FRONT

DICLOFENAC SODIUM 25 mg AND 50 mg GASTRO-RESISTANT TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 or nurse.

•    This medicine has been prescribed for you only. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

1.    What Diclofenac is and what it is used for

2.    What you need to know before you take Diclofenac

3.    How to take Diclofenac

4.    Possible side effects

5.    How to store Diclofenac

6.    Contents of the pack and other information

OWHAT DICLOFENAC IS AND WHAT IT IS USED FOR

Diclofenac is a non-steroidal anti-inflammatory (NSAID) drug.

Diclofenac 25 mg and 50 mg Gastro-resistant Tablets are used to relieve pain and inflammation in conditions such as:

• rheumatoid arthritis • osteoarthrosis

• ankylosing spondylitis (arthritis of the spine)

• low back pain

• other conditions affecting the muscles, joints, tendons and bones e.g. strains, sprains, fractures or dislocations • acute gout

• dental and other minor surgery.

Diclofenac 25 mg Gastro-resistant Tablets may also be used to relieve juvenile chronic arthritis.

Children aged 9 years and above

Diclofenac 25 mg Gastro-resistant Tablets may be used as a short treatment for fever, caused due to infections of the ear, nose or throat. Diclofenac 25 mg Gastro-resistant Tablets may be used alone or as an additional therapy with other pain killers to relieve pain caused due to surgery.

©WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOFENAC

Do not take Diclofenac if you:

• are allergic (hypersensitive) to diclofenac sodium or any of the other ingredients of this medicine

• have experienced asthma, an itchy or runny nose, skin rashes or breathing difficulties after taking any other NSAID (Non-steroidal anti-inflammatory drugs) e.g. aspirin or ibuprofen

• have, or have ever had, peptic ulceration (ulcer in your stomach or duodenum)

• have ever experienced stomach or intestinal bleeding (black tarry stools or vomiting blood) after taking any other NSAID • have severe liver, kidney or heart problems • are more than 6 months pregnant or you are planning to become pregnant (see 'Pregnancy and breast-feeding')

• 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). Warnings and precautions Talk to your doctor or pharmacist or nurse before taking diclofenac gastro-resistant tablets if you:

• suffer from any stomach or bowel disorders such as ulcerative colitis or Crohn's disease • suffer from a disease called porphyria (symptoms of porphyria are discolouration of the urine, serious skin disorders, anaemia, abdominal pains and severe mental disorders)

• suffer from or have in the past suffered from asthma

• suffer from serious illness with blistering of the skin, mouth, eyes and genitals or connective tissue disorders such as lupus • notice skin rash or appearance of lesions after starting this medicine, please seek medical advice immediately • suffer from runny nose, nasal polyps, chronic lung disease or chronic lung infection

• suffer from kidney, liver or heart problems or if you are elderly or recovering from major surgery • smoke

• suffer from diabetes • have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

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

This medicine may mask the sign and symptoms of infection.

Your doctor may decide to monitor your kidney function, liver function, blood sugar and blood cell counts whilst you are taking diclofenac sodium.

Medicines such as diclofenac 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, or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Other medicines and Diclofenac

Tell your doctor about any other medicines you are taking or took recently (in the last week) - even medicines you bought yourself without a prescription. Medicines can sometimes interfere with each other. Your doctor may limit your use of a medicine or you may need to take a different medicine. It is especially important to mention any of the following:

•    any other non-steroidal anti-inflammatory drug (NSAID) for pain relief such as ibuprofen, aspirin or cyclooxygenase-2 selective inhibitors. Taking two or more NSAID medicines at the same time is not recommended, but your doctor may decide that it is necessary for your treatment and the benefits you will gain outweigh the risks.

