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KOLANTICON GEL

Active substance(s): DICYCLOVERINE HYDROCHLORIDE / DRIED ALUMINIUM HYDROXIDE / MAGNESIUM OXIDE LIGHT / SIMETHICONE EMULSION / DICYCLOVERINE HYDROCHLORIDE / DRIED ALUMINIUM HYDROXIDE / MAGNESIUM OXIDE LIGHT / SIMETHICONE EMULSION / DICYCLOVERINE HYDROCHLORIDE / DRIED ALUMINIUM HYDROXID

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PATIENT INFORMATION LEAFLET
PATIENT INFORMATION
LEAFLET
KOLANTICON® GEL
Oral Suspension
KOLANTICON® GEL
Dicycloverine Hydrochloride, Aluminium Hydroxide Gel, Light Magnesium Oxide, Simeticone
Oral Suspension

Dicycloverine Hydrochloride, Aluminium Hydroxide Gel, Light Magnesium Oxide, Simeticone
Read all of this leaflet carefully because it contains important information for you.
This medicine
is leaflet
available
without because
prescription;
howeverimportant
you still need
to take Kolanticon
Read
all of this
carefully
it contains
information
for you. Gel
carefully to get the best results from it.
This
available
prescription;
however you still need to take Kolanticon Gel
• medicine
Keep thisisleaflet.
Youwithout
may need
to read it again.
carefully
getpharmacist
the best results
• Ask to
your
if youfrom
needit.more information or advice.
Keep thisa leaflet.
may
need to worsen
read it again.
•• Contact
doctor ifYou
your
symptoms
or do not improve.
Ask
your
pharmacist
if you
more
advice.
•• If
any
of the
side effects
getneed
serious
or information
if you noticeorany
side effects not listed in this
• leaflet,
Contactplease
a doctor
yourdoctor
symptoms
worsen or do not improve.
tellifyour
or pharmacist.
• If any of the side effects get serious or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Kolanticon Gel is and what it is used for
In this
leaflet:
2.
Before
you take Kolanticon Gel
1. How
Whatto
Kolanticon
Gel is and
3.
take Kolanticon
Gel what it is used for
2. Possible
Before you
take
Kolanticon Gel
4.
side
effects
3. How to store
take Kolanticon
5.
KolanticonGel
Gel
4. Further
Possibleinformation
side effects
6.
5. How to store Kolanticon Gel
6. KOLANTICON
Further information
1. WHAT
GEL IS AND WHAT IT IS USED FOR
• Kolanticon Gel contains an antispasmodic (relieves muscle spasm), an antiflatulent (relieves
1. WHAT
KOLANTICON
wind) and
antacids. GEL IS AND WHAT IT IS USED FOR
Kolanticon Gel
Gel is
contains
antispasmodic
(relieves muscle
antiflatulent
(relieves
•• Kolanticon
used toan
treat
stomach complaints,
such asspasm),
irritable an
bowel
syndrome,
where
wind) are
andproblems
antacids. such as painful cramps, indigestion and flatulence (wind).
there
Kolanticon
Gel is used
tocramps
treat stomach
complaints,
such of
asthe
irritable
bowelIt syndrome,
where
•• It
helps to relieve
painful
by relaxing
the muscles
intestine.
helps to relieve
there are problems
suchacidity,
as painful
indigestion
flatulence
(wind).
indigestion
by reducing
and cramps,
relieve flatulence
byand
bringing
together
all the small bubbles
• of
It helps
relieve
painful
cramps
by can
relaxing
the muscles of the intestine. It helps to relieve
gas totoform
a large
bubble
which
be expelled.
indigestion by reducing acidity, and relieve flatulence by bringing together all the small bubbles
be expelled.
of gas to form
large bubble
which can
2. BEFORE
YOUaTAKE
KOLANTICON
GEL
Do not take Kolanticon Gel if:
YOU TAKE
GEL
of the ingredients
(see Section 6)
•2. BEFORE
You are allergic
to anyKOLANTICON
not have
take Kolanticon
Gel if:
•DoYou
difficulty passing
urine because of an enlarged prostate or other condition
You have
are allergic
to any
of the
ingredients
(see affecting
Section 6)movement of food through the gastro•• You
ulcerative
colitis
or other
conditions
• intestinal
You havetract
difficulty passing urine because of an enlarged prostate or other condition
You have
have myasthenia
ulcerative colitis
or (a
other
affecting
movement of food through the gastro•• You
gravis
veryconditions
rare muscle
disease)
intestinal
• You
havetract
glaucoma (a condition involving increased pressure within the eye resulting in poor
• vision).
You have myasthenia gravis (a very rare muscle disease)
• You have
glaucoma
(a condition
involving
increased
pressure
Before
taking
Kolanticon
Gel tell your
doctor
/ pharmacist
if: within the eye resulting in poor
• vision).
You have or have had kidney problems
taking
Kolanticon
Gel diet
tell your doctor / pharmacist if:
•Before
You have
a low
phosphorus
You have
have a
orhiatus
have had
kidney
problems
•• You
hernia
(a condition
with symptoms such as acid or food regurgitation)
• You have a low phosphorus diet
• You have a hiatus hernia (a condition with symptoms such as acid or food regurgitation)

