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OTRIVINE ADULT NASAL SPRAY

Active substance(s): XYLOMETAZOLINE HYDROCHLORIDE

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

AWF 17897 – OTDC 302904
OTRIV SPR 0.1% F2 10 ML GB_304079_PIL
145 x 210 mm – P08 – PN-Notice-V10 – Recto/Verso
xxxx
P Reflex Blue U
Helvetica Neue LT Pro – Geometric
9 pts

NCH Nyon – CH
xxxxxx
NDMT CF – 07.06.2013

Draft Z

WARNING: Wrong display / print > switch overprint ON

Recto

11,5 mm

145 mm

®

Adult Nasal spray
Xylometazoline
Hydrochloride

Pharma code XXXX

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

72 mm

DO NOT use the spray if you:
• are allergic to xylometazoline hydrochloride or
any of the other ingredients in the spray
(see Section 6)
• are allergic to other decongestants
• have had recent neurosurgery.
Do not use this spray for children under
12 years old.

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 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.

210 mm

2. BEFORE YOU USE OTRIVINE ADULT
NASAL SPRAY

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.

1. WHAT OTRIVINE ADULT NASAL SPRAY
IS AND WHAT IT IS USED FOR

3. HOW TO USE OTRIVINE ADULT NASAL
SPRAY

Otrivine Adult 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.

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 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.

9 mm

127 mm

9 mm

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

AWF 17897 – OTDC 302904
OTRIV SPR 0.1% F2 10 ML GB_304079_PIL
145 x 210 mm – P08 – PN-Notice-V10 – Recto/Verso
xxxx
P Reflex Blue U
Helvetica Neue LT Pro – Geometric
9 pts

NCH Nyon – CH
xxxxxx
NDMT CF - 07.06.2013

Draft Z

WARNING: Wrong display / print > switch overprint ON

Verso

11,5 mm

145 mm

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.

Do not exceed the recommended dosage.

4. POSSIBLE SIDE EFFECTS

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 XXXX

If you use more Otrivine Adult Nasal Spray than
you should, consult your doctor or pharmacist.

6. FURTHER INFORMATION
What Otrivine Adult Nasal Spray contains

Like all medicines, Otrivine Adult 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.

210 mm

5. HOW TO STORE OTRIVINE ADULT NASAL
SPRAY

72 mm

Administration:
1. Clear your nose.
2. Lean forward slightly and insert the nozzle into a
nostril (see diagram).
3. Squeeze the bottle once and sniff at the same
time.
4. Remove the nozzle before releasing the pressure
on the bottle.
5. Repeat for the other nostril.

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.

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

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.

GB 304079 – XXXXXX

11,5 mm

Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at HYPERLINK
“http://www.mhra.gov.uk/yellowcard”
www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

Otrivine® is a registered trademark of Novartis AG.

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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