Prospect: Information for the Patient

Acarbosa Viatris 50 mg Tablets

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people 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 prospect. See section 4.

1.What is Acarbosa Viatris and how is it used

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

3.How to take Acarbosa Viatris

4.Possible adverse effects

5.Storage of Acarbosa Viatris

6.Contents of the package and additional information

The active ingredient of this medication isacarbosa, which belongs to a group of medications 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 a diet regimen and exercise alone are not sufficient to control blood glucose levels. Acarbosa acts by reducing the rate of digestion of carbohydrates (complex sugars) after each meal, thereby reducing blood glucose levels.

Do not take Acarbosa Viatris:

• If you are allergic to acarbosa or any of the other components of this medication (listed in section 6).
• If you have chronic intestinal disorders associated with digestion and food absorption problems.

• If you have any disease that may worsen due to 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 intestinal obstruction or are predisposed 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 had a gastric resection.

• If you have had a gastrectomy, acarbosa may act more quickly. This should not cause any problems, but if you do not feel well after taking acarbosa, contact your doctor.

During treatment

If you notice fatigue, nervousness, and tremors, and have tachycardia, cold sweating, and an urgent need to eat while taking this medication, you may have low blood sugar (hypoglycemia). You should take glucose as soon as possible to avoid worsening the symptoms. If blood sugar levels continue to decrease, you may experience significant mental confusion (delirium), seizures, 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 experience persistent constipation, decreased appetite, abdominal swelling, and vomiting, you may have intestinal obstruction. You should contact your doctor or go to the nearest emergency service immediately.

You should regularly check your blood sugar levels and urine.

You may need your doctor to check your liver function frequently, especially in the first 6-12 months of treatment.

You should continue to follow any dietary guidelines recommended by your doctor and ensure that you eat carbohydrates regularly throughout the day.

Children and adolescents

Due to insufficient information available on the effects and tolerability in children and adolescents under 18 years old, the use of Acarbosa Viatris 50 mg is not recommended in patients under 18 years old.

Taking Acarbosa Viatris with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Other antidiabetic medications, e.g. insulin, metformin, or sulfonylureas; you may need to adjust your doses.

• Intestinal adsorbents, e.g. activated charcoal.
• Medications that help improve digestion (including antacids, amylase, and pancreatin).
• Anti-inflammatory medications (corticosteroids).
• Medications to treat high cholesterol (cholestyramine).
• Digoxin (medications to treat heart failure).
• Medications to treat high blood pressure or fluid retention (thiazides and diuretics).
• Thyroid hormones.
• Female hormones (estrogens), oral contraceptives.
• Medications to treat muscle cramps or schizophrenia (phenytoin, phenothiazines).
• Medications that lower elevated lipid levels in the blood (nicotinic acid).
• Medications to treat high blood pressure or heart disease (calcium antagonists).
• Medications used to accelerate heart rate (sympathomimetics).
• Medications to treat tuberculosis (isoniazids).
• Neomycin, an antibiotic.

Taking Acarbosa Viatris with food and drinks

Sucrose (sugar cane) and foods containing sucrose may cause abdominal discomfort or even diarrhea due to the fermentation of carbohydrates in the colon during acarbosa treatment.

Pregnancy and breastfeeding

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

Do not take acarbosa if you are pregnant or breastfeeding.

The presence of acarbosa in breast milk is unknown.

Driving and operating machinery

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

Taking acarbosa combined with other medications called sulfonylureas, insulin, or metformin for diabetes treatment may cause hypoglycemia and therefore affect your ability to drive and operate machinery or work safely.Do not drive or operate machinery if you are affected.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.Consult withyour 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 (which corresponds to 150 mg per day).

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

The tablets can be taken whole with a glass of waterimmediately beforemeals or chewed with the first bite of food.

The groove in the 50mg tablet is only for breaking the tablet if it is difficult to swallow whole.

If you take more Acarbosa Viatris than you should

You may experience side effects such as stomach bloating, strong flatulence, or diarrhea if you have taken acarbosa with beverages or foods containing carbohydrates.In this case, do not consume or drink foods or beverages containing carbohydrates in the next 4 and 6 hours. Immediately consult your doctor, pharmacist, or call the toxicology 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.

If you forget to take Acarbosa Viatris

Do not take a double dose to compensate for the missed doses. Take the next dose with your next meal.

If you interrupt treatment with Acarbosa Viatris

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you think you may be experiencing any of the following side effects, stop taking this medicine and consult your doctor or go to the nearest hospital immediately:

• Yellowing of the skin or the white part 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 available data).
• Persistent constipation, decreased appetite, stomach bloating, and vomiting (ileus) (frequency cannot be estimated from available data).
• Allergic reactions such as rashes, skin redness, skin eruptions, 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 consuming foods containing sugar (saccharose). Symptoms can be reduced by avoiding foods and drinks containing sugar (saccharose, cane sugar). If your diarrhea does not disappear, your doctor will reduce the dose or in some cases discontinue treatment.Do not take remedies to alleviate indigestion as treatment for the side effects described above, 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 available data)

In addition, cases of liver disorder, abnormal liver function, and liver damage have been reported, especially in Japan. Cases of a rapid and fatal liver disease have been reported in Japan, but it is unclear if they are related to acarbose administration.

Reporting of side effects

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

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack, following «CAD». The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect from humidity.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty packaging and unused medications. Dispose of empty packaging and unused medications at the SIGRE point of the pharmacy. This will help protect the environment.

Composition of Acarbosa Viatris

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

The other components are microcrystalline cellulose (E460), cornstarch, anhydrous colloidal silica (E551) and magnesium stearate (E572).

Appearance of the product and contents of the packaging of Acarbosa Viatris

The tablets are white to off-white, round, marked with “AA (score) 50” on one face and “G” 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.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the EEA Member States with the following names:

Republic of CzechiaAkarboza Mylan

GermanyAcarbose dura 50 mg Tabletten

HungaryAcarbose Mylan 50 mg tabletta

ItalyAcarphage

PolandAcarGen

PortugalAcarbosa Mylan

SpainAcarbosa Viatris 50 mg tablets

Last review date of this leaflet: February 2018

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/