Otrivin Child

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 0.05 % (W/V)

Pharmaceutical form:

NASAL DROPS, SOLUTION

Composition:

XYLOMETAZOLINE HYDROCHLORIDE 0.05 % (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 CHILD
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
have 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, pharmacist or nurse.
This includes any possible
side effects not listed in this patient information leaflet. See
section 4
•
You must talk to a doctor if you do not feel better or if you feel
worse (if your symptoms
worsen or do not improve) after 5 days.
WHAT IS IN THIS LEAFLET
1
What OTRIVIN CHILD
is and what it is used for
2
What you need to know before you use OTRIVIN CHILD
3
How to use OTRIVIN CHILD
4
Possible side effects
5
How to store OTRIVIN CHILD
6
Contents of the pack and other information
1
WHAT OTRIVIN
CHILD IS AND WHAT IT IS USED FOR
WHAT OTRIVIN
CHILD IS
OTRIVIN CHILD
is a decongestant of nasal mucosa for children between the ages of 2
and 12
years old. OTRIVIN CHILD moisturizing formula also contains
moisturizing excipients that help
relieve dried out, irritated nasal passages.
WHAT OTRIVIN CHILD IS USED FOR
OTRIVIN CHILD is a local decongestant, for nasal use.
OTRIVIN CHILD contains xylometazoline, a sympathomimetic agent that
constricts the nasal
blood vessels, decongesting the muscosa of the nose and neighbouring
regions of the pharynx,
providing quick and prolonged relief from nasal congestion.
Consequently it helps to open up the
nasal passages and allows patients suffering from blocked noses to
breathe more easily.
The effect of OTRIVIN starts within 2 minutes and lasts for up to 10
hours.
OTRIVIN CHILD is well tolerated, even by patients with sensitive
mucous membranes.
You need to talk to a doctor if your child does not feel better or if
he/she fe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OTRIVIN CHILD
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
OTRIVIN
 CHILD MOISTURIZING FORMULA, NASAL DROPS, SOLUTION
0.05%:
Each 1 ml contains: 0.5 mg of xylometazoline hydrochloride
3.
PHARMACEUTICAL FORM
Nasal drops, solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of symptoms affecting the nasal mucosa due to the
common cold,
allergic rhinitis or sinusitis. To aid drainage of secretions in
affections of the
paranasal sinuses.
As an adjuvant in otitis media, to decongest the nasopharyngeal mucosa
and
facilitate rhinoscopy. Use of OTRIVIN
0.05% is recommended for children who
are 2 to 12 years old with adult supervision. In children who are 2 to
6 years old,
medical advice is recommended prior to administration.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Not to be used in children aged less than 2 years of age.
Use in children aged 2 and 6 years of age, medical advice is
recommended prior
to administration.
It is not recommended that the pharmaceutical product be administered
to children
between 2 to 12 years of age except with adult supervision.
_For children between 6 and 12 years of age: _
In general, 1-2 drops dose in each nostril two or three times a day is
sufficient.
Do not exceed 3 applications a day in each nostril and do not use for
more than 5
consecutive days.
_For children between 2 and 5 years of age _
In general, 1-2 drops in each nostril one or two times a day is
sufficient. Do not
exceed 2 applications a day in each nostril and do not use for more
than 5
consecutive days.
Do not exceed the recommended dosage.
4.3.
CONTRA-INDICATIONS
Hypersensitivity to xylometazoline or to any of the excipients listed
in section 6.1.
Like all other vasoconstrictors, OTRIVIN CHILD should not be used in
patients
after transsphenoidal hypophysectomy or nasal and sinus cavity surgery
in which
the dura mater has been exposed.
Use
of
OTRIVIN
CHILD
is
contraindicated
in
patients
with
atrophic
and
vasomotor rhinitis,