Hysan Adults 1 mg/ml nasal spray, solution

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Ursapharm Arzeneitmittel GmbH Industriestrasse, 66129 Saarbrucken, Germany

ATC code:

R01AA07

INN (International Name):

XYLOMETAZOLINE HYDROCHLORIDE 1 mg/ml

Pharmaceutical form:

NASAL SPRAY, SOLUTION

Composition:

XYLOMETAZOLINE HYDROCHLORIDE 1 mg/ml

Prescription type:

OTC

Therapeutic area:

NASAL PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-08-17

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
HYSAN ADULTS
1 mg/ml nasal spray, solution
For use in children over 6 years of age and adults
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. 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.
WHAT IS IN THIS LEAFLET
1.
What Hysan Adults is and what it is used for
2.
What you need to know before you use Hysan Adults
3.
How to use Hysan Adults
4.
Possible side effects
5.
How to store Hysan Adults
6.
Contents of the pack and other information
1.
WHAT HYSAN ADULTS IS AND AND WHAT IT IS USED FOR
Hysan Adults is for nasal use (rhinologic agent) and contains the
alpha-sympathomimetic agent
xylometazoline.
Xylometazoline has vasoconstrictive properties and thus effects
decongestion of the nasal mucosa.
INDICATIONS
Hysan Adults is used:
-
for short-term treatment to reduce the swelling (congestion) of the
nasal mucosa.
Hysan Adults is intended for use in children over 6 years of age and
adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYSAN ADULTS
DO NOT USE HYSAN ADULTS
-
if you are allergic to the active substance xylometazoline
hydrochloride or to any of the
ingredients of this medicine listed in section 6.
-
if you suffer from dry inflammation of the nasal mucosa with formation
of crusts (rhinitis
sicca),
-
condition after surgical removal of the pituitary gland through the
nose (transsphenoidal
hypophysectomy) or other surgical interventions which reveal the
cerebral membranes,
-
in children under the age of 6 years.
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WARNINGS AND PRECAUTIONS
Ta

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hysan Adults 1 mg/ml nasal spray, solution
For the use in children over 6 years of age and adults
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of nasal spray, solution contains 1 mg of xylometazoline
hydrochloride.
1 spray of Hysan Adults of 0.14 ml contains 0.14 mg of xylometazoline
hydrochloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For short-term treatment in case of congestion of the nasal mucosa.
Hysan Adults 1.0 mg/ml nasal solution is indicated for children over 6
years of age and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose in children over 6 years of age and adults is 1 spray of
Hysan Adults is to be applied into
each nostril, according to need, butnot more than 3 times per day.
Duration of use
Hysan Adults 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.
An interval of several days should elapse before re-administering the
medicinal product.
In chronic rhinitis, it may only be administered under medical
surveillance, due to the risk of nasal
mucosal atrophy.
Method of administration:
Nasal use
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4.3
CONTRAINDICATIONS
This medicinal product must not be used in case of:
-
hypersensitivity to the active substance xylometazoline hydrochloride
or to any of the excipients
listed in section 6.1.
-
dry inflammation of the nasal mucosa (rhinitis sicca).
-
after transsphenoidal hypophysectomy or other surgical interventions
which reveal the dura
mater.
-
children under the age of 6 years.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
New-born babies and infants should be treated with special care. In
sing