Oxalin Babi

Package Leaflet: Information for the Patient

Oxalin Baby, 0.25 mg/g, Nasal Gel

Oxymetazoline Hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3-5 days there is no improvement or the patient feels worse, contact a doctor.

Table of Contents of the Leaflet

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

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

Oxalin Baby is a nasal gel medicine containing oxymetazoline hydrochloride as the active substance, which belongs to a group of medicines called sympathomimetics.
Oxalin Baby, when applied locally to the nasal mucosa, constricts blood vessels, reduces swelling of the nasal mucosa, and inhibits excessive secretion, making it easier to breathe freely through the nose.
It clears the nasal passages and facilitates the drainage of secretions from the paranasal sinuses.
Oxalin Baby is in the form of a gel, which moisturizes the nasal mucosa and also causes the medicine not to flow down to the bottom of the nasal cavity and into the throat.
Oxalin Baby in the form of a nasal gel is intended for use in children over

• 1 year of age to 6 years.

Oxalin Baby 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 Baby

When not to use Oxalin Baby

• 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 crust formation).

Warnings and precautions

Before starting to use Oxalin Baby, discuss it with your doctor, pharmacist, or nurse.
Oxalin Baby may be used with special caution and only after consulting a doctor in the case of:

• treatment with monoamine oxidase inhibitors (MAOIs) and other medicines 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 ischemic heart disease, hypertension;
• chromaffin tumor of the adrenal gland (a tumor located in the glands above the kidneys);
• metabolic disorders, such as hyperthyroidism, diabetes.

Oxalin Baby 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 effect of the medicine and cause difficult-to-treat or even irreversible changes in the nasal mucosa.

Children

Do not use the medicine in children under 1 year of age.
Follow the dosage and duration of use recommendations contained in section 3 of the leaflet.

• 3. of the leaflet.

Oxalin Baby and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Overdose or accidental ingestion of the medicine, as well as the use of tricyclic antidepressants or monoamine oxidase inhibitors (medicines 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 medicine.

Driving and using machines

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

Oxalin Baby contains benzalkonium chloride

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

3. How to use Oxalin Baby

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

• Use the medicine only in the nose.
• For hygiene reasons, the medicine packaging should be used by only one patient.
• Do not use for more than 3 to 5 days.
• Do not use the medicine more than 3 times a day.
• Do not use doses greater than those specified below.

1 dose of gel with a volume of 45 µl (microliter) contains 11.48 µg (microgram) of oxymetazoline hydrochloride.
Oxalin Baby nasal gel is intended for children over 1 year of age.
Children over 1 year of age to 6 years:
1 dose into each nostril 2 to 3 times a day.

Method of administration

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

Using a higher dose of Oxalin Baby than recommended

If a patient has used a higher dose than recommended (overdosed) or accidentally ingested the medicine, especially if a child has done so, contact a doctor immediately.
Seek medical attention immediately if the following symptoms occur:

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

In case of further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

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

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

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

Rare (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 (occurs after the effect of the medicine has worn off, as a symptom of so-called reactive hyperemia).

Using the medicine for a period longer 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 any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse.
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
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 medicine.

5. How to store Oxalin Baby

Store in a temperature below 25°C.
Store the bottle tightly closed.
Keep the medicine out of the sight and reach of 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 specified month.
Do not use the medicine after 12 weeks from the first opening of the bottle.
Medicines should not be disposed of via wastewater or household waste containers.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Package contents and other information

What Oxalin Baby contains

• The active substance of the medicine is oxymetazoline hydrochloride.
  1 g of gel contains 0.25 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 Baby looks like and what the package contains

Oxalin Baby is a colorless or light yellow, transparent or slightly opalescent thick 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 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
phone: +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 update of the leaflet:December 2024