Taking other medicines:
Taking other medicines:

data
matrix

wind) and antacids.
• Kolanticon Gel is used to treat stomach complaints, such as irritable bowel syndrome, where
there are problems such as painful cramps, indigestion and flatulence (wind).
• It helps to relieve painful cramps by relaxing the muscles of the intestine. It helps to relieve
indigestion by reducing acidity, and relieve flatulence by bringing together all the small bubbles
of gas to form a large bubble which can be expelled.
2. BEFORE YOU TAKE KOLANTICON GEL
Do not take Kolanticon Gel if:
• You are allergic to any of the ingredients (see Section 6)
• You have difficulty passing urine because of an enlarged prostate or other condition
• You have ulcerative colitis or other conditions affecting movement of food through the gastrointestinal tract
• You have myasthenia gravis (a very rare muscle disease)
• You have glaucoma (a condition involving increased pressure within the eye resulting in poor
vision).
Before taking Kolanticon Gel tell your doctor / pharmacist if:
• You have or have had kidney problems
• You have a low phosphorus diet
• You have a hiatus hernia (a condition with symptoms such as acid or food regurgitation)

Tell your doctor or pharmacist if you are taking any other medicines, in pa
Taking other medicines:
tetracycline, ciprofloxacin, rifampicin), ACE inhibitors, anticoagulants, digo
penicillamine
or in
biphosphonates.
Tell
Tellyour
yourdoctor
doctorororpharmacist
pharmacistififyou
youare
aretaking
takingany
anyother
othermedicines,
medicines,
inparticular
particularantibiotics
antibiotics(e.g.
(e.g.
This
is because Kolanticon
Gel may affect the absorption of other medicin
tetracycline,
tetracycline,ciprofloxacin,
ciprofloxacin,rifampicin),
rifampicin),ACE
ACEinhibitors,
inhibitors,
anticoagulants,
anticoagulants,
digoxin,
digoxin,ketoconazole,
ketoconazole,
time.
penicillamine
penicillamineororbiphosphonates.
biphosphonates.
This
Thisisisbecause
becauseKolanticon
KolanticonGel
Gelmay
mayaffect
affectthe
theabsorption
absorptionofofother
othermedicines
medicinestaken
takenatatthe
thesame
same
Pregnancy and breast feeding:
time.
time.
Tell your doctor or pharmacist if you are or may be pregnant or if you are b
Pregnancy
Pregnancyand
andbreast
breastfeeding:
feeding:
3. HOWor
TO
TAKE
KOLANTICON
GEL
Tell
Tellyour
yourdoctor
doctorororpharmacist
pharmacistififyou
youare
areorormay
maybe
bepregnant
pregnant
orififyou
youare
are
breast
breastfeeding.
feeding.
Adults and Children over 12 years old:
3.3.HOW
HOWTO
TOTAKE
TAKEKOLANTICON
KOLANTICONGEL
GEL
• The usual dose of Kolanticon Gel is two to four 5ml spoonfuls (10 – 20m
Adults
Adultsand
andChildren
Childrenover
over12
12years
yearsold:
old:
needed.
Theusual
usualdose
