SUDAFED BLOCKED NOSE 1 Mg/Ml Nasal Spray Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

XYLOMETAZOLINE HYDROCHLORIDE

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

R01AA07

INN (International Name):

XYLOMETAZOLINE HYDROCHLORIDE

Dosage:

1 Mg/Ml

Pharmaceutical form:

Nasal Spray Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics, plain

Authorization status:

Authorised

Authorization date:

2011-04-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

SUDAFED BLOCKED NOSE 1MG/ML NASAL SPRAY SOLUTION 
_xylometazoline hydrochloride_ 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
Always take this medicine exactly as
described in this leaflet or as your doctor or pharmacist has
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 you do
not feel better or if you feel worse after 7 days. 

WHAT IS IN THIS LEAFLET  
1. 
What Sudafed Blocked Nose Nasal Spray is and what it is
used for 
2. 
What you need to know before you use Sudafed Blocked
Nose Nasal Spray 
3. 
How to use Sudafed Blocked Nose Nasal Spray 
4. 
Possible side effects 
5. 
How to store Sudafed Blocked Nose Nasal Spray 
6. 
Contents of the pack and other information 
1. 
WHAT SUDAFED BLOCKED
NOSE NASAL SPRAY IS AND WHAT IT IS USED FOR 
Olynth HA 1mg/ml contains Xylometazoline, which helps to
narrow the blood vessels in your nose, 
reducing swelling of the mucous membrane (the lining in
your nose), to help you breathe easier. 
Sudafed Blocked Nose
Nasal Spray also contains hyaluronic acid (in the form of sodium hyaluronate), 
which protects and moisturises the mucous membrane of the nose. 

The spray is
used for short term treatment of nasal congestion with a
running nose due to common 
cold or sinusitis. 
2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE SUDAFED BLOCKED
NOSE NASAL SPRAY 
DO NOT USE SUDAFED BLOCKED NOSE NASAL SPRAY IF YOU: 
• 
are allergic to
xylometazoline or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sudafed Blocked Nose 1 mg/ml Nasal Spray Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylometazoline hydrochloride 1 mg in 1 ml of solution
Each actuation (140µl) contains 140µg of xylometazoline
hydrochloride
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nasal spray, solution.
Clear to slightly opalescent, colourless to slightly yellowish
solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temporary symptomatic treatment of nasal congestion due to rhinitis or
sinusitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For nasal use.
Adults and children over 12 years old:
One spray, into each nostril not more often than three times per day.
This medicine should be used for a maximum of 7
days, unless directed otherwise by a doctor.
To minimise the risk of spreading infections, the medicinal product
should not be used by more than one person, and
the nozzle should be rinsed following use.
PAEDIATRIC POPULATION
Sudafed Blocked Nose Nasal Spray Solution, 1 mg/ml is contraindicated
in children less than 12 years of age (See
section 4.3).
ELDERLY PATIENTS
Dosage as for adults.
4.3 CONTRAINDICATIONS
Sudafed Blocked Nose Nasal Spray Solution 1mg/ml should not be used:
-
in patients with hypersensitivity to the active substance or to any of
the excipients stated in Section 6.1.
-
in patients with increased intraocular pressure, particularly in
patients with narrow angle glaucoma
-
in patients with dry inflammation of the nasal mucus membrane
(_Rhinitis sicca_)
-
in children under 12 years of age
-
after transsphenoidal hypophysectomy or such transnasal / transoral
operations where the dura mater has been
exposed
-
in patients who are being treated with monoaminooxidase inhibitors
(MAOI) or those who have used them within
the previous 2 weeks, or other medicaments with potential hypertensive
effect
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