Drug Database - Dicloflex

Generic Name: diclofenac (di-klo´fen-ak)

Brand Names: Dicloflex®

Classification: NSAID

In adults, Dicloflex tablets are used to relieve pain and inflammation in a wide range of conditions, including those listed below.

• Rheumatoid arthritis
• Osteoarthritis
• A form of arthritis affecting the joints of the spine (ankylosing spondylitis)
• Acute gout
• Acute disorders of the muscles and skeleton, such as frozen shoulder (periarthritis), tendon inflammation (tendinitis), tenosynovitis, bursitis
• Painful conditions due to accidents, such as sprains, strains, dislocations, fractures
• Lower back pain
• Pain and inflammation following dental, orthopaedic (bone) and other minor surgery

In children aged 1-12 years, Dicloflex 25mg e/c tablets are used for:

• Chronic juvenile arthritis

No other forms or strengths of Dicloflex tablets are suitable for this age group.

Dicloflex is NOT known to be marketed in the USA.

How Does It Work?

Dicloflex e/c tablets, Dicloflex SR tablets and Dicloflex retard tablets all contain the active ingredient diclofenac sodium, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are used to relieve pain and inflammation. (NB. Diclofenac is also available without a brand name, ie as the generic medicine.)

Diclofenac works by blocking the action of a substance in the body called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced by the body in response to injury and certain diseases and conditions, and cause pain, swelling and inflammation. Diclofenac blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.

Diclofenac is used to relieve pain and inflammation in a wide range of musculoskeletal conditions, including various forms of arthritis, gout, sprains, fractures, dislocations, back pain, tendinitis and frozen shoulder. It is also used to relieve pain and inflammation following dental, orthopaedic (bone) and other minor surgery.

Dicloflex e/c tablets have a special 'enteric coating' that is designed to prevent the absorption of the diclofenac in the stomach, and thus reduce the risk of stomach irritation. The diclofenac is absorbed when the tablet reaches the intestine. The tablets should be swallowed whole to avoid damaging this coating.

Dicloflex SR and Dicloflex retard tablets are modified-release tablets. They contain higher doses of diclofenac and are designed to release this slowly and continuously over a few hours. This provides more prolonged pain relief, so these tablets are usually taken once or twice a day. These tablets must also be swallowed whole to avoid damaging the modified-release action.

All types of Dicloflex tablet should preferably be taken with food to help avoid irritating the stomach.

Warnings

Dicloflex e/c tablets, Dicloflex SR tablets and Dicloflex retard tablets should be swallowed whole and not broken, crushed or chewed. They should preferably be taken with food.

This medicine may cause dizziness, drowsiness or visual disturbances and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.

This medicine may mask the signs and symptoms of infection, such as fever and inflammation. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.

Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimise the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.

NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see end of factsheet). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people having treatment with this medicine should stop taking it and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine, for example vomiting blood and/or passing black/tarry/bloodstained stools.

Studies have suggested that use of diclofenac may be associated with a small increase in the risk of heart attacks and stroke. The risks increase with higher doses and the longer the medicine is taken. If you have risk factors for heart disease or stroke, such as diabetes, high blood pressure, high cholesterol or smoking, your doctor will need to assess the overall benefits and risks before deciding if this medicine is suitable for you. You should tell your doctor if you experience shortness of breath, chest pains or ankle swelling while taking the medicine. Ask your doctor or pharmacist for further information.

Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.

If you have cirrhosis of the liver, heart failure or kidney disease, you are taking diuretic medicines, or you are recovering from major surgery, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.

During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.

Use With Caution

• Elderly people
• History of disorders affecting the stomach or intestines, such as ulceration or bleeding
• Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• Decreased kidney function
• Decreased liver function
• A type of life long inherited blood disease caused by a defect in the liver (hepatic porphyria)
• Heart failure
• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack
• Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA)
• Poor circulation in the arteries of the legs or feet (peripheral arterial disease)
• History of high blood pressure (hypertension)
• Raised levels of fats such as cholesterol in the blood (hyperlipidaemia)
• Diabetes
• Smokers
• History of asthma
• History of allergies
• People with blood clotting disorders or taking anticoagulant medicines
• Diseases affecting connective tissue, eg systemic lupus erythematosus

Not to be used in

• People in whom aspirin or other NSAIDs, eg ibuprofen, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema)
• Active peptic ulcer, perforation (hole) or bleeding in the gut
• People who have had recurrent peptic ulcers or bleeding from the gut (two or more episodes)
• People who have previously experienced bleeding or perforation of the gut as a result of taking an NSAID
• Severe heart failure
• Severe liver failure
• Severe kidney failure
• Third trimester of pregnancy
• Dicloflex 50mg e/c tablets, Dicloflex SR tablets and Dicloflex retard tablets are not suitable for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be taken in the third trimester of pregnancy because it may delay labour, increase the length of labour and cause complications in the newborn baby. It is not recommended for use in the first and second trimesters of pregnancy unless considered essential by your doctor. Some evidence suggests that NSAIDs such as this one should also be avoided by women attempting to conceive, as they may temporarily reduce female fertility during treatment and may also increase the risk of miscarriage or malformations. Seek medical advice from your doctor.

The medicine passes into breast milk in small amounts. At normal doses it is unlikely to harm the baby, however it is important to discuss this with your doctor before taking this medicine if you are breastfeeding.

Side Effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting, indigestion or abdominal pain
• Excess gas in the stomach and intestines (flatulence)
• Loss of appetite
• Headache
• Dizziness
• Balance disorders involving the inner ear (vertigo)
• Skin rashes
• Ulceration of the stomach or intestine
• Bleeding from the stomach or intestine
• Drowsiness
• Anxiety
• Depression
• Difficulty sleeping (insomnia)
• Fluid retention (oedema)
• Changes in blood pressure
• Sensation of ringing or other noise in the ears (tinnitus)
• Allergic reactions such as severe skin rashes, swelling of the lips, tongue and throat (angioedema) or narrowing of the airways (bronchospasm)
• Kidney, liver or blood disorders
• Small increased risk of heart attack (myocardial infarction) or stroke, particularly at high doses (150mg daily) and in long-term treatment

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Indigestion remedies such as antacids should not be taken at the same time as enteric-coated diclofenac tablets, as they will stop the special coating from working.

Diclofenac should not be taken in combination with painkilling doses of aspirin or any other oral NSAID, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of COX-2 such as celecoxib or etoricoxib should also be avoided for the same reason.

There may be an increased risk of ulceration or bleeding from the gut if diclofenac is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding from the gut if diclofenac is taken with the following medicines:

• anti-blood-clotting (anticoagulant) medicines such as warfarin
• anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
• SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
• venlafaxine

Diclofenac may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking diclofenac with an anticoagulant should be closely monitored by their doctor.

Diclofenac may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines. People taking diclofenac with any of these should be closely monitored by their doctor:

• digoxin
• lithium
• methotrexate

Ciclosporin may increase the blood level of diclofenac, and your doctor may prescribe a lower than normal dose of diclofenac if you are taking ciclosporin.

There may be an increased risk of side effects on the kidneys if diclofenac is taken with any of the following medicines:

• ACE inhibitors, eg enalapril
• angiotensin II receptor antagonists, eg losartan
• ciclosporin
• diuretics, eg furosemide
• tacrolimus

Diclofenac may oppose the blood pressure lowering effects of certain medicines to treat

• ACE inhibitors such as captopril
• angiotensin II receptor antagonists, eg losartan
• beta-blockers such as propranolol
• diuretics such as furosemide