Glucobay 100

Glucobay 50
Glucobay 100
Acarbose
Read the entire leaflet carefully before using the medicine.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any of the side effects worsen, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.

Table of contents of the leaflet:

1. What Glucobay is and what it is used for
2. Important information before taking Glucobay
3. How to take Glucobay
4. Possible side effects
5. How to store Glucobay
6. Further information

1. WHAT GLUCOBAY IS AND WHAT IT IS USED FOR

Acarbose, the active substance in Glucobay, works by delaying the digestion of carbohydrates in the intestines. As glucose is gradually released, its absorption slows down, resulting in reduced blood glucose levels after meals and, consequently, decreased fluctuations in glucose concentration and lower average blood glucose levels. During treatment with acarbose, a significant reduction in fasting blood glucose and in glycated hemoglobin (HbA1c) levels is observed.
Glucobay is practically not absorbed into the bloodstream, and its action is confined to the gastrointestinal tract.
Treatment with acarbose does not lead to weight gain.

Indications:
Glucobay is indicated for the treatment of type 2 (non-insulin-dependent) diabetes mellitus, particularly in obese patients, when diet and physical exercise alone have proven insufficient.

2. IMPORTANT INFORMATION BEFORE USING GLUCOBAY

When not to use Glucobay

• if the patient is allergic (hypersensitive) to acarbose or any of the other ingredients of Glucobay
• if the patient is under 18 years of age, as data on the safe use of acarbose in children and adolescents are insufficient
• if the patient has chronic gastrointestinal diseases associated with digestive and absorptive disorders
• if the patient has medical conditions that may worsen due to increased accumulation of gas in the intestines (e.g. Roemheld syndrome, large hernias, intestinal obstruction, intestinal ulceration)
• if the patient has inflammatory bowel disease, ulcerative colitis, partial intestinal obstruction, or is predisposed to intestinal obstruction
• if the patient has severe renal impairment (creatinine clearance < 25 ml/min)
• if the patient has severe hepatic insufficiency
• if the patient is pregnant or breastfeeding

When to exercise special caution when using Glucobay

• during treatment with Glucobay, a diabetic diet must be strictly followed.
• do not discontinue regular use of Glucobay without consulting a physician, as this may lead to increased blood glucose levels.
• in isolated cases—particularly after administration of high doses of acarbose—fulminant hepatitis may occur. Therefore, during the first 6–12 months of treatment with Glucobay, liver enzyme levels should be monitored regularly.
• Glucobay used as monotherapy does not cause hypoglycemia. However, in patients treated with Glucobay in combination with insulin, a sulfonylurea derivative, or metformin, if a decrease in glucose concentration indicating hypoglycemia occurs, glucose (not another sugar such as sucrose) should be administered.
• information about the use of Glucobay should be recorded in the patient's diabetes record book.

Use of other medicines
Inform your doctor about all medicines currently used or recently used, including those available without a prescription.
Exercise caution if:

• the patient is concurrently using other glucose-lowering medications. In isolated cases, acute hypoglycemia may occur; therefore, when Glucobay is used concomitantly with sulfonylurea derivatives, metformin, or insulin, a reduction in the dose of these medications may be necessary. In case of a sudden drop in blood glucose concentration, it should be remembered that during treatment with Glucobay, sucrose is more slowly broken down into glucose and fructose. Therefore, to rapidly increase blood glucose, glucose administration is most appropriate.
• the patient is taking digoxin, a medication used for heart conditions. The patient should consult their physician, who may recommend adjusting the digoxin dosage.
• the patient is using other medications containing sucrose, or consuming foods or beverages containing sucrose, as this may frequently cause gastrointestinal discomfort, including diarrhea, due to increased fermentation of carbohydrates in the large intestine.
• the patient is taking cholestyramine or other adsorbent agents, which may reduce the effectiveness of Glucobay. Concomitant use should be avoided.
• the patient is taking oral neomycin, as this may lead to increased postprandial reduction in blood glucose levels and more frequent and severe abdominal symptoms. If acute symptoms occur, the patient should contact their physician, who may consider temporarily reducing the dose of Glucobay.

