ACARBOSE 100MG TABLETS

Active substance: ACARBOSE

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231-30-76522-B LEA ACARBOSE A/S TAB TUK
Reason for revision: New templates as DBP are changing their supplier post-launch.

PL Number(s),
PL 00289/1114-5. TEVA UK Limited Licence
MA Holder & Packer: Packed at Cordon via DBP via Ulm.

Ref:

Version:

1
24 May 2012

290 mm
160 mm

3rd Party Code: TBC

Added by 3rd party

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

50mm

Original Artwork Scale = 1:1 (100%)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
FRS\ RI DQ\ UG 3DUW\ 6XSSOLHU·V 3URRI EHIRUH DSSURYDO WR SULQW ZLOO EH JUDQWHG

Base Font Size: 9pt

L:
W:
(PANTONE® is a registered
trademark of Pantone, Inc.)

Colours:

Format
160 x 290 mm

1
WHAT ACARBOSE TABLETS ARE AND
WHAT THEY ARE USED FOR

2

Fonts: Univers

Dimensions:
BLACK

PANTONE® GREEN

Art.-Nr.
xxxxxx

ACARBOSE
50 mg AND 100 mg TABLETS

Farben

1. What Acarbose Tablets are and what they
are used for
2. Before you take Acarbose Tablets
3. How to take Acarbose Tablets
4. Possible side effects
5. How to store Acarbose Tablets
6. Further information

Low blood sugar is a potentially serious
condition.

Read all of this leaflet carefully before you
start taking this medicine.
Other sugars such as
sucrose (table sugar) will not work because
Acarbose Tablets prevents them from being
absorbed.

Code

Taking other medicines

BEFORE YOU TAKE ACARBOSE
TABLETS

Do NOT take Acarbose Tablets:

Taking Acarbose Tablets with food and drink

Pregnancy and breast-feeding

Take special care with Acarbose Tablets

Driving and using machines

no print area
Technischer Bereich
Nur für Codes etc. !!!

231-30-76522-B LEA ACARBOSE A/S TAB TUK
Reason for revision: New templates as DBP are changing their supplier post-launch.

PL Number(s),
PL 00289/1114-5. TEVA UK Limited Licence
MA Holder & Packer: Packed at Cordon via DBP via Ulm.

Ref:

Version:

1
24 May 2012

L:
W:

290 mm
160 mm

3rd Party Code: TBC

Added by 3rd party

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

50mm

Original Artwork Scale = 1:1 (100%)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
FRS\ RI DQ\ UG 3DUW\ 6XSSOLHU·V 3URRI EHIRUH DSSURYDO WR SULQW ZLOO EH JUDQWHG

Base Font Size: 9pt

Fonts: Univers

Dimensions:
(PANTONE® is a registered
trademark of Pantone, Inc.)

Colours:
BLACK

PANTONE® GREEN

3

4

HOW TO TAKE ACARBOSE TABLETS
Uncommon (affects 1 to 10 users in 1,000):

Adults and elderly patients
Rare (affects 1 to 10 users in 10,000):

Other possible side effects (frequency cannot
be estimated from the available data):

Children and adolescents under 18 years
If you take more Acarbose Tablets than you
should

5

6

HOW TO STORE ACARBOSE TABLETS

Keep out of the reach and sight of children.

If you forget to take Acarbose Tablets

FURTHER INFORMATION

What Acarbose Tablets contain:

If you stop taking Acarbose Tablets

What Acarbose Tablets look like and contents
of the pack:

POSSIBLE SIDE EFFECTS

Marketing Authorisation Holder:

Manufacturer:

Very common (affects more than 1 user in 10):

This leaflet was last revised January 2012

Common (affects 1 to 10 users in 100):

xxxxxx/x

no print area
Technischer Bereich
Nur für Codes etc. !!!

