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IBUPROFEN TABLETS 200 MG

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IBUPROFEN 200MG TABLETS
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

1

WHAT THIS MEDICINE IS FOR

Ibuprofen 200mg Tablets 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.

2

BEFORE YOU TAKE THE MEDICINE

Do not take Ibuprofen 200mg Tablets 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 other NSAID painkillers, or aspirin with
a daily dose above 75mg
• are in the last 3 months of pregnancy.
Talk to your doctor or pharmacist before taking
ibuprofen tablets 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, diabetes,
high cholesterol 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, have previously had, or are at risk of heart
problems, high blood pressure or stroke. Medicines
such as Ibuprofen 200mg Tablets 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). 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 are taking other medicines
You must not take these tablets if you are taking
certain other medicines - see section 2 ‘Do not take
Ibuprofen 200mg Tablets if’.
Talk to your pharmacist or doctor before you take the
tablets if you are taking any regular medication,
especially:
• aspirin at low dose as an anti-platelet medicine
(i.e. 75mg or below daily) as taking ibuprofen may
reduce the effectiveness of the aspirin or cause
stomach problems
• other medicines for thinning the blood (anticoagulants (against clotting) and anti-platelet agents
such as warfarin and ticlopidin)
• medicines for high blood pressure (ACE-inhibitors
such as captopril, beta-blockers and angiotensin
II antagonists) and water tablets (diuretics)
• 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).
Pregnancy and Breast feeding
Do not take ibuprofen tablets if you are in the last 3
months of pregnancy. Talk to your doctor before
taking ibuprofen tablets if you are in the first 6 months
of pregnancy or are breastfeeding.
Ibuprofen 200mg Tablets belong to a group of
medicines, which may impair fertility in women. This
is reversible on stopping the medicine. It is unlikely
that the tablets, used occasionally, will affect your
chances of becoming pregnant. However, tell your
doctor before taking this medicine if you have problems
becoming pregnant.
Important information about some of the
ingredients of this medicine.
This product contains 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.
Further information overleaf.

3

HOW TO TAKE THE MEDICINE

Age
Adults, the
elderly and
children over
12 years

Dose and how often to take
Take 1 to 2 tablets up to 3 times
a day, as required. Swallow tablets
with a glass of water preferably
with or after food. Do not take more
often than every 4 hours. Do not
exceed 6 tablets in 24 hours.

The tablets are intended for short-term use only.
Use them for the shortest time needed to relieve
symptoms. Always use the lowest dose that
relieves your symptoms. Do not take Ibuprofen
200mg Tablets for longer than 10 days unless your
doctor tells you to.
Do not give to children under 12 years.
Talk to a doctor or pharmacist if you do not get better
or get worse, or if new symptoms occur.
If you take too many tablets: Talk to a doctor
straight away, or go to your nearest hospital casualty
department. Take the carton and this leaflet with you.

4

POSSIBLE SIDE EFFECTS

Most people take Ibuprofen 200mg Tablets 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.
STOP TAKING the tablets and contact your
doctor immediately if you develop any of the
following symptoms at any time while taking
your medicine:
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:
• stomach discomfort or pain, nausea, indigestion
or heartburn, stomach ulcer
• stomach bleeding which can result in vomit with
blood or dark particles (like coffee grounds), black
tarry stools or blood passed in your stools
• 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 200mg Tablets 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 autoimmune disorders such as lupus).
If you experience any of these symptoms, or have
any other unusual symptoms or concerns with your
medicine, stop taking the tablets and see your doctor.

5

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 all medicines out of the reach and sight
of children.

6

FURTHER INFORMATION

What is in this medicine:
The active ingredient is: Ibuprofen 200mg per
coated tablet.
The other ingredients are: Colloidal anhydrous
silica, maize starch, polyvinylpyrrolidone,
microcrystalline cellulose, alginic acid, magnesium
stearate, sodium lauryl sulphate, sodium starch
glycollate, sodium carboxymethylcellulose, talc,
sucrose, titanium dioxide (E171).
What this medicine looks like and contents of
the pack
Ibuprofen 200mg Tablets are white, circular, sugarcoated tablets.
This pack contains 24, 48 or 96 tablets.
Marketing Authorisation Holder:
Galpharm Healthcare Ltd, Upper Cliffe Road,
Dodworth Business Park, Dodworth,
South Yorkshire S75 3SP
Manufacturer:
Galpharm International Ltd, Upper Cliffe Road,
Dodworth Business Park, Dodworth,
South Yorkshire S75 3SP
Date of approval: 12/2009
00000

IBUPROFEN 200MG TABLETS
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

1

WHAT THIS MEDICINE IS FOR

Ibuprofen 200mg Tablets 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:
• rheumatic and muscular pain, backache
• neuralgia (nerve pain)
• headache, migraine
• dental pain, period pain
• fever (high temperature)
• the symptoms of colds and flu.

