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GLUCOBAY 50MG TABLETS

Active substance: ACARBOSE

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Package leaflet - information for the user

0 Glucobay

®

Tell your doctor about any
other medicines that you
are taking, or took recently.
This includes any products you
bought without a prescription.

50mg tablets
Acarbose

Keep this leaflet. You may need to read it again.
If you have more questions, ask your doctor
or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet

1

June

2013
REVISED

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

Read all of this leaflet carefully
before you start taking this
medicine.

1
2
3
4
5
6

Other medicines
and 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).

What Glucobay is and what it is used for

Pregnancy and breastfeeding

Before you take Glucobay

Do not take Glucobay if you are pregnant
or breastfeeding. If you think you might be
pregnant or are planning a family, tell your
doctor before taking Glucobay.

How you take Glucobay
Possible side effects
How to store Glucobay

Driving and using machines

Further information

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

What Glucobay is and
what it is used for

3

How you take Glucobay

Always take Glucobay exactly as your doctor
has told you.
• Adults including over 65s: the usual
dose is 1 or 2 tablets, three times a day
• Children and under 18s: Glucobay is
not recommended.
• The treatment is for long-term use.
Take the tablets for as long as your
doctor has told you to.

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.

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 200mg
three times a day.

2

Food and drink with Glucobay

Before you take Glucobay

Take special care with Glucobay:









If you are allergic to the active
ingredient (acarbose), or to any of the
other ingredients. The ingredients are
listed in section 6.
If you are pregnant or breastfeeding.
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.

Take special care 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 “Possible
side effects”), 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 "Possible side effects").

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 too many tablets

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.

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.
81331855

PMR 81331855 (O8/02/MU-0201306580) Pantone: Schwarz, Orange 021
148x315-07508

If you forget to take the tablets

If you get side effects

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.

4

Tell your doctor if any side effect gets
severe, or if you get any effects not listed
in this leaflet.

5

Possible side effects

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

Like all medicines, Glucobay can cause
side effects, although not everybody gets
them. The following side effects have been
observed during treatment with Glucobay.

Do not store above 25°C and keep in a dry
place. Store in the original carton.
Do not use after the expiry date which is
marked on both the outer container and on
each blister strip of tablets.

Effects occuring in first 2 or 3
days





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
diarrhoea.
Do not take indigestion preparations
(antacids) as they are unlikely to help

Do not dispose of medicines in waste water
or household rubbish. Any unused Glucobay
tablets should be returned to a pharmacist
(chemist) who will dispose of them properly.
This helps the environment.

6

Further information

What Glucobay 50mg tablets
contain
Glucobay tablets contain the active ingredient,
acarbose.

Very common side effects
(These may affect more than 1 in 10 people)
• wind (flatulence)

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

Common side effects

What’s in the pack

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

Each tablet contains 50 mg acarbose.

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

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: June 2013
Product licence number: PL 00010/0171

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 unknown)
• 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.

U

81331855

PMR 81331855 (O8/02/MU-0201306580) Pantone: Schwarz, Orange 021
148x315-07508

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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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