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IBUPROFEN 600 MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Ibuprofen 600 mg
film-coated tablets
IBUPROFEN

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 again.
• 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 is and what it is used for
2. What you need to know before you take
Ibuprofen tablets
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 is
and what it is used for
Ibuprofen tablets belong to a group of medicines
called NSAIDs (non-steroidal anti-inflammatory
drugs). Ibuprofen tablets reduces fever, relieves
pain and has an anti-inflammatory effect.
They can be used in symptomatic treatment of pain
and inflammation in rheumatoid arthritis (including
systemic Juvenile Idiopathic Arthritis [sJIA]),
osteoarthritis, seronegative arthropathies and in
painful swelling and inflammation after soft tissue
injuries.

2. What you need to know before
you take Ibuprofen tablets
Do not take Ibuprofen tablets:
• if you are allergic (hypersensitive) to ibuprofen or
any of the other ingredients of this medicine (listed
in section 6).
• if you are in the last three months of pregnancy.
• if you have an increased tendency to bleed.
• if you have severe liver and kidney disease.
• if you have severe heart failure or coronary heart
disease.
• if you have a stomach ulcer, duodenal ulcer, or if
you have had a stomach ulcer or duodenal ulcer
previously when treated with ibuprofen or a similar
product.
• if you have experienced allergic reactions (e.g.
breathing difficulties, nasal obstruction, rash) to
acetylsalicylic acid or other anti-inflammatory
drugs.
• If you are suffering from bleeding on the brain
(cerebrovascular bleeding) or other active
bleeding.
• if you are suffering from significant dehydration
(caused by vomiting, diarrhoea or insufficient fluid
intake).
• Ibuprofen 600mg tablets should not be given to
children younger than 12 years of age
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 tablets 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 of 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.
• Always aim for the lowest possible dose and
shortest possible treatment time to reduce the risk
of side effects. It is generally the case that higher
than recommended doses can entail risks. This
also means that the combination of several NSAID
products at the same administration time should
be avoided.
• People who have or have had the following
illnesses or symptoms should consult a doctor
before starting treatment with Ibuprofen tablets:
systemic lupus erythematosus (connective tissue
disease), impaired kidney or liver function, mild to
moderate heart failure, asthma, inflammatory
bowel diseases, previous stomach ulcer or other
increased tendency to bleed.
• Like other anti-inflammatory drugs, Ibuprofen
tablets can mask signs of infection.
• This product belongs to a group of medicines
(NSAIDs) which may impair the fertility in women.
This effect is reversible on stopping the medicine.
• Patients who have previously had gastrointestinal
tract problems, especially elderly patients, should
contact a doctor in the event of abdominal
symptoms, particularly at the start of treatment.
• Serious skin reactions have been reported in very
rare cases when using a NSAID. Patients seem to
be at highest risk early in the course of therapy,
the onset of the reaction occurring in the majority
of cases in the first month of treatment. Stop taking
Ibuprofen tablets and contact a doctor if you
develop a rash or mucous membrane lesions.
• In patients with Systemic lupus erythematosus and
mixed connective tissue disorders there may be an
increased risk of aseptic meningitis.
• Stop taking Ibuprofen tablets and contact a doctor
immediately if you develop any of the following
symptoms (angioedema)
• swelling of the face, tongue or throat,
• difficulties swallowing,
• hives and difficulties breathing.
• Medicines like Ibuprofen tablets may entail a
slightly increased risk of heart attack or stroke.
This increased risk is more likely when using high
doses and in long-term treatment. Do not exceed
the recommended dose or treatment time.
• Consult a doctor or pharmacist about your
treatment if you have heart problems, if you
previously have had a stroke or if you think that
you have an increased risk for these conditions
(for example, if you have high blood pressure,
diabetes, high cholesterol levels or if you smoke).
• Do not take Ibuprofen tablets if you are planning a
pregnancy. Consult your doctor first.
• During varicella it is advisable to avoid use of this
drug.
• Serious skin reactions have been reported in very
rare cases when using a NSAID. Stop taking
Ibuprofen tablets and contact a doctor if you
develop a rash or mucous membrane lesions. The
severe rashes may include blisters on the skin,
especially on the legs, arms, hands and feet which
can also involve the face and lips (erythema
multiforme, Stevens-Johnson´s syndrome). This
can get even more severe, where the blisters get
larger and spread out and parts of the skin may
slough off (toxic epidermal necrolysis). There may
also be severe infection with destruction (necrosis)
of skin, subcutaneous tissue and muscle.
• Ibuprofen tablets may cause a reduction in the
number of white blood cells and your resistance to
infection may be decreased. If you experience an
infection with symptoms such as fever and serious

