GLUCOBAY 100 mg. 30 tablets

WHAT GLUCOBAY AND WHAT IT IS USED FOR?

Glucobay belongs to a group of medicines to treat diabetes (an inhibitor of alpha-glucosidase).

The active substance of Glucobay is acarbose, a biological origin. Acarbose exerts its effect mainly in the small intestine. The active substance is hardly absorbed into the body. Glucobay slows the breakdown of carbohydrates. This slows down the release of glucose from carbohydrates and transfer into the blood. Thus Glucobay delays and decreases the rise in blood sugar after a meal. As a result of the balancing effect on the uptake of glucose from the intestine, daily changes in blood sugar levels are reduced and the mean blood glucose values decrease. Glucobay alone can cause hypoglycemia.

Glucobay be used for additional treatment with diet in patients with diabetes mellitus (diabetes mellitus).

Glucobay be used for the prevention of type 2 diabetes in patients with impaired glucose tolerance established * in combination with diet and exercise.

* Defined as the plasma concentration after glucose loading of a second time (2HPG) between 7.8 and 11.1 mmol / L (140-200 mg / Dl) and fasting levels of between 5.6 and 7.0 mmol / L (100-125 mg / dL)

2. BEFORE YOU USE GLUCOBAY

Do not use Glucobay:

- If you are allergic (hypersensitive) to acarbose or any of the other ingredients of Glucobay;

- In patients with severe hepatic impairment (liver cirrhosis);

- In patients with severe renal impairment (creatinine clearance <25 ml / min);

- If there are inflammatory intestinal diseases, intestinal ulcers, partial bowel obstruction, or susceptibility to blockage;

Take special care with Glucobay

- During the first 6-12 months of therapy in the rare cases can occur increases in liver enzymes during therapy Glucobay. Thus, during the first 6 to 12 months of treatment should be monitored liver enzymes. In evaluable cases these changes were reversible after discontinuation of Glucobay (see also "Possible side effects").

- If you develop symptoms of hypoglycemia (such as fast pulse, sweating, trembling), you must accept glucose and not household sugar (cane sugar) to relieve the problem (see also "Using other medicines").

Even taking Glucobay it is essential to strictly follow the prescribed diet. Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Glucobay lowers blood sugar levels, but alone does not cause very low blood sugar (hypoglycemia).

If Glucobay is prescribed in addition to drugs containing sulphonylureas or metformin, or in addition to insulin, lowering blood glucose hypoglycemia may require an appropriate reduction in the dose of sulfonylurea, metformin or insulin doses.

In some cases can have serious complaints related to low blood sugar (hypoglycemic shock).

If acute hypoglycaemia should be borne in mind that sucrose (cane sugar) is degraded and absorbed more slowly during treatment with Glucobay; for this reason sucrose is unsuitable for a rapid response to low blood sugar (hypoglycemia) and should be used glucose.

In some cases, acarbose may affect digoxin levels (active substance mainly used to treat heart failure), which may require dose adjustment of digoxin. Because it is likely cholestyramine, intestinal adsorbents and enzymes influence the performance of Glucobay, concomitant use should be avoided.

Do not take these medicines while you are taking Glucobay as they can weaken its effect:

- Cholestyramine (a drug that lowers high cholesterol levels in the blood) of activated carbon or other absorbents intestinal

- Substances which increase the digestion (digestive enzymes)

If taking oral Acarbose and Noemitsin at the same time, this can reduce the level of glucose in the blood after a meal and can lead to more frequent and severe abdominal discomfort. If symptoms are severe, tell your doctor. It can temporarily reduce acarbose.

Use of Glucobay with food and drink

Domestic sugar (cane sugar) and foods containing it, can easily lead to severe abdominal discomfort and diarrhea during treatment with Glucobay (see "Possible side effects").

Use in pediatric patients

Efficacy and safety of acarbose have not been studied in patients under 18 years of age.
Pregnancy and lactation

Ask your doctor or pharmacist before taking any medicine. pregnancy
Glucobay should not be used during pregnancy, as no information on the use in pregnant women.

breastfeeding

Glucobay not use while breastfeeding.
Driving and using machines

Glucobay monotherapy does not cause hypoglycaemia and therefore does not affect the ability to drive and use machines. Combination with other medicinal products that reduce blood sugar levels (metformin, sulfonylurea, insulin) may negatively affect your ability to drive or operate machines as potentially can cause hypoglycemia.

