Otrivine Allergy Relief 0.1% nasal spray

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Compra

Scarica Foglio illustrativo (PIL)
01-02-2016
Scarica Scheda tecnica (SPC)
13-04-2016

Principio attivo:

Xylometazoline hydrochloride

Commercializzato da:

Haleon UK Ltd

Codice ATC:

R01AA07

INN (Nome Internazionale):

Xylometazoline hydrochloride

Dosaggio:

1mg/1ml

Forma farmaceutica:

Spray

Via di somministrazione:

Nasal

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 12020200; GTIN: 5051562028204

Foglio illustrativo

                                Recto
Pharma code XXXX
Allergy Relief
0.1% Nasal Spray
Xylometazoline
Hydrochloride
Read all of this leaflet carefully because
it contains important information for you.
This medicine is available without a prescription.
However, you still need to use Otrivine Allergy 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 Allergy Relief 0.1% Nasal Spray
is and what it is used for
2. Before you use Otrivine Allergy Relief 0.1% Nasal
Spray
3. How to use Otrivine Allergy Relief 0.1% Nasal
Spray
4. Possible side effects
5. How to store Otrivine Allergy Relief 0.1% Nasal
Spray
6. Further information
1. What Otrivine Allergy Relief 0.1% Nasal
Spray is and what it is used for
Otrivine Allergy 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 inflam-
mation of the nasal mucous membranes, includ-
ing hay fever)
• sinusitis.
Otrivine Allergy 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 Allergy 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.
Do not use this spray for children under
12 years old.
Take special care
Before using the spray tell your doctor if you:
• have an overactive thyroid gland
(hyperthyroidism)
• have glaucoma
• have diabet
                                
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Scheda tecnica

                                OBJECT 1
OTRIVINE ALLERGY RELIEF 0.1% NASAL SPRAY
Summary of Product Characteristics Updated 01-Feb-2017 |
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 Adult Measured Dose Sinusitis Spray
Otrivine Adult Metered Dose, 0.1% Nasal Spray
Otrivine Allergy Relief, 0.1% Nasal Spray
2. Qualitative and quantitative composition
Active ingredient: 0.1% _wlv _Xylometazoline Hydrochloride
For excipients see 6.1
3. Pharmaceutical form
Nasal spray, solution
A clear, colourless solution
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
Adults and elderly: One application in each nostril 1 to 3 times
daily.
Not suitable for children under 12 years.
Route of administration: Application to the nasal passages.
4.3 Contraindications
Known hypersensitivity to xylometazoline.
Patients with t
                                
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