OTRIVIN ADULT NASAL SPRAY
Active ingredient: Xylometazoline hydrochloride 140 micrograms/spray
Consumer Medicine Information (CMI)
This leaflet provides important information about using Otrivin Adult Nasal Spray.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Otrivin Adult Nasal Spray.
Where to find information in this leaflet:
Otrivin Adult Nasal Spray contains the active ingredient Xylometazoline hydrochloride. Otrivin Adult Nasal Spray is a nasal decongestant. It quickly relieves your stuffy
nose and helps clear nasal passages by reducing excessive nasal secretions. It is
indicated in adults and in children 12 years and over.
Otrivin Adult Nasal Spray is used for the relief of blocked nose caused by colds,
flu, sinusitis, hay fever or other allergic rhinitis.
Do not use Otrivin Adult Nasal Spray:
in children below 12 years of age.
if you are allergic to xylometazoline or any other ingredients of this medicine. Always
check the ingredients to make sure you can use this medicine.
if you have had the pituitary gland removed by operation through the nose.
if you have undergone recent trans-nasal surgery (brain surgery where the operation
was carried out through the nose or mouth).
if you have narrow angle glaucoma (increased pressure in eyes).
if you have chronic nasal inflammation with very dry nasal passages (rhinitis sicca
or atrophic rhinitis).
Tell your doctor or pharmacist if any of the above apply because Otrivin Adult Nasal
Spray is not suitable for you in these circumstances.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Otrivin Adult Nasal Spray is for nasal use only and contains benzalkonium chloride
as a preservative.
Brief stinging sensation or sneezing may occur. Excessive use may damage lining of
nose.
Check with your doctor or pharmacist if you:
have any other medical conditions [high blood pressure; heart disease (e.g. long QT
syndrome); an overactive thyroid gland (hyperthyroidism); diabetes; difficulty in
urinating and/or an enlarged prostate gland (prostatic hypertrophy); a tendency to
have nose bleeds; have a rare tumour of the adrenal gland that produces high amounts
of adrenaline and noradrenaline (phaeochromocytoma)].
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.
Do not use Otrivin Adult Nasal Spray if you are pregnant.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Otrivin Adult Nasal Spray should only be used if recommended by your doctor.
Children and adolescents
Do not use Otrivin Adult Nasal Spray in children below 12 years of age. Otrivin Junior
Nasal Spray is available for children aged 6-11 years.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Otrivin Adult Nasal Spray and affect how it works.
It is particularly important to mention to your doctor or pharmacist if you are taking
or have taken the following medicines:
- Monoamine oxidase (MAO) inhibitors (used for treatment of depression): Otrivin Adult
Nasal Spray is not recommended if you are taking or have been taking these medicines
within the last 14 days. Use with Otrivin Adult Nasal Spray may substantially increase
blood pressure.
- Tri-cyclic and tetra-cyclic antidepressants: use with Otrivin Adult Nasal Spray
may increase the effects of xylometazoline (the main ingredient in Otrivin Adult Nasal
Spray).
If you use any of the above-mentioned medicines, consult a doctor before using Otrivin
Adult Nasal Spray.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Otrivin Adult Nasal Spray.
How much to use
Always use Otrivin Adult Nasal Spray exactly as recommended below. You should check
with your doctor or pharmacist if you are not sure.
1 spray into each nostril up to 3 times daily as needed. Do not exceed 3 applications
daily in each nostril. Do not use more often than every 8-10 hours.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage, especially in children and the elderly.
If you forget to use Otrivin Adult Nasal Spray do not take a double dose to make up
for a forgotten one.
When to use Otrivin Adult Nasal Spray
Otrivin Adult Nasal Spray should be used when necessary. Do not exceed 3 applications
daily in each nostril. Do not use more often than every 8-10 hours.
How to use Otrivin Adult Nasal Spray
1. Do not cut the nozzle. The metered dose spray is ready to prime before use.
2. Clear your nose.
3. Remove protective cap.
4. Before using for the first time, prime the pump by actuating 4 times. If the product has not been used for longer than 7 days, the pump will need to be re- primed with 4 actuations. If the full spray is not administered, the dose should not be repeated. Be careful not to spray in the eyes or mouth.
