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OTRIVINE CONGESTION RELIEF 0.1% NASAL SPRAY

Active substance(s): XYLOMETAZOLINE HYDROCHLORIDE

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Proof Z

9 mm

9 mm

11.5 mm

Recto

®

Congestion
Relief

0.1% Nasal Spray
Xylometazoline Hydrochloride

Pharma code 1334

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
This medicine is available without a prescription.
However, you still need to use Otrivine Congestion
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 Congestion Relief 0.1% Nasal Spray
is and what it is used for
2. Before you use Otrivine Congestion Relief 0.1%
Nasal Spray
3. How to use Otrivine Congestion Relief 0.1% Nasal
Spray
4. Possible side effects
5. How to store Otrivine Congestion Relief 0.1% Nasal
Spray
6. Further information
1. What Otrivine Congestion Relief 0.1% Nasal
Spray is and what it is used for

3. How to use Otrivine Congestion Relief 0.1%
Nasal Spray:
For Adults and Children over 12 years of age:
one spray in each nostril 1 to 3 times daily
as needed.

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72 mm

Otrivine Congestion 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.
Otrivine Congestion 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.

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
• have narrow angle glaucoma.
Do not use this spray for children under
12 years old.
Take special care
Before using the spray tell your doctor if you:
• have high blood pressure, heart or circulatory
disease
• have an overactive thyroid
• have diabetes mellitus
• are pregnant or breast-feeding.
Do not to take decongestants for more than 7 days
in a row. Prolonged or excessive use can cause the
stuffiness in the nose to return or worsen. Keep
away from the eyes and mouth. Like other products for the relief of blocked nose, this product
can give rise to sleep disturbances, dizziness and
tremor in very sensitive individuals. Consult your
doctor if these symptoms have proven troublesome to you.
Using other medicines
You should not use Otrivine Congestion Relief 0.1%
Nasal Spray if you are taking certain medicines used
for treatment of depression (monoamine oxidase
inhibitor (MAOI) or tri-cyclic and tetra-cyclic antidepressants).
Please tell your doctor or pharmacist if you are taking
or have recently taken any medicines including those
obtained without a prescription.
Pregnancy or breast-feeding
Do not use Otrivine Congestion Relief 0.1% Nasal
Spray during pregnancy.
If you are breast-feeding, Otrivine Congestion Relief
0.1% Nasal Spray should only be used if
recommended by your doctor.
Driving and using machinery
Otrivine has very little or no effect on your ability
to drive or use machines. If you are experiencing
blurred vision then do not drive or operate machines.
Important information about some of the other
ingredients:
The medicine contains polyoxylhydrogenated castor
oil (2.750 mg/ml) which may cause skin reactions.

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210 mm

2. Before you use Otrivine Congestion Relief
0.1% Nasal Spray

Proof Z

9 mm

9 mm

11.5 mm

Verso

4. Possible side effects

6. Further information
What Otrivine Congestion Relief 0.1% Nasal Spray
contains
The active ingredient is Xylometazoline hydrochloride
(0.1% w/v). Each ml contains 1 mg of xylometazoline
hydrochloride.
The other ingredients are: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate,
sodium chloride, disodium edetate, levomenthol,
cineole, sorbitol, polyoxylhydrogenated castor oil
(macrogol glycerol hydroxystearate) and purified water.
What Otrivine Congestion Relief 0.1% Nasal Spray
looks like and the contents of the pack
Otrivine Congestion Relief 0.1% Nasal Spray is a nasal
metered-dose spray containing a white solution with
menthol and eucalyptol odour, in a bottle with a pump
designed to deliver the correct amount of product.
The content of the pack is 10 ml.
Marketing Authorisation Holder
Novartis Consumer Health, Camberley, GU15 3YL, UK.
Manufacturer
Novartis Consumer Health GmbH, Zielstattstrasse 40,
81379, Munich, Germany.
This leaflet was last revised in April 2014.
Otrivine® is a registered trademark of Novartis AG.

GB 910883 – 148649

11.5 mm

Like all medicines, Otrivine Congestion 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.
STOP using Otrivine Congestion Relief 0.1% Nasal
Spray and seek medical help immediately
if you have any of the following which may be signs
of an allergic reaction:
difficulty breathing or swallowing, swelling of the face,
lips, tongue or throat, severe itching of the skin, with
a red rash or raised bumps.
Common side effects (may affect between
1 and 10 in every 100 patients).
Dryness or irritation of the nasal mucosa, nausea,
headache, local burning sensation.
Very rare side effects (may affect less than 1 in every
10,000 patients).

Keep this medicine out of the sight and reach
of children.
Do not use after the expiry date which is stated on the
bottle and carton after ‘EXP’.
The expiry date refers to the last day of that month.
Do not store above 25 °C.
Store in the original package.
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.

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210 mm

If you use more Otrivine Congestion Relief 0.1%
Nasal Spray than you should, consult your doctor
or pharmacist immediately.
If you forget to use Otrivine Congestion Relief 0.1%
Nasal Spray
Do not take a double dose to make up for a forgotten
one.

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

Pharma code 1334

Do not exceed the recommended dosage.

Allergic reactions (skin rash, itching), blurred vision,
irregular or fast heartbeat.
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.

72 mm

Administration
1. Blow the nose gently.
2. Remove protective cap.
3. Do not cut the nozzle.
The metered dose spray
is ready to prime before use.
4. Before the first application,
prime the pump by actuating (depressing the pump)
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, the pump will need to be re-primed
by actuating 4 times. Be very careful not to spray
in the eyes or mouth.
5. Hold the bottle upright with
thumb under base and nozzle
between two fingers.
6. Lean forward slightly and insert
the nozzle into the nostril.
7. Spray and breathe in gently
through the nose at the same
time.
8. Repeat with the other nostril.
9. Clean and dry the nozzle
before replacing back the
cap right after use.
To avoid possible spread of infection, this pack should
only be used by one person.

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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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