Oxalin junior

Package leaflet: Information for the user

Oxalin Junior, 0.5 mg/g, nasal gel
Oxymetazolini hydrochloridum
Please read the entire leaflet carefully before using this 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 a
physician, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If there is no improvement or if your condition worsens after 3–5 days, consult your physician.

Table of contents

1. What Oxalin Junior is and what it is 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. Contents of the pack and other information

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

Oxalin Junior is a nasal gel containing oxymetazoline hydrochloride as the active substance, belonging to a group of medicines known as sympathomimetics. When applied locally to the nasal mucosa, Oxalin Junior constricts blood vessels, reduces swelling of the nasal mucosa, and inhibits excessive secretion, thereby facilitating free nasal breathing. It clears the nasal passages and promotes drainage from the paranasal sinuses.

Oxalin Junior is formulated as a gel, which moisturizes the nasal mucosa and prevents the medicine from running down the back of the nose and into the throat.

Oxalin Junior is intended for use in children over 6 years of age and adults.

Oxalin Junior is used:

• in acute rhinitis;
• in vasomotor rhinitis;
• in allergic rhinitis;
• in sinusitis;
• in otitis media with Eustachian tube inflammation;
• in acute otitis media.

2. Important information before using Oxalin Junior

When not to use Oxalin Junior

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

Warnings and precautions
Before starting to use Oxalin Junior, consult a doctor, pharmacist, or nurse.
Oxalin Junior may be used with particular caution and only after medical advice in the following cases:

• Treatment with monoamine oxidase inhibitors (MAOIs) or other medicines that increase blood pressure;
• Increased intraocular pressure, particularly in the case of narrow-angle glaucoma;
• Severe cardiovascular diseases, e.g. ischemic heart disease, arterial hypertension;
• Pheochromocytoma (a tumor located in the glands above the kidneys);
• Hyperthyroidism, diabetes.

Oxalin Junior should not be used for longer than 3–5 days or in doses higher than recommended, as this may lead to reduced effectiveness of the medicine 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 in infants and children under 6 years of age.
Oxalin Junior and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Overdose or accidental ingestion of the medicine, as well as concomitant use of tricyclic antidepressants or monoamine oxidase inhibitors (medicines used, among others, for depression), either simultaneously or immediately before administration of oxymetazoline, may lead to increased blood pressure.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
During prolonged use of the medicine or use in higher than recommended doses, systemic cardiovascular effects cannot be ruled out. In such cases, psychomotor performance, ability to drive vehicles, and operate machinery may be impaired.
Oxalin Junior contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per g of gel. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Oxalin Junior

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor. If in doubt, consult a doctor or pharmacist.

• This medicine should be used for nasal use only.
• For hygienic reasons, the medicine container should be used by only one patient.
• Do not use for longer than 3 to 5 days.
• Do not use doses higher than those specified below.

One 0.1 ml dose of gel contains 0.05 mg of oxymetazoline hydrochloride.
Adults and children over 12 years of age:

• 1 dose into each nostril two to three times daily. Do not use the medicine more frequently than 3 times a day.

Children aged 6 to 12 years:

• 1 dose into each nostril twice daily. Do not use the medicine more frequently than 2 times a day.

Instructions for use
Before each use, remove the protective cap.
Before first use of a new bottle, due to the gel formulation, after removing the cap, press the pump several times until the medicine appears. Insert the pump nozzle into the nostril.
While holding the bottle vertically, press the pump to deliver a dose of the medicine into the nose.
After use, replace the protective cap.

Overdose of Oxalin Junior
If a patient has used more than the recommended dose (overdose) or accidentally swallowed the medicine, especially if this occurred in a child, contact a doctor immediately.
Seek immediate medical attention if any of the following symptoms occur:

• Dilated pupils;
• Nausea, vomiting;
• Cyanosis (bluish discoloration of the skin and mucous membranes);
• Fever;
• Muscle spasms;
• Cardiac dysfunction (e.g. rapid heartbeat, cardiac arrhythmia);
• Circulatory collapse (acute heart failure with sudden drop in blood pressure, manifesting as severe weakness, often with loss of consciousness);
• Cardiac arrest (causing cessation of blood circulation and life-threatening condition);
• Pulmonary edema (characterized by increasing shortness of breath, labored breathing with wheezing, pallor and cyanosis, decreased or increased arterial pressure);
• Psychiatric disturbances;
• Drowsiness;
• Hypothermia;
• Bradycardia;
• Sudden drop in arterial pressure;
• Apnea;
• Coma.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur:
Common (in more than 1 in 100 patients, but in less than 1 in 10 patients):

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

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

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

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

• motor restlessness, insomnia, headaches;
• fatigue;
• strong sensation of "nasal congestion" due to worsening of nasal mucosa swelling (occurring after the medicine's effect wears off, as a symptom of so-called reactive hyperemia).

Prolonged use of the medicine beyond the recommended duration and/or in doses higher than recommended may lead to difficult-to-treat or even irreversible changes in the nasal mucosa.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Oxalin Junior

Store below 25 °C.
Keep the bottle tightly closed.
Store the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the stated month.
Do not use the medicine after 12 weeks from first opening of the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Oxalin Junior contains

• The active substance is oxymetazoline hydrochloride. 1 g of gel contains 0.5 mg of oxymetazoline hydrochloride.
• 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 contents of the pack
Oxalin Junior is a colourless or light yellow, clear or slightly opalescent viscous liquid.
The medicine is available:

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

Marketing Authorisation 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