Otrivin 0.1% (Moisturising Formula) Nasal drops

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

XYLOMETAZOLINE HYDROCHLORIDE

Fáanlegur frá:

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

ATC númer:

R01AA07

INN (Alþjóðlegt nafn):

XYLOMETAZOLINE HYDROCHLORIDE 1 mg/ml

Lyfjaform:

NASAL DROPS, SOLUTION

Samsetning:

XYLOMETAZOLINE HYDROCHLORIDE 1 mg/ml

Gerð lyfseðils:

OTC

Lækningarsvæði:

NASAL PREPARATIONS

Leyfisstaða:

Authorised

Leyfisdagur:

2007-02-09

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OTRIVIN 0.1% NASAL DROPS
xylometazoline hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Otrivin 0.1%
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 your symptoms worsen or do not improve.
•
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 OTRIVIN 0.1% IS AND WHAT IT IS USED FOR
..................................................1
2
BEFORE YOU USE OTRIVIN 0.1%
.....................................................................................2
3
HOW TO USE OTRIVIN 0.1%
..............................................................................................3
4
POSSIBLE SIDE EFFECTS
...................................................................................................4
5
HOW TO STORE OTRIVIN 0.1%
.........................................................................................5
6
FURTHER INFORMATION
..................................................................................................5
1.
WHAT OTRIVIN 0.1% IS AND WHAT IT IS USED FOR
Otrivin 0.1% is indicated in adults and in adolescents over 12 years
of age. Otrivin 0.1% is a nasal
decongestant that quickly clears blocked noses.
Otrivin 0.1% clears your stuffy nose quickly so you can breathe
easier. It is used for the relief of
blocked nose caused by colds, hay fever or other allergic rhinitis,
sinusitis.
The effect of Otrivin 0.1% starts within minutes and lasts for up to
12 hours. It is well tolerated,
even by patients with a sensitive nasal mucosa.
Otrivin 0.1% may also be used in ear infections to help to decongest
the nasopharyngeal mucosa
(lining of nasal passages and throat). It may also

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OTRIVIN 0.1% AND 0.05% (MOISTURISING FORMULA)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Otrivin 0.1% contains 1 mg/ml of xylometazoline hydrochloride.
Otrivin 0.05% contains 0.5 mg/ml of xylometazoline hydrochloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORMS
Nasal Drops, Solution 0.1% F.5 clear, colourless and practically
odourless solution
Nasal Spray, Solution (metered-dose spray) 0.05% F.5 clear, colourless
and
practically odourless solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of nasal congestion due to colds, hay fever or other
allergic rhinitis,
sinusitis.
To aid drainage of secretions in affections of the paranasal sinuses.
As an adjuvant in otitis media, to decongest the nasopharyngeal
mucosa.
To facilitate rhinoscopy.
Otrivin 0.05% is indicated in children aged 1 to 11 years old with
adult supervision.
Otrivin 0.1% is indicated in adults and adolescents over 12 years of
age.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Paediatric population:
OTRIVIN 0.05%
should not be used in children aged less than 1 year old. It is
recommended for use in children aged 1 to 11 years old only under
adult
supervision.
OTRIVIN 0.1%
should not be used in children aged less than 12 years old.
Posology and method of administration:
OTRIVIN NASAL DROPS
Otrivin should not be used for more than ten consecutive days. (see
section 4.4)
2
The recommended dose should not be exceeded, especially in children
and older
people.
STRENGTH
AGE
POSOLOGY
0.1%
Adults
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.
Each drop of Otrivin 0.1% delivers 0.025 mg of xylometazoline
hydrochloride.
1.
Clear the nose.
2.
Tilt the head back as far as is comfortable or, if lying on a bed,
hang the head
over the side.
3.
Apply the drops into ea