3. HOW TO USE GLUCOBAY?

Always use Glucobay exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

Dosage should be determined by the doctor for each patient, as the efficacy and tolerability vary between individuals.

The usual dose is:

Further treatment in relation to diet in patients with diabetes mellitus:

If not otherwise prescribed the recommended dosage is as follows:

Initial dose 3x1 / 2 tablets. 100 mg Glucobay / day (equivalent to 150 mg acarbose / day)

In some patients gradually increase the dose helps to reduce gastrointestinal side effects, as the starting dose is:

1 to 2 times x x / y table. Glucobay 100 mg per day (equivalent to 50 to 100 mg per day acarbose).

Your doctor may gradually increase the dose depending on your blood sugar and also as a continuation of treatment if it is not sufficiently effective to:

3 x 1 tablet Glucobay 100 mg daily (equivalent to 300 mg acarbose daily).

In rare cases, if necessary, the dose can be further increased by:

3x2 tablets Glucobay 100 mg daily (equivalent to 600 mg acarbose daily).

You should start with a low dose over time to rise slowly to reduce possible gastrointestinal side effects.

If you experience serious symptoms despite strict adherence to diet (see "Possible side effects"), the dose should not be increased further if necessary should be reduced to some extent.

For the prevention of type 2 diabetes in patients with impaired glucose tolerance, the recommended dose is:

Your doctor will gradually increase the dose depending on your blood sugar and also as a continuation of treatment if it is not sufficiently effective to:
3 x 1 tablet Glucobay 100 mg daily (equivalent to 300 mg acarbose per day) How and when should you take Glucobay?

Glucobay tablets should be chewed with the first bite of food. If you prefer you can swallow the tablets whole with a little liquid immediately before a meal.

Efficacy and safety of acarbose not been studied in patients under 18 years of age.

If your doctor has prescribed and other antidiabetic drugs in addition to Glucobay should take those drugs.

How long should you take Glucobay?

Your doctor will decide how long you should take Glucobay. The duration of treatment depends on the severity and development of your disease.

If you use more than the amount Glucobay:

If you have exceeded the prescribed dose or in the event of overdose, you may experience diarrhea and other intestinal symptoms such as flatulence (flatulence) and abdominal pain.

Overdose the patient should not be given drinks or meals containing carbohydrates for the next 4-6 hours.

If you forget to take Glucobay:

If you forget to take one or more doses Glucobay not take the tablets between meals, and wait time for your next dose and continue with your schedule.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Glucobay can cause side effects, although not everybody gets them.

Reported the following side effects:

Very common side effects (affects more than 1 in 10 patients)

Gas formation (flatulence)

Common side effects (affects less than 1 in 10 but more than 1 in 100 patients), diarrhea, gastrointestinal and abdominal pain. These symptoms normally disappear with continued therapy and adherence to the prescribed diet.

Uncommon side effects

(affects less than 1 in 100 but more than 1 in 1000 patients), nausea, vomiting, digestive disorders, transient increase in liver enzymes

Rare side effects

(affects less than 1 in 1000 but more than 1 in 10,000 patients) swelling (fluid retention mainly in the legs) jaundice (yellowing of the skin)

Side effects with unknown frequency

reduce the number of platelets (thrombocytopenia), allergic reactions (redness, rash and irritated skin)

In addition, reported events such as liver problems, abnormal liver function and liver damage resulting primarily from Japan.

If symptoms persist for more than 2 or 3 days, or if they are severe, you should consult with your doctor, especially in cases of diarrhea.

These side effects may be worse if you do not follow the prescribed diabetic diet. If you experience severe pain despite strict adherence to the prescribed diet, call your doctor immediately. In such cases, your doctor may temporarily or permanently reduce the dose.

Gastrointestinal symptoms may be severe and pronounced. In such cases, immediately consult your doctor who will decide whether to continue treatment with Glucobay.

If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE GLUCOBAY?

Keep out of reach of children.

Glucobay not use after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Glucobay?

The active substance is acarbose. Glucobay one tablet contains 100 mg of acarbose. Other ingredients are: microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, corn starch.

Glucobay looks like and contents of the pack?

Glucobay is available in packs containing 30 tablets.