Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

The medicinal product must be used with caution in patients who are sensitive to adrenergic substances, which may give symptoms such as sleeping disturbances, dizziness, tremor, cardiac arrythmias or elevated blood pressure.

The medicinal product must be used with caution to patients with: • Hypertension, cardiovascular diseases. Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
• Hyperthyroidism, diabetes mellitus.
• Hypertrophy of the prostate, stenosis of the bladder bar.
• Pheochromocytoma
• Cystic fibrosis
•     monoamine oxidase inhibitor (MAOI) treatment or who have received them in the last two weeks (see section 4.5 Interactions)
• Tri and tetra-cyclic antidepressants treatment or who have received them in the last two weeks (see section 4.5 Interactions)
• Beta 2-agonists treatment (see section 4.5 Interactions)


Caution should be exercised in patients predisposed to:
• Angle closure glaucoma
• Epistaxis (e.g. elderly)
• Paralytic ileus
Immediate hypersensitivity including urticaria, angioedema, rash, bronchospasm, pharyngeal oedema and anaphylaxis may occur.


The treatment duration should not exceed 7 days, as chronic treatment with xylometazoline hydrochloride may cause swelling of the nasal mucosa and hypersecretion because of increased sensitivity of the cells, "rebound effect" (rhinitis medicamentosa).


Patients should be instructed to avoid spraying Otrivin Complete in or around the eyes. If Otrivin Complete gets in contact with the eyes, the following may occur: temporary blurred vision, irritation, pain, red eyes.
Aggravation of angle-closure glaucoma may also develop.


The patient should be instructed to rinse their eyes with cold water if Otrivin Complete gets in direct contact with the eyes and must seek medical attention if they experience eye pain in the eyes or blurred vision.


Keep out of the sight and reach of children.

Effects on Driving

4.7 Effects on ability to drive and use machines
Visual disturbances (including blurred vision and mydriasis), dizziness and fatigue have been reported after using Otrivin Complete. Patients should be advised that if they experience these symptoms they should not drive, operate machinery or take part in activities where these symptoms may put themselves or others at risk.