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GLUCOBAY 100MG TABLETS

Active substance(s): ACARBOSE / ACARBOSE

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Package leaflet: Information for the user

Warnings and precautions

Hypos and Glucobay

0 Glucobay

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.

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).

Other medicines and Glucobay

If you take more Glucobay than
you should

®

100 mg tablets
Acarbose

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.

0 Glucobay

®

100mg tablets
Acarbose

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.

What is in this leaflet

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85309730

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

Driving and using machines

What Glucobay is and
what it is used for

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.

What you need to know
before you take Glucobay

Do not take Glucobay:








Pregnancy and breast-feeding

Contents of the pack and other
information

Possible side effects

Glucobay is used to treat non-insulin
dependent diabetes.



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)

How to store Glucobay

How to 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.

PMR 85309730 (93/01_MU-201703799) Pantone: Black, Orange 021

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.

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.

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

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

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

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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).

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.

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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

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.

March

2017

REVISED

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 medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/
adrportal

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How to store Glucobay

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.
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.
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.

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Contents of the pack and
other information

Very common side effects

What Glucobay contains

(These may affect more than 1 in 10 people)
• wind (flatulence)

Glucobay tablets contain the active ingredient,
acarbose.

Common side effects

Glucobay tablets also contain starch, cellulose,
magnesium stearate and silicon dioxide.

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

What Glucobay looks like and
contents of the pack

Uncommon side effects

Each tablet contains 100 mg acarbose.

(These may affect up to 1 in 100 people)
• feeling sick (nausea)
• being sick (vomiting)
• indigestion
• increase in liver enzymes (transaminases) in
the blood

Marketing Authorisation Holder
and Manufacturer

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)

Each pack contains 90 tablets.

Marketing authorisation holder:
Bayer plc,
Bayer House, Strawberry Hill, Newbury
Berkshire RG14 1JA
Manufacturer:
Bayer Pharma AG,
Leverkusen, Germany
This leaflet was last revised in
March 2017.
Product licence number: PL 00010/0172

U

305x346-16866

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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.

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