SUMMARY OF PRODUCT CHARACTERISTICS 1    NAME OF THE MEDICINAL PRODUCT

Manx Healthcare Clear Nose Spray Xylometazoline Decongestant Nasal Spray 0.1% w/v

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Xylometazoline Hydrochloride B.P. 0.1% w/v

3.    PHARMACEUTICAL FORM

Nasal spray.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

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

4.2.    Posology and Method of Administration

(i) Posology

Adults, the elderly and children over 12 years of age One application in each nostril two or three times daily.

Children under 12 years Not recommended.

(ii) Method of administration Local application into the nostrils.

Contra-indications

Xylometazoline Decongestant Nasal Spray 0.1% w/v is contraindicated for use in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater and in individuals with known hypersensitivity to xylometazoline or any of the ingredients in the preparation. It is unsuitable for use in children under 12 years of age. The use of Xylometazoline Decongestant Nasal Spray

0.1% w/v should be avoided during pregnancy or breast feeding. It should additionally be avoided during treatment with monoamine oxidase inhibitors and for 14 days thereafter, in patients with vasomotor rhinitis, in view of the temptation to continue its use, and in atrophic rhinitis.

4.4. Special Warnings and Precautions for Use

Xylometazoline Decongestant Nasal Spray 0.1% w/v, like any other nasal 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 any cross infection, each container of Xylometazoline Decongestant Nasal Spray 0.1% w/v should be used by one person only.

Xylometazoline Decongestant Nasal Spray 0.1% 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 administration of alpha-sympathomimetic drugs may be contraindicated (e.g. coronary artery disease, hypertension, diabetes mellitus and hyperthyroidism) and in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.

4.5. Interactions with other Medicaments and other forms of Interaction

Interactions are unlikely if it is applied correctly at the recommended dose and frequency of application. However, if sufficient xylometazoline is absorbed systemically, there is a 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 overstimulation.

4.6. Pregnancy and Lactation

No foetal toxicity or fertility studies on xylometazoline have been carried out in animals. In view of this and its potential systemic vasoconstrictor effect, use of xylometazoline during pregnancy is inadvisable and the precaution should be taken to avoid its use. No information is available on the excretion of xylometazoline into breast milk.

4.7. Effects on Ability to Drive and Use Machines

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

4.8.    Undesirable Effects

The following side - effects have occasionally been encountered with xylometazoline: a burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa. Systemic cardiovascular effects have occurred with topical xylometazoline and this should be kept in mind when giving xylometazoline to people with cardiovascular disease.

Excessive use of the product may lead to tolerance with a diminished effect and rebound congestion may occur.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9.    Overdose

No cases of overdosage in adults have yet been reported with xylometazoline. 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.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Xylometazoline is a sympathomimetic amine of the imidazoline class and has a direct agonist action at alpha₂-adrenoceptors. It produces a rapid and prolonged vasoconstriction thereby decongesting the mucosa of the nose.

5.2. Pharmacokinetic Properties

Correct instillation of xylometazoline 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.

Little information is available at present concerning the distribution, metabolism and excretion of xylometazoline in man.

There is no evidence of any correlation between the plasma concentration of xylometazoline and its therapeutic effects which would, in any case, be unlikely with a topically applied agent

5.3. Preclinical Safety Data

No foetal toxicity or fertility studies have been carried out in animals.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Benzalkonium chloride USP Disodium edetate BP Sodium phosphate dihydrate BP Sodium acid phosphate BP Sodium chloride Ph. Eur.

Purified water BP/USP

6.2. Incompatibilities

No major incompatibilities are known.

6.3. Shelf Life

Two years.

Special Precautions for Storage

Store below 30°C.

6.5. Nature and Contents of Container

(1)    30 ml polyethylene white oval nasal spray bottle with a white nasal actuator, blue polypropylene overcap and pump valve with gold ferrule. or

(2)    15 ml PET amber nasal spray oval bottle with a nasal actuator with a clean overcap and 15 mm pump valve.

6.6. Instruction for Use/Handling

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 your 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 your 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

Manx Pharma Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom

MARKETING AUTHORISATION NUMBER

PL 15833/0016

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19 November 2003/19 August 2010

10 DATE OF REVISION OF THE TEXT

12/06/2015