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ROBITUSSIN DRY COUGH MEDICINE

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE

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PAA058849
PAA046486

DRY COUGH
MEDICINE

Dextromethorphan Hydrobromide
7.5 mg per 5 ml

Liquid for Oral Administration

Read all of this leaflet carefully because it contains important information for you
This medicine is available without prescription. However, you will still need to use this medicine
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 7 days.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Robitussin Dry Cough Medicine is and what it is used for
2. Before you take Robitussin Dry Cough Medicine
3. How to take Robitussin Dry Cough Medicine
4. Possible side effects
5. How to store Robitussin Dry Cough Medicine
6. Further information
1. What Robitussin Dry Cough Medicine is and what it is used for
The active ingredient dextromethorphan belongs to a group of medicines called cough suppressants
that work by providing relief from persistent dry irritant coughs.
2. Before you take Robitussin Dry Cough Medicine
Do not take this medicine if:
- You are allergic (hypersensitive) to dextromethorphan hydrobromide or any of the other
ingredients in this medicine.
- You are currently taking a prescription monoamine oxidase inhibitor (MAOI), used to treat
depression and Parkinson's disease or have taken this medicine in the last 14 days.
- You are currently taking a selective serotonin reuptake inhibitor (SSRI), used to treat depression
and anxiety or have taken this medicine in the last 14 days.
- You are currently taking any other medication for depression, psychiatric, or emotional
conditions, or Parkinson's disease or have done so in the last 14 days.
Take special care and talk to your doctor before taking this medicine if:
- You have had a cough for a long time or if you have asthma or suffer from serious asthma attacks,
or if your cough is accompanied by a fever, rash, or persistent headache.
- You have liver problems.
Pregnancy and breastfeeding
Talk to your doctor before taking this medicine if you are pregnant or breastfeeding.
Driving and using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
- Do not drive while taking this medicine until you know how it affects you.
- It may be an offence to drive when taking this medicine.
- However, you would not be committing an offence if:
• The medicine has been taken to treat a medical problem and
• You have taken it according to the information provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may
be found here: https://www.gov.uk/drug-driving-law
Taking other medicines
Do not take if you are taking any of the following medicines, or have done so in the last 14 days:
- A prescription monoamine oxidase inhibitor (MAOI), used to treat depression and Parkinson's disease.
- A selective serotonin reuptake inhibitor (SSRI), used to treat depression and anxiety.
- Any other medication for depression, psychiatric, or emotional conditions, or Parkinson’s disease.
If you are not sure if your prescription medicine contains one of these drugs, ask a doctor or
pharmacist before taking this product.
Talk to your doctor or pharmacist if you are:
- Taking Quinidine or Amiodarone, which are both used to treat some heart conditions.
Important information about some of the ingredients of this medicine:
- This medicine contains amaranth (E123), which may cause allergic reactions.
- If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine as it contains sorbitol and maltitol.

