Document: spc-doc_PL 00030-0461 change

• spc-doc_PL 00030-0461
• spc-doc_PL 44673-0151

---

SUMMARY OF PRODUCT CHARACTERISTICS

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 Congestion Relief 0.1% Nasal Spray should not be used in children aged less than 12 years old.

Method of administration

Stre ngth	Age	Posology
0.1	Adults and	1 spray into each nostril, 1 to 3 times daily as
%	adolescents over	needed. Do not exceed 3 applications daily into
	12 years of age	each nostril.

The metered-dose spray permits accuracy of dosage and ensures that the solution is well distributed over the surface of the nasal mucosa. It precludes the possibility of unintentional overdose.

Before the first application, prime the pump by actuating 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Should the spray not be ejected during the full actuation stroke, the pump will need to be reprimed with the same number of actuations as initially performed.

Be careful not to spray in the eyes.

1.    Blow the nose gently.

2.    Remove protective cap.

3.    Do not cut the nozzle. The metered dose spray is ready to prime before use.

4.    Hold the bottle upright with thumb under base and nozzle between two fingers.

5.    Lean forward slightly and insert the nozzle into a nostril.

6.    Spray and breathe in gently through the nose at the same time.

7.    Repeat in the other nostril

8.    Clean and dry the nozzle before replacing back the cap right after use.

To avoid possible spread of infection, the spray should only be used by one person.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Like other vasoconstrictors,

Otrivine Congestion Relief 0.1% Nasal Spray should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.

4.4 Special warnings and precautions for use

Otrivine Congestion Relief 0.1% Nasal Spray, like other sympathomimetic agents, should be used with caution in patients showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.

Otrivine Congestion Relief 0.1% Nasal Spray should not be used for more than seven consecutive days.

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

•    Keep medicines out of the sight and reach of children

Additional leaflet warnings and precautions

•    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 nasal drops.

•    Other side effects such as palpitations, nausea and headache are very rare Information concerning excipients

This medicine contains polyoxyl hydrogenated castor oil (2.750 mg/ml) which may cause skin reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Like 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 Fertility, pregnancy and lactation

Pregnancy

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 Congestion Relief 0.1% Nasal Spray during pregnancy.

Breastfeeding

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.

Label warning: If you are pregnant or taking any other medicines or are under a doctor’s care, consult your doctor before using Otrivine.

4.7 Effects on ability to drive and use machines

Otrivine Congestion Relief 0.1% Nasal Spray has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Systemic cardiovascular effects have occurred, and this should be kept in mind when giving this product to people with cardiovascular disease.

Adverse reactions are listed below, by system organ class and frequency.

Frequencies are defined as: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000) or very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse reactions

Immune system disorders
Very rare:	Hypersensitivity reaction (angioedema, rash, pruritus)
Nervous system disorders
Common:	Headache
Eye disorders
Very rare:	Transient visual impairment
Cardiac Disorders
Very rare:	Heart rate irregular and heart rate increased
Respiratory, thoracic and mediastinal disorders

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov .uk/yellowcard

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 clouding of consciousness.

There is no specific treatment. Appropriate supportive measures should be initiated and symptomatic treatment under medical supervision is indicated.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: decongestants for topical use, sympathomimetics, plain. ATC Code: R01A A07

Mechanism of action and pharmacodynamic effects

Xylometazoline is a sympathomimetic agent acting on alpha-adrenergic receptors in the nasal mucosa. Administered in the nose, it constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This decongests nasal passages and enables patients suffering from blocked nose to breathe more easily through the nose. The effect of Otrivine begins within a few minutes and lasts for up to 10 hours.

In a double-blind, saline solution controlled study in patients with common cold, the decongestant effect of Otrivine 0.1% nasal solution was significantly superior (p<0.0001) to saline solution based on rhinomanometry measurement. Relief of blocked nose developed twice as fast in the Otrivine group compared to saline solution as of 5 minutes post treatment (p= 0.047).

Otrivine is well tolerated, even by patients with a sensitive mucosa, and does not impair the mucociliary function.

5.2 Pharmacokinetic properties

Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection.

5.3 Preclinical safety data

Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium dihydrogen phosphate dihydrate

Disodium phosphate dodecahydrate

Sodium chloride

Disodium edetate

Levomenthol

Cineole

Sorbitol

Polyoxyl hydrogenated castor oil (macrogol glycerol hydroxystearate) Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months

Do not use the bottle for more than 28 days after opening.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5 Nature and contents of container

High density polyethylene bottle with a metered dose pump (materials in contact with product: low density polyethylene, stainless steel, compound PE/butyl) polypropylene nozzle with cap.

Content: 10 ml.

6.6 Special precautions for disposal

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK limited Trading as: Novartis Consumer Health Park View, Riverside Way, Camberley, GU15 3YL, UK.

8    MARKETING AUTHORISATION NUMBER(S)

PL 00030/0461

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/07/2014

DATE OF REVISION OF THE TEXT

10/07/2014