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For the relief of nasal congestion associated with the common cold, perennial and allergic rhinitis (including hay fever), sinusitis.
Dosage
Adults and elderly: Not applicable.
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v is contraindicated in children under 6 years of age.
Children between 6 and 12 years under adult supervision (all indications): 1 or 2 drops, in each nostril up to 2 times a day.
Do not use for more than 5 days without a doctor’s advice.
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
Direction for use:
Nasal use
Do not exceed the stated dose
Keep out of the reach and sight of children.
The adverse effects listed below are classified by system organ class and frequency according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/10), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Immune System Disorders
Very rare: Hypersensitivity reaction (angioedema, rash, pruritus)
Nervous System Disorders
Common: Headache
Unknown: Irritability, Anxiety, Restlessness, Excitability, Insomnia, Hallucinations and Paranoid Delusions – particularly with prolonged and/or excessive use
Eye Disorders
Very rare: Transient visual impairment
Cardiac Disorders
Very rare: Heart rate irregular, Heart rate increased – particularly with prolonged and/or excessive use
Unknown: Other cardiac dysrhythmias and hypertension- particularly with prolonged and/or excessive use
Respiratory, thoracic and mediastinal disorders
Common: Nasal Dryness, Nasal Discomfort
Uncommon: Epistaxis
Gastrointestinal disorders
Common: Nausea
General disorders and administration site
Common: Application site burning
Unknown:
• Tolerance with diminished effect – especially with prolonged and/or heavy use
• Rebound congestion (rhinitis medicamentosa) – especially with prolonged and/or heavy use
• Irritation & dryness
Patients are advised not to take decongestants for more than five consecutive days. Prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v, 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, tremor, cardiac arrhythmias or elevated blood pressure.
Use with caution in occlusive vascular disease.
If any of the following occur, Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v should be stopped
Keep away from eyes. Keep medicines out of the sight and reach of children. Do not use Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v in children under 6 years old.
Information concerning excipients
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v contains benzalkonium chloride. This may cause irritation of the nasal mucosa.
Do not store above 30°C. Protected from light. Keep the medicine out of reach of children.
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v comes in a 10 ml white HDPE bottle with a neck spray, packed in a unit carton with a pack insert.
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Conical Pharmaceuticals is a professionally managed and dynamic organization with decades of experience in the pharmaceutical field. With a desire of providing opportunities for a better life, we work very hard to bring quality drugs to our customers. We have instilled a level of trust and confidence amongst our clients by supplying the best quality products.