SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Non-Drowsy Sudafed Decongestant Nasal Spray

Sudafed Blocked Nose Spray

Sudafed Mucus Relief 0.1% Nasal Spray

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

This product is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation.

For excipients see 6.1.

3.    PHARMACEUTICAL FORM

Aqueous solution

4 CLINICAL PARTICULARS

4.1    Therapeutic indications

This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies.

4.2    Posology and method of administration

Adults and children 12 years and over:

Nasal. One spray to be expressed into each nostril 2-3 times daily, as necessary. Maximum daily dose: 3 sprays.

Use for more than seven consecutive days is not recommended, [See Undesirable effects].

Children under 12 years:

This product is not recommended for children under 12 years of age. The Elderly

Experience has indicated that normal adult dosage is appropriate, [See Pharmacokinetics in the elderly].

Hepatic/renal dysfunction

Normal adult dosage is appropriate, [See Pharmacokinetic properties].

4.3 Contraindications

This product is contraindicated in individuals with known hypersensitivity to the product or any of its constituents.

This product is contraindicated in individuals who are taking or have taken, monoamine oxidase inhibitors within the preceding two weeks.

This product is contraindicated in individuals with hypophysectomy or surgery exposing dura mater.

4.4 Special warnings and precautions for use

There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus.

Prolonged treatment may lead to reactive hyperemia of the nasal mucosa.

This rebound effect may lead to nasal congestion or nasal obstruction during continued use or after discontinuation, resulting in repeated or even continuous use of the medicine by the patient (see section 4.8).

4.5 Interaction with other medicinal products and other forms of interaction

Due to the low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is considered unlikely.

No interaction studies have been performed.

4.6    Fertility, pregnancy and lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus.

Lactation

It is not known whether xylometazoline or its metabolites are excreted in the human milk.

4.7    Effects on ability to drive and use machines

It is not known if xylometazoline has an effect on the ability to drive and use machines.

4.8    Undesirable effects

Xylometazoline nasal preparations are generally well tolerated following short-term use and local side effects are mild and infrequent. Localised burning, stinging, itching, soreness, dryness or irritation and sneezing may occur occasionally. Rarely, nausea and headache may occur.

Rebound congestion has been reported occasionally, particularly following longer-term use of xylometazoline.

4.9 Overdose

Symptoms and signs

Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits absorption. If systemic absorption does occur xylometazoline as an a₂-adrenergic agonist could be expected to produce effects similar to those of clonidine with a short lived rise in blood pressure, followed by more prolonged hypotension and sedation.

Treatment

Treatment of overdose should be supportive.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Xylometazoline is a sympathomimetic amine of the imidazoline class.

It act directly on a-adrenoreceptors but does not act on B-receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief.    Onset of action is within minutes, the

decongestant effect being prolonged and lasting for up to 10 hours.

5.2 Pharmacokinetic properties

Absorption, Distribution, Metabolism and Elimination

Little information is available concerning the absorption, distribution, metabolism and elimination of xylometazoline in man. Absorption into the nasal mucosal tissues is rapid.

Pharmacokinetics in Renal/Hepatic Impairment

There have been no specific studies of this product or xylometazoline in hepatic or renal impairment.

Pharmacokinetics in the Elderly

There have been no specific clinical studies of this product or xylometazoline in the elderly.

5.3 Preclinical safety data Mutagenicity

There is insufficient information available to determine whether xylometazoline has mutagenic potential.

Carcinogenicity

There is insufficient information available to determine whether xylometazoline has carcinogenic potential.

Teratogenicity

There is insufficient information available to determine whether xylometazoline has teratogenic potential.

Fertility

No studies have been conducted in animals to determine whether xylometazoline has the potential to impair fertility. There is no information on the effects of this product on fertility.

PHARMACEUTICAL PARTICULARS

List of excipients

Benzalkonium chloride solution Disodium edetate

Sodium dihydrogen phosphate dihydrate Sodium monohydrogen phosphate dihydrate Sodium chloride

Sorbitol solution, 70% (Non crystalline) Purified water

6.2    Incompatibilities

None known

6.3    Shelf life

3 years.

6.4    Special precautions    for    storage

Do not store above 25 °C.

6.5    Nature and contents of    container

Amber glass bottle of either 10 ml or 15 ml nominal fill volume.

The bottle is sealed with an integral snap-on metered 0.14 ml pump consisting of a white plastic actuator and natural polyethylene pull-off overcap.

6.6    Special precautions    for    disposal

No special requirements.

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

MARKETING AUTHORISATION HOLDER

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. MARKETING AUTHORIZATION NUMBER(S)

PL 15513/0074

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21 April 1999/04 August 2011

10 DATE OF REVISION OF THE TEXT 06/06/2013