Various types of head cold.
For easing the flow of mucus in inflammations of the nasal sinuses.
For otitis media as an adjunct for decongestion in the nasopharyngeal area. For
easing of rhinoscopy.

Otrivin Nasal Drops 0.05%/Otrivin Metered-Dose Spray 0.05% Children 6-12 years old use under
adult supervision.

Normally, 1–2 drops of the 0.05% solution 1–2x daily, or 1 spray with the 0.05% metered-dose spray
in each nostril are sufficient; you must not exceed 3 applications per day.
Children aged 1-2 years: use according to the doctor's prescription.
Children aged below 1 year: the product should not be used.
Otrivin Metered-Dose Spray 0.1%
Only suitable for adults and adolescents aged 12 years and above.
1 spray in each nostril. Repeat as needed, however, do not exceed 3 applications per day.
Otrivin nasal drops 0.1%/Otrivin Nebuliser 0.1% are only suitable for adults and adolescents from 12
years of age.
2–3 drops of the 0.1% solution or 1 spray (nebuliser 0.1%) in each nostril. Repeat as needed,

however, the dose must not exceed 3–4 applications a day.
The last application of the day should preferably be shortly before going to bed.
Otrivin should not be used for longer than 1 week as longer-term use can lead to Rhinitis
medicamentosa.
How to use the drops:
Clean (blow) the nose thoroughly before use.
Tilt the head back slightly. Insert the drops into each nostril and briefly keep the head tilted back so
that the drops can spread out. Clean and dry the dropper before screwing it back onto the bottle.
How to use the nebuliser:
Clean (blow) the nose thoroughly before use.

To ensure a fine mist, hold the nebuliser vertically with its opening pointing up. Ensure that the mist
does not come into contact with the eyes. Insert the spray nozzle into the nostril and squeeze the spray
container. Remove the spray nozzle before releasing pressure. Optimal distribution of the mist can be
achieved by breathing in lightly through the nose while spraying. Clean and dry the spray nozzle before
replacing the protective cap.
How to use the metered-dose spray:
Clean (blow) the nose thoroughly before use. remove the protective cap. Activate the pump
4 times before the first use. The metered-dose spray is ready to use for all other applications. If the mist
is not fully emitted after pumping, e.g. after a break from use, activate the pump again 4 times. Insert
the spray opening into the nostril and press down strongly on the nozzle, once. Optimal distribution of
the mist can be achieved by breathing in lightly through the nose while spraying. Replace the
protective cap after use.

Otrivin should be used with caution in patients
• with high blood pressure, cardiovascular disorders, Patients with a long QT syndrome have an
increased risk of severe ventricular arrhythmia when undergoing treatment with xylometazoline
• with hyperthyreosis, diabetes mellitus, phaeochromocytoma,
• with prostatic hypertrophy,
• who are being treated with MAO inhibitors or who have received these within the last 14
days (see "Interactions"),
• with intensified reactions to sympathomimetic substances with signs of insomnia, light
headedness, etc.
As with other topical vasoconstrictors, ongoing treatment with Otrivin lasting longer than 1 week is not
indicated as Rhinitis medicamentosa with nasal mucosal swelling can occur; this has very similar
symptoms to a head cold.
The recommended dose should not be exceeded, especially in children and elderly patients.
Otrivin/Otrivine Head Cold 0.05% (nasal drops and metered-dose spray) should not be used by children
aged under 1 year. For children aged from 1 to 2 years, use only according to the doctor's prescription. For
children aged from 2 to 11 years, use only under adult supervision.
Otrivin Metered-Dose Spray 0.1% should not be used by children under 12 years of age.

MAO inhibitors: xylometazoline can intensify the effect of MAO inhibitors and cause a hypertensive
crisis. Xylometazoline is not recommended for patients who are taking MAO inhibitors, or who have
taken one within the last 14 days (see "Warnings and precautions").
Tri- or tetra-cyclic antidepressants: the concurrent administration of tricyclic or tetracyclic
antidepressants with sympathomimetics can lead to intensification of the sympathomimetic effect of
xylometazoline and is therefore not recommended.

Pregnancy: As a precaution, Otrivin should not be used during pregnancy due to its vasoconstrictive
properties.
Lactation: it is not known whether xylometazoline passes into the breast milk. Otrivin should only be
used on medical advice during lactation.
Fertility: there is no relevant data regarding the effect of Otrivin on fertility and no controlled studies
in animals are available. As the systemic exposure of xylometazoline is very low, effects on fertility
are unlikely.