•    aspirin in order to prevent blood clots

•    medicines for high blood pressure

•    medicines for high blood sugar

•    diuretics ("water tablets") e.g. spironolactone

•    cardiac glycosides e.g. digoxin

•    lithium

•    methotrexate

•    mifepristone

•    corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances e.g. prednisolone

•    anti-coagulants e.g. warfarin

•    immunosuppressive agents e.g. ciclosporin, tacrolimus

•    quinolone antibiotics e.g. ciprofloxacin, ofloxacin

•    drugs for depression called selective serotonin reuptake inhibitors (SSRIs)

•    zidovudine, used to treat HIV infection

•    phenytoin (used to treat fits)

•    colestipol, cholestyramine (used to reduce the amount of cholesterol and certain fatty substances in your blood)

•    sulfinpyrazone (used to treat gout)

•    voriconazole (used to treat fungal infection). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, Breast-feeding and Fertility

•    DO NOT take Diclofenac if you are more than 6 months pregnant

•    If you are less than 6 months pregnant, ask your doctor for advice before taking this medicine

•    Diclofenac 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 becoming pregnant.

•    Diclofenac should not be taken if you are breast-feeding, therefore please talk to your doctor before taking this medicine.

Driving and using machines

•    Diclofenac may cause dizziness, drowsiness, tiredness, and problems with your vision. DO NOT drive or operate machinery if you are affected.

Diclofenac tablets contains Lactose

•    Patients who are intolerant to lactose should note that Diclofenac tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

^ HOW TO TAKE DICLOFENAC

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

The tablets should be swallowed preferably with a drink of water, with or after food. DO NOT chew the tablets. The tablets have been coated with a substance, which allows them to pass through the stomach before dissolving. It is important that the coating is not damaged by chewing. The usual dose is:

Use in children and adolescents

•    Adults

75 - 150 mg a day, in divided doses. The maximum daily dose is 150 mg.

•    Elderly

Elderly patients should take the lowest effective dose for the shortest possible time to reduce the risk of side effects.

•    Children 1 year old and over

The dose depends on the child's body weight. Your doctor will calculate the appropriate dose for your child.

•    Children under 1 year old Diclofenac is not recommended for use in children under 1 year old.

For treatment of surgical pain and fever caused due to infections of the ear and nose in children aged 9 years (with minimum 35 kg bodyweight) or over and adolescents

•    The dose depends on the bodyweight and severity of the disorder. Your doctor will decide the appropriate dose.

Diclofenac 50 mg Gastro-resistant Tablets should not be used in children under 12 years of age.

If you take more Diclofenac than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause headache, feeling sick, being sick, stomach pain, intestinal bleeding, diarrhoea, breathing problems, coma, drowsiness, dizziness, fits, ringing in the ears and fainting.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Diclofenac

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.

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

If you stop taking Diclofenac

Do not suddenly stop taking your tablets as side effects may occur. If treatment is to be stopped your doctor will gradually reduce your dose.

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

^ POSSIBLE SIDE EFFECTS

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

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens at any time during your treatment:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash, very low blood pressure or shock and hives)

•    passing blood in your faeces (stools/ motions)

•    passing black tarry stools

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

These are very serious side effects. You may need urgent medical attention or hospitalisation.

Stop taking the tablets and tell your doctor immediately if the following happens:

•    a serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)

•    a severe blistering rash in which the surface layers of the skin may peel off (Lyell's syndrome)

•    indigestion or heartburn

•    abdominal pain (pains in your stomach) or other abnormal stomach symptoms

•    symptoms which include stiff neck, headache, feeling and being sick, fever or disorientation, particularly in patients with systemic lupus erythematosus (SLE) or connective tissue disorders.

Medicines such as Diclofenac may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Usually the frequency of side effects is classified as follows:

Very common (more than 1 out of 10 persons) Common (more than 1 out of 100 persons) Uncommon (more than 1 out of 1,000 persons) Rare (more than 1 out of 10,000 persons)

Very rare (less than 1 out of 10,000 persons) Not known (cannot be estimated from the available data)

Blood Disorders

Very rare: blood disorders such as anaemia, reduction in the number of white blood cells, which may be characterised by fever or chills, sore throat, ulcers in your mouth or throat and infection.

