GLUCOBAY 100 mg Coated Tablet

Зміст інструкції

1. Glucobay 50 mg tablets, 100 mg tablets
   1. What is Glucobay and what is it used for
   2. What you need to know before taking Glucobay
2. Glucobay and oral neomycin may determine a greater reduction in blood glucose
   1. How to take Glucobay
   2. Possible side effects
   3. How to store Glucobay
   4. Contents of the pack and other information

Glucobay 50 mg tablets, 100 mg tablets

Acarbose

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Glucobay is and what it is used for
• 2. What you need to know before you take Glucobay
• 3. How to take Glucobay
• 4. Possible side effects
• 5. How to store Glucobay
• 6. Contents of the pack and other information

1. What is Glucobay and what is it used for

Glucobay contains the active substance acarbose, which belongs to the group of medicines known
as oral hypoglycemic agents.
Glucobay is a medicine used in the treatment of:

• Non-insulin-dependent diabetes mellitus in patients undergoing treatment with diet alone or with diet in association with oral hypoglycemic agents.
• Insulin-dependent diabetes mellitus in patients undergoing insulin and dietary therapy.

2. What you need to know before taking Glucobay

Do not take Glucobay:

• if you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see ‘Pregnancy and breastfeeding’);
• if you suffer from chronic enteropathies (inflammation or ulceration of the intestine, partial intestinal obstruction or predisposition to intestinal obstruction) associated or not with digestive and absorption disorders (for example, gluten-related diseases);
• if you are under 18 years of age;
• if you suffer from diseases that may be aggravated by an increase in gas production at the intestinal level, such as Roemheld syndrome, large hernias, intestinal obstructions or ulcerations;
• if you have undergone a gastrectomy (surgical removal of part or all of the stomach);
• if you suffer from severe kidney problems (severe renal insufficiency [creatinine clearance < 25 ml/min]);
• if you suffer from severe liver problems (severe impairment of liver function, such as liver cirrhosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Glucobay.
It is strictly necessary to follow your diet, even when you are taking
Glucobay. If you do not follow your diet, the risk of side effects increases (see
section 4).
Do not stop treatment with Glucobay without consulting your doctor first, as
hyperglycemia (high blood glucose levels) may occur when treatment is stopped.
Glucobay has an antihyperglycemic effect, but on its own does not cause hypoglycemia (excessive
reduction of blood glucose) in subjects who are only on a diet.
If Glucobay is prescribed in addition to other hypoglycemic medicines (e.g.
sulfonylureas, metformin or insulin), a drop in blood glucose levels may require an
adjustment of the dose of these medicines. If you develop acute hypoglycemia, your doctor will
prescribe glucose for rapid correction of the hypoglycemic state.
Cases of fulminant hepatitis have been reported during therapy with Glucobay. Your doctor
will check the level of liver enzymes (proteins found in the liver) in the first
6-12 months of treatment and if he observes an increase in their level, he may reduce
the dose of Glucobay or stop treatment (see section 4).
Therapy with Glucobay should be reported in the document certifying the patient's diabetic status.

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

Other medicines and Glucobay
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.

It is important to tell your doctor if you are taking:

• other antidiabeticmedicines (sulfonylureas, metformin or insulin). This is because in patients treated simultaneously with Glucobay and these medicines, blood glucose levels may drop to hypoglycemic levels and, therefore, an adjustment of the dose of the latter may be necessary. Glucobay has an antihyperglycemic effect but does not cause hypoglycemia on its own. Isolated cases of hypoglycemic shock have been reported.
• digoxin(a medicine used to increase the strength and speed of the heartbeat). In isolated cases, Glucobay may affect the bioavailability of digoxin, in such a way as to require an adjustment of its dosage.
• cholestyramine(a medicine used to treat high cholesterol), intestinal adsorbents(substances used in the symptomatic treatment of diarrhea, which adsorb water at the intestinal level and consequently compact the stool) or digestive enzymes (medicines used to

help digestion). You should not take these medicines at the same time as Glucobay
because they may affect the action of Glucobay.

• neomycin(an antibiotic used to treat infections). Concomitant administration of

Glucobay and oral neomycin may determine a greater reduction in blood glucose

postprandially (the level of sugar in the blood after a meal) and an increased risk of
undesirable effects on the stomach. In this case, the doctor may decide to
temporarily reduce your dosage of Glucobay.

• no interaction was observed with dimethiconeand simethicone(medicines used for intestinal disorders such as flatulence, i.e. excessive air in the stomach).
• medicines of the fluoroquinoloneclass (antibiotics used to treat infections). The concomitant administration of these medicines with Glucobay may alter glucose levels and increase the risk of hypoglycemia (excessive reduction of glucose in the blood) or hyperglycemia (excessive increase of glucose in the blood).

Glucobay with food and drink
Consumption of sucrose (sugar) and foods containing sugar during treatment with
Glucobay often causes intestinal disorders or even diarrhea due to increased fermentation of
carbohydrates in the colon.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Glucobay is contraindicated during pregnancy and breastfeeding.

Pregnancy
Glucobay should not be used during pregnancy, as there are no data from clinical
studies regarding the use of acarbose in pregnant women.

Breastfeeding
No data are available in humans; however, as the possibility of effects of acarbose on
infants cannot be excluded, it is recommended not to prescribe
Glucobay during breastfeeding.

