SeptaNazal 0.5 mg/ml + 50 mg/ml nasal spray, solution

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Commercializzato da:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

Codice ATC:

R01AB06

INN (Nome Internazionale):

DEXPANTHENOL 50 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml

Forma farmaceutica:

NASAL SPRAY, SOLUTION

Composizione:

DEXPANTHENOL 50 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml

Tipo di ricetta:

OTC

Area terapeutica:

NASAL PREPARATIONS

Dettagli prodotto:

Licence number in the source country: NOT APPLICAPABLE

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2023-03-16

Foglio illustrativo

Page
1
of
7
PACKAGE LEAFLET
Page
2
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTANAZAL 0.5 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 your child does not feel better or if
your child feels worse after 3
days.
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 children aged 2 to 6 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SEPTANAZAL
DO NOT USE SEPTANAZAL
if your child is allergi

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SeptaNazal 0.5 mg/ml + 50 mg/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 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 children aged 2 to 6 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
CHILDREN 2 TO 6 YEARS OF AGE
The usual dose of SeptaNazal in children aged 2 to 6 years is one
actuation into each nostril up to 3
times a day, as needed.
The administration of the product 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.
SeptaNazal 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.
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
sprayer.
4.