 3 or 4 times a day
8 years - 12 years
10 ml (5 ml + 5 ml) 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 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:

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.

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.
The symptoms can include nausea, stomach pain, vomiting (may be
blood streaked), headache, ringing in the ears, confusion and shaky
eye movement. At high doses, drowsiness, chest pain, palpitations,
loss of consciousness, convulsions (mainly in children), weakness and
dizziness, blood in urine, cold body feeling, and breathing problems
have been reported.

Component: 17-0470
Version: 10
Dimension: 252 x 169 mm
Date: 21/02/2018
Job Bag No.

17-0470

Version

10

Product

Calprofen Ibuprofen Suspension

Description

PIL 200ml

Country

UK

Date

21/02/2018

Manufacturer McNeil Iberica
Software

Print ready PDF

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.
a severe skin reaction known as DRESS syndrome can occur.
Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes
and an increase of eosinophils (a type of white blood cell).

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


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.



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 (e.g. indigestion,
heartburn) in some patients.



Dose
2.5 ml up to twice a day




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 or tiredness or getting more infections (such as
colds) than usual.

Profile

SIZE (w) x (h):

252 X 169 mm







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.
This medicine contains 4.67 mg propylene glycol (E1520) in each
5 ml dose, which is equivalent to 0.93 mg/ml.
This medicinal product contains small amounts of ethanol (alcohol),
less than 100 mg per 5 ml dose.

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.
Always use the syringe supplied with the pack.

How to use the syringe





Hold the syringe in place and turn the bottle upside
down and gently pull down the plunger to either
2.5 ml or 5 ml as appropriate (see tables for the
correct dose).



Turn the bottle the right way up.
Remove the syringe by holding onto the bottle and
twisting out gently.






Shake the bottle for at least 10 seconds and remove
the cap.
There is a plug with a hole in the neck of the bottle.
Insert the end of the syringe in to the hole and ensure
it is secure.

Place the syringe inside the child’s mouth against the cheek and press the
plunger slowly to gently release the medicine.
After use, the plug should remain in the neck of the bottle. Wipe the plug
and neck clean and rinse the cap before replacing.
The syringe should be washed and dried after use.
It can be cleaned by hand or in a dishwasher.
turn over

5 Storing this medicine

Do not take your medicine after the expiry date shown on the bottle.
Do not store above 25°C.
Keep this medicine out of the sight and reach 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 (containing propylene glycol
(E1520) and ethanol).

What the medicine looks like
CALPROFEN® is a whitish liquid available in 200 ml bottles. It contains
100 mg of the active ingredient Ibuprofen in every 5 ml of medicine.
Product Licence holder: McNeil Products Ltd, Maidenhead,
Berkshire, SL6 3UG, UK.
The manufacturer is McNeil Iberica S.L.U., 28805 Madrid, Spain.
This leaflet was revised February 2018.
For further information please contact:
McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
CALPROFEN® is a registered trade mark.

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.
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 or search for MHRA Yellow Card in the Google
Play or Apple App Store.
By reporting side-effects you can help provide more information on the safety
of this medicine.


COLOURS:
PMS
2617





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

Age
Babies and children
3 months and over
■ weighing over 5 kg

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.

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17-0470
900269A

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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