XYLOMETAZOLINE DECONGESTANT NASAL DROPS 0.05%W/V CHILDRENS

Active substance: XYLOMETAZOLINE HYDROCHLORIDE

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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













4.4.

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

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




4.5.

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

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
Immune system disorders
Psychiatric disorders
Nervous system disorder
Eye disorders
Cardiac disorders
Vascular disorders

Frequency unknown
Hypersensitivity, including cross-sensitivity
with other sympathomimetics
Irritability, anxiety, restlessness, excitability,
insomnia, hallucinations, paranoid delusions
Headache
Visual impairment (transient)
Tachycardia, palpitations, other cardiac
dysrhythmias
Hypertension

Respiratory, thoracic and
mediastinal disorders

Gastrointestinal disorders
Skin and subcutaneous
tissue disorders
Renal and urinary disorders
General disorders and
administration side
conditions

Throat irritation, Nasal discomfort.
Rebound nasal congestion (rhinitis
medicamentosa), especially with prolonged or
excessive use
Nausea, vomiting
Rash
Urinary retention
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.
2.
3.
4.

7.

Practice using the dropper to develop good dosage control.
Clear or wipe the child’s nose.
Shake the bottle gently and remove the cap.
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
04/10/2006

10

DATE OF REVISION OF THE TEXT
30/01/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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