PAGE 1: FRONT FACE (INSIDE OF REEL)

local pharmacy. It is a good idea to carry
some glucose with you at all times in case
you need to use it. Other sugars such as
PACKAGE LEAFLET: INFORMATION FOR THE USER
sucrose (table sugar) will not work
because Acarbose Tablets prevents them
Read all of this leaflet carefully before you
from being absorbed.
start taking this medicine.
• Keep this leaflet. You may need to read
If you have experienced the above
it again.
symptoms then you should make an
• If you have any further questions, ask
appointment to see your doctor for your
your doctor or pharmacist.
medication to be reviewed.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
Your doctor may decide to conduct blood
harm them, even if their symptoms are
tests to monitor your liver during
the same as yours.
treatment with Acarbose Tablets,
• If any of the side effects get serious, or if
particularly during the first 6 to 12 months
you notice any side effects not listed in
of treatment.
this leaflet, please tell your doctor or
pharmacist.
Taking other medicines
Talk to your doctor if you are taking any of
IN THIS LEAFLET:
the following:
1. What Acarbose Tablets are and what
• charcoal (used for treatment of
they are used for
poisoning or drug overdose)
2.Before you take Acarbose Tablets
• digestive enzyme preparations (e.g.
3.How to take Acarbose Tablets
pancreatin and amylase)
4.Possible side effects
• neomycin (antibiotic used before bowel
5.How to store Acarbose Tablets
surgery)
6.Further information
• colestyramine (used for treating
itchiness resulting from liver problems,
high cholesterol or diarrhoea)
• digoxin (used for treatment of heart
1 WHAT ACARBOSE TABLETS ARE
AND WHAT THEY ARE USED FOR
failure or heart rhythm problems).
• thiazides or calcium channel blockers
Your medicine belongs to a class of
(used in the treatment of high blood
medicines called “Alpha glucosidase
pressure)
inhibitors” and is used in the
• corticosteroids (used to treat
management of Type II diabetes (diabetes
inflammation)
that does not require treatment with
• phenytoin (used to treat epileptic fits)
insulin injections). It can be used alone or • phenothiazine (used to treat mental
in combination with a sulphonylurea and / health)
or metformin.
• thyroid medicines
• female sex hormone (oestrogens), oral
If you have Type II diabetes then levels of
contraceptives
sugar (glucose) in your blood are too
• nicotinic acid (used to lower blood
high. Your medicine works by slowing
cholesterol)
down digestion and absorption of sugars • medicines called “sympathomimetics”
from your diet. This stops levels of blood
such as epinephrine and
sugar from rising too high.
norepinephrine: these may be used in
the treatment of cardiac arrest, severe
During treatment you should also ensure
drop in blood pressure or premature
that you follow the diet recommended by
labour
your doctor.
• isoniazid (used to treat tuberculosis).

BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

3rd Party Code: 2585401

Reason for revision: New item for launch; mocked up on generic cutters, as cutters not yet confirmed. V2: Official template received and applied. V3: New templates
sent, leaflet length increased from 323mm to 420mm; pharma code applied. V4: Add/amend packing site codes, as requested 13/12/11.
V5: Regulatory text update. V6: Text corrections and updates from Regulatory 17/01/11.

Base Font Size: 10pt

Fonts: Univers

PL Number(s),
PL 00289/1114-5. TEVA UK Limited Licence (Responsible Regulatory Team = New Products),
MA Holder & Packer: Packed at Famar Italia SPA.

Ref:

231-30-76522-A LEA ACARBOSE A/S TAB TUK
Version:

6

20 January 2012

Dimensions:

L:
W:

420 mm
165 mm

700 (010111101)

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

Colours:

(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN

50mm

Original Artwork Scale = 1:1 (100%)

