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Summary of Product Characteristics last updated on the eMC: 08/02/2010

SPC	Otrivine Adult Nasal Drops

Table of Contents

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 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

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1. NAME OF THE MEDICINAL PRODUCT

Otrivine^®Adult Nasal Drops

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Xylometazoline Hydrochloride 0.1% w/v

For excipients see 6.1

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3. PHARMACEUTICAL FORM

Nasal drops, solution

The product is a clear, colourless solution

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.

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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

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4.3 Contraindications

Known hypersensitivity to Otrivine.

Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.

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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.

• Do not exceed the recommended dosage

• Decongestants should not be used 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 him before using Otrivine

• The adult drops should not be used for infants or children under 12 years

• Each Otrivine pack should be used by one person only to prevent any cross infection

• Some patients who have sensitive nasal passages may feel some local discomfort when applying nasal drops. Other side effects are very rare

• Keep medicines out of reach of children

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4.5 Interaction with other medicinal products and other forms of interaction

None

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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.

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4.7 Effects on ability to drive and use machines

None

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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.

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4.9 Overdose

No cases of overdosage in adults have yet been reported. 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, drowsiness, respiratory depression or irregularity. There is no specific treatment and appropriate supportive treatment should be initiated.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Otrivine Adult Nasal Drops 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 Nasal Drops begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Nasal Drops 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 Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

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5.2 Pharmacokinetic properties

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

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5.3 Preclinical safety data

There are no findings in the preclinical testing which are of relevance to the prescriber.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Benzalkonium chloride

Disodium phosphate dodecahydrate (Sodium phosphate)