IBUPROFEN 400MG COATED TABLETS
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Package leaflet: Information for the user
Max Strength Ibuprofen 400mg Coated Tablets
(Referred to as Ibuprofen tablets in the remainder of the leaflet)
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
– Keep this leaflet. You may need to read it
– If you have any further questions, ask
your doctor or pharmacist.
– 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. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Ibuprofen tablets are and what
they are used for
2. What you need to know before you take
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 Ibuprofen tablets are and
what they are used for
The name of your medicine is Ibuprofen
tablets. The active ingredient in your
medicine is ibuprofen. Ibuprofen belongs to
a group of medicines called Non-Steroidal
Anti-inflammatory Drugs (NSAIDs).
and migraine, backache, swelling and
stiffness in the joints and muscles
(rheumatic and muscular pain), arthritis,
fever and cold and flu symptoms.
2. What you need to know before you
take Ibuprofen Tablets
Do not take Ibuprofen tablets if you
• are allergic (hypersensitive), or have had
an allergic reaction to, ibuprofen, any
other NSAID, aspirin, or to any of the other
ingredients of this medicine (listed in
section 6). Symptoms of an allergic
reaction may include swollen eyelids, lips,
tongue, or throat
• have ever had a worsening of symptoms
of asthma (breathing difficulty), hayfever
(runny, itchy and inflamed nose with
sneezing), urticaria (an itchy rash), or
angioedema (swelling under the skin)
when taking ibuprofen, aspirin or similar
• currently have or have had a stomach
ulcer or bleeding in the stomach on two
• have ever had perforation or bleeding of
the gut when taking any NSAID
• suffer from severe liver, kidney or heart
• are in the last 3 months of pregnancy
• have abnormal bleeding or problems with
• are currently taking mifamurtide (a
medicine used to treat bone cancer).
Warnings and precautions
Take special care with Ibuprofen tablets
• develop a skin rash or allergic reaction
after taking this medicine. If you have any
of these symptoms stop taking this medicine
and contact your doctor immediately.
• are elderly, as you may be more prone to
side effects (see section 4. Possible Side
Effects) which in some cases may be
extremely serious or even life threatening
• have a history of asthma or other allergy
• have liver, kidney, or bowel problems
• have Systemic Lupus Erythematosus
(SLE), a condition of the immune system
resulting in joint pains, skin rashes,
kidney or liver problems
• have or have had high blood pressure or
heart problems. Speak to your doctor
who will advise you on your treatment
and may wish to monitor you
• have a history of bleeding in the stomach
or gut. Speak to your doctor immediately
if you notice any problems with your
stomach, especially at the start of your
• have an infection, as symptoms such as
fever, pain and swelling may be masked
• are a child with chickenpox
• are in the first 6 months of your pregnancy
• are taking other NSAID painkillers
including a specific type called COX-2
inhibitors, or aspirin, with a daily dose
• if you are on low-dose aspirin (up to 75mg).
There is a risk of renal impairment in
Speak to your doctor or pharmacist before
you take this medicine.
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 if you:
• 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.
Other medicines and Ibuprofen Tablets
Tell your doctor if you are taking, have
recently taken or might take any other
medicines, including medicines obtained
without a prescription. Ibuprofen may affect
or be affected by some other medicines.
• other pain killers including aspirin or
• medicines used to treat bacterial infections
• medicines that are anti-coagulants (i.e.
thin blood/prevent clotting e.g. aspirin/
acetylsalicylic acid, warfarin, ticlopidine)
• medicines used to treat depression, such
as selective serotonin re-uptake
inhibitors (SSRIs) and lithium
• medicines used to treat diabetes
• medicines used to treat epilepsy
• medicines that reduce high blood
pressure (ACE-inhibitors such as
captopril, beta-blockers such as atenolol
medicines, angiotensin-II receptor
antagonists such as losartan)
• medicines used to treat viral infections,
such as zidovudine and ritonavir
• medicines used to treat heart failure
• medicines used to treat various illnesses
that involve inflammation in the body
• medicines used to treat cancer, such as
methotrexate and mifamurtide
• medicines used during abortion, such as
• medicines used to relax muscles
• pentoxyfylline, used to treat blood
• diuretics, medicines used to help you
pass water (urine)
• medicines used to suppress the immune
system in patients who have had a
transplant, such as ciclosporin and
• penicillamine, used to treat a number of
conditions such as rheumatoid arthritis,
• cardiac glycosides, such as digoxin,
used to treat heart conditions
• antibiotics called quinolones such as
• aminoglycosides (a type of antibiotic)
• cholestyramine (a drug used to lower
• medicines known as sulphonylureas such
as glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (type of
• gingko biloba herbal medicine (there is a
chance you may bleed more easily if you
are taking this with ibuprofen).
