Acatar Control

Package Leaflet: Information for the Patient

Acatar Control

0.5 mg/ml (0.05%), 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 the package leaflet for the patient or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

1.

What is Acatar Control and what is it used for

2.

Important information before using Acatar Control

3.

How to use Acatar Control

4.

Possible side effects

5.

How to store Acatar Control

6.

Contents of the package and other information

1. What is Acatar Control and what is it used for

The active substance of Acatar Control is oxymetazoline hydrochloride, which has a decongestant effect on the nasal mucosa.
Administration of Acatar Control reduces the swelling of the inflamed nasal mucosa and inhibits excessive secretion. This leads to the opening of the nasal passages, making it easier to breathe through the nose and reducing congestion. The reduction of nasal mucosa congestion also leads to the dilation and opening of the paranasal sinuses and the Eustachian tube, facilitating the removal of secretions and the healing of bacterial infections. The effect of the medicine starts within a few seconds after administration and lasts up to 12 hours.
Acatar Control is used in the treatment of nasal mucosa swelling, occurring in acute rhinitis, allergic rhinitis, sinusitis, otitis media, and Eustachian tube dysfunction.

2. Important information before using Acatar Control

When not to use Acatar Control

• if you are allergic (hypersensitive) to the active substance (oxymetazoline hydrochloride) or any of the other ingredients of Acatar Control;
• if you have atrophic rhinitis (dry rhinitis with crust formation).

Warnings and precautions

Before starting treatment with Acatar Control, you should discuss it with your doctor or pharmacist if you are:

• taking medicines that may increase blood pressure;
• have increased intraocular pressure, especially narrow-angle glaucoma;
• have severe cardiovascular diseases (e.g., coronary heart disease, hypertension);
• have a pheochromocytoma;
• have metabolic disorders (e.g., hyperthyroidism, diabetes);
• are elderly, due to the increased risk of enhanced systemic effects.

You should avoid using the medicine for longer than recommended and/or in doses higher than recommended.
Prolonged use of decongestant nasal sprays may lead to a decrease in their effectiveness. Misuse of nasal sprays can lead to atrophy of the nasal mucosa and reactive hyperemia (increased swelling of the nasal mucosa after the effect of the medicine has worn off, see section 4) with drug-induced rhinitis.

Children and adolescents

Acatar Control can only be used in adults and children over 6 years of age.

Acatar Control and other medicines

Taking tricyclic antidepressants or MAOIs (medicines used, among others, in depression) at the same time or immediately before using Acatar Control may cause an increase in blood pressure.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

When using medicines containing oxymetazoline for a longer period or in higher doses than recommended, it cannot be excluded that symptoms from the cardiovascular and central nervous systems may occur. In such cases, the ability to drive or operate machinery may be impaired.

Acatar Control contains benzalkonium chloride

The medicine contains 0.01 mg of benzalkonium chloride per dose, which corresponds to 0.2 mg/ml. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Acatar Control

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Acatar Control is intended for nasal use only.
One package of the medicine should not be used by more than one person.

Acatar Control should not be used in children under 6 years of age.

Children from 6 to 12 years of age:should be given one dose into each nostril 2 times a day.
Adults and children over 12 years of age:should be given one dose into each nostril 2 to 3 times a day.
Use for a short period of 3 to 5 days, not longer than 7 days. Do not use higher doses than recommended.

Instructions for use

Before the first use, the pump should be primed by pressing the pump several times until the first full spray appears.
Holding your head in an upright position (not tilting it back), you should place the tip of the applicator in the nostril, without completely blocking its opening. Then, quickly and firmly press the pump, while taking a gentle breath in through the nose.
After use, the pump should be cleaned. Using the pump by more than one person may contribute to the spread of infection.

Using a higher dose of Acatar Control than recommended

After overdose or accidental ingestion of the medicine, the following symptoms may occur:
pupil dilation, nausea, vomiting, cyanosis (blue discoloration of the skin and mucous membranes), fever, muscle cramps, tachycardia (rapid heart rate), arrhythmias, circulatory collapse (a state of acute circulatory failure associated with a sudden drop in blood pressure, manifested by severe weakness, often with loss of consciousness), cardiac arrest, increased blood pressure, pulmonary edema (fluid accumulation in the lungs, manifested by shortness of breath), respiratory disorders, and mental disorders. Additionally, the following may also occur:
central nervous system depression with drowsiness, decreased body temperature, bradycardia (slow heart rate), decreased blood pressure as in shock, apnea, and coma.

In case of using a higher dose of the medicine than recommended, you should immediately contact your doctor.

Missing a dose of Acatar Control

You should not take a double dose to make up for a missed dose.
If you have any further doubts about using the medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, oxymetazoline can cause side effects, although not everybody gets them.
Common side effects(occurring in more than 1 in 100 but less than 1 in 10 people using the medicine): burning sensation in the nasal mucosa, dryness of the nasal mucosa, and sneezing, especially in sensitive patients.
Uncommon side effects(occurring in more than 1 in 1000 but less than 1 in 100 people using the medicine): palpitations, rapid heart rate, and increased blood pressure after local, nasal administration of the medicine.
Rare side effects(occurring in more than 1 in 10,000 but less than 1 in 1000 people using the medicine): headaches, insomnia, fatigue, anxiety.
In rare cases, after the effect of the medicine has worn off, there may be an increase in nasal mucosa swelling (so-called reactive hyperemia).
Prolonged or frequent use of oxymetazoline, especially in higher doses than recommended, may lead to drug-induced rhinitis. It may occur after 5-7 days of treatment and, if the use of the medicine is continued, may result in permanent damage to the nasal mucosa.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist.
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
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 provide more information on the safety of the medicine.

5. How to store Acatar Control

The medicine should be kept out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
The shelf life after opening the package is 1 year. Do not use the medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Acatar Control contains

The active substance is oxymetazoline hydrochloride. One ml of solution contains 0.5 mg of oxymetazoline hydrochloride.
The other ingredients are: benzalkonium chloride, disodium edetate, propylene glycol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, purified water.
One dose of the spray contains no more than 0.025 mg of oxymetazoline hydrochloride.

What Acatar Control looks like and contents of the package

Acatar Control is a clear liquid.
Packaging: 15 ml solution in a bottle (HDPE) with a dosing pump (HDPE/PP/POM/LDPE/EVA/ stainless steel) and a nozzle (HDPE) in a cardboard box.

Marketing authorization holder:

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

Importer:

US Pharmacia Sp. z o.o.,
ul. Ziębicka 40,
50-507 Wrocław
To obtain more detailed information, you should contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, tel. +48 (22) 543 60 00.

Date of last revision of the leaflet: