ACARBOSE 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Acarbose Aurovitas, 50 mg, tablets
3. Acarbose Aurovitas, 100 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
4. What is Acarbose Aurovitas and what is it used for
5. Important information before taking Acarbose Aurovitas
   1. When not to take Acarbose Aurovitas
   2. Warnings and precautions
   3. During treatment
   4. Children and adolescents
   5. Acarbose Aurovitas with other medicines
   6. Acarbose Aurovitas with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
6. How to take Acarbose Aurovitas
   1. Adults:
   2. Taking a higher dose of Acarbose Aurovitas than recommended
   3. Missing a dose of Acarbose Aurovitas
   4. Stopping treatment with Acarbose Aurovitas
7. Possible side effects
   1. If you experience any of the following side effects, stop taking this medicine and contact your doctor or go to the nearest hospital immediately:
   2. Other side effects
   3. Reporting side effects
8. How to store Acarbose Aurovitas
9. Contents of the pack and other information
   1. What Acarbose Aurovitas contains
   2. What Acarbose Aurovitas looks like and contents of the pack
   3. Pack sizes:
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder:
   6. Manufacturer/Importer:
   7. APL Swift Services (Malta) Ltd.
   8. Generis Farmacêutica, S.A.
   9. Arrow Génériques- Lyon
   10. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   11. Czech Republic:
   12. France:
   13. Portugal:
   14. Italy:
   15. Poland:
   16. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Acarbose Aurovitas, 50 mg, tablets

Acarbose Aurovitas, 100 mg, tablets

Acarbosum

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

• You should 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Acarbose Aurovitas and what is it used for

The active substance of this medicine is acarbose, which belongs to a group of medicines called alpha-glucosidase inhibitors. It is used to treat adults with type 2 diabetes mellitus.

Your doctor may prescribe Acarbose Aurovitas when diet and exercise alone are not enough to control your blood sugar levels. Acarbose Aurovitas works by slowing down the digestion of carbohydrates (complex sugars) after each meal, which reduces blood sugar levels.

2. Important information before taking Acarbose Aurovitas

When not to take Acarbose Aurovitas

• if you are allergic to Acarbose Aurovitas or any of the other ingredients of this medicine (listed in section 6),
• if you have a chronic intestinal disease that affects the absorption of nutrients,
• if you have a condition that may worsen due to gas accumulation in the intestines, such as Roemheld syndrome, intestinal obstruction, narrowing, or ulceration of the intestine,
• if you have inflammation or ulceration of the intestine,
• if you have intestinal obstruction or if it is likely to occur,
• if you have severe kidney failure,
• if you have severe liver problems.

Warnings and precautions

If you have had stomach surgery before taking Acarbose Aurovitas, you should talk to your doctor or pharmacist. It is possible that Acarbose Aurovitas may work faster. It is unlikely to cause problems, but if you feel unwell after taking Acarbose Aurovitas, you should contact your doctor.

During treatment

If you experience fatigue, nervousness, and tremors, as well as rapid heartbeat, cold sweats, or hunger attacks while taking this medicine, you may have low blood sugar (hypoglycemia). You should take glucose as soon as possible to prevent your condition from worsening. If your blood sugar level continues to drop, you may experience severe disorientation (confusion), convulsions, loss of self-control, shallow breathing, slow heartbeat, and even loss of consciousness. Since Acarbose Aurovitas delays the absorption of sucrose, you should not take sucrose or artificial sweeteners. You can buy glucose tablets, syrup, or sweets at a pharmacy.

If you have persistent constipation, decreased appetite, bloating, and vomiting, you may have intestinal obstruction. You should contact your doctor or go to the nearest emergency department immediately.

You should regularly check your blood and urine sugar levels.

Your doctor may need to regularly check your liver function, especially during the first 6-12 months of treatment.

You should continue to follow any dietary recommendations given to you by your doctor and make sure you eat carbohydrates regularly throughout the day.

Children and adolescents

Acarbose Aurovitas should not be used in patients under 18 years of age, as there is not enough information available on its effects and tolerance in children and adolescents under 18 years of age.

Acarbose Aurovitas with other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken.

Acarbose Aurovitas may change the effect of other medicines or, conversely, some medicines may change the effect of Acarbose Aurovitas:

• other anti-diabetic medicines, such as insulin, metformin, sulfonylurea derivatives; their dose may need to be adjusted;
• intestinal adsorbents, such as activated charcoal;
• digestive enzymes (including antacids, amylase, pancreatin);
• medicines used to treat high cholesterol (cholestyramine);
• digoxin (medicines used to treat heart failure);
• medicines used to treat high blood pressure or fluid retention (thiazides or diuretics);
• medicines that reduce inflammation (corticosteroids);
• thyroid hormones;
• female sex hormones (estrogens), oral contraceptives;
• medicines used to treat spasms or schizophrenia (phenytoin, phenothiazines);
• medicines used to lower elevated fat levels in the blood (nicotinic acid);
• medicines used to treat high blood pressure or heart disease (calcium channel blockers);
• medicines that accelerate heart rate (sympathomimetics);
• medicines used to treat tuberculosis (isoniazid);
• neomycin, an antibiotic.

Acarbose Aurovitas with food and drink

Sucrose (sugar) and foods containing sucrose may cause stomach discomfort, and even diarrhea, due to carbohydrate fermentation in the colon during treatment with Acarbose Aurovitas.

