PACKAGE LEAFLET: INFORMATION FOR THE USER

DUEXIS® 800 mg/26.6 mg film-coated tablets (ibuprofen and famotidine)

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    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.

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

Important things you need to know about your medicine:

•    DUEXIS is used for the relief of pain, swelling, redness and heat (inflammation) in people suffering from osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

•    DUEXIS should only be prescribed for you if all the following statements apply to you:

o a lower dose of ibuprofen, or another non-steroidal anti-inflammatory drug (NSAID) is unlikely to improve your pain o you require regular treatment with a NSAID

o you are at risk of getting peptic ulcers (ulcers in your stomach or duodenum) when taking NSAIDs o treatment with a proton pump inhibitor (a group of medicines that reduces stomach acid) is not appropriate for you

•    DUEXIS must be taken three times daily. If you miss a dose, you are more likely to develop a gastric or duodenal ulcer.

•    If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and get medical help at once:

o You pass blood in your faeces (stools, motions) o You pass black tarry faeces

o You vomit any blood or dark particles that look like coffee grounds

•    Read the rest of this leaflet before taking DUEXIS

In this leaflet:

1.    What DUEXIS is and what it is used for    4.

2.    Before you take DUEXIS    5.

3.    How to take DUEXIS    6.

1. What DUEXIS is and what it is used for

What DUEXIS is

DUEXIS contains two different medicines called ibuprofen and famotidine in a single tablet. Each of these medicines works in a different way.

•    Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It reduces pain and inflammation.

•    Famotidine belongs to a group of medicines called H2-blockers. It decreases the amount of acid in your stomach therefore reducing the risk of peptic ulcers (ulcers in your stomach or duodenum) which may develop in patients who need to take NSAIDs.

What DUEXIS is used for

DUEXIS is used for the relief of pain, swelling, redness and heat (inflammation) in people suffering from osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

You will be given this medicine if

•    a lower dose of ibuprofen, or another NSAID, is considered unlikely to improve your pain,

•    you require regular treatment,

•    you are at risk of getting ulcers in your stomach (gastric ulcer) and/or in the first part of your intestine (duodenal ulcers) when taking NSAIDs, and

•    if treatment with a proton pump inhibitor is not considered appropriate.

You must take this medicine three times daily to provide a high enough level of famotidine, which protects against gastric side effects. This protection may be less if a dose is missed.

2. Before you take DUEXIS

Do not take DUEXIS if you:

•    are allergic (hypersensitive) or have had an allergic reaction to ibuprofen, aspirin or other NSAIDs. An allergic reaction may include rash, itching, swelling of face, lips, or hands/feet, or breathing difficulties.

•    are allergic (hypersensitive) to famotidine or other H2-blockers, or any of the other ingredients of this medicine (listed in section 6).

•    are in the last 3 months of pregnancy (third trimester).

•    have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach.

•    have moderate or severe problems with your kidney.

•    have severe problems with your heart or liver.

•    have any bleeding disorder or serious and unexpected bleeding.

Do not take DUEXIS if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Take special care with DUEXIS

You must not take DUEXIS and talk to your doctor straight away if any of the following happen to you before or while you are taking DUEXIS, as this medicine may hide the symptoms of other disease:

•    you lose a lot of weight for no reason and have problems swallowing.

•    you start to vomit food or blood.

•    you pass black, tarry stools or have bloody diarrhoea.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.

Check with your doctor or pharmacist before taking this medicine if you:

•    are elderly, because of increased risks of side effects.

•    have inflammation of your intestines (Crohn's disease or ulcerative colitis).

•    have mild kidney problems, or mild to moderate liver problems, because of an increased risk of side effects. Your doctor may check your blood count, and liver and kidney function.

•    have problems with your blood clotting or you are taking medicines to thin the blood.

•    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.

•    have or have ever had asthma.

•    have any other problems taking lactose, rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or not able to absorb glucose-galactose.

Tell your doctor or pharmacist if any of the above applies to you.

If you have previously had a stomach ulcer or bleeding you should let your doctor know. You should report any stomach pain or nausea to your doctor.

Discuss your treatment with your doctor or pharmacist if you

•    have heart problems,

•    had previously had a stroke or

•    think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker).

