Nezebi 0,5 mg/ml Nässpray, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

oximetazolinhydroklorid

Tillgänglig från:

Perrigo Sverige AB

ATC-kod:

R01AA05

INN (International namn):

oxymetazoline hydrochloride

Dos:

0,5 mg/ml

Läkemedelsform:

Nässpray, lösning

Sammansättning:

oximetazolinhydroklorid 0,5 mg Aktiv substans

Receptbelagda typ:

Receptfritt

Produktsammanfattning:

Förpacknings: Plastflaska med dospump, 7,5 ml

Bemyndigande status:

Godkänd

Tillstånd datum:

2020-03-03

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEZEBI 0.5 MG/ML NASAL SPRAY, SOLUTION
oxymetazoline hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Nezebi is and what it is used for
2.
What you need to know before you take Nezebi
3.
How to take Nezebi
4.
Possible side effects
5.
How to store Nezebi
6.
Contents of the pack and other information
1.
WHAT NEZEBI IS AND WHAT IT IS USED FOR
Nezebi is used as a short-term treatment of nasal congestion due to
colds in adults and children from
10 years of age.
Nezebi has a rapid decongestant effect, which reduces nasal congestion
and facilitates breathing. The
effect comes on within a few minutes and lasts for up to 12 hours.
Nezebi contains also dexpanthenol that hydrates the nasal moucosa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEZEBI
DO NOT TAKE NEZEBI
-
if you are allergic to oxymetazoline hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)
-
if you have chronic nasal inflammation with very dry nasal passageways
(atrophic rhinitis or
rhinitis sicca)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nezebi if you:
-
have cardiovascular diseases (e.g. angina)
-
have raised blood pressure
-
have diabetes
-
have a benign tumour of the adrenal gland (phaeochromocytoma) that
produces high amounts of
adrenaline and noradrenaline
-
have difficulty in urinating and/or an enlarged prostate gland
-
have increased pressure in the eyes (narrow-angle glaucoma)
-
have

Produktens egenskaper

S
UMMARY OF PRODUCT CHARACTERISTICS
1
N
AME OF THE MEDICINAL PRODUCT
Nezebi 0.5 mg/ml nasal spray, solution
2
Q
UALITATIVE AND QUANTITATIVE COMPOSITION
1 ml
of the solution
contains 0.5 mg of oxymetazoline hydrochloride.
For a full list of excipients, see section 6.1.
Each spray has volume of 50 microliter which contains 0,025 mg
oxymetazoline
hydrochloride.
3
P
HARMACEUTICAL FORM
Nasal spray, solution
Clear, colourless to slightly coloured solution
4
C
LINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rhinitis and as a decongestant for sinusitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Age from_
_Strength_
_Dosage_
10 years and older
0.5 mg/ml
2 sprays in each nostril 2–3 times a day.
Nezebi nasal spray can be used for a maximum of 10 consecutive days.
The recommended daily dosage or the specified number of doses should
not be exceeded (see
section 4.4).
_Paediatric population_
Nezebi nasal spray is not appropriate for children under the age of 10
years.
Method of administration
Nasal use.
Before using: when the nasal spray is used for the first time the pump
must be primed. Keep
the bottle upright and spray 5 times in the air until the spray is
homogenous. If the pump has
not been used for a long time, it should be recharged with 3 sprays in
air.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
The product should not be used in patients with atrophic rhinitis or
rhinitis sicca.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The recommended dose should not be exceeded. The prolonged or
excessive use of the
product may cause rhinitis medicamentosa.
If the symptoms aggravate or persist during the use of this medicinal
product, a doctor or a
qualified health care practitioner should be consulted.
The product should be used with caution in:
• cardiovascular disease (e.g. ischaemic cardiac disease)
• hypertension
• diabetes mellitus
• pheochromocytoma
• prostatic hypertrophy
• angle-closure glaucoma
• hyperthyroidism
• patients