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MULTI-ACTION ACTIFED DRY COUGHS

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE / PSEUDOEPHEDRINE HYDROCHLORIDE / TRIPROLIDINE HYDROCHLORIDE / DEXTROMETHORPHAN HYDROBROMIDE / PSEUDOEPHEDRINE HYDROCHLORIDE / TRIPROLIDINE HYDROCHLORIDE / DEXTROMETHORPHAN HYDROBROMIDE / PSEUDOEPHEDRINE HYDROCHLORIDE / TRIPROLIDINE

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Multi-Action ACTIFED®
Dry Coughs
pseudoephedrine, triprolidine,
dextromethorphan
This medicine is used to help relieve symptoms of
cold and flu including irritating dry cough and related
congestion symptoms.
Q This medicine is for use by adults and children aged 12
years and over.
Q Do not use this medicine:
Q There are some people who should not use this
medicine. To find out if you are one of them See Section
2
Q If you have ever had a bad reaction to any of the
ingredients. For the list of ingredients See Section 6
Q Speak to your doctor:
Q If you suffer from any of the conditions mentioned in
Section 2. See Section 2
Q If you are taking any other medicines. See Section 2
Q Follow the dosage instructions carefully. These
are shown in the table. See Section 3
Now read this whole leaflet carefully before you
use this medicine. Keep the leaflet: you might need
it again.
Q

1 What the medicine is for
Multi-Action Actifed Dry Coughs is a medicine which
is used to help relieve dry coughs and related
congestion symptoms. The liquid contains triprolidine
hydrochloride which is an antihistamine that helps stop
sneezing, runny nose and watery eyes, pseudoephedrine
hydrochloride which is a decongestant that unblocks
stuffy noses and dextromethorphan hydrobromide
which is an antitussive to help stop coughing.
The medicine is for use in adults and children aged 12
years and over.

2 Before taking this
medicine
This medicine is suitable for most people but a few
people should not use it. If you are in any doubt, talk to
your doctor or pharmacist.

F310582 - PIL ACTIFED MA DRY COUGHS 100MLv11.2.indd 1

Do not use this medicine…
If you have ever had a bad reaction to any of
the ingredients.
If you have very high blood pressure or
severe heart disease.
Q If you are taking, or have taken in the last two
weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
Q If you are taking furazolidone (an
antibacterial agent).
Q If you have had a cough for a few weeks, or a
cough which brings up any blood or a lot of
mucus that may be caused by asthma or
other serious breathing difficulties.
Q If you are taking any other cough and cold
medicine.
Q For children under 12 years old.
If any of these apply to you, get advice from a
doctor or pharmacist without using MultiAction Actifed Dry Coughs.
Q
Q

Talk to your doctor or pharmacist…
If you suffer from liver or kidney problems.
Q If you have high blood pressure or heart
disease.
Q If you have diabetes or have been told by
your doctor that you have an intolerance to
some sugars.
Q If you have glaucoma (increased pressure in the
eye).
Q If you have an overactive thyroid gland.
Q If you have prostate problems (difficulty with
passing water or needing to pass water often).
Q If you are taking alcohol.
Q If you have a history of drug abuse.
Q If you have been told by your doctor that you
are a slow metabolizer of CYP2D6.
Q If you are taking any other medicines, including:
Q Sedatives (drugs used to treat anxiety and
tension).
Q Certain drugs for depression such as
selective serotonin reuptake inhibitors (SSRIs),
which includes fluoxetine, paroxetine and
sertraline and norepinephrine-dopamine
reuptake inhibitor (NDRI), which include
bupropion and tricyclic antidepressants (used
to treat mood disorders).
Q Sympathomimetic drugs (stimulants or appetite
suppressants and drugs used to treat
congestion and asthma).
Q

Antihypertensives (drugs used to treat high
blood pressure such as guanethidine,
methyldopa, alpha and beta blockers, debrisoquine,
bretylium and betanidine).
Q Antipsychotics (drugs used to treat mood
disorders such as haloperidol, thioridazine,
perphenazine).
Q Anti-arrhythmic agents (drugs used to treat
irregular heart beats such as amiodarone,
propafenone, quinidine and flecainide).
Q Calcimimetic, (drugs to treat secondary
hyperparathyroidism, elevated parathyroid
hormone levels such as cinacalcet).
Q Anti-fungals (terbinafine).
Q Opioids (methadone)
If you are not sure about any of the medicines
you are taking, show the bottle or pack to your
pharmacist.
If any of these bullet points apply to you now or in the
past, talk to a doctor or pharmacist.
Q

If you are pregnant or breast-feeding
Q

Ask your doctor or pharmacist for advice before
taking this medicine if you are pregnant or
breast-feeding.