doseofofKolanticon
KolanticonGel
Gelisistwo
twototofour
four5ml
5ml
spoonfuls
(10
20ml)
every
four
hours
• • The
(10
––20ml)
hours
• spoonfuls
You should
shake
theevery
bottlefour
before
useififto mix the ingredients properly.
needed.
needed.
amount you need onto a 5ml spoon and swallow the liquid.
you take more
than
youmeasure
should:
Youshould
shouldshake
shakethe
thebottle
bottlebefore
beforeuse
usetotomix
mixthe
theIfingredients
ingredients
properly.
Then
measureout
outthe
the
• • You
properly.
Then
amountyou
youneed
needonto
ontoaa5ml
5mlspoon
spoonand
andswallow
swallowthe
liquid.
amount
liquid.
•theIf
you accidentally take too much medicine you should consult your doc
youtake
takemore
morethan
thanyou
youshould:
should:
IfIfyou
hospital casualty department.
If you
forgetyour
to take
Kolanticon
Gel:nearest
youaccidentally
accidentallytake
taketoo
toomuch
muchmedicine
• • IfIfyou
medicineyou
youshould
should
consult
consult
your
doctor
doctor
ororgo
gototoyour
your
nearest
hospital
hospitalcasualty
casualtydepartment.
department.
• If you forget to take your medicine at the correct time, don’t worry. Do
IfIfyou
youforget
forgettototake
takeKolanticon
KolanticonGel:
Gel:
next time. Just take your medicine as soon as you remember and carry
youforget
forgettototake
takeyour
yourmedicine
medicineatatthe
thecorrect
correcttime,
time,don’t
don’tworry.
worry. Do
Donot
nottake
taketwice
twiceas
asmuch
much
• • IfIfyou
4.remember
POSSIBLE
SIDE
EFFECTS
nexttime.
time. Just
Justtake
takeyour
yourmedicine
medicineas
assoon
soonas
asyou
you
remember
and
carry
onas
asbefore.
before.
next
and
carry
on
Like all medicines, Kolanticon Gel can cause side effects, although not eve
Some people may get a dry mouth, blurred vision, constipation or difficulty
POSSIBLESIDE
SIDEEFFECTS
EFFECTS
4.4.POSSIBLE
If anyalthough
of the side
effects
getgets
serious,
or if you notice any side effects
Likeall
allmedicines,
medicines,Kolanticon
KolanticonGel
Gelcan
cancause
causeside
sideeffects,
effects,
although
noteverybody
everybody
getsthem.
them.
Like
not
leaflet, please
tell your
doctor
or pharmacist.
Somepeople
peoplemay
mayget
getaadry
drymouth,
mouth,blurred
blurredvision,
vision,constipation
constipation
difficulty
passing
urine.
Some
orordifficulty
passing
urine.
If any of the
side effects:
effects get
serious,
if you
notice
any
effects pharmacist
not listed in
Reporting
of side
If you
get anyorside
effects,
talk
to side
your doctor,
orthis
nurse.
5. HOW
TOYou
STORE
KOLANTICON
GEL directly
leaflet,
please
your doctor
or pharmacist.
This
includes
anytell
possible
side effects
not listed in this
leaflet.
can also
report side effects
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.
Keep out of the reach and sight of children.

