PATIENT INFORMATION LEAFLET

DICLOFENAC Tablets 25mg & 50mg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Diclofenac Tablets are and what they are used for

2.    Before you take Diclofenac Tablets

3.    How to take Diclofenac Tablets

4.    Possible side effects

5.    How to store Diclofenac Tablets

6.    Further information

1.    What Diclofenac Tablets are and what they are used for

Diclofenac belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs). It is most commonly used for relief of pain and stiffness and to reduce swelling in a variety of conditions including: rheumatoid arthritis, osteoarthritis, low back pain, sprains, strains, dislocations, fractures, ankylosing spondylitis, inflammation of tendons and tendon sheaths, stiff joints and frozen shoulder, bursitis (e.g. housemaid’s knee), acute gout, and pain following orthopaedic, dental and other minor surgical procedures. Diclofenac Tablets of 25 mg strength only, may also be used in children with juvenile chronic arthritis, and may be used in children aged 9 years and above (and with a minimum body weight of 35kg) for the short term treatment of fever due to ear, nose or throat infections, or together with another painkiller to relieve pain following an operation.

2.    Before you take Diclofenac Tablets

Do not take these tablets if you:

•    are allergic to diclofenac or to any of the other ingredients in the tablets (see section 6)

•    have had any form of allergic reaction (such as asthma, blocked or runny nose, swelling of the face or throat, skin rash or itching) to aspirin or any other non-steroidal anti-inflammatory drugs (NSAIDs) or painkillers e.g. ibuprofen, naproxen

•    have a stomach ulcer, perforation or bleeding, or have previously had two or more episodes of these in the past

•    have ever had stomach bleeding or perforation caused by taking NSAIDs

•    have severe heart, liver or kidney 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 more than 6 months pregnant

(see pregnancy and breastfeeding section).

Check with your doctor before taking

these tablets if you:

•    are elderly, as you may be more likely to suffer side effects (see section 4) and you may be prescribed a lower dose than the usual adult dose

•    have, or have ever had asthma,

as diclofenac might bring on an attack

•    suffer from hayfever or other allergies, polyps in your nose, breathing problems (COPD) or long-term respiratory infections

•    have heart, liver or kidney problems

•    have problems with the way your blood clots

•    have a history of problems with your stomach or intestines, e.g. ulcerative colitis or Crohn’s disease

•    have systemic lupus erythematosus (SLE) or mixed connective tissue disorder

(an immune system disorder)

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

•    have ever had high blood pressure or previously had heart failure

•    have liver porphyria

•    are recovering from major surgery

•    are a smoker

•    have diabetes.

Taking other medicines:

Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

•    medicines to thin the blood/prevent clotting (anti-coagulants or antiplatelet drugs) such as warfarin, clopidogrel

•    aspirin or other NSAIDs e.g. ibuprofen, naproxen, COX-2 inhibitors such as celecoxib

•    any medicines for diabetes e.g. glibenclamide, gliclazide, metformin

•    medicines to treat high blood pressure or heart problems including water tablets (diuretics) such as furosemide, ACE inhibitors (e.g. enalapril), beta-blockers (e.g. atenolol) or cardiac glycosides (e.g. digoxin)

•    lithium or a selective serotonin reuptake inhibitor (SSRI) to treat depression e.g. citalopram, fluoxetine, sertraline

•    methotrexate (a cancer drug which can also be used for treating psoriasis)

•    ciclosporin or tacrolimus (to prevent rejection following organ or bone marrow transplants)

•    trimethoprim (used to prevent and treat urinary tract infections)

•    oral steroids (used in hormone replacement therapy and to treat inflammation)

e.g. hydrocortisone, prednisolone

•    mifepristone (used to terminate a pregnancy)

•    quinolone antibiotics (for infections) e.g. ciprofloxacin, ofloxacin

•    zidovudine (to treat HIV infection)

•    phenytoin (used to treat epilepsy)

•    colestipol or cholestyramine (used to lower cholesterol)

•    medicines known as CYP2C9 inhibitors such as voriconazole (used to treat fungal infections).

Other special warnings:

•    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.

•    Diclofenac may reduce the symptoms usually seen as a result of an infection such as fever or headache, so if you feel unwell and need to see a doctor make sure you tell the doctor you are taking this medicine.

•    Your doctor may want to monitor you whilst you are taking this medicine, particularly if you are taking it for a long time.

Pregnancy and breastfeeding:

Do not take this medicine if you are more than 6 months pregnant.

Check with your doctor before taking if you are in the first 6 months of pregnancy, think you may be pregnant or if you are breastfeeding.

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.

Effects on driving or operating machinery:

Sometimes these tablets can make you feel dizzy, tired, drowsy, sleepy or might affect your vision. If you think this medicine has affected you, do not drive or operate machinery. Important information about some of the ingredients of Diclofenac Tablets:

The tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The tablets also contain methyl and propyl parahydroxybenzoates (E216, E218) which may cause allergic reactions (possibly delayed) and the 25mg tablets also contain tartrazine (E102) which may cause allergic reactions.

3. How to take Diclofenac Tablets

Swallow the tablets whole with a little water. Do not chew the tablets or break them.

Take with or after food.