ACARBOSE
50 mg AND 100 mg TABLETS

2

BEFORE YOU TAKE ACARBOSE
TABLETS

Do NOT take Acarbose Tablets:
• if you are allergic (hypersensitive) to
acarbose (the active ingredient in your
medicine) or to any of the other
ingredients
• if you have inflammatory bowel disease
• if you suffer from ulcers in your colon –
e.g. Crohn’s Disease or Ulcerative
colitis. Ask your doctor if unsure
• if you have or have previously suffered
from an obstruction in your intestines
(gut)
• if you suffer from any digestive
disorders caused by ongoing problems
with your intestines (gut). Ask your
doctor if unsure
• if you have any condition which may be
made worse by the formation of gas in
your intestine. For example, if you have
a large hernia. Ask your doctor if unsure
• if you have liver problems
• if you have severe kidney problems.
Take special care with Acarbose Tablets
You may experience low blood sugar
levels if you take other anti-diabetic
agents at the same time as acarbose, such
as sulphonylureas or insulin. Tell your
doctor if you are already taking medicines
for the treatment of your diabetes. Low
blood sugar levels can cause some of the
following symptoms:
• double vision
• confusion
• slurred speech
• faintness
• trembling
• palpitations (abnormal awareness of
your own heartbeat).
Low blood sugar is a potentially serious
condition. If you experience any of the
above symptons then take some glucose
to increase your levels of blood sugar
back to normal. You will be able to buy
glucose tablets, syrup or sweets at your

Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Taking Acarbose Tablets with food and
drink
Your tablets should be swallowed whole
immediately before a meal or chewed
with the first mouthful of food. Your
tablets should not be taken between
meals.
Sucrose (cane sugar) and foods
containing sucrose can cause abdominal
discomfort or even diarrhoea due to
carbohydrate-fermentation in the colon
during treatment with Acarbose Tablets.
Pregnancy and breast-feeding
Acarbose Tablets are not recommended
for use during pregnancy or
breast-feeding as the effects on your baby
are not known. If you are planning to
become pregnant, or are already
pregnant or breast-feeding, you should
speak to your doctor before taking
Acarbose Tablets.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Acarbose Tablets do not affect your ability
to drive or operate machinery if taken on
their own. However, you may experience
low blood sugar levels if you take other
anti-diabetic agents at the same time,
such as sulphonylureas or metformin. This
may affect your ability to drive or operate
machinery safely.

3

HOW TO TAKE ACARBOSE TABLETS

Always take Acarbose Tablets exactly as
your doctor has told you to. You should
check with your doctor or pharmacist if
you are not sure.

BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

3rd Party Code: 2585401

Reason for revision: New item for launch; mocked up on generic cutters, as cutters not yet confirmed. V2: Official template received and applied. V3: New templates
sent, leaflet length increased from 323mm to 420mm; pharma code applied. V4: Add/amend packing site codes, as requested 13/12/11.
V5: Regulatory text update. V6: Text corrections and updates from Regulatory 17/01/11.

Base Font Size: 10pt

Fonts: Univers

PL Number(s),
PL 00289/1114-5. TEVA UK Limited Licence (Responsible Regulatory Team = New Products),
MA Holder & Packer: Packed at Famar Italia SPA.

Ref:

231-30-76522-A LEA ACARBOSE A/S TAB TUK
Version:

6

20 January 2012

Dimensions:

L:
W:

420 mm
165 mm

700 (010111101)

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

Colours:

(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN

50mm

Original Artwork Scale = 1:1 (100%)

Adults and elderly patients
The usual dose is 50 mg three times a day
before meals. However, your doctor may
start you on a lower dose (e.g. 50 mg
once or twice a day) and increase your
dose slowly to reduce the risk of side
effects occurring.

• Indigestion
• Increase in liver enzymes, which may
cause a change in blood test results that
report on how the liver is working.
Rare (affects 1 to 10 users in 10,000):
• Fluid retention causing swelling of arms
and legs
• Jaundice (yellowing of the skin and
whites of the eyes).

