PACKAGE LEAFLET: INFORMATION FOR THE USER

DICLOFENAC SODIUM 50 mg TABLETS

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

-    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. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS

1.    What DICLOFENAC tablets are 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 FOR

DICLOFENAC is a Non-Steroidal Anti-Inflammatory Drug (NSAID) used to reduce pain and swelling in joint, bone or muscle diseases (e.g. rheumatoid arthritis, osteoarthritis, gout or musculoskeletal disorders). It can also be used to relieve pain before dental or surgical procedures or for lower back pain.

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE DICLOFENAC TABLETS.

Do not take DICLOFENAC tablets if you

•    are allergic to DICLOFENAC or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    are allergic to other NSAIDs (e.g. ibuprofen, aspirin)

•    have asthma or have had a skin rash, facial swelling or a blocked or runny nose after taking another NSAID

•    have or have had a serious heart condition

•    are in the last three months of your pregnancy

•    have or have had repeated ulcers or bleeding in the stomach or bowels

•    have or have had serious problems with your liver or kidneys

•    have an inherited iron disorder (porphyria).

Take special care with DICLOFENAC tablets

Tell your doctor before you take this medicine if you

•    are planning a pregnancy or are having problems becoming pregnant, as DICLOFENAC tablets may make it more difficult to become pregnant

•    have any stomach or bowel disorders including ulcerative colitis or Crohn's disease

•    have problems with your liver or kidneys or you are elderly

•    have a history of asthma or problems with your lungs

•    have blood clotting problems or are taking medicines to stop your blood clotting

•    have Systemic Lupus Erythematosus (an allergic condition which causes joint pain, skin rash and fever) or any similar condition.

Medicines such as DICLOFENAC tablets may be linked to a small increased risk of heart attack or stroke. Any risk is more likely with high doses or 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 (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how DICLOFENAC tablets work:

•    Aspirin or other NSAIDs for pain and swelling or Probenecid to treat gout

•    Methotrexate to treat cancer

•    Medicines to stop your blood clotting such as Warfarin

•    Medicines for high blood pressure or heart failure such as Digoxin

•    Medicines to suppress the immune system such as Tacrolimus or Ciclosporin

•    Steroid hormones such as Prednisolone

•    Medicines to treat bacterial infections such as Quinolone antibiotics for example Ciprofloxacin

•    Zidovudine to treat viral infections

•    Lithium for mental health problems

•    Medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs) for depression such as Venlafaxine

•    Phenytoin for epilepsy

•    Medicines called Sulphonylureas for diabetes such as Gliclazide or Tolbutamide

•    Medicines to increase urine production such as Furosemide

•    Mifepristone for abortion.

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking DICLOFENAC tablets.

Taking DICLOFENAC tablets with food and drink

You can take these tablets with or after food.

Pregnancy and breast-feeding

Do not take DICLOFENAC tablets if you are in the last three months of your pregnancy. Avoid these tablets if you are in first six months of your pregnancy or if you are breast-feeding, unless your doctor has advised you to take them.

Driving and using machines

DICLOFENAC tablets may cause headaches, dizziness, drowsiness, tiredness or problems with your vision. If affected do not drive or operate machinery.

Important information about some of the ingredients of DICLOFENAC tablets

This medicine contains:

Lactose. If you know you have an intolerance to lactose or other sugars contact your doctor before taking DICLOFENAC tablets.

Sunset yellow (E110). This may cause an allergic reaction.

3. HOW TO TAKE DICLOFENAC TABLETS

Always take DICLOFENAC tablets exactly as your doctor has told you. Do not crush or chew the tablets. Swallow them whole with a glass of water, with or after food.

Dosage

Your doctor will decide your dose, as it depends on your condition.

Adults and children aged 12 years and above:

Typical dose is 75-150 mg daily in two or three divided doses.

Elderly and patients with kidney problems: Require smaller doses. Follow your doctor's advice.