2

BEFORE YOU TAKE THE MEDICINE

Do not take Ibuprofen 200mg Tablets 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 other NSAID painkillers, or aspirin with
a daily dose above 75mg
• are in the last 3 months of pregnancy.
Talk to your doctor or pharmacist before taking
ibuprofen tablets 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, diabetes,
high cholesterol 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, have previously had, or are at risk of heart
problems, high blood pressure or stroke. Medicines
such as Ibuprofen 200mg Tablets 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). 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 are taking other medicines
You must not take these tablets if you are taking
certain other medicines - see section 2 ‘Do not take
Ibuprofen 200mg Tablets if’.
Talk to your pharmacist or doctor before you take the
tablets if you are taking any regular medication,
especially:
• aspirin at low dose as an anti-platelet medicine
(i.e. 75mg or below daily) as taking ibuprofen may
reduce the effectiveness of the aspirin or cause
stomach problems
• other medicines for thinning the blood (anticoagulants (against clotting) and anti-platelet agents
such as warfarin and ticlopidin)
• medicines for high blood pressure (ACE-inhibitors
such as captopril, beta-blockers and angiotensin
II antagonists) and water tablets (diuretics)
• 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).
Pregnancy and Breast feeding
Do not take ibuprofen tablets if you are in the last 3
months of pregnancy. Talk to your doctor before
taking ibuprofen tablets if you are in the first 6 months
of pregnancy or are breastfeeding.
Ibuprofen 200mg Tablets belong to a group of
medicines, which may impair fertility in women. This
is reversible on stopping the medicine. It is unlikely
that the tablets, used occasionally, will affect your
chances of becoming pregnant. However, tell your
doctor before taking this medicine if you have problems
becoming pregnant.
Important information about some of the
ingredients of this medicine.
This product contains 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.
Further information overleaf.

3

HOW TO TAKE THE MEDICINE

Age
Adults, the
elderly and
children over
12 years

Dose and how often to take
Take 1 to 2 tablets up to 3 times
a day, as required. Swallow tablets
with a glass of water preferably
with or after food. Do not take more
often than every 4 hours. Do not
exceed 6 tablets in 24 hours.

The tablets are intended for short-term use only.
Use them for the shortest time needed to relieve
symptoms. Always use the lowest dose that
relieves your symptoms. Do not take Ibuprofen
200mg Tablets for longer than 10 days unless your
doctor tells you to.
Do not give to children under 12 years.
Talk to a doctor or pharmacist if you do not get better
or get worse, or if new symptoms occur.
If you take too many tablets: Talk to a doctor
straight away, or go to your nearest hospital casualty
department. Take the carton and this leaflet with you.

4

POSSIBLE SIDE EFFECTS

Most people take Ibuprofen 200mg Tablets 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.
STOP TAKING the tablets and contact your
doctor immediately if you develop any of the
following symptoms at any time while taking
your medicine:
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:
• stomach discomfort or pain, nausea, indigestion
or heartburn, stomach ulcer
• stomach bleeding which can result in vomit with
blood or dark particles (like coffee grounds), black
tarry stools or blood passed in your stools
• 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 200mg Tablets 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 autoimmune disorders such as lupus).
If you experience any of these symptoms, or have
any other unusual symptoms or concerns with your
medicine, stop taking the tablets and see your doctor.

5

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 all medicines out of the reach and sight
of children.

6

FURTHER INFORMATION

What is in this medicine:
The active ingredient is: Ibuprofen 200mg per
coated tablet.
The other ingredients are: Colloidal anhydrous
silica, maize starch, polyvinylpyrrolidone,
microcrystalline cellulose, alginic acid, magnesium
stearate, sodium lauryl sulphate, sodium starch
glycollate, sodium carboxymethylcellulose, talc,
sucrose, titanium dioxide (E171).
What this medicine looks like and contents of
the pack
Ibuprofen 200mg Tablets are white, circular, sugarcoated tablets.
This pack contains 12 or 16 tablets.
Marketing Authorisation Holder:
Galpharm Healthcare Ltd, Upper Cliffe Road,
Dodworth Business Park, Dodworth,
South Yorkshire S75 3SP
Manufacturer:
Galpharm International Ltd, Upper Cliffe Road,
Dodworth Business Park, Dodworth,
South Yorkshire S75 3SP
Date of approval: 12/2009
PLL311T

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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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