Acatar Care Kids

Package Leaflet: Information for the Patient

Acatar Care Kids

0.25 mg/mL, nasal spray, solution
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 this package leaflet for the patient or as advised by
the doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 5-7 days, the doctor should be contacted.

Table of Contents of the Package Leaflet

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

1. What is Acatar Care Kids and what is it used for

Acatar Care Kids contains the active substance oxymetazoline hydrochloride, which narrows
blood vessels. The administration of Acatar Care Kids reduces the swelling of the inflamed mucous membrane and inhibits excessive secretion, making it easier to breathe through the nose. The reduction of nasal mucosal congestion also leads to the opening and dilation of the paranasal sinuses and unclogs the Eustachian tubes. This facilitates the removal of secretions and the healing of bacterial infections.
Acatar Care Kids is used in the treatment of nasal mucosal swelling that occurs in acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and middle ear inflammation.
The effect of oxymetazoline occurs within a few minutes after administration and lasts up to 12 hours.
Acatar Care Kids also contains the excipient sodium hyaluronate, which protects and moisturizes the nasal mucosa.
Acatar Care Kids does not contain preservatives

2. Important information before using Acatar Care Kids

When not to use Acatar Care Kids

• if the patient has dry rhinitis (rhinitis with the formation of crusts);
• if the patient is allergic to oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6). 1/5
• if the patient has undergone nasal surgery, e.g., removal of the pituitary gland or surgery involving the exposure of the dura mater (brain surgery performed through the nose or mouth). Acatar Care Kids may be used with caution and only after careful consideration by the doctor of the benefits and risks in the case of:
• treatment with monoamine oxidase inhibitors (MAOIs) and other medicines that may increase blood pressure;
• increased intraocular pressure, especially in the case of angle-closure glaucoma;
• severe heart and blood vessel diseases (e.g., coronary heart disease, hypertension);
• pheochromocytoma;
• metabolic disorders (e.g., hyperthyroidism, diabetes).

Warnings and precautions

The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to their prolonged use or overdose. This can lead to the use of increasingly larger doses or more frequent use of the medicine, which in turn can result in permanent use of the medicine. In the case of prolonged use or abuse of the medicine, its use should be stopped immediately.
Permanent use of the medicine can lead to a breathing difficulty caused by reactive nasal mucosal congestion (rebound effect) and chronic, drug-induced rhinitis (rhinitis medicamentosa), as well as atrophy of the nasal mucosa or dry rhinitis (rhinitis sicca). The rebound effect and tachyphylaxis should resolve after discontinuation of the medicine.
Similarly, the abuse of locally applied nasal medicines can lead to atrophy of the nasal mucosa and reactive nasal congestion with drug-induced rhinitis (rhinitis medicamentosa). The use of the medicine for longer than recommended or in excess should be avoided.

Children

Acatar Care Kids is intended for use in children over 1 year of age up to 6 years.

Acatar Care Kids and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The use of medicines containing oxymetazoline, such as Acatar Care Kids, simultaneously with certain medicines used in depression, such as MAOIs of the tranylcypromine type and tricyclic or tetracyclic antidepressants, may lead to an increase in blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Caution should be exercised when using the medicine during pregnancy or breastfeeding. The recommended dose should not be exceeded.

Driving and using machines

Acatar Care Kids is intended for use in children over 1 year of age up to 6 years.
In the case of adult use of the medicine, it should be taken into account that the use of oxymetazoline for a long period or in doses larger than recommended may lead to systemic effects on the cardiovascular and central nervous systems. In such cases, the ability to drive vehicles and operate machinery may be impaired.
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3. How to use Acatar Care Kids

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by
the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Acatar Care Kids is intended for nasal use only (also in Eustachian tube inflammation and middle ear inflammation).
The medicine packaging should be used by only one person.
Acatar Care Kids may only be administered to children over 1 year of age up to 6 years.
The medicine should not be used in infants under 1 year of age.
Children over 1 year of age up to 6 years
1 dose of Acatar Care Kids aerosol into each nostril 2 to 3 times a day.
The medicine should not be used for longer than 5 to 7 days.

