Hysan Paediatric 0.5 mg/ml nasal spray, solution

Nazione: Malta

Lingua: inglese

Fonte: Malta Medicines Authority

Commercializzato da:

Ursapharm Arzeneitmittel GmbH Industriestrasse, 66129 Saarbrucken, Germany

Codice ATC:

R01AA07

INN (Nome Internazionale):

XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml

Forma farmaceutica:

NASAL SPRAY, SOLUTION

Composizione:

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:

2022-02-21

Foglio illustrativo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
HYSAN PAEDIATRIC
0.5 mg/ml nasal spray, solution
For use by children between 2 and 6 years
Active substance: xylometazoline hydrochloride
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 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.
WHAT IS IN THIS LEAFLET
1.
What Hysan Paediatric is and what it is used for
2.
What you need to know before you use Hysan Paediatric
3.
How to use Hysan Paediatric
4.
Possible side effects
5.
How to store Hysan Paediatric
6.
Contents of the pack and other information
1.
WHAT HYSAN PAEDIATRIC IS AND WHAT IT IS USED FOR
Hysan Paediatric is a cold remedy (rhinologic agent,
alpha-sympathomimetic agent).
The active substance xylometazoline hydrochloride has vasoconstrictive
properties and thus leads to
decongestion of the nasal mucosa.
INDICATIONS
Hysan Paediatric is used
-
for decongestion of the nasal mucosa in case of cold, runny nose
(rhinitis vasomotorica), allergic
cold (rhinitis allergica).
-
for an alleviated draining of secretion in case of inflammations of
the nasal sinuses and in otitis
media (catarrh of the middle ear) in connection with cold.
Hysan Paediatric is intended for use by children between 2 and 6
years.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYSAN PAEDIATRIC
DO NOT USE HYSAN PAEDIATRIC
-
if you are allergic to the active substance xylometazoline
hydrochloride or to any of the other
ingredients of this medicine listed in section 6.
-
if you suffer from dry inflammation of the nasal mucosa with formation
of crusts (rhinitis sicca).

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hysan Paediatric 0.5 mg/ml nasal spray, solution
For use by children between 2 and 6 years
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of nasal spray, solution contains 0.5 mg of xylometazoline
hydrochloride.
1 spray of Hysan Paediatric of 0.07 ml contains 0.035 mg of
xylometazoline hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For decongestion of the nasal mucosa in case of cold, runny nose
(rhinitis vasomotorica) and allergic
cold (rhinitis allergica).
For an alleviated draining of secretion in case of inflammations of
the nasal sinuses and catarrh of the
middle ear in connection with cold.
Hysan Paediatric 0,5 mg/ml nasal solution is indicated for children
between 2 and 6 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage depends on the individual sensitivity and on the clinical
effect.
The dose is: 1 spray of Hysan Paediatric is applied, according to
need, but not more than 3 times per
day into each nostril of children between 2 and 6 years.
DURATION OF USE
Hysan Paediatric must not be used for longer than 7 days, unless
prescribed by a physician.
If after 7 days of treatment the patient feels not better or worse,
the clinical situation should be re-
evaluated. Long and excessive use can cause reactive hyperaemia or
rebound congestion respectively
(see section 4.4). The recommended dose should not be exceeded.
A physician should always be consulted about the duration of use in
children.
An interval of several days should elapse before re-administering the
medicinal product.
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In chronic rhinitis, it may only be administered under medical
surveillance, due to the risk of nasal
mucosal atrophy.
METHOD OF ADMINISTRATION
Nasal use
4.3
CONTRAINDICATIONS
This medicinal product should not be used in case of
-
hypersensitivity to the active substance or to any of the excipients
listed