IBUPROFEN 400 MG TABLETS

Active substance: IBUPROFEN

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IBUPROFEN 400MG PIL- P :IBUPROFEN 400MG PIL

6/18/13

11:02 AM

Page 1

PATIENT INFORMATION LEAFLET

IBUPROFEN 400MG TABLETS

Read all of this leaflet carefully before you start
taking this medicine.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist or nurse
has told you.
• 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 or nurse. 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.
In this leaflet:
1. What Ibuprofen is and what it is used for
2. What you need to know before you take
Ibuprofen
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information

1. What is Ibuprofen and what is it used for

• Ibuprofen belongs to the group of drugs termed

Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs).
• Ibuprofen Tablets can be used to treat painful
conditions such as rheumatic or muscular pain,
pain of non-serious arthritis, backache,
neuralgia, migraine, headache, dental pain,
dysmenorrhoea, feverishness, symptoms of
cold and flu.

2. What you need to know before you take
Ibuprofen
DO NOT TAKE Ibuprofen if you:

• are allergic to Ibuprofen or any other














ingredients of the product (these are listed in
Section 6), aspirin or other related painkillers
have or have had stomach ulcer, perforation
or bleeding
are taking more than 75mg of aspirin a day
suffer from severe liver, kidney or heart
failure
are in the last 3 months of pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before
taking these tablets if you are:
asthmatic or suffer from kidney, liver or
bowel problems
taking a low dose aspirin (up to 75mg daily)
suffering 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
trying to become pregnant- Ibuprofen belongs
to a group of medicines which may impair
fertility in women. This effect is reversible
upon 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 in becoming pregnant
in the first 6 months of pregnancy
told by your doctor that you have an
intolerance to some sugars

Medicines such as 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. Do not exceed the recommended dose
or duration of treatment (10 days) without
consulting your doctor or pharmacist.
If you have heart problems, previous stroke or
think that you may 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.
Other medicines and Ibuprofen
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, especially:
• anti-coagulants (i.e. thin blood/prevent
clotting e.g. aspirin/acetyl salicylic acid,
warfarin, ticlodipine)
• medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, betablockers such as atenolol, or angiotensin -II
receptor antagonists such as losartan)
• diuretics (water tablets)
• cardiac glycosides, such as digoxin, used to
treat heart conditions
• zidovudine (an anti-viral drug)
• steroids (used in the treatment of
inflammatory conditions)
• methotrexate (used to treat certain cancers)
• medicines known as immunosuppressants
such as ciclosporin and tacrolimus (used to
dampen down your immune response)
• medicines known as selective serotonin
reuptake inhibitors (SSRIs), used for the
treatment of depression
• antibiotics called quinolones such as
ciprofloxacin
• aminoglycosides (a type of antibiotic)
• mifepristone, lithium
• any other Ibuprofen preparations, such as
those you can buy without a prescription
• any other anti-inflammatory pain killer,
including aspirin
• cholestyramine (a drug used to lower
cholesterol)
• medicines known as sulphonylureas such as
glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (types of antifungal drugs)
• gingko biloba herbal medicine (there is a
chance you may bleed more easily if you are
taking this with Ibuprofen)

Driving and Using Machines
Ibuprofen may make you feel dizzy or drowsy. If
the tablets affect you in this way do not drive,
operate machinery or do anything that requires
you to be alert.
Pregnancy and breast-feeding
Ibuprofen belongs to a group of medicine which
may impair fertility in women. This effect is
reversible upon stopping the medicine. The use
of Ibuprofen whilst pregnant or breast feeding
should be avoided. Ibuprofen should not be used
in the last three months of pregnancy and should
only be taken in the first six months of
pregnancy on the advice of your doctor.
Ibuprofen Tablets contains sucrose
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine as it contains
sucrose.

IBUPROFEN 400MG PIL- P :IBUPROFEN 400MG PIL

3. How to take Ibuprofen

Always take Ibuprofen Tablets exactly as
described in this leaflet or as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist or nurse if you are not sure.
Adults, the elderly and children 12 years
and over: 1 tablet to be taken up to 3 times daily
with or after food. Do not take more than 3 tablets
in 24 hours. Leave at least 4 hours between each
dose.
Do not give to children under the age of 12
years.
This product is intended for short term use only.
You should take the lowest dose for the shortest
time necessary to relieve your symptoms. You
should not take these tablets for longer than 10
days unless your doctor tells you to. If symptoms
persist or worsen consult your doctor.
If you take more tablets than you should
If you take too many tablets, contact your doctor
or hospital immediately. Bring any remaining
tablets with you to show the doctor.
Symptoms of overdose: Include headache,
drowsiness, low blood pressure and sickness.
If you forget to take a dose
If you forget to take a dose, take as soon as you
remember, unless it is almost time for your next
dose. If it is, do not take the missed dose at all.
Never double up on a dose to make up for the
one you have missed.

4. Possible side effects

Like all medicines, your medicine can cause side
effects, although not everybody gets them. The
following side effects are very rare (less than 1 in
10,000 people) but if you experience any of the
effects then STOP TAKING this medicine
immediately and contact your doctor or
pharmacist.
• Severe allergic reactions: symptoms could
include faster heart rate, swelling of the face,
tongue and throat.
• Severe skin reactions (Steven’s JohnsonSyndrome, toxic epidermal necrolysis):
symptoms could include blistering of the
skin, mouth, eyes and genitals. Skin rash,
easy bruising or bleeding from the skin or
nose.
• Peptic ulceration or perforation: symptoms
could include severe abdominal pain,
indigestion, heartburn, feeling sick, vomiting
blood (or liquid with what looks like coffee
grounds), blood in the faeces (stools/
motions) or passing black tarry stools.
• Inflammation of the brain lining:
symptoms could include stiff neck, severe
headache, feeling or being sick, fever or
feeling disorientated.
• Worsening of asthma and wheezing or
difficulty in breathing.
• Fluid retention (e.g. swollen ankles),
yellowing of the eyes and/or skin.
• Blurred or disturbed vision or seeing/hearing
strange things.
If you experience any of the above mentioned side
effects then STOP TAKING this medicine
immediately and contact your doctor or
pharmacist.
Rare side effects (less than 1 in 1000):
• blood disorders, kidney problems, liver
problems may occur
Other side effects:
• headache, hallucinations, dizziness

6/18/13









11:02 AM

Page 2

tingling of hands and feet, ringing in the ears
depression, confusion, difficulty sleeping
anxiety, impaired hearing
diarrhoea, constipation, flatulence (wind)
unexpected sensitivity of the skin to the sun
tiredness, malaise, mood swings
swelling and irritation inside the nose

Ibuprofen has also been shown to sometimes
worsen the symptoms of Crohn’s disease or colitis.
Medicines such as Ibuprofen have been associated
with a small increased risk of heart attack
(myocardial infarction) or stroke.
If any of the side effects mentioned get serious or
if you notice any side effects not listed in this
leaflet, contact your doctor or pharmacist.

Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

5. How to store Ibuprofen

• This medicine should not be used after the

“expiry date” printed on the pack.

• Store in a cool and dry place protected from

light.

• Do not store above 30°C. Do not freeze.
• They should be kept in their original

packaging.

Keep all medicines out of the sight and reach of
children.
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 to protect the environment.

6. Contents of the pack and other
information

What Ibuprofen 400mg tablets contain

• The active substance (the ingredient that

makes the tablet work) is Ibuprofen. Each
tablet contains 400mg of Ibuprofen BP.
• The other ingredients are pregelatinised
starch, maize starch, povidone, sodium lauryl
sulphate, silicon dioxide, magnesium stearate,
sucrose, purified talc, titanium dioxide and
erythrosine aluminium lake (E127), bees wax
(white), carnauba wax.
What Ibuprofen tablets look like and
contents of the pack
• Ibuprofen 400mg are pink sugar coated
tablets.
• The pack sizes are “25, 50, 100 tablets in
plastic containers and 12, 16, 24, 48, 84 and
96 tablets in blister packs”. Not all pack sizes
may be marketed.

