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IBUPROFEN 400 MG SOFT CAPSULES

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibuprofen 400 mg Soft Capsules
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
has told you.
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Keep this leaflet. You may need to read it again.

-

Ask your pharmacist if you need more information or advice.

-

If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

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You must talk to a doctor if you do not feel better or if you feel worse after 3 days in
adolescents, after 4 days for pain or 3 days for fever and migraine headaches in adults.

In this leaflet:
1.

What Ibuprofen 400 mg soft capsules are and what they are used for

2.

What you need to know before you take Ibuprofen 400 mg soft capsules

3.

How to take Ibuprofen 400 mg soft capsules

4.

Possible side effects

5.

How to store Ibuprofen 400 mg soft capsules

6.

Contents of the pack and other information

1. What Ibuprofen 400 mg soft capsules are and what they are used for
Ibuprofen 400 mg soft capsules contain ibuprofen which belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving pain and fever.
Ibuprofen 400mg soft capsules are indicated in adults and adolescents from 40 kg and above
(12 years of age and above) for the relief of mild to moderate pain such as headache, acute
migraine headaches with or without aura, muscular pain, period pain, feverishness and pain
associated with a common cold.
2. What you need to know before you take Ibuprofen 400 mg soft capsules
Do NOT take Ibuprofen 400 mg soft capsules if you:
o are allergic to ibuprofen or any of the other ingredients of this medicine (listed in
section 6)
o ever suffered shortness of breath, asthma, runny nose, swelling or itching rash after
you have used acetylsalicylic acid (aspirin) or other related painkillers (NSAIDs)
o have a history of stomach or intestinal bleeding or perforation related to previous
NSAID therapy
o have (or have had two or more episodes of) a stomach ulcer or bleeding of the
stomach

o suffer from a blood coagulation disorder or have another bleeding disorder
o suffer from severe liver, kidney or heart failure
o suffer from cerebrovascular bleeding or other active bleeding
o suffer from unclarified blood-formation disturbances e.g. thrombocytopenia
o suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid
intake)
o are in the last 3 months of pregnancy
Do NOT use Ibuprofen 400 mg soft capsules in adolescents under 40 kg body weight or in
children under 12 years.
This medicinal product contains soya lecithin. If you are allergic to peanuts or soya do not
use this medicinal product.
Warnings and precautions
Talk to a pharmacist or your doctor before taking this medicine if you:
o suffer from Systemic Lupus Erythematosus (SLE) - 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
o suffer from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson
syndrome or toxic epidermal necrolysis. These capsules should be stopped
immediately at the first appearance of skin rash, lesions, or any other signs of allergic
reactions
o have hereditary blood formation disorder (acute intermittent porphyria)
o have or have ever had bowel problems or disease (ulcerative colitis, Crohn's disease)
o have or have had asthma or allergic disease, as shortness of breath may occur
o suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an
increased risk of allergic reactions exists. The allergic reactions may show as asthma
attacks (so called analgesic asthma), Quincke’s oedema or rash with raised, itchy
bumps
o are elderly, as you may be more likely to suffer from side effects
o suffer from kidney or liver disease
o have just had major surgery
o have swelling (oedema), high blood pressure (hypertension) or heart disease
o are trying to become pregnant (ibuprofen belongs to a group of medicines, NSAIDs
that may impair fertility in women. The effect is reversible upon stopping the
medicine)
o are in the first 6 months of pregnancy
o are taking low dose aspirin (up to 75 mg/day)
o have chicken pox (varicella); it is advisable not to take these capsules.
Side effects can be reduced by using the lowest effective dose for the shortest period of time.
There is a risk of renal impairment in dehydrated adolescents.

Medicines such as Ibuprofen 400 mg soft capsules 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 (in adults 4 days for pain or 3 days for fever or migraine headaches and in
adolescents 3days). If you have heart problems, previous stroke or think you might be at risk
of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or
are a smoker) you should discuss your treatment with your doctor or pharmacist.
For prolonged use of Ibuprofen 400 mg soft capsules, regular checking of:


