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TESCO CHILDRENS IBUPROFEN 100MG/5ML ORAL SUSPENSION

Active substance(s): IBUPROFEN

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Transcript
3.
HOW TO GIVE IBUPROFEN
Shake the bottle well before measuring the dose. A double-ended measuring spoon is provided to ensure
accuracy. The small spoon measures a 2.5 ml dose and the larger spoon measures 5 ml.

PATIENT INFORMATION LEAFLET
IBUPROFEN 100 mg/5 ml Oral Suspension
Ibuprofen 100 mg/5 ml
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to give Ibuprofen Oral Suspension to your
child carefully to get the best results from it.
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 if your child’s symptoms worsen or do not improve after a few days.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1.
What Ibuprofen is and what it is used for
2.
What you need to know before you give Ibuprofen
3.
How to give Ibuprofen
4.
Possible side effects
5.
How to store Ibuprofen
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN IS AND WHAT IT IS USED FOR
Ibuprofen 100 mg/5 ml Oral Suspension (“Ibuprofen”) contains ibuprofen as the active ingredient. This belongs to
a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is given to children as
a pain reliever for relief of mild to moderate muscular pain, headache, earache, sore throat, dental pain and
backache. This medicine can also be used in minor injuries such as sprains and strains. It also reduces
temperature in fever (e.g. post-immunisation fever), as well as other symptoms of cold and influenza.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE IBUPROFEN
Do NOT give this medicine if your child:

has an allergy or hypersensitivity to ibuprofen or any of the other ingredients in this medicine (see Section
6 and end of Section 2: Important information about ingredients).

has had an allergic reaction or wheezing after taking aspirin or other non-steroidal anti-inflammatory
painkillers. (Symptoms of a rare allergic reaction are given under Section 4: Possible side effects).

has ever had a stomach ulcer or a history of bleeding into, or perforation of, the intestine especially after
previous NSAID treatment

is taking any other non-steroidal anti-inflammatory painkillers (NSAIDs)

has ever had severe kidney, heart or liver problems

has an inherited intolerance of some sugars

is less than 3 months old
If any of these apply, ask for advice from a doctor or pharmacist before giving this medicine.
Warnings and Precautions
There is a risk of renal (kidney) impairment in dehydrated children.
You should discuss your child’s treatment with your doctor or pharmacist before giving Ibuprofen 100mg/5ml Oral
Suspension if your child:

has high blood pressure, kidney or liver problems

has asthma or diabetes

has lupus or mixed connective tissue disease

has a chronic inflammatory intestinal disease such as ulcerative colitis or Crohn’s disease or
gastrointestinal bleeding

has chicken pox
Other medicines and Ibuprofen 100mg/5ml Oral Suspension
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including
medicines obtained without a prescription. Ibuprofen 100mg/5ml Oral Suspension may affect or be affected by
some medicines. For example:
• Diuretics (drugs to help you pass water)
• Medicines that are anticoagulants (i.e.thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid,
warfarin, ticlopidine)
• Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• Lithium or Selective serotonin reuptake inhibitors (SSRI’s e.g. Fluoxetine) (used to treat mood
disorders)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)
• Zidovudine (used to treat HIV)
• Corticosteroids (anti-inflammatory drugs, such as Hydrocortisone)
• Cardiac glycosides (drugs used in the treatment of heart problems, such as Digoxin)
• Ciclosporin or Tacrolimus (used to supress the body’s immune system)
• Mifepristone (used to terminate a pregnancy)
• Quinolone antibiotics (used to treat a wide range of infections e.g. Ciprofloxacin)
• any other Ibuprofen preparations, including those you can buy without a prescription.
Some other medicines may also affect or be affected by the treatment of Ibuprofen 100mg/5ml. You should
therefore always seek the advice of your child’s doctor or pharmacist before you give Ibuprofen 100 mg/5ml Oral
Suspension with other medicines.
This product is intended for children aged between 3 months and 12 years. If you are an adult taking this
product; The above warnings and information apply, and in addition the following also applies:

Do NOT take this product if you are taking aspirin at doses above 75 mg daily. If you are on low dose
aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take this product.

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 or feet due to narrow or blocked
arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack (‘TIA’).

if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or
stroke, or if you are a smoker

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of
heart attack (’myocardial infarction’) or stroke, particularly when used at high doses. Do not exceed the
recommended dose or duration of treatment.

