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Active substance(s): ACARBOSE

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Warnings and

Package leaflet: Information for the user

0 Glucobay



Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.

Other medicines and Glucobay

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
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.

What is in this leaflet
What Glucobay is and what it is used for
What you need to know before you
take Glucobay


How to take Glucobay


What Glucobay is and
what it is used for

Possible side effects

Glucobay is unlikely to affect your ability to
drive or use machines.


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.

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.

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
• Neomycin, an antibiotic.
• Colestyramine, to treat high
• Digoxin, to treat heart problems.
• Other blood glucose lowering drugs (e.g
sulphonylureas, metformin, or insulin).

Driving and using machines

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.

Some medicines affect the way Glucobay
works in the body. Other medicines are
affected by Glucobay.

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.

Contents of the pack and other

Glucobay is used to treat non-insulin
dependent diabetes.

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

Pregnancy and breast-feeding

How to store Glucobay

The active ingredient in this medicine is
acarbose. This belongs to a group of
medicines called glucosidase inhibitors.



Talk to your doctor before
taking Glucobay

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.

50mg tablets



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
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).


PMR 82162690 (69/03/MU-0201503084) Pantone: Schwarz, Orange 021

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).

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 (see details
below). By reporting side effects you can help
provide more information on the safety of this

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

United Kingdom
Yellow Card Scheme

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.

ADR Reporting

If you have any further questions on the use of
this medicine, ask your doctor.



Possible side effects

Keep this medicine out of the sight and
reach of children.
Do not store above 25°C and keep in a dry
place. Store in the original package.

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.

Do not use this medicine after the expiry date
which is stated on both the outer carton and
on each blister strip of tablets after EXP. The
expiry date refers to the last day of that month.

Effects occuring in first 2 or 3

How to store Glucobay

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
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)

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.


Contents of the pack and
other information

What Glucobay contains
Glucobay tablets contain the active ingredient,
Glucobay tablets also contain starch, cellulose,
magnesium stearate and silicon dioxide.

Common side effects

What Glucobay looks like and
contents of the pack

(These may affect up to 1 in 10 people)
• diarrhoea
• stomach or abdominal pain

Each tablet contains 50 mg acarbose.
Each pack contains 90 tablets.

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)

Marketing Authorisation Holder
and Manufacturer
Marketing authorisation holder:
Bayer plc, Bayer House, Strawberry Hill,
Newbury, Berkshire RG14 1JA
Bayer Pharma AG,
Leverkusen, Germany
This leaflet was last revised in
May 2015.
Product licence number: PL 00010/0171

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
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



PMR 82162690 (69/03/MU-0201503084) Pantone: Schwarz, Orange 021

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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.