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Otrivin CMI

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OTRIVIN ADULT NASAL SPRAY

USE.
FOR
DIRECTIONS
THE
FOLLOW
AND
LABEL
THE
READ
ALWAYS
Spray
Nasal
Adult
Otrivin
Active ingredient: Xylometazoline hydrochloride 140 micrograms/spray

Consumer Medicine Information (CMI) Check with your doctor or pharmacist if you:
This leaflet provides important information about using Otrivin • have any other medical conditions [high blood pressure;
Adult Nasal Spray. You should also speak to your doctor heart disease (e.g. long QT syndrome); an overactive
or pharmacist if you would like further information or if thyroid gland (hyperthyroidism); diabetes; difficulty in
you have any concerns or questions about using Otrivin urinating and/or an enlarged prostate gland (prostatic
Adult Nasal Spray. hypertrophy); a tendency to have nose bleeds; have
Where to find information in this leaflet: a rare tumour of the adrenal gland that produces
high amounts of adrenaline and noradrenaline
1. Why am I using Otrivin Adult Nasal Spray? (phaeochromocytoma)].
2. What should I know before I use Otrivin Adult Nasal Spray? • take any medicines for any other condition.
3. What if I am taking other medicines? During treatment, you may be at risk of developing certain
4. How do I use Otrivin Adult Nasal Spray? side effects. It is important you understand these risks and
5. What should I know while using Otrivin Adult Nasal Spray? how to monitor for them. See additional information under
6. Are there any side effects? Section 6. Are there any side effects?
7. Product details Pregnancy and breastfeeding

1. Why am I using Otrivin Adult Nasal Spray? Check with your doctor or pharmacist if you are pregnant or
intend to become pregnant. Do not use Otrivin Adult Nasal
Otrivin Adult Nasal Spray contains the active ingredient Spray if you are pregnant.
Xylometazoline hydrochloride. Otrivin Adult Nasal Spray
Talk to your doctor or pharmacist if you are breastfeeding or
is a nasal decongestant. It quickly relieves your stuffy nose
intend to breastfeed. Otrivin Adult Nasal Spray should only be
and helps clear nasal passages by reducing excessive nasal
used if recommended by your doctor.
secretions. It is indicated in adults and in children 12 years
and over. Children and adolescents
Otrivin Adult Nasal Spray is used for the relief of blocked • Do not use Otrivin Adult Nasal Spray in children below 12
nose caused by colds, flu, sinusitis, hay fever or other years of age. Otrivin Junior Nasal Spray is available for
allergic rhinitis. children aged 6-11 years.

2. What should I know before I use Otrivin 3. What if I am taking other medicines?
Adult Nasal Spray?
Tell your doctor or pharmacist if you are taking any other
Warnings medicines, including any medicines, vitamins or supplements
that you buy without a prescription from your pharmacy,
Do not use Otrivin Adult Nasal Spray: supermarket or health food shop.
• in children below 12 years of age. Some medicines may interfere with Otrivin Adult Nasal Spray
• if you are allergic to xylometazoline or any other and affect how it works.
ingredients of this medicine. Always check the
It is particularly important to mention to your doctor or
ingredients to make sure you can use this medicine.
pharmacist if you are taking or have taken the following
• if you have had the pituitary gland removed by operation
medicines:
through the nose.
• if you have undergone recent trans-nasal surgery (brain - Monoamine oxidase (MAO) inhibitors (used for treatment of
surgery where the operation was carried out through the depression): Otrivin Adult Nasal Spray is not recommended
nose or mouth). if you are taking or have been taking these medicines within
• if you have narrow angle glaucoma (increased pressure the last 14 days. Use with Otrivin Adult Nasal Spray may
in eyes). substantially increase blood pressure.
• if you have chronic nasal inflammation with very dry - Tri-cyclic and tetra-cyclic antidepressants: use with Otrivin
nasal passages (rhinitis sicca or atrophic rhinitis). Adult Nasal Spray may increase the effects of xylometazoline
Tell your doctor or pharmacist if any of the above apply (the main ingredient in Otrivin Adult Nasal Spray).
because Otrivin Adult Nasal Spray is not suitable for you If you use any of the above-mentioned medicines, consult a
in these circumstances. doctor before using Otrivin Adult Nasal Spray.
Frequent or prolonged use may cause nasal congestion Check with your doctor or pharmacist if you are not sure
to recur or worsen. about what medicines, vitamins or supplements you are
Otrivin Adult Nasal Spray is for nasal use only and taking and if these affect Otrivin Adult Nasal Spray.
contains benzalkonium chloride as a preservative.
Brief stinging sensation or sneezing may occur.
Excessive use may damage lining of nose.

