ACARBOSA TECNIGEN 50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Acarbosa TecniGen 50 mg Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Acarbosa TecniGen 50 mg Tablets and what is it used for
2. What you need to know before taking Acarbosa TecniGen 50 mg Tablets
3. How to take Acarbosa TecniGen 50 mg Tablets
4. Possible side effects
5. Storage of Acarbosa TecniGen 50 mg Tablets
6. Package contents and additional information

1. What is Acarbosa TecniGen 50 mg Tablets and what is it used for

Acarbosa TecniGen belongs to the group of oral antidiabetic medications, which reduce blood glucose levels.

Acarbosa decreases the rate of carbohydrate (sugar) degradation in food, allowing for slower absorption. This way, blood sugar levels do not rise as sharply after eating. High blood sugar levels can cause serious damage to blood vessels and important organs such as the heart, brain, kidneys, eyes, and nervous system over time. Acarbosa helps maintain blood sugar levels within normal limits, reducing the incidence of damage or delaying its onset.

To achieve an optimal effect, acarbosa should be taken at the beginning of meals.

Acarbosa is administered to diabetic patients. It is used to treat adult diabetes when dietary regimen is insufficient or as an adjunct to treatment with sulfonylureas, metformin, or insulin.

2. What you need to know before taking Acarbosa TecniGen 50 mg Tablets

Do not takeAcarbosa TecniGen50 mg

• if you are allergic (hypersensitive) to acarbosa or any other component of this medication
• if you have chronic intestinal disorders associated with digestion and absorption disorders
• if you have any intestinal disease (e.g., Roemheld syndrome, major hernias, intestinal obstructions, and intestinal ulcers)
• if you have kidney disease
• if you have diabetic ketoacidosis or severe liver failure (e.g., liver cirrhosis).

Be cautious withAcarbosa TecniGen50 mg

• if you experience fatigue, loss of appetite, abdominal pain, dark urine, or yellowing of the skin or eyes, consult your doctor immediately
• during the first 6-12 months of treatment. In rare cases, liver enzyme levels may increase during treatment with acarbosa. Therefore, your doctor will monitor these enzymes during the first 6-12 months.

Other medications and Acarbosa TecniGen 50 mg

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription:

• if you are taking sulfonylurea, metformin, or insulin
• in case Acarbosa TecniGen causes diarrhea, it may interfere with the absorption of other oral medications. Concurrent administration with laxatives may enhance their effect. The efficacy of Acarbosa TecniGen may be reduced by the simultaneous use of antacids, some cholesterol-lowering medications, intestinal absorbents, or digestive enzyme preparations. Therefore, these combinations should be avoided.
• in isolated cases, acarbosa may affect the bioavailability of digoxin, requiring a dose adjustment of digoxin.
• if you take acarbosa and neomycin (a bactericidal antibiotic) at the same time, the increase in blood glucose after a meal may be reduced, and abdominal discomfort may become more frequent or severe. If symptoms are severe, consult your doctor. They may consider a temporary reduction in the dose of acarbosa.

TakingAcarbosa TecniGen50 mg with food and beverages

It is recommended to limit the intake of table sugar and foods containing it, as it may cause abdominal discomfort or diarrhea.

Pregnancy and lactation

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take acarbosa if you are pregnant, as there is no data on its safety in pregnant women.

In case of pregnancy or suspected pregnancy, inform your doctor. Additionally, the use of Acarbosa TecniGen is not recommended during breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been reported.

Treatment of diabetes with acarbosa as the only medication (monotherapy) does not produce hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or operate machinery. However, if you take acarbosa with other diabetes medications, hypoglycemia (symptoms of low blood sugar, such as fainting, confusion, increased sweating, vision changes, or difficulty concentrating) may occur, and you should exercise caution when driving or operating hazardous machinery.

3. How to take Acarbosa TecniGen 50 mg Tablets

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 50 mg (1 tablet), 3 times a day.

In rare cases, if necessary, the dose may be increased to a maximum of 200 mg (4 tablets), 3 times a day.

Your doctor will determine the frequency of administration and duration of treatment.

Tablets should be taken at the beginning of meals. They can be swallowed whole with a little liquid or chewed with the first bites of food.

Tablets should be removed from the blister pack immediately before each dose.

Use in children and adolescents:

The safety and efficacy of acarbosa in children and adolescents under 18 years of age have not been established.

If you take moreAcarbosa TecniGen50 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and package leaflet of the medication to the healthcare professional.

No specific symptoms are expected if an overdose of acarbosa is taken outside of meals, along with sugary foods or beverages; only an exacerbation of the described adverse reactions would occur. In such cases, the intake of sugary foods or beverages should be avoided for the next 4-6 hours after taking the medication. If any of these symptoms appear, consult your doctor or go to the nearest medical center immediately.

If you forget to takeAcarbosa TecniGen50 mg

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

If you stop taking Acarbosa TecniGen 50 mg Tablets

If you stop treatment with this medication suddenly, without adequate substitute treatment for diabetes, your blood glucose levels may rise. Consult your doctor before stopping this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Acarbosa TecniGen may cause side effects, although not everyone experiences them.

The following side effects have been reported, based on the following frequency data: very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), frequency not known (cannot be estimated from available data).

Blood and lymphatic system disorders

• Thrombocytopenia occurs with unknown frequency.

Immune system disorders

• Acute hypersensitivity reactions include mild or moderate allergic reactions of unknown frequency.

• Clinical symptoms associated with the skin (of unknown frequency: rash, erythema, exanthema, urticaria).

Vascular disorders

• Vascular symptoms, such as edema, occur rarely.

Gastrointestinal disorders

• Gastrointestinal and abdominal symptoms include flatulence, very common, and diarrhea and abdominal pain, common.

• Nausea, vomiting, and digestive problems are uncommon.

• Cases of unknown frequency of subobstruction/intestinal obstruction and pneumatosis cystoides intestinalis (formation of gas-filled cysts in the gastrointestinal wall) have been reported.

Hepatobiliary disorders

• Hepatic reactions consist of transient and uncommon elevations of liver enzymes (including increased transaminases, alkaline phosphatase, and γ-GT).

• Yellowing of the skin occurs rarely.

• Hepatitis has been reported with unknown frequency.

Skin and subcutaneous tissue disorders

• Acute generalized exanthematous pustulosis has been reported with unknown frequency.

After marketing, cases of hepatic disorders, altered liver function, and liver damage have been reported.

Isolated cases of fatal fulminant hepatitis have also been reported, particularly in Japan.

Gastrointestinal symptoms may worsen if you do not follow the diet. If these symptoms occur despite strict adherence to the diet, consult your doctor. In these cases, your doctor may consider temporarily or permanently reducing the dose.

If you consider any of the side effects you experience to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Acarbosa TecniGen 50 mg Tablets

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

Do not store above 30°C.

Remove the tablets from the original packaging immediately before administration. Acarbosa TecniGen should be stored in its original packaging.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition ofAcarbosa TecniGen 50 mg

The active ingredient is acarbosa. Each tablet contains 50 mg of acarbosa.

The other ingredients are pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and package contents

Acarbosa TecniGen 50 mg is available in packages of 30 or 100 tablets, in a transparent PVC/Aclar (PCTFE)/PVC blister pack sealed with an aluminum foil.

The tablets are round, white or yellowish, flat, and scored on one side. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Madrid, Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

Date of the last revision of this package leaflet:March 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/