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OTRIVINE EXTRA DUAL RELIEF 0.5MG/ML 0.6MG/ML NASAL SPRAY

Active substance(s): IPRATROPIUM BROMIDE / XYLOMETAZOLINE HYDROCHLORIDE / IPRATROPIUM BROMIDE / XYLOMETAZOLINE HYDROCHLORIDE

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AWF 25476 – OTDC 418880
OTRIVINE COMPLETE F100 10ML GB_317237_PIL
157.5 x 210 mm – PN-P12-V6 – Recto/Verso
XXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis421203 – KR – 10.04.2017

Draft B

WARNING: Wrong display / print > switch overprint ON

Recto
157.5 mm

11 mm

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Otrivine® Extra Dual Relief Nasal spray is used for the
treatment of nasal congestion with runny nose (rhinorrhea)
in connection with common colds.

210 mm

What is in this leaflet:
1. What Otrivine® Extra Dual Relief Nasal spray is and what
it is used for
2. What you need to know before you use Otrivine® Extra Dual
Relief Nasal spray
3. How to use Otrivine® Extra Dual Relief Nasal spray
4. Possible side effects
5. How to store Otrivine® Extra Dual Relief Nasal spray
6. Contents of the pack and other information

1. WHAT OTRIVINE® EXTRA DUAL RELIEF NASAL
SPRAY IS AND WHAT IT IS USED FOR
Otrivine® Extra Dual Relief Nasal spray is a combination
medicinal product consisting of two different substances
(xylometazoline hydrochloride and ipratropium bromide).
One of the active ingredients (ipratropium bromide) helps with
the runny nose, the other (xylometazoline hydrochloride) has
a decongesting effect.

Do not use Otrivine® Extra Dual Relief Nasal spray
• In children below 18 years of age, as adequate information
on safety and efficacy is not available
• If you are allergic to Xylometazoline hydrochloride
or ipratropium bromide or any of the other ingredients of this
medicine (listed in section 6)
• If you are allergic to atropine or similar substances,
e.g. hyoscyamine and scopolamine
• If you had your pituitary gland removed by surgery
carried out through the nose
• If you have had brain surgery where the operation
was carried out through the nose or mouth
• If you suffer from glaucoma (increased pressure in the eye)
• If you have a very dry nose (inflammatory nasal dryness,
rhinitis sicca).

Pharma code XXX

Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
Always use this medicine exactly as described in this leaflet
or as your doctor or pharmacist have told you.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
– This medicine should not be used for more than
7 consecutive days.
– You must talk to a doctor or pharmacist if you do not feel
better or if you feel worse.
– This medicine has been recommended for you only. Do not
pass it onto others. It may harm them, even if their signs
of illness are the same as yours.

72 mm

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE OTRIVINE® EXTRA DUAL RELIEF NASAL
SPRAY

Warnings and precautions
Talk to your doctor or pharmacist before using
Otrivine® Extra Dual Relief Nasal spray if you suffer from:
• Heart disease and/or raised blood pressure
• Diabetes
• An overactive thyroid gland (hyperthyroidism)
• Difficulty in urinating and/or an enlarged prostate gland
• Narrow-angle glaucoma (sudden build-up of pressure
in the eye)
• A tendency to have nosebleeds
• Obstruction of the gut (small intestine)
• Cystic fibrosis
• Benign tumour of the adrenal gland that produces
high amounts of adrenaline and nor-adrenaline
(phaeochromocytoma) or a particular sensitivity to
adrenaline and nor-adrenaline as you may experience
dizziness, tremor, rapid heart rate, raised blood pressure
and sleeplessness.
Immediate hypersensitivity (allergic reaction) may occur
in rare cases. This may be seen as itchy red rash with
raised inflammation of the skin (hives), difficulty breathing
or speaking, difficulty swallowing due to swelling of the lips,
face or throat. These symptoms may appear individually
or all combined as a severe allergic reaction. If this occurs,
immediately STOP using this medicine (see section 4).
Worsening of narrow-angle glaucoma may also occur.
Prolonged or excessive use may cause stuffiness
in the nose to return or worsen and swelling of the
nasal mucosa.

9 mm

10 mm

10 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 25476 – OTDC 418880
OTRIVINE COMPLETE F100 10ML GB_317237_PIL
157.5 x 210 mm – PN-P12-V6 – Recto/Verso
XXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis421203 – KR – 10.04.2017

Draft B

WARNING: Wrong display / print > switch overprint ON

Verso

9 mm

157.5 mm

Children, adolescents and elderly
Otrivine® Extra Dual Relief Nasal spray is not recommended for
use in children and adolescents below 18 years or in the
elderly above 70 years of age, as adequate information on
safety and efficacy is not available.
Other medicines and Otrivine® Extra Dual Relief Nasal
spray
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
It is particularly important that you mention the following:
• Monoamine oxidase inhibitors (used for treatment of
depression). If you are taking or have taken these in the last
two weeks, dangerous rises of the blood pressure may occur
• Tri-cyclic and tetra-cyclic antidepressants (if you are taking
or have taken these in the last two weeks)
• Medicines used for travel sickness (medicines containing
anticholinergic substances)
• Medicines used for gut disorders (particularly those for
abnormal motility) (medicines containing anticholinergic
substances).
If you use any of the above medicines, consult a doctor before
using Otrivine® Extra Dual Relief Nasal spray.
Pregnancy and breast-feeding
Otrivine® Extra Dual Relief Nasal spray should not be used
during pregnancy unless your doctor recommends it.

