Acatar care kids

Package leaflet: Information for the patient

Acatar Care Kids
0.25 mg/mL, nasal spray, solution
Oxymetazolini hydrochloridum
Please read carefully the entire 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 according to
the instructions given by the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• 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 doctor or pharmacist. See section 4.
• If there is no improvement after 5–7 days, or if you feel worse, contact your doctor.

Table of contents

1. What Acatar Care Kids is and what it is 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 pack and other information

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

Acatar Care Kids contains oxymetazoline hydrochloride as the active substance, which constricts blood vessels. Administration of Acatar Care Kids reduces swelling of the inflamed mucous membrane and inhibits excessive secretion, thereby facilitating free nasal breathing. Reduction of nasal mucosal congestion also opens and widens the drainage pathways of the paranasal sinuses and unblocks the Eustachian tubes. This facilitates the removal of mucus and helps resolve bacterial infection.
Acatar Care Kids is indicated for mucosal edema occurring in acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and otitis media.
The effect of oxymetazoline begins within minutes after administration and lasts up to 12 hours.
Acatar Care Kids contains sodium hyaluronate as an excipient, 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 nasal mucositis (inflammation of the nasal mucosa with formation of crusts);
• if the patient has hypersensitivity to oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6). 1/5
• if the patient has undergone surgery performed through the nose, e.g. removal of the pituitary gland or surgery involving exposure of the dura mater (brain surgery performed through the nose or mouth).

Acatar Care Kids may be used with particular caution and only after careful consideration by a physician of the benefits and risks in the following cases:

• treatment with monoamine oxidase inhibitors (MAO inhibitors) and other medicines which may increase blood pressure;
• increased intraocular pressure, especially in cases of closed-angle glaucoma;
• severe cardiovascular diseases (e.g. ischemic heart disease, arterial hypertension);
• pheochromocytoma;
• metabolic disorders (e.g. hyperthyroidism, diabetes).

Warnings and precautions

The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to prolonged use or overdosing. This may lead to the need for increasingly higher doses or more frequent administration of the medicine, which in turn may result in continuous use of the medicine. In cases of prolonged use or misuse, the treatment should be immediately discontinued.

Continuous use of the medicine may lead to breathing difficulties caused by reactive hyperemia of the nasal mucosa (rebound effect) and chronic medicamentosa rhinitis (rhinitis medicamentosa), as well as atrophy of the mucosa or dry inflammation of the nasal mucosa (rhinitis sicca). The rebound effect and tachyphylaxis should resolve after discontinuation of the medicine.

Similarly, misuse of topically applied nasal medicines may lead to atrophy of the mucosa and reactive hyperemia with medicamentosa rhinitis (rhinitis medicamentosa). Prolonged use beyond the recommended duration and overdosing should be avoided.

Children

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

Acatar Care Kids and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Concomitant use of medicines containing oxymetazoline, such as Acatar Care Kids, with certain antidepressant medicines, such as tranylcypromine-type MAO inhibitors and tricyclic or tetracyclic antidepressants, 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 have a child, she should consult a doctor or pharmacist before using this medicine.

Caution should be exercised when using this medicine during pregnancy or breastfeeding. The recommended dose should not be exceeded.

Driving and operating machinery

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

In case of use by adults, it should be considered that during prolonged use or use in doses higher than recommended, systemic effects affecting the cardiovascular system and central nervous system may occur. In such cases, the ability to drive motor vehicles or 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 this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Acatar Care Kids is intended for nasal use only (including in cases of eustachian tube inflammation and middle ear inflammation).
The medicine package 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 of age.
This medicine must not be used in infants during their first year of life.
Children over 1 year of age up to 6 years of age
1 dose of Acatar Care Kids aerosol into each nostril 2 to 3 times daily.
This medicine should not be used for longer than 5 to 7 days.

Instructions for use of the medicine
Before first use, press the pump several times to obtain a full dose.
Keep the head in an upright position (do not tilt backwards) and insert the applicator tip into the nostril, without completely blocking the nasal passage.
Direct the nozzle away from the nasal septum (the wall between the nostrils)—that is, in the right nostril, point the nozzle toward the right eye, and in the left nostril, toward the left eye.

Then press the dispenser quickly and firmly while simultaneously inhaling gently through the nose.
Do not spray the aerosol directly onto the nasal septum, as this may cause damage to the nasal mucosa.

After use, clean the dispenser. Using the dispenser by more than one person may contribute to the spread of infection.

Use of a higher than recommended dose of Acatar Care Kids
In case of overdose or accidental ingestion, the following symptoms may occur: pupil dilation, nausea, vomiting, cyanosis (bluish discoloration of the skin and mucous membranes), fever, muscle spasms, tachycardia (increased heart rate), cardiac arrhythmia, circulatory collapse (sudden deterioration in blood circulation, cardiac arrest),
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elevated blood pressure, pulmonary edema (fluid accumulation in the lungs, manifesting, among others, as shortness of breath), respiratory disturbances, and mental disturbances.
Additionally, central nervous system depression, drowsiness, decreased body temperature, bradycardia (slowed heart rate), sudden drop in blood pressure as seen in shock, apnea, and coma may occur.
If a higher than recommended dose of the medicine has been taken, seek medical advice immediately.

Missed dose of Acatar Care Kids
Do not use a double dose to make up for a missed dose.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Acatar Care Kids can cause adverse effects, although not everyone experiences them.
The frequency of adverse effects is classified as follows:
Common (may occur in fewer than 1 in 10 people): burning or dryness of the nasal mucosa, sneezing, especially in sensitive patients.
Uncommon (may occur in fewer than 1 in 100 people): systemic symptoms such as palpitations, increased heart rate, and elevated blood pressure, occurring after local (nasal) administration of the medicine.
Rare (may occur in fewer than 1 in 1,000 people): headache, insomnia, or fatigue.
In rare cases, after the effect of the medicine wears off, there may be a worsening of nasal mucosal swelling (so-called rebound congestion).
Prolonged or frequent use, as well as use of doses higher than recommended, of Acatar Care Kids may lead to rebound congestion and drug-induced inflammation of the nasal mucosa. Such effects may occur as early as after 5–7 days of treatment and, if the medicine is continued, may result in permanent damage to the nasal mucosa.
Long-term use or abuse of oxymetazoline may also lead to reduced effectiveness of the medicine (tachyphylaxis) (frequency unknown – frequency cannot be determined from available data).
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 4921301, fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorization holder.
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Reporting adverse effects allows the collection of additional information on the safety of using the medicine.

5. How to store Acatar Care Kids

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
The shelf life of Acatar Care Kids after first opening the container is 12 months.
Do not use Acatar Care Kids after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Acatar Care Kids contains
The active substance 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.
One 45 microlitre dose of aerosol contains 11.25 micrograms of oxymetazoline hydrochloride.
What Acatar Care Kids looks like and contents of the pack
A clear, colourless solution.
HDPE bottle containing 15 mL of solution, with a dosing pump made of HDPE, LDPE/PP, PTFE/PET (in
APF system), and a cap made of LDPE, in a cardboard box.
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
Poland
Manufacturer
Lomapharm GmbH
Langes Feld 5
Emmerthal, Lower Saxony, 31860
Germany
For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
tel. +48 (22) 543 60 00
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