Diclomax SR are yellow capsules with Diclomax SR 75 mg printed on them. Each capsule contains 75 mg of the active ingredient, Diclofenac sodium. Each capsule also contains the following ingredients: sucrose, maize starch, purified stearic acid, polyethylene glycol 6000, ammonia methacrylate copolymer type A, talc, lactose, polysorbate 80, gelatin, E172 and E171.

Each blister pack contains 56 capsules.

Diclomax SR is one of a group of medicines called non-steroidal anti-inflammatory analgesics. These are used for control of pain and inflammation.

The product licence holder is Parke, Davis & Company, Usk Road, Pontypool, Gwent, NP4 0YH. The manufacturer of Diclomax SR is Eurand SpA, Via Privata Pasteur 1, 20092 Cinisello, Balsamo, Milan, Italy.

Diclomax SR is used to treat a number of painful conditions affecting the joints and muscles. These include rheumatoid arthritis; osteoarthritis; low back pain; acute musculo-skeletal disorders such as periarthritis (especially frozen shoulder), tendinitis (inflammation of a tendon), tenosynovitis (inflammation of the tendon sheath), bursitis (inflammation of the bursa-connective tissue surrounding a joint); sprains; strains and dislocations; relief of pain in fractures; acute gout; ankylosing spondylitis; control of pain and inflammation in orthopaedic, dental and other minor surgery.

• If you are pregnant, think you might be pregnant, trying to become pregnant or are breastfeeding, you should tell your doctor.

If the answer to any of the following questions is yes, tell your doctor or pharmacist at once.

• Are you allergic to diclofenac sodium, aspirin or any other medicines used to treat painful conditions affecting the joints and muscles? Allergies may cause symptoms such as sickness, runny nose, stomach pains, wheezing, heartburn or skin rashes.
• Do you have or have you ever had a gastric or duodenal ulcer or gastrointestinal bleeding, including vomiting fresh blood or with the appearance of coffee grounds - or passing black tarry stools.
• Do you suffer from asthma?
• Do you suffer from heart, liver or kidney disease?
• Do you suffer from porphyria?
• Do you suffer from Crohn’s disease or ulcerative colitis?
• Do you have or have you ever had bloody diarrhoea?
• Do you suffer from any blood disorders including abnormal bleeding or bruising?
• Are you taking any of the following medicines?

• Are you taking any other medicines which your doctor does not know about?

Adults: The normal dose is one or two 75 mg capsules daily to be taken as directed by your doctor.

• Swallow the capsules whole with food or just after food. Do not chew the capsules or remove the contents as this will affect the special "slow release" properties.
• If you forget to take a dose, take it as soon as you remember, then go on as before.
• If you accidentally take too many capsules contact your doctor at once or go to your nearest hospital casualty department.
• If you go into hospital or visit a dentist or another doctor, tell them you are taking this medicine.

Diclomax SR can sometimes cause side-effects. The side effects seen most often are:

• Headache
• Dizziness
• Vertigo
• Skin rashes
• Stomach pain

Other reactions more rarely seen are:

• Peptic ulcers and gastro-intestinal bleeding
• Bloody diarrhoea
• Skin troubles such as eruptions or itching
• Drowsiness or tiredness
• Yellowing of your skin or whites of your eyes due to liver disorders
• Wheezing or shortness of breath
• Body swelling and allergies
• Abnormal blood tests of liver function

If any of these side effects or any other side effects occur and continue for longer than a few days, or are troublesome you should tell your doctor.

Whilst you are taking Diclomax SR your doctor may want to give you a check up from time to time

and this may include a check on your blood, liver and kidneys, particularly if you are taking

Diclomax SR for a long time or with Diuretics.

• Do not use Diclomax SR after the expiry date on the package.
• Store Diclomax SR below 25°C and protect from heat and moisture in the original pack
• As with all medicines keep your Diclomax SR capsules out of reach of children.
• If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.
• If the capsules look as if they are deteriorating in any way, do not take them and return them to the pharmacist.

This leaflet provides a summary of the information available on your medicine. This information applies only to Diclomax SR capsules. If you have any questions or are not sure of anything, ask your doctor or pharmacist who have access to additional information.

For further information please contact: Parke Davis, Lambert Court, Chestnut Avenue, Eastleigh, Hampshire, SO53 3ZQ

Date issued: December 1994