Vicks Sinex Decongestant Nasal Spray

국가: 몰타

언어: 영어

출처: Malta Medicines Authority

유효 성분:

OXYMETAZOLINE

제공처:

Procter & Gamble (Health & Beauty Care) Limited The Heights Brooklands, Weybridge, Surrey KT13 0XP, United Kingdom

ATC 코드:

R01AA05

INN (국제 이름):

OXYMETAZOLINE 0.05 % (W/V)

약제 형태:

NASAL SPRAY, SOLUTION

구성:

OXYMETAZOLINE 0.05 % (W/V)

처방전 유형:

OTC

치료 영역:

NASAL PREPARATIONS

승인 상태:

Withdrawn

승인 날짜:

2007-03-02

환자 정보 전단

Page 1 of 4 

PACKAGE LEAFLET: INFORMATION FOR THE USER  
_ _ 
VICKS SINEX DECONGESTANT NASAL SPRAY 
Oxymetazoline hydrochloride 0.05% w/v 
_ _
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 VICKS SINEX 
DECONGESTANT NASAL SPRAY carefully to get the best results
from it.  
- Keep this leaflet. You may need to read it again.  
- Ask your pharmacist if you need more information
or advice.  
- You must contact a doctor if your symptoms worsen or do
not improve after 7 days. 
- If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet, please tell 
your doctor or pharmacist. 

IN THIS LEAFLET:  
1. What VICKS SINEX DECONGESTANT NASAL SPRAY is and
what it is used for  
2. Before you use VICKS SINEX DECONGESTANT NASAL SPRAY 
3. How to use VICKS SINEX DECONGESTANT NASAL SPRAY 
4. Possible side effects  
5. How to store VICKS SINEX DECONGESTANT NASAL SPRAY 
6. Further information  

1. WHAT VICKS SINEX DECONGESTANT NASAL SPRAY IS AND WHAT IT IS
USED FOR  

Vicks Sinex
Decongestant Nasal Spray is used for localised relief of the
symptoms of a blocked nose in 
association with a cold, hay fever or sinusitis (inflammation
of the passages leading to the nose). The 
effect of the spray starts after several minutes and
lasts for 6-8 hours. 
The active substance is Oxymetazoline hydrochloride. 

2. BEFORE YOU USE VICKS SINEX DECONGESTANT NASAL SPRAY 

_  _
DO NOT USE VICKS SINEX DECONGESTANT NASAL SPRAY IF YOU: 

  are allergic (hypersensitive) to the active
substance oxymetazoline hydrochloride or any other 
ingredients of Vicks Sinex (see section 6) 

  are taking (or have taken during the last 14 days) monoamine
oxidase inhibitors (

제품 특성 요약

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE PROPRIETARY MEDICINAL PRODUCT 

Vicks Sinex Decongestant Nasal Spray 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

ACTIVE INGREDIENT 

Percentage quantity   
Specification 

Oxymetazoline hydrochloride  
0.050% w/v 

Ph. Eur 

3. 
PHARMACEUTICAL FORM (INCLUDING ROUTE OF ADMINISTRATION) 

Non-pressurised, aqueous nasal spray solution. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

The symptomatic relief of congestion of the upper
respiratory tract due to the common cold, 

hay fever and sinusitis. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adults and children over 12  years:  1-2 sprays per nostril
every 6-8 hours unless otherwise 

advised by your doctor. 

Topical application as a nasal spray. 

4.3 
CONTRAINDICATIONS 

 Hypersensitivity to oxymetazoline or any of
the other ingredients. 

Inflammation or lesions of the skin around the nostrils or nasal
mucosa. 

Trans-sphenoidal hypophysectomy or nasal surgery exposing the
dura mater 

Concomitant use of other sympathomimetic decongestants 

Phaeochromocytoma  

Children under 12 years of age. 

Page 2 of 5 
4.4 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

 Consult a doctor before taking this medicine in case of: 

  High blood pressure, heart disease including angina,
diabetes mellitus, hyperthyroid 
disease, hepatic and renal disorders and prostatic hypertrophy.  
  Patients currently taking monoamine oxidase inhibitors
(MAOIs) or who have taken 
MAOIs in the last 14 days. 
  Use with caution in occlusive vascular disease 
  If any of the following occur, Vicks
Sinex Micromist should be stopped; 
o  Hallucinations 
o  Restlessness 
o  .Sleep disturbances  
  Patients who have