deterioration of your general condition, or fever
with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you
should see your doctor immediately. A blood test
will be taken to check possible reduction of white
blood cells (agranulocytosis). It is important to
inform your doctor about your medicine.
• If you have been told by your doctor that you have
intolerance to some sugars.
Children and adolescents
There is a risk of renal impairment in dehydrated
children and adolescents.
Other medicines and Ibuprofen tablets:
Do not use different types of pain-relieving
medicines at the same time unless directed by a
doctor.
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines, including medicines obtained without a
prescription.
Ibuprofen tablets may affect or be affected by some
other medicines. For example:
- tumours and immune system disorders
(methotrexate, tacrolimus, ciclosporin,
pemetrexed),
- manic depressive illness (lithium),
- irregular heart beat (digoxin),
- pain (acetylsalicylic acid),
- medicines that are anti-coagulants (i.e. thin
blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine, dicumarol),
- depression (medicines called SSRIs),
- medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, beta-blockers
such as atenolol medicines, angiotensin-II receptor
antagonists such as losartan)
- inflammation (corticosteroids).
- fungal infections (antifungals particularly
voriconazole or fluconazole)
- diabetes mellitus (sulphonylureas)
- human immunodeficiency virus (HIV) infection
(zidovudine, ritonavir)
- antibiotic (quinolones such as ciprofloxacin)
- aminoglycosides (a type of antibiotic)
- mifepristone
- probenecid
- any other ibuprofen preparations, such as those
you can buy without a prescription
- any other anti-inflammatory pain killer, including
acetylsalicylic acid
- cholestyramine (a drug used to lower cholesterol)
- Gingko biloba herbal medicine (there is a chance
you may bleed more easily if you are taking this
with ibuprofen).
For this reason, the doctor treating you needs to
know about all the medicines you are taking.
Some other medicines may also affect or be
affected by the treatment of Ibuprofen tablets. You
should therefore always seek the advice of your
doctor or pharmacist before you use Ibuprofen
tablets with other medicines.
Ibuprofen tablets with food and drink
Ibuprofen tablets could be used together with food
and drinks.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
Pregnant women should not use Ibuprofen tablets
during the three final months of the pregnancy. Use
of Ibuprofen tablets should be avoided by women
who are planning a pregnancy or are pregnant.
Treatment at any time in pregnancy should only take
place as directed by a doctor.
Breast-feeding
Ibuprofen tablets passes into breast milk. The use of
Ibuprofen tablets is therefore not recommended
while breast-feeding. However, consult a doctor if
using Ibuprofen tablets more than occasionally while
breast-feeding is required.
Fertility
The use of Ibuprofen tablets may affect fertility. The
use of Ibuprofen tablets is not recommended while
attempting to conceive or during investigation of
infertility.
Driving and using machines
Ibuprofen tablets may impair reactions in some
people. This should be taken into consideration on
occasions when high alertness is required.
Undesirable effects such as dizziness, drowsiness,
fatigue and visual disturbances are possible after
taking NSAIDs. If affected, patients should not drive
or operate machinery.
You alone are responsible to decide if you are in fit
condition to drive a motor vehicle or perform other
tasks that demand increased concentration.
Because of their effects or undesirable effects, one
of the factors that can reduce your ability to do these
things safely is your use of medicines. Descriptions
of these effects can be found in other sections.
Read all the information in this leaflet for guidance.
Discuss with your doctor, nurse or pharmacist if you
are unsure about anything.
Ibuprofen tablets contains lactose monohydrate
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. You should check with your doctor or
pharmacist if you are not sure.
Take your ibuprofen tablets with or after food, with
plenty of fluid. Ibuprofen tablets should be
swallowed whole and not chewed, broken, crushed
or sucked on to avoid oral discomfort and throat
irritation
Adults and adolescents (12 years and older, >40kg):
Rheumatic diseases
One 600 mg tablet three times daily. An interval of
at least 4-6 hours should be allowed between
doses. Some patients can be maintained on
600-1200mg daily. In severe or acute conditions, it
can be advantageous to increase the dosage until
the acute phase is brought under control, provided
that the total daily dose does not exceed 2400mg in
divided doses. This tablet cannot be halved and in
some instances a different strength or formulation
of ibuprofen must be used.
Juvenile Rheumatoid Arthritis
Adolescents over 12 years of age (>40 kg): The
recommended dose is 20-30mg/kg body weight
daily in 3 to 4 divided doses up to a maximum of 40
mg/kg body weight daily in severe cases. Ibuprofen
600mg tablet is not suitable for children and
adolescents younger than 12 years of age as
correct dosing is not possible.
If you have severe liver and kidney disease or are
elderly your doctor will tell you the correct dose to
take which will be the lowest dose possible.
If you take more Ibuprofen tablets than you
should
If you have taken more Ibuprofen tablets than you
should, or if children have been taken medicine by
accident always contact a doctor or hospital to get
an opinion of the risk and advice on action to be
taken.