The Marketing Authorization Holder and
company responsible for manufacture:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex, UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433

To request a copy of this leaflet in large print or
audio format, please contact the licence holder at
the address (or telephone, fax) above.
PL 04556 / 0023
Reference: 00230513/01
Date leaflet last revised: May 2013

P

IBUPROFEN 400MG PIL-

POM :IBUPROFEN 400MG PIL

6/18/13

11:03 AM

Page 1

PATIENT INFORMATION LEAFLET

IBUPROFEN 400MG TABLETS

Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
In this leaflet:
1. What Ibuprofen is and what it is used for
2. What you need to know before you take
Ibuprofen
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information

1. What is Ibuprofen and what is it used for

• Ibuprofen belongs to the group of drugs termed
Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs).
• Ibuprofen tablets can be used to relieve pain and
inflammatory effects such as rheumatoid arthritis
(including juvenile rheumatoid arthritis or Still’s
disease), ankylosing spondylitis, osteoarthritis
and other non-rheumatoid arthropathies.
• Other conditions such as arthritis of the spine,
swollen joints, frozen shoulder, bursitis,
tendonitis, tenosynovitis, lower back pain, sprains
and strains.
• Ibuprofen Tablets can also be used to treat other
painful conditions such as dysmenorrhoea,
toothache, pain after operations, period pain and
headache, including migraine and neuralgia,
feverishness and the symptoms of cold and flu.

2. What you need to know before you take
Ibuprofen

DO NOT TAKE Ibuprofen if you:
• are allergic to Ibuprofen or any other
ingredients of the product (these are listed in
Section 6), aspirin or other related painkillers
• have or have had stomach ulcer, perforation or
bleeding
• are taking more than 75mg of aspirin a day
• suffer from severe liver, kidney or heart
failure
• are in the last 3 months of pregnancy
Warnings and precautions
Talk to your doctor or pharmacist before taking
these tablets if you are:
• asthmatic or suffer from kidney, liver or bowel
problems
• suffering 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
• trying to become pregnant- Ibuprofen belongs
to group of medicines which may impair
fertility in women. This effect is
reversible upon 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 in becoming
pregnant
• in the first 6 months of pregnancy

• told by your doctor that you have an
intolerance to some sugars
Medicines such as 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. Do
not exceed the recommended dose or duration of
treatment.
If you have heart problems, previous stroke or
think that you may 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.
Other medicines and Ibuprofen
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, especially:
• anti-coagulants (i.e. thin blood/prevent clotting
e.g. aspirin/acetyl salicylic acid, warfarin,
ticlodipine)
• medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, betablockers such as atenolol, or angiotensin -II
receptor antagonists such as losartan)
• diuretics (water tablets)
• cardiac glycosides, such as digoxin, used to
treat heart conditions
• zidovudine (an anti-viral drug)
• steroids (used in the treatment of inflammatory
conditions)
• methotrexate (used to treat certain cancers)
• medicines known as immunosuppressants such
as ciclosporin and tacrolimus (used to dampen
down your immune response)
• medicines known as selective serotonin
reuptake inhibitors (SSRIs), used for the
treatment of depression
• antibiotics called quinolones such as
ciprofloxacin
• aminoglycosides (a type of antibiotic)
• mifepristone, lithium
• any other Ibuprofen preparations, such as those
you can buy without a prescription
• any other anti-inflammatory pain killer,
including aspirin
• cholestyramine (a drug used to lower
cholesterol)
• medicines known as sulphonylureas such as
glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (types of antifungal drugs)
• gingko biloba herbal medicine (there is a
chance you may bleed more easily if you are
taking this with Ibuprofen)
Driving and Using Machines
Ibuprofen may make you feel dizzy or drowsy. If
the tablets affect you in this way do not drive,
operate machinery or do anything that requires you
to be alert.
Pregnancy and breast-feeding
Ibuprofen belongs to a group of medicine which
may impair fertility in women. This effect is
reversible upon stopping the medicine. The use of
Ibuprofen whilst pregnant or breast feeding should
be avoided. Ibuprofen should not be used in the
last three months of pregnancy and should only be
taken in the first six months of pregnancy on the
advice of your doctor.

IBUPROFEN 400MG PIL-

POM :IBUPROFEN 400MG PIL

Ibuprofen Tablets contains sucrose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine as it contains sucrose.

