ACARBOSA FARMALIDER 50 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Acarbosa Farmalider 50 mg tablets

Acarbosa

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

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Acarbosa Farmalider and what is it used for
2. What you need to know before you take Acarbosa Farmalider
3. How to take Acarbosa Farmalider
4. Possible side effects
5. Storage of Acarbosa Farmalider
6. Contents of the pack and further information

1. What is Acarbosa Farmalider and what is it used for

This medicine belongs to a group of medicines called "alpha-glucosidase inhibitors". It is used to treat adult patients with non-insulin-dependent diabetes mellitus (type 2 diabetes), when diet and exercise are not enough to control blood sugar levels, and it can also be given with other anti-diabetic medicines (such as metformin, sulfonylureas, or insulin) when they are not enough to control blood sugar levels.

It works by slowing down the breakdown of carbohydrates (complex sugars) after each meal, and consequently reducing blood sugar levels.

2. What you need to know before you take Acarbosa Farmalider

Do not take Acarbosa Farmalider

• if you are allergic to acarbosa or any of the other ingredients of this medicine

(listed in section 6).

• if you have chronic intestinal disorders associated with digestive and absorption disorders.
• if you have any disease that may worsen as a result of gas generation in the intestines (e.g., Roemheld syndrome, major intestinal hernias, intestinal obstructions, or intestinal ulcers).
• if you have severe kidney disease.
• if you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acarbosa Farmalider

• if you have hypoglycemia. Hypoglycemia is characterized by a lack of glucose in the blood.

This can cause you to feel tired, nervous, and shaky, and can cause rapid heartbeat, cold sweating, or painful hunger. If blood glucose levels continue to decrease, you may experience significant mental confusion (delirium), convulsions, loss of self-control, shallow breathing, decreased pulse, and you may lose consciousness. In most cases, the signs of low sugar levels disappear quickly after consuming glucose (grape sugar), but not sucrose (cane sugar) or artificial sweeteners. Acarbosa delays the absorption of sucrose. Therefore, sucrose is not suitable for the immediate treatment of hypoglycemia.

• in very rare cases, intestinal obstruction has been reported in patients taking acarbosa. If you suspect you may have intestinal obstruction, you should contact your doctor or go to the nearest hospital immediately.
• if you have had a gastrectomy, acarbosa may act more quickly.

This should not cause you any problems, but if you do not feel well after taking acarbosa, you should contact your doctor.

• you should regularly check your blood and urine sugar levels.
• because acarbosa can rarely cause a temporary increase in liver enzymes in the blood, even without experiencing any signs of it, your doctor should check your liver function frequently, especially in the first 6-12 months of treatment.
• you should continue to follow any dietary advice given by your doctor and make sure to eat carbohydrates regularly throughout the day.
• since there is not enough information on the efficacy and tolerance in children and adolescents, this medicine should not be used in children under 18 years of age.

Using Acarbosa Farmalider with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or may take any other medicines.

• other anti-diabetic medicines, e.g., insulin, metformin tablets, or sulfonylurea tablets, as the dose will need to be adjusted.
• intestinal absorbents, e.g., activated charcoal
• medicines that help improve digestion (including antacids, amylase, and pancreatin)
• medicines for high cholesterol (cholestyramine)
• medicines for heart failure (digoxin)
• medicines for high blood pressure or fluid retention (thiazide and diuretics)
• anti-inflammatory medicines (corticosteroids)
• thyroid medicines
• female hormones (estrogens), oral contraceptives
• medicines for muscle cramps or schizophrenia (phenytoin, phenothiazines)
• medicines that lower high lipid levels in the blood (nicotinic acid)
• medicines for high blood pressure or heart disease (calcium antagonists)
• medicines used to accelerate heartbeats (sympathomimetics)
• medicines for tuberculosis (isoniazids)

Taking Acarbosa Farmalider with food, drinks, and alcohol

Sucrose (cane sugar) and foods containing sucrose can cause abdominal discomfort or even diarrhea due to the fermentation of carbohydrates in the colon during treatment with Acarbosa Farmalider 50 mg.

