Otrivin 0.1% Nasal Spray solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

XYLOMETAZOLINE HYDROCHLORIDE

Available from:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

ATC code:

R01AA07

INN (International Name):

XYLOMETAZOLINE HYDROCHLORIDE 0.1 % (W/V)

Pharmaceutical form:

NASAL SPRAY, SOLUTION

Composition:

XYLOMETAZOLINE HYDROCHLORIDE 0.1 % (W/V)

Prescription type:

OTC

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-02-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OTRIVIN
Xylometazoline hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. You must always use
this medicine
exactly as described in this leaflet or as your doctor or pharmacist
has told you.
•
Keep this leaflet. You may need to read it again
•
Ask your pharmacist if you need more information or advice
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this patient information leaflet.
See section 4.
•
You need to talk to a doctor if you do not feel better or if you feel
worse (If
your symptoms worsen or do not subside) after 5 days.
IN THIS LEAFLET
1.
What OTRIVIN is and what it is used for
2.
What you need to know before you use OTRIVIN
3.
How to use OTRIVIN
4.
Possible side effects
5.
How to store OTRIVIN
6.
Contents of the pack and other information
1.
WHAT OTRIVIN IS AND WHAT IT IS USED FOR
OTRIVIN is a decongestant of the nasal mucosa for adults and children
over 12 years
of age.
OTRIVIN
preservative free does not contain preservatives.
What OTRIVIN
is used for
OTRIVIN is a topical decongestant, for adults and children over 12
years of age.
OTRIVIN contains xylometazoline a sympathomimetic agent that
constricts the nasal
blood vessels, decongesting the mucosa of the nose and neighbouring
areas of the
pharynx and providing fast and prolonged relief from nasal congestion,
thereby
helping to open up the nasal passages and allowing patients who suffer
from a stuffy
nose to breathe better. The effect of OTRIVIN starts within 2 minutes
and lasts for up
to 10 hours. OTRIVIN is well tolerated, even by patients with a
sensitive nasal
mucosa.
You need to talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVIN
DO NOT USE OTRIVIN:
•
If you are allergic (hypersensitive) to the active substance or any

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OTRIVIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
OTRIVIN preservative free: nasal spray, solution (metered dose) 0.1%:
Each 1 ml contains: 1 mg of xylometazoline hydrochloride.
Each dose contains 0.14 ml of solution (0.14 mg/dose).
3.
PHARMACEUTICAL FORMS
Nasal spray, solution (metered dose).
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of symptoms affecting the nasal mucosa due to common
cold, allergic
rhinitis or sinusitis.
To aid drainage of secretions in diseases of the paranasal sinuses.
As an adjuvant in otitis media, to decongest the nasopharyngeal mucosa
and
facilitate rhinoscopy.
_ADULTS AND CHILDREN OVER 12 YEARS OF AGE _
OTRIVIN 0.1% is recommended for adults and adolescents over 12 years
of age.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
•
OTRIVIN preservative free: nasal spray, solution (metered dose) 0.1%
_For adults and children over 12 years of age_
:
2 to 3 times a day: 1 spray from the metered dose atomizer in each
nostril
over a period of time not exceeding 5 consecutive days.
Do not exceed the recommended dose.
4.3.
CONTRA-INDICATIONS
Hypersensitivity to xylometazoline or to any of the excipients listed
in section 6.1.
Like other vasoconstrictive agents, OTRIVIN should not be administered
to
patients after transsphenoidal hypophysectomy or nasal and buccal
cavity surgery
in which the dura mater has been exposed.
OTRIVIN
is contraindicated in the case of atrophic and vasomotor rhinitis,
rhinitis
due
to
mucosal
dryness,
hypertension,
diabetes
mellitus
and
closed-angle
glaucoma.
OTRIVIN
0.1% spray should not be used by children below 12 years of age.
For children between 2 and 12 years of age, 0.05% drops are
recommended.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
OTRIVIN, like all other sympathomimetic agents, should be used with
caution in
patients showing a strong reaction to adrenergic substances, as is
evidenced with
symptoms of insomnia, vertigo, tremor, cardiac arrhythmias or elev