ACARBOSA FARMALIDER 100 mg TABLETS

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 when 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 check your blood and urine sugar levels regularly.

• Because acarbosa can rarely cause an 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 about 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 to treat high cholesterol (cholestyramine)
• medicines to treat heart failure (digoxin)
• medicines to treat high blood pressure or fluid retention (thiazide and diuretics)
• anti-inflammatory medicines (corticosteroids)
• thyroid medicines
• female hormones (estrogens), oral contraceptives
• medicines to treat muscle cramps or schizophrenia (phenytoin, phenothiazines)
• medicines that lower high lipid levels in the blood (nicotinic acid)
• medicines to treat high blood pressure or heart conditions (calcium antagonists)
• medicines used to accelerate heartbeats (sympathomimetics)
• medicines used to treat 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 100 mg.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is no data on the use of acarbosa during pregnancy, so it should not be administered 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 your 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 instructions for administration 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 tablet of acarbosa 50 mg three times a day (which corresponds to 150 mg daily).

To reduce the possibility of stomach upset, some patients may start with one tablet of acarbosa 50 mg one or two times a day (which corresponds to 50 mg or 100 mg daily). Your doctor may gradually increase the dose if necessary up to 2 tablets of acarbosa 50 mg or 1 tablet of acarbosa 100 mg three times a day (which corresponds to 300 mg daily).

(There are other presentations on the market that contain 50 mg of acarbosa). Acarbosa can be used for long-term treatment.

Children and adolescents under 18 years

The use of acarbosa 100 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 ingested. Do not take any food or drink that contains carbohydrates. The symptoms of an overdose may cause abdominal bloating (due to an excessive amount of 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 meal and continue with the treatment as usual.

If you stop taking Acarbosa Farmalider

It is important that you continue the treatment with Acarbosa Farmalider 100 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 product, 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, interrupt treatment. Do not take remedies to relieve indigestion as treatment for the above side effects, as they may worsen the 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 the 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 the presence of 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 Healthcare 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. Storing 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 which is stated on the carton. The expiry date refers to the last day of the month shown.

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 to protect the environment.

6. Contents of the pack and other information

Composition of Acarbosa Farmalider

• The active substance is acarbosa. Each tablet contains 100 mg of acarbosa.
• The other ingredients are pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and pack contents

Acarbosa Farmalider 100 mg are round, biconvex tablets, white/white-colored, scored on one side and with the inscription "ACA 100" on the other.

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

Via Zambeletti, 25

20021 Baranzate (MI)

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 Healthcare Products (AEMPS) http://www.aemps.gob.es/