Fenactol (diclofenac)

- Fenactol e/c tablets, Fenactol SR tablets and Fenactol 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.

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.
- Fenactol 50mg e/c tablets, Fenactol SR tablets and Fenactol 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.

- 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

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- Take this medication with or after food.
- This medication is to be swallowed whole, not chewed.