Otrivin Allergi

Leaflet attached to the packaging: information for the user

Otrivin Allergy

(2.5 mg + 0.25 mg)/ml, nasal spray, solution
Phenylephrine + Dimetindene maleate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Otrivin Allergy and what is it used for
• 2. Important information before using Otrivin Allergy
• 3. How to use Otrivin Allergy
• 4. Possible side effects
• 5. How to store Otrivin Allergy
• 6. Contents of the packaging and other information

1. What is Otrivin Allergy and what is it used for

Otrivin Allergy contains two active substances:

• phenylephrine - reducing nasal congestion.
• dimetindene maleate - inhibiting the action of histamine responsible for allergic reactions. The active substances of Otrivin Allergy facilitate the clearance of nasal passages and reduce excessive secretion (runny nose), without disrupting the function of the cilia of the nasal mucosa. Otrivin Allergy quickly and persistently reduces nasal congestion. It clears the nose, making it easier to breathe. The medicine is intended for use on the nasal mucosa.

Indications for use

Treatment of symptoms of a cold, nasal congestion, acute and chronic rhinitis, seasonal (hay fever) and non-seasonal allergic rhinitis, vasomotor rhinitis. Supportively in acute and chronic sinusitis and in otitis media.
Pre- and post-operative care in nasal surgery.
If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Otrivin Allergy

When not to use Otrivin Allergy

• if the patient is allergic to phenylephrine, dimetindene maleate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has atrophic rhinitis (chronic rhinitis with crust formation),
• if the patient is currently taking monoamine oxidase inhibitors (medicines used, among others, in depression) or has taken them within the last 14 days. In case of doubt, whether the medicines taken belong to the group of monoamine oxidase inhibitors, the patient should consult their doctor or pharmacist before using Otrivin Allergy,
• if the patient has narrow-angle glaucoma,
• in children under 6 years of age.

Warnings and precautions

Before starting to use Otrivin Allergy, the patient should consult their doctor:

• if the patient has cardiovascular disease (e.g. coronary artery disease, hypertension);
• if the patient has hyperthyroidism;
• if the patient has diabetes;
• if the patient has prostatic hyperplasia, as urinary retention may occur;
• if the patient has epilepsy;
• if the patient is taking antidepressant medicines or medicines used in hypertension (such as beta-blockers), see also section "Otrivin Allergy and other medicines";
• if the patient is hypersensitive to adrenergic substances (e.g. adrenaline, ephedrine), manifested by insomnia, dizziness, tremors, arrhythmias or increased blood pressure.

Before using Otrivin Allergy, the patient should consult their doctor, even if the above warnings concern situations that occurred in the past.

Otrivin Allergy should not be used for more than 7 consecutive days. If symptoms persist, the patient should consult their doctor. Using it for a longer period than recommended may cause nasal congestion and recurrence or worsening of symptoms.
A higher dose than recommended should not be used. Overuse, especially by small children and the elderly (over 65 years of age), may lead to systemic side effects.
The patient should use the lowest effective number of doses of the medicine, for the shortest possible time.
The patient should not exceed the recommended number of doses or the recommended dosing frequency.

Children and adolescents

Otrivin Allergy is not recommended for use in children under 6 years of age.
In children from 6 to 12 years of age, the medicine should be used under adult supervision.

Otrivin Allergy and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Before using Otrivin Allergy, the patient should consult their doctor if they are currently taking or have recently taken the following medicines:

• monoamine oxidase inhibitors (medicines used, among others, in depression), see section "When not to use Otrivin Allergy";
• tricyclic and tetracyclic antidepressants (such as imipramine, amitriptyline) or medicines used in hypertension (such as propranolol, atenolol, metoprolol), see section "Warnings and precautions".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy and breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Otrivin Allergy contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride in each ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

Otrivin Allergy contains a fragrant substance from lavender oil (geraniol, linalol, coumarin, and limonene)

It may cause allergic reactions.

3. How to use Otrivin Allergy

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor.
In case of doubt, the patient should consult their doctor or pharmacist.

Otrivin Allergy should be used only for the nose (also in otitis media).

Otrivin Allergy should be used after thorough nasal cleansing.
For hygiene reasons, the medicine packaging should be used by only one patient.

Children under 6 years of age

The use of this medicine is not recommended.
Children from 6 to 12 years of age(under adult supervision)
1 to 2 doses into each nostril 3 to 4 times a day.

Adults and children over 12 years of age

1 to 2 doses into each nostril 3 to 4 times a day: the last dose should be taken shortly before bedtime.
Otrivin Allergy should not be used for more than 7 consecutive days. If symptoms persist, the patient should consult their doctor.

Otrivin Allergy should not be used in children under 6 years of age.

Method of administration:

• 1. Remove the protective cap.
• 2. Before the first use, press the pump several times until the doser works. The prepared spray is ready for use.
• 3. The patient should be careful not to spray the medicine into their eyes.
• 4. The patient should place the doser tip into the nostril, press the pump firmly, and then remove it from the nostril without releasing the pressure. Proper spraying occurs when performed during a slight inhalation through the nose.
• 5. After use, the patient should clean the doser tip and immediately put on the protective cap.

• 6. To limit the potential spread of infection, the medicine packaging should be used by only one patient.

The bottle containing 10 or 15 ml of the medicine is equipped with a dosing pump that determines the content of active substances in a single dose, thus excluding the likelihood of unintentional overdose.

Use in children

Otrivin Allergy is not recommended for use in children under 6 years of age.
In children from 6 to 12 years of age, Otrivin Allergy should be used under adult supervision.

Using a higher dose of Otrivin Allergy than recommended

In case of using a higher dose of the medicine than recommended, the patient should immediately contact their doctor.
The following symptoms may occur: feeling of fatigue, abdominal pain, accelerated heart rate, increased blood pressure, anxiety, insomnia, paleness of the skin, nausea, vomiting, tremors, dizziness.
Gastric lavage is usually not necessary. Children aged 6 years should be given activated charcoal and laxatives, while older children and adults usually only need to be given a large amount of fluid.
Further treatment should be in accordance with clinical guidelines or the recommendations of the poison treatment center.

Missing a dose of Otrivin Allergy

The patient should not use a double dose to make up for a missed dose.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Otrivin Allergy can cause side effects, although not everybody gets them.
Side effects are rare (less than 1 in 1000 people using the medicine):
discomfort in the nose, dryness of the nose, nosebleeds, burning sensation at the site of administration.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
tel: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Otrivin Allergy

Bottle with LDPE containing 10 ml of solution:
Store in a temperature below 30°C. Protect from light.
Bottle with HDPE containing 15 ml of solution:
Store in a temperature below 25°C. Protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Otrivin Allergy contains

• The active substances of the medicine are phenylephrine and dimetindene maleate. One ml of solution contains 2.5 mg of phenylephrine and 0.25 mg of dimetindene maleate. One dose contains 0.3536 mg of phenylephrine and 0.0354 mg of dimetindene maleate.
• The other ingredients of the medicine are: benzalkonium chloride, anhydrous sodium phosphate, citric acid monohydrate, sorbitol, lavender oil deterpenated (contains, among others, geraniol, linalol, coumarin, limonene), purified water.

What Otrivin Allergy looks like and what the packaging contains

Otrivin Allergy is a nasal spray.
The packaging contains 10 ml or 15 ml of solution.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Importer:

Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany

Date of last revision of the leaflet: