SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Manx Healthcare Clear Nose Drops - Child Formula

Xylometazoline Decongestant Nasal Drops 0.05% w/v Children’s Formula

2.    Qualitative and Quantitative Composition

Xylometazoline Hydrochloride 0.05%w/v

3.    PHARMACEUTICAL FORM

Nasal drops.

4.1.    Therapeutic Indications

For the relief of nasal congestion associated with the common cold, perennial and allergic rhinitis (including hay fever) and sinusitis.

4.2.    Posology and Method of Administration

Adults and elderly: Not applicable.

Xylometazoline Decongestant Nasal Drops 0.05% w/v (Children’s Formula) are contra-indicated in children under 6 years of age.

Children between 6 and 12 years (all indications):

1 or 2 drops, in each nostril 1 or 2 times daily.

Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Not more than 2 doses should be given in any 24 hours.

Route of administration: Nasal use

Do not exceed the stated dose

Keep out of the sight and reach of children

4.3.    Contra-Indications

•    Known hypersensitivity to xylometazoline or any of the excipients

•    Concomitant use of other sympathomimetic decongestants

•    Cardiovascular disease including hypertension

•    Diabetes mellitus

•    Phaeochromocytoma

•    Hyperthyroidism

•    Closed angle glaucoma

•    Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

•    Beta-blockers - (see section 4.5)

•    Inflammation of the skin and/or mucosa of the nasal vestibule

•    Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater

•    Not to be used in children under the age of 6 years

4.4.    Special Warnings and Precautions for Use

Patients are advised not to take decongestants for more than five consecutive days.

Xylometazoline Decongestant Nasal Drops 0.05% w/v (Children’s Formula), 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 stated dose

•    Do not take with any other cough and cold medicine.

•    Do not use continuously for more than five consecutive days. If symptoms persist consult your doctor

•    Keep away from the eyes

•    If your child is receiving medication or is under a doctor's care, consult the doctor before giving Xylometazoline Decongestant Nasal Drops

0.05% w/v (Children’s Formula)

•    Each Xylometazoline Decongestant Nasal Drops 0.05% w/v (Children’s Formula) pack should be used by one person only to prevent any cross infection

•    For reasons of hygiene do not use this bottle for more than 28 days after first opening it

•    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

•    Occasionally children may show restlessness or sleep disturbance when xylometazoline is used. If this occurs Xylometazoline

Decongestant Nasal Drops 0.05% w/v (Children’s Formula) should be stopped

•    Keep medicines out of sight and reach of children

•    Expectant mothers should consult their doctors before using Xylometazoline Decongestant Nasal Drops 0.05% w/v (Children’s Formula) for themselves

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 undesirable effects have been reported in the scientific literature and spontaneously during post-marketing use of sympathomimetic agents such as xylometazoline. Systemic effects are more likely with oral sympathomimetic agents but may occur with topical administration, especially with prolonged and/or excessive use. A frequency cannot be estimated from available data.

System Organ Class	Frequency unknown
Immune system disorders	Hypersensitivity, including cross-sensitivity with other sympathomimetics
Psychiatric disorders	Irritability, anxiety, restlessness, excitability, insomnia, hallucinations, paranoid delusions
Nervous system disorder	Headache
Eye disorders	Visual impairment (transient)
Cardiac disorders	Tachycardia, palpitations, other cardiac dysrhythmias
Vascular disorders	Hypertension

Respiratory, thoracic and mediastinal disorders	Throat irritation, Nasal discomfort. Rebound nasal congestion (rhinitis medicamentosa), especially with prolonged or excessive use
Gastrointestinal disorders	Nausea, vomiting
Skin and subcutaneous tissue disorders	Rash
Renal and urinary disorders	Urinary retention
General disorders and administration side conditions	Application site irritation, application site dryness. Drug tolerance, with diminished effects, especially with prolonged and/or excessive use

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

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 excesssive 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.

6.1. List of Excipients

Benzalkonium chloride Disodium edetate Sodium phosphate dihydrate Sodium acid phosphate Sodium chloride Purified water

6.2 Incompatibilities

No major incompatibilities are known. 6.3. Shelf Life

24 months.

6.4 Special Precautions for Storage

Store below 30°C.

6.5.    Nature and Contents of Container

10 ml white, tamper evident, LDPE bottle with a white dropper plug and white, wadless, tamper evident screw cap.

6.6.    Instruction for Use/Handling

1.    Practice using the dropper to develop good dosage control.

2.    Clear or wipe the child’s nose.

3.    Shake the bottle gently and remove the cap.

4.    Tilt the child’s head right back and apply one or two drops of solution to each nostril.

Marketing Authorisation Holder

Manx Pharma Ltd Taylor Group House Wedgnock Lane Warwick CV34 5YA UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 15833/0014

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

19 November 2003/19 August 2010

10 DATE OF REVISION OF THE TEXT

30/01/2015