Septanazal 1 mg/ 50 mg in 1 ml nasal spray solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Xylometazoline hydrochloride; Dexpanthenol

Available from:

KRKA, d.d., Novo mesto

ATC code:

R01AB; R01AB06

INN (International Name):

Xylometazoline hydrochloride; Dexpanthenol

Dosage:

1mg/50 milligram(s)

Pharmaceutical form:

Nasal spray, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics, combinations excl. corticosteroids; xylometazoline

Authorization status:

Not marketed

Authorization date:

2016-12-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTANAZAL 1 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 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 for adults 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
aged 6 years or over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SEPTANAZAL
DO NOT USE SEPTANAZAL:
-
if you or your child

Summary of Product characteristics

Health Products Regulatory Authority
27 August 2021
CRN009Y4V
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septanazal 1 mg/ 50 mg in 1 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 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 OVER 12 YEARS OF AGE
_ _
The usual dose of Septanazal for adults and adolescents is one
actuation into each nostril up to 3 times a day as needed.
The dosage depends on individual sensitivity and clinical efficacy.
If after 7 days of treatment no improvement or worsening of the
symptoms is observed, the clinical situation should be
re-evaluated. Duration of treatment is limited to 7 days. Repeated use
is possible only after a break of several days.
_ _
_Paediatric population_
The administration of the product in children under 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.
CHILDREN 6-12 YEARS OF AGE
The usual dose of Septanazalin children aged 6 years or over is one
actuation into each nostril up to 3 times a day, as needed.
Septanazal is contraindicated in children under 6 years of age (see
section