PS02754

PACKAGE LEAFLET: INFORMATION FOR THE USER

VIMOVO™ 500 mg/20 mg modified-release tablets

naproxen and esomeprazole

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

p Keep this leaflet. You may need to read it again.    i

•    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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What VIMOVO is and what it is used for

2.    What you need to know before you take VIMOVO

3.    How to take VIMOVO

4.    Possible side effects

5.    How to store VIMOVO

6.    Contents of the pack and other information

1. What VIMOVO is and what it is used for

What VIMOVO is

VIMOVO contains two different medicines called naproxen and esomeprazole. Each of these medicines works in a different way.

•    Naproxen belongs to a group of medicines called “Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs). It reduces pain and inflammation.

•    Esomeprazole belongs to a group of medicines called “proton pump inhibitors". It reduces the amount of acid in your stomach.

Esomeprazole helps to reduce the risk of ulcers and stomach problems developing in patients who need to take NSAIDs.

What VIMOVO is used for

VIMOVO is used for the relief of symptoms of:

•    Osteoarthritis.

•    Rheumatoid arthritis.

•    Ankylosing spondylitis.

VIMOVO helps to reduce pain, swelling, redness and heat (inflammation).

You will be given this medicine if a lower dose of NSAID is considered unlikely to relieve your pain and you are at risk of getting a stomach ulcer or an ulcer in the first part (duodenum) of your small intestine (gut) when taking NSAIDs.

2. What you need to know before you take VIMOVO

Do not take VIMOVO if:

•    You are allergic (hypersensitive) to naproxen.

•    You are allergic to esomeprazole or other proton pump inhibitor medicines.

•    You are allergic to any of the other ingredients of this medicine (listed in Section 6).

•    You are taking a medicine called “atazanavir" or “nelfinavir" (used to treat HIV).

•    If acetylsalicylic acid (e.g. aspirin), naproxen or other NSAIDS such as ibuprofen, diclofenac or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have caused you to have asthma (wheeziness) or an allergic reaction such as itchiness or skin rash (urticaria).

•    You are in the last 3 months of pregnancy.

•    You have severe problems with your liver, kidney or heart.

•    You have an ulcer in your stomach or gut.

•    You have any bleeding disorder or serious and unexpected bleeding.

Do not take VIMOVO if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking VIMOVO.

Warnings and Precautions

Talk to your doctor or pharmacist before taking VIMOVO.

You must not take VIMOVO and talk to your doctor straight away if any of the following happen to you before or while you are taking VIMOVO, 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 stools (blood-stained faeces).

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

•    You have any other problems with your liver or kidneys or if you are elderly.

•    You are taking medicines such as corticosteroids taken by mouth, warfarin, clopidogrel, Selective Serotonin Reuptake Inhibitors (SSRIs), acetylsalicylic acid (aspirin) or NSAIDs including COX-2 inhibitors (see section Other medicines and VIMOVO).

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

If you have previously experienced stomach ulcer or bleeding you should let your doctor know. You will be asked to report any unusual symptoms from your stomach (e.g. pain) to your doctor.

Medicines such as VIMOVO 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. Do not exceed the recommended dose or length of treatment.

VIMOVO contains the NSAID naproxen. As for all NSAIDs, naproxen should be used at the lowest effective dose for the shortest duration possible to reduce the risk of undesirable effects. Your doctor will therefore assess at a regular interval whether VIMOVO is still appropriate for you.

VIMOVO is not suitable to achieve rapid relief of acute pain, as it takes several hours before the painkilling substance naproxen is taken up in your blood.

Also, check with your doctor before taking this medicine if you have any heart problems, previous stroke or think you might be at risk of these problems. You may be at risk of getting these problems if:

•    You have high blood pressure.

•    You have problems with your blood circulation or with your blood clotting.

•    You have diabetes.

•    You have high cholesterol.

•    You are a smoker.

Taking a proton pump inhibitor (which is a component of VIMOVO), especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Children and adolescents

VIMOVO is not recommended for use in children or adolescents aged 18years or younger.

Other medicines and VIMOVO

Please 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. This is because VIMOVO can affect the way some other medicines work. Also some other medicines can affect the way VIMOVO works.

Do not take this medicine and tell your doctor or pharmacist if you are taking:

•    A medicine called “atazanavir" or “nelfinavir" (used to treat HIV).

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

•    Acetylsalicylic acid (aspirin). If you take low dose acetylsalicylic acid (aspirin) you can still take VIMOVO.

•    Other NSAID medicines (including COX-2 inhibitors).

•    Certain drugs such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat infections caused by a fungus).

•    Erlotinib (or another anticancer drug from the same class).

•    Cholestyramine (used to reduce cholesterol).

•    Clarithromycin (used to treat infection).

•    “Quinolone antibiotic" (for infections), such as ciprofloxacin or moxifloxacin.

•    Diazepam (used to treat anxiety, to relax your muscles or used in epilepsy).

•    Hydantoins such as phenytoin (used to treat epilepsy).

•    Lithium (used to treat some types of depression).

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

•    Probenecid (for gout).

•    “Selective Serotonin Reuptake Inhibitors" (SSRIs) (used to treat major depression or anxiety disorder).

•    Ciclosporin or tacrolimus (medicines used to dampen down the body's immune reactions).

•    Digoxin (used to treat heart disorders).

•    Sulphonylureas such as glimepiride (oral medicines used to control your blood sugar in diabetes).

•    Medicines used to treat high blood pressure called diuretics (such as furosemide or hydrochlorothiazide), ACE inhibitors (such as enalapril), angiotensin II receptor antagonists (such as losartan) and beta-blockers (such as propranolol).

•    Corticosteroid medicines such as hydrocortisone or prednisolone (used as anti-inflammatory medicines).

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

•    Rifampicin (used for treatment of tuberculosis).

•    St. John's Wort (Hypericum perforatum) (used to treat mild depression).

•    Cilostazole (used for pain in the legs due to poor blood flow).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking VIMOVO. VIMOVO with food and drink

Do not take VIMOVO with food as this may reduce and/or delay the effect of VIMOVO. Take your tablets at least 30 minutes before you have a meal.

Pregnancy, breast-feeding and fertility

•    Do not take VIMOVO if you are in the last 3 months of pregnancy.

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

•    Do not breast-feed if you are taking VIMOVO. This is because small amounts may pass into the mothers' milk. If you are planning to breast-feed you should not take VIMOVO.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, might become pregnant or are breast-feeding. VIMOVO may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems to become pregnant.

Driving and using machines

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

VIMOVO contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These ingredients may cause allergic reactions. These reactions may not happen straight away.

3. How to take VIMOVO

Always take this medicine exactly as your doctor has told you. 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.

•    Take your tablets at least 30 minutes before you have a meal. Food may reduce the protective effect of VIMOVO on your stomach and gut. Food may also cause a considerable delay in the relief of pain and inflammation.

•    If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).

How much to take

•    Take one tablet twice a day for as long as your doctor has told you.

•    VIMOVO is only available in 500 mg/20 mg. If your doctor thinks this dose is not suitable for you they may prescribe another treatment.

If you take more VIMOVO than you should

If you take more VIMOVO than you should, talk to your doctor or pharmacist straight away. Symptoms of an overdose may include dizziness, drowsiness, upper abdominal pain and or discomfort, heartburn, nausea, confusion, vomiting, bleeding of the stomach or intestines, loss of consciousness, severe swelling of the face, allergic reactions and uncontrolled movements of the body.

If you forget to take VIMOVO

•    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.

4. Possible side effects

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

effects may happen with this medicine.

Stop taking VIMOVO and see a doctor immediately if you notice any of the following serious side effects -

you may need urgent medical treatment:

•    Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).

•    Reddening of your skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.

•    Yellowing of the skin or the whites of your eyes, having dark urine and tiredness which can be symptoms of liver problems.

•    Medicines such as VIMOVO may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Signs include chest pain spreading to your neck and shoulders and down your left arm, confusion or muscle weakness or numbness which may only be on one side of your body.

•    You pass black sticky bowel motions (stools) or have bloody diarrhoea.

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

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Talk to your doctor as soon as possible if you experience any of the following:    I

iVIMOVO may in rare cases affect the white blood cells leading to immune deficiency.

If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medication at this time.

Other possible side effects include:

Common (affects 1 to 10 users in 100)

•    Headache.

•    Feeling tired.

•    Feeling thirsty.

•    Feeling depressed.

•    Feeling breathless.

•    Increased sweating.

•    Itchy skin and skin rashes.

•    Spinning feeling (vertigo).

•    Red or purple marks, bruising or spots on your skin.

•    Feeling sick (nausea) or being sick (vomiting).

•    A fluttering feeling in your heart (palpitations).

•    Disturbed sleep or trouble sleeping (insomnia).

•    Hearing problems such as ringing in your ears.

•    Dizziness, feeling drowsy or feeling light-headed.

•    Swelling of your hands, feet and ankles (oedema).

•    An inflammation inside the mouth, a sore mouth or mouth ulcers.

•    Eyesight problems such as blurred vision, conjunctivitis or eye pain.

•    Diarrhoea, stomach pain, heartburn, indigestion, constipation, burping or wind (flatulence).

Uncommon, rare or very rare (affects 1 to 10 users in 1,000 or less)

•    Fever.

•    Fainting.

•    Dry mouth.

•    Aggression.

•    Hearing loss.

•    Asthma attack.

•    Fits or seizures.

•    Period problems.

•    Weight changes.

•    Hair loss (alopecia).

•    Lumpy rash (hives).

•    Joint pain (arthralgia).

•    Enlarged breasts in men.

•    Sore or swollen tongue.

•    Twitching or muscle tremor.

•    Appetite problems or taste changes.

•    Muscle weakness or pain (myalgia).

•    Your blood may take longer to clot.

•    Problems for women in getting pregnant.

•    Fever, redness or other signs of infection.

•    An irregular, slow or very fast heart beat.

•    Tingling feelings such as “pins and needles".

•    Difficulty with your memory or concentration.

•    Feeling agitated, confused, anxious or nervous.

•    Generally feeling unwell, weak and lacking energy.

•    Swollen or painful parts of your body because you have gained water.

•    High or low blood pressure. You may feel faint or dizzy.

•    Skin rash or blistering, or your skin becoming more sensitive on exposure to sunlight.

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

•    Changes in your blood test results, such as to see how your liver is working. Your doctor can explain more.

•    An infection called “thrush" which can affect the gut and is caused by a fungus.

•    Blood in your urine (water) or other kidney problems. You may have back pain.

•    Difficulty breathing, which may get slowly worse. This may be signs of pneumonia or swelling of your lungs developing.

•    Low levels of salt (sodium) in your blood. This may cause weakness, being sick (vomiting) and cramps.

•    Symptoms of meninigitis such as fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion.

•    Problems with your pancreas. Signs include severe stomach pain which spreads to your back.

•    Pale coloured stools which are a sign of serious liver problems (hepatitis). Serious liver problems may lead to liver failure and inflammation of the brain.

•    Colitis or worsening of inflammatory bowel disease such as Crohn's disease or ulcerative colitis. Signs include stomach pain, diarrhoea, vomiting and weight loss.

•    Blood problems such as a reduced number of red cells (anaemia), white cells or platelets. This can cause weakness, bruising, fever, severe chills, sore throat or make infections more likely.

•    Problems with the way your heart pumps blood around the body or damage to your blood vessels. Signs may include tiredness, shortness of breath, feeling faint, chest pain or general pain.

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

•    If you are on VIMOVO for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Do not be concerned by this list of possible side effects. You may not get any of them.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

|Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Malta

ADR Reporting

The Medicines Authority

Post-Licensing Directorate

i203 Level 3, Rue D'Argens    I

lGZR-1368 Gzira

Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store VIMOVO

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 carton, bottle or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Bottle: Store in the original package and keep the bottle tightly closed in order to protect from moisture.

Blister: Store in the original package in order to protect from 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 to protect the environment.

6. Contents of the pack and other information

What VIMOVO contains

•    The active substances are naproxen 500 mg and esomeprazole 20 mg.

•    The other ingredients (excipients) in the tablet core are croscarmellose sodium, magnesium stearate, povidone, colloidal silicon dioxide, and in the film coating carnauba wax, glycerol monostearate 40-55, hypromellose,

iron oxide (E172, yellow, black), macrogol 8000, methacrylic acid-ethyl acrylate copolymer, methyl parahydroxybenzoate (E218), polydextrose, polysorbate 80, propylene glycol, propyl parahydroxybenzoate (E216), sodium laurilsulfate, titanium dioxide (E171), triethyl citrate.

What VIMOVO looks like and contents of the pack These are oval yellow tablets marked 500/20 in black ink Bottle:

Pack sizes - 6, 20, 30, 60, 100, 180 or 500 modified-release tablets.

The bottles contain silica-gel desiccant (to keep the tablets dry). Do not eat the sachet containing the desiccant. Aluminium blister package:

Pack sizes- 10, 20, 30, 60 or 100 modified-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation for VIMOVO is held by AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, United Kingdom.

VIMOVO is manufactured by AstraZeneca AB, SE-151 85 Sodertalje, Sweden.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information: Product name    Reference number

VIMOVO 500 mg/20 mg tablets 17901/0263 This is a service provided by the Royal National Institute of Blind People.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Vimovo

Belgium Vimovo

Bulgaria Vimovo

Czech Republic Vimovo

Denmark Vimovo

Estonia Vimovo

Finland Vimovo

Germany Vimovo

Greece Vimovo

Hungary Vimovo

Ireland Vimovo

Italy Vimovo

LatviaVimovo

LithuaniaVimovo

LuxembourgVimovo

Malta Vimovo

Netherlands Vimovo

Norway Vimovo

Poland Vimovo

Portugal Vimovo

Romania Vimovo

Slovakia Vimovo

SloveniaVimovo

Spain Vimovo

Sweden Vimovo

United Kingdom Vimovo

This leaflet was last updated in July 2013.

VIMOVO is a trade mark of the AstraZeneca group of companies.

© AstraZeneca 2013 PAI 13 0016

AstraZeneca

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