Package leaflet: Information for the user

Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

(diclofenac sodium and misoprostol)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

-    If you have further questions, please ask your doctor, pharmacist or nurse.

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

What is in this leaflet

1.    What Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets is and what it is used for

2.    What you need to know before you use Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

3.    How to take Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

4.    Possible side effects

5.    How to store Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

6.    Contents of the pack and other information

1.    What Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets is and what it is used for

Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets 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.

This medicinal product 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. This medicinal product also contains misoprostol which is very similar to these prostaglandins and may help protect your stomach.

This medicinal product is used in adults.

2.    What you need to know before you use Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

Do not take Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets if you:

•    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, or any of the other ingredients of this medicine (listed in section 6)

•    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

•    have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (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)

•    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 this medicinal product.

Warnings and precautions

Talk to your doctor or pharmacist before taking Diclofenac sodium and Misoprostol 50 mg/200 microgram modified release tablets.

Make sure your doctor knows, before you are given diclofenac

•    If you smoke

•    If you have diabetes

•    If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides Check with your doctor if any of the following applies to you:

If you:

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

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

•    previously had an ulcer or bleeding in your stomach or intestines. Do not take this medicine 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 this medicine 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 Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets can cause bleeding or ulceration. If this occurs, treatment should be stopped.

Medicines such as Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets 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.

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

As with other NSAIDs (e.g. ibuprofen) these tablets 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 Diclofenac sodium and Misoprostol 50 mg/200 microgram modified release tablets.

Some medicines can affect the way other medicines work. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription:

•    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 heatburn, 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. Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets should not be taken within 8-12 days of taking mifepristone.

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.

Do not use these tablets if you are pregnant or trying to become pregnant. Women who have not reached the menopause should use reliable contraception while they are taking Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets.

Do not use these tablets while you are breast-feeding.

Diclofenac sodium and Misoprostol 50 mg/200 microgram modified release tablets 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

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

Diclofenac sodium and Misoprostol 50 mg/200 microgram modified release tablets contains

Lactose

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

Hydrogenated castor oil

May cause stomach upset and diarrhea.

3.    How to take Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

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

The recommended dose is:

Adults:

Take one tablet two times a day, or as directed by your doctor.

In the elderly and patients with liver or kidney disorders, your doctor may want to monitor you more closely. No change in dose is needed.

Use in children and adolescents: Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets is for adults only, it is not for use in children (under 18 years).

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Method of administration

Oral use

Diclofenac sodium and Misoprostol 50 mg/200 microgram modified release tablets should be swallowed whole with a drink of water (not chewed). Tablets should be taken during or after mealtimes.

If you take more Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets 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 Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

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 Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

Do not stop taking these tablets 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 Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets does have a side effect. This medicine sometimes causes side effects but these usually go away during treatment as your body gets used to the medicine.

If any of the following happen, stop taking Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets and tell your doctor immediately:

If you have

•    severe stomach pain or any sign of bleeding or rupture in the stomach or intestines, such as passing black or bloodstained 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 this medicine 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 (post-marketing experience, frequency unknown):

•    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 fetus), 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 Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.Do not use Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month. 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 Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets contains

The active substances are diclofenac sodium and misoprostol.

Each modified-release tablet contains 50 mg diclofenac sodium and 200 micrograms misoprostol.

The other ingredients are

Core: microcrystalline cellulose, lactose monohydrate, maize starch, povidone (PVP K-30), magnesium stearate, purified talc, sodium starch glycollate, hydrogenated castor oil

Coat: hydroxy propyl methyl cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) (Eudrajit), triethyl citrate

What Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets looks like and contents of the pack

Diclofenac sodium and misoprostol 50 mg/200 microgram modified release tablets is available as white, circular, biconvex uncoated tablet plain on one side and embossed with “DM2”on the other side.

The Diclofenac sodium/Misoprostol Cipla 50 mg/200 micrograms modified release tablets are presented in cold formed aluminium blisters in pack sizes of 20, 30, 40, 60, 90, 100, 120 and 140 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

Manufacturer:

For UK - Pharmadox Healthcare Ltd.,KW20A Kordin Industrial Park, Paola, PLA 3000, Malta Cipla (EU) Limited, 20 Balderton Street,

London, W1K 6TL, United Kingdom

S&D Pharma CZ, spol. s r.o., Theodor 28, 273 08 Pchery, (Pharmos a.s. facility) Czech republic Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium

For The Netherlands - Sandoz B.V., Veluwezoom 22, 1327 AH Almere, PO. box 10332, 1301 AH Almere, The Netherlands

This leaflet was last revised in 04/2016.    x

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