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CALPROFEN 100MG/ 5 ML ORAL SUSPENSION

Active substance(s): IBUPROFEN

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Leaflet-0379

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.

Main body text

(PIL’s only)

6.5 pts
210 x 148 mm

A print out of this image should not be used for exact colour matching but to check if the layout,
spelling, text and colour references are correct. Please check thoroughly.





Pinewood

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

Manufacturer

3 How to use this medicine

09/01/2014

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.

UK



Some of the ingredients can cause problems



Date




Country




Pil 100ml



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).

Calprofen

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.

Talk to your doctor or pharmacist…



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.

Description

1 What the medicine is for

!

!

Product

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



13-0142

100 mg/5 ml Oral Suspension

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.

SIZE:



Cutter

Do not give your child this medicine…

Version

X

Black

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.

Job Bag No.

®

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.

Magenta

2 Before giving the
medicine to your child

COLOURS:

NOT MARKETED

turn over c

Pg. 1

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.
 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



Leaflet-0379

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 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.

What the medicine looks like
Calprofen 100 mg/5 ml Oral Suspension is a whitish liquid, available in
100 ml and 200 ml bottles, not all packs may be marketed. It contains
100 mg of the 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.

6.5 pts
210 x 148 mm

Cutter

A print out of this image should not be used for exact colour matching but to check if the layout,
spelling, text and colour references are correct. Please check thoroughly.

Dose

Babies and children
3 months and over
weighing over 5 kg

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.

Pinewood

Age

What’s in this medicine?

Manufacturer

For Post-Immunisation Fever:

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.

(PIL’s only)

6 Further Information






Main body text

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

SIZE:

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.

09/01/2014

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.

5 Storing this medicine

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.

Date



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.

Pil 100ml

8 years - 12 years

Other effects reported include:



UK

3 years - 7 years

4 Possible side-effects



Country

1 year - 2 years

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.

Calprofen

6 months - 1 year

If you forget to give the medicine

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.

Description

One small 2.5 ml spoonful
3 times a day. Do not use for more
than 24 hours
One small 2.5 ml spoonful
3 times a day
One small 2.5 ml spoonful
3 or 4 times a day
One large 5 ml spoonful
3 or 4 times a day
Two large 5 ml spoonfuls
3 or 4 times a day

Very rare:




Product

3 months - 6 months
weighing over 5 kg

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.

Black

Dose

If anyone has taken too much

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

Magenta

Age

!

Headache.

Rare:



13-0142

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

Uncommon:



1

i

Other effects which may occur are listed below:

Version

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

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.

Job Bag No.



Babies under 3 months

COLOURS:

i

13-0142

Pg. 2

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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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