IBUPROFEN 200 MG COATED TABLETS, IBULAR TABLETS 200 MG - patient leaflet, side effects, dosage

2. what you need to know before you take ibular tablets 200mg and 400mg

Do not take Ibular Tablets if you:

! Are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).

! Have previously had a reaction e.g. asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these types of medicines (NSAIDs including aspirin)

! 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 (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

! Have severe liver or kidney problems or have heart failure

! Are in the last 3 months of pregnancy

! Have a condition which increases your tendency to bleed.

Warning and precautions

Talk to your doctor, pharmacist or nurse before taking Ibular Tablets if you:

! Have an infection – please see heading „Infections“ below.

! Have kidney, heart, 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 you may be at risk of these condition (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)

! Are currently taking other NSAIDs.

Infections

Ibular Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibular Tablets may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Other warnings

Ibular Tablets belong 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.

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 Ibular Tablets if you: ! 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), 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

nogen Pharma

There is a risk of renal impairment in dehydrated children and adolescents.

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, pharmacist or nurse before taking this medicine.

Skin reactions

Serious skin reactions have been reported in association with ibuprofen treatment. You should stop taking Ibular Tablets and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

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 that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl­salicylic acid, warfarin, ticlopidine), 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 medicine. In particular you should tell your doctor or pharmacist of you are taking any of the following medicines in addition to those mentioned above.

Ibular Tablets may affect or be affected by some other medicines. For example:

! Aspirin or other non-steroidal anti-inflammatory 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

! Medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl­salicylic acid, warfarin, ticlopidine)

! Medicines that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).

Some other medicines may also be affected by the treatment of Ibular Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Ibular Tablets with other medicines.

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, tired or have 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, contact your doctor before taking this medicinal product.

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.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

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.

Use in children

The recommended daily dosage is 20 mg per kg of bodyweight, given in divided dose.

For children who weigh less that 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 If you have taken more Ibular Tablets than you should, or if children have taken this medicine by accident always contact a doctor or nearest 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, drowsiness, chest pain, palpitation, loss of consciousness, convulsion (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

If you forget to take Ibular 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. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

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

STOP TAKING Ibular Tablets and seek immediate medical help if you experience:

! 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.

! A red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibular Tablets if you develop these symptoms and seek medical attention

immediately. See also section 2.

TELL YOUR DOCTOR AND STOP TAKING IBULAR 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)

A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

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

Medicines such as Ibular Tablets 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).

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

Other side effects

Common (may affect up to 1 in 10 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 (may affect up to 1 in 100 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

! Inflammation of your stomach lining

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

! Difficulty breathing, wheezing or

coughing, asthma or worsening of

asthma

! Ringing in ears (tinnitus)

! Sensation of feeling dizzy or spinning (vertigo)

! Mouth ulcers

! Serious allergic reaction which causes swelling of the face or throat.

Rare (may affect up to 1 in 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).

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

! Liver failure

! 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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 label. 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. 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 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 substance ibuprofen.

The other ingredients are: Lactose (see section 2, “Ibular Tablets contain lactose and sucrose”), Povidone, Maize starch, Purified talc, Magnesium stearate, Colloidal Anhydrous Silica, Croscarmellose sodium, Macrogol, Calcium Carboante, Sucrose (see section 2, “Ibular Tablets contain lactose and sucrose”), Erythrosine E127, Titanium dioxide and carnauba wax.

What Ibular Tablets looks like and contents of the pack

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

Ibular 200mg and 400mg Tablets are supplied in PVC/Aluminium foil blister packs containing 14, 28, 30, 56, 60, 84, 90 and 100 tablets.

Ibular 200mg Tablets are supplied in securitainers containing 84 and 500 tablets.

Ibular 400mg Tablets are supplied in securitainers containing 84 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Ltd

Unit G4, Riverside Industrial Estate

Riverside Way, Dartford. DA1 5BS, United Kingdom

This leaflet was last revised in January 2021.

~z. LU