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-

This medicinal product contains 2.5 % v/v alcohol (ethanol) (196 mg per 10 ml dose).
This is equivalent to approximately 2 ml wine per dose which can be harmful for those suffering
- from
This medicinal
contains
2.5 %into
v/vaccount
alcohol (ethanol)
mg per
10 ml dose). or have
alcoholismproduct
and should
be taken
if you are (196
pregnant
or breastfeeding
This
equivalent
to approximately 2 ml wine per dose which can be harmful for those suffering
liver is
disease
or epilepsy.
from to
alcoholism
and shouldDry
be taken
intoMedicine
account if you are pregnant or breastfeeding or have
3. How
take Robitussin
Cough
liveruse
disease
For oral
only.or epilepsy.
3.
How to
Robitussin
Dry Cough
Medicine
Adults,
thetake
elderly
and children
over 12
years: Take 10 ml up to four times daily, as required.
For
oral useunder
only. 12 years: Do not use.
Children
Adults,
the elderly
and children
Use the dosing
cup provided
with the over
pack. 12 years: Take 10 ml up to four times daily, as required.
Children under 12 years: Do not use.
Do not exceed the stated dose.
Use
dosing
cupmedicine
provided with
the pack.
Stopthe
using
this
and ask
a healthcare professional if you have had a cough for more
Do
exceed
dose.
thannot
7 days
or ifthe
youstated
have any
other symptoms which might be related to your cough, for example
Stop
using
medicine
and ask a healthcare professional if you have had a cough for more
fever, rash
or this
persistent
headache.
than
daysmore
or if you
have anythan
otheryou
symptoms
which might be related to your cough, for example
If you7take
medicine
should:
fever,
headache.
If you rash
take or
toopersistent
much of this
medicine, consult your doctor or hospital immediately.
If
youany
take
more medicine
thanyou
you
should:
Bring
remaining
medicine with
to show
the doctor.
If
take tooside
mucheffects
of this medicine, consult your doctor or hospital immediately.
4.you
Possible
Bring
remainingRobitussin
medicine Dry
withCough
you to Medicine
show the doctor.
Like allany
medicines,
can cause side effects, although not everybody
4.
Possible
side
effects
gets
them. Side
effects
with dextromethorphan hydrobromide are rare. However, susceptible
Like
all medicines,
Robitussin
Dry Cough
individuals
may experience
unwanted
sideMedicine
effects. can cause side effects, although not everybody
gets
hydrobromide
are rare.
However,
susceptible
If anythem.
of theSide
sideeffects
effectswith
getsdextromethorphan
serious or you experience
any other
side effects,
STOP
taking this
individuals
may experience
unwanted
effects.
medicine immediately
and consult
yourside
doctor:
If
of the reactions.
side effectsSymptoms
gets serious
or you
experience
anyorother
sidedifficulty
effects,breathing,
STOP taking
this
- any
Allergic
could
include
itchy skin
rashes,
faster
heart
medicine
immediately
and
consult
doctor:
rate, swelling
of the
face
or theyour
throat.
- Allergic
Stomachreactions.
upset. Symptoms could include itchy skin or rashes, difficulty breathing, faster heart
swelling of the face or the throat.
- rate,
Dizziness.
-If you
Stomach
get anyupset.
side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
-effects
Dizziness.
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
If
get any side effects, talk to your doctor,
pharmacist
or nurse.
any possible
at:you
www.mhra.gov.uk/yellowcard.
By reporting
side effects
youThis
canincludes
help provide
more side
effects
not listed
this leaflet.
can also report side effects directly via the Yellow Card Scheme
information
on theinsafety
of thisYou
medicine.
at:
www.mhra.gov.uk/yellowcard.
By reporting
side effects you can help provide more
5. How
to store Robitussin Dry Cough
Medicine
information
on the
of this
medicine.
- Do not use
thissafety
medicine
after
the expiry date shown on the top end of the carton.
5.
store
Robitussin Dry Cough Medicine
- How
Storeto
below
25°C.
- Do
notout
use
expiry date shown on the top end of the carton.
Keep
of this
the medicine
sight and after
reachthe
of children.
-6. Further
Store below
25°C.
information
-What
Keep
out of the Dry
sightCough
and reach
of children.
Robitussin
Medicine
contains:
6.
Further
information
Each
5 ml contains
7.5 mg of the active substance dextromethorphan hydrobromide.
What
Robitussin
Dry Cough
Medicine
contains:Glycerol, sodium carboxymethyl cellulose,
Robitussin
Dry Cough
Medicine
also contains:
Each
5 ml
containsdisodium
7.5 mg ofedetate,
the active
substance
hydrobromide.
sodium
benzoate,
maltitol
(E965),dextromethorphan
ethanol, citric acid
anhydrous, amaranth (E123),
Robitussin
Drylevomenthol,
Cough Medicine
also contains:
sodium 70%,
carboxymethyl
cellulose,
caramel (E150),
cherry/grenadine
flavour, Glycerol,
sorbitol solution
sodium cyclamate,
sodium
benzoate,
disodium
edetate,water.
maltitol (E965), ethanol, citric acid anhydrous, amaranth (E123),
acesulfame
potassium
salt, purified
caramel
(E150),
levomenthol,
cherry/grenadine
flavour,
sodium
cyclamate,
Robitussin
Dry Cough
Medicine
is a liquid, supplied
in asorbitol
100 mlsolution
bottle or70%,
250 ml
bottle.
acesulfame
purified water.
Not all packpotassium
sizes may salt,
be marketed.
Robitussin
Dryand
Cough
Medicine
is medicine:
a liquid, supplied in a 100 ml bottle or 250 ml bottle.
Who makes
supplies
this
Not
all pack sizes
may be marketed.
The Marketing
Authorisation
holder for Robitussin Dry Cough Medicine is:
Who
andHealthcare
suppliesLtd,
thisRamsgate
medicine:
Pfizer makes
Consumer
Road, Sandwich, Kent, CT13 9NJ, UK.
The
Authorisation
holder forby:
Robitussin Dry Cough Medicine is:
TheMarketing
dosing cup
is manufactured
Pfizer
Consumer
Healthcare
Ramsgate
Road,
Sandwich,
Kent,
CT13
9NJ,
UK.
Humphrey
Cosburn
Plastics, Ltd,
89 Union
Street,
Toronto,
Ontario,
M6N
3N2,
Canada.
The
dosing
cup
is
manufactured
by:
The EU Authorised Representative is: Pfizer Consumer Healthcare Ltd.
Humphrey Cosburn Plastics, 89 Union Street, Toronto, Ontario, M6N 3N2, Canada.
This medicine is manufactured by:
The
EUPharmaceuticals,
Authorised Representative
is: Hampshire,
Pfizer Consumer
Healthcare
Wyeth
New Lane, Havant,
PO9 2NG,
UnitedLtd.
Kingdom.
This
Or medicine is manufactured by:
Wyeth Pharmaceuticals,
New Lane, 90,
Havant,
Hampshire,
Lederle S.r.l., Via Nettunese
04011
Aprilia (LT)PO9
Italy.2NG, United Kingdom.
Or
If you have any queries, comments about this medicine or require information in large print, tape or
Wyeth Lederle S.r.l., Via Nettunese 90, 04011 Aprilia (LT) Italy.
CD please contact the Careline by phone or write to:
If
you havePfizer
any queries,
comments
about
medicine
requireKT20
information
in large print, tape or
Careline,
Consumer
Healthcare
Ltd,this
Walton
Oaks,orSurrey,
7NS, UK.
CD
please contact the Careline by phone or write to:
or carelineUK@pfizer.com
Careline,
Pfizer Consumer
Healthcare Ltd, Walton Oaks, Surrey, KT20 7NS, UK.
prepared:
March2015
2014
Leaflet
April
or
PLcarelineUK@pfizer.com
Number: 00165/0100
Leaflet
prepared: March 2014
MA111/00402
PAA058849
PL
Number: 00165/0100
PAA046486
MA111/00402
PAA046486

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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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