The symptoms can include nausea, stomach pain,
vomiting (may be blood streaked), headache,
ringing in the ears, confusion and shaky eye
movement. At high doses, loss of consciousness,
convulsions (mainly in children), weakness and
dizziness, blood in urine, cold body feeling, and
breathing problems have been reported.
If you forget to take Ibuprofen tablets
Do not use 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.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Ibuprofen tablets and contact a
doctor immediately if you develop any of the
following symptoms
- signs of angioedema such as
• swelling of the face, tongue or throat,
• difficulties swallowing,
• hives and difficulties breathing.
- 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 (stools/motions),
• passing black tarry stools,
• vomiting any blood or dark particles that look like
coffee grounds.
Tell your doctor and stop taking Ibuprofen
tablets if you experience:
- 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 as
agranulocytosis).
- Blurred or disturbed vision (visual impairment) or
seeing/hearing strange things (hallucinations).
- 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 tablets have been
associated with a small increased risk of heart
attack (myocardial infarction) or stroke.

5. How to store Ibuprofen tablets
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which
is stated on the blister or carton. The expiry date
refers to the last day of that month.
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.

6. Contents of the pack and other
information
What Ibuprofen tablets contains
The active substance is ibuprofen.
Each film-coated tablet contains 600 mg ibuprofen
The other ingredients are:
Tablet core:
Lactose monohydrate, maize starch, croscarmellose
sodium, colloidal anhydrous silica, microcrystalline
cellulose, magnesium stearate.
Tablet coating:
Hypromellose, triacetin, titanium dioxide (E171),
erythrosine aluminum lake (E127).
What Ibuprofen tablets looks like and contents
of the pack
Ibuprofen 600 mg film-coated tablets are pink
coloured, oblong shape, approximately 19 mm in
length, 8 mm in width, biconvex film coated tablets
debossed with ‘DL’ separated by breakline on one
side and plain on other side. The score line is not
intended for breaking the tablet.
Ibuprofen 600 mg tablets are packaged in PVC Aluminium blisters or PVC/PVdC – Aluminium
Blisters.
Pack sizes: 10, 14, 21, 28, 30, 40, 42, 50, 60, 84,
100 or 500 film-coated tablets in carton.
Not all pack sizes may be marketed.
Marketing Authorisation holder:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom

Medicines such as Ibuprofen tablets have in
exceptional cases been associated with severe skin
problems for patients with chicken pox or shingles

Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom

Blood disorders, kidney problems, liver problems or
severe skin reactions may occur rarely with
ibuprofen.

Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary

Very rarely Ibuprofen tablets may cause aseptic
meningitis (inflammation of the protective membrane
surrounding the brain).

This medicinal product is authorised in the
Member States of the EEA under the
following names:

Ibuprofen tablets has also been shown to
sometimes worsen the symptoms of Crohn's
disease or colitis.

Member States
United Kingdom

Other side effects
Common (may affect up to 1 in 10 people):
- Headache, lightheadedness.
- Gastrointestinal side effects (indigestion,
diarrhoea, nausea, vomiting, abdominal pain,
flatulence, constipation, black stools, bleeding in
stomach and intestine, vomiting blood).
- Rash.
- Tiredness.
Uncommon (may affect up to 1 in 100 people):
- Rhinitis, insomnia, anxiety.
- Visual disturbances, hearing impairment.
- Difficulty breathing, bronchial spasm, asthma.
- Mouth ulceration. Stomach ulcer, ruptured
stomach ulcer, inflammation of mucous membrane
of stomach.
- Hepatitis. Jaundice. Abnormal liver function.
- Hives, itching, small bruises in skin and mucous
membranes.
- Photosensitivity.
- Impaired kidney function.
- Drowsiness.
- Tingling sensation.
- Hearing loss.
- Anaemia (a reduction in red blood cells or
hemoglobin, which can make the skin pale and
may lead to weakness).

Austria
Bulgaria
Estonia
Finland
Ireland
Italy
Malta
Netherland
Sweden
France

Proposed (Invented) Names
Ibuprofen 200/400/600 mg
Film-coated Tablets
Ibuprofen Accord 400/600 mg
Filmtabletten
Ibuprofen Акорд 200/400/600 мг
филмирани таблетки
Ibuprofen Accord
Ibuprofen Accord 400/600 mg
tabletti, kalvopäällysteinen
Ibuprofen 200/400/600 mg
Film-coated Tablets
Ibuprofene Accord
Ibuprofen 200/400/600 mg
Film-coated Tablets
Ibuprofen Accord 200/400/600 mg
Filmomhulde tabletten
Ibuprofen Accord 200/400 mg
filmdragerade tabletter
Ibuprofene Accord 200/400 mg,
comprimés pelliculés

The leaflet was last revised in 07/2016.

Rare (may affect up to 1 in 1,000 people)
- Non-bacterial meningitis.
- Allergic reaction.
- Depression, confusion.
- Impaired vision, dizziness
- Liver damage and fluid retention in body.
- Changes in blood count including agranulocytosis.
- Tinnitus (ringing in ears) and vertigo.
Very rare (may affect up to 1 in 10,000 people):
- Inflammation of the pancreas, liver failure.
- Skin and mucous membrane changes (sometimes
severe) such as epidermal necrolysis and/or
erythema multiforme.
Not known (frequency cannot be estimated from the
available data):
- Exacerbation of Colitis and Crohn’s Disease.
- Cardiac failure.
- Myocardial infarction.
- Hypertension.
Please note that Ibuprofen tablets can prolong
bleeding time.
There have been reports of high blood pressure and
heart failure as well as worsening of ulcers in the
large intestine and Crohn’s disease (inflammatory
bowel disease) in treatment with pain-relieving
medicines (NSAIDs).
Exceptional serious infections of the skin in case of
varicella. Exacerbation of infection-related
inflammations (e.g. development of necrotising
fasciitis) coinciding with the use of NSAIDs has
been described.
Medicines like Ibuprofen tablets may entail a slightly
increased risk of heart attack or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via
United Kingdom
Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie,
e-mail: medsafety@hpra.ie
Malta
ADR Reporting,
Website: ww.medicinesauthority.gov.mt/adrportal.
By reporting side effects you can help provide more
information on the safety of this medicine.

INP001
10 00000 0 000000

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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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