nogen Pharma

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 200MGAND 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:

•

allergic reaction (e.g asthma, inflammation of the insides of the nose, swelling of the skin) to other NSAIDs like aspirin or diclofenac or any other ingredients in this medicine

•    Have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding in the past

•

perforation when previously taking NSAIDs

•

•    Are in the last 3 months of pregnancy

•    You have a condition which increases your tendency to bleeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before

taking this medicine ifyou:

•

•

condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs

•

e.g. hayfever

•

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)

•

as ulcerative colitis or Crohn's disease)

•

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.

Medicines such as Ibular 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 treatment. Do not exceed the recommended dose or duration of treatment. You should discuss your treatment with your doctor or pharmacist before taking Ibular Tablets ifyou:

• Have heart problems including heart failure, angina (chest pain) or you have had a heart attack, bypass surgery or peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries)

•    Have any kind of stroke or think that you might be at risk of these conditions (e.g. if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol or are a smoker).

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

Some medicines that are 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-ll receptorantagonists 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.

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

•    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)

•    Cholestyramine (a drug used to lower cholesterol)

•    Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)

•    Medicines to treat fungal infections such as voriconazole or fluconazole.

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 of600mg 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.

•    Ringing in ears (tinnitus)

•    Sensation of feeling dizzy or spinning (vertigo)

•    Mouth ulcers

•    Serious allergic reaction which causes swelling ofthe face or throat.

Rare (affects up to1 ina 1000 people):

•    Feeling depressed or confused

•    Fluid retention (oedema)

•    A brain infection called 'non-bacterial meningitis'

•    Loss of vision

•    Changes in blood count - the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, bleeding from the nose and the skin

•    Reduction in blood cells (anaemia)

•    Serious allergic reaction which causes difficulty in breathing or dizziness

•    Severe sore throat with high fever (agranulocytosis).

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side

effects, although not everyone gets them.

STOP TAKING Ibular Tablets and seek

immediate medical help ifyou experience:

•    Signs ofaseptic meningitis such as severe headache, high temperature, stiffness ofthe neck or intolerance to bright light.

•    Signs of intestinal bleeding such as

►    Passingbloodinyourfaeces (stools/motions)

►    Passing black tarry stools

►    Vomiting any blood or dark particles that look like coffee grounds

TELL YOUR DOCTOR AND STOP TAKING

IBULARTABLETS IFYOU EXPERIENCE:

•    Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling sickand/or vomiting

•    Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be symptoms ofan 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 ofskin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches, and feverishness).

Very rare (affects up to 1 in 10,000 people):

•    Liverfailure

•    Heart failure

•    Heart attack

•    Inflammation of the pancreas

•    Skin problems (which can also affect inside your mouth, nose or ears) such as 'Stevens-Johnson syndrome', 'toxic epidermal necrolysis' or 'erythema multiforme'

•    High blood pressure.

Not known (frequency cannot be estimated from available data):

• Worsening of ulcerative colitis or Crohn's Disease (inflammation of the colon).

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 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.

Do not use this medicine if you notice visible signs ofdeterioration.

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.

Medicines such as IbularTablets have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.

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

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

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

IbularTablets have also been shown to sometimes worsen the symptoms of Crohn's disease or colitis.

Other side effects

Common (affects uptol in10 people):

•    Rash

•    Feeling dizzy or tired

•    Stomach pain, indigestion, diarrhoea, feeling sick, being sick, wind, constipation

•    Headache - if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.

Uncommon (affects up to1 ina100 people):

•    Feeling drowsy

•    Feeling anxious

•    Feeling a tingling sensation or 'pins and needles'

•    Difficulty sleeping

•    Hives, itching

•    Skin becomes sensitive to light

•    Visual disturbances, hearing problems

•    Hepatitis, yellowing of your skin or eyes, reduced liver function

•    Reduced kidney function, inflammation of the kidneys, kidney failure

•    Sneezing, blocked, itchy or runny nose (rhinitis)

•    Stomach or gut ulcer, hole in the wall of the digestive tract

•    Inflammationofyourstomachlining

•    Small bruises on your skin or inside your mouth, nose or ears

•    Difficulty breathing, wheezing or coughing, asthma or worsening of asthma

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, 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)

1-20060, ITALY

This leaflet was last revised in August 2016.