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DICYCLOVERINE HYDROCHLORIDE 10MG TABLETS

Active substance(s): DICYCLOVERINE HYDROCHLORIDE

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Dicycloverine hydrochloride
10mg Tablets
taking this medicine
• If you have any further 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

please tell your doctor or pharmacist
1. What Dicycloverine hydrochloride Tablets are and
what they are used for
2. Before you take Dicycloverine hydrochloride Tablets
3. How to take Dicycloverine hydrochloride Tablets
5. How to store Dicycloverine hydrochloride Tablets
6. Further information
1. What Dicycloverine hydrochloride
Tablets are and what they are used for
What Dicycloverine hydrochloride Tablets are
Dicycloverine hydrochloride Tablets contain a medicine
called dicycloverine hydrochloride. This belongs to a
group of medicines called antispasmodics.
What Dicycloverine hydrochloride Tablets are used for
• Cramps
• Pain in the stomach or intestine (gut)
• Stomach or intestine (gut) problems - such as
irritable bowel.
How Dicycloverine hydrochloride Tablets work
Dicycloverine hydrochloride Tablets work by relaxing
the muscles in your stomach and gut (intestine). It stops
sudden muscle contractions (spasms). In doing this, it
relieves cramps, pain, bloating, wind and discomfort.
2. Before you take Dicycloverine hydrochloride Tablets
Do not take Dicycloverine hydrochloride
Tablets if:
× You are allergic (hypersensitive) to dicycloverine
hydrochloride or any of the other ingredients in
Dicycloverine hydrochloride Tablets (see Section 6:
Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Dicycloverine hydrochloride Tablets.

Take special care with Dicycloverine
hydrochloride Tablets. Check with your doctor or
pharmacist before taking your medicine if:
 You have glaucoma (signs include painful eyes
with blurred vision)
 You have an enlarged prostate
 You have indigestion or heart burn caused by a
‘hiatus hernia’ (where part of your stomach
pushes through the diaphragm)
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Dicycloverine hydrochloride Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines.
Dicycloverine hydrochloride Tablets should not be taken
at the same time as other medicines. This is because
the way Dicycloverine hydrochloride Tablets work.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking this
medicine if:
• You are pregnant, might become pregnant, or
think you may be pregnant
• You are breast-feeding or planning to breast-feed
Driving and using machines
You may feel dizzy, tired or sleepy or have blurred
eyesight whilst taking Dicycloverine hydrochloride Tablets.
If this happens, do not drive or use any tools or machines
Important information about some of the
ingredients of Dicycloverine hydrochloride Tablets
Dicycloverine hydrochloride Tablets contain sugars
(lactose, sucrose and glucose). If you have been told by
your doctor that you cannot tolerate or digest some
sugars, talk to your doctor before taking this medicine
3. How to take Dicycloverine hydrochloride Tablets
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets with a glass of water
• Take before or after meals
How much to take
The usual dose is:
Adults and children 12 years of age or
older
• One or two tablets 3 times each day
Children 2 to 11 years of age
• One tablet 3 times each day
• Dicycloverine hydrochloride Syrup is also
available for use in this age group

If you take more Dicycloverine hydrochloride
Tablets than you should
Talk to your doctor or go to a hospital straight away.
Remember to take any medicine that is left with you
so the doctor knows what you have taken.
swallowing, blurred eyesight and hot dry skin.
If you forget to take Dicycloverine hydrochloride
Tablets
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for the
next dose, skip the missed dose.
If you stop taking Dicycloverine hydrochloride
Tablets
Keep taking Dicycloverine hydrochloride Tablets
until your doctor tells you to stop. Do not stop
taking Dicycloverine hydrochloride Tablets just
because you feel better. If you stop, your cramps or
pain may come back.

5. How to store Dicycloverine hydrochloride Tablets
Keep this medicine in a safe place where children
cannot see or reach it
Do not use Dicycloverine hydrochloride Tablets after
the expiry date which is stated on the blister or
carton after EXP. The expiry date refers to the last
day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further Information
What Dicycloverine hydrochloride hydrochloride
Tablets contains
• Each tablet contains 10mg of the active
substance, dicycloverine hydrochloride
• The other ingredients are: lactose, calcium
hydrogen phosphate, icing sugar (sucrose and
starch), maize starch, glucose liquid, magnesium

Like all medicines, Dicycloverine hydrochloride
everybody gets them.
Stop taking Dicycloverine hydrochloride Tablets
and see a doctor or go to a hospital straight
away if;
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
Tell your doctor or pharmacist if any of the
than a few days. Also tell them if you notice any










Dry mouth or thirst
Feeling dizzy
Feeling tired or sleepy
Blurred eyesight
Rash
Loss of appetite (anorexia)
Feeling sick (nausea) or being sick (vomiting)
Constipation
Headache

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.

