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IBULAR TABLETS 400MG

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibular Tablets 200mg and 400mg
{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, pharmacist or nurse.
! 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet, see section
4.
What is in this leaflet
1. What Ibular Tablets 200mg and 400mg are
and what they are used for
2. What you need to know before you take
Ibular Tablets 200mg and 400mg
3. How to take Ibular Tablets 200mg and
400mg
4. Possible side effects
5. How to store Ibular Tablets 200mg and
400mg
6. Contents of the pack and other information
1. WHAT IBULAR TABLETS 200MG AND
400MG ARE AND WHAT THEY ARE USED
FOR
Ibular Tablets belong to a group of medicines
called Non-steroidal anti-inflammatories (NSAIDs).
They work by relieving pain, reducing
inflammation, swelling and fever.
Ibular Tablets are used in the treatment of
rheumatoid arthritis, including juvenile rheumatoid
arthritis, ankylosing spondylitis, osteoarthrosis and
other non-rheumatoid arthropathies.
These tablets can also be used to treat capsulitis,
bursitis, tendinitis, tenosynovitis, low back pain,
and soft tissue injuries such as sprains and strains.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE IBULAR TABLETS 200MG AND
400MG
Do not take Ibular Tablets:
If you are allergic to or have ever had an
allergic reaction to (e.g. asthma, inflammation
of the insides of the nose, swelling of the skin)
ibuprofen, aspirin, other NSAIDS (e.g.
diclofenac) or any of the other ingredients of
this medicine (listed in section 6)
! Have (or have had two or more episodes of) a
stomach ulcer, perforation or bleeding in the
past
! Have had gastrointestinal bleeding or
perforation when previously taking NSAIDs
! Suffer from severe liver, kidney or heart failure
! Are in the last 3 months of pregnancy.

!

Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking this medicine if you:
! Have kidney, liver or bowel problems
! Have Systemic Lupus Erythematosus (SLE) a
condition of the immune system affecting
connective tissue resulting in joint pain, skin
change and disorders of other organs
! Are asthmatic or suffer from allergic reactions
e.g. hayfever
! Are in the first 6 months of pregnancy
! Have heart problems, have had a previous
stroke or think that you may be at risk of these
conditions (for example if you have high blood
pressure, diabetes or high cholesterol or are a
smoker)
! Have a history of gastrointestinal disease (such
as ulcerative colitis or Crohn's disease).

Other warnings:
Ibular Tablets belongs to a group of medicines
which may impair female fertility. This is reversible
on stopping the medicine. It is unlikely that Ibular
Tablets used occasionally will affect your chances
of becoming pregnant. However, tell your doctor
before taking this medicine if you have problems
becoming pregnant.
Ibular Tablets may be associated with a small
increased risk of heart attack or stroke. Any risk is
more likely with high doses or prolonged treatment.
Do not exceed the recommended dose or duration
of treatment.
There is an increased risk of the elderly having
side effects.
If you are not sure if any of the above apply to
you, talk to your doctor, or pharmacist or nurse
before taking this medicine.
Other medicines and Ibuprofen
Some medicines may affect or be affected by
treatment with Ibuprofen.
You should avoid taking these tablets with the
following:
! Aspirin or other non-steroidal antiinflammatory drugs (NSAIDs) for pain relief
! Corticosteroids (e.g hydrocortisone) given to
treat a variety of conditions such as allergies
and hormone imbalances
! Quinolones e.g ciprofloxacin (antibiotics
used to treat infections) may cause fits and
aminoglycosides (e.g. gentamicin) used to
treat infections
! Gingko biloba the herbal extract used to treat
memory disturbances
! Anticoagulants such as warfarin to prevent
bleeding. If taking these at the same time is
unavoidable you will be closely monitored by
your doctor
! Cardiac glycosides such as digoxin (used for
some heart conditions) may worsen heart
failure
! Diuretics (water tablets) effects may be
decreased. Potassium sparing diuretics may
increase the blood level of potassium
! Ciclosporin or tacrolimus (medicines used to
prevent rejection after transplant) - may harm
kidney function
! Lithium (medicine to treat depression) or
digoxin (medicine to treat impaired heart
function) increase in blood levels of these
medicines
! Selective serotonin reuptake inhibitors
(SSRIs) e.g fluoxetine used to treat depression
! Mifepristone (used to induce abortion).
NSAIDs should not be used 8-12 days after
taking mifepristone as NSAIDs can reduce
mifepristone's effectiveness
! Methotrexate (to treat psoriasis, rheumatoid
arthritis and certain tumors)
! Medicines to treat HIV (e.g. zidovudine)
! ACE-inhibitors e.g captopril (medicines used
to treat high blood pressure). Blood pressure
lowering effect may be reduced.
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.
Ibular Tablets should not be used in late pregnancy
(the last three months) and should only be taken in
the first six months of pregnancy on the advice of
your doctor.