Do not take if you are in the last three months of pregnancy.
Speak to your doctor or pharmacist before taking if;

you are in the first six months of pregnancy

you are elderly

you are trying to get pregnant. Ibuprofen belongs to a group of medicines which may impair fertility in
women. This 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.
Pregnancy and breast-feeding
Ibuprofen should NOT be taken in the last 3 months of pregnancy, as it may be harmful to the unborn child.
Pregnant women intending to use this product should seek medical advice before use as it should only be taken
on doctor’s advice during the first 6 months of pregnancy.
Important information about some of the ingredients of this medicine

Maltitol (E965), may have a mild laxative effect (a 5 ml dose contains 1.335 g of maltitol). If your child
has an intolerance to some sugars, contact your doctor before giving this medicine.

Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217), may cause
allergic reactions (possibly delayed).
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This medicine should NOT be given if your child weighs less than 5 kg. The usual daily dose in children is 20 mg
per kg of bodyweight in divided doses, every 6 to 8 hours if required. Leave at least 4 hours between doses.
For short term use only. Consult a doctor promptly if symptoms persist or worsen.
WARNING: DO NOT EXCEED THE STATED DOSE
DOSAGE: Children (A spoon is provided to measure doses of 2.5 ml or 5 ml)
3 - 6 months (weighing over 5 kg)
2.5 ml 3 times a day
Do not give for more than 24 hours.
6 months – 1 year
2.5 ml 3 to 4 times a day
Do not give to children aged 6
1 year – 4 years
5 ml 3 times a day
months and older for more than
4 years – 7 years
7.5 ml 3 times a day
3 days.
7 years – 12 years
10 ml 3 times a day
Do not give to babies under 3 months
For infants 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 and in adolescents this medicinal product is required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
Post-immunisation fever: One small spoonful (2.5 ml), followed by another small spoonful (2.5 ml) 6 hours later
if necessary. No more than 2 doses should be given in 24 hours. If fever is not reduced, consult a doctor.
If you forget to give this medicine
If you forget to give a dose, give it as soon as you remember, unless it is almost time for the next dose. Never
give a double dose to make up for the missed dose.
If you give more medicine than you should
If your child or someone else accidentally takes a lot more than the stated dose (an overdose), you should contact
a doctor immediately, or go to the nearest hospital casualty department, and take the bottle with you if you can.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Ibuprofen can cause side-effects although not everybody gets them.
You should STOP giving Ibuprofen and seek advice from your doctor if your child experiences a very rare
allergic reaction, including skin rashes, increased sensitivity to light, swelling of the face and tongue,
inflammation of the blood vessels, fever or shock. Skin and mucous membrane reactions may also occur.
The most common side-effect is irritation of the stomach which can cause problems in some patients.
If your child suffers from the following, stop giving the medicine and seek immediate medical help:

Passing blood in their faeces (stools/motions)

Passing 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, racing of the heart or fluid retention e.g. swollen
ankles, not passing enough urine

stiff neck, headache, nausea, vomiting, fever and disorientation.
If your child experiences any of the following, stop giving the medicine and tell your doctor:

If your child’s skin starts to turn red or they develop a varied skin reaction or their skin starts to blister or
peel, this is very rare

Unexplained stomach pain, indigestion, heartburn, feeling sick and/or vomiting

Yellowing of the eyes and/or skin

Severe sore throat with high fever or unexplained bleeding, bruising and tiredness.
Other unusual effects may include:
Uncommon:

Headache.
Rare:

Ibuprofen 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

Flatulence, diarrhoea or constipation.
Very Rare:

Occasionally hypersensitivity reactions may occur which can cause skin rashes

Liver and kidney problems may occur with Ibuprofen

Crohn's disease or ulcerative colitis or other stomach problems may be exacerbated.
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.
HOW TO STORE IBUPROFEN
Keep this medicine out of the sight and reach of children. Do not use after the expiry date shown on the bottle.
Do not store above 25°C.
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Ibuprofen contains:
The active ingredient is ibuprofen 100 mg per 5 ml
The other ingredients are: glycerol (E422), xanthan gum, maltitol (E965), polysorbate 80, saccharin sodium
(E954), citric acid monohydrate, sodium methyl hydroxybenzoate (E219), sodium propyl hydroxybenzoate (E217),
purified water and strawberry flavour.
What Ibuprofen looks like and contents of the pack:
Ibuprofen is a sugar free, colour-free and strawberry flavoured oral suspension.
This medicine comes in amber glass bottles or polyethylene bottles of: 50 ml, 100 ml, 150 ml or 200 ml with a
child-resistant closure.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL Number: 04917/0044
This leaflet was prepared in October 2015

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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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