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GLUCOBAY 50MG TABLETS

Active substance(s): ACARBOSE

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®

85959069

What Glucobay is and
what it is used for

Contents of the pack and other
information

How to store Glucobay

Possible side effects

How to take Glucobay

What you need to know before you take
Glucobay

What Glucobay is and what it is used for

What you need to know
before you take Glucobay

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Do not take Glucobay if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist.

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:

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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.

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 is used to treat non-insulin
dependent diabetes.

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

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What is in this leaflet

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.

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 have any further questions, ask your
doctor or pharmacist.

Keep this leaflet. You may need to read it again.

PMR 85959069 (AB/01-C_MU-201709656) Pantone: Black, Orange 021

Acarbose

50 mg tablets

0 Glucobay

Acarbose

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

0
®

Glucobay
50 mg tablets

Package leaflet: Information for the user

How to take Glucobay

Household sugar (cane sugar) and foods
containing it can lead to severe abdominal
discomfort and diarrhoea during treatment with
Glucobay (see section 4).

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.

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.

Food and drink with Glucobay

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.

Always take this medicine exactly as your
doctor has told you. Check with your doctor if
you are not sure.
s Adults including old people: the usual
dose is 1 or 2 tablets, three times a day
s Children and adolescents: Glucobay is
not recommended.
s The treatment is for long-term use.
Take the tablets for as long as your doctor
has told you to.

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

Driving and using machines

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.

Pregnancy and breast-feeding

Tell your doctor if you are taking:
s Medicines called intestinal absorbants, such
as charcoal.
s Medicines containing digestive enzymes
that help digestion, such as amylase and
lipase.
s Neomycin, an antibiotic.
s Colestyramine, to treat high cholesterol.
s Digoxin, to treat heart problems.
s Other blood glucose lowering drugs (e.g
sulphonylureas, metformin, or insulin).

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

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

Other medicines and Glucobay

Talk to your doctor before taking Glucobay
s If you have a kidney disorder tell your
doctor before you take Glucobay.
s Glucobay may affect the enzyme levels in
your blood. Your doctor may want to do
regular tests to check this.

Warnings and precautions

Possible side effects

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

increased wind (flatulence)
rumbling in your stomach
a feeling of fullness or abdominal cramps.

(Frequency not known: frequency cannot be
estimated from the available data)
s a decrease in the number of blood cells
necessary for clotting
s allergic reaction, such as rash, redness of
the skin, skin eruptions, itching
s a decrease in bowel activity
s inflammation of the liver (hepatitis)
s gas pockets in the bowel (pneumatosis
cystoides intestinalis)
s rash with pus filled pimples/blisters (acute
generalised exanthematous pustulosis)

Other side effects

(These may affect up to 1 in 1,000 people)
s swelling
s yellowing of the whites of the eyes or skin
(jaundice)

Rare side effects

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

Uncommon side effects

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

Common side effects

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

Very common side effects

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Effects occuring in first 2 or 3
days

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.

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

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 forget to take Glucobay

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.

If you take more Glucobay than
you should

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).

Hypos and Glucobay
August
REVISED

2017

How to store Glucobay

Contents of the pack and
other information

305x346-16866

U

Product licence number: PL 00010/0171

This leaflet was last revised in
August 2017.

Marketing authorisation holder:
Bayer plc, 400 South Oak Way
Reading
RG2 6AD
Manufacturer:
Bayer AG,
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

Marketing Authorisation Holder
and Manufacturer

Each pack contains 90 tablets.

Each tablet contains 50 mg acarbose.

What Glucobay looks like and
contents of the pack

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

Glucobay tablets contain the active ingredient,
acarbose.

What Glucobay contains

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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.

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 store above 25°C and keep in a dry
place. Store in the original package.

Keep this medicine out of the sight and
reach of children.

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Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/
adrportal

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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.

Reporting of side effects

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.

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