SeptaNazal 1 mg/ml + 50 mg/ml nasal spray, solution

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

XYLOMETAZOLINE HYDROCHLORIDE, DEXPANTHENOL

Dostopno od:

KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Koda artikla:

R01AB06

INN (mednarodno ime):

XYLOMETAZOLINE HYDROCHLORIDE 1 mg/ml DEXPANTHENOL 50 mg/ml

Farmacevtska oblika:

NASAL SPRAY, SOLUTION

Sestava:

XYLOMETAZOLINE HYDROCHLORIDE 1 mg/ml DEXPANTHENOL 50 mg/ml

Tip zastaranja:

OTC

Terapevtsko območje:

NASAL PREPARATIONS

Povzetek izdelek:

Licence number in the source country: NOT APPLICAPABLE

Status dovoljenje:

Authorised

Datum dovoljenje:

2021-05-25

Navodilo za uporabo

PAGE 1 OF 6
PACKAGE LEAFLET
PAGE 2 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTANAZAL 1 MG/ML + 50 MG/ML NASAL SPRAY, SOLUTION
xylometazoline hydrochloride/dexpanthenol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
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 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 after 7 days (3 days in
children).
WHAT IS IN THIS LEAFLET
1.
What SeptaNazal is and what it is used for
2.
What you need to know before you use SeptaNazal
3.
How to use SeptaNazal
4.
Possible side effects
5.
How to store SeptaNazal
6.
Contents of the pack and other information
1.
WHAT SEPTANAZAL IS AND WHAT IT IS USED FOR
SeptaNazal nasal spray contains xylometazoline hydrochloride and
dexpanthenol.
Xylometazoline hydrochloride rapidly constricts blood vessels in the
nasal mucous membrane and
reduces the swelling of the nasal mucous membrane and mucus secretion.
In this way the feeling of a
blocked nose is reduced. Dexpanthenol is a derivative of the vitamin
pantothenic acid, which promotes
healing and protects the nasal mucous membrane.
SeptaNazal is used:
-
for reducing the swelling of the nasal mucous membrane in nasal mucous
membrane
inflammation (rhinitis) and to promote healing of mucous membrane
lesions,
-
for relief in non-allergic nasal mucous membrane inflammation
(vasomotor rhinitis).
Upon medical advice only, SeptaNazal is also used for the treatment of
worsened breathing through
the nose after nasal surgery.
_ _
This medicine is intended for use in adults, adolescents and children
6 years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SEPTANAZAL
DO NOT USE SEPTANAZ

Lastnosti izdelka

PAGE 1 OF 8
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 8
1.
NAME OF THE MEDICINAL PRODUCT
SeptaNazal 1 mg/ml + 50 mg/ml nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of nasal spray, solution, contains 1 mg xylometazoline
hydrochloride and 50 mg
dexpanthenol.
One actuation contains 0.1 ml of nasal spray, solution, containing 0.1
mg xylometazoline
hydrochloride and 5.0 mg dexpanthenol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution (Nasal spray)
Clear, colourless liquid solution.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SeptaNazal is indicated:
-
for reducing the swelling of the nasal mucosa in rhinitis and as
supportive treatment for healing
of mucous membrane lesions,
_ _
-
for relief in vasomotor rhinitis (rhinitis vasomotorica),
_ _
-
for the treatment of nasal respiratory obstruction after nasal
surgery.
_ _
SeptaNazal is indicated for adults, adolescents and children over 6
years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and adolescents 12 years of age and older _
The usual dose of SeptaNazal is one actuation into each nostril up to
3 times a day as needed.
The dosage depends on individual sensitivity and clinical efficacy.
Duration of treatment is limited to 7 days. Repeated use is possible
only after a break of several days.
_ _
_Children between 6 and 12 years of age _
The usual dose of SeptaNazal in children between 6 and 12 years of age
is one actuation into each
nostril up to 3 times a day.
The administration of the product in children between 6 and 12 years
of age should be supervised by
an adult.
If after 3 days of treatment no improvement or worsening of the
symptoms is observed, the clinical
situation should be re-evaluated.
Regarding the duration of treatment in children, a doctor should
always be consulted.
_Children under 6 years of age _
SeptaNazal is contraindicated in children under 6 years of age (see
section 4.3).
Method of administration
PAGE 3 OF 8
Nasal use.
First the