Medicines such as DUEXIS may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long lasting treatment. Therefore, do not exceed the recommended dose or length of treatment (see section 3).

Children

DUEXIS is not recommended for use in children.

Taking other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription, including herbal medicines. DUEXIS and other medicines may affect each other causing serious side effects and/or affect the way they each work.

Tell your doctor or pharmacist if you are taking any of the following medicines:

•    acetylsalicylic acid (aspirin): if you take low dose aspirin you can still take DUEXIS

•    other NSAID medicines (including those called COX-2 inhibitors)

•    atazanavir or zidovudine (used to treat HIV)

•    ketoconazole or itraconazole (used to treat infections caused by a fungus)

•    antacids (used to treat increased stomach acid)

•    quinolone antibiotic (for infections), such as ciprofloxacin or moxifloxacin

•    lithium (used to treat some types of depression)

•    methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer)

•    probenecid (used to treat gout)

•    sucralfate (used to treat ulcers)

•    mifepristone (medication for pregnancy termination)

•    selective serotonin reuptake inhibitors (SSRIs) (used to treat major depression or anxiety disorder)

•    ciclosporin or tacrolimus (medicines used to reduce the body's immune reactions)

•    digoxin (used to treat heart disorders)

•    medicines used to treat high blood pressure, including diuretics (such as furosemide or hydrochlorothiazide) and ACE inhibitors (such as enalapril)

•    corticosteroid medicines (anti-inflammatory medicines) such as hydrocortisone or prednisolone

•    medicines to stop your blood clotting, like warfarin, dicoumarol, heparin or clopidogrel

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking DUEXIS or any other medicine.

Taking DUEXIS with food and drink

You can take this medicine at any time of the day, with or without food.

Pregnancy and breast-feeding

•    Do not take DUEXIS if you are in the last 3 months of pregnancy (third trimester).

• Talk to your doctor before taking this medicine if you are in the first or second trimester of pregnancy. Your doctor will decide if you can take DUEXIS.

• Do not breast-feed whilst taking this medicine because small amounts may pass into the mothers' milk.

DUEXIS may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy or experience headaches while taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of DUEXIS

DUEXIS contains 12.7 mg of lactose per tablet. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take DUEXIS

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Swallow your tablets whole with a drink of water. Do not chew, split or crush the tablets. It is important that you take your tablets whole for your medicine to work properly.

•    If you are taking this medicine for a long time, your doctor will want to monitor you by checking your blood count, liver and kidney

function (particularly if you are taking it for more than a year).    ■■■■

How much to take

•    Take one tablet three times per day for as long as your doctor has told you. You must take all three tablets a day for DUEXIS to work properly.

•    Do not take more than three tablets a day. If you think your dose is either too weak or too strong your doctor may prescribe another treatment.

If you take more DUEXIS than you should

If you take more DUEXIS than you should, contact or go to your nearest casualty department straight away. An overdose may cause dizziness, drowsiness, upper abdominal pain and or discomfort, heartburn, nausea, diarrhoea, confusion, vomiting, bleeding of the stomach or intestines, loss of consciousness, severe swelling of the face, allergic reactions and uncontrolled movements of the body. Take this leaflet or some tablets with you so that your doctor knows exactly what you have taken.

If you forget to take DUEXIS

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking DUEXIS

Take your tablets as directed and for as long as directed by your doctor. Do not stop them, even if you feel better otherwise the symptoms may return. It is important to take the full course prescribed by your doctor.

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

4. Possible side effects

L_

Other possible side effects include:

Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects listed below.

Very common side effects (may affect more than 1 in 10 people):

•    Stomach problems such as feeling sick (nausea), vomiting, passing wind, diarrhoea, constipation

Common side effects (may affect up to 1 to 10 people):

•    peptic ulcers (ulcer of the stomach or duodenum), inflammation of the large bowel

•    worsening of existing bowel disease (Crohn's disease, ulcerative colitis, diverticulitis)

•    infections of the throat, sore throat, blocked stuffy nose, feeling like you have the flu or cold, sinusitis

•    infections of the urinary tract, pain or discomfort when urinating, feeling like you need to urinate a lot more

•    anaemia which can cause you to feel weak, tired and suffer from bruising

•    disturbed sleep or trouble sleeping (insomnia)

