Otrivine Child nasal drops

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Xylometazoline hydrochloride

Предлага се от:

Haleon UK Ltd

АТС код:

R01AA07

INN (Международно Name):

Xylometazoline hydrochloride

дозиране:

500microgram/1ml

Лекарствена форма:

Nasal drops

Начин на приложение:

Nasal

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 12020200; GTIN: 5051562013309

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62000000203012
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 Child Nasal Drops
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 5 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 Child Nasal Drops are and what they
are used for
2.
Before you use Otrivine Child Nasal Drops
3.
How to use Otrivine Child Nasal Drops
4.
Possible side effects
5.
How to store Otrivine Child Nasal Drops
6.
Further information
1. WHAT OTRIVINE CHILD NASAL DROPS ARE
AND WHAT THEY ARE USED FOR
Otrivine Child Nasal Drops are for application in the nose
to give relief from:
• nasal congestion (blocked nose, including colds)
• perennial and allergic rhinitis (r

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Otrivine Child Nasal Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylometazoline Hydrochloride 0.05% w/v
For excipients see 6.1.
3
PHARMACEUTICAL FORM
Nasal drops, solution
The product is a clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of nasal congestion associated with the common cold,
perennial and
allergic rhinitis (including hay fever), sinusitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly: Not applicable.
Otrivine Child Nasal Drops are contra-indicated in children under 6
years of age.
Children between 6 and 12 years under adult supervision (all
indications): 1 or 2
drops, in each nostril up to 2 times a day.
Not to be used for more than 5 days without the advice of a doctor.
(see warnings and
precautions)
Parents or carers should seek medical attention if the child’s
condition deteriorates
during treatment.
Not more than 2 doses should be given in any 24 hours.
Route of administration: Nasal use Do not exceed the stated dose
Keep out of the reach and sight of children.
4.3
CONTRAINDICATIONS
Known hypersensitivity to Otrivine or any of the excipients
Concomitant use of other sympathomimetic decongestants
Cardiovascular disease including hypertension
Diabetes mellitus
Phaeochromocytoma
Prostatic hypertrophy
Hyperthyroidism
Closed angle glaucoma
Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping
treatment, see
section 4.5)
Beta-blockers – (see section 4.5)
Inflammation of the skin and/or mucosa of the nasal vestibule
Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura
mater
Not to be used in children under the age of 6 years
Rhinitis sicca or atrophic rhinitis
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients are advised not to take decongestants for more than five
consecutive days.
Prolonged or excessive use may cause rebound congestion and/or atrophy
of the nasal
mucosa.
Otrivine, like other preparations belonging to the same class of