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PATIENT INFORMATION LEAFLET

INFLAMID 25mg AND 50mg CAPSULES

Read all of this leaflet carefully before you start taking this medicine. o Keep this leaflet. You may need to read it again. o If you have further questions, ask your doctor or your pharmacist.

o This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

o If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Inflamid belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Inflamid works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles. Inflamid is used to relieve some symptoms caused by: o gout (pain and inflammation of the joints) o rheumatoid arthritis o osteoarthritis

o acute musculoskeletal disorders (e.g. sprains, strains and other injuries, such as backache and neckache) o lower back pain

o ankylosing spondylitis (arthritis of the spine) o degenerative hip disease o pain following bone and joint surgery o period pain

DO NOT take Inflamid Capsules if you:

o are allergic (hypersensitive) to Inflamid or any other ingredients in these capsules. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue

o suffer from severe heart failure, a disease of the heart that causes shortness of breath and swelling of the feet or legs due to fluid build up

o suffer from porphyria (disorder in which an important part of blood, haem, is not made properly) o have previously taken another NSAID (including aspirin) and suffered an allergic reaction including skin rashes, swelling (especially of the throat) or a runny nose o have a stomach ulcer or bleeding in your stomach, or have had more than one episode of stomach ulcers, stomach bleeding or perforation o suffer from severe liver or kidney disease

o suffer from nasal polyps (growths within the nose) o are pregnant or breast-feeding

Inflamid is NOT recommended for use in children.

If any of the above applies to you, you should NOT take Inflamid. Tell your doctor IMMEDIATELY.

Take special care with Inflamid Capsules if you:

o are taking other anti-inflammatory agents, including aspirin o suffer from asthma

o have kidney problems, especially if you are also elderly, have diabetes, have liver problems, have an infection or are taking other medicines which can affect the kidney o are elderly - you may be more susceptible to gastrointestinal bleeding and perforation o have bleeding disorders or blood clotting problems, or are taking any anticoagulants such as warfarin

o suffer from any diseases of the bowel such as Crohn’s disease or ulcerative colitis,

gastrointestinal cancers, diverticulitis (inflamed or infected pouches/ pockets in the colon) o suffer from any conditions of the liver or heart that cause fluid retention, or high blood pressure o suffer from a psychiatric disorder, epilepsy or parkinsonism (may be made worse if taking inflamid)

o suffer with systemic lupus erythematosus (SLE) or any other connective tissue disorder o develop an infection during treatment as inflamid may mask the signs of infection. Your doctor will prescribe antibiotics immediately if this occurs during your treatment o are receiving treatment with live vaccines

o notice changes to your eyes - you may need to have eye checks if you are taking this medicine for a long period of time o are due to have an operation

SPECIAL WARNING: Medicines such as Inflamid 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.

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Tell your doctor if any of the above apply to you.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription, herbal and homeopathic remedies.

It is especially important to mention if you are taking:

o aspirin or related medicines (salicylates) - used to relieve minor aches and pains, reduce inflammation and reduce fever o other NSAIDs including diflunisal

o antidepressants (e.g. selective serotonin reuptake inhibitors (SSRIs) e.g. citalopram, fluoxetine) o corticosteroids (e.g. cortisone, prednisone) o medicines to stop the blood clotting (e.g. warfarin) o medicines to treat diabetes (e.g. tolbutamide, chlorpropamide, glipizide)

o medicines to treat high blood pressure (e.g. furosemide, thiazide, triamterene, atenolol, bisoprolol, propranolol, captopril, quinapril, hydralazine, losartan, nifedipine) o lithium or haloperidol (medicines to treat mental illness)

o antiviral medicines (e.g. zidovudine or ritonavir) o medicines to treat heart conditions (e.g. digoxin)

o immunosuppressive drugs e.g. ciclosporin or tacrolimus (used after an organ transplant operation in order to reduce the risk of organ rejection)

o methotrexate (used to treat some cancers, severe psoriasis and severe rheumatoid arthritis) o desmopressin (hormone preparation used for night-time bed wetting) o mifepristone (used to induce abortion) o baclofen (muscle relaxant)

o pentoxifylline (used to improve blood flow through the blood vessels) o probenecid (used to treat gout)

o antacids (used to relieve heartburn, upset stomach or acid indigestion) o tiludronic acid (used to treat bone diseases) o quinolone antibiotics (e.g. ciprofloxacin)

Pregnancy and breast-feeding

DO NOT take Inflamid Capsules if you are pregnant or breast-feeding. Tell your doctor if you are planning to become pregnant or if you are having problems becoming pregnant. Always speak to your doctor or pharmacist before taking any medicine.

WARNING: Inflamid belongs to a group of medicines which may affect fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Inflamid will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Driving or using machines

This medicine may make you feel drowsy, dizzy, tired or affect your vision. If affected, do not drive or operate machinery.

Effects on laboratory tests

If you need to have any tests such as blood or urine tests, tell the doctor that you are taking Inflamid Capsules. You may need to stop taking this medicine before you have the test.

You should swallow the capsules whole with a glass of water with, or immediately after food. Always take Inflamid Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

DOSAGE

Adults

The usual adult dose is 50mg - 200mg daily.

Acute rheumatoid arthritis:

Initially 25mg two or three times a day.

Long term rheumatic disorders:

25mg two or three times daily increasing by 25mg up to 150mg daily, rarely more than 200mg daily is necessary.

