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«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 ...»

-- [ Page 1 ] --

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

In this leaflet

1. What DICLOFLEX is and what it is used for

2. Before you take DICLOFLEX

3. How to take DICLOFLEX

4. Possible side effects

5. How to store DICLOFLEX

6. Further 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 a number of conditions

affecting the joints and muscles:

• 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. BEFORE YOU TAKE DICLOFLEX

Do not take if

• you are allergic (hypersensitive) to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or any of the other ingredients of DICLOFLEX tablets (these are listed under section 6 "FURTHER INFORMATION" of the leaflet).

• 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 have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, face and mouth, skin rashes or a runny nose.

• you have an active or a history of recurrent (more

–  –  –

Take special care

• if you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease

• if you have kidney or liver problems, or you are elderly

• if you have a condition called porphyria

• if you suffer from any blood or bleeding disorder

• if you ever had asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic pulmonary diseases or infections of the respiratory tract.

• if you have heart problems 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)

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

Other special warnings

• You should take the lowest effective dose of DICLOFLEX for the shortest possible time to control symptoms, particularly if you are underweight or elderly.

• You should be aware that 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.

• Whilst you are taking these medicines your doctor may want to give you a check-up or order a blood test 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 these are anti-inflammatory medicines, they 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 DICLOFLEX tablets.

Taking other medicines Some medicines can interfere with your treatment. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription,

especially any of the following:

• Medicines to treat diabetes





• Any other NSAID or COX-2 (cyclo-oxygenase-2) inhibitor, for example aspirin or ibuprofen 155mmx560mm

–  –  –

3. HOW TO TAKE DICLOFLEX The doctor will tell you how many DICLOFLEX tablets to take and when to take them. Always take DICLOFLEX exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Keep taking your tablets for as long as you have been told, unless you have any problems.

In that case, check with your doctor. The usual dose is:

Adults: One tablet daily. 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.

Swallow the tablets whole with a glass of water, with or after food. Do NOT crush or chew the tablets as this will affect the special "slow release" system.

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).

–  –  –

STOP TAKING DICLOFLEX and tell your doctor if you notice:

• Indigestion or heartburn

• Abdominal pain (pains in your stomach), wind, nausea (feeling sick) or vomiting (being sick) or other abnormal stomach symptoms.

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

Effects on the stomach and intestine:

Common side effects (may affect up to 1 in 10 people): nausea (feeling sick), vomiting, diarrhoea, wind, indigestion, heartburn, loss of appetite, abdominal (stomach) pain.

Rare side effects (may affect up to 1 in 1,000 people): gastritis (inflammation of the stomach), any sign of bleeding, for example when emptying your bowls, black tarry stools, blood in your vomit, stomach and/ or intestine ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly).

Very rare side effects(may affect up to 1 in 10,000 people): colitis (inflammation of the lower gut which causes symptoms such as abdominal pain, diarrhoea) and worsening of existing ulcerative colitis or Crohn’s disease, constipation, inflammation of the mouth (including mouth ulcers), inflammation of the tongue, oesophageal disorders (causes symptoms such as difficulty swallowing and chest or back pains)

Immune system disorders:

Rare side effects (may affect up to 1 in 1,000 people): allergic reactions (see in section 4 "Some side effects can be serious"), anaphylactic and anaphylactoid reactions (serious allergic reaction which causes symptoms such as fast throbbing heart beat, flushing, dizziness, fainting, difficulty breathing).

Very rare side effects (may affect up to 1 in 10,000 people): angioedema (serious allergic reaction which causes swelling mainly of the face, lips, tongue, throat).

Effects on the heart or chest:

Very rare side effects (may affect up to 1 in 10,000 people): heart attack (‘myocardial infarction’), chest pain, palpitations (fast or irregular heart beat), heart failure.

Effects on the vascular system:

Rare side effects (may affect up to 1 in 1,000 people): low blood pressure which may include faintness, giddiness or light headedness Very rare side effects (may affect up to 1 in 10,000 people): high blood pressure, inflammation of blood vessels.

Effects on the kidneys:

Very rare side effects (may affect up to 1 in 10,000 people): abnormal kidney function or failure causing swelling particularly of the ankles (fluid retention), high or low blood pressure, presence of blood or protein in the urine, an unexpected change in the amount of urine produced and/or its appearance.

Effects on the liver:

Common side effects (may affect up to 1 in 10 people): elevated liver enzymes in the blood (shows up in blood tests).

Rare side effects (may affect up to 1 in 1,000 people): abnormal liver function, including hepatitis and jaundice (yellowing of the skin and the whites of the eyes).

Very rare side effects (may affect up to 1 in 10,000 people): rapidly progressive hepatitis, liver failure.

Effects on the nervous system:

Common side effects (may affect up to 1 in 10 people): headaches, dizziness.

Rare side effects (may affect up to 1 in 1,000 people): drowsiness, tiredness.

Very rare side effects (may affect up to 1 in 10,000 people): tingling or numbness in the hands and/or feet, loss of memory, fits, anxiety, shaking, change in sense of taste, sleeplessness, stroke, non-infectious meningitis (particularly if you suffer from auto-immune disorders such as Systemic Lupus Erythematosus (SLE)) with symptoms such as stiff neck, headache together with a dislike of bright lights, feeling sick, vomiting, fever or disorientation, disturbances in sensation.

Psychiatric disorders:

Very rare side effects (may affect up to 1 in 10,000 people): disorientation, mood changes, depression, difficulty sleeping, nightmare, irritability, mental disorders.

Effects on hearing:

Common side effects (may affect up to 1 in 10 people): Vertigo (sensation of irregular or spinning motion).

Very rare side effects (may affect up to 1 in 10,000 people): ringing in the ears, hearing loss or impairment.

Effects on vision:

Very rare side effects (may affect up to 1 in 10,000 people): blurred or double vision, partial or complete loss of eyesight.

–  –  –

blistering of the skin, itching, eczema (inflammatory skin disease), redness of the skin, photosensitivity (increased sensitivity to sunlight), loss of hair.

Effects on the respiratory system:

Rare side effects (may affect up to 1 in 1,000 people): asthma, difficulty and/or shortness of breath.

Very rare side effects (may affect up to 1 in 10,000 people): pneumonitis (inflammation of the lungs which causes breathlessness, cough and raised temperature).

General disorders:

Rare side effects (may affect up to 1 in 1,000 people): oedema (water retention leading to swelling of the hands, ankles or feet).

Other side effects that have also been reported include (frequency cannot be estimated from the

available data):

Impotence, throat disorders, hallucinations, confusion, general feeling of discomfort, inflammation of the nerves of the eyes.

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.

–  –  –

6. FURTHER 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.

–  –  –

Marketing Authorisation Holder / Manufacturer:



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