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.

Acarbose Aurovitas should not be used during pregnancy or breastfeeding.

It is not known whether Acarbose Aurovitas passes into breast milk.

Driving and using machines

Taking Acarbose Aurovitas alone (monotherapy) does not cause low blood sugar (hypoglycemia) and therefore does not affect the ability to drive or use machines.

Taking Acarbose Aurovitas in combination with sulfonylurea, insulin, or metformin for the treatment of diabetes may cause low blood sugar, which can affect the ability to drive or use machines or work safely. Do not drive or use machines if you do not feel well.

3. How to take Acarbose Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults:

The recommended dose is one 50 mg tablet of Acarbose Aurovitas three times a day (corresponding to 150 mg per day).

To reduce the likelihood of stomach upset, some patients may start with one 50 mg tablet of Acarbose Aurovitas once or twice a day (corresponding to 50 mg to 100 mg per day). If necessary, your doctor may gradually increase the dose to 2 tablets of 50 mg or 1 tablet of 100 mg of Acarbose Aurovitas three times a day (corresponding to 300 mg per day). The maximum recommended dose is 2 tablets of 100 mg of Acarbose Aurovitas three times a day (corresponding to 600 mg per day).

Swallow the tablets whole with a glass of water, immediately beforea meal or chew with the first bite of food.

Taking a higher dose of Acarbose Aurovitas than recommended

If you take Acarbose Aurovitas with drinks or foods containing carbohydrates, you may experience side effects such as stomach bloating, severe bloating, or diarrhea. In this case, do not eat or drink carbohydrates for 4 to 6 hours. You should see a doctor or go to the nearest hospital immediately. Take the packaging and any remaining tablets with you.

Missing a dose of Acarbose Aurovitas

Do not take a double dose to make up for a forgotten dose. Take the next dose with the next meal.

Stopping treatment with Acarbose Aurovitas

If you stop taking Acarbose Aurovitas suddenly, your blood sugar levels may rise. Before stopping this medicine, consult your doctor.

If you have any further questions on the use of 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.

If you experience any of the following side effects, stop taking this medicine and contact your doctor or go to the nearest hospital immediately:

• yellowing of the whites of the eyes or skin (jaundice) (rare, may affect up to 1 in 1,000 people);

• liver inflammation. You may feel sick, vomit, lose your appetite, have a fever, feel itchy, have jaundice (see above), pale stools, or dark urine (frequency cannot be estimated from the available data);
• persistent constipation, decreased appetite, stomach bloating, and nausea (vomiting) (intestinal obstruction) (frequency cannot be estimated from the available data);
• allergic reactions, such as rash, skin redness, skin eruptions, or skin itching.

Other side effects

Very common(may affect more than 1 in 10 people)

• gas;
• rumbling in the stomach;
• feeling of bloating.

Common(may affect up to 1 in 10 people)

• diarrhea;
• stomach or intestinal pain.

These side effects may occur after a meal containing sugar (sucrose). Symptoms can be alleviated by avoiding foods and drinks containing sugar (sucrose, sugar). If diarrhea does not improve, your doctor may reduce the dose or, in some cases, stop treatment. Do not take medicines for indigestion to treat these side effects, as they may worsen symptoms.

Uncommon(may affect up to 1 in 100 people)

• nausea;
• vomiting;
• indigestion;
• increased activity of liver enzymes, which can be observed in blood tests.

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

• skin swelling (edema).

Not known(frequency cannot be estimated from the available data)

• unexplained bruising or bleeding that lasts longer than usual. These may be signs of a low platelet count;
• constipation;
• gas pockets in the intestinal wall (Pneumatosis cystoides intestinalis);
• rash with blisters and (or) pus-filled blisters (acute generalized exanthematous pustulosis).

Additionally, side effects such as liver function disorders, abnormal liver function, and liver damage have been reported, especially in Japan. In Japan, single cases of rapid and fatal liver disease have been reported, although it is not clear whether they are due to Acarbose Aurovitas.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects 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, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 Acarbose Aurovitas

Keep this medicine out of the sight and reach of children.

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.

Store in a temperature below 30°C.

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 Acarbose Aurovitas contains

The active substance is acarbose.

Each tablet contains 50 mg or 100 mg of acarbose.

The other ingredients are:

• microcrystalline cellulose (type 102), cornstarch, colloidal anhydrous silica, magnesium stearate.

What Acarbose Aurovitas looks like and contents of the pack

Tablet.

Acarbose Aurovitas, 50 mg, tablets

White or almost white, round, uncoated tablets with the inscription "AC" on one side and "50" on the other side.

Acarbose Aurovitas, 100 mg, tablets

White or almost white, uncoated, oblong tablets with the letters "A" and "C" separated by a score line on one side and the number "100" with a score line on the other side. The tablet can be divided into equal doses.

Acarbose Aurovitas is available in blisters, packaged in cartons.

Pack sizes:

50 mg: 30, 40, 90, and 270 tablets.

100 mg: 30, 40, 90, 120, and 270 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Arrow Génériques- Lyon

26 avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Akarbosa Aurovitas

France:

Acarbose Arrow 50 mg tablet

Acarbose Arrow 100 mg divisible tablet

Portugal:

Acarbose Generis Phar

Italy:

Acarbosio Aurobindo

Poland:

Acarbose Aurovitas

Date of last revision of the package leaflet: