Package leaflet: Information for the user

Masidemen 75mg/200microgram Modified-release Tablets

Diclofenac sodium/Misoprostol

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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

J What Masidemen is and what it is used for ^1 What you need to know before you take Masidemen

How to take Masidemen Possible side effects How to store Masidemen 6| Contents of the pack and other information

J What Masidemen is and what it is used for

Masidemen helps to relieve the pain and swelling of rheumatoid arthritis and osteoarthritis, and may help to protect patients at risk of irritation or ulceration of the stomach or intestines.

Masidemen contains diclofenac and misoprostol.

Diclofenac belongs to a group of medicinal products called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Although NSAIDs relieve the pain, they can reduce the amount of natural protective substances called prostaglandins in the stomach lining.

This means that NSAIDs can lead to stomach upsets or stomach ulcers. Masidemen also contains misoprostol which is very similar to these prostaglandins and may help protect your stomach.

^1 What you need to know before you take Masidemen

Do not take Masidemen if you:

•    are pregnant, or trying to become pregnant, because it may cause a miscarriage. Women who have

not reached the menopause should use reliable contraception while they are taking Masidemen

•    are allergic to diclofenac sodium/misoprostol or any of the other ingredients of this medicine (listed in section 6)

•    have had an allergic reaction such as a skin rash, swelling or itchiness of the skin, severe nasal congestion, asthma or wheezing after taking diclofenac or other NSAIDs such as aspirin (acetylsalicylic acid), misoprostol or another prostaglandin medicine

•    have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, ministroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages

•    have or have had problems with your blood circulation (peripheral arterial disease)

•    have had bleeding from your stomach or intestines after taking diclofenac or other NSAIDs

•    currently have an ulcer or perforation (hole) in your stomach or intestines

•    currently suffer from bleeding in your stomach, intestines or brain

•    are undergoing or you have just had coronary artery bypass graft (CABG) surgery

•    have severe kidney or liver failure.

Warnings and precautions

Make sure your doctor knows, before you are given diclofenac if you:

•    smoke

•    have diabetes

•    have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides

•    have other health problems such as a disease of the liver or kidneys. Do not take Masidemen if you have severe kidney or liver failure

•    previously had an ulcer or bleeding in your stomach or intestines. Do not take Masidemen if you currently have an ulcer or bleeding in your stomach or intestines

•    bleed or bruise easily

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

•    have, or have ever had asthma or an allergic disease

•    have an infection, as Masidemen may mask a fever or other signs of infection

•    are dehydrated

•    are over the age of 65 as your doctor may want to keep a regular check on you.

NSAID medicines such as Masidemen can cause bleeding or ulceration. If this occurs, treatment should be stopped.

Medicines such as Masidemen are linked to an increased risk of heart attack (myocardial infarction) or stroke. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Do not exceed the recommended dose or duration of treatment.

As with other NSAIDs (e.g. ibuprofen) Masidemen may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.

If you have heart, liver or kidney problems, your doctor will want to monitor you regularly.

Other medicines and Masidemen

Some medicines can affect the way other medicines work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

•    Aspirin (acetylsalicylic acid) or other NSAIDs (e.g. ibuprofen)

•    Medicines used to treat osteoarthritis or rheumatoid arthritis known as cyclo-oxygenase-2 (COX-2) inhibitors

•    Diuretics (used to treat excess fluid in the body)

•    Ciclosporin or tacrolimus (used for immune system suppression e.g. after transplants)

•    Lithium (used to treat some types of depression)

•    Digoxin (a medicine for an irregular heart beat and/or heart failure)

•    Warfarin or other oral anticoagulants (blood-thinning agents that reduce blood clotting)

•    Medicines used to treat anxiety and depression known as Serotonin Selective Re-uptake Inhibitors (SSRIs)

•    Medicines used to control your blood sugar (oral hypoglycaemics for diabetes)

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

•    Steroid medications (e.g. corticosteroids, which are often used as anti-inflammatory medicines)

•    Medicines for high blood pressure (anti-hypertensives)

•    Magnesium containing antacids (used to treat heartburn, indigestion)

•    Quinolone antibiotics (used to treat some infections)

•    Ketoconazole (used to treat some fungal infections)

•    If you have taken a medicine called mifepristone (used to terminate pregnancy) within the last 12 days. Masidemen should not be taken within 8-12 days of taking mifepristone.

Pregnancy and breast-feeding

Do not use Masidemen if you are pregnant or trying to become pregnant. Women who have not reached the menopause should use reliable contraception while they are taking Masidemen.

Do not use Masidemen while you are breast-feeding. Driving and using machines

If you feel dizzy or drowsy after taking Masidemen, do not drive and do not use any tools or machines until these effects have worn off.

Masidemen contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Masidemen.

^ How to take Masidemen

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

The recommended dose is one Masidemen 75mg/200microgram tablet taken two times a day.

Masidemen should be swallowed whole with a drink of water (not chewed), taken during or after mealtimes.

Elderly and patients with liver or kidney disorders:

The doctor may want to monitor these patients more closely. No change in dose is needed.

Use in children and adolescents Children:

Masidemen is for adults only. It is not for use in children and adolescents (under 18 years).

