VICKS SINEX MICROMIST

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

OXYMETAZOLINE HYDROCHLORIDE

Dostępny od:

Procter & Gamble (Health & Beauty Care) Limited

Kod ATC:

R01AA05

INN (International Nazwa):

OXYMETAZOLINE HYDROCHLORIDE

Dawkowanie:

0.05 %w/v

Forma farmaceutyczna:

Nasal Spray Solution

Typ recepty:

Product not subject to medical prescription

Dziedzina terapeutyczna:

oxymetazoline

Status autoryzacji:

Marketed

Data autoryzacji:

1998-07-13

Ulotka dla pacjenta

1. WHAT VICKS SINEX MICROMIST IS AND WHAT IT IS
USED FOR
Vicks Sinex Micromist is a nasal spray used for
localised relief of the symptoms of a blocked nose
in association with a cold, hay fever or sinusitis
(infl ammation 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 MICROMIST
DO NOT USE VICKS SINEX MICROMIST IF YOU:
• are allergic (hypersensitive) to the active substance
oxymetazoline hydrochloride or any of the other
ingredients of Vicks Sinex Micromist (see section 6)
• have infl amed skin or mucous membranes of your
nostrils or have scabs in your nose.
DO NOT GIVE VICKS SINEX MICROMIST TO CHILDREN
UNDER 12 YEARS OF AGE
TAKE SPECIAL CARE WITH VICKS SINEX MICROMIST
Before using tell your doctor if you have:
• diffi culty urinating due to an enlarged prostate gland
• high blood pressure
• heart disease including angina
• diabetes
• disturbance in your thyroid function
• hepatic or renal disorder
• suffer from increased eyeball-pressure
(narrow-angle glaucoma) TAKING OTHER MEDICINES
Please inform your doctor or pharmacist if you are
taking, or have recently taken, any other medicines,
even those obtained without a prescription.
• MONOAMINE OXIDASE INHIBITORS (MAOIs) are
used in the treatment of Parkinson’s disease and
depression - DO NOT USE Vicks Sinex Micromist if
you have taken MAOIs during the last two weeks
• PHENOTHIAZINES AND TRICYCLIC ANTIDEPRESSANTS -
inform your doctor if you are taking drugs used in the
treatment of depression such as amitriptyline and
imipramine
• HIGH BLOOD PRESSURE MEDICINES - inform your
doctor before use if you are taking digoxin, beta
blockers or any other drugs for lowering blood
pressure
• PARKINSON’S DISEASE MEDICINE (SUCH AS
BROMOCRIPTINE) - treatment with Vicks Sinex Micromist
may be affected if it is used at the same time.
• DO NOT TAKE with other medications containing
decongestants PREGNANC

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vicks Sinex Micromist 0.05% w/v Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Solution (Nasal Spray)
Non-pressurised, metered dose, aqueous nasal spray solution. Solution
is a clear liquid with a slight yellowish
colouration.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The symptomatic relief of acute rhinitis in allergic or upper
respiratory tract infection, including the common cold or
influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical application as a nasal spray.
Adults and children over 12 years:
1-2 sprays per nostril every 6-8 hours unless otherwise advised by
your doctor.
Not to be used for children under 12 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to oxymetazoline or any of the other ingredients.
Where there is inflammation or lesions of the skin around the nostrils
or nasal mucosa.
Not to be used for children under 12 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients are advised to consult their doctor before taking this
medicine if they:
Have high blood pressure, heart disease including angina, diabetes,
thyroid disease, hepatic or renal disorders.
Are currently taking (or have taken during the last two weeks)
monoamine oxidase inhibitors (MAOIs).
Have narrow angle glaucoma.
Active ingredient:
% w/v
Oxymetazoline hydrochloride
0.05
Excipients:
% w/v
Benzalkonium chloride solution (50%)
0.04
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