Acarbose aurovitas

Package leaflet: Information for the user

Acarbose Aurovitas, 50 mg, tablets
Acarbose Aurovitas, 100 mg, tablets
Acarbosum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Acarbose Aurovitas is and what it is used for
2. Important information before taking Acarbose Aurovitas
3. How to take Acarbose Aurovitas
4. Possible side effects
5. How to store Acarbose Aurovitas
6. Contents of the pack and other information

1. What Acarbose Aurovitas is and what it is used for

The active substance in this medicine is acarbose, which belongs to a group of medicines called alpha-glucosidase inhibitors. It is used in the treatment of adults with non-insulin-dependent diabetes (type 2 diabetes). Your doctor may prescribe Acarbose Aurovitas when diet and exercise alone are not sufficient to control blood glucose levels. Acarbose Aurovitas works by slowing down the digestion of carbohydrates (complex sugars) after each meal, thereby reducing blood sugar levels.

2. Important information before using Acarbose Aurovitas

When not to use Acarbose Aurovitas

• if the patient is allergic to Acarbose Aurovitas or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has a chronic intestinal disease causing digestive or absorption problems,
• if the patient has a condition that may worsen due to accumulation of gas in the intestines, e.g. Roemheld syndrome, colonic diverticulosis, intestinal stricture or ulceration,
• if the patient has intestinal inflammation or ulceration,
• if the patient has intestinal obstruction or there is a likelihood that it may occur,
• if the patient has severe renal insufficiency,
• if the patient has severe liver problems.

Warnings and precautions
If the patient has undergone gastric resection prior to treatment with Acarbose Aurovitas, the patient should consult a doctor or pharmacist. Acarbose Aurovitas may act more rapidly. It is unlikely to cause problems, but if the patient feels unwell after taking Acarbose Aurovitas, medical advice should be sought.
During treatment
If, during treatment with this medicine, the patient experiences fatigue, nervousness, tremor, rapid heartbeat, cold sweats or hunger attacks, low blood glucose (hypoglycaemia) may have occurred. Glucose should be taken as soon as possible to prevent worsening of symptoms. If blood glucose continues to fall, the patient may experience significant confusion (delirium), convulsions, loss of self-control, shallow breathing, slow heartbeat, or even loss of consciousness. Because Acarbose Aurovitas delays the absorption of sucrose, sucrose or artificial sweeteners should not be used. Glucose tablets, syrup or sweets can be purchased at a pharmacy.
If the patient has persistent constipation, reduced appetite, bloating and vomiting, intestinal obstruction may be present. Immediate contact with a doctor or visit to the nearest emergency department is necessary.
The patient should regularly monitor blood and urine glucose levels.
Regular monitoring of liver function by a doctor may be necessary, especially during the first 6–12 months of treatment.
The patient should continue to follow all dietary recommendations provided by the doctor and ensure regular intake of carbohydrates throughout the day.
Children and adolescents
Use of Acarbose Aurovitas is not recommended in patients under 18 years of age, as available data on efficacy and safety in children and adolescents under 18 years of age are still insufficient.
Acarbose Aurovitas and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken by the patient.
Acarbose Aurovitas may alter the effects of other medicines, or conversely, some medicines may alter the effect of Acarbose Aurovitas:

• other antidiabetic medicines, e.g. insulin, metformin, sulfonylurea derivatives; dose adjustment may be necessary;
• intestinal adsorbents, e.g. activated charcoal;
• digestive enzyme supplements (including gastric acid neutralizers, amylase, pancreatin);
• medicinal products used to treat high cholesterol (cholestyramine);
• digoxin (medicinal products used to treat heart failure);
• medicinal products used to treat high blood pressure or fluid retention (thiazides or diuretics);
• anti-inflammatory medicinal products (corticosteroids);
• thyroid medications;
• female sex hormones (estrogens), oral contraceptives;
• medicinal products used to treat seizures or schizophrenia (phenytoin, phenothiazines);
• medicinal products that lower elevated blood lipid levels (nicotinic acid);
• medicinal products used to treat high blood pressure or heart disease (calcium channel blockers);
• medicinal products that increase heart rate (sympathomimetics);
• medicinal products used to treat tuberculosis (isoniazid);
• neomycin, an antibiotic.

Acarbose Aurovitas with food and drink
Sucrose (cane sugar) and foods containing sucrose may cause abdominal discomfort or even diarrhoea due to fermentation of carbohydrates in the colon during treatment with Acarbose Aurovitas.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Acarbose Aurovitas during pregnancy or while breastfeeding.
It is unknown whether Acarbose Aurovitas passes into human breast milk.
Driving and operating machinery
Taking Acarbose Aurovitas alone (monotherapy) does not cause low blood sugar (hypoglycaemia) and therefore does not affect the ability to drive or operate machinery.
However, taking Acarbose Aurovitas in combination with medicines called sulfonylureas, insulin or metformin for diabetes treatment may cause low blood sugar levels and thus affect the ability to drive or operate machinery or work safely. Do not drive or operate machinery if the patient does not feel well.