Instructions for using the medicine

Before the first use, the pump should be pressed several times to obtain a full dose.
Holding the head in an upright position (not tilting it back) the applicator tip should be placed in the nostril, without completely blocking its opening.
The dosing nozzle should be directed away from the nasal septum (the wall between the nostrils)
toward the eye on the same side, i.e., in the right nostril toward the right eye, and in the left nostril toward the left eye.

Then the dosing nozzle should be pressed quickly and firmly, while taking a gentle breath in through the nose.

The aerosol should not be sprayed directly onto the nasal septum, as this may cause damage to the nasal mucosa.

After use, the dosing nozzle should be cleaned. Using the dosing nozzle by more than one person may contribute to the spread of infection.

Using a higher dose of Acatar Care Kids than recommended

In the case of overdose or accidental ingestion of the medicine, the following symptoms may occur: dilated pupils, nausea, vomiting, cyanosis (blue discoloration of the skin and mucous membranes), fever, muscle spasms, tachycardia (rapid heart rate), arrhythmia, circulatory collapse (sudden decrease in blood circulation, cardiac arrest, increased blood pressure, pulmonary edema (fluid accumulation in the lungs, manifested by shortness of breath), respiratory disorders, mental disorders.
Additionally, there may be a decrease in the activity of the central nervous system, drowsiness, decreased body temperature, bradycardia (slow heart rate), sudden drop in blood pressure as in shock, apnea, and coma.

In the case of using a higher dose of the medicine than recommended, the doctor should be consulted immediately.

Missing a dose of Acatar Care Kids

A double dose should not be used to make up for a missed dose.
In case of doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Acatar Care Kids can cause side effects, although not everybody gets them.
The frequency of side effects has been classified as follows:
Common(may occur in up to 1 in 10 people): burning or dryness of the nasal mucosa,
sneezing, especially in sensitive patients.
Uncommon(may occur in less than 1 in 100 people): systemic effects, such as rapid heart rate and increased blood pressure, occurring after local (nasal) use of the medicine.
Rare(may occur in less than 1 in 1,000 people): headache, insomnia or fatigue.
In rare cases, after the effect of the medicine has worn off, there may be an exacerbation of nasal mucosal congestion (so-called reactive nasal congestion).
Prolonged or frequent use, as well as the use of higher doses of Acatar Care Kids, may lead to reactive nasal congestion with drug-induced rhinitis. Such an effect may occur after 5-7 days of treatment and, in the case of continued use of the medicine, may lead to permanent damage to the nasal mucosa.
Long-term use or abuse of oxymetazoline may also lead to a decrease in the effectiveness of the medicine (tachyphylaxis) (unknown frequency of occurrence - frequency cannot be determined based on available data).
If any of the side effects worsen or any side effects not listed in the package leaflet occur, the doctor or pharmacist should be informed.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 4921301, fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
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Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Acatar Care Kids

The medicine should be stored out of sight and reach of children.
There are no special precautions for the storage of the medicine.
The shelf life of Acatar Care Kids after the first opening of the packaging is 12 months.
Acatar Care Kids should not be used 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. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Contents of the package and other information

What Acatar Care Kids contains

The active substance of the medicine is oxymetazoline hydrochloride. 1 mL of solution contains 0.25 mg of oxymetazoline hydrochloride.
The other ingredients are: glycerol 85%, sodium citrate, citric acid monohydrate, sodium hyaluronate,
hydrochloric acid 25% (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
1 dose of Acatar Care Kids aerosol with a volume of 45 microliters contains 11.25 micrograms of oxymetazoline hydrochloride.

What Acatar Care Kids looks like and what the package contains

Clear, colorless solution.
HDPE bottle containing 15 mL of solution, with a dosing pump made of HDPE, LDPE/PP, PTFE/PET (in the APF system), and a cap made of LDPE, in a cardboard box.

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Lomapharm GmbH
Langes Feld 5
Emmerthal, Niedersachsen, 31860
Germany

For more detailed information, please contact:

USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
phone: +48 (22) 543 60 00
Date of the last update of the package leaflet:March 2022
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