Otrivine Congestion Relief 0.1% nasal spray

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Xylometazoline hydrochloride

Pieejams no:

Haleon UK Ltd

ATĶ kods:

R01AA07

SNN (starptautisko nepatentēto nosaukumu):

Xylometazoline hydrochloride

Deva:

1mg/1ml

Zāļu forma:

Spray

Ievadīšanas:

Nasal

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 12020200; GTIN: 5051562033505

Lietošanas instrukcija

Recto
Pharma code XXXX
®
Congestion
Relief
0.1% Nasal Spray
Xylometazoline Hydrochloride
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
This medicine is available without a prescription.
However, you still need to use Otrivine Congestion
Relief 0.1% 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 the 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 Otrivine Congestion Relief 0.1% Nasal Spray
is and what it is used for
2. Before you use Otrivine Congestion Relief 0.1%
Nasal Spray
3. How to use Otrivine Congestion Relief 0.1% Nasal
Spray
4. Possible side effects
5. How to store Otrivine Congestion Relief 0.1% Nasal
Spray
6. Further information
1. What Otrivine Congestion Relief 0.1% Nasal
Spray is and what it is used for
Otrivine Congestion Relief 0.1% Nasal Spray is for
application in the nose to give relief from:
• nasal congestion (blocked nose, including colds)
• perennial and allergic rhinitis (recurring
inflammation of the nasal mucous membranes,
including hay fever)
• sinusitis.
Otrivine Congestion Relief 0.1% Nasal Spray contains
the active ingredient xylometazoline hydrochloride
which helps to open up and clear the nasal passages
by reducing the excessive nasal secretions and
returning the swollen blood vessels to their
normal size.
2. Before you use Otrivine Congestion Relief
0.1% Nasal Spray
DO NOT use the spray if you:
• are allergic to xylometazoline hydrochloride or any
of the other ingredients in the spray (see Section 6)
• have had recent neurosurgery
• have narrow angle glaucoma.
Do not use this spray for children under
12 years old.
Take special care
Before using the spray tell your doctor

Produkta apraksts

OBJECT 1
OTRIVINE CONGESTION RELIEF 0.1% NASAL SPRAY
Summary of Product Characteristics Updated 02-Nov-2016 |
GlaxoSmithKline Consumer Healthcare
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Otrivine Congestion Relief 0.1% Nasal Spray
2. Qualitative and quantitative composition
Otrivine Congestion Relief 0.1% Nasal Spray, nasal solution contains 1
mg/ml of xylometazoline
hydrochloride. Each metered-dose spray delivers 0.14 mg of
xylometazoline hydrochloride.
Excipients with known effect: polyoxyl hydrogenated castor oil (2.750
mg/ml)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nasal spray, (solution)
Metered-dose spray: opalescent, white solution, with menthol and
eucalyptol (cineole) odour.
4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic relief of nasal congestion, perennial and allergic
rhinitis (including hay fever),
sinusitis.
4.2 Posology and method of administration
Posology
_Paediatric population_
Otrivine Co