Otrivine Adult Menthol 0.1% w/v Nasal Spray, 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 spray, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics, plain; xylometazoline

Authorization status:

Not marketed

Authorization date:

1998-07-13

Patient Information leaflet

OTRIVINE ADULT MENTHOL 0.1% W/V NASAL SPRAY
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
Menthol 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 Adult Menthol Nasal Spray is and what it is used for
2. Before you use Otrivine Adult Menthol Nasal Spray
3. How to use Otrivine Adult Menthol Nasal Spray
4. Possible side effects
5. How to store Otrivine Adult Menthol Nasal Spray
6. Further information
1. WHAT OTRIVINE ADULT MENTHOL NASAL SPRAY IS AND WHAT IT IS USED FOR
Otrivine Adult Menthol 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 Adult Menthol 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.
2. BEFORE YOU USE OTRIVINE ADULT MENTHOL NASAL SPRAY
DO NOT USE THE SPRAY IF YOU:
• are allergic to xylometazoline hydrochloride or any of the other
ingredients in the spray (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
depression known as monoamine Oxidase
Inhibitors (MAOIs)
• have an overactive thyroid gland (hyperthyroidism)
• have acute heart disease
• have undergone r

Summary of Product characteristics

Health Products Regulatory Authority
28 November 2023
CRN00DQ8Y
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine Adult Menthol 0.1% w/v Nasal Spray, 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 spray, solution (nasal spray)
Colourless to whitish, clear to opalescent nasal spray solution with
an odour of menthol and eucalyptus.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of nasal congestion, perennial and allergic
rhinitis (including hay fever), sinusitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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:
1 to 2 sprays 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 Menthol Nasal Spray should not be used in children aged
less than 12 years old.
ROUTE OF ADMINISTRATION: Nasal use.
1.
To produce a fine spray, the nebuliser should be held upright with the
nozzle pointing upwards. Be careful not to
spray in the eyes.
2.
Blow your nose gently.
3.
Remove protective cap.
4.
Lean forward slightly and insert the nozzle into a nostril.
5.
Squeeze the bottle once and breathe in gently at the same time.
6.
Remove the nozzle before releasing the pressure on the bottle.
7.
Repeat with the other nostril.
8.
Clean and dry the nozzle before replacing back the cap right after
use.
4.3 CONTRAINDICATIONS
Hypersensitivity to xylometazoline or to any of the excipients (see
list in section 6.1).
Otrivine should not be used in patients with trans-sphenoidal
hypophysectomy or surgery exposing the dura mater.