Some other medicines may also affect or
be affected by the treatment of Ibuprofen.
You should therefore always seek the
advice of your doctor or pharmacist before
you use ibuprofen with other medicines.
Ibuprofen tablets with food and drink
Do not drink alcohol whilst taking this
Pregnancy, breast-feeding and fertility
Do not take Ibuprofen tablets if you are in
the last 3 months of pregnancy.
Ibuprofen Tablets should be avoided in the
first six months of pregnancy.
Ibuprofen tablets belong to a group of
medicines which may impair fertility in
women. This effect is reversible on
stopping the medicine. It is unlikely that
Ibuprofen tablets, used occasionally, will
affect your chances of becoming pregnant,
however, tell your doctor before taking this
medicine if you are having problems when
trying to become pregnant.
Ask your doctor or pharmacist for advice
before taking any medicine.
It is possible that this medicine can pass
into breast milk. If you are breastfeeding,
speak to your doctor or pharmacist for
advice before taking this, or any medicine.
Driving and using machines
This medicine may make you feel dizzy,
drowsy or tired. You may also experience
blurry vision. Do not drive or use tools or
machines if you are affected in any way
after taking this medicine.
Important information about some of the
ingredients of Ibuprofen tablets
This product contains sucrose. If you have
been told by your doctor that you have
intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. How to take Ibuprofen tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
Adults, Elderly and Children over 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 Ibuprofen
tablets for longer than 10 days unless your
doctor tells you to. If symptoms persist or
worsen consult your doctor.
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Numark Maximum Strength Ibuprofen Tablets 400mg
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6th & 10th March, 2017
R 1st PDF sent on - 10TH MARCH 1017
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CHANGE CONTROL : Version changes due to change in:
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This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 03/2017
What Ibuprofen tablets contain
The active ingredient is ibuprofen.
Each Max Strength Ibuprofen 400mg
Coated Tablet contains 400mg of
The other ingredients are colloidal
anhydrous silica, starch, povidone,
microcrystalline cellulose, alginic acid,
magnesium stearate, sodium lauryl
sulphate, sodium starch glycollate and
The coating contains polyvinyl acetate
phthalate, stearic acid, purified talc,
sucrose, calcium carbonate, acacia,
titanium dioxide (E171) and carnauba wax.
What Ibuprofen tablets look like and
contents of the pack
Ibuprofen tablets are round, white, sugar
Ibuprofen tablets are available in the
• blister packs of 8, 12, 16, 24, 32, 48, 56,
64, 72, 84, or 96 tablets
• plastic bottles with a child proof cap, in
pack sizes of 25 and 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North,
Wrexham LL13 9UF, UK
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge: 0800 198 5000 (UK only).
Please be ready to give the following
6. Contents of the pack and other
Keep this medicine out of the sight and
reach of children.
Do not use Ibuprofen tablets after the
expiry date stated on the blister or carton.
The expiry date refers to the last day of that
Do not store above 25°C. Store in the
original package in order to protect from
light and moisture.
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.
5. How to store Ibuprofen Tablets
Like all medicines, Ibuprofen tablets can
cause side effects, although not everybody
gets them. If any side effects become
serious or if you notice any side effects that
are not listed in this leaflet, please tell your
doctor or pharmacist. You can minimise the
risk of side effects by taking the least
amount of tablets for the shortest amount of
time necessary to control your symptoms.
STOP TAKING Ibuprofen Caplets and
seek immediate medical help if you
• Signs of aseptic meningitis such as severe
headache, high temperature, stiffness of
the neck or intolerance to bright light.
• Signs of intestinal bleeding such as
Passing blood in your faeces
Passing black tarry stools
Vomiting any blood or dark particles that
look like coffee grounds.
TELL YOUR DOCTOR AND STOP
TAKING IBUPROFEN CAPLETS IF YOU
• Unexplained stomach pain (abdominal
pain) or other abnormal stomach
symptoms, indigestion, heartburn, feeling
sick and/or vomiting.
• Unexplained wheezing, shortness of
breath, skin rash, itching or bruising (these
may be symptoms of an allergic reaction).
• Yellowing of the eyes and/or skin (jaundice).
• Severe sore throat with high fever (these
may be symptoms of a condition known
• Blurred or disturbed vision (visual
impairment) or seeing/hearing strange
• Fluid retention e.g. swollen ankles (this
may be a sign of kidney problems).
• Severe spreading skin rash (Stevens –
Johnson Syndrome and erythema
multiforme, symptoms include severe
skin rash, blistering of skin, including
inside mouth, nose, and genitals, as well
as skin peeling which may be
accompanied with symptoms such as
aching, headaches, and feverishness).
Medicines such as Ibuprofen Caplets have
been associated with a small increased risk
of heart attack (myocardial infarction) or
Medicines such as Ibuprofen Caplets have
in exceptional cases been associated with
severe skin problems for patients with
chicken pox or shingles.
Blood disorders, kidney problems, liver
problems or severe skin reactions may
occur rarely with ibuprofen.
Very rarely Ibuprofen Caplets may cause
aseptic meningitis (inflammation of the
protective membrane surrounding the brain).
Ibuprofen has also been shown to
sometimes worsen the symptoms of
Crohn’s disease or colitis.
Other side effects
Common (affects up to 1 in 10 people):
• feeling dizzy or tired
• stomach pain, or indigestion, diarrhoea,
feeling sick, being sick, wind, constipation
• headache – if this happens while you are
taking this medicine it is important not to
take any other medicines for pain to help
• passing black tarry stools
• passing blood in your faeces
• vomiting any blood
Uncommon (affects up to 1 in 100 people):
• feeing drowsy
• feeling anxious
• feeling a tingling sensation or ‘pins and
• difficulty sleeping
• hives, itching
• skin becomes sensitive to light
• visual disturbances, hearing problems
• hepatitis, yellowing of your skin or eyes,
reduced liver function
• reduced kidney function, inflammation of
the kidneys, kidney failure
• sneezing, blocked, itchy or runny nose
• stomach or gut ulcer, hole in the wall of
4. Possible side effects
the digestive tract
• inflammation of your stomach lining
• small bruises on your skin or inside your
mouth, nose or ears
• difficulty breathing, wheezing or coughing,
asthma or worsening of asthma
• ringing in ears (tinnitus)
• sensation of feeling dizzy or spinning
• mouth ulcers
• serious allergic reaction which causes
swelling of the face or throat
Rare (affects up to 1 in a 1000 people):
• feeling depressed or confused
• fluid retention (oedema)
• a brain infection called ‘non-bacterial
• loss of vision
• changes in blood count – the first signs
are: high temperature, sore throat, mouth
ulcers, flu – like symptoms, feeling very
tired, bleeding from the nose and the skin
• reduction in blood cells (anaemia)
• serious allergic reaction which causes
difficulty in breathing or dizziness
• severe sore throat with high fever
Very rare (affects up to 1 in 10,000
• liver failure
• heart failure
• heart attack
• inflammation of the pancreas
• skin problems (which can also affect
inside your mouth, nose or ears) such as
‘Stevens – Johnson syndrome’, ‘toxic
epidermal necrolysis’ or ‘erythema
• high blood pressure
Not known (frequency cannot be
of the colon)
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
By reporting side effects you can help
provide more information on the safety of
The usual dose is 400mg (1 tablet) to be
taken with a drink of water, preferably with
or after food, up to three times a day as
required. The dose should not be repeated
more frequently than every 4 hours. Do not
take more than 1200mg (3 tablets) in
Taking this medicine with or after food or
milk may only partially reduce stomach side
effects such as indigestion (see section 4).
If in adolescents this medicinal product is
required for more than 3 days, or if symptoms
worsen a doctor should be consulted.
If you take more Ibuprofen tablets than
If you accidentally take too many Ibuprofen
tablets, you should contact your doctor or
go to your nearest hospital casualty
department immediately. Take this leaflet
and any unused tablets with you to show
The symptoms of an overdose include
vomiting (being sick), nausea (feeling sick),
stomach pain and possibly diarrhoea.
Dizziness, ringing in the ears (tinnitus) and
fainting can also be signs of an overdose.
The doctor will assess your condition and
decide how to treat your overdose.
If you forget to take Ibuprofen tablets
If you forget to take your medicine take it
as soon as you remember. If it is almost
time for your next dose do not take the
missed dose at all. Do not take a double
dose to make up for a forgotten dose.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.
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.