If you require a larger dose your doctor
may decide to increase your dose further
to 100 mg three times a day. Occasionally
it may be necessary to increase the dose Other possible side effects (frequency
cannot be estimated from the available
to 200 mg three times a day.
data):
• Gas pockets in the bowel.
Acarbose Tablets should be swallowed
whole immediately before meals or
During treatment it is important to follow
chewed with the first mouthful of food.
the diet that your doctor has
recommended carefully. If you do not
Children and adolescents under 18
follow this diet some of the side effects
years
described above such as flatulence
Use of Acarbose Tablets is not
(wind), diarrhoea and abdominal pain
recommended.
may be made worse.
If you take more Acarbose Tablets than
If any of the side effects get serious, or if
you should
If you (or someone else) swallow a lot of you notice any side effects not listed in
this leaflet, please tell your doctor or
the tablets all together, or if you think a
pharmacist.
child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
You should also not consume any
5 HOW TO STORE ACARBOSE
TABLETS
carbohydrate containing food or drink. An
overdose is likely to cause a swollen
abdomen (resulting from the presence of Keep out of the reach and sight of
children.
excessive amounts of gas), flatulence
Do not store above 25°C. Store in the
(wind) and diarrhoea. Please take this
original packaging in order to protect
leaflet, any remaining tablets and the
from moisture.
container with you to the hospital or
Do not use Acarbose Tablets after the
doctor so that they know which tablets
expiry date that is stated on the outer
were consumed.
packaging. The expiry date refers to the
last day of that month.
If you forget to take Acarbose Tablets
Medicines should not be disposed of via
If you forgot to take a dose of your
wastewater or household waste. Ask your
medicine then do not take the missed
dose between meals. Wait until your next pharmacist how to dispose of medicines
no longer required. These measures will
scheduled dose and meal and continue
taking your tablets as per normal. Do not help to protect the environment.
take a double dose to make up for a
forgotten tablet.
If you stop taking Acarbose Tablets
It is important to keep taking Acarbose
Tablets according to your doctor’s
instructions to ensure that levels of blood
sugars do not rise too high. Do not stop
taking Acarbose Tablets without
discussing it with your doctor first.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

6

FURTHER INFORMATION

What Acarbose Tablets contain:
• The active ingredient is acarbose.
• Each Acarbose 50 mg Tablet contains
50 mg acarbose. Each Acarbose 100 mg
Tablet contains 100 mg acarbose.
• The other ingredients are
microcrystalline cellulose,
pregelatinized maize starch, anhydrous
colloidal silica and magnesium stearate.

What Acarbose Tablets look like and
contents of the pack:
• Acarbose 50 mg Tablets are round,
POSSIBLE SIDE EFFECTS
4
biconvex, white to off-white tablets with
“ACA 50” on one side.
Like all medicines, Acarbose Tablets can
• Acarbose 100 mg Tablets are round,
cause side effects, although not
biconvex, white to off-white tablets,
everybody gets them.
with a score-line on one side and “ACA
100” on the other side. The scoreline is
Some of the side effects are serious. The
only to facilitate breaking for ease of
frequencies of the following side effects
swallowing and not to divide into equal
are unknown. However, if you suffer from
doses.
any of these reactions you should seek
• Acarbose Tablets are available in pack
urgent medical attention:
sizes of 20, 21, 30, 40, 50, 60, 90, 100,
• Bleeding or bruising more easily than
105, 120 and 270 tablets.
normal (caused by a reduction in blood
platelets)
Marketing Authorisation Holder:
• Allergic reaction (rash, redness of the
TEVA UK Limited
skin, skin eruptions, nettle rash)
Eastbourne
• Partial or complete obstruction of the
BN22 9AG
intestine leading to pain and vomiting
United Kingdom.
• Inflammation of the liver (may cause
abdominal discomfort, jaundice, loss of
Manufacturer:
appetite).
FAMAR ITALIA S.P
.A
The following side effects have also been Via Zambeletti 25
20021 Baranzate (MI)
reported:
Italy.
Very common (affects more than 1 user in
This leaflet was last revised January 2012
10):
• Flatulence (wind).
PL 00289/1114
PL 00289/1115
Common (affects 1 to 10 users in 100):
• Diarrhoea
• Pain in the stomach or abdomen.
Uncommon (affects 1 to 10 users in
1,000):
• Nausea
• Vomiting
2585401
IS-165-420-50D2

76522-A

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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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