Glucobai 50

Patient Information Leaflet: User Information

Glucobay 50, 50 mg, tablets

Glucobay 100, 100 mg, tablets

Acarbose

Read the leaflet carefully before taking the medicine.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Glucobay and what is it used for

The action of acarbose, the active substance of Glucobay, involves delaying the digestion of carbohydrates in the intestines. Glucose is released slowly and absorbed more slowly, which reduces its concentration in the blood after meals and, as a result, reduces glucose fluctuations and average blood glucose levels. During treatment with acarbose, there is a significant decrease in fasting glucose levels and a decrease in glycated hemoglobin (HbA1c) levels. Glucobay is practically not absorbed, and its action is limited to the gastrointestinal tract. Taking acarbose does not cause weight gain. Indications: Glucobay is used to treat type 2 diabetes (non-insulin-dependent), especially in obese people, in whom diet and physical exercise have been ineffective.

2. Important information before taking Glucobay

When not to take Glucobay

When to be cautious when taking Glucobay

• while taking Glucobay, you must strictly follow a diabetic diet.
• do not stop taking Glucobay regularly without consulting your doctor, as this may lead to increased blood glucose levels.
• in single cases, especially after taking high doses of acarbose, liver inflammation may occur. Therefore, during the first 6-12 months of treatment with Glucobay, liver enzyme levels should be regularly checked.
• Glucobay used as monotherapy does not cause hypoglycemia. If blood glucose levels decrease, indicating hypoglycemia, in patients taking Glucobay in combination with insulin, sulfonylurea derivatives, or metformin, they should take glucose, not other sugars (sucrose).
• information about taking Glucobay should be recorded in the patient's diabetes logbook.

Taking other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription. Be cautious if:

• you are taking other medicines that lower blood sugar levels. In single cases, acute hypoglycemia may occur, so when taking Glucobay with sulfonylurea derivatives, metformin, or insulin, it may be necessary to reduce the doses of these medicines. If blood glucose levels drop sharply, remember that during treatment with Glucobay, sucrose is broken down into glucose and fructose more slowly. Therefore, to quickly increase blood glucose levels, it is best to take glucose.
• you are taking digoxin, a medicine used to treat heart conditions. You should consult your doctor, who may recommend changing the digoxin dosage.
• you are taking other medicines containing sucrose, sucrose, or foods containing sucrose, as taking sucrose often causes gastrointestinal discomfort and even diarrhea due to increased carbohydrate fermentation in the large intestine.
• you are taking cholestyramine, an adsorbent that may weaken the effect of Glucobay. It is recommended to avoid taking them together.
• you are taking oral neomycin, as this may lead to increased reduction of postprandial blood glucose levels and more frequent and intense abdominal symptoms. If acute symptoms occur, you should contact your doctor, who may consider temporarily reducing the Glucobay dosage.

Taking Glucobay with food and drink

While taking Glucobay, you must strictly follow a diabetic diet. Do not consume foods containing sucrose due to the possibility of gastrointestinal symptoms (including diarrhea). Glucobay should be taken before a meal or with the first bites of a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Glucobay should not be taken during pregnancy or breastfeeding.

Driving and using machines

Glucobay does not affect the ability to drive or use machines.

3. How to take Glucobay

Always take Glucobay exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Recommended dosage for the treatment of type 2 diabetes, in combination with diet and physical exercise

Taking Glucobay according to the following scheme reduces the risk of side effects, especially bloating: The tablets work only when swallowed whole with a small amount of liquid immediately before a meal or with the first bites of a meal. In patients under 18 years old, the efficacy and safety of acarbose have not been studied.

Taking a higher dose of Glucobay than recommended

If you have taken more Glucobay than recommended, do not consume drinks or meals containing carbohydrates for 4-6 hours - this will usually prevent gastrointestinal symptoms. If a higher dose of Glucobay is taken with drinks and/or meals containing carbohydrates, bloating, gas, and diarrhea may occur.

Missing a dose of Glucobay

Do not take a double dose to make up for a missed dose. If you have any doubts about taking the medicine, consult your doctor or pharmacist.

Stopping treatment with Glucobay

If you have any further doubts about taking the medicine, consult your doctor or pharmacist. Do not stop taking Glucobay regularly without consulting your doctor, as this may lead to increased blood glucose levels.

4. Possible side effects

Like all medicines, Glucobay can cause side effects, although not everybody gets them. Very common side effects: (may affect more than 1 in 10 people)

• bloating

Common side effects: (may affect more than 1 in 100 people)

• diarrhea, abdominal pain, lower abdominal pain

Uncommon side effects: (may affect less than 1 in 100 people)

• nausea, vomiting, indigestion, increased liver enzyme activity (shown in laboratory tests)

Rare side effects: (may affect less than 1 in 1000 people)

• edema, jaundice

Frequency not known side effects: (frequency cannot be estimated from the available data)

• allergic reactions (e.g., rash, erythema, eruption, urticaria), intestinal obstruction, subobstruction, intestinal pneumatosis, hepatitis, thrombocytopenia (decreased platelet count), acute generalized exanthematous pustulosis

After the product has been marketed, cases of liver disorders, abnormal liver function, and liver damage have been reported. There have also been reports of single cases of fulminant hepatitis ending in death, especially in Japan.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glucobay

Keep the medicine out of the sight and reach of children. Store in a temperature not exceeding 25°C. Take the tablets out of the packaging immediately before use. Tablets taken out of the packaging and stored according to the recommendations can be used for 2 weeks. Tablets left without packaging and at a higher temperature may change color. Do not take Glucobay after the expiry date stated on the carton. The expiry date refers to the last day of the month. Medicines should 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. One Glucobay 50 tablet contains 50 mg of acarbose. One Glucobay 100 tablet contains 100 mg of acarbose.
• The other ingredients are: microcrystalline cellulose, silicon dioxide, anhydrous, magnesium stearate, corn starch.

What Glucobay looks like and contents of the pack

Glucobay 50 tablets: white or slightly yellowish round, convex tablets with a diameter of 7 mm and a radius of curvature of 10 mm, with the letters "G" and "50" embossed on one side and the Bayer logo on the other. Glucobay 100 tablets: white or slightly yellowish oval, convex tablets with a length of 13 mm and a width of 6 mm, a radius of curvature of 5.5 mm. On one side of the tablet, the letter "G", a score line dividing the tablet into two halves, and the number "100" are embossed. On the other side of the tablet, there is a score line dividing the tablet into two halves. The carton contains 30, 90, or 120 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen, Germany

Manufacturer:

Bayer AG, Kaiser-Wilhelm-Allee, 51368 Leverkusen, Germany, Representative of the marketing authorization holder, Bayer Sp. z o.o., Al. Jerozolimskie 158, 02-326 Warsaw, Poland, tel. (0-22) 572-35-00

Date of approval of the leaflet: