Vicks Sinex Micromist nasal spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxymetazoline hydrochloride

Available from:

Procter & Gamble (Health & Beauty Care) Ltd

ATC code:

R01AA05

INN (International Name):

Oxymetazoline hydrochloride

Dosage:

500microgram/1ml

Pharmaceutical form:

Spray

Administration route:

Nasal

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 12020200

Patient Information leaflet

VICKS SINEX MICROMIST
Oxymetazoline hydrochloride 0.05% w/v
PATIENT INFORMATION LEAFLET
IN THIS LEAFLET:
1.
WHAT VICKS SINEX MICROMIST IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE VICKS SINEX MICROMIST
3.
HOW TO USE VICKS SINEX MICROMIST
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE VICKS SINEX MICROMIST
6.
FURTHER INFORMATION
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
Micromist 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.

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 contact your pharmacist if your symptoms worsen or do not
improve after 7 days.
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 (inflammation
of the passages leading to the
nose). The effect of the spray starts within 2-30 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)

are taking (or have taken during the last 14 days) monoamine oxidase
inhibitors (MAO
inhibitors are used in the treatment of Parkinson’s disease and
depression)

have had an operation to remove your pituitary gland

have inflamed skin or mucous membranes of your nostrils or have scabs
in your nose

do not take with other medications containing decongestants

have had nasal surgery

suffer from a tumour of the adrenal glands

DO NOT GIVE VICKS SINEX MICROMIST TO CHILDREN UNDE

Summary of Product characteristics

OBJECT 1
VICKS SINEX MICROMIST
Summary of Product Characteristics Updated 16-Jan-2018 | Procter &
Gamble (Health & Beauty Care)
Ltd.
1. Name of the medicinal product
Vicks Sinex Micromist
2. Qualitative and quantitative composition
NAME OF ACTIVE SUBSTANCE
QUANTITY
UNIT
Oxymetazoline hydrochloride
0.05
%w/v
3. Pharmaceutical form
Nasal spray, solution
Non-pressurised, metered dose, 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, hayfever,
and sinusitis.
4.2 Posology and method of administration
Nasal spray: for topical nasal use.
Adults and children over 12 years: 1-2 sprays per nostril every 6-8
hours unless otherwise advised by
your doctor.
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.
4.4 Special warnings and 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 or
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 narrow angle glaucoma
Patients are advised to use for a maximum of 7 consecutive days to
avoid rebound effect and drug
induced rhinitis.
If symptoms persist consult a doctor.
Keep away from eyes.
Keep out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of
interaction
Hypertensive interactions may occur between s