Adeksa

Package Leaflet: Information for the User

ADEKSA, 50 mg, tablets

ADEKSA, 100 mg, tablets

Acarbose

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, please inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

• 1. What is Adeksa and what is it used for
• 2. Important information before taking Adeksa
• 3. How to take Adeksa
• 4. Possible side effects
• 5. How to store Adeksa
• 6. Contents of the pack and other information

1. What is Adeksa and what is it used for

Adeksa contains the active substance acarbose. Its action is based on slowing down the digestion of carbohydrates in the intestines. The glucose released is absorbed more slowly, which reduces its concentration in the blood after meals, and as a result, reduces the fluctuations in glucose concentration and average glucose values (glycemia). During treatment with acarbose, there is a significant decrease in fasting glucose levels and a decrease in the content of glycated hemoglobin (HbA1c). The Adeksa tablet is practically not absorbed, and its action is limited to the gastrointestinal tract. Taking acarbose does not cause weight gain. Indications for use:

• treatment of type 2 diabetes (non-insulin-dependent), especially in obese people, in whom diet and physical exercise have been ineffective.

2. Important information before taking Adeksa

When not to take Adeksa

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• If you are under 18 years old, as there is not enough data on the safety and efficacy of acarbose in children and adolescents;
• If you have chronic intestinal diseases with impaired digestion and absorption;
• If you have conditions that may worsen due to increased gas accumulation in the intestines (e.g., Roemheld syndrome, large hernias, intestinal obstruction, intestinal ulcers);
• If you have severe renal impairment (creatinine clearance below 25 ml/min);
• If you are pregnant or breastfeeding.

Warnings and precautions

• During treatment with Adeksa, you must strictly follow a diabetic diet;
• Do not stop taking Adeksa without consulting your doctor, as this may lead to an increase in blood glucose levels;
• In individual cases, especially after taking high doses of acarbose, asymptomatic increases in liver enzyme activity may occur. Therefore, during the first 6 to 12 months of treatment with Adeksa, your doctor may order regular tests to check the levels of these enzymes. These changes usually disappear after the medicine is discontinued;
• Adeksa, when used as monotherapy, does not cause hypoglycemia. However, when taken with other glucose-lowering medicines, it may cause hypoglycemia (see section: Taking other medicines);
• Information about taking Adeksa should be recorded in the patient's diabetes logbook.

Adeksa and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. Be cautious if:

• you are taking other glucose-lowering medicines(e.g., sulfonylurea derivatives, metformin, or insulin), as this may lead to a sudden decrease in blood glucose levels (acute hypoglycemia). Therefore, these medicines should be taken under medical supervision, and the doctor will determine the appropriate dosage. In case of severe hypoglycemia, you should take glucose (to increase its level in the blood). It is essential not to take other sugars (like sucrose);
• you are taking digoxin(a medicine used to treat heart conditions), you should discuss this with your doctor, who may recommend changing the digoxin dosage;
• you are taking other medicines 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(a medicine that lowers cholesterol levels in the blood) and adsorbents, which may reduce the effectiveness of Adeksa, so it is recommended to avoid taking them at the same time;
• you are taking oral neomycin(an antibiotic), as this may lead to a significant decrease in postprandial glucose levels in the blood and more frequent and intense abdominal discomfort. If you experience severe discomfort, you should contact your doctor, who may consider temporarily reducing the dose of Adeksa. Taking medicines for indigestion and bloating (containing the active substances dimethicone or simethicone) does not affect treatment with Adeksa.

Adeksa with food and drink

During treatment with Adeksa, you must strictly follow a diabetic diet. Do not consume food products containing sucrose, as this may cause gastrointestinal symptoms (including diarrhea). Take Adeksa before a meal or with the first bites of food.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Adeksa should not be taken during pregnancy and breastfeeding.

Driving and using machines

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

Adeksa contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 50 mg tablet, which is considered "sodium-free".

3. How to take Adeksa

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose in the treatment of type 2 diabetes should be related to diet and physical exercise. Taking Adeksa according to the scheme below reduces the risk of side effects, especially bloating:

Breakfast Lunch Dinner Number of days

• 1 time Adeksa 50 mg 3 days
• 1 time Adeksa 50 mg 1 time Adeksa 50 mg 3 days 1 time Adeksa 50 mg 1 time Adeksa 50 mg 1 time Adeksa 50 mg 7 days 1 time Adeksa 50 mg 1 time Adeksa 50 mg 2 times Adeksa 50 mg 3 days 1 time Adeksa 50 mg 2 times Adeksa 50 mg 2 times Adeksa 50 mg 3 days 1 time Adeksa 100 mg 1 time Adeksa 100 mg 1 time Adeksa 100 mg from 4 to 8 weeks

Swallow the tablets whole, do not chew them. The tablets only work when swallowed whole. Take Adeksa immediately before a meal or with the first bites of food. Adeksa is not recommended for patients under 18 years old, as the efficacy and safety of acarbose in this age group have not been studied.

Taking more than the recommended dose of Adeksa

If you have taken more medicine than recommended, do not drink fluids or eat meals containing carbohydrates for 4 to 6 hours. This usually helps avoid gastrointestinal symptoms. If you have taken a higher dose of Adeksa with drinks and/or meals containing carbohydrates, you may experience bloating, gas, and diarrhea.

Missing a dose of Adeksa

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Adeksa

Do not stop taking Adeksa without consulting your doctor, as this may lead to an increase in blood glucose levels. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 up to 1 in 10 people):

• diarrhea;
• abdominal pain;
• lower abdominal pain.

Uncommon side effects(may affect up to 1 in 100 people):

• nausea;
• vomiting;
• indigestion (bloating, belching, heartburn, and constipation);
• transient increase in liver enzyme activity (detected by laboratory tests).

Rare side effects(may affect up to 1 in 1,000 people):

• edema;
• jaundice (yellowing of the skin and whites of the eyes).

Frequency not known side effects(may affect less than 1 in 10,000 people):

• allergic reactions (skin redness and itching, such as rash, erythema, eruption, urticaria);
• intestinal obstruction (severe abdominal cramps, vomiting, bloating, inability to pass gas or stool);
• subobstruction (severe abdominal pain, bloating, constipation, or complete lack of stool, loss of appetite, weight loss);
• intestinal pneumatosis (usually asymptomatic, gas-filled cysts in the intestinal wall);
• hepatitis (early symptoms are: pain under the right costal arch, flu-like symptoms, nausea, vomiting, aversion to meat, constipation, diarrhea, and bloating. Later, yellowing of the skin and whites of the eyes may occur);
• thrombocytopenia (decreased platelet count, which increases the risk of bleeding and bruising).

Additionally, the following events have been reported: liver disorders, abnormal liver function, and liver damage.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. 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.: 22 49-21-301, Fax: 22 49-21-309, website: https://smz.ezdrowie.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 Adeksa

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C. Store in the original package to protect from moisture. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated. 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. Contents of the pack and other information

What Adeksa contains

• The active substance is acarbose.

One Adeksa 50 mg tablet contains 50 mg of acarbose.

• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

One Adeksa 100 mg tablet contains 100 mg of acarbose.

• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

What Adeksa looks like and contents of the pack

Adeksa 50 mg are white or almost white, round, biconvex tablets. Adeksa 100 mg are white or almost white, round, biconvex tablets with a score line on one side. The score line is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. The pack contains 30, 60, or 90 tablets of 50 mg or 100 mg.

Marketing authorization holder and manufacturer

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno, Poland, Tel.: (24) 357 44 44, Fax: (24) 357 45 45, e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: