ACARBOSIO 50 mg Tablet

Зміст інструкції

1. Acarbosio TecniGen 50 mg tablets
   1. What is Acarbosio TecniGen and what is it used for
   2. What you need to know before taking Acarbosio TecniGen
   3. How to take Acarbosio TecniGen
   4. Possible side effects
   5. How to store Acarbosio Tecnigen
   6. Contents of the pack and other information
2. Acarbosio TecniGen 100 mg tablets
   1. What is Acarbosio TecniGen and what is it used for
   2. What you need to know before taking Acarbosio TecniGen
   3. How to take Acarbosio TecniGen
   4. Possible side effects
   5. How to store Acarbosio TecniGen
   6. Package contents and other information

Acarbosio TecniGen 50 mg tablets

acarbosio
Generic 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 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 Acarbosio TecniGen is and what it is used for.
• 2. What you need to know before you take Acarbosio TecniGen.
• 3. How to take Acarbosio TecniGen.
• 4. Possible side effects.
• 5. How to store Acarbosio TecniGen.
• 6. Contents of the pack and other information.

1. What is Acarbosio TecniGen and what is it used for

Acarbosio is used in the treatment of non-insulin-dependent diabetes mellitus in patients not
adequately controlled with diet alone, or with diet in association with oral hypoglycemic agents.
This medicine has been prescribed for you by your doctor to treat diabetes. Acarbosio will help to
control your blood sugar levels. This is because acarbosio works by slowing down the digestion of
carbohydrates (complex sugars) from your diet, reducing the abnormally high levels of
blood sugar that are found after each meal.

2. What you need to know before taking Acarbosio TecniGen

Do not take Acarbosio TecniGen

• If you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from inflammation or ulceration of the intestine, e.g. ulcerative colitis or Crohn's disease.
• If you have an intestinal obstruction, or are susceptible to it.
• If you have a liver disease.

If you have a kidney disorder, do not take acarbose without first consulting your doctor.
If you think you may be suffering from any of these conditions, ask your doctor for advice.
No adjustment of the normal dosage regimen is necessary for elderly patients.
Acarbosio is not recommended in patients under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acarbosio TecniGen

Treatment of hypoglycemic episodes (“hypos”).As a diabetic patient, you may be receiving other
treatments for diabetes.

• If you are taking insulin or medicines based on sulfonylurea to control blood sugar levels, you are likely used to avoiding hypoglycemic episodes by taking sugar when you feel your blood sugar is too low.
• when you are taking acarbose, do not treat a hypoglycemic episode with ordinary sugar (sucrose), but rather take glucose (also called dextrose) in tablets, syrup or sweets, available at your local pharmacy.
• If you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Other medicines and Acarbosio TecniGen
Acarbosio can alter the effect of other medicines or, alternatively, some medicines can alter the effect
of acarbose. If you are using any of the following medicines, consult your doctor or pharmacist
before taking this medicine:

• Medicines known as intestinal adsorbents, e.g. activated charcoal.
• Medicines that can help digestion (digestive enzyme preparations, e.g. amylase, pancreatin).
• The antibiotic neomycin.
• Cholestyramine, a medicine used to treat high cholesterol.
• Digoxin.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Acarbosio TecniGen with food, beverages and alcohol
Acarbose tablets can be swallowed with some liquid immediately before a meal.

Pregnancy, breastfeeding and fertility
Acarbosio is not recommended in case of pregnancy or breastfeeding.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Acarbosio does not affect your ability to drive or operate machinery.

3. How to take Acarbosio TecniGen

To get the most benefit from acarbose, you must adhere to the diet prescribed for you by your doctor. This will also
help to reduce the side effects you may experience.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is one or two tablets taken with meals three times a day. However, at the beginning
of treatment, your doctor may recommend that you take the tablets one or two times a day before
increasing the dose to three times a day. This medicine is intended for long-term use.
Acarbose tablets should be chewed with the first bite of food. If you prefer not to
chew the tablets, swallow them with a little liquid immediately before the meal.
The score line is to facilitate breaking the tablet if you have difficulty swallowing it whole and
not to divide it into equal parts.

If you take more Acarbosio TecniGen than you should
If you exceed the prescribed dose, or in case of overdose, you may experience diarrhea and other intestinal symptoms
such as flatulence (gas) and abdominal pain.
If you take more than the prescribed dose, or in case of overdose, avoid consuming food or beverages containing
carbohydrates and seek immediate medical advice. If possible, take the tablets or the
package with you to show the doctor.

If you forget to take Acarbosio TecniGen
If you forget to take one or more doses of Acarbosio TecniGen, do not take the tablets between meals but
rather wait until the next dose and scheduled meal and continue as before.
Do not take a double dose to make up for a forgotten tablet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed during treatment with acarbose.
Very common side effects (may affect more than 1 in 10 people):

• Air in the intestine (flatulence)

Common side effects (may affect up to 1 in 10 people):

• Diarrhoea
• Stomach or abdominal pain

Uncommon side effects (may affect up to 1 in 100 people):

• Feeling unwell (nausea)
• Vomiting
• Indigestion
• Increased liver enzymes (transaminases) in the blood.

Rare side effects (may affect up to 1 in 1,000)

• Swelling
• Yellowing of the skin and whites of the eyes (jaundice)

Other side effects
(frequency not known)

• Decreased number of cells needed for blood clotting
• Allergic reactions, such as rash, redness of the skin, skin eruptions, itching
• Decreased intestinal activity
• Inflammation of the liver (hepatitis)
• Gas pockets in the intestine (intestinal cystic pneumatosis)
• Acute generalized exanthematous pustulosis

In addition, side effects such as liver disorders, abnormal liver function and
liver damage have been reported. There have also been isolated reports of a rapidly progressive and fatal form of liver
damage, particularly from Japan.
The intensity of side effects affecting the gastrointestinal tract (e.g. flatulence, diarrhoea) tends to
be accentuated by failure to comply with the prescribed diet. If symptoms occur or
worsen despite correct adherence to the diet, inform your doctor.
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 Italian Medicines Agency - Website: http://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 Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging after
“Exp.”. The expiry date refers to the last day of that month.
Do not store above 30°C. Keep in the original packaging to protect the
medicine from light and moisture.
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 Acarbosio Tecnigen contains

• The active ingredient is acarbose. Each tablet contains 50 mg of acarbose.
• The excipients are: microcrystalline cellulose, pregelatinized starch, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Acarbosio Tecnigen and contents of the pack
White, flat and round tablets, with an incision on one side.
The incision line is intended to facilitate breaking the tablet if you have difficulty swallowing it
whole and not to divide it into equal parts.
Acarbosio Tecnigen 50 mg tablets is available in packs of 10, 20, 30, 50, 60, 90, 120 and
270 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturer responsible for batch release:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
United Kingdom: Acarbose 50mg Tablets
Ireland: Acarbose Tecnigen 50, mg Tablets
Italy: Acarbosio Tecnigen 50mg tablets
Poland: Symrose
Hungary: Acarbose Tecnigen 50mg Tabletta
Romania: Acarbose Tecnigen 50mg Comprimate
Greece: Acarbose Tecnigen 50mg Δισκία
May 2012

Acarbosio TecniGen 100 mg tablets

acarbose
Generic 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 their symptoms are the same as yours because 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:

• 6. What Acarbosio TecniGen is and what it is used for.
• 7. What you need to know before you take Acarbosio TecniGen.
• 8. How to take Acarbosio TecniGen.
• 9. Possible side effects.
• 10. How to store Acarbosio TecniGen.
• 11. Contents of the pack and other information.

7. What is Acarbosio TecniGen and what is it used for

Acarbosio is used in the treatment of non-insulin-dependent diabetes mellitus in patients not
adequately controlled with diet alone, or with diet in association with oral hypoglycemic agents.
This medicine has been prescribed for you by your doctor to treat diabetes. Acarbosio will help to
control your blood sugar levels. This is because acarbosio works by slowing down the digestion of
carbohydrates (complex sugars) from your diet, reducing the abnormally high levels of
blood sugar that are found after each meal.

8. What you need to know before taking Acarbosio TecniGen

Do not take Acarbosio TecniGen

• If you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from inflammation or ulceration of the intestine, e.g. ulcerative colitis or Crohn's disease.
• If you have an intestinal obstruction, or are susceptible to it.
• If you have a liver disease.

If you have a kidney disorder, do not take acarbose without first consulting your doctor.
If you think you may suffer from any of these conditions, ask your doctor for advice.
No dosage adjustment is necessary in elderly patients for the usual dosage regimen.
Acarbosio is not recommended in patients under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acarbosio TecniGen.

Treatment of hypoglycemic episodes (“hypos”).As a diabetic patient, you may be receiving other
treatments for diabetes.