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Driving and using machines:
Visual disturbances (including blurred vision and dilation of the
pupil), dizziness and fatigue have been reported with Otrivine®
Extra Dual Relief Nasal spray. If affected, you should avoid
driving, operating machinery or taking part in activities where
these symptoms may put yourself or others at risk.

3. HOW TO USE OTRIVINE® EXTRA DUAL RELIEF
NASAL SPRAY
Always use this medicine exactly as described in this leaflet
or your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is:
Adults: One puff in each nostril as needed, up to 3 times
daily for maximum 7 days. Leave at least 6 hours between
two doses. Do not exceed 3 applications daily into each nostril.

11 mm

It is recommended that you stop treatment with Otrivine® Extra
Dual Relief Nasal spray as soon as your symptoms improve,
even if this is sooner than 7 days, in order to minimise the risk
of adverse reactions.

Instructions for use:
• Always blow your nose before using the nasal spray
• Remove the dust cap
• Do not cut the nozzle. The metered dose spray is ready
to prime before use

• Before the first application, prime the pump by pumping
4 times. Once primed the pump will normally remain
charged throughout regular daily treatment periods. Should
the spray not be ejected during the full actuation stroke,
or if the product has not been used for longer than 6 days,
the pump will need to be reprimed with 4 pumps as initially
performed
• Hold the bottle upright
• Bend your head slightly forward
• Close one nostril by placing your finger against the side
of your nose and insert the spray tip into the other nostril.
Press the pump quickly while inhaling through the nose
• Repeat this procedure in the other nostril

210 mm

During breast-feeding Otrivine® Extra Dual Relief Nasal spray
should not be used unless your doctor decides the advantages
outweigh the potential risks to the infant.

If you think the effect of this medicine is too strong or too
weak, consult your doctor or pharmacist.

The effect occurs within 5-15 minutes.
Avoid spraying Otrivine® Extra Dual Relief Nasal spray in or
around the eyes. If this happens thoroughly rinse the eyes with
cold water. Your vision may become temporarily blurred and the
eye irritated, painful and red. If this happens contact your
doctor for advice.
If you use more Otrivine® Extra Dual Relief Nasal spray
than you should:
If you, or someone else, have taken more medicine than you
should, contact your doctor, hospital or emergency room for
assessment of the risk. It is advisable to take this leaflet,
bottle or pack with you. This is particularly important for
children who are more likely to develop adverse events than
adults.
Symptoms of overdose are severe dizziness, sweating, severely
lowered body temperature, headache, slow heart beat, rapid
heart beat, impaired breathing, coma, convulsion, hypertension
(high blood pressure) which may be followed by hypotension
(low blood pressure).
Other symptoms may be dry mouth, difficulties focusing with
the eye and hallucinations.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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10 mm

10 mm

Order – AWF
Reference
Format
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Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 25476 – OTDC 418880
OTRIVINE COMPLETE F100 10ML GB_317237_PIL
157.5 x 210 mm – PN-P12-V6 – Recto/Verso
XXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis421203 – KR – 10.04.2017

Draft B

WARNING: Wrong display / print > switch overprint ON

Recto
157.5 mm

11 mm

Gluing Area
STOP using Otrivine® Extra Dual Relief Nasal spray and
seek medical help immediately if you have any of the
following:
• Palpitations and increased heart rate (affects less than
1 in 100 people)
• Signs of an allergic reaction as difficulty breathing, speaking
or swallowing; swelling of the face, lips, tongue or throat;
severe itching of the skin, with a red rash or raised bumps
(frequency not known cannot be estimated from available
data)
• Disturbances of vision (including blurred vision, worsening
of glaucoma or increased pressure in the eye), rainbowcoloured circles/haloes around bright lights and/or eye pain
(frequency not known cannot be estimated from available
data).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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.

The most common side effects are nose bleeding and nasal
dryness. Many of the side effects reported are also symptoms
of common cold.

Do not freeze.

Very common side effects (may affect more than
1 in 10 people):
• Nose bleeding, nasal dryness.

