Package Insert: Information for the Patient

Acarbosa TecniGen 50 mg Tablets

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

AcarbosaTecniGenbelongs to the group of oral antidiabetic medications, which reduce blood glucose levels.

Acarbosa reduces the rate of carbohydrate (sugar) degradation from food, thereby absorbing it more slowly. In this way, blood sugar levels do not increase as abruptly after food intake. Elevated blood sugar levels can cause, in the long term, severe damage to blood vessels and important organs such as the heart, brain, kidneys, eyes, and nervous system. Acarbosa helps maintain blood sugar levels within normal limits, reducing the incidence of damage or delaying its onset.

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

Acarbosa is administered to diabetic patients. It serves for the treatment of adult diabetes in which the dietary regimen is insufficient or as an adjunct to treatment with sulfonylureas, metformin, or insulin.

Do not takeAcarbosa TecniGen50 mg

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

Be especially careful withAcarbosa TecniGen50 mg

• if you notice fatigue, loss of appetite, abdominal pain, dark urine, or yellowish discoloration of the skin or eyes, consult your doctor immediately
• during the first 6-12 months of treatment. In very rare cases, during acarbosa treatment, an increase in liver enzymes may occur. Your doctor will perform controls of 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 used recently, or may need to use any other medication, including those purchased without a prescription:

• if you are taking sulfonilurea, metformin, or insulin
• in the event that Acarbosa TecniGen causes diarrhea, it may interfere with the absorption of other oral medications. Concurrent administration with laxatives may potentiate their effect. There is a possibility that 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 an adjustment to the digoxin dose.
• if you take acarbosa and neomicin (a bactericidal antibiotic) at the same time, the increase in blood glucose after a meal may be reduced and may lead to more frequent or more severe abdominal discomfort. If the symptoms are severe, speak with your doctor. He or she may consider a temporary reduction in the acarbosa dose.

TakingAcarbosa TecniGen50 mg with food and beverages

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

Pregnancy and lactation

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

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

In the event of pregnancy or suspected pregnancy, you must inform your doctor. Additionally, Acarbosa TecniGen is not recommended during lactation.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

The treatment of diabetes with acarbosa as the only medication (monotherapy) does not produce hypoglycemia (low blood sugar levels) and therefore does not affect the ability to drive or operate machinery. However, if you take acarbosa with other medications to treat your diabetes, hypoglycemia (symptoms of low blood sugar levels such as dizziness, confusion, increased sweating, visual disturbances, or difficulty concentrating) may occur, and you should exercise extreme caution when driving and operating hazardous machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 up to a maximum of 200 mg (4 tablets), 3 times a day.

Your doctor will determine the administration frequency and treatment duration.

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 have not been established in children and adolescents under 18 years old.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

No special symptoms are expected if acarbosa is ingested outside of meals, along with drinks or foods containing sugars. Only an aggravation of the described adverse reactions would occur. In such cases, the intake of sugary foods or drinks should be avoided for 4-6 hours after taking the medication. If any of these symptoms appear, inform your doctor immediately or go to the nearest medical center.

If you forgot to takeAcarbosa TecniGen50 mg

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Acarbosa TecniGen 50 mg tablets

If you interrupt treatment with this medication abruptly, without an adequate substitute treatment for diabetes, your blood glucose may increase. Talk to your doctor before stopping this medication.

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

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

The following side effects have been described, based on the following frequency data:muy frecuentes (may affect more than 1 in 10 patients), frecuentes (may affect up to 1 in 10 patients), poco frecuentes (may affect up to 1 in 100 patients), raros (may affect up to 1 in 1,000 patients), muy raros (may affect up to 1 in 10,000 patients), frecuencia no conocida (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.

• Associated clinical symptoms relate to the skin (unknown frequency: rash, erythema, exanthema, urticaria).

Vascular disorders

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

Gastrointestinal disorders

• Non-specific gastrointestinal and abdominal symptoms consist of flatulence, very frequent, and diarrhea and abdominal pain, frequent.

• Nausea, vomiting, and digestive problems are infrequent

• Unknown frequency cases of intestinal subobstruction/obstruction and pneumatosis cystoides intestinalis (formation of gas-filled cysts, located in the gastrointestinal tract) have been described.

Hepatobiliary disorders

• Liver reactions consist of transient and infrequent elevations of liver enzymes (including increased transaminases, alkaline phosphatase, and gamma-GT).

• Jaundice occurs rarely.

• Unknown frequency, hepatitis has been described.

Skin and subcutaneous tissue disorders

- Unknown frequency, generalized acute pustular exanthema has been described.

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

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

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 are experiencing to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

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

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

Do not store at a temperature 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition ofAcarbosa TecniGen 50 mg

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

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

Appearance of the product and content of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas, Madrid, Spain

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas SA

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

Date of the last review of this leaflet:March 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/