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MAX-STRENGTH IBUPROFEN 400MG COATED TABLETS

Active substance(s): IBUPROFEN

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• Common leaflet artwork for all the locations
Neutral code not required.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Maximum Strength Ibuprofen 400mg Coated Tablets
Ibuprofen
(Referred to as Ibuprofen tablets in the remainder of the leaflet)
Read all of this leaflet carefully before you
start to take this medicine.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, please
ask your doctor or pharmacist.
– This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
– If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Ibuprofen tablets are and what
they are used for
2. Before you take Ibuprofen tablets
3. How to take Ibuprofen tablets
4. Possible side effects
5. How to store Ibuprofen tablets
6. Further 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).
Ibuprofen works by reducing inflammation
and relieving pain including period pain,
nerve related pain (neuralgia), dental pain,
headaches
and migraine,
backache,
swelling and
stiffness in
the joints and
muscles
(rheumatic
and muscular
pain), arthritis, fever and cold and flu
symptoms.
2. 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 in this medicine (see section 6.
Further information). 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
painkillers
• currently have or have had a stomach
ulcer or bleeding in the stomach on two
previous occasions
• have ever had perforation or bleeding of
the gut when taking any NSAID
• suffer from severe liver, kidney or heart
problems
• are in the last 3 months of pregnancy
• have abnormal bleeding or problems with
abnormal bruising
• are currently taking mifamurtide (a
medicine used to treat bone cancer).
Take special care with Ibuprofen tablets
if you
• 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
disorders
• 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
treatment
• smoke
• 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
above 75mg
• if you are on low-dose aspirin (up to 75mg).
Speak to your doctor or pharmacist before
you take this medicine.
Medicines such as Ibuprofen 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 treatments. 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.
Taking other medicines
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription. The following medicines can
affect or be affected by treatment with:
• other pain killers including aspirin or
other NSAIDs
• medicines used to treat bacterial infections
• medicines to prevent blood clotting
(anti-coagulants) such as warfarin and
heparin, or clopidogrel and 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 used to treat high blood
pressure including ACE inhibitors such
as captopril, angiotensin-II antagonists
such as losartan, beta-blockers such as
atenolol, and vasodilators
• 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
(corticosteroids)
• medicines used to treat cancer, such as
methotrexate and mifamurtide
• medicines used during abortion, such as
mifepristone
• medicines used to relax muscles
• pentoxyfylline, used to treat blood
circulation problems
• 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
tacrolimus
• penicillamine, used to treat a number of
conditions such as rheumatoid arthritis,
Wilson's disease.
Taking Ibuprofen tablets with food and
drink
Do not drink alcohol whilst taking this
medicine.
Pregnancy
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.
Breastfeeding
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 machinery
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 Ibuprofen tablets exactly as
your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
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.
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 24 hours.
Taking this medicine with or after food or
milk may only partially reduce stomach side
effects such as indigestion (see section 4).
If you take more Ibuprofen tablets than
you should
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 doctor.
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
102483/7

ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:

Process
Black

Maximum Strength Ibuprofen Tablets 400mg
Wockhardt UK
FP2613; FP2726; FP2781; FP2862; FP2864; FP3020;
FP3103; FP3280; FP3281; FP3449; FP3450; FP3606;
FP3858; FP3859; FP3922; FP3923; FP3924
PLANT LOCATION :
Daman
DIMENSIONS :
(w)128 x (h)420mm
SAP CODE No. :
215323
PHARMACODE No. : 2284
TEXT FONT SIZE :
8 pt.
FILE NAME :
Max Strength Ibu Tablet_400mg_Lit_102483-7.ai
SOFTWARE :
Adobe Illustrator CS5
TYPEFACES :
Arial Regular / Bold
ARTWORK (DETAILS) 10th & 17th September, 2013
RECEIVED ON :
PROOF REVISION :
 1st PDF sent on - 24TH SEPT. 2013
 2nd PDF sent on - 27TH SEPT. 2013
 3rd PDF sent on - 30TH SEPT. 2013
 4th PDF sent on - 20TH MARCH 2014
 5th PDF sent on - 24TH MARCH 2014
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Product name changed to ‘Maximum Strength Ibuprofen’
• New Wockhardt logo
• Pharmacode re-positioned on 7mm from the left edge

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Keep out of the reach and sight 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 month.
Do not store above 25°C. Store in the
original package in order to protect from
light and moisture
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

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5. How to store Ibuprofen tablets

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215323

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What Ibuprofen tablets contain
The active ingredient is ibuprofen.
Each Maximum Strength Ibuprofen 400mg
Coated Tablet contains 400mg of ibuprofen.
The other ingredients are colloidal
anhydrous silica, starch, povidone,
microcrystalline cellulose, alginic acid,
magnesium stearate, sodium lauryl sulfate,
sodium starch glycollate and
croscarmellose sodium.
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 the
contents of the pack
Ibuprofen tablets are round, white, sugar
coated tablets.
Ibuprofen tablets are available in the
following packs:
• 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
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Other formats:
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
information:
Product name
Reference numbers
Maximum Strength
PL 29831/0117
Ibuprofen 400mg
Coated Tablets
This is a service provided by the Royal
National Institute of Blind People.
Leaflet Prepared: September 2013.

