What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL 14017/0009, PL 14017/0008.

Dicloflex 75 mg SR and Dicloflex Retard 100mg Prolonged-release tablets

PATIENT INFORMATION LEAFLET

DICLOFLEX 75 mg SR and DICLOFLEX RETARD 100 mg

Prolonged-release tablets

(diclofenac sodium)

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.

In this leaflet

1.What DICLOFLEX is and what it is used for
2.What you need to know before you take DICLOFLEX
3.How to take DICLOFLEX
4.Possible side effects
5.How to store DICLOFLEX
6.Contents of the pack and other information

1. WHAT DICLOFLEX IS AND WHAT IT IS USED FOR

Diclofenac sodium, the active ingredient in DICLOFLEX tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. DICLOFLEX tablets are especially formulated to release the diclofenac sodium slowly.

DICLOFLEX tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including:

  • Rheumatoid arthritis, osteoarthritis, acute gout (painful inflammation of the joints especially in the feet and hands). ankylosing spondylitis (form of spinal arthritis).
  • Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures
  • Conditions affecting the tendons for example, tendonitis, tenosynovitis, bursitis.

They are also used to treat pain and inflammation associated with dental and minor surgery.

DICLOFLEX tablets are not suitable for children.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOFLEX

Do not take DICLOFENAC SODIUM if:

  • you are allergic to diclofenac sodium, aspirin, ibuprofen or to any other NSAID, or any of the other ingredients of DICLOFLEX tablets (these are listed under section 6 "CONTENTS OF THE PACK AND OTHER INFORMATION" of the leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction.
  • you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)
  • you have had stomach or bowel problems after you have taken other NSAIDs
  • you have severe heart, kidney or liver failure
  • you 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.
  • you have or have had problems with your blood circulation (peripheral arterial disease).
  • you are more than six months pregnant

Warnings and precautions

Talk to your doctor or pharmacist before taking Diclofenac if:

  • you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s disease
  • you have kidney or liver problems, or you are elderly
  • you have a condition called porphyria
  • you suffer from any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets.
  • you ever had asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic pulmonary diseases or infections of the respiratory tract.
  • you are breast feeding
  • you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
  • you have heart problems or if you had a stroke or you think 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 have diabetes
  • you smoke
  • you have Systemic Lupus Erythematosus SLE (inflammatory, auto-immune disorder which causes symptoms such as joint pain, joint inflammation, skin rashes, fever) or any similar condition
  • you have an intolerance to some sugars such as sucrose (these tablets contain sucrose)

Tell your doctor or pharmacist if you have any of these conditions because DICLOFLEX might not be the right medicine for you.

Children

DICLOFLEX tablets are not suitable for children.

Other medicines and DICLOFLEX

Some medicines can interfere with your treatment. Please tell your doctor or pharmacist if you are taking any of the following:

  • Medicines to treat diabetes
  • Anticoagulants (blood thinning tablets like warfarin)
  • Diuretics (water tablets)
  • Lithium (used to treat some mental problems)
  • Methotrexate (for treatment of some inflammatory diseases and some cancers)
  • Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
  • Trimethoprim (a medicine used to prevent or treat urinary tract infections)
  • Quinolone antibiotics (for infections)
  • Any other NSAID or COX-2 (cyclo-oxygenase-2) inhibitor, for example aspirin or ibuprofen
  • Mifepristone (a medicine used to terminate pregnancy)
  • Cardiac glycosides (for example digoxin), used to treat heart problems
  • Medicines known as SSRIs (used to treat depression)
  • Oral steroids (an anti-inflammatory drug)
  • Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitors
  • Voriconazole (a medicine used to treat fungal infections).
  • Phenytoin (a medicine used to treat seizures)
  • Colestipol/cholestyramine (used to lower cholesterol)

DICLOFLEX with food and drink

Take this medicine with or after food

Pregnancy and breast-feeding

  • Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take DICLOFLEX during the last 3 month of pregnancy as it may affect the baby's circulation.
  • You should advise your doctor or pharmacist if you think you might be pregnant or are up to 6 month pregnant.
  • Taking DICLOFLEX may make it more difficult to become pregnant. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
  • You should avoid taking DICLOFLEX whilst breast feeding.

Driving and using machines

Very occasionally people have reported that diclofenac sodium tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.

Other special warnings

  • You should take the lowest effective dose of Diclofenac Sodium for the shortest possible time particularly if you are underweight or elderly.
  • There is a small increased risk of heart attack or stroke when you are taking any medicine like Diclofenac Sodium. The risk is higher if you are taking high doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for.
  • Whilst you are taking these medicines your doctor may want to give you a check-up from time to time.
  • If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.
  • Because it is an anti-inflammatory medicine, Diclofenac Sodium tablets may reduce the symptoms of infection, for example, headache, and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac Sodium tablets.

DICLOFLEX tablets contain

DICLOFLEX contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE DICLOFLEX

The doctor will tell you how many DICLOFLEX tablets to take and when to take them. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the tables with or after food.

Swallow the tablets whole with a glass of water. DO NOT crush or chew the tablets as this will affect the special “slow release” system.