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If you take more Masidemen than you should

You should not take more tablets than your doctor tells you to. If you take too many tablets contact your doctor, pharmacist or hospital as soon as possible, and take your medicine with you.

If you forget to take Masidemen

If you forget to take a tablet, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Masidemen

Do not stop taking Masidemen unless your doctor tells you to.

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

4| Possible side effects

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

If you are worried about side effects, ask your doctor. It is important that you know what can happen, so that you can take action if Masidemen does have a side effect. Masidemen sometimes causes side effects but these usually go away during treatment as your body gets used to the medicine.

Stop taking Masidemen and tell your doctor immediately if you experience any of the following symptoms:

•    severe stomach pain or any sign of bleeding or rupture in the stomach or intestines, such as passing black or blood stained stools, or vomiting blood - this occurs very rarely.

•    a serious skin reaction such as rash, blistering or peeling of the skin (Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis) - this occurs very rarely.

•    a serious allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing (anaphylactic shock) - this occurs rarely.

•    jaundice (your skin or the whites of your eyes look yellow) - this occurs rarely.

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

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

•    Stomach ache, diarrhoea, nausea (feeling sick), indigestion.

Diarrhoea is the most common problem and is occasionally severe. You have less chance of getting diarrhoea if you take Masidemen with food. If you use an antacid (something to reduce acid in the stomach) you should avoid antacids with magnesium in them as these may make diarrhoea worse. Your pharmacist can help you choose a suitable antacid. If this diarrhoea continues and is severe tell your doctor.

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

•    Rash, itching

•    Vomiting, wind, constipation, burping, gastritis (indigestion, stomach ache, vomiting)

•    Ulcers in the stomach or intestines

•    Headache, dizziness

•    Difficulty sleeping

•    Changes in blood tests relating to the liver.

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

•    Swelling of the mouth

•    Abnormal or unexpected bleeding from the vagina, menstrual disturbances

•    Reduction in the number of blood platelets (increased chance of bleeding or bruising)

•    Purpura (purple spots on the skin)

•    Urticaria (raised itchy rash).

Rare side effects (may affect up to 1 in 1,000 people):

•    Inflammation of the liver (possible yellow discoloration of skin, headache, fever, chills, general weakness).

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

•    Severe liver disorders including liver failure.

Additional side effects experienced in actual use (postmarketing experience, frequency cannot be estimated from the available data):

•    Heart failure, chest pain, palpitations (awareness of your heartbeat)

•    Damage to the gullet

•    Worsening of ulcerative colitis or Crohn's disease (inflammation of the intestines)

•    Kidney or liver problems

•    Shortness of breath

•    Seizures

•    Allergic reaction, (including asthma, breathing problems, itching, hair loss, inflamed blood vessels (can cause fever, aches, purple blotches))

•    Symptoms of meningitis (stiff neck, headache, nausea (feeling sick), vomiting, fever or loss of consciousness)

•    Fluid build-up in the body that can cause swollen ankles and legs

•    Vomiting blood

•    Psychotic reactions (mental disorder that features loss of contact with reality)

•    Swelling of the tongue, mouth ulcers, dry mouth

•    Depression, feeling anxious, mood swings, irritability, memory problems, feeling confused, feeling shaky, nightmares, drowsiness, tiredness

•    Difficulty seeing, impaired or blurred vision, ringing in the ears, changes in the way things taste

•    Chills, fever, increased sensitivity to light, inflammation

•    Loss of appetite

•    Abnormal contractions of the womb, rupture in the womb, retained placenta after giving birth, clotting in the amniotic fluid (fluid covering the foetus), bleeding in the womb, miscarriage, death of the unborn baby, birth defects, premature birth

•    Low blood pressure, high blood pressure

•    Reduction in the number of white blood cells (these help protect the body from infection and disease)

•    Anaemia (low number of red blood cells) which can lead to pale skin and cause weakness or breathlessness.

Medicines such as Masidemen may be associated with a small increased risk of heart attack or stroke.

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 the Yellow Card Scheme, Website: www.mhra.gov.uk/ yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

^1 How to store Masidemen

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

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 Masidemen contains

•    The active substances are diclofenac sodium and misoprostol.

•    Each Masidemen 75mg/200microgram modified-release tablet contains 75mg diclofenac sodium and 200microgram misoprostol.

•    The other ingredients are:

Core tablet: microcrystalline cellulose (E460), lactose monohydrate, maize starch, povidone K30, magnesium stearate (E470b), purified talc (E553b)

Tablet coating: hydroxypropylmethylcellulose type 2910 (E464), methacrylic acid-ethyl acrylate copolymer (1:1), purified talc (E553b), triethyl citrate (E1505), sodium starch glycolate and hydrogenated castor oil.

What Masidemen looks like and contents of the pack

The tablets are white, circular, biconvex and uncoated, plain on one side and embossed "DM1" on the other side.

The tablets are packed in blisters and supplied in cartons of 60 tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland

Manufacturer

Aesica Pharmaceuticals GmbH Alfred-Nobel Str 10 und Mittelstr.15,

40789 Monheim am Rhein,

North Rhine Westphalia Germany

This leaflet was last revised in February 2014

If you would like a leaflet with larger text, please contact 01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

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