210 mm

Common side effects (may affect up to 1 in 10 people):
• Nasal discomfort, congestion of the nose, dry and irritated
throat, pain in the nose
• Dry mouth
• Altered taste sensation, headache.
Uncommon (may affect up to 1 in 100 people):
• Nasal ulcer, sneezing, pain in the throat, cough, hoarseness
• Stomach upsets, nausea
• Altered smell sensation, dizziness, shakiness
• Discomfort, tiredness
• Sleeplessness
• Irritation of the eyes, dry eyes
Rare (may affect up to 1 in 1,000 people):
• Runny nose
Frequency not known (cannot be estimated from available
data):
• Rash, hives
• Discomfort around the nose
• Discomfort in the chest, thirst
• Sudden spasm of throat muscle
• Irregular pulse
• Difficulties focusing with the eyes, dilation of the pupils
• Itching
• Difficulties emptying the bladder.
In order to minimise the risk of side effects such as nose
bleeding and other effects on the nose, it is recommended
that you stop treatment with Otrivine® Extra Dual Relief Nasal
spray when your symptoms improve even if this is sooner than
7 days.

5. HOW TO STORE OTRIVINE® EXTRA DUAL
RELIEF NASAL SPRAY
Keep this medicine out of the sight and reach of children.
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.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Otrivine® Extra Dual Relief Nasal spray contains
The active substances are xylometazoline hydrochloride and
ipratropium bromide.
1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg
ipratropium bromide.
1 puff contains 70 micrograms xylometazoline hydrochloride
and 84 micrograms ipratropium bromide.
The other ingredients are disodium edetate, glycerol (85%),
purified water, sodium hydroxide and hydrochloric acid.
What Otrivine® Extra Dual Relief Nasal spray looks like and
contents of the pack
Otrivine® Extra Dual Relief Nasal spray is a clear solution.
The bottle contains approximately 70 puffs.
Otrivine® Extra Dual Relief Nasal spray is available as a 10 ml
nasal spray with a metered-dose spray pump.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford, TW8 9GS, U.K.
This medicinal product is authorised in the Member
States of the EEA under the following names:
AT

Otrivin Duo 0,5 mg/ml + 0,6 mg/ml Nasenspray,
Lösung

BE

Otrivine Duo 0,5mg/ml + 0,6mg/ml neusspray
oplossing

BG

Otrivin Extra 0.5 mg/ml + 0.6 mg/ml nasal spray,
solution
9 mm

10 mm

10 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 25476 – OTDC 418880
OTRIVINE COMPLETE F100 10ML GB_317237_PIL
157.5 x 210 mm – PN-P12-V6 – Recto/Verso
XXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

Diadeis421203 – KR – 10.04.2017

Draft B

WARNING: Wrong display / print > switch overprint ON

Verso

CY

Otrivin Advance

CZ

Otrivin Rhinostop

DE

Otriven Duo mit Xylometazolin und Ipratropium

DK

Otrivin Comp næsespray, opløsning

EE

Otrivin Total

EL

Otrivin Advance

ES

Rhinovín Duo 0,5 mg/ml + 0,6 mg/ml solución para
pulverización nasal

FI

Otrivin Comp 0,5mg/ml + 0,6mg/ml nenäsumute, liuos

HU

Otrivin Plus 0,5mg/ml + 0,6mg/ml oldatos orrspray

IE

Otrivine® Extra Dual Relief Nasal spray Relief 0.5mg/
ml, 0.6mg/ml Nasal Spray

IS

Otrivin Comp 0,5mg/ml + 0,6mg/ml nefuoi lausn

IT

RINAZINA DOPPIA AZIONE 0,5 mg/ml + 0,6 mg/ml
spray nasale, soluzione

LT

OtriDuo 0,5 mg/ml + 0,6 mg/ml nosies purškalas,
tirpalas
Otrivine Duo

LV

Otrivin Total 0,5 mg/ml + 0,6mg/ml nasal spray
solution

MT

Otrivine Extra Dual Relief 0.5mg/ml, 0.6mg/ml
Nasal Spray

Otrivin Duo Xylometazoline hydrochloride & Ipratropium
bromide, 0,5/0,6 mg/ml, neusspray, oplossing

NO

Otrivin Comp 0,5mg/ml + 0,6mg/ml nesespray,
opplosning

PL

Otrivin Ipra MAX

PT

Vibrocil ActilongDuo 0.5mg/ml + 0.6mg/ml soluçao
para pulverizaçao

RO

Vibrocil Duo 0,5mg/ml + 0,6mg/ml spray nazal, solutie

SE

Otricomb 0,5mg/ml + 0,6 mg/ml nässpray lösning

SI

Otrivin Duo 0,5 mg/0,6 mg v 1 ml pršilo za nos,
raztopina

SK

Otrivin Comp 0,5mg/ml + 0,6 mg/ml nässpray lösning

UK

Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml
Nasal Spray

This leaflet was last revised on April 2017.
Otrivine® is a registered trademark owned by or licensed to the
GSK group of companies.

GB 317237 – XXXXXX

11 mm

72 mm

LU

NL

210 mm

Pharma code XXX

9 mm

157.5 mm

Gluing Area

10 mm

10 mm

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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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