Summary of Product Characteristics (SmPC) - Xylometazoline Decongestant nasal drops 0.05%w/v Childrens, Manx Healthcare Clear Nose drops - Child Formula
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
Excipients with known effect
Benzalkonium chloride
Sodium
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nasal drops.
4 CLINICAL PARTICULARS
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
- 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.
Do not exceed the stated dose
Keep out of the sight and reach of children
4.3 Contraindications
- 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 Interaction with other medicinal products and other forms of interaction
As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.
4.6 Fertility, 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, it is advisable to take the precaution of not using xylometazoline during pregnancy.
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Xylometazoline Decongestant Nasal Drops 0.05%w/v (Children’s Formula) should be used only on the advice of a doctor whilst breastfeeding.
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: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.
Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Xylometazoline Decongestant Nasal Drops 0.05%w/v (Children’s Formula) to people with cardiovascular disease. In isolated cases, systemic allergic reactions and transient visual disturbances.
| Oral agents | |
| Cardiovascular effects |
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| CNS effects |
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| Skin Reactions including rash | Hypersensitivity reactions, including cross-sensitivity with other sympathomimetics |
| Other Reactions |
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| Topical agents | |
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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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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, and sometimes consciousness clouding. There is no specific treatment. Appropriate supportive treatment should be initiated.
5.1 Pharmacodynamic properties
Xylometazoline is a sympathomimetic agent with marked alpha-adrenergic activity and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighboring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. Xylometazoline is generally well tolerated and does not impair the function of ciliated epithelium.
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
There are no findings in the preclinical testing which are of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
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 Special precautions for disposal and other handling
Keep all medicines out of the reach of children
7 MARKETING AUTHORISATION HOLDER
Manx Healthcare Ltd,
Taylor Group House,
Wedgnock Lane,
Warwick,
CV34 5YA
8 MARKETING AUTHORISATION NUMBER(S)
PL 14251/0085
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19 November 2003/19 August 2010
10 DATE OF REVISION OF THE TEXT
30/10/2019