ACARBOSA VIATRIS 50 mg TABLETS

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 disorders of digestion and absorption of food.

• 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

Talk to your doctor or pharmacist before taking acarbosa if you have had a gastric resection.

• 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.

During treatment

If you notice fatigue, nervousness, and tremors, and have a rapid heartbeat, 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 room 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 is still insufficient, it is not recommended to take Acarbosa Viatris 50 mg in patients under 18 years.

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; your dose may need to be adjusted.

• 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 stomach upset 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 if acarbosa is present in breast milk.

Driving and using machines

Taking acarbosa alone (monotherapy) does not cause low blood sugar levels (hypoglycemia) and therefore does not affect 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. Ask your doctor or pharmacist if you have any questions.

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 100 mg tablets three times a day (corresponding to 600 mg per day).

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

The score line on the 50 mg tablet is only to help you break the tablet if you have difficulty swallowing it whole.

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 eat or drink foods or drinks that contain carbohydrates for the next 4 to 6 hours. Contact your doctor, pharmacist, or call the toxicology information service, phone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to take the packaging and the 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 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 contact your doctor or go to the emergency room 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 eating 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 may reduce the dose or, in some cases, stop the 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):

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 if 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 side effects 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 the sight and reach of children.

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

Do not store above 25°C. Store in the original packaging 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 packaging and any unused medicine in the SIGRE collection point at your pharmacy. This will help protect the environment.

6. Contents of the pack and further information

Composition of Acarbosa Viatris

The active substance is acarbosa. Each tablet contains 50 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, round, marked with “AA (score line) 50” on one side 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.

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 by contacting 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 50 mg Tabletten

Hungary Acarbose Mylan 50 mg tablet

Italy Acarphage

Poland AcarGen

Portugal Acarbosa Mylan

Spain Acarbosa Viatris 50 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) http://www.aemps.gob.es/