Sudafed Sinus-Ease 0.1% nasal spray

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Xylometazoline hydrochloride

Fáanlegur frá:

McNeil Products Ltd

ATC númer:

R01AA07

INN (Alþjóðlegt nafn):

Xylometazoline hydrochloride

Skammtar:

1mg/1ml

Lyfjaform:

Spray

Stjórnsýsluleið:

Nasal

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 12020200; GTIN: 3574661433400

Upplýsingar fylgiseðill

FONTS USED
CTE
SFO01 2861 Sudafed Sinus Ease 0.1% 15ml CCDS Leaflet GB CC/SS/LG
03/03/2018
614719_V1
Leaflet
N/A
N/A
N/A
18-0126
148 x 210mm
N/A
N/A
N/A
BLACK
PMS 186 C
Bliss Pro-ExtraBold
Bliss Pro-ExtraLight Italic
Bliss Pro-Italic
Bliss Pro-Regular
Qlassik Bold-Regular
Wingdings 3-Regular
Zapf Dingbats-Regular
BODY COPY SIZE
7.5pt
n
This medicine is used to help clear the blocked up
feeling in your nose and sinuses, and helps relieve
congestion caused by sinusitis, colds and hayfever.
n
This medicine is for use by adults and children aged
12 years and over.
n
DO NOT TAKE THIS MEDICINE:
n
There are some people who should not take this
medicine. _To find out if you are one of them see _
_section 2_

n
If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients see section 6_

n
SPEAK TO YOUR DOCTOR:
n
If you suffer from any of the conditions
mentioned in section 2. _See section 2_

n
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These
are shown in the table. _See section 3_

NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE. Keep the leaflet: you might need it again.
1
WHAT THE MEDICINE IS FOR
Sudafed Sinus-Ease 0.1% Nasal Spray is a medicine
which is used to help clear the blocked up feeling in
your nose and sinuses, and helps relieve congestion
caused by sinusitis, colds and hayfever. The metered
spray gives an exact dose that lasts for up to 10 hours.
The spray contains xylometazoline hydrochloride,
which is a topical decongestant that relieves nasal and
sinus congestion.
This medicine is for use in adults and children aged
12 years and over.
2
BEFORE TAKING THIS
MEDICINE
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 THIS MEDICINE…
n
If you have ever had a BAD REACTION (e.g.
rash, swelling of the face and throat, difficulty
breathing) to any of the ingredients.
n
If you are taking, or have taken in the last
two weeks, DRUGS FOR DEPRESSION known as
Mo

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Non-Drowsy Sudafed Decongestant Nasal Spray
Sudafed Blocked Nose Spray
Sudafed Mucus Relief 0.1% Nasal Spray
Sudafed Sinus-Ease 0.1% Nasal Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This product is an aqueous solution of Xylometazoline Hydrochloride
0.1%
w/v presented in a metered-dose pack, delivering 0.14 ml per
actuation.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Aqueous solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This product 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
Posology
ADULTS AND CHILDREN 12 YEARS AND OVER:
One spray to be expressed into each nostril 2-3 times daily, as
necessary.
Maximum daily dose: 3 sprays in 24 hours.
Use for more than seven consecutive days is not recommended, [See
section
4.4].
CHILDREN UNDER 12 YEARS:
Do not give to children under 12 years of age.
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].
Method of administration
Nasal
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Children under 12 years of age.
This product is contraindicated in individuals who are taking or have
taken
monoamine oxidase inhibitors within the preceding two weeks.
This product is contraindicated in individuals with hypophysectomy or
surgery
exposing dura mater.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is minimal systemic absorption with topically applied
imidazoline
sympathomimetics such as xylometazoline, however, this product should
be
used with caution in patients suffering coronary artery disease,
hypertension,
hyperthyroidism or diabetes mellitus. Patients with long QT syndrome
treated
w