OTRIVINE ALLERGY RELIEF 0.1% NASAL SPRAY

Active substance: XYLOMETAZOLINE HYDROCHLORIDE

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

AWF 15896 – OTDC 270680
OTRIV MD 0.1% F5 NASAL SPRAY 10 ML GB_305772_PIL
145 x 210 mm – PN-Notice-V10 – P08 – Recto/Verso
XXXX
P Reflex Blue U
Helvetica Neue LT Pro
9 pts

NCH Nyon – CH
XXXXXX

Pre-press

Ducommun SA – DO-13-E1354 – 14.05.2013

Recto

Draft B

11,5 mm

145 mm

Otrivine Adult Metered Dose 0.1% Nasal Spray
contains the active ingredient xylometazoline
hydrochloride which helps to open up and clear the
nasal passages by reducing the excessive nasal
secretions and returning the swollen blood vessels
to their normal size.
2. Before you use Otrivine Adult Metered
Dose 0.1% Nasal Spray

Otrivine Adult Metered Dose 0.1% Nasal
Spray
Xylometazoline hydrochloride

210 mm

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without a prescription.
However, you still need to use Otrivine Adult
Metered Dose 0.1% Nasal Spray 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 the 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.
Pharma code XXXX

In this leaflet:
1. What Otrivine Adult Metered Dose 0.1% Nasal
Spray is and what it is used for
2. Before you use Otrivine Adult Metered Dose 0.1%
Nasal Spray
3. How to use Otrivine Adult Metered Dose 0.1%
Nasal Spray
4. Possible side effects
5. How to store Otrivine Adult Metered Dose 0.1%
Nasal Spray
6. Further information

72 mm

1. What Otrivine Adult Metered Dose 0.1%
Nasal Spray is and what it is used for

Do not use this spray for children under
12 years old.
Take special care
Before using the spray tell your doctor if you:
• have an overactive thyroid gland
(hyperthyroidism)
• have glaucoma
• have diabetes mellitus
• have heart or circulatory disease
• are pregnant or breast-feeding.
• have hypertension
Do not take decongestants for more than 7 days
in a row.
Using other medicines
Please tell your doctor or pharmacist before using
this product if you are taking or have recently taken
any medicines (especially monoamine oxidase
inhibitors or other antidepressants) including those
obtained without a prescription.
Pregnancy or breast-feeding
If you are pregnant or breast-feeding, consult your
doctor before using Otrivine.
Ask your doctor or pharmacist for advice before
taking any medicine.
3. How to use Otrivine Adult Metered Dose
0.1% Nasal Spray
Dosage:
For Adults and Children over 12 years of age
1 spray in each nostril 2 or 3 times daily.

11,5 mm

Otrivine Adult Metered Dose 0.1% Nasal Spray is
for application in the nose to give relief from:
• nasal congestion (blocked nose, including colds)
• perennial and allergic rhinitis (recurring inflammation of the nasal mucous membranes, including hay fever)
• sinusitis.

DO NOT use the spray if you:
• are allergic to xylometazoline hydrochloride or
any of the other ingredients in the spray (see
Section 6)
• have had recent neurosurgery.

9 mm

127 mm

9 mm

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

AWF 15896 – OTDC 270680
OTRIV MD 0.1% F5 NASAL SPRAY 10 ML GB_305772_PIL
145 x 210 mm – PN-Notice-V10 – P08 – Recto/Verso
XXXX
P Reflex Blue U
Helvetica Neue LT Pro
9 pts

NCH Nyon – CH
XXXXXX

Pre-press

Ducommun SA – DO-13-E1354 – 14.05.2013

Draft B

Verso

11,5 mm

145 mm

5. How to store Otrivine Adult Metered Dose 
0.1% Nasal Spray

Pharma code XXXX

6. Further information
What Otrivine Adult Metered Dose 0.1% Nasal
Spray contains

Do not exceed the recommended dosage.
If you use more Otrivine Adult Metered Dose
0.1% Nasal Spray than you should, consult your
doctor or pharmacist.

210 mm

72 mm

Administration:
1. Clear your nose.
2. Lean forward slightly and insert the nozzle into a
nostril (see diagram).
3. Depress pump and sniff at the same time.
4. Repeat for the other nostril.
To avoid possible spread of infection, this pack
should only be used by one person.
For reasons of hygiene do not use this bottle for
more than 28 days after opening it.

Keep this medicine out of the sight and reach of
children. Do not use after the expiry date which is
stated on the bottle after “EXP”. The expiry date
refers to the last day of that month.
Do not store above 25 °C.
Do not use this bottle for more than 28 days after
opening it.
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.

4. Possible side effects
Like all medicines, Otrivine Adult Metered Dose
0.1% Nasal Spray can cause side effects, although
not everybody gets them. Local discomfort may be
felt after applying the spray if you have sensitive
nasal passages.
Occasionally the following side effects have been
reported:
• A burning sensation in the nose and throat
• local irritation
• nausea
• headache
• dryness of the nasal membranes
• temporary and passing visual disturbances
• allergic reactions.

The active ingredient is xylometazoline hydrochloride (0.1% w/v).
The other ingredients are Benzalkonium chloride,
sodium phosphate, disodium edetate, sodium acid
phosphate, sodium chloride, sorbitol, hypromellose
and purified water.
What Otrivine Adult Metered Dose 0.1% Nasal
Spray looks like and the contents of the pack
Otrivine Adult Metered Dose 0.1% Nasal Spray is a
clear, colourless aqueous solution packed in 10 ml
bottles.
Marketing Authorisation Holder and
Manufacturer
Novartis Consumer Health, Camberley,
GU15 3YL, UK
This leaflet was last revised May 2013.
Otrivine® is a registered trademark of Novartis AG.

Cardiovascular effects, for example, palpitations may also occur especially if you have heart
problems.

GB 305772 – XXXXXX

11,5 mm

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.

9 mm

127 mm

9 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Min. fonte size
Reference MKT
Production site
Reference Site
Pre-press

Draft Z

AWF 15894 – OTDC 270676
OTRIVINE ALLERGY MD 0.1% F5 10 ML GB_304738_PIL
145 x 210 mm – P08 – PN-Notice-V10 – Recto/Verso
XXX
P Reflex Blue U
Helvetica Neue LT Pro
9 pts

NCH Nyon – CH
XXXXXX
Ducommun sa – DO-12-E2204 – 13.05.2013

145 mm

11,5 mm

Recto

Otrivine Allergy Relief 0.1% Nasal Spray contains
the active ingredient xylometazoline hydrochloride
which helps to open up and clear the nasal
passages by reducing the excessive nasal
secretions and returning the swollen blood vessels
to their normal size.
2. Before you use Otrivine Allergy Relief 0.1%
Nasal Spray

Otrivine Allergy Relief 0.1% Nasal Spray
Xylometazoline hydrochloride

210 mm

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without a prescription.
However, you still need to use Otrivine Allergy Relief
0.1% Nasal Spray 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 the 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.

Pharma code XXX

In this leaflet:
1. What Otrivine Allergy Relief 0.1% Nasal Spray is
and what it is used for
2. Before you use Otrivine Allergy Relief 0.1% Nasal
Spray
3. How to use Otrivine Allergy Relief 0.1% Nasal
Spray
4. Possible side effects
5. How to store Otrivine Allergy Relief 0.1% Nasal
Spray
6. Further information
1. What Otrivine Allergy Relief 0.1% Nasal
Spray is and what it is used for