Otrivin Adult Nasal Spray ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE. 1
If you use too much Otrivin Adult Nasal Spray
4. How do I use Otrivin Adult Nasal Spray?
If you think that you have used too much Otrivin Adult Nasal
How much to use
Spray, or in case of accidental ingestion, you may need
• Always use Otrivin Adult Nasal Spray exactly as urgent medical attention.
recommended below. You should check with your doctor Signs of an overdose may include severe dizziness,
or pharmacist if you are not sure. sweating, severely lowered body temperature, headache,
• 1 spray into each nostril up to 3 times daily as needed. slow heartbeat, rapid heartbeat, impaired breathing, coma,
Do not exceed 3 applications daily in each nostril. Do not convulsion, hypertension (high blood pressure) which may be
use more often than every 8-10 hours. followed by hypotension (low blood pressure).
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage, especially in You should immediately:
children and the elderly. • phone the Poisons Information Centre
• If you forget to use Otrivin Adult Nasal Spray do not take (telephone: Australia 13 11 26; New Zealand 0800 764
a double dose to make up for a forgotten one. 766), or
• contact your doctor, or
When to use Otrivin Adult Nasal Spray
• go to the Emergency Department at your nearest
• Otrivin Adult Nasal Spray should be used when hospital.
necessary. Do not exceed 3 applications daily in each You should do this even if there are no signs of
nostril. Do not use more often than every 8-10 hours. discomfort or poisoning.
How to use Otrivin Adult Nasal Spray
5. What should I know while using Otrivin
1. Do not cut the nozzle. The metered dose spray is ready
to prime before use. Adult Nasal Spray?
Things you should do
If congestion persists, seek medical advice.
Each pack should be used by only one person, for reasons of
hygiene.
If irritation occurs or you have signs of allergy, discontinue
2. Clear your nose.
use.
3. Remove protective cap.
4. Before using for the first time, prime the pump by If you accidently spray into your eyes, rinse the eyes
actuating 4 times. If the product has not been used for thoroughly with running water and contact your doctor
longer than 7 days, the pump will need to be re- primed immediately for advice as to what treatment is needed. You
with 4 actuations. If the full spray is not administered, the may experience temporary blurring of vision, irritation of
dose should not be repeated. Be careful not to spray in the eye, painful or red eyes. Worsening of narrow-angle
the eyes or mouth. glaucoma may also occur.
5. Hold bottle upright with thumb under base and nozzle Remind any doctor, dentist or pharmacist you visit that you
between two fingers are using Otrivin Adult Nasal Spray.
Things you should not do
• Otrivin Adult Nasal Spray is not intended for use in the
eyes or mouth.
• Do not use in or around the eyes.
• Do not use for more than 3 days at a time unless advised
6. Lean forward slightly and insert the nozzle into the by a doctor or pharmacist. If congestion persists, seek
nostril. medical advice.
7. Spray and breathe in gently through the nose at the Product tampering
same time.
• Otrivin Adult Nasal Spray is enclosed in a tamper-
evident carton to help protect you from product
tampering. If you find that the carton seals have been
broken or are missing, do not use the product and return
it to the place of purchase.
Driving or using machines
8. Repeat with the other nostril. Be careful before you drive or use any machines or tools
9. Clean and dry the nozzle before replacing back the cap until you know how Otrivin Adult Nasal Spray affects
right after use. you.
10. To avoid possible spread of infection, the spray should
Otrivin Adult Nasal Spray has no or negligible influence on
only be used by one person.
the ability to drive and use machines.

