Oxalin Iunior

Package Leaflet: Information for the Patient

Oxalin Junior, 0.5 mg/g, Nasal Gel

Oxymetazoline Hydrochloride

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3-5 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Oxalin Junior and what is it used for
• 2. Important information before using Oxalin Junior
• 3. How to use Oxalin Junior
• 4. Possible side effects
• 5. How to store Oxalin Junior
• 6. Package contents and other information

1. What is Oxalin Junior and what is it used for

Oxalin Junior is a nasal gel containing oxymetazoline hydrochloride as the active substance, which belongs to a group of medicines called sympathomimetics. When applied locally to the nasal mucosa, Oxalin Junior constricts blood vessels, reduces swelling of the nasal mucosa, and inhibits excessive secretion, making it easier to breathe through the nose. It clears the nasal passages and facilitates the drainage of secretions from the paranasal sinuses. Oxalin Junior is in the form of a gel, which moisturizes the nasal mucosa and also prevents the medication from flowing down to the bottom of the nasal cavity and into the throat. Oxalin Junior is intended for use in children over 6 years of age and adults. Oxalin Junior is used:

• for acute rhinitis;
• for vasomotor rhinitis;
• for allergic rhinitis;
• for sinusitis;
• for otitis media;
• for middle ear inflammation.

2. Important information before using Oxalin Junior

When not to use Oxalin Junior

• If the patient is allergic to oxymetazoline hydrochloride or any of the other ingredients of this medication (listed in section 6).
• If the patient has dry rhinitis (atrophic rhinitis with crust formation).

Warnings and precautions

Before starting to use Oxalin Junior, discuss it with your doctor, pharmacist, or nurse. Oxalin Junior may be used with special caution and only after medical advice in the following cases:

• treatment with monoamine oxidase inhibitors (MAOIs) and other medications that increase blood pressure;
• increased eye pressure, especially in the case of so-called closed-angle glaucoma;
• severe heart and blood vessel diseases, such as coronary heart disease, hypertension;
• pheochromocytoma (a tumor located in the glands above the kidneys);
• hyperthyroidism, diabetes.

Oxalin Junior should not be used for more than 3-5 days or in doses greater than recommended, as this may lead to a decrease in the effectiveness of the medication and cause difficult-to-treat changes in the nasal mucosa.

Children and adolescents

Oxalin Junior is intended for use in children over 6 years of age. Do not use the medication in infants and children under 6 years of age.

Oxalin Junior and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Overdose or accidental ingestion of the medication, as well as the use of tricyclic antidepressants or monoamine oxidase inhibitors (medications used, among other things, in depression) at the same time or immediately before using oxymetazoline, may cause an increase in blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

During prolonged use of the medication or use in higher doses than recommended, it cannot be ruled out that systemic effects on the circulatory system may occur. In such cases, psychophysical fitness, the ability to drive vehicles, and operate machinery may be impaired.

Oxalin Junior contains benzalkonium chloride

The medication contains 0.1 mg of benzalkonium chloride per 1 g of gel. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Oxalin Junior

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor. In case of doubts, consult a doctor or pharmacist.

• Use the medication only for the nose.
• For hygiene reasons, the medication packaging should be used by only one patient.
• Do not use for more than 3 to 5 days.
• Do not use doses greater than those recommended below.

1 dose of gel with a volume of 0.1 ml contains 0.05 mg of oxymetazoline hydrochloride. Adults and children over 12 years of age:

• 1 dose into each nostril 2 to 3 times a day. Do not use the medication more than 3 times a day.

Children from 6 to 12 years of age:

• 1 dose into each nostril 2 times a day. Do not use the medication more than 2 times a day.

Method of administration

Each time before using the medication, remove the protective cap. Before using a new bottle for the first time, due to the gel-like form of the medication, after removing the cap, press the dispenser several times until the medication appears. Insert the dispenser tip into the nostril. Holding the bottle vertically, press the dispenser, which will administer a dose of the medication into the nose. After using the medication, put the protective cap back on.

Using a higher dose of Oxalin Junior than recommended

If you have used a higher dose than recommended (overdosed) or accidentally ingested the medication, especially if a child has done so, contact your doctor immediately. You should immediately consult a doctor if you experience any of the following symptoms:

• pupil dilation;
• nausea, vomiting;
• cyanosis (blue discoloration of the skin and mucous membranes);
• fever;
• muscle spasms;
• heart rhythm disturbances (e.g., accelerated heart rate, arrhythmia);
• circulatory collapse (acute heart failure with a sudden drop in blood pressure, manifested by severe weakness, often with loss of consciousness);
• cardiac arrest (which causes the cessation of blood circulation and is life-threatening);
• pulmonary edema (characterized by increasing shortness of breath, difficulty breathing with wheezing, pallor, and cyanosis, a drop or increase in blood pressure);
• psychiatric disorders;
• drowsiness;
• decreased body temperature;
• slowed heart rate;
• sudden drop in blood pressure;
• apnea;
• coma.

In case of any further doubts related to the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Oxalin Junior can cause side effects, although not everybody gets them. The following side effects may occur:

Frequently (in more than 1 in 100 patients, but less than 1 in 10 patients):

• burning sensation at the site of application, dryness of the nasal mucosa, sneezing.

Less frequently (in more than 1 in 1,000 patients, but less than 1 in 100 patients):

• palpitations, accelerated heart rate;
• increased blood pressure.

Rarely (in more than 1 in 10,000 patients, but less than 1 in 1,000 patients):

• restlessness, insomnia, headaches;
• fatigue;
• strong feeling of "nasal congestion" due to increased swelling of the nasal mucosa (occurring after the effect of the medication has ceased, as a symptom of so-called reactive hyperemia).

Using the medication for a longer period than recommended and/or in doses greater than recommended may cause difficult-to-treat or even irreversible changes in the nasal mucosa.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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, you can help gather more information on the safety of the medication.

5. How to store Oxalin Junior

Store at a temperature below 25°C. Store the bottle tightly closed. Keep the medication out of the sight and reach of children. Do not use this medication after the expiration date stated on the carton and bottle after: EXP. The expiration date means the last day of the specified month. Do not use the medication after 12 weeks from the first opening of the bottle. Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Oxalin Junior contains

• The active substance of the medication is oxymetazoline hydrochloride. 1 g of gel contains 0.5 mg of oxymetazoline hydrochloride.
• The other ingredients are: sodium chloride; disodium phosphate dodecahydrate; sodium dihydrogen phosphate monohydrate; disodium edetate; hydroxyethylcellulose; glycerol; benzalkonium chloride solution; purified water.

What Oxalin Junior looks like and what the package contains

Oxalin Junior is a colorless or light yellow, transparent or slightly opalescent thick liquid. The medication is available:

• in glass bottles with an atomizer containing 10 g of gel, in a cardboard box,
• in 15 ml polyethylene bottles with a dosing pump and applicator with a protective cap, containing 10 g of gel, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Medana branch in Sieradz, ul. Władysława Łokietka 10, 98-200 Sieradz, Date of last revision of the leaflet:December 2024