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IBULAR TABLETS 400 MG

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT USER
Ibular Tablets 200mg and Ibular Tablets 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.
2.
3.
4.
5.
6.

1.

What Ibular Tablets 200mg and 400mg are and what they are used for
What you need to know before you take Ibular Tablets 200mg and 400mg
How to take Ibular Tablets 200mg and 400mg
Possible side effects
How to store Ibular Tablets 200mg and 400mg
Contents of the pack and other information

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, rhinitis,
angioedema) 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 Ibular Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines called anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/
acetylsalicylic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor
antagonists such as losartan) and other medicines may affect or be affected by treatment
with Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before
you use Ibuprofen with other medicines.
In particular you should tell your doctor or pharmacist if you are taking any of the following
medicines in addition to those mentioned above:
 Diuretics (water tablets)
 Cardiac glycosides, such as digoxin, used to treat heart conditions













Lithium
Zidovudine (an anti-viral drug)
Steroids (used in the treatment of inflammatory conditions)
Methotrexate (used to treat certain cancers)
Medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to
dampen down your immune response)
Medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the
treatment of depression
Antibiotics called quinolones such as ciprofloxacin
Aminoglycosides (a type of antibiotic)
Mifepristone
Any other anti-inflammatory pain killers, including aspirin and other Ibuprofen
medicines
Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are
taking this with ibuprofen).

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.
Important information about some of the ingredients in this medicine
This medicine contains 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

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.
The label on the box will tell you exactly how much this will be.
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

Like all medicines, this medicine can cause side effects, although not everybody gets them. You
can minimise the risk of side effets by taking the least amount of tablets for the shortest amount
of time necessary to control your symptoms.
If you suffer from any of the following at any time during your treatment STOP TAKING
Ibular Tablets and SEEK IMMEDIATE MEDICAL HELP:
• Severe headache, high temperature, stiffness of the neck or intolerance to light
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds.
TELL YOUR DOCTOR AND STOP TAKING THE TABLETS IF YOU EXPERIENCE:
• Unexplained stomach pain or other abnormal stomach symptoms, indigestion, heartburn,
feeling sick and/or vomiting
• Unexplained wheezing, shortness of breath, skin rash, itching or bruising
• Yellowing of the eyes and/or skin
• Severe sore throat with high fever
• Blurred or disturbed vision or seeing/hearing strange things
• Fluid retention (e.g. swollen ankles).
Medicines such as Ibular Tablets have been associated with a small increased risk of heart attack
(myocardial infarction) or stroke.
Blood disorders, kidney problems or liver problems may occur rarely with Ibuprofen.
Severe skin reactions such as Stevens Johnson Syndrome with symptoms such as flushing, fever,
blisters and ulcers, Toxic Epidermal Necrolysis with symptoms of reddening, peeling and

swelling of the skin often resembling burns, Erythema multiforme with symptoms of circular,
irregular red patches on the skin and photosensitivity reactions with unexpected sunburn or a dry,
bumpy or blistering rash on sun-exposed skin (face, neck, arms, backs of hands and often lower
legs and feet). The rash may or may not be itchy.
Very rarely Ibular Tablets may cause aseptic meningitis (inflammation of the protective
membrane surrounding the brain).
Other side effects may include headache, hallucinations, dizziness, tingling of hands and feet,
ringing in the ears, depression, confusion, difficulty sleeping, anxiety, impaired hearing,
diarrhoea, constipation, flatulence (wind), unexpected sensitivity of the skin to the sun,
tiredness, malaise, mood swings and swelling and irritation inside the nose.
Ibular Tablets have also been shown to sometimes worsen the symptoms of Crohn’s disease or
colitis.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

5.

HOW TO STORE IBULAR TABLETS

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

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 conatins 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
Ibuprofen 200mg and 400mg Tablets are pink, circular sugar coated tablets.

Coated tablets 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 2014

Expand Transcript

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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