ACARBOSE TECNIGEN

Package Leaflet: Information for the User

Acarbosio TecniGen 50 mg tablets

acarbose
Generic medicine
Please 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact 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 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.

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

Acarbose is used in the treatment of non-insulin-dependent diabetes mellitus in patients who are not
adequately controlled by diet alone, or by diet in combination with oral hypoglycaemic agents.
This medicine has been prescribed for you by your doctor to treat diabetes. Acarbose will help you
control your blood sugar levels. This is because acarbose works by slowing down the digestion of
carbohydrates (complex sugars) from your diet, thereby reducing abnormally high blood sugar levels that occur after meals.

2. What you need to know before taking Acarbosio TecniGen

Do not take Acarbosio TecniGen

• If you are allergic to acarbose or to any of the excipients of this medicine (listed in section 6).
• If you have intestinal inflammation or ulceration, e.g. ulcerative colitis or Crohn's disease.
• If you have intestinal obstruction, or are prone to it.
• If you have liver disease.

If you have kidney problems, do not take acarbose without first consulting your doctor.
If you think you may have any of these conditions, please consult your doctor.
No modification of the normal dosage regimen is required in elderly patients.
Acarbose is not recommended for patients under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acarbosio TecniGen
Treatment of hypoglycaemic episodes ("hypos"). As a diabetic patient, you may be receiving other treatments for diabetes.

• If you are taking insulin or sulfonylurea medicines to control your blood sugar levels, you are probably used to treating hypoglycaemic episodes by taking sugar when you feel your blood sugar level is too low.
• when taking acarbose, do not treat a hypoglycaemic episode with ordinary sugar (sucrose), but instead take glucose (also known as dextrose) in the form of 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
Acarbose may alter the effect of other medicines or, conversely, certain medicines may alter the effect of acarbose. If you are taking 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 aid digestion (digestive enzyme preparations, e.g. amylase, pancreatin).
• The antibiotic neomycin.
• Colestyramine, a medicine used to treat high cholesterol.
• Digoxin.

Inform 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 a little liquid immediately before a meal.
Pregnancy, breastfeeding and fertility
Acarbose is not recommended during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Acarbose does not affect your ability to drive or operate machinery.

3. How to take Acarbose TecniGen

To get the maximum benefit from acarbose, you must follow the diet prescribed by your doctor. This will also help reduce any side effects you may experience.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any 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 initially advise you to take the tablets once or twice daily 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 whole with a little liquid immediately before the meal.
The break line on the tablet is intended to facilitate breaking the tablet if you have difficulty swallowing it whole, and is not meant for dividing the tablet into equal parts.

If you take more Acarbose TecniGen than you should
If you exceed the prescribed dose or experience an overdose, you may experience diarrhoea 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 drinks containing carbohydrates and seek immediate medical advice. If possible, take the tablets or the packaging along with you to show the doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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):

• Gas 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 people):

• Swelling (bloating)
• Yellowish discoloration of the skin and whites of the eyes (jaundice)

Other side effects
(frequency not known):

• Decrease in the number of cells required for blood clotting (thrombocytopenia)
• Allergic reactions, such as rash, redness of the skin, skin eruptions, itching
• Decreased intestinal activity
• Inflammation of the liver (hepatitis)
• Gas-filled cysts in the intestine (intestinal pneumatosis)
• Generalized acute exanthematous pustulosis

In addition, adverse effects such as liver disorders, abnormalities in liver function and liver damage have been reported.
Isolated cases of a rapidly progressive and fatal form of liver damage have also been reported, particularly from Japan.
The severity of gastrointestinal side effects (e.g. flatulence, diarrhoea) tends to be increased by failure to follow the prescribed diet.
If symptoms occur or worsen despite correct adherence to the diet, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the blister and carton 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Acarbosio Tecnigen contains

• The active substance 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 pack contents
White, round, flat tablets, with a score mark on one side.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole, and is not intended for dividing the tablet into equal parts.
Acarbosio Tecnigen 50 mg tablets are available in packs containing 10, 20, 30, 50, 60, 90, 120 and 270 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the European Economic Area member states under the following names:
United Kingdom: Acarbose 50mg Tablets
Ireland: Acarbose Tecnigen 50 mg Tablets
Italy: Acarbosio Tecnigen 50mg compresse
Poland: Symrose
Hungary: Acarbose Tecnigen 50mg Tabletta
Romania: Acarbose Tecnigen 50mg Comprimate
Greece: Acarbose Tecnigen 50mg Δισκία
May 2012

Package Leaflet: Information for the User

Acarbosio TecniGen 100 mg tablets

acarbose
Generic medicinal product
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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking Acarbosio TecniGen.
8. How to take Acarbosio TecniGen.
9. Possible side effects.
10. How to store Acarbosio TecniGen.
11. Package contents and other information.

