Septanazal for children 0.5 mg/ 50 mg in 1 ml nasal spray solution

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Xylometazoline hydrochloride; Dexpanthenol

Verfügbar ab:

KRKA, d.d., Novo mesto

ATC-Code:

R01AB; R01AB06

INN (Internationale Bezeichnung):

Xylometazoline hydrochloride; Dexpanthenol

Dosierung:

0.5 mg/50 milligram(s)

Darreichungsform:

Nasal spray, solution

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Sympathomimetics, combinations excl. corticosteroids; xylometazoline

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2016-12-02

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTANAZAL FOR CHILDREN 0.5 MG/50 MG IN 1 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 your child do not feel better or if your
child feels worse after 3
days.
WHAT IS IN THIS LEAFLET
1.
What Septanazal for children is and what it is used for
2.
What you need to know before you use Septanazal for children
3.
How to use Septanazal for children
4.
Possible side effects
5.
How to store Septanazal for children
6.
Contents of the pack and other information
1.
WHAT SEPTANAZAL FOR CHILDREN IS AND WHAT IT IS USED FOR
Septanazal for children 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 for children 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 for children is also used for the
treatment of worsened
breathing through the nose after nasal surgery.
This medicine is intended for use in children aged 2 to 6 years.
2.
WHAT YOU NEED TO KN

Fachinformation

Health Products Regulatory Authority
18 July 2023
CRN00DMJS
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septanazal for children 0.5 mg/ 50 mg in 1 ml nasal spray solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of nasal spray, solution, contains 0.5 mg xylometazoline
hydrochloride and 50 mg dexpanthenol.
One actuation contains 0.1 ml of nasal spray, solution, containing
0.05 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 for children is indicated:
- for reducing the swelling of the nasal mucosa in rhinitis and as
supportive treatment for healing mucous membrane lesions,
- for relief in vasomotor rhinitis (rhinitis vasomotorica),
- for the treatment of nasal respiratory obstruction after nasal
surgery.
Septanazal for children is indicated for children aged 2 to 6 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
CHILDREN 2 TO 6 YEARS OF AGE
The usual dose of Septanazal for children in children aged 2 to 6
years is one spray into each nostril up to 3 times a day, as
needed.
Septanazal for children is contraindicated in children under 2 years
of age (see section 4.3).
Method of administration
Nasal use.
First the protective cap should be removed from the sprayer.
Before the first use or if the spray has not been used for a long
period of time, the spray head should be pressed 5 times until a
fine spray appears.
Health Products Regulatory Authority
18 July 2023
CRN00DMJS
Page 2 of 6
The sprayer tip should be inserted as upright as possible into one
nostril and the spray head should be pressed once. Patient
should gently inhale through the nose while spraying. If necessary,
the procedure should be repeated for the other nostril.
After each use, the sprayer tip should be wiped with a paper tissue
and the cap placed back on the spr