your liver values, kidney function and blood count is required.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation
is experienced or suspected, medical advice should be obtained and treatment should be
discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in
patients who have frequent or daily headaches despite (or because of) the regular use of
headache medications.
In general, the frequent use of painkillers can lead to lasting severe kidney problems. This
risk may be increased under physical strain associated with dehydration. Do not take this
medicine if you feel dehydrated.
Taking NSAIDs may mask the symptoms of an infection. Speak to your doctor if you feel
unwell.
Other medicines and Ibuprofen 400mg soft capsules
What should you avoid when you are taking this medicine?
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid/aspirin,
warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g.
captopril, betareceptor blocking medicines, angiotensin II antagonists), and even some other
medicines may affect or be affected by the treatment of ibuprofen. Therefore, always seek
the advice of doctor before you use ibuprofen with other medicines’.
The use of ibuprofen 400 mg capsule, soft with concomitant NSAIDs including
cyclooxygenase-2 selective inhibitors should be avoided
Avoid the use of this medicine if you are taking:
o other NSAID painkillers (including cyclooxygenase-2 selective inhibitors (COX-2
inhibitors)).
o aspirin above 75 mg daily.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription, especially any of the
following medicines:
o low-dose aspirin (up to 75 mg a day)
o diuretics (drug to help you pass water)
o anticoagulants e.g. warfarin and heparin and anti-platelet drugs such as clopidogrel
and ticlopidine (drugs that thin the blood)
o antihypertensives (drugs used to treat high blood pressure e.g. captopril or
propranolol)

o lithium, digoxin, phenytoin or selective serotonin reuptake inhibitors (SSRIs e.g.
fluoxetine - used to treat mood disorders)
o methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)
o zidovudine (used to treat HIV)
o corticosteroids (anti-inflammatory drugs, such as prednisone)
o cyclosporin or tacrolimus (used to suppress the body’s immune system)
o quinolone antibiotics (used to treat a wide range of infections e.g. ciprofloxacin)
o probenecid and sulfinpyrazole (used to treat gout)
o aminoglycosides (an antibiotic)
o cholestyramine (used to reduce cholesterol)
o sulphonylureas (used to treat diabetes)
o Any other ibuprofen preparations or NSAID painkillers, including those you can
buy without a prescription.
Ibuprofen 400 mg soft capsules with food and drink
Ibuprofen 400 mg soft capsules may be taken on an empty stomach. However, a small
number of people might experience mild indigestion with this medicine. If you experience
mild indigestion, it is recommended to take this medicine with food or milk to avoid
gastrointestinal (digestive) problems.
Some side effects, such as those affecting the digestive system can be more likely when
alcohol is taken at the same time as Ibuprofen 400 mg soft capsules.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant whilst taking Ibuprofen 400 mg soft capsules.
If you are in the first 6 months of pregnancy talk to your doctor or a pharmacist before taking
these capsules.
If you are in the last 3 months of pregnancy do NOT take this medicine because it might
cause problems to the unborn child or complications during delivery.
Ibuprofen passes into breast milk, but may be taken during breast-feeding at the
recommended doses, for the shortest time possible.
Ibuprofen 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, when
taken 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.
Driving and using machines
If you start to experience dizziness, drowsiness, vertigo or visual disturbances do not drive or
use machines.
Ibuprofen 400 mg soft capsules contain:
sorbitol - If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking these capsules.

3. How to take Ibuprofen 400 mg soft capsules
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not sure.
For oral use.
For short term use only.
Adolescents (age range: ≥ 12years to < 18 years):
If you feel worseor this medicinal product is required for more than 3 days, talk to your
doctor.
Adults:
If you feel worse-or you do not feel better after 4 days for pain or 3 days for fever and
migraine headaches talk to a doctor.
Adults and adolescents over 40 kg in weight (12 years and above):
One capsule (400 mg ibuprofen) up to 3 times a day, as required. Take only as much as you
need to relieve your symptoms and leave at least 6 hours between each dose. Swallow the
capsule with plenty of liquid. Do not chew.
Do NOT take more than 3 capsules (1200 mg ibuprofen) in any 24 hour period.
The minimum effective dose should be used for the shortest time necessary to relieve
symptoms.
If you feel worse-or you do not feel better after 4 days for pain or 3 days for fever and
migraine headaches talk to a doctor.
Elderly: take care, as you may be more likely to suffer from side effects.
Children: Ibuprofen 400 mg soft capsules are NOT to be given to adolescents under 40 kg
body weight or children under 12 years.
If you take more Ibuprofen 400 mg soft capsules than you should
If you accidentally take too many capsules, contact your doctor or hospital immediately. Take
the remaining capsules with you to show to the doctor.
The symptoms of an overdose include: nausea, stomach pain, vomiting containing blood or
brown grit (like ground coffee), diarrhoea, ringing in the ears, headache, dizziness,
drowsiness, confusion, disorientation and rarely, loss of consciousness.
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 suffer from any of the following at any time whilst taking these capsules STOP
TAKING the medicine and seek immediate medical help:
o blood in your faeces (stools/motions)
o black tarry stools
o vomit any blood or dark particles that look like coffee grounds