Driving and using machines
These tablets may make you feel dizzy, drowsy
and you may have a headache or visual
disturbances. If you think that you are affected
after taking these tablets do not drive or operate
machinery until you feel better.
Ibular Tablets contain lactose and sucrose
If you have been told by your doctor that you have
an intolerance to some sugars you should talk to
your doctor before taking this medicine.
3. HOW TO TAKE IBULAR TABLETS 200MG
AND 400MG
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
Take your tablets with or after food, with a glass of
water. The tablets should be swallowed whole.
Adults:
The recommended initial dose is 1,200mg daily in
divided doses.
A maintenance dose of 600mg to 1,200mg daily
may be prescribed.
For more severe conditions your doctor may
prescribe up to 1,600mg daily until your condition
is under control.
Children:
The usual daily dosage is 20 mg per kg of
bodyweight, given in divided doses.
For children who weigh less than 30kg the
maximum dose in 24 hours is 500mg.
Your doctor will decide on the dose.
If you take more Ibular Tablets than you should
You should contact a doctor or go to the nearest
hospital casualty department IMMEDIATELY
taking your tablets with you.
If you forget to take your tablets
Take them as soon as you remember, unless it is
almost time for your next dose. If it is, do not take
the missed dose at all. Never double up on a dose
to make up for the one you have missed.
If you have any further questions on the use of this
medicine, ask your doctor, or pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS

!

Pains in your stomach or other
unusual stomach problems.

TELL YOUR DOCTOR if you have any of
the following side effects:
! Allergic reactions such as skin
rashes, itching and peeling
! Headaches
! Flatulence (wind), diarrhoea,
constipation
! Changes in your blood (which will be
identified in a blood test) such as
unexplained or unusual bruising or bleeding,
fever, sore throat, mouth ulcers, flu-like
symptoms and severe exhaustion
! Stomach or intestinal ulcers, sometimes with
bleeding and perforation, inflammation of the
lining of the mouth with ulceration (ulcerative
stomatitis), inflammation of the stomach
(gastritis)
! Swelling (oedema), high blood pressure, heart
failure or attack
! Worsening of colitis and Crohn's disease
! Blurred or disturbed vision or seeing/hearing
strange things
! Ringing in the ears, feeling of a 'spinning
sensation' (vertigo)
! Depression, confusion, tingling of hands and
feet, difficulty sleeping, malaise.
Medicines such as Ibular Tablets have been
associated with a small increased risk of heart
attack (myocardial infarction) or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes 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.
5. HOW TO STORE IBULAR TABLETS 200MG
AND 400MG
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Store in a cool dry place.

Like all medicines, this medicine can cause side
effects, although not everyone gets them.

Do not use this medicine if you notice visible signs
of deterioration.

If you suffer from any of the following at any time
during your treatment STOP TAKING Ibular
Tablets and SEEK IMMEDIATE MEDICAL HELP:
! Signs of intestinal bleeding such as bright red
faeces (stools/motions), black tarry stools,
vomiting blood or dark particles that look like
coffee grounds
! Signs of a serious allergic reaction such as:
, Difficulties in breathing or unexplained
wheezing
, Dizziness
, Severe forms of skin reactions such as
itchiness, Stevens-Johnson syndrome
(symptoms include flushing, fever, blisters
and ulcers), Toxic Epidermal Necrolysis
(symptoms include reddening, peeling and
swelling of the skin often resembling
burns), Erythema multiforme (symptoms
include circular, irregular red patches of
skin) and photosensitivity reactions with
unexpected sunburn or a dry, bumpy or
blistering rash on sun-exposed skin
, Swelling of the face, tongue or throat
! Signs of kidney problems such as
, Passing less or more urine
, Cloudy urine or blood in the urine
, Pain in the back and or swelling
(particularly in the legs)
! Signs of aseptic meningitis with symptoms
such as neck stiffness, headache, feeling sick,
being sick, fever or feeling disorientated.
Patients with existing autoimmune disorders
(e.g. lupus, mixed connective tissue disease)
may be more likely affected
! Signs of liver problems such as yellowing of
the skin or whites of the eyes (jaundice).

Do not throw away any medicines via wastewater
or household waste. Return any left over tablets to
your pharmacist. These measures will help protect
the environment.

STOP TAKING the tablets and tell your doctor if
you experience the following side effects:
! Indigestion, heartburn, feeling sick or being
sick

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Ibular Tablets contain
! The active substance is Ibuprofen.
! Each Ibular 200mg Tablet contains 200mg of
the active ingredient ibuprofen.
! Each Ibular 400mg Tablet contains 400mg of
the active ingredient ibuprofen.
The other ingredients are: lactose, povidone,
maize starch, talc, magnesium stearate, colloidal
sodium, gelatin, macrogol 1540, calcium
carbonate, sucrose and erythrosine E127.
What Ibular Tablets looks like and contents of
the pack
Ibular Tablets 200mg and 400mg are pink, circular
sugar coated tablets.
Coated tablets are supplied in securitainers
containing 14, 28, 30, 56, 60, 84, 90, 100 and 500
tablets.
Marketing Authorisation Holder
Ennogen Pharma Ltd
Unit G4, Riverside Industrial Estate
Riverside Way, Dartford, DA1 5BS, United
Kingdom
Manufacturer
Sofar SPA
Via Firenze 40, Trezzano Rosa (MI)
I-20060, ITALY
This leaflet was last revised in January 2015.

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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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