Psychological disorders

Very rare: disorientation, depression, difficulty in sleeping, nightmares, irritability and psychological problems.

Nervous system disorders

Common: headache, dizziness Rare: drowsiness

Very rare: abnormal sensation of skin (e.g. tingling, numbness), memory impairment, fits, anxiety, shaking, serious inflammation of the linings of the brain (Aseptic meningitis), taste disorders, stroke

Not known: optic nerve inflammation, sensation disorders.

Eye disorders

Very rare: visual disturbances, blurred vision and double vision.

Ear disorders

Common: a feeling of dizziness or "spinning" Very rare: ringing in the ears, hearing impairment.

Heart Disorders

Very rare: palpitation, chest pain and heart failure, stroke.

Blood circulation disorders

Very rare: high blood pressure and

inflammation of blood vessels, often with skin

rash.

o

Breathing disorders

Rare: asthma including shortness of breath Very rare: inflammation of lungs, symptoms you may feel are like fever, shortness of breath, chills etc.

Very rare: inflammation of colon causes abdominal pain or diarrhoea, aggravation of existing digestive problems such as colitis and Crohn's disease, constipation, inflammation or ulceration of the mouth e.g. mouth ulcers and cold sores, inflammation of the tongue, inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back

Not known: throat lesions, damage of colon, narrowing in the intestine.

Liver disorders

Common: abnormal liver function tests Rare: yellowing of the skin or whites of the eyes caused by liver or blood problems, inflammation of liver, liver disorders Very rare: very serious liver disease, acute liver failure.

Skin disorders Common: rash Rare: nettle rash

Very rare: skin reaction causing large blisters, eczema, redness of the skin, serious illness with blistering of the skin, mouth, eyes and genitals, scaly skin, loss of hair, sensitivity to light, bruise like rash, itching.

Kidney and urinary disorders Very rare: kidney failure, blood in the urine, increased amount of protein in the urine, serious kidney disorders.

General disorders

Rare: fluid retention resulting in swelling of the ankles or feet.

Other disorders

Not known: Difficulty in getting and maintaining an erection.

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.

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.

HOW TO STORE DICLOFENAC

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

The tablets should be stored below 25°C, in a dry place in the original package or container supplied. Keep the container tightly closed. Do not transfer them to another container.

Do not use Diclofenac after the expiry date that is stated on the outer packaging. 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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Diclofenac Gastro-resistant Tablets contain:

•    The active ingredient is diclofenac sodium, 25 mg or 50 mg

•    The other ingredients are lactose monohydrate, maize starch, povidone (E1201), sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate (E572). The gastro-resistant coating contains hydroxypropyl methylcellulose (E464), citric acid monohydrate (E330), methacrylic acid copolymer, purified talc (E553b), polyethylene glycol (E1520) and the colours are titanium dioxide (E171), sunset yellow (E110) and iron oxide yellow (E172). The 50 mg tablets also contain iron oxide red (E172). The 25 mg tablets also contain quinoline yellow (E104).

The black printing ink contains shellac, iron oxide black (E172) and propylene glycol (E1520).

What Diclofenac Gastro-resistant Tablets look like and contents of the pack:

•    The 25 mg tablets are yellow, round, biconvex, bevel-edged, gastro-resistant tablets. They are printed '25' over '0518' and plain on the reverse.

•    The 50 mg tablets are tan, round, biconvex, bevel-edged, gastro-resistant tablets. They are printed '50' over '0519' and plain on the reverse.

•    The product is available in pack sizes of 10, 20, 28, 30, 50, 56, 60, 84, 100, 250, 500, and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: 02/2014

PL 00289/0738 and 0739

Stomach and bowel disorders Common: feeling sick, being sick, loose stools, abdominal pain, indigestion, wind, loss of appetite

Rare: inflammation of the lining of the stomach, vomiting blood, black tarry stools, ulcers.

84233-E