Medine.co.uk

Otrivine Allergy Relief 0.1% Nasal Spray

Document: leaflet MAH BRAND3_PL 00030-0117 change

l\) NOVARTIS


Order - AWF

AWF 15117 - OTDC 258443

Reference

OTRIVINE ALLERGY MD 0.1% F5 10 ML GB_908725_PIL

Format

145 x 210 mm - P08 - PN-Notice-V10 - Recto/Verso

Pharma code

1749

Colour

P Reflex Blue U

Font

Helvetica Neue LT Pro

Min. fonte size

9 pts

Reference MKT

-

Production site

NCH Nyon - CH

Reference Site

146201

Pre-press

Ducommun sa - DO-12-E1159 - 08.05.2012


Proof Z


145 mm


Recto

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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

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.

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 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.

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.


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.


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.


9 mm ■*—►-<


127 mm


9 mm ►-<—►


l\) NOVARTIS


Order - AWF

AWF 15117 - OTDC 258443

Reference

OTRIVINE ALLERGY MD 0.1% F5 10 ML GB_908725_PIL

Format

145 x 210 mm - P08 - PN-Notice-V10 - Recto/Verso

Pharma code

1749

Colour

P Reflex Blue U

Font

Helvetica Neue LT Pro

Min. fonte size

9 pts

Reference MKT

-

Production site

NCH Nyon - CH

Reference Site

146201

Pre-press

Ducommun sa - DO-12-E1159 - 08.05.2012


Proof Z


145 mm

f<—

Verso


A E


LO

^ Y



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


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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.


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.


6. Further information


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Do not exceed the recommended dosage.


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


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.

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.

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

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.


What Otrivine Allergy Relief 0.1% Nasal Spray contains

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 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.

Marketing Authorisation Holder and Manufacturer

Novartis Consumer Health, Horsham,

RH12 5AB, UK

This leaflet was last approved in 02/2012.

Otrivine® is a registered trademark of Novartis AG.


GB 908725 - 146201    (Jj NOVARTIS


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9 mm ■*—►-<


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ArtWorkFlow™


_Approvals

OTRIVINE ALLERGY MD 01 F5 10 ML GB_908725Z_146201_PIL Version: 1.2

Name

521

Type

Reason for Signature

Date

Rochat James

rochaja2

Approve

Signed by T&D

2012-05-08 14:47:12

Rochat James

rochaja2

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Signed by T&D

2012-05-08 14:55:51

Whipman Sasha

wliipmsal

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Signed by Client

2012-05-09 09:16:20

McLouglilin Joanna

mcloujol

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Signed by Client

2012-05-22 10:52:37

Document electronically signed