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ACARBOSE 100MG TABLETS

Active substance: ACARBOSE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ACARBOSE 50 mg TABLETS
ACARBOSE 100 mg TABLETS
(acarbose)

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
•  eep this leaflet. You may need to read it again.
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•  f you have any further questions, ask your
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doctor or pharmacist.
•  his medicine has been prescribed for you only.
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Do not pass it on to others. It may harm them,
even if the signs of illness are the same as yours.
•  f you get any side effects, talk to your doctor
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or pharmacist. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1.  hat Acarbose is and what it is used for.
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2.  hat you need to do before you take Acarbose.
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3.  ow to take Acarbose.
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4.  ossible side effects.
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5.  ow to store Acarbose.
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6.  ontents of the pack and other information.
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1.  HAT ACARBOSE IS AND WHAT IT IS USED FOR
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Your doctor may wish to see you more frequently
in order to monitor the levels of these enzymes.
Your doctor may decide to reduce the dose or stop
treatment with Acarbose.
Other medicines and Acarbose
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Acarbose may alter the effect of other
drugs, or alternatively, some drugs may alter the
effect of Acarbose:
•  edicines called intestinal absorbants, such
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as charcoal
•  edicines containing digestive enzymes that
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help digestion, such as amylase and lipase
•  eomycin, an antibiotic
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•  olestyramine, to treat high cholesterol
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•  igoxin, to treat heart problems
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•  ther blood glucose lowering drugs (e.g.
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sulphonylureas, metformin, or insulin).
Acarbose with food and drink
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 Acarbose may
need to be reduced.

The active ingredient in this medicine is acarbose.
This belongs to a group of medicines called
glucosidase inhibitors.
Acarbose is used in the treatment of non-insulin
dependent diabetes mellitus in patients
inadequately controlled on diet alone, or on
diet and oral hypoglycaemic agents. Acarbose
is indicated in adults aged over 18 years.
This medicine has been prescribed for you by
your doctor to treat your diabetes. Acarbose will
help to control your blood sugar levels. This is
because Acarbose works by slowing down the
digestion of carbohydrates (complex sugars) from
your diet, and this reduces the abnormally high
blood sugar levels that occur after each meal.

Household sugar (cane sugar) and foods
containing it can cause abdominal discomfort or
even diarrhoea due to carbohydrate-fermentation
in the colon during treatment with Acarbose.

2.  HAT YOU NEED TO KNOW BEFORE YOU TAKE
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ACARBOSE

Driving and using machines
Acarbose is unlikely to affect your ability to drive
or use machines.

Do not take Acarbose:
• f you are allergic to acarbose or any of the other
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ingredients of this medicine (listed in Section 6)
• f you are pregnant or breast-feeding
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• f you suffer from inflammation or ulceration of
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the bowel, for example ulcerative colitis or
Crohn’s disease
• f you have an obstruction in your intestines, or
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are likely to get this
• f you have a large hernia, or any other condition
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where increased gas in your intestine may make
it worse
• f you have an intestinal disease where you do
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not digest or absorb food properly
• f you have severe kidney problems
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• f you have a liver disorder.
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If you have a kidney disorder, do not take
Acarbose without consulting your doctor first.
If you are unsure whether you might have any
of these conditions, please ask your doctor.
Warnings and Precautions
Treating hypoglycaemic episodes ('hypos')
As a diabetic you may also be receiving other
treatments for your diabetes.
•  f you are taking insulin or sulphonylureas drugs
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to control your blood sugar, you will probably be
used to avoiding hypoglycaemic episodes by
taking sugar when you feel that your blood
sugar level is too low.
•  hen taking acarbose do not treat a
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hypoglycaemic episode with ordinary sugar
(sucrose) instead take some glucose (also known
as dextrose) tablets, syrup, or sweets which
should be available from your pharmacist.
This medicine may affect the level of certain
proteins called enzymes in your blood.

You may notice side effects such as severe flatulence
and diarrhoea if you have taken Acarbose together
with carbohydrate containing drinks or food. In this
case, do not eat or drink carbohydrate containing
drinks or food for 4 to 6 hours.
Pregnancy and breast-feeding
Do not take Acarbose if you are pregnant or
breast-feeding. If you think you might be pregnant
or are planning a family, tell your doctor before
taking this medicine.