Taking Glucobay with food and drink
During treatment with Glucobay, a diabetic diet must be strictly followed. Do not consume food products containing sucrose due to the risk of gastrointestinal symptoms (including diarrhea). Glucobay should be taken before a meal or with the first bites of food.

Pregnancy and breastfeeding
Glucobay should not be used during pregnancy or breastfeeding.

Driving and operating machinery
Glucobay does not affect the ability to drive or operate machinery.

3. HOW TO USE GLUCOBAY

Glucobay must always be used according to the doctor's instructions. If in doubt, consult your doctor or pharmacist again.
Recommended dosage for the treatment of type 2 diabetes, in conjunction with diet and physical exercise
Using Glucobay according to the following scheme helps reduce the risk of adverse effects, especially flatulence:

The tablets should be taken whole with a small amount of liquid immediately before a meal or together with the first bites of the meal.
The efficacy and safety of acarbose in patients under 18 years of age have not been studied.
Administration of a higher than recommended dose of Glucobay
If a patient has taken more medication than recommended, they should not consume any drinks or meals containing carbohydrates for the next 4–6 hours – this usually prevents gastrointestinal symptoms.
If a higher than recommended dose of Glucobay was taken together with drinks or (and) meals containing carbohydrates, bloating, flatulence, and diarrhea may occur.
Missed dose of Glucobay
A double dose should not be taken to make up for a missed dose.
If in doubt regarding the use of the medication, consult a physician or pharmacist.
Discontinuation of Glucobay
If there are any further doubts concerning the use of the medication, consult a physician or pharmacist. Do not discontinue regular use of the medication without consulting a physician, due to the risk of increased blood glucose levels.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Glucobay may cause adverse reactions, although not everybody experiences them.

Very common adverse reactions:
(may occur in more than 1 out of 10 people)

• flatulence

Common adverse reactions:
(may occur in less than 1 out of 10, but more than 1 out of 100 people)

• diarrhoea, gastrointestinal and abdominal pain

Uncommon adverse reactions:
(may occur in between 1 out of 100 and 1 out of 1000 people)

• nausea, vomiting, dyspepsia, increased liver enzyme activity (detected in laboratory tests)

Rare adverse reactions:
(may occur in less than 1 out of 1000 people)

• oedema, jaundice

Adverse reactions with unknown frequency:
(may occur in less than 1 out of 10,000 people)

• allergic reactions (e.g. rash, erythema, exanthema, urticaria), intestinal obstruction, partial intestinal obstruction, intestinal pneumatosis, hepatitis, thrombocytopenia (reduced number of blood platelets), acute generalized exanthematous pustulosis

After marketing authorization of the medicinal product, cases of liver disorders, abnormal liver function and liver damage have been reported. Isolated cases of fulminant hepatitis resulting in death have also been reported, particularly in Japan.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].

Adverse reactions can also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. HOW TO STORE GLUCOBAY

Keep out of the reach and sight of children.
Store at a temperature not exceeding 25°C.
Tablets should be removed from the packaging immediately before use. Tablets removed from the packaging
and stored according to recommendations may be used within 2 weeks. Tablets left unpackaged
and exposed to higher temperatures may change colour.
Do not use Glucobay after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What Glucobay contains

• The active substance is acarbose. Glucobay 50 tablet contains 50 mg of acarbose. Glucobay 100 tablet contains 100 mg of acarbose.
• Other ingredients are: microcrystalline cellulose, colloidal anhydrous silicon dioxide, magnesium stearate, corn starch.

What Glucobay looks like and contents of the pack
Glucobay 50 is in the form of round tablets.
Glucobay 100 is in the form of oval tablets.
Pack contains 30, 90 or 120 tablets.
Marketing Authorisation Holder:
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Manufacturer:
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen, Germany
Representative of the Marketing Authorisation Holder
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw, Poland
tel. (0-22) 572-35-00