OTRIVINE CHILD NASAL DROPS

Active substance: 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 17895 – OTDC 302891
OTRIV DRPS 005 F5 10 ML GB_304071_PIL
145 x 210 mm – Recto/Verso
xxxx
P Reflex Blue U
Helvetica Neue LT Pro – Geometric
9 pts
XXXXXX
NCH Nyon – CH
xxxxxx
NDMT CF - 07.06.2013

Draft B

WARNING: Wrong display / print > switch overprint ON

Recto

11,5 mm

145 mm

1. WHAT OTRIVINE CHILD NASAL DROPS ARE AND
WHAT THEY ARE USED FOR

®

• nasal congestion (blocked nose, including colds)
• perennial and allergic rhinitis
(recurring inflammation of the nasal mucous
membranes, including hay fever)
• sinusitis.

Nasal Drops
Xylometazoline
Hydrochloride

210 mm

Cough and Cold in children
It is usual for children to get several colds a year. As
they get older, their immunity builds up and they get
fewer colds. Most colds will get better within a few
days and you may not need to do more than keep
your child comfortable until they get over it.
Fever: If they are feverish, give them plenty of fluids
to drink. Their temperature may be lowered with a
suitable medicine which has doses for children. For
further advice, talk to your healthcare professional.
Coughs: Although it can be distressing to hear your
child cough, in fact this helps to clear phlegm from
the chest and mucus from the nose. Give your child
plenty of warm clear fluids.
Pharma code xxx

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 Child Nasal
Drops 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 5 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.

Otrivine Child Nasal Drops contain 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 CHILD NASAL DROPS

DO NOT use the drops if your child:

• is under 6 years old
• is allergic to xylometazoline hydrochloride or any of the
other ingredients in the drops
(see Section 6)
• has an inflamed nasal passage
• is allergic to other decongestants
• has had recent neurosugery or nasal surgery
• has heart disease or hypertension
• has diabetes
• has hyperthyroidism (overactive thyroid gland)
• has closed angle glaucoma
• has phaeochromocytoma (a tumour of the nerves
associated with the hormone glands)
• is taking monoamine oxidase inhibitors (MAOIs) or has
stopped taking them in the last 14 days
• is taking betablockers
Take special care

Before using the drops tell your doctor if your child:
• has heart or circulatory disease
• is taking any other medicine or is under doctor's care
If your child experiences hallucinations, restlessness
or sleep disturbances stop using Otrivine Child Nasal
Drops.

Do not to take Otrivine Child Nasal Drops for
more than 5 days in a row. Keep away from the eyes.
Using other medicines
Do not use these drops if your child is using other
decongestants. Please tell your doctor or pharmacist
if your child is taking or has recently taken any
medicines (especially antidepressants, moclobemide,
medicines for high blood pressure or heart problems,
appetite suppressants, oxytocin or ergot alkaloids)
including those obtained without a prescription.

11,5 mm

72 mm

In this leaflet:
1. What Otrivine Child Nasal Drops are and what
they are used for
2. Before you use Otrivine Child Nasal Drops
3. How to use Otrivine Child Nasal Drops
4. Possible side effects
5. How to store Otrivine Child Nasal Drops
6. Further information

Otrivine Child Nasal Drops are for application in the
nose to give relief from:

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 17895 – OTDC 302891
OTRIV DRPS 005 F5 10 ML GB_304071_PIL
145 x 210 mm – Recto/Verso
xxxx
P Reflex Blue U
Helvetica Neue LT Pro – Geometric
9 pts
XXXXXX
NCH Nyon – CH
xxxxxx
NDMT CF - 07.06.2013

Draft B

WARNING: Wrong display / print > switch overprint ON

Verso

11,5 mm

145 mm

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.

Dosage:
For children aged 6–12 years:
1 to 2 drops in each nostril once or twice daily. Not more
than 2 doses should be given in any 24 hours.

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.

72 mm

3. HOW TO USE OTRIVINE CHILD NASAL DROPS

Palpitations, changes in heart rhythm or increased blood
pressure may also occur, especially if you have heart
problems.

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.
5. HOW TO STORE OTRIVINE CHILD NASAL DROPS

210 mm

Do not exceed the recommended dosage.
Do not take with any other cough and cold medicines.
If you use more Otrivine Child Nasal Drops than you
should, consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION
What Otrivine Child Nasal Drops contain
The active ingredient is xylometazoline hydrochloride
(0.05 % w/v).
The other ingredients are sodium chloride, sodium
phosphate, sodium acid phosphate, disodium edetate,
benzalkonium chloride, sorbitol, hypromellose and water.
What Otrivine Child Nasal Drops look like and
the contents of the pack
Otrivine Child Nasal Drops are 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.
Otrivine® is a registered trademark of Novartis AG.

GB 304071 – XXXXXX

11,5 mm

Like all medicines, Otrivine Child Nasal Drops can cause
side effects, although not everybody gets them.
Local discomfort may be felt after applying the drops
if you have sensitive nasal passages.
If your child experiences hallucinations, restlessness
or sleep disturbances stop using Otrivine Child Nasal
Drops.
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.

Pharma code xxx

Do not use in children under 6 years of age.
Administration:
1. Practise using the dropper to develop good dosage
control
2. Clear and wipe your child's nose
3. Tilt your child's head right back (see diagram)
4. Apply drops to each nostril as per dosage instructions.
Parents or carers should seek medical attention if the
child's condition worsens.
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 “Expiry”. The expiry date refers to the last day
of that month.
Protect from heat.
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.

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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