ACARBOSA VIATRIS 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Acarbosa Viatris 100 mg Tablets

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. See section 4.

Contents of the pack:

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

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

The active substance of this medicine is acarbosa, which belongs to a group of medicines called alpha-glucosidase inhibitors. It is used to treat adults with non-insulin-dependent diabetes mellitus (type 2 diabetes). Your doctor may prescribe acarbosa when diet and exercise alone are not enough to control your blood sugar levels. Acarbosa works by slowing down the digestion of carbohydrates (complex sugars) after each meal, which reduces blood sugar levels.

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

Do not take Acarbosa Viatris:

• If you are allergic to acarbosa or any of the other ingredients of this medicine (listed in section 6).
• If you have chronic intestinal diseases associated with digestive and absorption disorders.

• If you have any disease that may worsen as a result of gas accumulation in the intestines (e.g. Roemheld syndrome, severe intestinal hernias, intestinal narrowing and ulceration).
• If you have intestinal inflammation or ulcers.
• If you have an intestinal obstruction or are prone to it.
• If you have severe kidney failure.

• If you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take acarbosa if you have undergone gastric resection.

• If you have had a gastrectomy, it is possible that acarbosa will 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.

During treatment

If you notice fatigue, nervousness, and tremors, and you have tachycardia, cold sweating, and an urgent need to eat while taking this medicine, you may have low blood sugar levels (hypoglycemia). You should take glucose as soon as possible to avoid worsening symptoms. If your blood sugar 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. Because acarbosa delays the absorption of sucrose, do not take sucrose or artificial sweeteners. You can find glucose tablets, syrups, or candies at the pharmacy.

If you suffer from persistent constipation, decreased appetite, stomach bloating, and vomiting, you may have an intestinal obstruction. You should contact your doctor or go to the nearest emergency service immediately.

You should regularly check your blood and urine sugar levels.

Your doctor may need to 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.

Children and adolescents

Because the information available on the effects and tolerability in children and adolescents under 18 years of age is still insufficient, it is not recommended to take Acarbosa Viatris 50 mg in patients under 18 years of age.

Taking Acarbosa Viatris with other medicines

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

Acarbosa may alter the effect of other medicines, or alternatively, some medicines may alter the effect of acarbosa.

• Other anti-diabetic medicines, e.g. insulin, metformin, or sulfonylureas; it may be necessary to adjust their doses.

• Intestinal absorbents, e.g. activated charcoal.
• Medicines that help improve digestion (including antacids, amylase, and pancreatin).
• Anti-inflammatory medicines (corticosteroids).
• Medicines for high cholesterol (cholestyramine).
• Digoxin (medicines for heart failure).
• Medicines for high blood pressure or fluid retention (thiazide and diuretics).
• 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).
• Neomycin, an antibiotic.

Taking Acarbosa Viatris with food and drinks

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.

Pregnancy and breastfeeding

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.

Do not take acarbosa if you are pregnant or breastfeeding.

It is not known whether acarbosa is present in breast milk.

Driving and using machines

Taking acarbosa alone (monotherapy) does not cause low blood sugar levels (hypoglycemia) and therefore has no effect on your ability to drive or operate machines.

Taking acarbosa in combination with other medicines called sulfonylureas, insulin, or metformin for the treatment of diabetes may cause hypoglycemia and therefore affect your ability to drive and operate machines or work safely. Do not drive or operate machines if you feel affected.

3. How to take Acarbosa Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Unless your doctor tells you otherwise, the recommended dose is:

Adults

Take one Acarbosa Viatris 50 mg tablet three times a day (corresponding to 150 mg daily).

To reduce the possibility of stomach upset, some patients may start with one Acarbosa Viatris 50 mg tablet one or two times a day (corresponding to 50 mg or 100 mg daily). Your doctor may gradually increase the dose as needed up to 2 Acarbosa Viatris 50 mg tablets or 1 Acarbosa Viatris 100 mg tablet three times a day (corresponding to 300 mg daily). The maximum recommended dose is 2 Acarbosa Viatris 100 mg tablets three times a day (corresponding to 600 mg per day).

The tablets can be taken whole with a glass of water immediately beforea meal or chewed with the first bite of food.

The 100 mg tablets can be divided into equal doses.

If you take more Acarbosa Viatris than you should

You may notice side effects such as stomach bloating, strong flatulence, or diarrhea if you have taken acarbosa with drinks or foods that contain carbohydrates. In this case, do not ingest or drink foods or drinks that contain carbohydrates for the next 4 to 6 hours. Consult your doctor, pharmacist, or call the toxicology information service immediately, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Acarbosa Viatris

Do not take a double dose to make up for forgotten doses. Take the next dose with your next meal.

If you stop taking Acarbosa Viatris

If you stop taking Acarbosa Viatris suddenly, your blood sugar levels may increase. Talk to your doctor before stopping treatment with this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking this medicine and consult your doctor or go to the nearest hospital emergency department immediately:

• Yellowing of the skin or the whites of the eyes (jaundice) (rare, may affect up to 1 in 1,000 people).
• Liver inflammation. You may experience nausea, vomiting, loss of appetite, fever, itching, jaundice (see above), pale stools, or dark urine (frequency cannot be estimated from the available data).
• Persistent constipation, decreased appetite, stomach bloating, and vomiting (ileus) (frequency cannot be estimated from the available data).
• Allergic reactions such as rash, skin redness, skin rash, or skin itching.

Other possible side effects:

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

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

These side effects usually occur after ingesting foods that contain sugar (sucrose). You can reduce the symptoms 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 alleviate indigestion as treatment for the above side effects, as they may worsen the symptoms.

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

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

• Swelling of the skin (edema).

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

Additionally, side effects such as liver disorder, abnormal liver function, and liver damage 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.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acarbosa Viatris

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date is the last day of the month stated.

Do not store above 25°C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Dispose of the package and any unused medicine in the SIGRE collection point at your pharmacy. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acarbosa Viatris

The active substance is acarbosa. Each tablet contains 100 mg of acarbosa.

The other ingredients are microcrystalline cellulose (E460), corn starch, colloidal anhydrous silica (E551), and magnesium stearate (E572).

Appearance and packaging of Acarbosa Viatris

The tablets are white to off-white, oval, marked with "AA (score line) 100" on one side and "G" with a score line on the other.

Acarbosa Viatris is available in blister packs containing 20, 21, 30, 40, 50, 90, 100, 105, 120, and 180 tablets, and multi-packs containing 105 (3 packs of 35) tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate. Grange Road (Dublin) – 13 – Ireland

or

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the EEA under the following names:

Czech Republic Akarboza Mylan

Germany Acarbose dura 100 mg Tabletten

Hungary Acarbose Mylan 100 mg tabletta

Italy Acarphage

Poland AcarGen

Portugal Acarbosa Mylan

Spain Acarbosa Viatris 100 mg tablets

Date of last revision of this leaflet: February 2018

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/