Otrivine Adult 0.1% w/v Nasal Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Xylometazoline hydrochloride

Available from:

Haleon Ireland Limited

ATC code:

R01AA; R01AA07

INN (International Name):

Xylometazoline hydrochloride

Dosage:

0.1 percent weight/volume

Pharmaceutical form:

Nasal drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics, plain; xylometazoline

Authorization status:

Marketed

Authorization date:

1984-05-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OTRIVINE
ADULT 0.1% W/V NASAL DROPS
Xylometazoline hydrochloride
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 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 7 days.
–
If any of the side effects get 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 Adult Nasal Drops are and what they are
used for
2.
What you need to know before you use Otrivine Adult
Nasal Drops
3.
How to use Otrivine Adult Nasal Drops
4.
Possible side effects
5.
How to store Otrivine Adult Nasal Drops
6.
Contents of the pack and other information
1. WHAT OTRIVINE ADULT NASAL DROPS ARE AND WHAT
THEY ARE USED FOR
HAT OTRIVINE ADULT NASAL DROPS ARE AND
WHAT THEY ARE USED
Otrivine Adult Nasal Drops are 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 Adult 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. WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE
ADULT NASAL DROPS
HAT YOU NEED TO KNOW BEFORE YOU USE
OTRIVINE
ADULT NASAL DROPS
DO NOT USE THE DROPS IF YOU:
–
Are allergic to xylometazoline hydrochloride or any
of the other ingredients in the drops
(see Section 6). Symptoms include: rash, swelling of the face and
throat, difficulty
breathing.
–
are taking, or have taken in the last two weeks, drugs
for depress

Summary of Product characteristics

Health Products Regulatory Authority
28 November 2023
CRN00DQ8Y
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine Adult 0.1% w/v Nasal Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylometazoline Hydrochloride 0.1% w/v
Excipients: Benzalkonium chloride 0.01% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal drops, solution (nasal drops)
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a nasal decongestant for relief of the symptoms of acute rhinitis
in allergic or upper respiratory tract infections, including
the common cold or influenza. Relief of sinusitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS OVER 12 YEARS OF AGE:
Otrivine should not be used for more than seven consecutive days (see
section 4.4).
The recommended dose should not be exceeded, especially in children
and the elderly.
Adults (including the elderly) and adolescents over 12 years of age: 2
to 4 drops into each nostril, up to 3 times daily as needed.
Do not exceed 3 applications daily into each nostril. It is
recommended to make the last application shortly before retiring to
bed.
PAEDIATRIC POPULATION:
Otrivine Adult Nasal Drops should not be used in children aged less
than 12 years old.
ROUTE OF ADMINISTRATION: Nasal use.
1.
Blow your nose gently.
2.
Before using, practice using the dropper to develop good dosage
control.
3.
Tilt your head back as far as is comfortable or, if lying on a bed,
hang the head over the side.
4.
Without touching your nose with the dropper, apply the drops into each
nostril and keep the head tilted back for a
short time to allow the drops to spread throughout the nose.
5.
If the drop completely misses your nose, administer the drop again.
6.
If any part of the drop gets into your nose, do not administer the
drop again.
7.
Repeat with the other nostril.
8.
Clean and dry the dropper before replacing it back into the bottle
right after use.
4.3 CONTRAINDICATIO