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

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

8. What you need to know before taking Acarbose TecniGen

Do not take Acarbose TecniGen

• If you are allergic to acarbose or to any of the excipients of this medicine (listed in section 6).
• If you have intestinal inflammation or ulceration, e.g. ulcerative colitis or Crohn's disease.
• If you have intestinal obstruction, or are prone to it.
• If you have liver disease.

Do not take acarbose if you have kidney problems without first consulting your doctor.
If you think you may have any of these conditions, consult your doctor.
No adjustment of the normal dosage regimen is required in elderly adults.
Acarbose is not recommended for patients under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acarbose TecniGen.
Treatment of hypoglycaemic episodes (“hypos”). As a diabetic patient, you may be receiving other treatments for diabetes.

• If you are taking insulin or sulfonylurea medicines to control your blood sugar levels, you are probably used to preventing hypoglycaemic episodes by taking sugar when you feel your blood sugar level is too low.
• when taking acarbose, do not treat a hypoglycaemic episode with ordinary sugar (sucrose); instead, take glucose (also known as dextrose) in the form of tablets, syrup, or sweets, available from your local pharmacy.
• If you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Other medicines and Acarbose TecniGen
Acarbose may alter the effect of other medicines or, conversely, certain medicines may alter the effect of acarbose. If you are taking 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 aid digestion (digestive enzyme preparations, e.g. amylase, pancreatin).
• The antibiotic neomycin.
• Cholestyramine, a medicine used to treat high cholesterol.
• Digoxin.

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

Acarbose TecniGen with food, drinks and alcohol
Acarbose tablets can be swallowed with a small amount of liquid immediately before a meal.

Pregnancy, breastfeeding and fertility
Acarbose is not recommended during pregnancy or while breastfeeding. If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Acarbose does not affect your ability to drive or operate machinery.

9. How to take Acarbose TecniGen

To get the maximum benefit from acarbose, you must follow the diet prescribed for you by your doctor. This will also help reduce any unwanted effects you may experience.
Take this medicine exactly as directed by your doctor or pharmacist.
If you have any 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 taking the tablets once or twice 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 whole with a little liquid immediately before the meal.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole, and is not intended for dividing the tablet into equal parts.

If you take more Acarbose TecniGen than you should
If you exceed the prescribed dose or take too much medicine, you may experience diarrhoea 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 drinks containing carbohydrates and seek immediate medical advice. If possible, take the tablets or the packaging with you to show the doctor.

If you forget to take Acarbose TecniGen
If you forget to take one or more doses of Acarbose TecniGen, do not take the tablets between meals; instead, wait until your next scheduled meal and dose, then 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):

• Gas 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 people):

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

Other side effects
(frequency not known):

• Decrease in the 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-filled cysts in the intestine (intestinal pneumatosis)
• Generalised acute exanthematous pustulosis

In addition, adverse effects such as liver disorders, abnormalities of liver function, and liver damage have been reported. Isolated cases of a rapidly progressive and fatal form of liver damage have also been reported, particularly from Japan.

The intensity of gastrointestinal side effects (e.g. flatulence, diarrhoea) tends to be increased if the prescribed diet is not followed. If symptoms appear or worsen despite correct adherence to the diet, inform your doctor.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 stated on the blister and carton 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 via 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 substance is acarbose. Each tablet contains 100 mg of acarbose.
• The excipients are: microcrystalline cellulose, pregelatinized starch, anhydrous colloidal silicon dioxide, and magnesium stearate.

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

Marketing Authorization Holder and manufacturer
Marketing Authorization Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal
Sales concessionaire:
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy
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 authorized in the European Economic Area member states under the following names:
United Kingdom: Acarbose 100 mg Tablets
Italy: Acarbosio TecniGen 100 mg compresse
Poland: Symrose