Driving and operating machinery
No data are available on impairment of the ability to drive vehicles and operate
machinery during treatment with Glucobay.

3. How to take Glucobay

Take this medicine always exactly as your doctor or pharmacist has told you. If you have doubts, ask your doctor or pharmacist.
The doctor will establish the appropriate dosage for your case, because the efficacy and tolerability of the
medicine vary for each individual patient.

Unless otherwise prescribed by your doctor, the recommended dose for an adult is:

• 1 tablet of 50 mg (or half a tablet of 100 mg) 3 times a day at the beginning of treatment;
• 2 tablets of 50 mg or 1 tablet of 100 mg 3 times a day for the maintenance phase, if necessary, increaseable to 2 tablets 3 times a day. If your condition does not improve after 4-8 weeks from the start of therapy, your doctor may increase your dosage.

Inform your doctor if any undesirable effects occur, despite strict adherence to the prescribed
diet. In this case, your doctor may reduce your dose of Glucobay.
On average, the effective dose for an adult is 100 mg of Glucobay 3 times a
day.
If you are taking 200 mg of Glucobay 3 times a day, your doctor will need to monitor your condition with
extreme attention.

Method of use
Swallow the Glucobay tablet with a small amount of liquid or chew and
swallow the tablet with the first mouthfuls of food. In both cases, take the tablet
at the beginning of the meal.

Recommended checks during treatment
The doctor will check the level of liver enzymes during the first 6-12 months of treatment.
In some cases, an increase in liver enzymes may occur without symptoms.
In documented cases, these effects have disappeared after stopping therapy with
Glucobay.

Use in the elderly
No dosage adjustments are necessary in relation to the patient's age.

Use in children and adolescents
Since sufficient information on the effects and tolerability of the medicine is not available
in children and adolescents, Glucobay should not be administered to patients under the age of
18 years.

Use in patients with impaired liver function (liver)
No dosage adjustments are necessary in patients with pre-existing mild or moderate impairment of
liver function (for patients with severe impairment of the
liver function, see paragraph “Do not take Glucobay”).

Use in patients with impaired renal function (kidneys)
Glucobay should not be used in patients with severe impairment of renal
function (creatinine clearance < 25 ml/min).

Duration of treatment
Glucobay can be taken without any time restriction.

If you take more Glucobay than you should
If Glucobay is taken in association with foods or beverages containing carbohydrates
(sugar, bread, rice, pasta, etc.), an overdose may cause bloating, flatulence (gas
in the intestine) and diarrhea.
However, if Glucobay is ingested in an overdose without food, no
excessive intestinal symptoms are expected.
In case of overdose, do not take foods or beverages containing carbohydrates for 4-6
hours after taking the medicine.
In case of accidental ingestion/intake of an excessive dose of Glucobay, immediately inform
your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Within each frequency grouping, side effects are listed in order of decreasing seriousness. The frequencies are defined as:

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

• intestinal gas (flatulence)

Common(may affect up to 1 in 10 people)

• diarrhoea and gastro-intestinal and abdominal pain.

Uncommon(may affect up to 1 in 100 people)

• nausea, vomiting and indigestion (dyspepsia);
• increased liver enzymes.

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

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

not known (frequency cannot be estimated from available data)

• abnormally decreased number of platelets in the blood (thrombocytopenia);
• hypersensitivity reactions (drug-induced hypersensitivity) such as skin rash, erythema (redness of the skin), exanthema (skin eruption) and urticaria;
• - partial or total blockage of the intestine, causing pain and vomiting (subileus/ileus) and cystic intestinal pneumatosis (consisting of the presence of gas-filled cysts within the intestinal wall);
• severe liver damage (hepatitis);
• red skin rash with small blisters filled with white/yellow fluid (acute generalized pustular exanthem);
• Cases of liver changes, abnormal liver function and liver damage have been reported;
• isolated cases of fulminant hepatitis with fatal outcome, particularly in Japan.

Failure to comply with the prescribed diabetic diet may accentuate the intensity of the side effects
on the gastrointestinal tract (flatulence, diarrhoea and gastro-intestinal and abdominal pain, nausea, vomiting and dyspepsia). If these occur despite
correct adherence to the diet, inform your doctor and most likely the doctor will
consider a temporary or permanent reduction of the dose of Glucobay that you
are taking.
In patients treated with the recommended dose of 150-300 mg/day of Glucobay, clinically relevant
alterations of liver function tests (3 times above the upper limit of normal) have been rarely
observed. During treatment with Glucobay,
temporary abnormal values may be found (see paragraph “Warnings and precautions”).

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 provide more information on the safety of this medicine.

5. How to store Glucobay

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging box
after EXP. The expiry date refers to the last day of that month. The expiry date
indicated refers to the product in intact packaging, correctly stored.
Store in the original packaging, at a temperature not exceeding 30°C. Protect
from humidity.
Do not dispose of any medicine in wastewater 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 Glucobay contains

• The active ingredient is acarbose. Each tablet contains acarbose 50 mg or 100 mg.
• The other ingredients are: corn starch, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Glucobay and contents of the pack
40 tablets of 50 mg
40 tablets of 100 mg

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bayer S.p.A. Viale Certosa 130 – Milan

Manufacturer responsible for batch release
Bayer HealthCare Manufacturing S.r.l. - via delle Groane 126, Garbagnate Milanese (MI)