Otrivine Adult 0.1% nasal drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Xylometazoline hydrochloride

Available from:

Haleon UK Ltd

ATC code:

R01AA07

INN (International Name):

Xylometazoline hydrochloride

Dosage:

1mg/1ml

Pharmaceutical form:

Nasal drops

Administration route:

Nasal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12020200; GTIN: 5051562013705

Patient Information leaflet

RECTO
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 Adult
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 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 Adult Nasal Drops are and what
they are used for
2. Before you use Otrivine Adult Nasal Drops
3. How to use Otrivine Adult Nasal Drops
4. Possible side effects
5. How to store Otrivine Adult Nasal Drops
6. Further information
1. WHAT OTRIVINE ADULT NASAL DROPS ARE
AND WHAT THEY ARE USED FOR
Otrivine Adult Nasal Drops are 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 Adult Nasal Drops contain 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 ADULT NASAL
DROPS
DO NOT use the drops if you:
• are allergic to xylometazoline hydrochloride
or any of the other ingredients in the drops
(see Section 6)
• are allergic to other decongestants
• have had recent neurosurgery.
Do not use these drops for children under
12 years old.
Take special care
Before using the drops tell your doctor if you:
• have an overactive thyroid gland
(hyperthyroidism)
• have glaucoma
• have diabetes mellitus
• have heart or circulatory disease
• are pregnant or breast-feeding.
• have hypertension
Do not take decongestants for more than 7 days
in a

Summary of Product characteristics

OBJECT 1
OTRIVINE ADULT NASAL DROPS
Summary of Product Characteristics Updated 15-Jul-2016 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Otrivine Adult Nasal Drops
2. Qualitative and quantitative composition
Xylometazoline Hydrochloride 0.1% 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 symptomatic relief of nasal congestion, perennial and allergic
rhinitis (including hay fever),
sinusitis.
4.2 Posology and method of administration
Adults and elderly (all indications): 2 or 3 drops in each nostril 2
or 3 times daily.
The drops are suitable for children over 12 years of age.
Route of administration: Nasal use.
4.3 Contraindications
Known hypersensitivity to Otrivine.
Patients with trans-sphenoidal hypophysectomy or surgery exposing the
dura mater.
4.4 Special warnings and precautions for use
Patients are advised not to take decongestants for more than seven
consecutive days. Otrivine, like other
preparations belonging to the same class of active substances, should
be used only with caution in patients
showing a strong reaction to sympathomimetic agents as evidenced by
signs of insomnia, dizziness etc.
Caution is recommended in patients with hypertension, cardiovascular
disease, hyperthyroidism, narrow
angle glaucoma or diabetes mellitus.
Label warnings and precautions
• Do not exceed the stated dose
• Do not use continuously for more than seven consecutive days. If
symptoms persist, consult your doctor
• If you are pregnant or taking other medicines or are under a
doctor's care, consult your doctor before
using Otrivine
• Not to be used for infants or children under 12 years
• Each Otrivine pack should be used by one person only to prevent
any cross infection
• For reasons of hygiene do not use this bottle for more than 28
days after first opening it
• Keep medicines out of the reach of children
Additional leaflet warnings and precautions
• Do