Pregnancy, breastfeeding, and fertility

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

Acarbosa should not be used during pregnancy, as there are no data on its use during pregnancy.

Do not use this medicine during breastfeeding, as it is not known whether acarbosa is excreted in breast milk in nursing women. Acarbosa is excreted in the milk of lactating animals in small amounts.

Driving and using machines

Treatment of diabetes with acarbosa as the only medicine (monotherapy) does not produce hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machinery.

However, if you take acarbosa with other medicines for diabetes, hypoglycemia (symptoms of low blood sugar, such as fainting, confusion, increased sweating, vision changes, or difficulty concentrating) may occur, and you should be extremely careful when driving or using hazardous machinery.

3. How to take Acarbosa Farmalider

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adult and elderly patients

The recommended dose is:

One 50 mg acarbosa tablet three times a day (corresponding to 150 mg daily).

To reduce the possibility of stomach upset, some patients may start with one 50 mg acarbosa tablet one or two times a day (corresponding to 50 mg or 100 mg daily). Your doctor may gradually increase the dose if necessary up to two 50 mg acarbosa tablets or one 100 mg acarbosa tablet three times a day (corresponding to 300 mg daily).

(There are other presentations on the market that contain 100 mg of acarbosa). Acarbosa can be used for long-term treatment.

Children and adolescents under 18 years of age

Acarbosa Farmalider 50 mg is not recommended.

If you take more Acarbosa Farmalider 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 medicine and the amount taken. Do not take any food or drink containing carbohydrates. The symptoms of an overdose may cause abdominal bloating (due to excessive gas), flatulence, and diarrhea. Bring this leaflet, the remaining tablets, and the box so that the doctor can know what medicine it is.

If you forget to take Acarbosa Farmalider

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

If you forget to take a dose, do not take it between meals. Wait until your next dose with food and continue treatment as usual.

If you stop taking Acarbosa Farmalider

It is important that you continue treatment with Acarbosa Farmalider 50 mg tablets as your doctor has indicated, so that your blood sugar levels do not rise too high. Do not stop treatment without consulting your doctor first.

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

4. Possible side effects

Like all medicines, Acarbosa Farmalider can cause side effects, although not everybody gets them.

The side effects listed below have been described with the following frequencies:

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

• Flatulence

Common (may affect up to 1 in 10 people):

• Diarrhea
• Stomach or abdominal pain

These side effects usually occur after consuming foods that contain sugar (sucrose). Symptoms can be reduced by avoiding foods and drinks that contain sugar (sucrose, cane sugar). If your diarrhea does not disappear, your doctor will reduce the dose or, in some cases, stop treatment. Do not take remedies to relieve indigestion as treatment for the above side effects, as they may worsen symptoms.

Uncommon (may affect up to 1 in 100 people):

• Nausea
• Vomiting
• Indigestion
• Transient increase in liver enzymes in the blood

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

• Swelling of the skin (edema)
• Jaundice (yellowing of the skin and whites of the eyes)

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

Additionally, adverse effects such as liver disorder, abnormal liver function, and liver injury have been reported, especially in Japan. Individual cases of a type of rapid and fatal liver disease have been reported in Japan, but it is not clear whether they are due to the administration of acarbosa.

If you suspect intestinal obstruction, you should contact your doctor or go to the nearest hospital immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acarbosa Farmalider

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the pack. The expiry date is the last day of the month stated.

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 further information

Composition of Acarbosa Farmalider

• The active substance is acarbosa. Each tablet contains 50 mg of acarbosa.
• The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and pack contents

Acarbosa Farmalider 50 mg are white/white tablets, round, biconvex, and with the inscription "ACA 50" on one side.

Each carton contains 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Farmalider, S.A.

C/ Aragoneses, 15

28108 Alcobendas (Madrid)

Manufacturer:

FAMAR Italia, s.p.a.

Via Zambeletti, 25, 20021 – Milan

Italy

Date of last revision of this leaflet: November 2023

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