Always take the medicine exactly as directed by your doctor. Your doctor will decide the dose that is best for you. The pharmacist’s label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist. Adults:

The usual adult dose is 75 to 150 mg a day, taken in 2 or 3 divided doses.

The recommended maximum daily dose is 150 mg.

Elderly:

Your doctor may have told you to take a lower dose than the usual adult dose stated above. Follow your doctor’s instructions.

Your doctor may want to do some tests after you start taking these tablets to check you are not bleeding in your stomach or intestines.

Children aged between 1 to 12 years, for juvenile chronic arthritis:

Using Diclofenac Tablets 25 mg, the usual dose is 1 -3 mg per kg of bodyweight per day, taken in divided doses.

Children aged 9 years or over (and weighing at least 35kg), for fever or pain following an operation:

Using Diclofenac Tablets 25 mg, the dose is up to 2 mg per kg of bodyweight per day in 3 divided doses.

Diclofenac Tablets 50 mg should NOT be used in children under 12 years of age.

If you have taken too many tablets: Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.

If you forget to take a dose:

Take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSE.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

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

•    pass blood in your faeces (stools/motions), pass black tarry stools, vomit any blood or dark particles that look like coffee granules. These may be signs of a stomach ulcer or bleeding in your stomach.

•    Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac Tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain.

STOP TAKING the medicine and tell your doctor as soon as possible if you experience:

•    indigestion or heartburn

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

•    allergic reactions such as skin rash, itching, bruising, painful red areas, peeling or blistering, dizziness, difficulty in breathing, wheezing or shortness of breath, swollen face, throat, lips, hands or fingers

•    blistering of skin when exposed to sunlight

•    yellowing of your skin or the whites of your eyes and/or pale stools, dark urine,

loss of appetite as these may be signs of liver problems

•    passing more or less urine than normal, cloudy or foamy urine, blood or protein in the urine, pain in the back, swelling (particularly of the ankles) as these may be signs of kidney problems.

If you get any of the following very rare effects (may affect less than 1 in 10,000 people) stop taking the tablets and tell your doctor as soon as possible:

•    inflammation of the pancreas causing severe pain in the abdomen and back

•    Stevens-Johnson syndrome or toxic epidermal necrolysis (serious illnesses causing blistering of the skin, mouth, eyes and genitals)

•    aseptic meningitis (especially in patients with auto-immune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck, muscle pain, feeling or being sick, eyes being very sensitive to bright light or disorientation.

Tell your doctor or pharmacist if you suffer from any of the following other side effects:

Common (may affect less than 1 in 10 people):

•    feeling or being sick, loss of appetite, diarrhoea, flatulence (wind), changes in blood enzymes, headache, feeling of dizziness or “spinning”.

Rare (may affect less than 1 in 1,000 people):

•    oedema (water retention), bloody diarrhoea, drowsiness or sleepiness.

Very rare (may affect less than 1 in 10,000 people):

•    high blood pressure, heart failure (which can cause shortness of breath or swollen ankles)

■    constipation, sore, swollen or inflamed mouth or throat, lower gut disorders including worsening of the symptoms of colitis and Crohn’s disease, or in isolated cases damage to/problems with the colon.

■    blood disorders including severe reduction in the number of white or red blood cells which may cause pale skin, weakness or breathlessness and increase the risk of bleeding or bruising, or make infections more likely

■    eczema, reddening or scaling of the skin, increased sensitivity to sunlight or loss of hair

•    ringing in the ears or impaired hearing

•    eyesight problems (such as blurred, double, partial or complete loss of vision, blind spots, halos around lights)

•    convulsions, tremor, tingling and numbness in the hands or feet, changes in memory or taste

•    difficulty sleeping, depression, anxiety, irritability, mood changes, nightmares

■    palpitations, chest pain

•    low blood pressure (symptoms include feeling faint and light-headed) or shock

•    inflammation of the blood vessels or of the lung tissue

■    medicines such as diclofenac may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Other side effects include:

•    tiredness, confusion, inflammation of the optic nerve in the eye, changes in sensation, hallucinations or impotence.

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 Tablets

Do not store above 25°C. Store in the original package.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information

Ingredients:

Diclofenac tablets are available in two strengths and contain either 25 or 50 mg of diclofenac sodium as the active ingredient. The tablets are gastro-resistant which means it has a coating which prevents it from dissolving until it has passed through the stomach.

The tablets also contain the following other ingredients: lactose, maize starch, magnesium stearate and purified talc.

The 25mg tablets also contain sodium starch glycollate and microcrystalline cellulose, and the 50mg tablets also contain povidone. The tablet coating contains methacrylic acid ethyl acrylate copolymer, hypromellose, red iron oxide (E172), titanium dioxide (E171), sodium hydroxide, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and disodium edetate (E385). The 25 mg tablet coating also contains tartrazine (E102), and the 50 mg tablet coating also contains yellow iron oxide (E172).

What the medicine looks like:

Diclofenac Tablets 25 mg are yellowish-mustard coloured round tablets.

Diclofenac Tablets 50 mg are light-brown coloured round tablets.

The tablets are available in pack sizes of 28, 50, 84 or 100 tablets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.

Date leaflet revised: May 2016 If you would like this leaflet in a different format please contact the licence holder at the above address.

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