Do not use your medicine after the expiry date on the label, or if the medic
HOWTO
TOSTORE
STOREKOLANTICON
KOLANTICONGEL
GEL
5.5.HOW
°C.
any way.
Keepout
outofofthe
thereach
reachand
andsight
sightofofchildren.
children.
Keep
Donot
notuse
useyour
yourmedicine
medicineafter
afterthe
theexpiry
expirydate
dateon
onthe
the
label,
themedicine
medicine
has
deteriorated
Keep
your
in the
original
bottle and
Do
label,
ororififmedicine
the
has
deteriorated
inin store below 25
anyway.
way.
any
6. FURTHER
Keepyour
yourmedicine
medicineininthe
theoriginal
originalbottle
bottleand
andstore
storebelow
below
25°C. INFORMATION
Keep
25°C.
What Kolanticon Gel Contains:
The active ingredients are:
FURTHERINFORMATION
INFORMATION
6.6.FURTHER
Each 5ml spoonful of Kolanticon Gel contains: 2.5mg dicycloverine hydroc
WhatKolanticon
KolanticonGel
GelContains:
Contains:
What
aluminium hydroxide, 100mg magnesium oxide and 20mg simeticone.
Theactive
activeingredients
ingredientsare:
are:
The
Each5ml
5mlspoonful
spoonfulofofKolanticon
KolanticonGel
Gelcontains:
contains:2.5mg
2.5mgdicycloverine
dicycloverinehydrochloride,
hydrochloride,200mg
200mg
Each
The
other
ingredients are: Magnesium sulphate, methylcellulose 450, be
aluminiumhydroxide,
hydroxide,100mg
100mgmagnesium
magnesiumoxide
oxideand
and20mg
20mg
simeticone.
aluminium
simeticone.
ic acid, oil of cinnam
lauryl sulphate, saccharin sodium, alcohol 95%, methyl parahydroxybenzo
parahydroxybenzoate,
butyl
parahydroxybenzoate,
citr
The
450,
alcohol,
sodium
Theother
otheringredients
ingredientsare:
are:Magnesium
Magnesiumsulphate,
sulphate,methylcellulose
methylcellulose
450,benzyl
benzyl
alcohol,
sodium
spearmint,
oil of cedar leaf,
oil of nutmeg, eucalyptol, menthol and demine
lauryl
parahydroxybenzoate,
propyl
laurylsulphate,
sulphate,saccharin
saccharinsodium,
sodium,alcohol
alcohol95%,
95%,methyl
methyl
parahydroxybenzoate,
propyl
parahydroxybenzoate,
parahydroxybenzoate,butyl
butylparahydroxybenzoate,
parahydroxybenzoate,citric
citricacid,
acid,oiloilofofcinnamon,
cinnamon,peppermint
peppermintoil,
oil,oiloilofof
Kolanticon
Gel lookswater.
like:
spearmint,
menthol
and
spearmint,oiloilofofcedar
cedarleaf,
leaf,oiloilofofnutmeg,
nutmeg,eucalyptol,
eucalyptol,What
menthol
anddemineralised
demineralised
water.
Kolanticon Gel is a thick, white liquid available in bottles of 200ml and 500
What
WhatKolanticon
KolanticonGel
Gellooks
lookslike:
like:
Marketing
Authorisation
Kolanticon
ofof200ml
and
KolanticonGel
Gelisisaathick,
thick,white
whiteliquid
liquidavailable
availableininbottles
bottles
200ml
and500ml.
500ml. Holder:
Peckforton Pharmaceuticals Ltd., Crewe Hall, Crewe, Cheshire, CW1 6UL
Marketing
MarketingAuthorisation
AuthorisationHolder:
Holder:
Manufactured
by:
Peckforton
Cheshire,
6UL,
PeckfortonPharmaceuticals
PharmaceuticalsLtd.,
Ltd.,Crewe
CreweHall,
Hall,Crewe,
Crewe,
Cheshire,CW1
CW1
6UL,England.
England.
Fleet Laboratories Ltd., 94 Rickmansworth Road, Watford, Hertfordshire, W
Manufactured
Manufacturedby:
by:
Date of
revision: JulyWD1
2008
Fleet
Hertfordshire,
England.
FleetLaboratories
LaboratoriesLtd.,
Ltd.,94
94Rickmansworth
RickmansworthRoad,
Road,Watford,
Watford,
Hertfordshire,
WD17JJ,
7JJ,England.

Date
Dateofofrevision:
revision:June
July 2015
2008

LTFxxxx

Expand Transcript

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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