o unexplained wheezing, shortness of breath, skin rash (which may be severe and
include blistering or peeling of the skin), itching or bruising, light-headedness, racing
of the heart or fluid retention e.g. swollen ankles, not passing enough water
o aseptic meningitis with stiff neck, headache, nausea, vomiting, fever and
consciousness clouding. Patients with autoimmune disorders (lupus, mixed
connective-tissue disease) appear to be predisposed.
o problems in the blood cell production – first signs are: severe sore throat with high
fever or unexplained bleeding, bruising and tiredness, superficial mouth ulcers, flulike symptoms, severe exhaustion, nose and skin bleeding
o allergic reactions with hives and itching, as well as asthma attacks
o severe allergic reactions: swelling of face, tongue and throat, shortness of breath,
palpitations, severe shock.
STOP TAKING the medicine and tell your doctor if you experience:
o indigestion or heartburn
o abdominal pain (pains in your stomach) or other abnormal stomach symptoms
o yellowing of the eyes and/or skin.
The following are other side effects that may be experienced.
Common (may affect up to 1 in 10 people)


stomach complaints, such as indigestion, acid burn, stomach pain and nausea,
diarrhoea, vomiting (being sick), flatulence (wind) and constipation, slight blood
losses in stomach and/or bowel that may cause anaemia in exceptional cases.

Uncommon (may affect up to 1 in 100 people)


headache, dizziness, sleeplessness, agitation, irritability and tiredness



visual disturbances



various skin rashes.



Gastrointestinal ulcers, potentially with bleeding and perforation. Ulcerative
stomatitis, exacerbation of colitis and Crohn’s disease, gastritis.

Rare (may affect up to 1 in 1,000 people)


tinnitus (ringing in the ears)



pain in the sides and/or abdomen, blood in the urine and a fever may be signs of
damage to the kidneys. Raised urea concentration in the blood shown in blood test.

Very rare (may affect up to 1 in 10,000 people)


psychotic reactions, depression, nervousness



heart palpitations, heart failure, heart attack



high blood pressure



asthma, shortness of breath and wheezing



inflammation of the gullet (oesophagus), inflammation of the pancreas, lesions
(diaphragm-like strictures) in the bowel resulting in abdominal pain, nausea, vomiting
and constipation



passing less urine than normal, swelling (oedema) and cloudy urine (nephrotic
syndrome), inflammatory kidney disease (interstitial nephritis) that may lead to acute
kidney failure



anaemia, shown in a blood test.



Exacerbation of infection-related inflammations (e.g. necrotising fasciitis)



Damage to the liver, acute hepatitis



Severe forms of skin reactions including rash with redness and blistering, StevensJohnson syndrome and dead-tissue. Exceptionally, severe skin infection and soft
tissue complications during chicken pox (varicella) infections.

Medicines such as Ibuprofen 400 mg soft capsules may be associated, with a small increased
risk of heart attack (“myocardial infarction") or stroke.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects
not listed in this leaflet. You can also report side effects directly via the national reporting
system. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Ibuprofen 400 mg soft capsules
Keep this medicine out of the sight and reach of children.
Do not store above 30˚C.
Do not use Ibuprofen 400 mg soft capsules after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Ibuprofen 400 mg soft capsules contain
The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen
The other ingredients are: macrogol 600, potassium hydroxide, purified water
Capsule shell: gelatin, sorbitol liquid partially dehydrated (E420) (see end of Section 2 for
further information on sorbitol)
Processing Aids
Medium chain triglycerides, Lecithin.
Capsule printing: Purified water, Black iron oxide, Propylene glycol, Isopropyl alcohol,
HPMC 2910/hypromellose 6cP
What Ibuprofen 400 mg soft capsules look like and contents of the pack
Ibuprofen 400 mg soft capsules are clear oval transparent soft gelatin capsules available in
PVC/PE/PVdC/Al or PVC/PE/PVdC/Paper/PET/Al blisters of pack sizes: 4, 6, 10, 12, 15, 16,
20, 24, 30 and 50 capsules. Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
MA Holder:

McNeil Products Limited,
Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer:
Patheon Softgels B.V.
De Posthoornstraat 7, 5048 AS Tilburg, The Netherlands.
Or
Janssen-Cilag
Domaine de Maigremont, 27 100 Val-de-Reuil, France
Or
Johnson & Johnson Consumer NV/SA
Antwerpseweg 15-17, B-2340 Beerse
This leaflet was last revised in May 2016.

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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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