Drinasal Paediatric 1 ml Nasal Drops and Metered Spray, solution

DriNasal Paediatric 0,025 % is indicated for the relief of nasal congestion due to the common cold, sinusitis, allergic rhinitis and hay fever. Indicated as adjunctive treatment in middle ear infection.

Posology
DriNasal Paediatric 0,025 % is indicated for children up to the age of 6 years.
Metered Spray: 2 to 3 sprays in each nostril 2 to 3 times a day.
Drops: 2 to 3 drops of the liquid into each nostril 2 to 3 times a day.
DriNasal Paediatric 0,025 % should not be used for a period longer than 5 days.

Method of administration
Nasal administration
Metered Spray: For best results keep both the head and spray bottle slightly tilted to the back. Remove the cap by pulling. With the middle and forefinger around the bottom of the nozzle and the thumb on the base of the bottle, press once to fill the pump mechanism completely. Insert the nozzle of the spray loosely into the nostril, squeeze the pump spray 2 to 3 times and simultaneously sniff in to ensure an even distribution of the fine spray. Repeat for other nostril.
Drops: Fill glass dropper unit by placing the open end into the liquid and depressing the rubber teat. Tilt the head back and instill 2 to 3 drops of the liquid into each nostril 2 to 3 times a day.

• Hypersensitivity to Oxymetazoline hydrochloride or to any of the excipients listed in section 6.1.
• Rhinitis sicca (inflammation of the skin and mucosa of the nasal vestibule and encrustation).
• In patients following a trans-sphenoidal hypophysectomy

In the following cases, DriNasal Paediatric 0,025 % may only be used after carefully weighing the risk-to-benefit ratio:
u2022 Patients treated with monoamine oxidase inhibitors or have taken MAOIs in the previous 2 weeks, or who have been treated with tricyclic antidepressants and other medicines such as stated in 4.5.
u2022 Medicines potentially increasing blood pressure.
u2022 Increased intraocular pressure, especially narrow-angle glaucoma.
u2022 Severe cardiovascular diseases (e.g. coronary heart disease, angina, hypertension, cardiac asthma).
u2022 Phaeochromocytoma.
u2022 Metabolic disorders (e.g. hyperthyroidism, diabetes mellitus, porphyria).
u2022 Hyperplasia of the prostate.
u2022 Do not exceed the recommended dose.
u2022 If symptoms worsen or do not improve after 3 days, a medical practitioner should re-evaluate clinical situations.
u2022 DriNasal Paediatric 0,025 % should be used for a maximum of 5 consecutive days to avoid a rebound-effect and drug-induced rhinitis. Long-term use and overdosage of DriNasal Paediatric 0,025 % should be avoided. The efficacy of DriNasal Paediatric 0,025 % may be reduced (tachyphylaxis) with long-term use or overdose. This may lead to use of higher doses or to more frequent usage which, in turn, can result in permanent use. If long-term use or overdose occurs, treatment should be discontinued immediately. Continuous use may cause nasal congestion due to reactive hyperaemia of the nasal mucosa (rebound effect) and chronic swelling of the nasal mucosa (rhinitis medicamentosa) as well as mucosal atrophy or rhinitis sicca. Rebound effects and tachyphylaxis should stop once use of DriNasal Paediatric 0,025 % is discontinued.
Medical supervision is indicated in patients with chronic rhinitis. Dosages higher than recommended may only be used under medical supervision. DriNasal Paediatric 0,025 % contains 0,15 mg benzalkonium chloride (a preservative) in each millilitre nasal solution which is equivalent to 0,015 % (m/v).

The concomitant use of DriNasal Paediatric 0,025 % and certain mood-stimulating medicines with hypertensive effect (e.g. MAO inhibitors and tricyclic antidepressants) may lead to an increase in blood pressure or hypertensive crisis due to their cardiovascular activity. The efficacy of beta-blocking medicines such as methyldopa, bethanidine, debrisoquine and guanethidine or other anti-hypertensive medicines may be reduced with concomitant use of DriNasal Paediatric 0,025 %. Possible additive cardiovascular toxicity may occur when sympathomimetics are given with antiparkinsonian medicines such as bromocriptine.

Pregnancy and lactation
DriNasal Paediatric 0,025 % should only be used after consultation with a medical practitioner during pregnancy and lactation. The recommended dosage must not be exceeded.
Fertility
No data are available on the effects of DriNasal Paediatric 0,025 % on human fertility.

No impairment is to be expected if used as recommended. Systemic effects with involvement of the cardiovascular or central nervous system cannot be excluded after prolonged administration of DriNasal Paediatric 0,025 % or intake of oxymetazoline containing cold remedies in doses higher than recommended. In these cases, the ability to drive a vehicle or operate machinery can be impaired.

Tabulated list of adverse reactions
Immune system disorders
Frequency unknown
Hypersensitivity reaction (angioedema, rash, pruritis)
Psychiatric disorders
Frequency unknown
Insomnia, restlessness
Nervous system disorders
Less frequent
Headache or light-headedness, nervousness, anxiety, irritability
Frequency unknown
Somnolence, sedation, hallucinations, convulsions
Cardiac disorders
Frequency unknown
Palpitations, tachycardia
Vascular disorders
Frequency unknown
Hypertension (increased blood pressure)
Respiratory, thoracic and mediastinal disorders
Frequent
Aqueous nasal secretions, crusted nose
Less frequent
Rebound congestion (increase in runny or stuffy nose)
Frequency unknown
Nasal discomfort (stinging or burning of the nasal mucosa), dryness of the nose, mouth and throat, sneezing, after the effect has worn off increased swelling of the mucosa (reactive hyperaemia), epistaxis
General disorders and administration site conditions
Frequency unknown
Fatigue, tachyphylaxis (associated with long-term use or overdose). Systemic effects have occurred after local administration.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Overdosage may occur after nasal or accidental oral administration. The efficacy of DriNasal Paediatric 0,025 % may be reduced (tachyphylaxis) with long-term use or overdose. This may lead to use of higher doses or to more frequent usage which, in turn, can result in permanent use. If long-term use or overdose occurs, treatment should be discontinued immediately. The clinical picture following intoxication with imidazol-derivatives may be unclear due to the occurrence of episodes of hyperactivity alternated with episodes of depression of the central nervous system and of the cardiovascular and pulmonary system.
Symptoms
Symptoms of an overdose may be: Hypertension, tachycardia, palpitations, cardiac dysrhythmia, cardiac arrest, sweating, agitation, convulsion, mydriasis, nausea, vomiting, cyanosis, fever, spasms, circulatory collapse, pulmonary oedema, respiratory disorders, psychic disorders, drowsiness, paleness, miosis, decrease in body temperature, bradycardia, shock-like hypotension, apnoea, loss of consciousness and coma. In children above 6 years, in particular, overdose often causes dominating central nervous effects with convulsions and coma, bradycardia, apnoea as well as hypertension possibly followed by hypotension.
Therapeutic measures after overdosage
In-house intensive-care therapy is indicated in cases of severe overdose. Administration of medicinal charcoal (absorbent) or sodium sulfate (laxative) should be performed rapidly. A non-selective alpha-blocker can be given as antidote. If required, initiate fever lowering measures, anticonvulsive therapy and oxygen ventilation. Vasopressors are contraindicated.