Acarbose Doc Generici

Package leaflet: Information for the user

ACARBOSIO DOC Generici

50 mg tablets
100 mg tablets
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If any adverse reaction occurs, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ACARBOSIO DOC Generici is and what it is used for
2. What you need to know before taking ACARBOSIO DOC Generici
3. How to take ACARBOSIO DOC Generici
4. Possible side effects
5. How to store ACARBOSIO DOC Generici
6. Contents of the pack and other information

1. What ACARBOSIO DOC Generici is and what it is used for

This medicinal product belongs to a class of medicines called "alpha-glucosidase inhibitors"
and is used to treat type II diabetes (diabetes that does not require treatment with insulin injections).
It can be used alone or in combination with sulfonylureas and/or metformin.
If you have type II diabetes, the levels of sugar (glucose) in your blood are too high.
This medicine works by slowing down the digestion and absorption of sugars consumed in food.
This prevents blood sugar levels from rising too much.
During treatment, you must also ensure that you follow the diet recommended by your doctor.

2. What you should know before taking ACARBOSIO DOC Generici

Do not take ACARBOSIO DOC Generici:

• if you are allergic to acarbose (the active substance in this medicine) or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if you have an inflammatory bowel disease;
• if you have colonic ulcers – for example Crohn’s disease or ulcerative colitis. Ask your doctor if you are unsure;
• if you have or have previously had intestinal obstructions;
• if you have any type of digestive problems caused by ongoing intestinal disorders. Ask your doctor if you are unsure;
• if you suffer from conditions that could be worsened by increased intestinal gas production. For example, if you have a large hernia. Ask your doctor if you are unsure;
• if you have severe liver impairment (e.g. hepatic cirrhosis);
• if you have severe renal insufficiency (creatinine clearance < 25 ml/min).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking ACARBOSIO DOC Generici.
You may experience low blood sugar levels if you take other antidiabetic medicines together with acarbose, such as sulfonylureas or insulin. Inform your doctor if you are already taking medicines for diabetes. Low blood sugar levels can cause one or more of the following symptoms:

• double vision
• confusion
• difficulty speaking
• fainting sensation
• tremor
• palpitations (abnormal awareness of heartbeat)

Low blood sugar is a potentially serious condition. If you experience any of the symptoms listed above, take some glucose to restore your blood sugar levels to normal. Glucose is available in tablet, syrup, or candy form at pharmacies. It is advisable to always carry some glucose with you in case it is needed. Other sugars such as sucrose (table sugar) will not work, because ACARBOSIO DOC Generici would prevent its absorption.
If you experience any of the symptoms listed above, you must make an appointment with your doctor to reassess your treatment.
Cases of fulminant hepatitis have been reported during treatment with acarbose. If liver enzymes increase, dose reduction or discontinuation of treatment may be indicated, especially if the elevation persists.
Your doctor may decide to perform blood tests to monitor your liver function during treatment with ACARBOSIO DOC Generici, especially during the first 6–12 months of treatment.
Acarbose has an anti-hyperglycemic effect but does not in itself cause hypoglycemia. However, in patients treated simultaneously with acarbose and sulfonylureas, metformin, or insulin, blood glucose levels may drop to hypoglycemic levels, and therefore adjustment of the dose of these medicines may be necessary.

Children and adolescents
The safety and efficacy of acarbose in patients under 18 years of age have not been established.

Other medicines and ACARBOSIO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• charcoal (used in the treatment of poisoning or drug overdose);
• digestive enzyme preparations (e.g. pancreatin and amylase);
• neomycin (an antibiotic used before intestinal surgery);
• cholestyramine (used to treat itching caused by liver problems, high cholesterol, or diarrhea);
• digoxin (used for heart failure and heart rhythm disorders);
• thiazides or calcium channel blockers (used to treat high blood pressure);
• corticosteroids (used to treat inflammation);
• phenytoin (used to treat epileptic seizures);
• phenothiazines (used to treat mental disorders);
• thyroid medicines;
• female sex hormones (estrogens), oral contraceptives;
• nicotinic acid (used to lower blood cholesterol);
• medicines called "sympathomimetics" such as epinephrine and norepinephrine: these may be used in the treatment of cardiac arrest, severe drop in blood pressure, or premature labor.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

ACARBOSIO DOC Generici with food, drinks, and alcohol
The tablets must be swallowed immediately before a meal or chewed with the first bite of food. The tablet should not be taken between meals.
Consumption of sucrose (cane sugar) and foods containing sugar may cause abdominal discomfort or even diarrhea due to fermentation of carbohydrates in the colon during treatment with acarbose.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not take ACARBOSIO DOC Generici if you are pregnant or breastfeeding, as the effects on the baby are unknown. If you are planning a pregnancy, are already pregnant, or are breastfeeding, consult your doctor before taking ACARBOSIO DOC Generici.

