OTRIVIN COMPLETE

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

IPRATROPIUM BROMIDE; XYLOMETAZOLINE HYDROCHLORIDE

Dostopno od:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

Koda artikla:

R01AX03

Farmacevtska oblika:

NASAL SPRAY, SOLUTION

Sestava:

IPRATROPIUM BROMIDE 0.6 MG/ML; XYLOMETAZOLINE HYDROCHLORIDE 0.5 MG/ML

Pot uporabe:

NASAL

Tip zastaranja:

Not required

Izdeluje:

NOVARTIS CONSUMER HEALTH SA, SWITZERLAND

Terapevtsko območje:

IPRATROPIUM BROMIDE

Terapevtske indikacije:

Symptomatic treatment of nasal congestion and rhinorrhea in connection with common cold in adults.

Datum dovoljenje:

2017-02-28

Navodilo za uporabo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed without a doctor’s prescription
OTRIVIN COMPLETE 0.05% W/V + 0.06% W/V
METERED DOSE NASAL SPRAY
Ipratropium Bromide 0.06% w/v
Xylometazoline Hydrochloride 0.05% w/v
Inactive ingredients and allergens in the medicine – see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have additional questions,
refer to the doctor or the pharmacist.
Use the medicine according to the instructions in the section “How
should you use the medicine?” in
this leaflet. Consult the pharmacist if you need more information.
Refer to the doctor if signs of the ailment (symptoms) worsen or do
not improve after 7 days.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Treatment of symptoms of nasal congestion and rhinitis associated with
the common
cold in adults.
THERAPEUTIC CLASS:
Ipratropium bromide, an anticholinergic agent, which helps in case of
rhinitis.
Xylometazoline hydrochloride, a sympathomimetic agent, which has a
decongesting effect.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are a child or are treating a child under the age of 18, as no
information is
available regarding its safety and efficacy.

You are sensitive (allergic) to the active ingredients (ipratropium
bromide,
xylometazoline hydrochloride) or to any of the other components the
medicine
contains (see section 6).

There is a known sensitivity to atropine or to similar agents, such as
hyoscyamine
and scopolamine.

You have undergone surgery in which the hard external membrane in the
central
nervous system (dura mater) was penetrated, e.g., surgery to remove
your pituitary
gland (hypophysis) through the nose, or other surgery carried out
through the nose.

You have glaucoma (increased pressure in the eye).

You have a very dry nose (inflammatory nasal dryness, rhinitis sicca
or atrophic
rhinitis).
SPECIAL WARNINGS REGARDING THE USE

Lastnosti izdelka

OTRIVIN COMPLETE
1.
NAME OF THE MEDICINAL PRODUCT
Otrivin Complete 0.05 % w/v + 0.
0
6% w/v nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IPRATROPIUM BROMIDE 0.06% w/v
XYLOMETAZOLINE HYDROCHLORIDE 0.05% w/v
1 puff approx. 140 microliters contains 70 micrograms xylometazoline
hydrochloride and
84 micrograms ipratropium bromide.
For the full list of excipients see 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution
The product is a clear, colorless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of nasal congestion and rhinorrhea in connection
with common
cold in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_ 1 puff in each nostril up to 3 times daily. At least 6 hours
should elapse between two
doses.
The treatment duration should not exceed 7 days (see section 4.4)
Do not exceed the stated dose. The lowest dose necessary to achieve
efficacy should
be used for the shortest duration of treatment.
It is recommended to stop treatment, when the symptoms have
diminished, even before the
maximum duration of treatment of 7 days, in order to minimize the risk
of adverse
reactions (see section 4.8).
_Paediatric population: _
Otrivin Complete is not recommended for use in children and
adolescents below 18 years of
age due to lack of sufficient documentation.
_ _
_Geriatrics_
There is only limited experience of use in patients above 70 years of
age.
Method of administration
Two fingers vertically actuated pump:
Before the first application, prime the pump by actuating 4 times.
Once primed the pump will
normally remain charged throughout regular daily treatment periods.
1. Clear the nose.
2. Hold the bottle upright with thumb under base and nozzle between
two fingers.
3. Lean forward slightly and insert the nozzle into a nostril.
4. Spray and breathe in gently through the nose at the same time.
5. Repeat this procedure in the other nostril.
6. Clean and dry the nozzle before replacing back the cap right after
use.
Should the spray not be ejected during