Sudden flare up of long-term condition:

Up to 150 - 200mg daily.

Severe muscular aches and pains:

Initially 50mg two or three times daily, according to severity, usually for 10 - 14 days. Normally 150mg daily, rarely 200mg daily.

Lower back pain:

50mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.

Gout:

50mg three or four times daily until symptoms subside.

Following bone or joint surgery:

100 - 150mg daily in divided doses until symptoms subside.

Period pain:

Up to 75mg daily, continuing for as long as symptoms last.

Elderly

If you are elderly your doctor may prescribe a lower daily dose and reduce the duration of treatment.

Your doctor will see you more often while you are taking this medicine.

Children

Inflamid is not recommended for use in children.

Your doctor may advise you to take your medicine in a different way. You should always follow your doctor’s advice about when and how to take your medicine and always read the label.

If you take more of your medicine than you should

If you take more of your medicine than you should, contact your doctor or go to the nearest hospital accident and emergency department immediately. If an overdose has been taken there may be signs such as headache, feeling sick or being sick, stomach pain or bleeding, drowsiness, dizziness, ringing in the ears or fainting.

If you forget to take your medicine

If you forget to take your medicine, take it as soon as you remember, unless it is almost time for your next dose. DO NOT take a double dose to make up for a forgotten dose.

If you stop taking your medicine

Inflamid should only be used for the shortest period of time to control your symptoms. If you feel that you do not require this medicine anymore please talk to your doctor before you stop your treatment.

Like all medicines Inflamid Capsules can cause side effects in some patients, particularly when you first start taking it.

STOP taking Inflamid Capsules and talk to your doctor IMMEDIATELY or go to your nearest hospital emergency department if you:

o suffer any allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing

o experience severe abdominal pains (pain in your stomach) or other abnormal stomach symptoms including inflammation of the mouth, indigestion, ulceration of the intestines which can cause bleeding, obstruction or perforation, worsening of Crohn’s disease or ulcerative colitis o pass blood in your faeces (stools/ motions), pass black tarry stools o vomit blood or dark particles that look like coffee grounds

o suffer inflammation of the liver - symptoms include fever, fatigue, nausea, stomach pain, loss of appetite, dark coloured urine, light coloured stools o become jaundiced (yellowing of the skin and whites of the eyes)

o develop aseptic meningitis - symptoms include headache, fever, stiff neck, tiredness, feeling ill, eyes being sensitive to bright light o develop blistering or peeling of the skin

WARNING: Medicines such as Inflamid may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Other possible side effects

o Effects on the blood: changes in the numbers and types of blood cells (this will be seen in the results of blood tests), bruising, sore throat, nose bleeds, infections o Effects on the nervous system: fatigue, drowsiness, dizziness, headaches, problems with speech, fainting, nervousness, coma, light-headedness, vertigo, tiredness, hallucinations (seeing things that are not there), difficulty sleeping, depression, confusion, anxiety, mental disturbances, involuntary movements, loss of co-ordination, numbness and tingling, fits or worsening of fits and Parkinson’s syndrome (symptoms include tremor, stiffness and shuffling of the body) o Effects on the eye: pain in and around the eye, blurred or double vision, deposits on the front surface of the eye (cornea), poor vision and bright flashes of light or floating black spots o Effects on the ear: ringing or buzzing or other hearing disturbances (rarely deafness) o Effects on the heart: high or low blood pressure (symptoms include dizziness, fainting, lightheadedness, nausea, heart attack), chest pains, fast or irregular heartbeats and heart failure (symptoms include shortness of breath, tiredness, increased heart rate, flushing, swelling -especially of the ankles). Medicines such as inflamid may be associated with a small increased risk of heart attack or stroke.

o Effects on the stomach: feeling or being sick, anorexia, constipation or diarrhoea, flatulence o Effects on the skin: rash, sensitivity to light, worsening of psoriasis, hair loss, sweating o Effects on the kidneys: may be manifested by lower back pain, fever, pain while urinating, blood in urine or kidney failure, cloudy or light red urine, urinating more often, swelling in the ankles, legs, arms or hands, weakness, muscle cramps

o Other effects: worsening of asthma, increase in blood sugar, sugar in the urine, bleeding from the vagina, breast enlargement and tenderness, breast development in men, mouth ulcers, muscle/cartilage weakness

If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Do not use your medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Keep the capsules in the original container.

Protect your medicine from light, heat (store below 25^oC) and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

What Inflamid Capsules contain

The name of your medicine is Inflamid Capsules. Each capsule contains 25mg or 50mg of the active ingredient inflamid. Each capsule also contains starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, gelatin, yellow iron oxide (E172), and titanium dioxide (E171).

What Inflamid Capsules look like and contents of the pack

The 25mg strength capsule is ivory coloured and printed in black on the capsule is “INDO 25”.

The 50mg strength capsule is ivory coloured and printed in black on the capsule is “INDO 50”. Inflamid 25mg Capsules are available in packs of 28, 84, 100, 500 and 1000 capsules.

Inflamid 50mg Capsules are available in packs of 28, 84, 100, 250 and 500 capsules.

Not all pack sizes may be marketed.

Inflamid Capsules are available only on prescription from your doctor.

Marketing authorisation holder

Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.

PL 06453/0013 and PL 06453/0014 This leaflet was last revised April 2012.