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IBUPROFEN 100 MG CHEWABLE CAPSULES SOFT

Active substance(s): IBUPROFEN

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PL 14338/0006

Ibuprofen 100 mg, chewable capsules, soft

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibuprofen 100 mg, chewable capsule, soft
Ibuprofen

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you or your child get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days (for children
aged 7 to 12 years and adolescents 12 to 18 years) or 10 days (for adults).

What is in this leaflet:
1. What Ibuprofen 100 mg, chewable capsule, soft is and what it is used for
2. What you need to know before you give or take Ibuprofen 100 mg, chewable capsule, soft
3. How to give/take Ibuprofen 100 mg, chewable capsule, soft
4. Possible side effects
5. How to store Ibuprofen 100 mg, chewable capsule, soft
6. Contents on the pack and other information

1.

What Ibuprofen 100 mg, chewable capsule, soft is and what it is used for

The active ingredient (which makes this medicine work) is ibuprofen which is a non-steroidal-antiinflammatory (NSAID) painkiller.
Ibuprofen 100 mg, chewable capsule, soft is for the symptomatic treatment of mild to moderate pain such
as headache, period pain, dental pain and fever and pain associated with the common cold.
You must talk to a doctor if you do not feel better or if you feel worse after 10 days (for adults). You must
talk to a doctor if your child does not feel better or if your child feels worse after 3 days (for children aged
7 to 12 years and adolescents 12 to 18 years).

2.

What you need to know before you give or take Ibuprofen 100 mg, chewable capsule, soft

Please read the following information.
Do not give/take this medicine if you or your child:
• are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• ever had a reaction (e.g. asthma, runny nose, rash, swelling of the face, tongue, lips or throat)
after taking ibuprofen, aspirin or other non steroidal anti-inflammatory (NSAID) medicines, or
any of the other ingredients in this medicine (see Section 6 and Section 2: Important information
about some of the ingredients)
• are under 7 years of age
• has (or had two or more episodes) of a stomach ulcer, perforation or bleeding
• has severe kidney, heart or liver failure
• are in the last three months of pregnancy

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There is a risk of renal impairment in dehydrated children (7 to 12 years) and adolescents (12 to 18 years).
Warnings and precautions .
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of
heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or
duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen 100 mg,
chewable capsule, soft if
• you or your child has heart problems including heart failure, angina (chest pain), or if you or your
child has had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs
of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or
transient ischaemic attack “TIA”).
• you or your child has high blood pressure, diabetes, high cholesterol, have a family history of
heart disease or stroke, or if you or your child is a smoker.
• you or your child has a condition which may put them at risk of heart problems, such as diabetes
or high cholesterol
• you or your child has asthma or any allergic disease of the lungs
• you or your child has, or has had liver, kidney or bowel problems
• you or your child has SLE (Systemic Lupus Erythematosus, a condition of the immune system
affecting connective tissue resulting in joint pain, skin changes and disorders of other organs) or a
mixed connective tissue disease
• you or your child has hereditary blood formation disorder (acute intermittent porphyria)
• you or your child suffers from serious skin reactions such as exfoliative dermatitis, StevensJohnson syndrome and toxic epidermal necrolysis. The use of Ibuprofen 100 mg, chewable
capsule, soft should be stopped immediately at the first appearance of skin rash, mucosal lesions,
or any other signs of allergic reaction.
• you or your child suffers from chronic inflammatory bowel disease such as Crohn's disease or
ulcerative colitis
• you or your child has just had major surgery
• during chicken pox (varicella) it is advisable to avoid use of Ibuprofen 100 mg, chewable capsule,
soft
If you are an adult taking this medicine
The warnings and information given in this section apply and in addition the following:
• ibuprofen belongs to a group of medicines which may impair fertility in women. This is
reversible on stopping the medicine. It is unlikely that this medicine, 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
• medicines such as Ibuprofen 100 mg, chewable capsule, soft 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. Do not exceed the recommended dose or duration of
treatment
• if you have heart problems, previous stroke or think that you might be at risk of these conditions
(for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist
• if you have a blood coagulation disorder or if you have another bleeding disorder you should
discuss your treatment with your doctor or pharmacist
Elderly patients
If you are elderly talk to your doctor before using this medicine, as you may be more likely to suffer from
side effects.
Other medicines and Ibuprofen 100 mg, chewable capsule, soft

