Voltarol tablets (diclofenac)

- 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, Voltarol 25mg e/c tablets are used for:

- Chronic juvenile arthritis.

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

Warning!

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- Voltarol e/c tablets, Voltarol SR tablets and Voltarol Retard tablets should be swallowed whole and not broken, crushed or chewed. They should preferably be taken with food.
- Voltarol dispersible tablets should be dispersed in a glass of water before taking. They should also be taken with or after food. This type of Voltarol tablet is more likely to cause stomach irritation than the others and should not be used for longer than three months.
- 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.

Use with caution in

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- 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.
- Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
- History of high blood pressure .
- 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.
- Voltarol 50mg e/c tablets, Voltarol dispersible tablets, Voltarol SR tablets and Voltarol 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.

Label warnings

- Take this medication with or after food.