Otrivin spray

Active Ingredients

Metered dose nasal spray Otrivin contains:

Xylometazoline Hydrochloride 0.1% w/v

Indications

Therapeutic class:

Otrivin contains xylometazoline hydrochloride, which belongs to the sympathomimetic agents class.

Otrivin spray is intended for rapid relief of nasal congestion for up to 10 hours. It helps open and clear the nasal passages by reducing the formation of excess nasal secretions and returning the swollen blood vessels to their original size.

Instructions

Do not swallow! This medicine is intended for external use only.

1. Do not cut the nozzle. The Metered Dose Spray is ready for use.

2. Blow your nose.

3. Remove the protective cap.

Before the first use, prime the pump by pumping 4 times. Once primed, the pump will normally remain charged throughout the daily treatment period. If the spray is not ejected following full actuation of the pump, or if the medicine has not been used for longer than 7 days, the pump will need to be reprimed. Press the pump 4 times as initially performed. Be very careful not to spray into your eyes or mouth.

4.Hold the bottle in an upright position with the thumb under its base and the nozzle between your two fingers.

5.Bend your head slightly forward and insert the nozzle into the nostril.

6.Press the pump while inhaling through the nose.

7.Repeat these steps in the other nostril.

8.Immediately after use, clean and dry the nozzle before replacing the protective cap. To prevent the spread of infection, this pack is intended to be used by one person only.

The generally accepted dosage is:

For children above 12 years of age and adults:

One spray in each nostril 3 times per day, as necessary. Do not exceed 3 applications per day into each nostril.

Do not exceed the recommended dose.

Do not use this medicine frequently or for more than 3 consecutive days without consulting the doctor. Prolonged or excessive use may cause worsening of the congestion and damage the nasal mucosa. If the symptoms persist, consult the doctor.

Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 3 days.

Warnings

Do not use Otrivin spray if You are sensitive (allergic) to the active ingredient (xylometazoline hydrochloride) or to any one of the other ingredients the medicine contains.

Do not use this medicine if you have had a trans-sphenoidal resection (through the nasal cavity) of the pituitary or an operation during which the outer meninges of the central nervous system was exposed.

Do not use this medicine if you have narrow angle glaucoma.

Do not use this medicine if you have chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis).

Do not use this medicine if you have an enlarged prostate gland.

Do not use this medicine if you have a rare tumor in the adrenal gland that produces excess adrenaline and noradrenaline (pheochromocytoma).

Do not use this medicine if you are taking medicines that inhibit the enzyme monoamine oxidase (MAO inhibitors) or if you have stopped taking them in the last 14 days.

Do not use the preparation in children under the age of 12 years.

Before using Otrivin tell the doctor if:

• You have an overactive thyroid gland (hyperthyroidism)
• You have diabetes
• You have heart or vascular disease (e.g. long QT syndrome)
• You are pregnant or breastfeeding
• You have hypertension.

As with other decongestants, Otrivin spray may cause sleep disturbances, dizziness and tremor in people who are very sensitive to it. Consult the doctor if these symptoms bother you.

Do not take decongestants for more than 3 consecutive days. Prolonged or excessive use may cause recurrence or worsening of the congestion.

If you are taking or have recently taken other medicines including non-prescription medicines and nutritional supplements, tell the doctor or the pharmacist. Especially if you are taking medicines for treatment of depression, particularly of the monoamine oxidase inhibitors class (MAOI).

Using Otrivin spray is not recommended if you are pregnant or breastfeeding. Consult the doctor before using Otrivin spray.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.