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Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription. Especially if it regards one of the
following medicines:
o other medicines containing ibuprofen or other NSAIDs
o low dose aspirin (up to 75 mg a day)
o diuretics (to help you pass water)
o anticoagulants (i.e. thin blood/prevent clotting e.g. aspirin (acetylsalicylic acid), warfarin,
ticlopidine)
o medicines for high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol medicines, angiotensin-II receptor antagonists such as losartan)
o lithium (for mood disorders)
o phenytoin (antiepileptic)
o methotrexate (for psoriasis, arthritis and types of cancer)
o zidovudine (for HIV)
o corticosteroids (anti-inflammatory medicines, such as prednisone)
o cardiac glycosides (for heart problems)
o ciclosporin or tacrolimus (to prevent organ rejection after transplant)
o mifepristone (for termination of pregnancy)
o quinolone antibiotics (for infections)
o probenecid and sulfinpyrazone (used to treat gout)
o SSRI antidepressant medicines
o antiplatelet medicines (blood thinning medicines) e.g. dipyridamole, clopidogrel
o sulfonylurea medicines (to lower the blood glucose level).
Some other medicines may also affect or be affected by the treatment of Ibuprofen 100 mg, chewable
capsule, soft. You should therefore always seek the advice of your doctor or pharmacist before you use
Ibuprofen 100 mg, chewable capsule, soft with other medicines.
Seek the advice of your doctor or pharmacist if any of the above apply. If you are not sure what
types of medicines your child is taking, show the medicine to the doctor or pharmacist.
Ibuprofen 100 mg, chewable capsule, soft with food, drink and alcohol
Ibuprofen 100 mg, chewable capsule, soft may be taken on an empty stomach without water. However, a
small number of people might experience mild indigestion with this medicinal product. If you or your
child experience mild indigestion, it is recommended to take this medicine with food or milk, to avoid
gastrointestinal problems.
If you are an adult taking this medicine, please note that some side effects, such as those affecting the
gastrointestinal system can be more likely when alcohol is taken at the same time as Ibuprofen 100 mg,
chewable capsule, soft.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you become pregnant while taking Ibuprofen 100 mg, chewable capsule, soft. If you
are in the first six months of pregnancy talk to your doctor or a pharmacist before using Ibuprofen 100
mg, chewable capsule, soft.
If you are in the last three months of pregnancy do not use this medicine because it might cause problems
to the unborn child or complications during delivery.
Ibuprofen 100 mg, chewable capsule, soft passes into breast milk, but may be used during breast-feeding
at the recommended doses, for the shortest duration possible.
This product belongs to a group of medicines (NSAIDs) which might impair fertility in women. This
effect is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally, will
affect your chances of becoming pregnant however, talk to your doctor before using it if you have
problems becoming pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.

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Driving and using machines
Do not drive or use machines if you start to experience dizziness, drowsiness, vertigo or visual
disturbances.
Ibuprofen 100 mg, chewable capsule, soft contains glucose and sucrose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal
product

3.

How to give/take Ibuprofen 100 mg, chewable capsule, soft

Always take this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if
you are not sure.
Ibuprofen 100 mg, chewable capsule, soft is for oral use.
The capsules should be chewed and then swallowed. Capsules can be taken with or without liquid.
This medicine is for short term use only.
The minimum effective dose should be used for the shortest time necessary to relieve symptoms.
Use in children
Do not give Ibuprofen 100 mg, chewable capsule, soft to children under 7 years of age
The recommended dose is:
Age
Younger than 7 years
7 years – 9 years
10 years – 12 years
Over 12 years

Dose
Do not give to children under 7 years of age
Two capsules 3 times in 24 hours*
Three capsules 3 times in 24 hours*
Two to four capsules up to 3 times a day.
Do not take more than 12 capsules in 24 hours.

