SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Oxymetazoline Decongestant Nasal Spray 0.05%w/v

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient    Percentage Formula

Oxymetazoline Hydrochloride USP    0.05%w/v

3    PHARMACEUTICAL FORM

Nasal Spray

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The relief of the discomfort and symptoms of head colds and hay fever.

4.2    Posology and method of administration

(i)    Posology

Adults, the elderly and children over 5 years of age

Two - three sprays to be instilled into each nostril in the morning and at bedtime. Children under 5 years Not recommended

(ii)    Method of Administration

Local instillation into the nostrils

4.3 Contraindications

Oxymetazoline Decongestant Nasal Spray 0.05%w/v is contraindicated for use in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater, in individuals with known hypersensitivity to oxymetazoline or any other ingredients in the preparation. It is unsuitable for use in children under 5 years of age. The use of Oxymetazoline Decongestant Nasal Spray 0.05%w/v should be avoided during pregnancy and breast-feeding. It should additionally be avoided during treatment with monoamine oxidase inhibitors and for 14 days thereafter, in vasomotor rhinitis, in view of the temptation to continue its use, and in atrophic rhinitis.

4.4 Special warnings and precautions for use

Oxymetazoline Decongestant Nasal Spray 0.05%w/v, like other decongestants should not be used for more than seven consecutive days. If symptoms persist a doctor should be consulted. A doctor should also be consulted if any other medication is being used. To prevent cross infection, each container of Oxymetazoline Decongestant Nasal Spray 0.05%w/v should be used by one person only.

Oxymetazoline Decongestant Nasal Spray 0.05%w/v, like other preparations belonging to the same class of active substances, should be used only with caution during concurrent use of other sympathomimetics, in patients for whom the systemic absorption of alpha-sympathomimetic drugs may be contraindicated (e.g. coronary artery diseases, hypertension, glaucoma, diabetes mellitus and hyperthyroidism) and in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions are unlikely if applied correctly at the recommended dose and frequency of application. However, if sufficient oxymetazoline is absorbed systemically, there is the possibility that interactions may occur with monoamine oxidase inhibitors resulting in severe hypertensive crisis or with other sympathomimetics (e.g. ephedrine, phenylephrine) resulting in cardiovascular and CNS stimulation.

4.6 Pregnancy and lactation

No teratogenic effects have been found in rats and no drug related abnormalities or effects on the offspring have been found following subcutaneous administration to rabbits. The safety of oxymetazoline in human pregnancy has not been established. In view of this and its possible systemic effects, it should not be used during pregnancy. No information is available on the excretion of oxymetazoline into breast milk.

4.7 Effects on ability to drive and use machines

No effects on the ability to drive or use machines would be expected.

4.8 Undesirable effects

The following side effects have occasionally been encountered with oxymetazoline: local stinging, burning and discomfort, sneezing, dryness in the nose and throat and headache. Systemic cardiovascular and CNS effects have been reported following the use of topical oxymetazoline. Prolonged use may cause rebound nasal congestion.

4.9 Overdose

Overdose or accidental ingestion of oxymetazoline or other imidazoline nasal decongestants have been reported to cause sedation. Other symptoms of oxymetazoline overdosage would be expected to include dry mouth, sweating, bradycardia, hypotension, arrhythmias, nervousness and irritability. There is no specific treatment for overdosage and appropriate supportive treatment should be indicated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Oxymetazoline is a sympathomimetic amine of the imidazoline class and has a direct agonist action at alpha-adrenoceptors. It produces rapid and prolonged vasoconstriction thereby decongesting the mucosa of the nose.

5.2 Pharmacokinetic properties

Correct instillation of oxymetazoline into the nose does not usually lead to significant systemic absorption largely because of the vasoconstriction produced by the drug. Incorrect or excessive intranasal application may, however result in some of the drug being absorbed from the nasal mucosa or the gastrointestinal tract after swallowing. Ingestion may provoke systemic effects, especially in young children and the elderly.

Oxymetazoline enters the tissues rapidly and is released slowly. No data are available for the brain. The plasma half-life is 5 - 8 days. Thirty percent of any absorbed drug is eliminated in the urine in the 72 hours post dose, mainly as unchanged drug.

Approximately 10 percent is eliminated in the faeces. Little is known about the metabolism of oxymetazoline.

Since oxymetazoline is only used topically, no correlation between the plasma concentration of the drug and it’s clinical effect would be expected.

5.3 Preclinical safety data

No pre-clinical data are available on carcinogenicity or mutagenicity.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzalkonium Chloride USP 0.015%w/w Disodium Edetate BP 0.01%w/w Sodium Phosphate Dihydrate BP 0.33%w/w Citric Acid Monohydrate BP 0.22%w/w Purified Water BP/USP 99.375%w/w

6.2 Incompatibilities

No major incompatibilities are known.

6.3 Shelf life

Two years.

6.4 Special precautions for storage

Store below 30°C.

6.5 Nature and contents of container

(i)    15ml PET amber nasal oval bottle with a nasal actuator with overcap and 15mm pump valve.

(ii)    30ml polyethylene white oval nasal actuator, blue polypropylene overcap and pump valve with gold ferrule.

6.6 Special precautions for disposal

1.    Clear the nose.

2.    Shake the bottle gently and remove the cap.

3.    Hold the spray with your forefinger and middle finger either side of the nozzle and you thumb underneath the bottle.

4.    Close one nostril and put the nozzle in the other nostril. Tilt your head forward slightly and keep the spray upright.

5.    Start to breathe in through the nose and while breathing in press down with your fingers once to release a spray.

6.    Repeat steps 4 and 5 with the other nostril.

7.    Wipe the nozzle with a clean tissue or handkerchief and replace the cap.

7 MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0123

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/07/2006

10 DATE OF REVISION OF THE TEXT

25/01/2011