What Dicycloverine hydrochloride Tablets looks
like and contents of the pack
Dicycloverine hydrochloride 10mg Tablets are white,
round, biconvex tablets with a ‘M’ in two concentric
circles on one side. They are supplied in blister packs
of 100 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva,
One Onslow Street,
Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Sanofi-Aventis Sp. z o.o.
ul. Lubelska 52
35-233 Rzeszów
Poland
about your medicine. If you have any questions or
are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in April 2014
© Zentiva 2014

521560

PACKAGE LEAFLET: INFORMATION FOR THE USER

leaflet: Dicycloverine hydrochloride 10mg leaflet /GB
Format: 148 x 210 mm
Code: 521560
Laetus: 1117
Color: 1/Pantone Reflex Blue
min size of text 8 pt
Rzeszów Plant_Version 02
Date: 04/2014

Brand:
PACKAGE LEAFLET: INFORMATION FOR THE USER

Dicycloverine hydrochloride
10mg Tablets
Read all of this leaflet carefully before you start
taking this medicine
• 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. 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. What Dicycloverine hydrochloride Tablets are and
what they are used for
2. Before you take Dicycloverine hydrochloride Tablets
3. How to take Dicycloverine hydrochloride Tablets
4. Possible side effects
5. How to store Dicycloverine hydrochloride Tablets
6. Further information
1. What Dicycloverine hydrochloride
Tablets are and what they are used for
What Dicycloverine hydrochloride Tablets are
Dicycloverine hydrochloride Tablets contain a medicine
called dicycloverine hydrochloride. This belongs to a
group of medicines called antispasmodics.
What Dicycloverine hydrochloride Tablets are used for
• Cramps
• Pain in the stomach or intestine (gut)
• Stomach or intestine (gut) problems - such as
irritable bowel.
How Dicycloverine hydrochloride Tablets work
Dicycloverine hydrochloride Tablets work by relaxing
the muscles in your stomach and gut (intestine). It stops
sudden muscle contractions (spasms). In doing this, it
relieves cramps, pain, bloating, wind and discomfort.
2. Before you take Dicycloverine hydrochloride Tablets
Do not take Dicycloverine hydrochloride
Tablets if:
× You are allergic (hypersensitive) to dicycloverine
hydrochloride or any of the other ingredients in
Dicycloverine hydrochloride Tablets (see Section 6:
Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Dicycloverine hydrochloride Tablets.

Take special care with Dicycloverine
hydrochloride Tablets Check with your doctor or
pharmacist before taking your medicine if:
▲ You have glaucoma (signs include painful eyes
with blurred vision)
▲ You have an enlarged prostate
▲ You have indigestion or heart burn caused by a
‘hiatus hernia’ (where part of your stomach
pushes through the diaphragm)
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Dicycloverine hydrochloride Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines.
Dicycloverine hydrochloride Tablets should not be taken
at the same time as other medicines. This is because
Dicycloverine hydrochloride Tablets may affect the way
other medicines work. Also some medicines may affect
the way Dicycloverine hydrochloride Tablets work.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking this
medicine if:
• You are pregnant, might become pregnant, or
think you may be pregnant
• You are breast-feeding or planning to breast-feed
Driving and using machines
You may feel dizzy, tired or sleepy or have blurred
eyesight whilst taking Dicycloverine hydrochloride Tablets.
If this happens, do not drive or use any tools or machines
Important information about some of the
ingredients of Dicycloverine hydrochloride Tablets
Dicycloverine hydrochloride Tablets contain sugars
(lactose, sucrose and glucose). If you have been told by
your doctor that you cannot tolerate or digest some
sugars, talk to your doctor before taking this medicine
3. How to take Dicycloverine hydrochloride Tablets
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets with a glass of water
• Take before or after meals
How much to take
The usual dose is:
Adults and children 12 years of age or
older
• One or two tablets 3 times each day
Children 2 to 11 years of age
• One tablet 3 times each day
• Dicycloverine hydrochloride Syrup is also
available for use in this age group

LLET RFED DICYCLOVERINE HCL 10MG

Category:
LEAFLET
Argus Code: 593
Spec No:
30439200
Supersedes: N/A
Core Spec No: 60100200
Ticket No:
Date:
Issue No:
Operator:
Page:

293017
08.02.11
1
KY
1 of 2

FOR SCHAWK
USE ONLY

Unwind:
FRONT 5
Size:
148 x 210 mm
Win/RFL Ref: RFL 026
Barcode:
N/A
Mag:
N/A
BWR:
N/A
BWR to be assigned by printer.
Fonts:

Ocean Sans MT Pro

No. colours and varnish: 1
Pantone
Reflex Blue

Artwork Approval
Reason for Circulation:

FOR
..................................
WINTHROP USE
..................................
. . . . . . . . . . . .ONLY
......................
..................................

..................................
Winthrop Marketing
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No
Date:
Signature:

N/A

THESE
SIGNATURES
ARE
Winthrop
Pharmacist/Medical Affairs
Approved: Yes
No
N/A
Date:
FOR WINTHROP
Signature:
HEAD
OFFICE
USE
Winthrop
Regulatory
Affairs
Approved: Yes
No
ONLY
Date:
Signature:

3 0 4 3 96 021 0 002 000

Brand:
If you take more Dicycloverine hydrochloride
Tablets than you should
Talk to your doctor or go to a hospital straight away.
Remember to take any medicine that is left with you
so the doctor knows what you have taken.
The following effects may happen: headache, feeling
dizzy, feeling sick, dry mouth or difficulty in
swallowing, blurred eyesight and hot dry skin.
If you forget to take Dicycloverine hydrochloride
Tablets
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for the
next dose, skip the missed dose.
If you stop taking Dicycloverine hydrochloride
Tablets
Keep taking Dicycloverine hydrochloride Tablets
until your doctor tells you to stop. Do not stop
taking Dicycloverine hydrochloride Tablets just
because you feel better. If you stop, your cramps or
pain may come back.
4. Possible side effects
Like all medicines, Dicycloverine hydrochloride
Tablets can cause side effects, although not
everybody gets them.
Stop taking Dicycloverine hydrochloride Tablets
and see a doctor or go to a hospital straight away if;
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer
than a few days. Also tell them if you notice any
side effects not listed in this leaflet:
• Dry mouth or thirst
• Feeling dizzy
• Feeling tired or sleepy
• Blurred eyesight
• Rash
• Loss of appetite (anorexia)
• Feeling sick (nausea) or being sick (vomiting)
• Constipation
• Headache
• Difficulty or pain on passing water (urine)

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further Information
What Dicycloverine hydrochloride hydrochloride
Tablets contains
• Each tablet contains 10mg of the active
substance, dicycloverine hydrochloride
• The other ingredients are: lactose, calcium
hydrogen phosphate, icing sugar (sucrose and
starch), maize starch, glucose liquid, magnesium
stearate and purified water
What Dicycloverine hydrochloride Tablets looks
like and contents of the pack
Dicycloverine hydrochloride 10mg Tablets are white,
round, biconvex tablets with a ‘M’ in two concentric
circles on one side. They are supplied in blister packs
of 100 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva,
One Onslow Street,
Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Sanofi Synthelabo Limited
Fawdon Manufacturing Centre
Edgefield Avenue, Fawdon
Newcastle Upon Tyne
NE3 3TT United Kingdom
This leaflet does not contain all the information
about your medicine. If you have any questions or
are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in January 2011
© Zentiva 2011

LLET RFED DICYCLOVERINE HCL 10MG

Category:
LEAFLET
Argus Code: 593
Spec No:
30439200
Supersedes: N/A
Core Spec No: 60100200
Ticket No:
Date:
Issue No:
Operator:
Page:

293017
08.02.11
1
KY
2 of 2

FOR SCHAWK
USE ONLY

Unwind:
BACK 1
Size:
148 x 210 mm
Win/RFL Ref: RFL 026
Barcode:
N/A
Mag:
N/A
BWR:
N/A
BWR to be assigned by printer.
Fonts:

Ocean Sans MT Pro

No. colours and varnish: 1
Pantone
Reflex Blue

Artwork Approval
Reason for Circulation:

FOR
WINTHROP USE
..................................
. . . . . . . . . . . .ONLY
......................
..................................
..................................

..................................

5. How to store Dicycloverine hydrochloride Tablets
Keep this medicine in a safe place where children
cannot see or reach it
Do not use Dicycloverine hydrochloride Tablets after
the expiry date which is stated on the blister or
carton after EXP. The expiry date refers to the last
day of that month.
Do not store above 25°C.

Winthrop Marketing
Approved: Yes
No
Date:
Signature:

30439200
593

N/A

THESE
SIGNATURES
ARE
Winthrop
Pharmacist/Medical Affairs
Approved: Yes
No
N/A
Date:
FOR WINTHROP
Signature:
HEAD
OFFICE
USE
Winthrop
Regulatory
Affairs
Approved: Yes
No
ONLY
Date:
Signature:

3 0 4 3 96 021 0 002 000

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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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