Sudafed 0.1% w/v Nasal spray solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Xylometazoline hydrochloride

Tersedia dari:

Johnson & Johnson (Ireland) Limited

Kode ATC:

R01AA; R01AA07

INN (Nama Internasional):

Xylometazoline hydrochloride

Dosis:

0.1 percent weight/volume

Bentuk farmasi:

Nasal spray, solution

Jenis Resep:

Product not subject to medical prescription

Area terapi:

Sympathomimetics, plain; xylometazoline

Status otorisasi:

Marketed

Tanggal Otorisasi:

2003-06-30

Selebaran informasi

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However,
you still need to use Sudafed Nasal Spray carefully to get
the best results from it.
n Keep this leaflet. You may need to read it again.
n Ask your pharmacist if you need more information or
advice.
n If any of the side-effects get serious, or if you notice
any side-effect not listed in this leaflet, please tell your
doctor or pharmacist.
n You must talk to a doctor if you do not feel better or if
you feel worse after 5 days.
WHAT IS IN THIS LEAFLET:
n
WHAT SUDAFED NASAL SPRAY IS AND WHAT IT IS USED FOR
n
WHAT YOU NEED TO KNOW BEFORE YOU USE SUDAFED
NASAL SPRAY
n
HOW TO USE SUDAFED NASAL SPRAY
n
POSSIBLE SIDE-EFFECTS
n
HOW TO STORE SUDAFED NASAL SPRAY
n
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT SUDAFED NASAL SPRAY IS
AND WHAT IT IS USED FOR
Sudafed Nasal Spray is a medicine which is used to help
clear the stuffy, blocked up feeling in your nose and sinuses
caused by colds and allergies such as hay fever.
The spray contains xylometazoline hydrochloride, which
is a topical decongestant that relieves nasal and sinus
congestion.
This product is non-drowsy.
This medicine is for use in adults and children aged 6 years
and over.
2
WHAT YOU NEED TO KNOW BEFORE
YOU USE SUDAFED NASAL SPRAY
This medicine is suitable for most people but a few
people should not use it. If you are in any doubt, talk to
your doctor or pharmacist.
DO NOT USE SUDAFED NASAL SPRAY...
n If you have ever had a hypersensitive reaction (e.g.
rash, swelling of the face and throat, difficulty
breathing) to xylometazoline or to any of the
ingredients listed in Section 6.
n If you are taking, or have taken in the last two
weeks, DRUGS FOR DEPRESSION known as Monoamine
Oxidase Inhibitors (MAOIs).
n If you have recently had brain surgery.
n If you have had your pituitary gland removed.
n For a child under 6 years old.
If any of these apply to you, GET ADVICE FROM A DOCTOR
OR PHARMACIST WITHOUT TAKING SUDAFED

Karakteristik produk

Health Products Regulatory Authority
07 July 2021
CRN00CG3C
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sudafed 0.1% w/v Nasal spray solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The Solution contains 0.1% w/v Xylometazoline Hydrochloride. Each
metered spray (0.14 ml) delivers 140 micrograms of
xylometazoline hydrocholoride
Excipients: The solution contains 0.040% w/v benzalkonium chloride
solution and 2 % w/v sorbitol liquid.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nasal spray solution (nasal spray)
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sudafed Nasal Spray is indicated for the symptomatic relief of nasal
congestion associated with the common cold, influenza,
sinusitis, allergic and non-allergic rhinitis, and other upper
respiratory tract allergies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER:
Nasal. One spray to be expressed into each nostril 2-3 times daily, as
necessary.
Maximum daily dose: 3 Sprays per nostril.
Do not exceed the stated dose.
Use for more than seven consecutive days is not recommended. [See
section 4.4].
CHILDREN AGED 6 TO 12 YEARS:
Nasal. One spray to be expressed into each nostril 2-3 times daily, as
necessary.
Maximum daily dose: 3 Sprays per nostril.
Do not exceed the stated dose.
Consult a doctor or pharmacist before use. Use only when simple
measures have failed to bring adequate relief. Use for more
than five consecutive days is not recommended. [See section 4.4].
CHILDREN UNDER 6 YEARS:
Do not give SUDAFED decongestant Nasal Spray to children under 6 years
of age [see section 4.3].
THE ELDERLY
Experience has indicated that normal adult dosage is appropriate, [See
section 5.2].
HEPATIC/RENAL DYSFUNCTION
Normal adult dosage is appropriate, [See section 5.2].
4.3 CONTRAINDICATIONS
Sudafed Nasal Spray is contraindicated in individuals with known
hypersensitivity to the product or any of its constituents.
Sudafed Nasal Spray is contraindicated