• If you are taking insulin or sulfonylurea-based medicines to control your blood sugar levels, you are probably used to avoiding hypoglycemic episodes by taking sugar when you feel your blood sugar is too low.
• when taking acarbose, do not treat a hypoglycemic episode with ordinary sugar (sucrose), but rather take glucose (also called dextrose) in tablets, syrup or sweets, available from your local pharmacy.
• If you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Other medicines and Acarbosio TecniGen
Acarbosio can alter the effect of other medicines or, alternatively, some medicines can alter the effect
of acarbose. If you are using any of the following medicines, consult your doctor or pharmacist
before taking this medicine:

• Medicines known as intestinal adsorbents, e.g. activated charcoal.
• Medicines that can help digestion (digestive enzyme preparations, e.g. amylase, pancreatin).
• The antibiotic neomycin.
• Cholestyramine, a medicine used to treat high cholesterol.
• Digoxin.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Acarbosio TecniGen with food, drinks and alcohol
Acarbose tablets can be swallowed with some liquid immediately before a meal.

Pregnancy, breastfeeding and fertility
Acarbosio is not recommended in case of pregnancy or breastfeeding. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Acarbosio does not affect your ability to drive or operate machinery.

9. How to take Acarbosio TecniGen

To obtain the maximum benefit from acarbose, you must adhere to the diet prescribed for you by your doctor. This will also
help to reduce the side effects you may experience.
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose is one or two tablets taken with meals three times a day. However, at the beginning
of treatment your doctor may recommend that you take the tablets one or two times a day before
increasing the dose to three times a day. This medicine is intended for long-term use.
Acarbose tablets should be chewed with the first mouthful of food. If you prefer not to
chew the tablets, swallow them with a little liquid immediately before the meal.
The score line is to facilitate breaking the tablet if you have difficulty swallowing it whole and
not to divide it into equal parts.

If you take more Acarbosio TecniGen than you should
If you exceed the prescribed dose, or in case of overdose, you may experience diarrhea and other intestinal symptoms
such as flatulence (gas) and abdominal pain.
If you take more than the prescribed dose, or in case of overdose, avoid ingesting food or beverages containing
carbohydrates and seek immediate medical advice. If possible, take the tablets or the
package with you to show the doctor.

If you forget to take Acarbosio TecniGen
If you forget to take one or more doses of Acarbosio TecniGen, do not take the tablets between meals but
rather wait until the next dose and scheduled meal and continue as before.
Do not take a double dose to make up for a forgotten tablet.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed during treatment with acarbose.
Very common side effects (may affect more than 1 in 10 people):

• Air in the intestine (flatulence)

Common side effects (may affect up to 1 in 10 people):

• Diarrhoea
• Stomach or abdominal pain

Uncommon side effects (may affect up to 1 in 100 people):

• Feeling unwell (nausea)
• Vomiting
• Indigestion
• Increased liver enzymes (transaminases) in the blood.

Rare side effects (may affect up to 1 in 1,000)

• Swelling
• Yellowing of the skin and whites of the eyes (jaundice)

Other side effects
(frequency not known)

• Decreased number of blood cells needed for blood clotting
• Allergic reactions, such as rash, redness of the skin, skin eruptions, itching
• Decreased intestinal activity
• Inflammation of the liver (hepatitis)
• Gas-filled sacs in the intestine (intestinal cystic pneumatosis)
• Acute generalized exanthematous pustulosis

In addition, side effects such as liver disorders, abnormal liver function and
liver damage have been reported. There have also been isolated cases of a rapidly progressive and fatal form of liver
damage, particularly from Japan.
The intensity of side effects affecting the gastrointestinal tract (e.g. flatulence, diarrhoea) tends
to be accentuated by failure to adhere to the prescribed diet. If symptoms occur or worsen
despite correct adherence to the diet, inform your doctor.
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 Italian
Medicines Agency - Website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side
effects you can help provide more information on the safety of this medicine.

11. How to store Acarbosio TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store above 30°C. Keep in the original packaging to protect the medicine from
light and 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.

12. Package contents and other information

What Acarbosio TecniGen contains

• The active ingredient is acarbose. Each tablet contains 100 mg of acarbose.
• The excipients are: microcrystalline cellulose, pregelatinized starch, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Acarbosio TecniGen and package contents
White, flat and round tablets, with a notch on one side.
The notch is intended to facilitate breaking the tablet if you have difficulty swallowing it whole and
not to divide it into equal parts.
Acarbosio TecniGen 100 mg tablets is available in packs of 10, 20, 30, 40, 50, 60, 90, 120 and 270
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Distributor for sales
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)

Manufacturer responsible for batch release:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following names:
United Kingdom: Acarbose 100 mg Tablets
Italy: Acarbosio TecniGen 100 mg tablets
Poland: Symrose