Do not use this spray for children under
12 years old.
Take special care
Before using the spray tell your doctor if you:
• have an overactive thyroid gland
(hyperthyroidism)
• have glaucoma
• have diabetes mellitus
• have heart or circulatory disease
• are pregnant or breast-feeding.
• have hypertension
Do not take decongestants for more than 7 days
in a row.
Using other medicines
Please tell your doctor or pharmacist before using
this product if you are taking or have recently taken
any medicines (especially monoamine oxidase
inhibitors or other antidepressants) including those
obtained without a prescription.
Pregnancy or breast-feeding
If you are pregnant or breast-feeding, consult your
doctor before using Otrivine.
Ask your doctor or pharmacist for advice before
taking any medicine.
3. How to use Otrivine Allergy Relief 0.1%
Nasal Spray
Dosage:
For Adults and Children over 12 years of age
1 spray in each nostril 2 or 3 times daily.

11,5 mm

72 mm

Otrivine Allergy Relief 0.1% Nasal Spray is for
application in the nose to give relief from:
• nasal congestion (blocked nose, including colds)
• perennial and allergic rhinitis (recurring inflammation of the nasal mucous membranes, including hay fever)
• sinusitis.

DO NOT use the spray if you:
• are allergic to xylometazoline hydrochloride or
any of the other ingredients in the spray (see
Section 6)
• have had recent neurosurgery.

9 mm

127 mm

9 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Min. fonte size
Reference MKT
Production site
Reference Site
Pre-press

Draft Z

AWF 15894 – OTDC 270676
OTRIVINE ALLERGY MD 0.1% F5 10 ML GB_304738_PIL
145 x 210 mm – P08 – PN-Notice-V10 – Recto/Verso
XXX
P Reflex Blue U
Helvetica Neue LT Pro
9 pts

NCH Nyon – CH
XXXXXX
Ducommun sa – DO-12-E2204 – 13.05.2013

145 mm

11,5 mm

Verso

5. How to store Otrivine Allergy Relief 0.1%
Nasal Spray



Administration:
1. Clear your nose.
2. Lean forward slightly and insert the nozzle into a
nostril (see diagram).
3. Depress pump and sniff at the same time.
4. Repeat for the other nostril.

Do not store above 25 °C.
Do not use this bottle for more than 28 days after
opening it.
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.
Pharma code XXX

To avoid possible spread of infection, this pack
should only be used by one person.
For reasons of hygiene do not use this bottle for
more than 28 days after opening it.

72 mm

Keep this medicine out of the sight and reach of
children. Do not use after the expiry date which is
stated on the bottle after “EXP”. The expiry date
refers to the last day of that month.

6. Further information
Do not exceed the recommended dosage.

What Otrivine Allergy Relief 0.1% Nasal Spray
contains
The active ingredient is xylometazoline hydrochloride (0.1% w/v).

210 mm

If you use more Otrivine Allergy Relief 0.1%
Nasal Spray than you should, consult your
doctor or pharmacist.

The other ingredients are Benzalkonium chloride,
sodium phosphate, disodium edetate, sodium acid
phosphate, sodium chloride, sorbitol, hypromellose
and purified water.

4. Possible side effects
Like all medicines, Otrivine Allergy Relief 0.1%
Nasal Spray can cause side effects, although not
everybody gets them. Local discomfort may be felt
after applying the spray if you have sensitive nasal
passages.

What Otrivine Allergy Relief 0.1% Nasal Spray
looks like and the contents of the pack
Otrivine Allergy Relief 0.1% Nasal Spray is a clear,
colourless aqueous solution packed in 10 ml
bottles.

Occasionally the following side effects have been
reported:
• A burning sensation in the nose and throat
• local irritation
• nausea
• headache
• dryness of the nasal membranes
• temporary and passing visual disturbances
• allergic reactions.

Marketing Authorisation Holder and
Manufacturer
Novartis Consumer Health,
Camberley, GU15 3YL, UK
This leaflet was last revised May 2013.
Otrivine® is a registered trademark of Novartis AG.

Cardiovascular effects, for example, palpitations may also occur especially if you have heart
problems.

GB 304738 – XXXXXX

11,5 mm

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.

9 mm

127 mm

9 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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