Special warnings about this medicine
This medicine may cause drowsiness. If affected, do
not operate machinery. Avoid alcoholic drink.
Q This medicine can affect your ability to drive as it
may make you sleepy or dizzy.
Q Do not drive whilst taking this medicine until
you know how this medicine affects you.
It may be an offence to drive when taking this
medicine if your ability to drive safely is affected.
Q However, you would not be committing an
offence if:
Q The medicine has been taken to treat a medical
or dental problem and
Q You have taken it according to the information
provided with the medicine and
Q 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
Q

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Some of the ingredients can cause
problems

Each 5 ml of this medicine contains 2.8 g of
sucrose. This should be taken into account in
patients with diabetes mellitus. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking
this medicine.
Q This medicine contains 5% v/v ethanol (alcohol),
which is up to 190 mg per 5 ml, equal to 5 ml beer
or 2 ml wine per 5 ml. This can be harmful for
those suffering from alcoholism. The ethanol content
should be taken into account in pregnant or breastfeeding women, children and high-risk groups such
as patients with liver disease and epilepsy.
Q Methyl hydroxybenzoate (E218) may cause allergic
reactions such as skin rash; this may happen after
a few days.
Q The colouring in this medicine may cause allergic
reactions.
Q

3 How to take this
medicine
Check the table below to see how much
medicine to take.
For oral use only.
Q Always shake the bottle thoroughly before use.
Q Do not take more than the stated dose shown in the
table.
Q Do not overfill the spoon.
There is a double-ended
spoon in the pack.
Q

Children under 12 years old
Do not give this medicine to children under 12
years old.

Adults and Children aged 12 years
and over
Age
Adults and
children aged 12 years
and over

Dosage
Take two large 5 ml spoonfuls
every 4 - 6 hours, up to 4 times
a day.

QDo not take more than 4 doses in 24 hours.
Q Leave at least 4 hours between doses.
QIf symptoms persist talk to your doctor or pharmacist.

F310582 - PIL ACTIFED MA DRY COUGHS 100MLv11.2.indd 2

If you forget to take the medicine

Do not use this medicine after the expiry date which is
stated on the label after EXP. The expiry date refers to
the last day of that month.
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.

If you forget to take a dose, take the next dose
when needed provided that the last dose was taken
at least 4 hours ago. Do not take a double dose.

6 Further Information

If anyone has too much
If anyone has too much contact a doctor or
your nearest Accident and Emergency Department
(Casualty) taking this leaflet and pack with you.

4 Possible side-effects
Multi-Action Actifed Dry Coughs can have side-effects,
like all medicines, although these don’t affect everyone
and are usually mild.

If you experience any of the following,
stop taking this medicine and talk to
your doctor:
A few people have had hallucinations, but this
is rare.
Q Occasionally people get skin rashes that are
sometimes itchy.
Q A few people may find their heartbeat increased.
Q A few men, especially those with prostate
problems, may have trouble passing water.
Q Nausea, vomiting and upset stomach.
Q

Other effects which may occur include:
Q
Q
Q

Restlessness, having trouble getting to sleep or
bad dreams.
Drowsiness.
Dry mouth, nose or throat.

What’s in this medicine?
The active ingredients in 5 ml of Multi-Action
Actifed Dry Coughs are:
Triprolidine hydrochloride 1.25 mg, pseudoephedrine
hydrochloride 30 mg and dextromethorphan hydrobromide
10 mg.
Other ingredients are: Sorbitol, sucrose, sodium
benzoate (E211), methyl hydroxybenzoate (E218), ponceau
4R (E124), alcohol, blackberry flavour, levomenthol, vanillin
and purified water.

What the medicine looks like
Multi-Action Actifed Dry Coughs is a clear red
liquid available in 100 ml bottles.
The Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
The Manufacturer: Famar Orléans,
5 avenue de Concyr, 45071 Orleans, Cedex 2, France
This leaflet was revised December 2016.
Actifed is a registered trade mark.

Reporting of side-effects
If you get any side-effects, talk to your doctor,
pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet. You can also report sideeffects 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 Storing this medicine
Do not store this product above 25ºC.
Keep the bottle in the outer carton and away from light.
Keep this medicine out of the sight and reach of
children.

F310582
16-0658

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Component: F310582
Client 11.2
JNJ
Version:
Change request #
0802
Dimensions: 160 x 210 CRD
mm
Product
ACTIFED MULTI-ACTION DRY
Minimum font size: 7.5 pts
100ML UK
Component #
Old component #
ATW version
Component type
Dimensions
Drawing #
Safety code type & #
Client code
Main font type
Minimum font size
Colours
Recto 1
Verso 1

F310582 - PIL ACTIFED MA DRY COUGHS 100MLv11.2.indd 3

PMS 206

PMS 206

Black

Black

F310582
F310445
11.2
Rolled Leaflet
160 x 210 mm
NOTC010
Datamatrix F310582
16-0658
Gill sans Condensed
7.5 pts
Recto 2

Verso 2

06/12/2016 11:11

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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