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. 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.

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. 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 glucose values (glycemia). During treatment with acarbose, there is a significant decrease in fasting glucose levels and a decrease in glycated hemoglobin (HbA1c) levels. Adeksa 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, your doctor may order regular checks of these enzymes during the first 6 to 12 months of treatment. These changes usually disappear after stopping the medicine;
• 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 medicines you are taking, have recently taken, or plan to take.

• 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);
• If you are taking digoxin(a medicine used for heart conditions), you should consult your doctor, who may recommend changing the digoxin dosage;
• If 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;
• If 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;
• If 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 gastrointestinal symptoms. If severe symptoms occur, 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).

Adeksa should be taken immediately before a meal or with the first bites of food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 and use machines.

Adeksa contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Adeksa

This medicine should always be taken 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

Tablets should be swallowed whole, without chewing. Tablets only work when swallowed whole.

Adeksa should be taken immediately before a meal or with the first bites of food.

Adeksa is not recommended for use in patients under 18 years old, as the efficacy and safety of acarbose in this age group have not been studied.

Taking a higher dose of Adeksa than recommended

If you have taken more medicine than recommended, you should 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 (shown in 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 (redness and itching of the skin, such as rash, erythema, eruption, urticaria);
• intestinal obstruction (severe crampy abdominal pain, vomiting, bloating, the patient does not 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, events such as liver disorders, abnormal liver function, and liver damage have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 which is stated on the carton and blister after 'EXP'. 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 protect the environment.

6. Contents of the pack and other information

What Adeksa contains

• The active substance is acarbose.

One tablet of Adeksa 50 mg contains 50 mg of acarbose.

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

One tablet of Adeksa 100 mg 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: [email protected]

Date of last revision of the leaflet: