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IBUPROFEN 400MG CAPLETS

Active substance(s): IBUPROFEN

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Profile 1

Ibuprofen 400mg Caplets
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains
important information for you.
• 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 or pharmacist if your
symptoms worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
WHAT THIS MEDICINE IS FOR
Ibuprofen 400mg Caplets contain ibuprofen, which
belongs to a group of medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs). These medicines
work by changing how the body responds to pain,
swelling and high temperature.
This medicine is used to relieve:
• pain of non-serious arthritic conditions
• rheumatic and muscular pain, backache
• neuralgia (nerve pain)
• headache, migraine
• dental pain, period pain
• fever (high temperature)
• the symptoms of colds and flu.
BEFORE YOU TAKE THE MEDICINE
Do not take Ibuprofen 400mg Caplets if you:
• have or have had a stomach ulcer, perforation or
bleeding of the stomach
• are allergic to ibuprofen, to any of the ingredients
(listed in section 6), or to aspirin or other painkillers
(an allergic reaction may be recognised as shortness
of breath, runny nose, skin rash or itching)
• have kidney or heart failure or severe liver failure
• are taking more than 75mg of aspirin a day
• are in the last 3 months of pregnancy.
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
400mg Caplets if you:
• are elderly, because you may be at more risk of
having serious side effects, particularly stomach
problems
• have or have suffered from asthma or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn’s
disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) – an
illness which affects your immune system. It causes

joint pains, skin changes and problems with
other parts of your body
• 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").
• have high blood pressure, diabetes, high
cholesterol, have a family history of heart disease
or stroke, or if you are a smoker.
Children and adolescents:
There is a risk of renal impairment in dehydrated
adolescents.
Other medicines and Ibuprofen 400mg Caplets
You must not take these caplets if you are taking
certain other medicines - see section 2 ‘Do not
take Ibuprofen 400mg Caplets if’.
Ibuprofen 400mg Caplets may affect or may be
affected by some other medicines. For example:
• medicines that are anti-coagulants (i.e. thin
blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such
as atenolol medicines, angiotensin-II receptor
antagonists such as losartan)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart
failure)
• cyclosporin and tacrolimus (immunosuppressant
medicines often used following organ transplants)
• mifepristone (a medicine used to terminate
pregnancy – NSAIDs should not be used for 12
days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to treat
bacterial infections).
Some other medicines may also affect or be
affected by the treatment of Ibuprofen 400mg
Caplets. You should therefore always seek the
advice of your doctor or pharmacist before you use
Ibuprofen 400mg Caplets with other medicines.
Pregnancy and Breastfeeding
Do not take ibuprofen caplets if you are in the last
3 months of pregnancy. Talk to your doctor before
taking ibuprofen caplets if you are in the first 6
months of pregnancy or are breastfeeding.
Ibuprofen 400mg Caplets belong to a group of
medicines which may affect fertility in women.
Fertility goes back to normal when you stop taking
the medicine. It is unlikely that if you only take
these caplets occasionally it will affect your
chances of becoming pregnant. If you have
problems becoming pregnant talk to your doctor
before taking this medicine.
Important information about some of the
ingredients of this medicine.
This product contains sucrose and lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
Further information overleaf ➥

HOW TO TAKE THE MEDICINE
Age

Dose and how often to take

Adults, the
elderly and
children over
12 years

Take 1 caplet up to 3 times a day,
as required. Swallow caplets with
a glass of water preferably with or
after food. Do not take more often
than every 4 hours. Do not exceed
3 caplets in 24 hours.

• This medicine is for short-term use only
• Take the lowest dose for the shortest time necessary
In Adults: Do not take Ibuprofen 400mg Caplets for
longer than 10 days unless your doctor tells you to.
Talk to a doctor or pharmacist if you do not get
better or get worse, or if new symptoms occur.
In Children and Adolescents between 12 and 18
years: If in children and adolescents this medicinal
product is required for more than 3 days, or if
symptoms worsen, a doctor should be consulted.
Do not give to children under 12 years.
If you take too many caplets:
Talk to a doctor straight away, or go to your nearest
hospital casualty department. Take the carton and
this leaflet with you.
POSSIBLE SIDE EFFECTS
Most people take Ibuprofen 400mg Caplets
without any problems, but it can have side effects,
like all medicines.
To reduce the chance of side effects, especially if
you are elderly, use the lowest effective dose for the
shortest possible time.
If you get any of the following at any time
during your treatment STOP TAKING, and get
medical help straight away:
Allergic reactions:
The following reactions may mean you are having
an allergic reaction to this medicine:
• asthma, worsening of asthma, unexplained
wheezing or shortness of breath
• swelling of the face, lips, tongue and throat
(causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse
• also, there may be skin reaction (including hives,
rash and itching) – very rarely these can be
severe with blistering and peeling skin.
Stomach and bowel problems including:
• indigestion or heartburn
• pains in your stomach (abdomen) or other
abnormal stomach problems
• pass blood in your stools or motions
• pass black tarry stools or motions
• vomit any blood or dark particles that look like
coffee grounds
• worsening of bowel problems (ulcerative colitis or
Crohn’s disease).
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding

• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion.
Heart and circulation effects: Medicines such as
Ibuprofen 400mg Caplets may be associated with
a small increased risk of heart attack (myocardial
infarction), high blood pressure, heart failure,
swelling due to fluid build-up (oedema) or stroke.
Other side effects that may occur include:
Other stomach and intestine effects including:
diarrhoea, flatulence, constipation and vomiting.
Liver problems that might be indicated by yellowing
of the skin and eyes (jaundice) and/or pale coloured
stools and dark urine.
Kidney problems that might be indicated by
passing less or more urine than normal, cloudy urine,
blood in the urine, pain in the back and/or swelling
(particularly of the legs) – very rarely kidney failure.
Nervous system problems including headache
and aseptic meningitis (which can have symptoms
such as severe headache, stiff neck, disorientation,
fever and eye sensitivity to light in those with
existing auto-immune disorders such as lupus).
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.
STORING THE MEDICINE
Do not use after the expiry date shown on the pack.
Do not store above 25°C.
Store in the original container.
Keep out of the sight and reach of children.
FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Ibuprofen 400mg per
coated tablet.
The other ingredients are: Lactose Monohydrate,
Povidone, Maize Starch, Talc, Croscarmellose
Sodium, Magnesium Stearate, Silica, Colloidal
Anhydrous, Sucrose and Titanium Dioxide (E171).
What this medicine looks like and contents of
the pack
Ibuprofen 400mg Caplets are white, capsule
shaped sugar-coated tablets.
This pack contains 24, 48 or 96 caplets.
Marketing Authorisation Holder:
Galpharm Healthcare Ltd., Wrafton, Braunton,
Devon, EX33 2DL, United Kingdom.
Manufacturer:
Galpharm International Ltd., Elmhirst Park,
Middle Field Road, Barnsley, South Yorkshire,
S75 4LS, United Kingdom.
Text revised: November 2015.

4006120

Profile 2

Ibuprofen 400mg Caplets
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains
important information for you.
• 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 or pharmacist if your
symptoms worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
WHAT THIS MEDICINE IS FOR
Ibuprofen 400mg Caplets contain ibuprofen, which
belongs to a group of medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs). These medicines
work by changing how the body responds to pain,
swelling and high temperature.
This medicine is used to relieve:
• pain of non-serious arthritic conditions
• rheumatic and muscular pain, backache
• neuralgia (nerve pain)
• headache, migraine
• dental pain, period pain
• fever (high temperature)
• the symptoms of colds and flu.
BEFORE YOU TAKE THE MEDICINE
Do not take Ibuprofen 400mg Caplets if you:
• have or have had a stomach ulcer, perforation or
bleeding of the stomach
• are allergic to ibuprofen, to any of the ingredients
(listed in section 6), or to aspirin or other painkillers
(an allergic reaction may be recognised as shortness
of breath, runny nose, skin rash or itching)
• have kidney or heart failure or severe liver failure
• are taking more than 75mg of aspirin a day
• are in the last 3 months of pregnancy.
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
400mg Caplets if you:
• are elderly, because you may be at more risk of
having serious side effects, particularly stomach
problems
• have or have suffered from asthma or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn’s
disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) – an
illness which affects your immune system. It causes

joint pains, skin changes and problems with
other parts of your body
• 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").
• have high blood pressure, diabetes, high
cholesterol, have a family history of heart disease
or stroke, or if you are a smoker.
Children and adolescents:
There is a risk of renal impairment in dehydrated
adolescents.
Other medicines and Ibuprofen 400mg Caplets
You must not take these caplets if you are taking
certain other medicines - see section 2 ‘Do not
take Ibuprofen 400mg Caplets if’.
Ibuprofen 400mg Caplets may affect or may be
affected by some other medicines. For example:
• medicines that are anti-coagulants (i.e. thin
blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such
as atenolol medicines, angiotensin-II receptor
antagonists such as losartan)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart
failure)
• cyclosporin and tacrolimus (immunosuppressant
medicines often used following organ transplants)
• mifepristone (a medicine used to terminate
pregnancy – NSAIDs should not be used for 12
days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to treat
bacterial infections).
Some other medicines may also affect or be
affected by the treatment of Ibuprofen 400mg
Caplets. You should therefore always seek the
advice of your doctor or pharmacist before you use
Ibuprofen 400mg Caplets with other medicines.
Pregnancy and Breastfeeding
Do not take ibuprofen caplets if you are in the last
3 months of pregnancy. Talk to your doctor before
taking ibuprofen caplets if you are in the first 6
months of pregnancy or are breastfeeding.
Ibuprofen 400mg Caplets belong to a group of
medicines which may affect fertility in women.
Fertility goes back to normal when you stop taking
the medicine. It is unlikely that if you only take
these caplets occasionally it will affect your
chances of becoming pregnant. If you have
problems becoming pregnant talk to your doctor
before taking this medicine.
Important information about some of the
ingredients of this medicine.
This product contains sucrose and lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
Further information overleaf ➥

HOW TO TAKE THE MEDICINE
Age

Dose and how often to take

Adults, the
elderly and
children over
12 years

Take 1 caplet up to 3 times a day,
as required. Swallow caplets with
a glass of water preferably with or
after food. Do not take more often
than every 4 hours. Do not exceed
3 caplets in 24 hours.

• This medicine is for short-term use only
• Take the lowest dose for the shortest time necessary
In Adults: Do not take Ibuprofen 400mg Caplets for
longer than 10 days unless your doctor tells you to.
Talk to a doctor or pharmacist if you do not get
better or get worse, or if new symptoms occur.
In Children and Adolescents between 12 and 18
years: If in children and adolescents this medicinal
product is required for more than 3 days, or if
symptoms worsen, a doctor should be consulted.
Do not give to children under 12 years.
If you take too many caplets:
Talk to a doctor straight away, or go to your nearest
hospital casualty department. Take the carton and
this leaflet with you.
POSSIBLE SIDE EFFECTS
Most people take Ibuprofen 400mg Caplets
without any problems, but it can have side effects,
like all medicines.
To reduce the chance of side effects, especially if
you are elderly, use the lowest effective dose for the
shortest possible time.
If you get any of the following at any time
during your treatment STOP TAKING, and get
medical help straight away:
Allergic reactions:
The following reactions may mean you are having
an allergic reaction to this medicine:
• asthma, worsening of asthma, unexplained
wheezing or shortness of breath
• swelling of the face, lips, tongue and throat
(causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse
• also, there may be skin reaction (including hives,
rash and itching) – very rarely these can be
severe with blistering and peeling skin.
Stomach and bowel problems including:
• indigestion or heartburn
• pains in your stomach (abdomen) or other
abnormal stomach problems
• pass blood in your stools or motions
• pass black tarry stools or motions
• vomit any blood or dark particles that look like
coffee grounds
• worsening of bowel problems (ulcerative colitis or
Crohn’s disease).
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding

• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion.
Heart and circulation effects: Medicines such as
Ibuprofen 400mg Caplets may be associated with
a small increased risk of heart attack (myocardial
infarction), high blood pressure, heart failure,
swelling due to fluid build-up (oedema) or stroke.
Other side effects that may occur include:
Other stomach and intestine effects including:
diarrhoea, flatulence, constipation and vomiting.
Liver problems that might be indicated by yellowing
of the skin and eyes (jaundice) and/or pale coloured
stools and dark urine.
Kidney problems that might be indicated by
passing less or more urine than normal, cloudy urine,
blood in the urine, pain in the back and/or swelling
(particularly of the legs) – very rarely kidney failure.
Nervous system problems including headache
and aseptic meningitis (which can have symptoms
such as severe headache, stiff neck, disorientation,
fever and eye sensitivity to light in those with
existing auto-immune disorders such as lupus).
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.
STORING THE MEDICINE
Do not use after the expiry date shown on the pack.
Do not store above 25°C.
Store in the original container.
Keep out of the sight and reach of children.
FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Ibuprofen 400mg per
coated tablet.
The other ingredients are: Lactose Monohydrate,
Povidone, Maize Starch, Talc, Croscarmellose
Sodium, Magnesium Stearate, Silica, Colloidal
Anhydrous, Sucrose and Titanium Dioxide (E171).
What this medicine looks like and contents of
the pack
Ibuprofen 400mg Caplets are white, capsule
shaped sugar-coated tablets.
This pack contains 24, 48 or 96 caplets.
Marketing Authorisation Holder:
Galpharm Healthcare Ltd., Wrafton, Braunton,
Devon, EX33 2DL, United Kingdom.
Manufacturer:
Galpharm International Ltd., Elmhirst Park,
Middle Field Road, Barnsley, South Yorkshire,
S75 4LS, United Kingdom.
Text revised: November 2015.

4006119

Expand view ⇕

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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