Driving and using machines
There are no data available on the impairment of the ability to drive vehicles or operate machinery during treatment with acarbose. However, low blood sugar levels may occur if you take other antidiabetic medicines at the same time, such as sulfonylureas or metformin. This may affect your ability to drive or operate machinery safely.

Important information about some of the components of ACARBOSIO DOC Generici
ACARBOSIO DOC Generici tablets contain the following ingredients: microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, maize starch.
Inform your doctor if you know you are allergic to or intolerant of any of these ingredients.

3. How to take ACARBOSIO DOC Generici

Take ACARBOSIO DOC Generici exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Adult and elderly patients
The usual dose is 50 mg three times daily, taken before meals. However, your doctor may start you on a lower dose (e.g. 50 mg once or twice daily) and gradually increase it to reduce the risk of unwanted side effects.
If you require a higher dose, your doctor may decide to increase your dose up to 100 mg three times daily. Occasionally, it may be necessary to increase the dose to 200 mg three times daily.
ACARBOSIO DOC Generici must be swallowed whole immediately before meals or chewed together with the first bite of food.
Use in children and adolescents under 18 years of age
The use of ACARBOSIO DOC Generici is not recommended. The score line on the 100 mg tablet is only intended to assist in breaking the tablet if you have difficulty swallowing it whole.
If you take more ACARBOSIO DOC Generici than you should
If you (or someone else) take many tablets at once, or if you think a child has taken any tablets, contact your nearest emergency department or doctor immediately.
Additionally, do not consume foods or drinks containing carbohydrates. Overdose may likely cause bloated abdomen (due to excessive gas), flatulence (intestinal gas), and diarrhoea.
Take this leaflet, any remaining tablets, and the container with you to the hospital or doctor, so they can determine how many tablets have been consumed.
If you forget to take ACARBOSIO DOC Generici
If you forget to take a dose, do not take the missed dose between meals. Wait until the next meal and the next scheduled dose, then continue as usual. Do not take a double dose to make up for a forgotten tablet.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects are serious. The frequency of the following side effects is unknown.
However, if any of these reactions occur, you must contact your doctor immediately.

• Bleeding or easy bruising (caused by a reduction in platelets in the blood)
• Allergic reaction (rash, skin redness, skin eruption, hives)
• Partial or complete blockage of the intestine, leading to pain and vomiting
• Inflammation of the liver (may cause abdominal discomfort, jaundice, loss of appetite)

The following side effects have been reported:
Very common (may affect more than 1 in 10 people)

• flatulence (gas)

Common (may affect up to 1 in 10 people)

• diarrhoea
• stomach ache or abdominal pain

Uncommon (may affect up to 1 in 100 people)

• nausea
• vomiting
• indigestion
• increased liver enzymes, which may cause changes in blood test results indicating how the liver is functioning

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

• fluid accumulation in tissues causing swelling of arms and legs
• jaundice (yellowing of the skin and whites of the eyes)

Other possible side effects (frequency cannot be determined from available data)

• formation of gas bubbles in the intestine
• thrombocytopenia
• hypersensitivity reactions to the medicine and hypersensitivity (skin rash, erythema, exanthema, urticaria)
• subileus/ileus pneumatosus cystoides intestinalis
• hepatitis
• generalised acute exanthematous pustulosis

During treatment, it is important to carefully follow the diet recommended by your doctor.
If you do not follow this diet, some of the side effects described above, such as flatulence (gas), diarrhoea, and abdominal pain, may worsen.
If you experience any side effect, talk to your doctor, pharmacist or nurse. This includes any possible side effect not listed in this leaflet.
Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACARBOSIO DOC Generici

Keep this medicine out of the sight and reach of children.
Store this medicine at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the outer packaging after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACARBOSIO DOC Generici contains

• The active substance is acarbose. Each tablet of ACARBOSIO DOC Generici 100 mg contains 100 mg of the active substance acarbose. Each tablet of ACARBOSIO DOC Generici 50 mg contains 50 mg of the active substance acarbose.
• The other components are: colloidal silicon dioxide, magnesium stearate, maize starch, microcrystalline cellulose.

Description of the appearance of ACARBOSIO DOC Generici and contents of the pack
The 50 mg tablets are white to yellowish, round, biconvex.
The 100 mg tablets are white to yellowish, round, biconvex, with a break line on one side. The break line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l.
Via F. Turati, 40
20121 Milan
Italy

Manufacturer
Bluepharma Indústria Farmacêutica S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal: Acarbose DOC Generici
Italy: ACARBOSIO DOC Generici