•    feeling anxious, nervous, irritable or agitated

•    feeling dizzy

•    headache

•    cough

•    back pain, joint pain

•    pain and swelling in your arms and legs

•    high blood pressure (hypertension)

Uncommon side effects (may affect up to 1 to 100 people):

•    suffering from more infections

•    blood tests show you have problems with your thyroid (underactive thyroid)

•    blood tests show an increase in blood fat levels, high cholesterol

•    blood tests show that you have changes in the levels of salts such as low calcium, high chloride levels

•    blood tests show changes in the glucose levels in your blood

•    blood tests show increased levels of liver enzymes

•    blood tests show increased levels of protein in your blood

•    decreased appetite

•    dehydration, symptoms include increased thirst, headache, feeling dizzy

•    feeling depressed, confused

•    migraine

•    feeling sleepy/drowsy, feeling light-headed, feeling weak or fainting

•    increased urge to move the legs and other parts of the body uncontrollably (restless leg syndrome)

•    pain in your nerves including sciatica pain

•    pins and needles

•    transient ischaemic attack, symptoms include temporary loss of vision, difficulty speaking, weakness on one side of the body

•    problems with your eyesight, red or pink eye, blurred vision

•    ringing in the ears (tinnitus)

•    stomach distension (bloating) and tenderness, belching

•    dry mouth, changes in or loss of your sense of smell and taste

•    pain and swelling of the oesophagus (throat) which may lead to difficulty in swallowing

•    irritable bowel syndrome

•    problems with your skin such as dry skin, eczema, hair loss

•    swollen joints, muscle pain, pain in your tendons (tendonitis)

•    kidney failure

•    blood in your urine

•    painful and swollen prostate glands in men

•    abnormally heavy and long menstrual period

•    weight changes

•    skin rash or blistering, your skin becoming more sensitive when you go out in the sun

•    fever

Rare side effects (may affect up to 1 in 1000 people):

•    an irregular, slow or very fast heart beat

•    aseptic meningitis (inflammation of the protective membrane surrounding the brain)

•    feeling aggressive

•    seeing, feeling or hearing things that are not there (hallucinations)

•    blood tests show a reduced number of white blood cells, red blood cells or platelets

•    increased tendency to bleed

•    optic neuritis (inflammation of the nerve at the back of the eye)

•    hearing problems

•    reduced libido or impotence

•    fits

•    muscle cramps

•    pancreatitis (inflammation of the gland which produced digestive juices)

•    lung problems because of swelling and fluids on your lungs. Symptoms include difficulty breathing which may slowly get worse, chest pain and breathlessness

•    problems with your mouth and throat such as mouth ulcers, swollen mouth/lips, throat ulcers which cause difficulty in swallowing

•    feeling like you need to vomit with nothing coming out (retching)

•    increased mucous secretion due to allergies

•    blood tests show an increase in alkaline phosphatase, which may mean problems with your liver Do not be concerned by this list of possible side effects. You may not get any of them.

If any of these side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. How to store DUEXIS

Keep out of the reach and sight of children.

Do not use DUEXIS after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month.

Do not store above 30°C.

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 to protect the environment.

6. Further information

What DUEXIS contains

•    The active substances are ibuprofen 800 mg and famotidine 26.6 mg.

•    The other ingredients are microcrystalline cellulose, lactose anhydrous, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80, povidone, poly(vinyl alcohol), macrogol 3350, talc, indigo carmine aluminium lake (E132) and brilliant blue FCF aluminium lake (E133).

What DUEXIS looks like and contents of the pack

DUEXIS tablets are blue oval film coated tablets marked with 'HZT on one side. They are supplied in bottles with 90 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder    Manufacturer

Horizon Pharma GmbH, Joseph-Meyer Strasse 13-15,    Sanofi Winthrop Industrie - Usine de Compiegne

68167 M_annh_ei_m, G_ermany    56, route de Choisy-au-Bac, 60205 Compiegne, France

This medicinal product is authorised in the United Kingdom under the following names: DUEXIS

This leaflet was last revised in March 2013

DUEXIS is a registered trademark of Horizon Pharma USA, Inc.

©Horizon Pharma 2013