ACARBOSIO 50 mg Coated Tablet

Зміст інструкції

1. ACARBOSIO DOC Generici
   1. What is ACARBOSIO DOC Generici and what it is used for
   2. What you need to know before taking ACARBOSIO DOC Generici
   3. How to take ACARBOSIO DOC Generici
2. ACARBOSIO DOC Generici must be swallowed whole immediately before meals or
   1. Possible side effects
   2. How to store ACARBOSIO DOC Generici
   3. Contents of the pack and other information

ACARBOSIO DOC Generici

50 mg tablets
100 mg tablets
Generic equivalent medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is ACARBOSIO DOC Generici and what it is used for

This medicine 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 together with sulfonylurea and/or metformin.
If you have type II diabetes, the levels of sugar (glucose) in your blood are too high. The
medicine works by slowing down the digestion and absorption of sugars taken with food.
This prevents blood sugar levels from rising too much.
During treatment you must also make sure to follow the diet recommended by your doctor.

2. What you need to know before taking ACARBOSIO DOC Generici

Do not take ACARBOSIO DOC Generici:

• if you are allergic to acarbose (the active ingredient of your medicine) or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding
• if you have inflammatory bowel disease
• if you suffer from colon ulcers - for example Crohn's disease or ulcerative colitis. Ask your doctor if you are not sure
• if you have or have previously had intestinal obstructions
• if you have digestive problems of any kind caused by problems with the intestines. Ask your doctor if you are not sure
• if you suffer from diseases that may be aggravated by an increase in gas production at the intestinal level. For example if you have a large hernia. Ask your doctor if you are not sure.
• if you have severe liver impairment (e.g. cirrhosis of the liver).
• if you have severe kidney failure (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 acarbose together with other medicines
for diabetes, such as sulfonylureas or insulin. Tell your doctor if you are already taking medicines
to treat diabetes. Levels of sugar that are too low can cause some of the following symptoms:

• double vision
• confusion
• difficulty speaking
• feeling faint
• tremor
• palpitations (abnormal heart beat perception)

Low blood sugar levels are a potentially serious condition. If you experience one
of the symptoms listed above, take some glucose to restore blood sugar levels
to normal. You can buy glucose in tablets, syrup or sweets at the pharmacy. It is a good
idea to always carry some glucose with you to use if needed. Other sugars such as
sucrose (table sugar) would not work, because ACARBOSIO DOC Generici would
prevent its absorption.
If you have experienced the symptoms listed above, you should make an appointment with your doctor to re-evaluate
your therapy.
Cases of fulminant hepatitis have been reported during therapy with acarbose. If an
increase in liver enzymes occurs, a dose reduction or discontinuation of therapy may be indicated,
especially if the increase persists.
Your doctor may decide to have blood tests to check your liver during
treatment with ACARBOSIO DOC Generici, especially during the first 6-12 months of treatment.
Acarbose has an anti-hyperglycemic effect, but does not cause hypoglycemia itself. In patients
treated simultaneously with acarbose and sulfonylurea, metformin or insulin, blood glucose
levels may drop to hypoglycemic levels and therefore an 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 has not been established.

Other medicines and ACARBOSIO DOC Generici
Tell 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 overdose of medicines)
• digestive enzyme preparations (e.g. pancreatin and amylase)
• neomycin (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 problems)
• thiazides or calcium channel blockers (used to treat high blood pressure)
• corticosteroids (used to treat inflammation)
• phenytoin (used to treat seizures)
• phenothiazine (used to treat mental health problems)
• thyroid medicines
• female sex hormones (estrogens), oral contraceptives
• nicotinic acid (used to lower cholesterol in the blood)
• medicines called “sympathomimetics” such as epinephrine and norepinephrine: these can be used in the treatment of cardiac arrest, severe drop in blood pressure or premature labor
• isoniazid (used to treat tuberculosis)

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

ACARBOSIO DOC Generici with food, beverages and alcohol
The tablets should 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 can cause abdominal discomfort or even diarrhea due to the fermentation of carbohydrates in the colon during treatment
with acarbose.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are 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 because
the effects on the baby are unknown. If you are planning a pregnancy, are already pregnant or are
breastfeeding, ask your doctor for advice before taking ACARBOSIO DOC
Generici.

Driving and operating machinery
There is 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 such as a sulfonylurea or
metformin at the same time. This may affect your ability to drive or operate machinery safely.

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

3. How to take ACARBOSIO DOC Generici

Take ACARBOSIO DOC Generici following the instructions of your doctor or pharmacist exactly as indicated. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adult and elderly patients
The usual dose is 50 mg three times a day before meals. However, your doctor may start you on a lower dose (e.g. 50 mg once or twice a day) and gradually increase the dose to reduce
the risk of undesirable effects.
If you need a higher dose, your doctor may decide to increase your dose up to 100 mg
three times a day. Occasionally, it may be necessary to increase the dose to 200 mg three times a day.

ACARBOSIO DOC Generici must be swallowed whole immediately before meals or

chewed with the first mouthful of food.

Use in children and adolescents under 18 years of age
The use of ACARBOSIO DOC Generici is not recommended. The dividing line on the 100 mg tablet
is only to help break 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 all at once or if you think a child has
taken some tablets, contact the nearest emergency room or your doctor immediately.
Also, you should not consume foods or beverages containing carbohydrates. An overdose may
likely cause a bloated abdomen (due to the presence of excessive amounts of gas), flatulence (air
in the intestine) and diarrhea.
Bring this leaflet, all remaining tablets and the container with you to the hospital or doctor,
so they can understand how many tablets have been consumed.

If you forget to take ACARBOSIO DOC Generici
If you have forgotten to take a dose, do not take the forgotten dose between meals.
Wait until the next meal and the next scheduled dose and continue as usual. Do not
take a double dose to make up for the missed tablet.
If you have any questions about the use of this medicine, ask 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 can be serious. The frequency of the following side effects is not
known.
However, if any of these reactions occur, you should urgently contact your doctor.

• Bleeding or easy bruising (caused by a decrease in platelets in the blood)
• Allergic reaction (rash, redness of the skin, skin eruption, urticaria)
• Partial or complete blockage of the intestine, leading to pain and vomiting
• Inflammation of the liver (can 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 discomfort or abdominal pain

Uncommon (may affect up to 1 in 100 people)

• nausea
• vomiting
• indigestion
• increased liver enzymes, which can cause a change in blood test results indicating how the liver is working

Rare (may affect up to 1 in 1000 people)

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

Other possible side effects (frequency cannot be defined based on available data)

• formation of gas bubbles in the intestine
• thrombocytopenia
• hypersensitivity reactions to the medicine and hypersensitivity (skin rash, erythema, exanthem, urticaria)
• subileus/pneumatotic cystic intestinal ileus
• hepatitis
• acute generalized 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 effects, talk to your doctor, pharmacist or nurse. This
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help to
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 below 30°C.
Do not use this medicine after the expiry date which is stated on the outer packaging after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACARBOSIO DOC Generici contains.

• The active ingredient is acarbose. Each ACARBOSIO DOC Generici 100 mg tablet contains 100 mg of the active ingredient acarbose. Each ACARBOSIO DOC Generici 50 mg tablet contains 50 mg of the active ingredient acarbose.
• The other ingredients are: colloidal silica, magnesium stearate, corn 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 fracture line on one side.
The fracture 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 Milano
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 denominations:
Portugal: Acarbose DOC Generici
Italy: ACARBOSIO DOC Generici