3. How to take Acarbose Aurovitas

This medicine should always be taken as prescribed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Unless otherwise directed by your doctor, the recommended dose is:
Adults:
Take one Acarbose Aurovitas 50 mg tablet three times daily (equivalent to 150
mg per day).
To reduce the likelihood of stomach upset, some patients may start with one
Acarbose Aurovitas 50 mg tablet once or twice daily (equivalent to 50 mg to 100 mg per
day). If necessary, your doctor may gradually increase the dose to two Acarbose Aurovitas 50
mg tablets or one Acarbose Aurovitas 100 mg tablet three times daily (equivalent to 300 mg per day).
The maximum recommended dose is two Acarbose Aurovitas 100 mg tablets three times daily (equivalent
to 600 mg per day).
Swallow the tablets whole with a glass of water, immediately before a meal or chew them with the
first bite of food.
Taking more Acarbose Aurovitas than recommended
If you take more Acarbose Aurovitas together with foods or drinks containing carbohydrates, you may
experience adverse effects such as stomach bloating, severe flatulence, or diarrhea. In such a case, do
not eat or drink any carbohydrate-containing foods or drinks for 4 to 6 hours. Seek immediate medical
attention from your doctor or the nearest hospital.
Bring the packaging and any remaining tablets with you.
Missing a dose of Acarbose Aurovitas
Do not take a double dose to make up for a missed dose. Take the next dose with your next meal.
Stopping Acarbose Aurovitas
If you suddenly stop taking Acarbose Aurovitas, your blood glucose levels may rise. Consult your doctor
before discontinuing this medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient suspects they may be experiencing any of the following adverse reactions, they should
stop taking this medicine immediately and contact a doctor or go immediately to the
nearest hospital:

• yellowing of the whites of the eyes or skin (jaundice) (rare, may occur in no more than 1 in 1,000
  people);
• hepatitis. The patient may experience nausea, vomiting, loss of appetite, fever, itching, jaundice (see above), pale stools or dark urine (frequency cannot be determined from available data);
• persistent constipation, reduced appetite, stomach swelling and nausea (vomiting) (intestinal obstruction) (frequency cannot be determined from available data);
• allergic reactions such as rash, redness of the skin, skin eruptions or itching of the skin.

Other adverse reactions
Very common (may affect more than 1 in 10 people)

• flatulence;
• abdominal rumbling;
• bloating.

Common (may affect up to 1 in 10 people)

• diarrhoea;
• abdominal or intestinal pain.

These adverse reactions may occur after a meal containing sugar (sucrose). Symptoms can be
relieved by avoiding foods and drinks containing sugar (sucrose, cane sugar). If diarrhoea persists,
the doctor may reduce the dose or, in some cases, discontinue treatment. Do not take antacids or
other medicines for indigestion to treat the above adverse reactions, as this may worsen symptoms.
Uncommon (may affect up to 1 in 100 people)

• nausea;
• vomiting;
• dyspepsia;
• increased liver enzyme activity, which can be observed in blood tests.

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

• skin swelling (angioedema).

Not known (frequency cannot be determined from available data)

• unexplained bruising or bleeding lasting longer than usual. These may be symptoms of low platelet count;
• constipation;
• gas-filled cysts in the intestinal wall (Pneumatosis cystoides intestinalis);
• pustular rash and (or) blisters filled with pus (acute generalized exanthematous pustulosis).

In addition, adverse reactions such as liver function disorders, abnormal liver function and liver
damage have been reported, particularly in Japan. In Japan, isolated cases of rapidly progressing
and fatal liver disease have been reported, although it is not clear whether they were caused by
the use of Acarbose Aurovitas.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Acarbose Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the bottle after "EXP". The expiry date refers to the last day of the specified month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Acarbose Aurovitas contains
The active substance is acarbose.
Each tablet contains 50 mg or 100 mg of acarbose.
The other ingredients are:

• Microcrystalline cellulose (type 102), corn starch, colloidal anhydrous silica, magnesium stearate.

What Acarbose Aurovitas looks like and contents of the pack
Tablet.
Acarbose Aurovitas 50 mg tablets
White or almost white, round, uncoated tablets, embossed with the code "AC" on one side and "50" on the other side.
Acarbose Aurovitas 100 mg tablets
White or almost white, uncoated, oblong tablets, embossed with the letters "A" and "C" separated by a score line on one side and the number "100" and a score line on the other side. The tablet can be divided into equal doses.
The medicinal product Acarbose Aurovitas is available in blister packs, packed in cardboard boxes.
Pack sizes:
50 mg: 30, 40, 90 and 270 tablets.
100 mg: 30, 40, 90, 120 and 270 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland
Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Arrow Génériques - Lyon
26 avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Akarbosa Aurovitas
France: Acarbose Arrow 50 mg comprimé
Acarbose Arrow 100 mg comprimé sécable
Portugal: Acarbose Generis Phar
Italy: Acarbosio Aurobindo
Poland: Acarbose Aurovitas