*Doses should be given approximately every 6 to 8 hours, (or with a minimum of 6 hours between each dose if
required)
Consult your doctor if sympoms persist or worsen for more than 10 days in adults. For children aged 7 years to 12
years and adolescents 12 to 18 years, contact a docter if symptoms persist or worsen after 3 days .

If you give/take more Ibuprofen 100 mg, chewable capsule, soft than you should
If you accidentally give or take more than the recommended dose of medicine, contact your doctor
straight away.
If you forget to give or take Ibuprofen 100 mg, chewable capsule, soft
If you forget a dose, give or take the next dose when needed, provided that the last dose was taken at least
4 hours ago. Do not give/take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you or your child experiences any of the following, stop taking this medicine and tell your doctor
immediately:

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Ibuprofen 100 mg, chewable capsules, soft

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blood in the stools (faeces/motions)
black tarry stools
vomiting blood or dark particles that look like coffee grounds
unexplained wheezing, shortness of breath, skin rash (which may be severe with blistering or
peeling of the skin), itching or bruising, light-headedness, racing heart, fluid retention (swollen
ankles or decreased levels of passing urine)
stiff neck, headache, nausea, vomiting, fever and disorientation
swelling of the face.

If you or your child experiences any of the following side effects, stop taking this medicine and tell
your doctor
• unexplained stomach pain, indigestion, heartburn, nausea or vomiting
• yellowing of the eyes and/or skin, pale stools and dark urine
• severe sore throat with high fever
• unexplained bruising or tiredness or getting more infections, such as colds, than normal.
The following frequencies are taken as a basis when evaluating side effects:
very common
common
uncommon
rare
very rare
not known

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than1 user in 10,000
cannot be estimated from the available data

Other side effects which may occur are:
Uncommon (affects 1 to 10 users in 1,000)
• headache
Rare (affects 1 to 10 users in 10,000)
• diarrhoea, wind, vomiting or constipation. Tell your doctor if these last for more than a few days
or become troublesome.
Very rare (affects less than 1 user in 100,000)
• kidney and liver problems
• stroke or heart problems. This is unlikely at the dose level given to children.
• worsening of inflammation of the large intestine (colitis) and chronic inflammatory bowel disease
(Crohn's disease)
• high blood pressure.
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, website:
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 100 mg, chewable capsule, soft

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the
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last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents on the pack and other information

What Ibuprofen 100 mg, chewable capsule, soft contains
The active substance is ibuprofen. Each chewable capsule contains 100 mg of ibuprofen
The other ingredients are: Gelatin, Purified water, Glucose liquid, Sucrose, Fumaric acid (E297),
Sucralose, Citric acid (E330), Acesulfame K (E950), Disodium edetate, Glycerin, Natural Orange
Flavour* and Opacode White NS-78-18011**
*The flavour contains: (R)-p-mentha-1,8-diene (d-limonene), Ethyl acetate and Alpha-Pinene
**The ink contains: Purified water, titanium dioxide (E171), propylene glycol, isopropyl alcohol,
HPMC 2910/hypromellose 3cP (E464)

-

What Ibuprofen 100 mg, chewable capsule, soft looks like and contents of the pack
Ibuprofen 100 mg, chewable capsule, soft is a light to dark yellow, square shaped chewable soft gelatin
capsule with a hashtag (#) in white ink.
Ibuprofen 100 mg, chewable capsule, soft is available in PVC/PE/PVdC/Al blisters.
Packs of 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Banner Pharmacaps Europe
De Posthoornstraat 7
5048 AS Tilburg
The Netherlands
Manufacturer
Patheon Softgels B.V.
De Posthoornstraat 7
5048 AS Tilburg
The Netherlands
This leaflet was last approved in 12/2015.

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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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