The recommended dose is:

Adults: 100-150mg daily divided into two or three doses. The number of tablets which you take will depend on the strength the doctor has given you.

Your doctor may wish to increase your daily dose if required to 150mg.

Elderly: The lowest effective dose should be used. Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Close surveillance is advisable.

Children: These tablets are not suitable for children.

The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.

If you take more DICLOFLEX than you should

If you, or anyone else, accidentally takes too much DICLOFLEX, tell your doctor or go to your nearest hospital casualty department immediately. Take your medicine pack with you so that people can see what you have taken.

Symptoms of an overdose can include: headache, nausea (feeling sick), vomiting, abdominal pain, stomach or intestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, ringing in the ears, fainting, or occasionally convulsions (seizures, uncontrolled fits).

If you forget to take DICLOFLEX

It is important that you do not miss a dose. If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, just take the next dose and forget about the one you missed. DO NOT take a double dose to make up for a forgotten tablet. Do not take more than 150 mg in 24 hours. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

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

4. POSSIBLE SIDE EFFECTS

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

Some side effects can be serious

STOP TAKING DICLOFLEX and tell your doctor straight away if you notice:

  • Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)
  • Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces
  • Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering
  • Wheezing or shortness of breath (bronchospasm)
  • Swollen, face, lips, hands or fingers
  • Yellowing of your skin or the whites of your eyes
  • Persistent sore throat or high temperature
  • An unexpected change in the amount of urine produced and/or its appearance.
  • Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with DICLOFLEX and followed by rectal bleeding or bloody diarrhea usually within 24 hours of the onset of abdominal pain
  • Stevens-Johnson syndrome (serious illnesses with blistering of the skin, mouth, eyes and genitals)

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

The side effects listed below have also been reported.

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

  • Stomach pain, heartburn, nausea, vomiting, diarrhea, indigestion, wind, loss of appetite
  • Headache, dizziness, vertigo
  • Skin rash or spots
  • Raised levels of liver enzymes in the blood

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

  • Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)
  • Gastritis (inflammation, irritation or swelling of the stomach lining)
  • Vomiting blood
  • Diarrhoea with blood in it or bleeding from the back passage
  • Black, tarry faeces or stools
  • Drowsiness, tiredness
  • Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)
  • Skin rash and itching
  • Fluid retention, symptoms of which include swollen ankles
  • Liver function disorders, including hepatitis and jaundice

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

Effects on the nervous system:

Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation

Effects on the stomach and digestive system:

Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including of the colon or worsening of ulcerative colitis or Crohn’s disease).

Effects on the heart, chest or blood:

Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), heart disorders, including congestive heart failure or heart attack, blood disorders (including anaemia).

Effects on the liver or kidneys:

Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine

Effects on skin or hair:

Serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.

Hair loss

Other side effects that have also been reported include:

Inflammation of the pancreas, impotence. Facial swelling, inflammation of the lining of the brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye

Do not be alarmed by this list - most people take Diclofenac Sodium Tablets without any problems. If any of the side effects becomes serious, or if you notice side effects not listed in this leaflet, please tell your doctor. He/she may want to give you a different medicine.

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 DICLOFLEX

Keep out of the sight and reach of children.

Do not use DICLOFLEX tablets after the expiry date which is printed after ‘Exp’on the carton.

Do not store above 25°C. Keep the tablets in their original pack.

Medicines should not be disposed of via waste water 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 DICLOFLEX tablets contain

The name of your medicine is DICLOFLEX 75 mg SR or DICLOFLEX RETARD 100 mg.

DICLOFLEX 75 mg SR: Each prolonged-release tablet contains 75 mg of the active ingredient diclofenac sodium, and also contains the following inactive ingredients: tablet core: cetostearyl alcohol, colloidal anhydrous silica, compressible sugar, talc, povidone and magnesium stearate. Subcoat: copovidone and sucrose. Tablet film coat: hydroxypropylmethylcellulose, polyethylene glycol, iron oxide red (E172), titanium dioxide (E171) and gum acasia. Polish: carnauba wax.

DICLOFLEX RETARD 100 mg: Each prolonged-release tablet contains 100 mg of the active ingredient diclofenac sodium, and also contains the following inactive ingredients: tablet core: cetostearyl alcohol, colloidal anhydrous silica, compressible sugar, talc, povidone, magnesium stearate. Subcoat: copovidone and sucrose. Tablet film coat: hydroxypropylmethylcellulose, polyethylene glycol, iron oxide red (E172), titanium dioxide (E171) and gum acasia. Polish: carnauba wax.

What DICLOFLEX look like and contents of the pack

DICLOFLEX 75 mg SR are marked DICL75 on one side and are pink in colour, and are packed in cartons containing 28 tablets or 56 tablets in foil blister strips.

DICLOFLEX RETARD 100 mg are marked DICL100 on one side and are pink in colour, and are packed in cartons containing 28 or 100 tablets in foil blister strips.

Not all pack sizes may be marketed.

Marketing Authorisation Holder / Manufacturer:

Dexcel®-Pharma Ltd.
7 Sopwith Way
Drayton Fields
Daventry
Northamptonshire
NN11 8PB
UK

This leaflet was last revised in July 2017

V-1363