Effects on ability to drive and use machines
For longer-term application or higher doses of xylometazoline head cold drugs, possible systemic actions with cardiovascular effects cannot be excluded.

The undesirable effects are listed below according to system class and frequency. The frequencies are
defined as follows: Very common (≥1/10), common (≥1/100 to <1/10) uncommon (≥1/1,000 to
<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). The undesirable effects are listed in
decreasing order of severity within each frequency group.
Immune system:
Very rare: hypersensitivity reactions (angio-oedema, rash, pruritus).
Nervous system:
Common: headaches.
Eyes:
Very rare: temporary visual disturbances.
Heart:
Very rare: irregular and increased heart rate, hypertension, arrhythmias.
Respiratory tracts:
Common: nose dryness, nasal discomfort, burning sensation, Rhinitis medicamentosa. 

Gastrointestinal disorders:
Common: nausea.
General:
Common: a burning sensation at the application site.
To reports any side effect(s):

Saudi Arabia:
• The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- - E-mail: npc.drug@sfda.gov.sa
- - Website: https://ade.sfda.gov.sa/

Other GCC States:
- Please contact the relevant competent authority.

Excessive use of topical xylometazoline or accidental ingestion can cause sympatholytic effects,
including CNS depression (such as drowsiness, coma), hypertension by or hypotension, as well as tachycardia and bradycardia. Gastrointestinal symptoms such as nausea and vomiting can also
occur. Further symptoms include paleness, excessive sweating, hypothermia, miosis, respiratory
depression, ataxia and restlessness.
Severe symptoms after accidental exposure have not been observed; however, in a newborn (2 weeks
old) the use of 1 drop of 0.1% solution in each nostril led to a coma.
In infants, the ingestion of up to 0.5 mg/kg body weight did not lead to clinically relevant symptoms.
Owing to a lack of data, severe symptoms following the ingestion of more than
0.5 mg/kg body weight cannot be excluded. In such cases, medical monitoring and administration of a
single dose of activated charcoal is indicated after consultation with an experienced clinician or a
toxicological information centre. There is no specific antidote. The therapy is symptomatic;
bradycardia can be treated with atropine.

ATC code: R01AA07
Mechanism of action
Xylometazoline is a sympathomimetic and acts on the alpha-adrenergic receptors in the nasal
mucosa.
After application in the nose, the blood vessels are constricted which decreases the swelling in the
nasal mucosa and the neighbouring areas of the pharynx. This eases nasal breathing.

Furthermore, Otrivin contains ingredients (sorbitol solution and methylhydroxypropyl cellulose)
intended to prevent the drying of the nasal mucosa.
The effect begins within minutes and lasts for up to 12 hours. Otrivin does not affect the function of the
ciliated epithelium.

After nasal application, the plasma concentrations of xylometazoline in humans are generally
low and close to the limit of detection.

Xylometazoline has no mutagenic effect. No teratogenic effects were observed following
subcutaneous application of xylometazoline in mice and rats.

Disodium hydrogenphosphate, sodium dihydrogenphosphate, disodium edetate, sodium chloride,
sorbitol, methylhydroxypropylcellulose, water, preservative: benzalkonium chloride.

NA

Do not store above 30°C

What Otrivin contains?
• Active Ingredient
Otrivin 0.1% (Each ml contains 1mg of Xylometzoline hydrochloride)
- Otrivin 0.1% Metered-Dose Nasal Spray:
Each metered dose spray delivers 0.14 ml per actuation (0.14 mg of Xylometazoline
hydrochloride)
- Otrivin 0.1% Nasal Drops:
Each drop delivers 0.025 mg of Xylometazoline hydrochloride
• The products contain the following excipients:
Benzalkonium chloride (as a preservative), Sodium dihydrogen phosphate dihydrate,
Disodium phosphate dodecahydrate, Disodium edetate, Sodium chloride, Sorbitol 70%
(Non crystallising), Methylhydroxypropylcellulose 4000 mPa.s, Purified water.
- What Otrivin looks like and the content of the pack?
Otrivin 0.1% Metered-Dose Nasal Spray:
- Clear solution in a bottle with a pump delivering just the right amount of product.
- The content of the pack is 10 ml.
Otrivin 0.1% Metered-Dose Nasal Spray
– High density polyethylene bottle mounted with a metered-dose pump (materials
in contact with the solution: low density polyethylene, high density polyethylene,
polyethylene / butyl, stainless steel) and a polypropylene nozzle with a protective cap
Otrivin 0.1%Nasal Drops:
- Clear solution in a bottle with a pipette.
- The content of the pack is 10 ml.

NA