Sinutab Nasal Sprayn 1 mL Solution

Sinutab Nasal Spray is indicated for relief of nasal congestion accompanying hay fever, allergic rhinitis, colds and sinusitis.

Adults and children over 12 years of age:
One spray into each nostril 2 u2013 3 times a day, as required. (Maximum daily dose: 3 sprays).
Children under 12 years of age: Not recommended. Do not use for more than 7 days. Do not exceed recommended dosage.

Method of administration
To use:
1. Remove the plastic cap from the nozzle.
2. On first use, press the plunger downwards, and release until a single spray is delivered.
3. Hold the bottle upright and place nozzle into one nostril. Depress the plunger and at the same time breathe in through your nose. Release the plunger and remove nozzle from the nostril. Repeat this procedure for the other nostril.
4. To keep clean, wipe the nozzle and replace the plastic cap after use.

• Hypersensitivity to xylometazoline hydrochloride or to any of the other ingredients (see section 6.1).
• Contraindicated in children under 12 years of age.
• The prolonged use of vasoconstrictor medicines is not indicated in cases of chronic rhinitis.
• Not to be used with antihypertensive medicines of the adrenergic neuron blocking type or monoamine oxidase inhibitors (MAOIs) or within 10 days of their discontinuation.
• Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.

Sinutab Nasal Spray is intended for short-term use only. Prolonged use of decongestants may lead to reactive hyperaemia, with increased nasal congestion and obstruction. This may lead to repeated or even continuous use of the Sinutab Nasal Spray by the patient (see section 4.8).

Sinutab Nasal Spray should be used with caution in patients showing a strong reaction to sympathomimetic medicines, as evidenced by signs of insomnia, dizziness. etc. Sinutab Nasal Spray should be used with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus.

Patients should be instructed to discontinue use and consult a physician if symptoms persist or worsen, or if new symptoms occur.

Sinutab Nasal Spray contains preservatives. Sinutab Nasal Spray contains benzalkonium chloride. Long-term use may cause oedema of the nasal mucosa.

As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline, as in Sinutab Nasal Spray, by concomitant use of monoamine oxidase inhibitors (MOAIs), tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.

Pregnancy
The safety of Sinutab Nasal Spray in pregnancy has not been established. No foetal toxicity or fertility studies have been carried out in animals.

Lactation
No evidence of any adverse effect on the breastfed infant. However, it is unknown whether xylometazoline or its metabolites are excreted in human milk, therefore Sinutab Nasal Spray should only be used on the advice of a doctor while breastfeeding.

Fertility
No data available.

Sinutab Nasal Spray can cause side effects, such as drowsiness. Caution is advised before driving a vehicle or operating machinery until the effects of Sinutab Nasal Spray are known.

Immune system disorders: Frequency unknown: hypersensitivity
Psychiatric disorders: Frequency unknown: insomnia, somnolence
Nervous system disorders: Less frequent: burning sensation mucosal Frequency unknown: headache
Eye disorders: Frequency unknown: transient visual disturbance
Cardiac disorders: Frequency unknown: palpitations
Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Sinutab Nasal Spray to people with cardiovascular disease.
Respiratory, thoracic and mediastinal disorders: Less frequent: nasal dryness, local irritation Frequency unknown: sneezing, epistaxis
Gastrointestinal disorders: Frequency unknown: nausea
General disorders and administration site conditions: Less frequent: rebound effect.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of Sinutab Nasal Spray is important. It allows continued monitoring of the benefit/risk balance of Sinutab Nasal Spray. Health care 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 or accidental oral administration may cause hypertension, nausea, vomiting, headache, delirium, muscle twitching, epileptiform convulsions, depression of the central nervous system and marked reduction in body temperature and symptoms of drowsiness and coma, particularly in children. There is no specific treatment. Treatment is symptomatic.