Please read this leaflet carefully before you start to take your tablets. This leaflet provides only a summary of the information available on your medicine. If you have any questions or want further information or advice, please ask your doctor or pharmacist.

Keep this leaflet whilst you are taking Preservex, you may want to read it again.

Preservex is one of a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs. Specifically, Preservex is from the class of NSAIDs derived from phenylacetic acid. The active ingredient in Preservex is aceclofenac. Preservex works by blocking chemicals called prostaglandins. Prostaglandins are released at the site of an injury and are responsible for producing pain and inflammation following tissue damage and immune reactions. By preventing the synthesis of these chemicals Preservex reduces inflammation and pain associated with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Each tablet contains 100 mg of the active ingredient aceclofenac, and a number of inactive ingredients used to bind and coat the tablet (these are microcrystalline cellulose, sodium croscarmellose, polyvidone, glyceryl palmitostearate, and the film coat, containing partially substituted hydroxypropyl methylcellulose, polyoxyethylene 40 stearate and titanium dioxide).

The company licensed to sell and distribute Preservex in the UK is

Bristol-Myers Squibb Pharmaceuticals Limited

Hounslow,

Middlesex

England

Preservex Tablets 100 mg are made by:

Prodes S A

Calle Trabajo s/n

08960 Sant Just Desvern

Barcelona

Spain

Please inform your doctor if the answer to any of the following questions is yes.

• Do you have or have you ever had a stomach or duodenal ulcer?
• Have you had an allergic reaction, eg skin rash or wheezing, to any other non-steroidal anti-inflammatory agent eg diclofenac or aspirin?
• Have you ever experienced an increase in the severity and duration of an asthmatic attack, urticaria (rash), or acute rhinitis (runny nose) when taking aspirin or any other non-steroidal anti-inflammatory agent?
• Have you ever experienced stomach discomfort, nausea, or heartburn after taking aspirin?
• Do you suffer from heart, kidney or liver disease?
• Have you recently undergone major surgery?
• Are you taking another form of NSAID? Concomitant treatment with other NSAIDs may increase the frequency of side effects (more information on these is described later in the leaflet).
• Are you taking anticoagulants (ie blood thinning tablets like warfarin), or diuretics such as furosemide, hydrochlorothiazide or triamterene? Are you taking any other medicines which your doctor does not know about?

• Are you pregnant or trying to become pregnant? Are you breast feeding?

Preservex is NOT recommended for use in children.

The tablets should be taken regularly and as directed by your doctor. The recommended dose is

200 mg per day, taken as one tablet in the morning and one in the evening.

Swallow tablets whole with a drink of water. Do not crush or chew the tablets. You may take Preservex with or without food, whichever is convenient.

1. Never change the dose of your medicine without talking to your doctor first.
2. Continue to take your tablets for as long as your doctor recommends. Do not stop taking them if you begin to feel better, unless you are told to do so by your doctor.
3. If you miss a dose, do not worry, just take the next dose when it is due.
4. It you accidentally take too many Preservex tablets contact your doctor immediately or go to your nearest hospital casualty department. Take this leaflet or the box the Preservex tablets came in to the hospital so that they will know what you have taken.
5. Your box of Preservex contains 60 tablets. The box is marked by a "Use by" date. Do not take the tablets after this date.

Like many medicines, Preservex may cause unwanted side effects in some people and these can vary from patient to patient.

• Stomach discomfort or heartburn;
• Vomiting blood or passing black stools;
• Skin troubles such as rash or itching;
• Wheezing or shortness of breath;
• Yellowing of your skin or the whites of your eyes;

Other effects which have occasionally been reported are:

• Headache or dizziness
• Sleepiness or tiredness.

These effects are often mild and may wear off after a few days treatment. If they are severe or persist for more than a few days, tell your doctor. Also, if your tablets upset you in any other way, tell your doctor.

As a precaution, you should refrain from driving or operating machinery if you feel dizzy or sleepy when you take Preservex. Do not perform any of these actions until the effects wear off.

Whilst taking Preservex, your doctor may want to give you a check-up from time to time. Consult your doctor before taking any new medicines whilst you are on Preservex.

As with all medicines, keep Preservex out of the reach of children, and store in a cool dry place – a locked cupboard or medicine cabinet is often best.

If your doctor tells you to stop taking your medicine, you should return any remaining tablets to the pharmacist, unless the doctor tells you to keep them at home.

This medicine is for YOU. Only a doctor can prescribe it, so never offer it to any other person, even if their symptoms are similar to, or the same as yours

This leaflet has been prepared in accordance with current European Union Directive 92/27/EEC.

The information given applies only to Preservex tablets.

Product Licence No: PL08448/0001

THIS LEAFLET WAS PREPARED IN: October 1995.