GLUCOBAY (PRECOSE)™

Acarbose tablets 50mg and 100mg

WHAT GLUCOBAY (PRECOSE) IS USED FOR

GLUCOBAY (PRECOSE) tablets contain the active drug acarbose. They are used for the treatment of diabetes (both non-insulin and insulin dependant) in association with diet.

How GLUCOBAY (PRECOSE) works in diabetes

Glucobay (Precose) helps to control your blood sugar levels in conjunction with diet, exercise, weight loss and other measures by slowing down the digestion of carbohydrates (complex sugars) from your diet. This reduces the abnormally high blood sugar levels that occur after each meal.

BEFORE YOU TAKE GLUCOBAY (PRECOSE)

When you must not take GLUCOBAY (PRECOSE)

Do not take GLUCOBAY (PRECOSE) if you have had a previous allergic reaction to acarbose or to any of the ingredients in the tablets. See Product Description at the end of this leaflet.

Do not take GLUCOBAY (PRECOSE) if you are pregnant or breast-feeding. Tell your doctor if you become pregnant while you are taking Glucobay (Precose).

Do not take GLUCOBAY (PRECOSE) if you are under 18 years of age.

Do not take GLUCOBAY (PRECOSE) if you have a severe kidney disorder (creatinine clearance < 25 mL/min).

Do not take GLUCOBAY (PRECOSE) if you suffer from intestinal obstruction, inflammation or ulceration of the bowel, e.g. ulcerative colitis or Crohn's disease.

Do not take GLUCOBAY (PRECOSE) if you have a hernia or have had previous abdominal surgery. If so, consult your doctor first.

Do not take GLUCOBAY (PRECOSE) if your tablets have passed the expiry date (EXP) printed on the label of the carton and on each strip of tablets, e.g. 11 00 refers to the eleventh month of 2000.

Before you start to take GLUCOBAY (PRECOSE)

Tell your doctor if:

• you are taking other medicines, including any you have bought without a prescription from your pharmacy, supermarket or health food shop.
• you are allergic to any other medicines or any foods, dyes or preservatives
• you have any of the conditions listed in the above paragraph.

Taking other medicines

Some medicines in common use may interfere with the effect of GLUCOBAY (PRECOSE). These medicines include:

• Neomycin (Neosulf™)
• Cholestyramine (Questran Lite™)
• Intestinal adsorbents (e.g. charcoal)
• Digestive enzyme preparations (Cotazym-S Forte™, Creon™, Pancrease™, Pancrex V™, Viokase™).

These medicines may be affected by Glucobay (Precose) or may affect how well Glucobay (Precose) works. You may need to take different amounts of you medicine or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to avoid while taking Glucobay (Precose).

You should avoid taking cane sugar (sucrose) and products containing sugar. They may cause stomach discomfort or even diarrhoea if taken while you are on GLUCOBAY (PRECOSE) tablets.

HOW TO TAKE GLUCOBAY (PRECOSE)

How much to take

To gain the maximum benefit from GLUCOBAY (PRECOSE) it is important that you follow the prescribed diet as well as taking the exact dose of GLUCOBAY (PRECOSE) prescribed by your doctor. This will help control your blood sugar levels and reduce side-effects from GLUCOBAY (PRECOSE).

When and how to take it

Take the tablets as prescribed by your doctor. This will normally be one or two tablets taken with breakfast, lunch and dinner.

When you first start your treatment, your doctor may recommend that you take your tablets once or twice a day, before increasing your dose to three times a day. Chew the tablets with the first few mouthfuls of food. If you prefer not to chew the tablets then swallow them whole with a little liquid immediately before the meal.

If you are taking other medicines containing sulfonylureas or metformin and tend to have low blood sugar levels in the afternoon, tell your doctor before using GLUCOBAY (PRECOSE).

The average adult dose is one GLUCOBAY (PRECOSE) 100 mg tablet taken with breakfast, lunch and dinner.

How long to take it

Your doctor will determine how long you should take GLUCOBAY (PRECOSE) tablets. Do not stop taking the tablets unless you are told to do so by your doctor. If you do not feel well while you are taking them see your doctor. (see SIDE EFFECTS)

If you forget to take it

If you forget to take GLUCOBAY (PRECOSE) at the time you are supposed to, do not take the tablets between meals. Wait until it is time for you to take your next dose and take GLUCOBAY (PRECOSE) with your meal and continue as before. Do not take a double dose.

If you take too much (Overdose)

If you have taken too many GLUCOBAY (PRECOSE) tablets, avoid foods or drinks containing carbohydrates and call your doctor or the Poisons Centre Phone 0800 POISON or 0800 764 766 for advice.

When Glucobay (Precose) is taken with drinks and/or meals containing carbohydrates, overdosage can lead to diarrhoea and other intestinal symptoms such as flatulence (wind) and abdominal cramps.

