Acarbose Tecnigen 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acarbosa TecniGen 50 mg tablets

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Acarbosa TecniGen 50 mg tablets are and what they are 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. How to store Acarbosa TecniGen 50 mg tablets
6. Contents of the pack and other information

1. What Acarbosa TecniGen 50 mg tablets are and what they are used for

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

Acarbosa slows down the breakdown of carbohydrates (sugars) present in food, thereby slowing their absorption. As a result, blood sugar levels do not rise as sharply after eating. Persistently high blood sugar levels may, over time, cause serious damage to blood vessels and major organs such as the heart, brain, kidneys, eyes, and nervous system. Acarbosa helps maintain blood sugar levels within normal limits, reducing the occurrence or delaying the onset of such complications.

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

Acarbosa is administered to diabetic patients. It is indicated for the treatment of adult-onset diabetes when dietary management alone is insufficient, or as an adjunct to treatment with sulfonylureas, metformin, or insulin.

2. What you need to know before starting to take Acarbosa TecniGen 50 mg tablets

Do not take Acarbosa TecniGen 50 mg

• if you are allergic (hypersensitive) to acarbose or to any of the other ingredients of this medicine
• if you have chronic intestinal disorders associated with digestion and absorption problems
• if you suffer from any intestinal disease (e.g. Roemheld syndrome, large hernias, intestinal obstructions, or intestinal ulcers)
• if you suffer from kidney disease
• if you have diabetic ketoacidosis or severe hepatic insufficiency (e.g. hepatic cirrhosis).

Take special care with Acarbosa TecniGen 50 mg

• if you experience fatigue, loss of appetite, stomach pain, dark urine, or yellowing of the skin or eyes, consult your doctor immediately
• during the first 6–12 months of treatment. Very rarely, during treatment with acarbose, an increase in liver enzymes may occur. Therefore, your doctor will monitor these enzymes during the first 6–12 months.

Other medicines and Acarbosa TecniGen 50 mg

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription:

• if you are taking sulfonylureas, metformin, or insulin
• if Acarbosa TecniGen causes you diarrhea, it may interfere with the absorption of other oral medications. Concomitant use with laxatives may enhance their effect. The effectiveness of Acarbosa TecniGen may be reduced by simultaneous use of antacids, certain cholesterol-lowering drugs, intestinal adsorbents, or digestive enzyme preparations. Therefore, these combinations should be avoided.
• in isolated cases, acarbose may affect the bioavailability of digoxin, requiring an adjustment in digoxin dosage.
• if you take acarbose and neomycin (a bactericidal antibiotic) at the same time, the post-meal rise in blood glucose may be further reduced and may lead to more frequent or more severe abdominal discomfort. If symptoms are severe, speak with your doctor. Your doctor may consider a temporary reduction in the dose of acarbose.

Taking Acarbosa TecniGen 50 mg with food and drinks

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

Pregnancy and breastfeeding

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

Do not take acarbose if you are pregnant, as there are no data available regarding its safety in pregnant women.

If you become pregnant or suspect pregnancy, inform your doctor. The use of Acarbosa TecniGen is also not recommended during breastfeeding.

Driving and use of machines

No effects on the ability to drive or operate machinery have been reported.

The treatment of diabetes with acarbose as monotherapy does not cause hypoglycemia (low blood sugar levels) and therefore does not affect the ability to drive or operate machinery. However, if you take acarbose together with other antidiabetic medicines, hypoglycemia may occur (symptoms of low blood sugar such as fainting, confusion, increased sweating, visual disturbances, or difficulty concentrating), and therefore you should take extra precautions when driving or operating dangerous machinery.

3. How to take Acarbosa TecniGen 50 mg tablets

Follow exactly the instructions for use of this medicine 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.

On rare occasions, if considered necessary, the dose may be increased up to a maximum of 200 mg (4 tablets), 3 times a day.

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

The tablets should be taken at the beginning of meals. They can be swallowed whole with a small amount of liquid or chewed together with the first bites of food.

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

Use in children and adolescents:

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

If you take more Acarbosa TecniGen 50 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine container and leaflet to the healthcare professional.

No specific symptoms are expected if an overdose of acarbose is taken outside of meals. However, if taken together with drinks or foods containing sugars, only a worsening of the described adverse reactions would occur. In such cases, the intake of sugary foods or drinks should be avoided during the 4–6 hours following the administration of the medicine. If one or more of these symptoms occur, inform your doctor immediately or go to the nearest medical center.

If you forget to take Acarbosa TecniGen 50 mg

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

If you stop taking Acarbosa TecniGen 50 mg tablets

If you stop treatment with this medicine suddenly, without appropriate substitute treatment for diabetes, your blood glucose levels may rise. Talk to your doctor before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, Acarbosa TecniGen may cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported, with frequency assessments based on the following categories: 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 frequency not known.

Immune system disorders

• Acute hypersensitivity reactions include mild or moderate allergic reactions with frequency not known.

• Associated clinical symptoms involve the skin (frequency not known: rash, erythema, exanthema, urticaria).

Vascular disorders

• Non-specific vascular symptoms, such as edema, occur rarely.

Gastrointestinal disorders

• Non-specific gastrointestinal and abdominal symptoms include flatulence (very common), and diarrhea and abdominal pain (common).

• Nausea, vomiting, and digestive disturbances are uncommon.

• Cases of frequency not known have been reported for subobstruction/ intestinal obstruction and intestinal pneumatosis cystica (formation of gas-filled cysts located in the gastrointestinal wall).

Hepatobiliary disorders

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

• Yellowish discoloration of the skin occurs rarely.

• Hepatitis has been reported with frequency not known.

Skin and subcutaneous tissue disorders

• Generalized acute exanthematous pustulosis has been reported with frequency not known.

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

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acarbose TecniGen 50 mg tablets

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

Do not store above 30°C.

Remove the tablets from the original packaging immediately before administration. Acarbose TecniGen must be stored in its original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acarbose TecniGen 50 mg

The active substance is acarbose. Each tablet contains 50 mg of acarbose.

The other components are pregelatinized corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

Appearance of the medicine and contents of the pack

Acarbose TecniGen 50 mg is available in packs containing 30 or 100 tablets, in transparent PVC/Aclar(PCTFE)/PVC blisters sealed with an aluminum foil.

The tablets are round, white or slightly yellowish, flat, and scored on one side. The score mark is intended only to facilitate breaking the tablet for ease of swallowing, and not to divide the tablet 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 most recent revision of this leaflet: March 2024

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