Otrivin Adult Nasal Spray ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE. 2
Drinking alcohol Common side effects What to do

Tell your doctor or pharmacist if you drink alcohol. • Nasal dryness serious side
• Nasal discomfort effects and
Looking after your medicine they worry you.
Gastrointestinal disorders:
• Store below 30°C. • Nausea
• Keep out of reach and sight of children.
• Do not use Otrivin Adult Nasal Spray after the expiry date General disorders and
which is stated on the outer pack and on the immediate administration site conditions:
container. The expiry date refers to the last day of that • Application site burning
month.
• Store in the original package. Very rare side effects
Follow the instructions in the carton on how to take care of
your medicine properly. Very rare side effects What to do

Store it in a cool dry place away from moisture, heat or Immune system disorders: Call your
sunlight; for example, do not store it: • Hypersensitivity reaction doctor straight
• in the bathroom or near a sink, or (angioedema, rash, pruritus) away, or go
• in the car or on window sills.
Eye disorders:
straight to the
Emergency
Keep it where young children cannot reach it. • Transient visual impairment Department at
Getting rid of any unwanted medicine Cardiac disorders: your nearest
hospital if you
If you no longer need to use this medicine or it is out of date, • Heart rate irregular notice any of
take it to any pharmacy for safe disposal. Do not throw away • Heart rate increased these serious
your medicine in your household waste. side effects.
Respiratory, thoracic and
Do not use this medicine after the expiry date. mediastinal disorders:
• Apnoea in young infants and
6. Are there any side effects? newborns
All medicines can have side effects. If you do experience Tell your doctor or pharmacist if you notice anything else
any side effects, most of them are minor and temporary. that may be making you feel unwell.
However, some side effects may need medical attention.
Other side effects not listed here may occur in some people.
Like other products for the relief of blocked nose, Otrivin
Adult Nasal Spray may give rise to sleep disturbances, Reporting side effects
dizziness, tremor in very sensitive patients. Consult your After you have received medical advice for any side
doctor if such signs prove troublesome. If any of the above effects you experience, you can report side effects to the
apply, do not use Otrivin Adult Nasal Spray before talking to Therapeutic Goods Administration online at www.tga.gov.au/
your doctor or pharmacist. reporting-problems in Australia or to the Centre for Adverse
If you have an allergic reaction, immediately stop using Reactions Monitoring at https://pophealth.my.site.com/
Otrivin Adult Nasal Spray and seek medical help. carmreportnz/s/ in New Zealand. By reporting side effects,
you can help provide more information on the safety of this
Immediate hypersensitivity (allergic reaction) may occur.
medicine.
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 7. Product details
symptoms may appear individually or all combined as a
This medicine is available over-the-counter without a doctor's
severe allergic reaction.
prescription
Stop using Otrivin Adult Nasal Spray and seek immediate
medical attention if you experience sudden severe What Otrivin Adult Nasal Spray contains
headaches, nausea and vomiting, or visual disturbances.
Active ingredient Xylometazoline hydrochloride
These symptoms may be associated with a rare but serious
(main ingredient) 140 micrograms/spray
side effect.
See the information below and, if you need to, ask your Other ingredients Sorbitol
doctor or pharmacist if you have any further questions.
(inactive Monobasic sodium phosphate
ingredients) dihydrate (Sodium dihydrogen
Common side effects
phosphate dihydrate)
Common side effects What to do Hypromellose
Nervous system disorders: Speak to your Sodium chloride
• Headache doctor or Dibasic sodium phosphate
pharmacist if dodecahydrate (Disodium
Respiratory, thoracic and you have any phosphate dodecahydrate)
mediastinal disorders: of these less
Disodium edetate

Otrivin Adult Nasal Spray ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE. 3
Benzalkonium chloride
Purified water

Potential allergens Benzalkonium chloride


(preservative)

Do not use this medicine if you are allergic to any of


these ingredients.
What Otrivin Adult Nasal Spray looks like
Otrivin Adult Nasal Spray is a clear, colourless and practically
odourless solution in a metered-dose spray container.
Who distributes Otrivin Adult Nasal Spray
Haleon
Sydney, NSW, Australia & Auckland, New Zealand
AU: 1800 028 533
NZ: 0800 540 144

This e-leaflet was prepared in November 2023.

Otrivin Adult Nasal Spray ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE. 4

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