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6. Further information

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Like all medicines, Ibuprofen tablets can
cause side effects, although not everybody
gets them.
For the assessment of side effects, the
following descriptions of frequency have
been used:
Very common
More than 1 in 10 patients treated
Common
Less than 1 in 10 patients treated
Uncommon
Less than 1 in 100 patients treated
Rare
Less than 1 in 1,000 patients treated
Very rare
Less than 1 in 10,000 patients treated
Not known
Frequency cannot be established
If you have an allergic reaction to Ibuprofen
tablets, tell your doctor straight away. The
signs of an allergic reaction include:
• swelling of your face, lips, or tongue
• difficulty breathing
• itchy lumpy rash or a painful rash of dark
red spots under the skin which do not go
away when you put pressure on them.
The following effects are very rare, but if
you suffer from any of the following at any
time during your treatment STOP TAKING
the medicine and seek immediate medical
help:
• pass blood in your stools or motions
(faeces)
• pass black tarry stools
• vomit blood or dark particles that look
like coffee grounds.
STOP TAKING the medicine and tell your
doctor if you experience any of the
following uncommon effects:
• indigestion or heartburn
• pain in your stomach or any other
unusual stomach pains.
The following side effects may be
experienced when taking Ibuprofen tablets.
Infections
Very rare
• stiff neck, headache, nausea, vomiting,
fever and disorientation. This can be a
sign of inflammation of the brain.
Blood disorders
Very rare
• frequent infections, fever, bruising more
easily, feeling weak, sore throat, mouth
ulcers, nose bleeds, bleeding gums,
chills, tiredness, pale skin (often with a
yellow tinge), shortness of breath. This
maybe a sign of a blood disorder.
Metabolic disorders
Not known
• tiredness, confusion, and muscle weakness
and muscle cramps. This may be due to
low levels of potassium in your body
• tired, weak, confused and have muscles
that ache, are stiff or do not work well.
This may be due to low sodium levels in
your blood.
Psychiatric disorders
Not known
• depression
• feeling nervous or confused
• difficulty sleeping (insomnia)
• seeing or hearing things that are not
there (hallucinations).
Nervous system disorders
Uncommon
• headaches
Not known
• feeling dizzy
• feeling drowsy
• unusual feelings such as numbness,
tingling, pricking, burning or creeping on
the skin (paraesthesia).
Eye disorders
Not known
• changes in your vision
• inflammation of the eye.
Ear disorders
Not known
• ringing in the ears (tinnitus)
• feeling dizzy with a spinning feeling (vertigo).
Cardiac disorders
Not known
• high blood pressure
• fluid retention (swelling) that may cause
heart failure
• heart attack.
Vascular disorders
Not known
• inflammatory disease of the blood
vessels, which is often associated with a
skin rash or bruising
• stroke.
Respiratory disorders
Not known
• difficulty breathing, wheezing, tightness
in the chest.
Gastrointestinal disorders
Uncommon
• nausea (feeling sick)
Rare
• diarrhoea, wind, constipation
• vomiting (being sick)
Very rare
• infectious disease of the mouth,
characterised by shallow ulcers on the
cheeks, tongue and lips
• inflammation of the bowel or stomach
• perforation or bleeding of the gut

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4. Possible side effects

• burning, aching pain with an empty
feeling and hunger. This may be caused
by an ulcer in your stomach or gut
• inflammatory disease of the intestines, or
worsening of Crohn's disease
Not known
• severe stomach pain which may reach
through to your back. This could be a
sign of pancreatitis.
Liver disorders
Not known
• yellowing of your skin or eyes and your
urine may become darker in colour. This
could be a liver problem, such as
jaundice or hepatitis.
Skin disorders
Very rare
• itchy skin rash that can affect the mouth,
genitals, nails and hair
• blistering or peeling of the skin around
the lips, eyes, mouth, nose and genitals,
flu like symptoms and fever. This could
be a condition called Steven's Johnson
syndrome
Not known
• your skin may become more sensitive to
sunlight.
Kidney disorders
Very rare
• changes in the way the kidneys are working
• renal failure
Not known
• blood in the urine
• pain in the side or the small of the back.
General disorders
Not known
• general feeling of being unwell
• feeling tired.
Medicines
such as
Ibuprofen
tablets may
be associated
with a small
increased risk
of heart
attack
("myocardial
infarction") or stroke.
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
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.

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as soon as you remember. If it is almost
time for your next dose do not take the
missed dose at all. NEVER take a double
dose to make up for the one missed.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

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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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