OTRIVINE ALLERGY RELIEF 0.1% NASAL SPRAY

Active substance: XYLOMETAZOLINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

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 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






4.5

Do not use if you are sensitive to any of the ingredients of Otrivine
Do not use if you have had recent neurosurgery
Consult your doctor before using Otrivine if you have heart or circulatory disease
Some patients who have sensitive nasal passages may feel some local discomfort
when applying the product.
Other side effects such as palpitations, nausea and headache are very rare

Interaction with other medicinal products and other forms of interaction

As for all sympathomimetics, a reinforcement of the systemic effects of
xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic
or tetracyclic antidepressants, cannot be excluded, especially in case of
overdose.

4.6
Pregnancy and lactation
No foetal toxicity or fertility studies have been carried out in animals. In view of its
potential systemic vasoconstrictor effect, it is advisable to take the precaution of not
using Otrivine during pregnancy.
Label warning: If you are pregnant or taking any other medicines, or are under a
doctor’s care, consult him before using Otrivine.
No evidence of any adverse effect on the breast-fed infant. However, it is not known
if xylometazoline is excreted in breast milk, therefore caution should be exercised and
Otrivine should be used only on the advice of a doctor whilst breastfeeding.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects

The following side effects have occasionally been encountered: A burning sensation
in the nose
and throat, local irritation, nausea, headache and dryness of the nasal mucosa.
Systemic cardiovascular effects have occurred, and this should be kept in mind when
giving
Otrivine to people with cardiovascular disease.
In isolated cases, systemic allergic reactions and transient visual disturbances.

4.9
Overdose
In rare instances of accidental poisoning in children, the clinical picture has been
marked chiefly by signs such as acceleration and irregularity of the pulse, elevated
blood pressure and sometimes consciousness clouding.
There is no specific treatment. Appropriate supportive measures should be initiated.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Otrivine Adult Measured Dose Sinusitis Spray is a sympathomimetic agent
with marked alpha-adrenergic activity, and is intended for use in the nose. It
constricts the nasal blood vessels, thereby decongesting the mucosa of the
nose and neighbouring regions of the pharynx. This enables patients suffering
from colds to breathe more easily through the nose. The effect of Otrivine
Adult Measured Dose Sinusitis Spray begins within a few minutes and lasts
for up to 10 hours. Otrivine Adult Measured Dose Sinusitis Spray is generally
well tolerated and does not impair the function of ciliated epithelium.
In a double-blind, saline solution (Otrisal) controlled study in patients with
common cold, the
decongestant effect of Otrivin was significantly superior (p<0.0001) to Otrisal
saline solution based on rhinomanometry measurement at 1 hour after
administration of the study drugs.

5.2

Pharmacokinetic properties
Systemic absorption may occur following nasal application of xylometazoline
hydrochloride solutions. It is not used systemically.

5.3

Preclinical safety data
Not applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Benzalkonium chloride
Disodium phosphate dodecahydrate (Sodium phosphate)
Disodium edetate
Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)
Sodium chloride
Sorbitol
Hypromellose
Purified water

6.2

Incompatibilities
None

6.3

Shelf life
Unopened: 36 months
Opened:
28 days

6.4

Special precautions for storage
No special precautions.

6.5

Nature and contents of container
High density polyethylene bottle with a polypropylene/polyethylene metered dose
pump in a cardboard carton.
Pack size 10 ml.

6.6

Special precautions for disposal
Medicines should be kept out of the reach of children.

7.

MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Limited
Park View,
Riverside Way,
Watchmoor Park,
Camberley,
Surrey,
GU15 3YL
United Kingdom.
Trading as: Novartis Consumer Health

8.

MARKETING AUTHORISATION NUMBER
PL 00030/0117

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1st October 1997/19TH August 2010

10

DATE OF REVISION OF THE TEXT
28/05/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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