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ACARBOSE 50MG TABLETS

Active substance(s): ACARBOSE

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Ref: 1648/080716/1/F

®

Glucobay 50mg Tablets
(Acarbose)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Glucobay 50mg Tablets but will be referred to as
Glucobay throughout the leaflet.
What is in 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 Glucobay is and what it is used for

The active ingredient in this medicine is acarbose. This belongs to a group
of medicines called glucosidase inhibitors.
Glucobay is used to treat non-insulin dependent diabetes.
It helps to control your blood sugar levels. It works by slowing down the
digestion of carbohydrates (complex sugars) which reduces the abnormally
high blood sugar levels in your body after each meal.
Glucobay can be used to treat diabetes when a restricted diet alone or a
restricted diet plus other sugar-lowering drugs do not work well enough.

2

What you need to know before you take 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 breast-feeding.
* If you have inflammation or ulceration of the bowel, for example
ulcerative colitis or Crohn’s disease.
* If you have an obstruction in your intestines, or are likely to get this.
* If you have a severe liver disorder.
* If you have an intestine disease where you do not digest or absorb food
properly.
* If you have a large hernia, or any other condition where increased gas in
your intestine may make it worse.
Do not take Glucobay if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before taking Glucobay
* If you have a kidney disorder tell your doctor before you take Glucobay.
* Glucobay may affect the enzyme levels in your blood. Your doctor may
want to do regular tests to check this.

Other medicines and Glucobay
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Some medicines affect the way Glucobay works in the body. Other
medicines are affected by Glucobay.
Tell your doctor if you are taking:
* Medicines called intestinal absorbants, such as charcoal.
* Medicines containing digestive enzymes that help digestion, such as
amylase and lipase.
* Neomycin, an antibiotic.
* Colestyramine, to treat high cholesterol.
* Digoxin, to treat heart problems.
* Other blood glucose lowering drugs (e.g sulphonylureas, metformin, or
insulin).
Pregnancy and breast-feeding
Do not take Glucobay if you are pregnant or breast-feeding. If you are
pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Driving and using machines:
Glucobay is unlikely to affect your ability to drive or use machines.

3

How to take Glucobay

Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.
* Adults including old people: the usual dose is 1 or 2 tablets, three times
a day
* Children and adolescents: Glucobay is not recommended.
* The treatment is for long-term use. Take the tablets for as long as your
doctor has told you to.
To start treatment your doctor may recommend taking the tablets only once
or twice a day. He or she will then increase your dose to three times a day.
The maximum dose is 200 mg three times a day.
Food and drink with Glucobay
Take Glucobay with your meal. Chew the tablets with your first mouthful of
food. If you prefer not to chew, swallow the tablets whole with a little liquid
immediately before your meal.
Keep to the diet prescribed by your doctor. If distressing complaints develop
in spite of strict adherence to your diet (see section 4), contact your doctor
as your dose of Glucobay may need to be reduced.
Household sugar (cane sugar) and foods containing it can lead to severe
abdominal discomfort and diarrhoea during treatment with Glucobay (see
section 4).
Hypos and Glucobay
You may be used to taking ordinary sugar to treat a hypo. Do not take
ordinary sugar (sucrose) if you take Glucobay. Take glucose (or dextrose)
to treat a hypo. Glucose tablets, syrup or sweets are available from your
pharmacist (chemist).
If you take more Glucobay than you should
Get medical help immediately. Do not take food or drinks
containing carbohydrates. If possible take your tablets or the box
with you to show the doctor

Ref: 1648/080716/1/B

®

Glucobay 50mg Tablets
(Acarbose)
Patient Information Leaflet (continued)
If you forget to take Glucobay
If you forget a dose, wait until the next mealtime and take your next dose.
Do not take the missed dose. Do not take the tablets between meals.
If you have any further questions on the use of this medicine, ask your
doctor.

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 Glucobay.
Effects occuring in first 2 or 3 days
* increased wind (flatulence)
* rumbling in your stomach
* a feeling of fullness or abdominal cramps.
Contact your doctor if these effects continue for more than 2 or 3 days, if
they are severe, or particularly if you have diarrhoea.
Do not take indigestion preparations (antacids) as they are unlikely to
help
Very common side effects
(These may affect more than 1 in 10 people)
* wind (flatulence)
Common side effects
(These may affect up to 1 in 10 people)
* diarrhoea
* stomach or abdominal pain
Uncommon side effects
(These may affect up to 1 in 100 people)
* feeling sick (nausea)
* being sick (vomiting)
* indigestion
* increase in liver enzymes (transaminases) in the blood
Rare side effects
(These may affect up to 1 in 1,000 people)
* swelling
* yellowing of the whites of the eyes or skin (jaundice)
Other side effects
(Frequency not known: frequency cannot be estimated from the available
data)
* a decrease in the number of blood cells necessary for clotting
* allergic reaction, such as rash, redness of the skin, skin eruptions, itching
* a decrease in bowel activity
* inflammation of the liver (hepatitis)
* gas pockets in the bowel (pneumatosis cystoides intestinalis)
* rash with pus filled pimples/blisters (acute generalised exanthematous
pustulosis)
In addition, side effects like liver disorder, abnormal liver function and liver
injury have been reported. Individual cases of a rapidly progressive and fatal
form of liver injury have also been reported, particularly from Japan.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5

How to store Glucobay

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in a dry place.
Do not take Glucobay after the expiry date which is stated on the
blister label and carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the tablet becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.

6

Contents of the pack and other information

What Glucobay contains:
Each tablet contains 50mg of acarbose.
Other ingredients are microcrystalline cellulose, silica colloidal anhydrous,
magnesium stearate, maize starch
What Glucobay look like and contents of the pack
A white to yellow-tinged round, convex tablets marked with ‘G50’ on one side
and the BAYER-cross on the other side.
Each pack contains 90 Tablets.
Manufacturer and Licence Holder
Manufactured by Bayer Pharma AG D - 51368, Leverkusen, Germany and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1648

Glucobay 50mg Tablets

Glucobay is a registered trademark of Bayer Intellectual Property GmbH
Revision date: 08/07/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1648/08076/2/F

Acarbose 50mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Acarbose 50mg Tablets but will be referred to as
Acarbose throughout the leaflet.
What is in this leaflet:
1

What Acarbose is and what it is used for

2

What you need to know before you take Acarbose

3

How to take Acarbose

4

Possible side effects

5

How to store Acarbose

6

Contents of the pack and other information

1

What Acarbose is and what it is used for

The active ingredient in this medicine is acarbose. This belongs to a group
of medicines called glucosidase inhibitors.
Acarbose is used to treat non-insulin dependent diabetes.
It helps to control your blood sugar levels. It works by slowing down the
digestion of carbohydrates (complex sugars) which reduces the abnormally
high blood sugar levels in your body after each meal.
Acarbose can be used to treat diabetes when a restricted diet alone or a
restricted diet plus other sugar-lowering drugs do not work well enough.

2

What you need to know before you take Acarbose

Do not take Acarbose:
* If you are allergic to acarbose or any of the other ingredients of this
medicine (listed in section 6).
* If you are pregnant or breast-feeding.
* If you have inflammation or ulceration of the bowel, for example
ulcerative colitis or Crohn’s disease.
* If you have an obstruction in your intestines, or are likely to get this.
* If you have a severe liver disorder.
* If you have an intestine disease where you do not digest or absorb food
properly.
* If you have a large hernia, or any other condition where increased gas in
your intestine may make it worse.
Do not take Acarbose if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before taking Acarbose
* If you have a kidney disorder tell your doctor before you take Acarbose.
* Acarbose may affect the enzyme levels in your blood. Your doctor may
want to do regular tests to check this.

Other medicines and Acarbose
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Some medicines affect the way Acarbose works in the body. Other
medicines are affected by Acarbose.
Tell your doctor if you are taking:
* Medicines called intestinal absorbants, such as charcoal.
* Medicines containing digestive enzymes that help digestion, such as
amylase and lipase.
* Neomycin, an antibiotic.
* Colestyramine, to treat high cholesterol.
* Digoxin, to treat heart problems.
* Other blood glucose lowering drugs (e.g sulphonylureas, metformin, or
insulin).
Pregnancy and breast-feeding
Do not take Acarbose if you are pregnant or breast-feeding. If you are
pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Driving and using machines:
Acarbose is unlikely to affect your ability to drive or use machines.

3

How to take Acarbose

Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.
* Adults including old people: the usual dose is 1 or 2 tablets, three times
a day
* Children and adolescents: Acarbose is not recommended.
* The treatment is for long-term use. Take the tablets for as long as your
doctor has told you to.
To start treatment your doctor may recommend taking the tablets only once
or twice a day. He or she will then increase your dose to three times a day.
The maximum dose is 200 mg three times a day.
Food and drink with Acarbose
Take Acarbose with your meal. Chew the tablets with your first mouthful of
food. If you prefer not to chew, swallow the tablets whole with a little liquid
immediately before your meal.
Keep to the diet prescribed by your doctor. If distressing complaints develop
in spite of strict adherence to your diet (see section 4), contact your doctor
as your dose of Acarbose may need to be reduced.
Household sugar (cane sugar) and foods containing it can lead to severe
abdominal discomfort and diarrhoea during treatment with Acarbose (see
section 4).
Hypos and Acarbose
You may be used to taking ordinary sugar to treat a hypo. Do not take
ordinary sugar (sucrose) if you take Acarbose. Take glucose (or dextrose)
to treat a hypo. Glucose tablets, syrup or sweets are available from your
pharmacist (chemist).
If you take more Acarbose than you should
Get medical help immediately. Do not take food or drinks
containing carbohydrates. If possible take your tablets or the box
with you to show the doctor

Ref: 1648/08/0716/2/B

Acarbose 50mg Tablets
Patient Information Leaflet (continued)
If you forget to take Acarbose
If you forget a dose, wait until the next mealtime and take your next dose.
Do not take the missed dose. Do not take the tablets between meals.
If you have any further questions on the use of this medicine, ask your
doctor.

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.
Effects occuring in first 2 or 3 days
* increased wind (flatulence)
* rumbling in your stomach
* a feeling of fullness or abdominal cramps.
Contact your doctor if these effects continue for more than 2 or 3 days, if
they are severe, or particularly if you have diarrhoea.
Do not take indigestion preparations (antacids) as they are unlikely to
help
Very common side effects
(These may affect more than 1 in 10 people)
* wind (flatulence)
Common side effects
(These may affect up to 1 in 10 people)
* diarrhoea
* stomach or abdominal pain
Uncommon side effects
(These may affect up to 1 in 100 people)
* feeling sick (nausea)
* being sick (vomiting)
* indigestion
* increase in liver enzymes (transaminases) in the blood
Rare side effects
(These may affect up to 1 in 1,000 people)
* swelling
* yellowing of the whites of the eyes or skin (jaundice)
Other side effects
(Frequency not known: frequency cannot be estimated from the available
data)
* a decrease in the number of blood cells necessary for clotting
* allergic reaction, such as rash, redness of the skin, skin eruptions, itching
* a decrease in bowel activity
* inflammation of the liver (hepatitis)
* gas pockets in the bowel (pneumatosis cystoides intestinalis)
* rash with pus filled pimples/blisters (acute generalised exanthematous
pustulosis)
In addition, side effects like liver disorder, abnormal liver function and liver
injury have been reported. Individual cases of a rapidly progressive and fatal
form of liver injury have also been reported, particularly from Japan.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5

How to store Acarbose

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in a dry place.
Do not take Acarbose after the expiry date which is stated on the
blister label and carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the tablet becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.

6

Contents of the pack and other information

What Acarbose contains:
Each tablet contains 50mg of acarbose.
Other ingredients are microcrystalline cellulose, silica colloidal anhydrous,
magnesium stearate, maize starch
What Acarbose look like and contents of the pack
A white to yellow-tinged round, convex tablets marked with ‘G50’ on one side
and the BAYER-cross on the other side.
Each pack contains 90 Tablets.
Manufacturer and Licence Holder
Manufactured by Bayer Pharma AG D - 51368, Leverkusen, Germany and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1648

Acarbose 50mg Tablets

Revision date: 08/07/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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