3. HOW TO TAKE ACARBOSE
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist
if you are not sure.
Adults including over 65s:
The recommended dose is 1 or 2 tablets, three
times a day. 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.
Use in children and adolescents under 18 years
of age:
Acarbose is not recommended in patients under
18 years of age.
Method of administration
Tablets are swallowed whole with a glass of water
immediately before the meal or chew with the
first mouthful of food.
The score line on the 100 mg tablet is not intended
for breaking the tablet.
The treatment is for long-term use. Take the tablets
for as long as your doctor has told you to.
If you take more Acarbose than you should
Go to your doctor or nearest hospital immediately.
Take the container and any remaining tablets with
you. Do not take food or drinks containing
carbohydrates.
If you forget to take Acarbose
Do not take a double dose to make up for a
forgotten dose. Take the next dose with your next
meal. Do not take the tablets between meals.

Date: 30 Apr 2015
Description Acarbose 50/100 mg 90
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 629145

SAP No. N/A

Superceded Affiliate Item Code 568529
TrackWise PR No. 629145
MA No. 04569/1619 & 1620

Vendor Job No. 253359
Proof No. 1
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

Time: 12:55
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 360 mm

Body Text Size 9.5 pt
Min Text Size used 7 pt

If you stop taking Acarbose
If you suddenly stop taking Acarbose your blood
glucose level may rise. Speak to your doctor
before stopping this medicine.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4.  OSSIBLE SIDE EFFECTS
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Like all medicines, Acarbose can cause side effects,
although not everybody gets them.
Effects occurring in the first two or three days:
• ncreased wind (flatulence)
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•  umbling in your stomach
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•  eeling of fullness or abdominal cramps.
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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.
If you think you may have any of the following
side effects, stop taking this medicine and
contact your doctor or go to your nearest
hospital emergency room immediately:
•  ellowing of the whites of the eyes or skin
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(jaundice) (rare, may affect up to 1 in 1,000
people)
• nflammation of the liver (hepatitis) (frequency
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not known).
Other possible side effects:
Very common: may affect more than 1 in 10
people:
• wind (flatulence).
Common: may affect up to 1 in 10 people:
• diarrhoea
•  tomach or abdominal pain.
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These side effects are likely to occur after a meal
containing sugar (sucrose). Symptoms may be
reduced by avoiding foods and drinks that contain
sugar (sucrose, cane sugar). If your diarrhoea does
not go away your doctor will reduce your dose or
in some cases stop treatment. Do not take
indigestion remedies to treat the above side
effects as this can make the symptoms worse.
Uncommon: may affect up to 1 in 100 people:
•  eeling sick (nausea)
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•  eing sick (vomiting)
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• indigestion
• ncrease in liver enzymes (transaminases) in the
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blood.
Rare: may affect up to 1 in 1,000 people:
•  wollen skin (oedema).
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Not known: frequency cannot be estimated from
the available data:
•  decrease in the number of blood cells
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necessary for clotting
•  llergic reaction, such as rash, redness of the skin,
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skin eruptions, itching
•  decrease in bowel activity
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•  as pockets in the bowel (Pneumatosis cystoides
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intestinalis)
•  ash with pus filled pimples/blisters (acute
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generalised exanthematous pustulosis).

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the 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.  OW TO STORE ACARBOSE
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•  eep this medicine out of the sight and reach of
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children.
•  o not use this medicine after the expiry date,
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which is stated on the carton and blister after
'EXP'. The expiry date refers to the last day of
that month.
•  his medicinal product does not require any
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special temperature storage conditions. Store
in the original package in order to protect from
moisture.
•  o not use this medicine if you notice any
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discolouration.
•  o not throw away any medicines via
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wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.
6.  ONTENTS OF THE PACK AND OTHER
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INFORMATION
What Acarbose tablets contain
•  he active substance is acarbose. Each tablet
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contains either 50 mg or 100 mg of acarbose.
•  he other ingredients are silica, colloidal
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anhydrous; maize starch; magnesium stearate;
cellulose, microcrystalline.
What Acarbose tablets look like and contents
of the pack
Your medicine comes as a white round tablet.
Acarbose 50 mg tablets are marked 'A' over '50' on
one side of the tablet and 'M' on the other side.
Acarbose 100 mg tablets are marked 'AB'
(breakline) '100' on one side of the tablet and 'M'
on the other side.
Acarbose is available in blister packs of 90 and
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca
1, Hungary.
Generics [UK] Ltd, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

In addition, events reported as liver disorder,
abnormal liver function and liver injury have been
received, particularly from Japan.
Individual cases of sudden hepatitis with a fatal
outcome have been reported in Japan. It is not
clear whether those are as a result of taking
acarbose.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.

This leaflet was last revised in: May 2015

Date: 30 Apr 2015
Description Acarbose 50/100 mg 90
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 629145

SAP No. N/A

Superceded Affiliate Item Code 568529
TrackWise PR No. 629145
MA No. 04569/1619 & 1620

Vendor Job No. 253359
Proof No. 1
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

629145

Time: 12:55
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 360 mm

Body Text Size 9.5 pt
Min Text Size used 7 pt

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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