3. How to take Ibuprofen

Always take Ibuprofen Tablets exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Take your Ibuprofen Tablets with or after food.
Leave at least 4 hours between each dose.
Adults - The usual dosage is 600 to 1800 mg
spread throughout the day. Your doctor may
choose to increase this depending on what you are
being treated for, but not more than 2400 mg
should be taken in one day in divided doses.
Children - The usual daily dosage is 20 mg
per kg of bodyweight, given in divided doses,
except that in children weighing less than 30 kg,
the total of Ibuprofen given in 24 hours should not
exceed 500mg. Ibuprofen Tablets should NOT be
taken by children weighing less than 7 kg.
In cases of severe juvenile arthritis your doctor
may increase the dosage up to 40 mg/kg of
bodyweight daily in divided doses.
Elderly – The elderly are at increased risk of
the serious consequences of adverse reactions. If
an NSAID is considered necessary, the lowest dose
should be used and for the shortest possible
duration. The patient should be monitored
regularly for GI bleeding during NSAID therapy.
If you take more tablets than you should
If you take too many tablets, contact your doctor or
hospital immediately. Bring any remaining tablets
with you to show the doctor.
Symptoms of overdose: Include headache,
drowsiness, low blood pressure and sickness.
If you forget to take a dose
If you forget to take a dose, take as soon as you
remember, unless it is almost time for your next
dose. If it is, do not take the missed dose at all.
Never double up on a dose to make up for the one
you have missed.

4. Possible side effects

Like all medicines, your medicine can cause side
effects, although not everybody gets them. The
following side effects are very rare (less than 1 in
10,000 people) but if you experience any of the
effects then STOP TAKING this medicine
immediately and contact your doctor or pharmacist.
• Severe allergic reactions: symptoms could
include faster heart rate, swelling of the face,
tongue and throat.
• Severe skin reactions (Steven’s JohnsonSyndrome, toxic epidermal necrolysis):
symptoms could include blistering of the skin,
mouth, eyes and genitals. Skin rash, easy
bruising or bleeding from the skin or nose.
• Peptic ulceration or perforation: symptoms
could include severe abdominal pain,
indigestion, heartburn, feeling sick, vomiting
blood (or liquid with what looks like coffee
grounds), blood in the faeces (stools/ motions)
or passing black tarry stools.
• Inflammation of the brain lining: symptoms
could include stiff neck, headache, feeling or
being sick, fever or feeling disorientated.
• Worsening of asthma and wheezing or
difficulty in breathing.
• Fluid retention (e.g. swollen ankles),
yellowing of the eyes and/or skin.
• Blurred or disturbed vision or seeing/hearing
strange things.
If you experience any of the above mentioned side
effects then STOP TAKING this medicine
immediately and contact your doctor or pharmacist.

6/18/13

11:03 AM

Page 2

Rare side effects (less than 1 in 1000):
• blood disorders, kidney problems, liver
problems may occur
Other side effects:
• headache, hallucinations, dizziness
• tingling of hands and feet, ringing in the ears
• depression, confusion, difficulty sleeping
• anxiety, impaired hearing
• diarrhoea, constipation, flatulence (wind)
• unexpected sensitivity of the skin to the sun
• tiredness, malaise, mood swings
• swelling and irritation inside the nose

Ibuprofen has also been shown to sometimes worsen
the symptoms of Crohn’s disease or colitis.
Medicines such as Ibuprofen have been associated
with a small increased risk of heart attack
(myocardial infarction) or stroke.

If any of the side effects mentioned get serious or if
you notice any side effects not listed in this leaflet,
contact your doctor or pharmacist.

Also you can help to make sure that medicines
remain as safe as possible by reporting any unwanted
side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10
a.m. to 2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

5. How to store Ibuprofen

• This medicine should not be used after the
“expiry date” printed on the pack.
• Store in a cool and dry place protected from
light.
• Do not store above 30°C. Do not freeze.
• They should be kept in their original
packaging.
Keep all medicines out of the sight and reach of
children.
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 to protect the environment.

6. Contents of the pack and other information

What Ibuprofen 400mg tablets contain
• The active substance (the ingredient that
makes the tablet work) is Ibuprofen. Each
tablet contains 400mg of the active ingredient
Ibuprofen BP.
• The other ingredients are pregelatinised
starch, maize starch, povidone, sodium lauryl
sulphate, silicon dioxide, magnesium stearate,
sucrose, purified talc, titanium dioxide and
erythrosine aluminium lake (E127), bees wax
(white), carnauba wax.
What Ibuprofen tablets look like and
contents of the pack
• Ibuprofen 400mg are pink sugar coated tablets.
• The dispensing pack size is 250 tablets in
plastic containers.

The Marketing Authorization Holder and
company responsible for manufacture:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex, UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433

To request a copy of this leaflet in large print or
audio format or additional copies, please contact the
licence holder at the address (or telephone, fax)
above.
PL 04556 / 0023
Reference: 00230613/01
Date leaflet last revised: June 2013

POM

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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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