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ACARBOSE 100MG TABLETS

Active substance(s): ACARBOSE

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Package leaflet: Information for the patient

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.
• 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 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

1. What Acarbose is and what it is used for
2. What you need to know before you take Acarbose
3. How to take Acarbose
4. Possible side effects
5. How to store Acarbose
6. Contents of the pack and other information

1. What Acarbose is and what it is
used for
Acarbose contains the active substance acarbose,
which belongs to a group of medicines called
glucosidase inhibitors.
Acarbose is used in the treatment of non-insulin
dependent (type II) diabetes mellitus in patients
inadequately controlled on diet alone, or on diet
and oral hypoglycaemic agents. Acarbose is for
adults aged over 18 years. This medicine has
been prescribed for you by your doctor to treat
your diabetes.

This medicine may affect the level of certain proteins
called enzymes in your blood which show how your
liver is working. 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:
In particular tell your doctor or pharmacist if
you are taking:
• medicines called intestinal absorbants,
such as charcoal
• medicines containing digestive enzymes that help
digestion, such as amylase and pancreatin
• neomycin, an antibiotic
• colestyramine, to treat high cholesterol
• digoxin, to treat heart problems
• other blood glucose lowering drugs
(e.g. sulfonylureas, metformin, or insulin).

Acarbose with food and drink

Keep to the diet prescribed by your doctor. If
distressing stomach or digestive complaints develop
in spite of strict adherence to your diet (see section
4), contact your doctor as your dose of acarbose may
need to be reduced.
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.
You may notice side effects such as severe wind
(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.

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.

Pregnancy and breast-feeding

2. What you need to know before you
take Acarbose

Driving and using machines

Do not take Acarbose:

3. How to take Acarbose

• 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 suffer from 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 large hernia, or any other condition
where increased gas in your intestine may make
it worse
• if you have an intestinal disease where you do not
digest or absorb food properly
• if you have severe kidney problems
• if you have a severe liver disorder.
If you have a kidney or liver 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.

Do not take acarbose if you are pregnant or
breastfeeding. If you think you might be pregnant or
are planning to have a baby, tell your doctor before
taking this medicine.
Acarbose is unlikely to affect your ability to drive or
use machines.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Adults (including over 65s):

The recommended initial dose is 50 mg, three times a
day. To start treatment your doctor may recommend
taking 50 mg only once or twice a day to help
minimise side effects. Your doctor will then increase
your dose to 50 mg, three times a day.
If after six to eight weeks treatment your medicine
is not working as well as it should your doctor may
increase your dose up to 100 mg, three times a day.
The maximum dose is 200 mg, three times a day.

Use in children and adolescents:

Acarbose is not recommended in patients under
18 years of age.

Warnings and precautions

Method of administration

• If you are taking insulin, metformin or sulfonylureas
(e.g. glimepiride, glipizide) 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.
• When taking acarbose DO NOT treat a
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.

The score line on the 100 mg tablet is not intended
for breaking the tablet.

Treating hypoglycaemic episodes (‘hypos’)
As a diabetic you may also be receiving other
treatments for your diabetes.

Talk to your doctor or pharmacist before taking
acarbose if you have any questions on the above.

Tablets are swallowed whole with a glass of water
immediately before the meal or chewed with the first
mouthful of food.

This medicine 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. If you have taken more tablets than you should
do not take food or drinks containing carbohydrates
for the next 4 to 6 hours. Symptoms of overdose may
include: severe flatulence and diarrhoea.
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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.

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. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Side effects which may occur in the first two or
three days of treatment:
• increased wind (flatulence)
• rumbling in your stomach
• 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.

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 department immediately:

Rare (may affect up to 1 in 1,000 people):
• yellowing of the whites of the eyes or
skin (jaundice)
Not known (frequency cannot be estimated from the
available data):
• inflammation of the liver (hepatitis). You may feel
sick, notice yellowing of the skin and eyes, and
have abdominal pain and swelling. Some cases
of hepatitis with a fatal outcome have been
reported, but it is not clear if this occurs as a result
of taking acarbose.
• allergic reaction, such as rash, redness of the skin,
skin eruptions, itching
• gas pockets in the bowel (Pneumatosis cystoides
intestinalis). This will show up in a radiograph
(e.g. CT scan, MRI).
• a decrease in bowel activity
(e.g. severe constipation)
Other possible side effects

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 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. How to store Acarbose
• Keep this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry date,
which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.
• This medicine does not require any special
temperature storage conditions. Store in the
original package in order to protect from moisture.
• Do not use this medicine if you notice
any discolouration.
• 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.

6. Contents of the pack and
other information
What Acarbose contains

• The active substance is acarbose. Each tablet
contains either 50 mg or 100 mg of acarbose.
• The other ingredients are silica, colloidal anhydrous;
maize starch; magnesium stearate; cellulose,
microcrystalline.

What Acarbose looks like and contents
of the pack

Your medicine comes as a white to off-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

Very common (may affect more than 1 in
10 people):
• wind (flatulence).

Manufacturer

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

Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1,
Hungary

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 need to 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.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland

Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Uncommon (may affect up to 1 in 100 people):
• feeling sick (nausea)
• being sick (vomiting)
• indigestion (dyspepsia)
• increase in liver enzymes (transaminases) in the
blood. This would show in blood tests.
Rare (may affect up to 1 in 1,000 people):
• swelling (oedema).
Not known (frequency cannot be estimated from
the available data):
• a decrease in the number of blood cells necessary
for clotting (thrombocytopenia)
• rash with pus filled pimples/blisters (acute
generalised exanthematous pustulosis)
In addition, events reported as liver disorder,
abnormal liver function and liver injury have
been received.

This leaflet was last revised in July 2015.

22 Jul 2015

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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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