Children aged 12 years and above with juvenile arthritis: Your child will be given a dose depending on their bodyweight. Typical dose is 1-3 mg/kg daily in divided doses.

Children aged 12 years and above with fever related to an ear, nose or throat infection, or with pain following surgery: Your child will be given a dose depending on their bodyweight. Typical dose is 2 mg/kg daily in three divided doses; however this will depend on your child's condition.

DICLOFENAC 50mg tablets are not recommended for use in children under 12 years of age.

If you take more DICLOFENAC tablets than you should

Contact your doctor or pharmacist immediately. Show them the package or container.

If you forget to take DICLOFENAC tablets

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. POSSIBLE SIDE EFFECTS

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

STOP TAKING this medicine and seek immediate medical help if you pass blood in your stools, pass black tarry stools or vomit blood or dark particles that look like coffee grounds.

STOP TAKING this medicine and tell your doctor

if you have:

•    indigestion, heartburn or aches and pains in the stomach area

•    an allergic reaction, which may cause asthma, wheezing or difficulty breathing; skin rash, itching or red and raised lumps (hives), skin peeling; swelling of the face or throat; blistering of the skin, mouth, eyes and genitals or sensitivity to sunlight

•    yellowing of the skin or whites of the eyes (jaundice)

•    unexplained bleeding, bruising, sore throat, general illness or fever. Your doctor may wish to test your blood.

Medicines such as DICLOFENAC tablets may be linked to a small increased risk of heart attack or stroke.

Other side effects include:

Common side effects:

•    headache, dizziness, nausea, vomiting

•    aches and pains in the stomach area

•    constipation, diarrhoea

•    gas, indigestion, heartburn

•    loss of appetite.

Rare side effects:

Effects on the heart:

•    fluid retention, high blood pressure

•    chest pain, a fast or irregular heart beat

•    heart failure.

Effects on the liver or kidneys:

•    liver function disorders, including hepatitis

•    raised levels of liver enzymes in the blood

•    kidney problems, which may lead to swelling of the face and ankles, kidney failure or the presence of blood or protein in the urine.

Effects on the blood:

•    reduction in red blood cells (anaemia), which can make the skin pale and cause weakness or breathlessness.

Aseptic meningitis which may cause:

•    stiff neck, headache, nausea, vomiting, fever disorientation.

Other effects:

•    numbness or tingling in the fingers, shaking, blurred or double vision, sudden loss of vision or pain on movement of the eye, hearing loss or impairment, ringing in the ears, sleeplessness, nightmares, feeling irritable, depression, anxiety, nervousness, mental disorders, confusion, hallucinations, loss of memory, fits

•    drowsiness, a feeling of dizziness or spinning (vertigo), tiredness, general illness

•    difficulty breathing

•    loss of hair, disturbances in sensation

•    a red swollen tongue, mouth ulcers, taste changes

•    worsening of ulcerative colitis or Crohn's disease

•    an inflamed pancreas, which can cause severe pain in the stomach area and back.

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

5. HOW TO STORE DICLOFENAC TABLETS

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the package or container. 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. FURTHER INFORMATION

What DICLOFENAC tablets contain

The active ingredient in DICLOFENAC tablets is sodium diclofenac. The other ingredients are lactose, microcrystalline cellulose, maize starch, magnesium stearate, colloidal anhydrous silica, cellulose acetate phthalate, macrogol 6000, castor oil, hydroxypropylcellulose, titanium dioxide (E171) and sunset yellow (E110).

What DICLOFENAC tablets look like and contents of the pack

DICLOFENAC 50 mg tablets are round orange tablets with the Chatfield logo engraved one side and DIC50 on the other.

The tablets come in blisters packs and containers of 14, 15, 21, 28, 42, 56, 70, 84 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

11 Boumpoulinas, Nicosia, PC. 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road, London, SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 10/2014

CL0143/O/PIL/CL1