5. Hold 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.
10. To avoid possible spread of infection, the spray should only be used by one person.
If you use too much Otrivin Adult Nasal Spray
If you think that you have used too much Otrivin Adult Nasal Spray, or in case of
accidental ingestion, you may need urgent medical attention.
Signs of an overdose may include severe dizziness, sweating, severely lowered body
temperature, headache, slow heartbeat, rapid heartbeat, impaired breathing, coma,
convulsion, hypertension (high blood pressure) which may be followed by hypotension
(low blood pressure).
You should immediately:
phone the Poisons Information Centre
(telephone: Australia 13 11 26; New Zealand 0800 764 766), or
(telephone: Australia 13 11 26; New Zealand 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
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 use.
If you accidently spray into your eyes, rinse the eyes thoroughly with running water
and contact your doctor immediately for advice as to what treatment is needed. You
may experience temporary blurring of vision, irritation of the eye, painful or red
eyes. Worsening of narrow-angle glaucoma may also occur.
Remind any doctor, dentist or pharmacist you visit that you 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 by a doctor or pharmacist.
If congestion persists, seek medical advice.
Product tampering
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
Be careful before you drive or use any machines or tools until you know how Otrivin
Adult Nasal Spray affects you.
Otrivin Adult Nasal Spray has no or negligible influence on the ability to drive and
use machines.
Looking after your medicine
Store below 30°C.
Keep out of reach and sight of children.
Do not use Otrivin Adult Nasal Spray after the expiry date which is stated on the
outer pack and on the immediate container. The expiry date refers to the last day
of that month.
Store in the original package.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal. Do not throw away your medicine in your household waste.
Do not use this medicine after the expiry date.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Like other products for the relief of blocked nose, Otrivin Adult Nasal Spray may
give rise to sleep disturbances, dizziness, tremor in very sensitive patients. Consult
your doctor if such signs prove troublesome. If any of the above apply, do not use
Otrivin Adult Nasal Spray before talking to your doctor or pharmacist.
If you have an allergic reaction, immediately stop using Otrivin Adult Nasal Spray
and seek medical help.
Immediate hypersensitivity (allergic reaction) may occur. 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 symptoms
may appear individually or all combined as a severe allergic reaction.
Stop using Otrivin Adult Nasal Spray and seek immediate medical attention if you experience
sudden severe headaches, nausea and vomiting, or visual disturbances. These symptoms
may be associated with a rare but serious side effect.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions.
Common side effects
|
Common side effects
|
What to do
|
|---|---|
|
Nervous system disorders:
Headache
Respiratory, thoracic and mediastinal disorders:
Nasal dryness
Nasal discomfort
Gastrointestinal disorders:
Nausea
General disorders and administration site conditions:
Application site burning
|
Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
|
Very rare side effects
|
Very rare side effects
|
What to do
|
|---|---|
|
Immune system disorders:
Hypersensitivity reaction (angioedema, rash, pruritus)
Eye disorders:
Transient visual impairment
Cardiac disorders:
Heart rate irregular
Heart rate increased
Respiratory, thoracic and mediastinal disorders:
Apnoea in young infants and newborns
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems in Australia or to the Centre for Adverse Reactions Monitoring at https://pophealth.my.site.com/carmreportnz/s/ in New Zealand. By reporting side effects, you can help provide more information
on the safety of this medicine.
This medicine is available over-the-counter without a doctor's prescription
What Otrivin Adult Nasal Spray contains
|
Active ingredient
(main ingredient)
|
Xylometazoline hydrochloride 140 micrograms/spray
|
|---|---|
|
Other ingredients
(inactive ingredients)
|
Sorbitol
Monobasic sodium phosphate dihydrate (Sodium dihydrogen phosphate dihydrate)
Hypromellose
Sodium chloride
Dibasic sodium phosphate dodecahydrate (Disodium phosphate dodecahydrate)
Disodium edetate
Benzalkonium chloride
Purified water
|
|
Potential allergens
|
Benzalkonium chloride (preservative)
|
Do not use this medicine if you are allergic to any of these ingredients.
