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 ofthe insides ofthe nose, swelling ofthe 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).

nogen Pharma

Otherwarnings:

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 treatmentwith 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 orvisual 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.

Ifyou take more IbularTablets 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.

•    Pains in your stomach or other unusual stomach problems.

TELL YOUR DOCTOR if you have any of

the following side effects:    m

•    Allergic reactions such as skin    _m

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 ofthe lining ofthe 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 IbularTablets 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

4. POSSIBLE SIDE EFFECTS

Keep this medicine out ofthe sight and reach ofchildren.

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 ofdeterioration.

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 ofa 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 ora 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, feverorfeeling 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).

STOP TAKING the tablets and tell your doctor if

you experience the following side effects:

•    Indigestion, heartburn, feeling sick or being sick

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 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

IbularTablets 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 (Ml)

I-20060, ITALY

This leaflet was last revised in January 2015.