WHILE YOU ARE TAKING GLUCOBAY (PRECOSE)

Things you must do

Take GLUCOBAY (PRECOSE) exactly as instructed by your doctor. If you do not follow your doctor's instructions, your blood sugar level may not be controlled.

Tell all doctors and pharmacists who are treating you that you are taking GLUCOBAY (PRECOSE) tablets.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking GLUCOBAY (PRECOSE).

Things you must not do

Do not give GLUCOBAY (PRECOSE) tablets to anyone else even if they appear to have the same medical condition as yours.

Things to be careful of

Treating hypoglycaemia ("hypos" or low blood sugar)

As a diabetic you may also be receiving other medicines for your diabetes. If GLUCOBAY (PRECOSE) is prescribed for you in addition to sulfonylureas or metformin to control your diabetes, your doctor may need to adjust the dosages of these drugs to avoid the occurrence of "hypos".

When taking GLUCOBAY (PRECOSE) together with these drugs, do not treat a "hypo" with ordinary sugar (sucrose). It will not work fast enough. Instead, you should take some GLUCOSE (also known as dextrose) tablets, honey, syrup or sweets, which should be available from your local chemist.

SIDE EFFECTS

All medicines have side effects. Sometimes they are serious; most of the time they are not. In serious cases, you may need to obtain medical treatment.

Some patients may experience unwanted side effects during GLUCOBAY (PRECOSE) treatment. These side effects are more common at the start of the treatment, but some may persist or develop after treatment, or when the dosage of GLUCOBAY (PRECOSE) is adjusted by your doctor.

If while undergoing treatment with GLUCOBAY (PRECOSE), you experience any side-effects or symptoms which you think may be due to this medication (whether or not it is mentioned below) please inform your doctor or pharmacist as early as possible. You may need medical treatment in some cases.

During the first few days or weeks of treatment with GLUCOBAY (PRECOSE) you may have more flatulence (wind), abdominal "rumbling" noises, a feeling of fullness and less commonly, stomach cramps. You may also pass softer stools or have diarrhoea, particularly if you have eaten foods containing sugar. Normally these symptoms will disappear if you continue treatment and keep to your prescribed diet. These symptoms may get worse if you do not keep to your prescribed diet.

If your symptoms persist for more than 2 or 3 days, or if they are severe, consult your doctor, particularly in the case of diarrhoea.

Do not take antacids to treat these symptoms, as they are unlikely to give you any relief.

Less common side effects include hypoglycaemia ("hypos" or low blood sugar), nausea, headache, vomiting, increased appetite, dizziness and loss of appetite. These side effects generally occur when GLUCOBAY (PRECOSE) is taken together with sulfonylureas or metformin.

Rare reactions that have been reported for GLUCOBAY (PRECOSE) treatment include inflammation of the liver (hepatitis), jaundice (yellowing of the skin) and skin reactions such as redness, rash and urticaria (hives). GLUCOBAY (PRECOSE) tablets may cause an increase in the results of certain liver function tests. These effects go away when treatment is stopped.

There may be other unwanted side effects of GLUCOBAY (PRECOSE), which are presently unknown. If you have any concerns about this issue, please consult your doctor. Also be sure to tell your doctor immediately about any unusual symptoms while you are on GLUCOBAY (PRECOSE).

AFTER TAKING GLUCOBAY (PRECOSE)

When treatment with GLUCOBAY (PRECOSE) is to be stopped, your prescribing doctor may need to alter the dose of other medication(s) accordingly and monitor your condition.

Storage

It is best if you store your GLUCOBAY (PRECOSE) tablets in the manufacturer's original container. The tablets should be kept in a cool, dry place where the temperature is not likely to go above 25°C.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Do not take tablets if blister foil is not intact .

If you find that you have some GLUCOBAY (PRECOSE) tablets that have gone past their EXPIRY DATE, return them to your pharmacist who will dispose of them properly.

If you have any further questions on your GLUCOBAY (PRECOSE) treatment, or are unsure of any of the above information, please see your doctor or dispensing pharmacist, who will be able to assist you.

Disposal

If your doctor tells you to stop taking GLUCOBAY (PRECOSE), ask your pharmacist what to do with the remaining tablets.

PRODUCT DESCRIPTION

GLUCOBAY (PRECOSE) tablets are available in a blister pack of 90's in two strengths.

GLUCOBAY (PRECOSE) 50mg:

White to yellow-tinged round biconvex tablets, with the Bayer cross marked on one side and "G" and "50" on the reverse.

GLUCOBAY (PRECOSE) 100mg:
White to yellow-tinged round biconvex tablets, scored, with the Bayer cross marked on one side and "G" and "100" on the reverse.

GLUCOBAY (PRECOSE) tablets also contain the following inactive ingredients: cellulose, corn starch, silica colloidal anhydrous and magnesium stearate.