Sinuzolin

Package Leaflet: Information for the Patient

Sinuzolin, 0.5 mg/ml, Nasal Drops, 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 directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet

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

1. What is Sinuzolin and what is it used for

Sinuzolin contains the active substance oxymetazoline hydrochloride, which is a local vasoconstrictor that relieves congestion of the nasal mucosa and sinuses.
Sinuzolin is used for the symptomatic treatment of acute rhinitis, allergic rhinitis, and vasomotor rhinitis, as well as for the treatment of sinusitis and otitis media in combination with rhinitis.
Sinuzolin is used to reduce swelling of the mucous membranes for diagnostic purposes.
Sinuzolin in the form of nasal drops is intended for use in adults and children over 6 years of age.
If there is no improvement after 7 days or the patient feels worse, they should consult their doctor.

2. Important information before using Sinuzolin

When not to use Sinuzolin:

• if the patient is allergic to oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if the patient has inflammation or skin changes around the nostrils or nasal mucosa (atrophic rhinitis).
• in patients after transsphenoidal surgery or other surgical procedures involving exposure of the dura mater.

Sinuzolin should not be used if any of the above situations apply to the patient.
In case of doubt, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting to use Sinuzolin, the patient should discuss with their doctor if any of the following points apply to them:

• very high blood pressure,
• severe heart disease or blood vessel disease,
• metabolic disorders (diabetes, hyperthyroidism),
• pheochromocytoma,
• prostatic hyperplasia (enlargement of the prostate gland),
• porphyria (a metabolic disorder),
• increased intraocular pressure, especially in the case of narrow-angle glaucoma,
• if the patient is taking medicines for depression or Parkinson's disease known as monoamine oxidase inhibitors (MAOIs) or other medicines that may increase blood pressure.

Sinuzolin should not be used for more than 7 days, as the nasal mucosa may become congested again after stopping prolonged use of this medicine. This is called rebound effect.
Prolonged use of Sinuzolin may also cause drug-induced rhinitis. If symptoms worsen or do not improve after 7 days, the patient should contact their doctor. Do not exceed the recommended dose.

Children and adolescents

Before giving Sinuzolin to a child, the patient should consult their doctor or pharmacist.
Sinuzolin should not be used in children under 6 years of age.

Sinuzolin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should tell their doctor if they are taking:

• certain medicines used for depression: monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants.

The patient should ask their doctor or pharmacist if they are unsure whether they are taking any of these medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using Sinuzolin.
Sinuzolin should not be used during pregnancy or breastfeeding, unless the doctor considers it necessary.

Driving and using machines

Using preparations containing oxymetazoline in excessive doses or for a longer period may lead to systemic cardiovascular symptoms. In such cases, the ability to drive vehicles and operate machinery may be impaired.

Sinuzolin contains benzalkonium chloride

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
The medicine contains approximately 0.02 mg of benzalkonium chloride per milliliter of solution.

3. How to use Sinuzolin

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

Adults and children over 6 years of age:

The recommended dose is 1-2 drops into each nostril, 2 to 3 times a day, as needed.
Sinuzolin should not be used more than 3 times a day in each nostril.
Sinuzolin nasal drops are intended for short-term use (usually 3 to 5 days). Do not use this medicine for more than 7 days, unless the doctor has advised otherwise.

Use in children

Before giving Sinuzolin to a child in the form of nasal drops, the patient should consult their doctor or pharmacist. Sinuzolin should not be used in children under 6 years of age.

Method of administration

Intranasal administration.

Using more than the recommended dose of Sinuzolin

In case of overdose, the patient should immediately contact their doctor or the nearest hospital. The patient should take the package of this medicine with them so that the doctor knows which medicine was taken.

Missing a dose of Sinuzolin

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sinuzolin can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

• Palpitations, increased heart rate (tachycardia), increased blood pressure.

Rare side effects (may affect up to 1 in 1,000 people):

• Headache, anxiety, difficulty sleeping, fatigue, drowsiness, sedation.
• Rebound congestion of the nasal mucosa after stopping the use of the medicine (see also section "Warnings and precautions").

Prolonged use of Sinuzolin nasal drops may cause inflammation or skin changes around the nostrils or in the nasal mucosa (atrophic rhinitis).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sinuzolin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after: EXP. The expiry date refers to the last day of the month.
After first opening, do not use for more than 1 year.
After first opening, store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sinuzolin contains

• The active substance of Sinuzolin is oxymetazoline hydrochloride. 1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride.
• The other ingredients are: citric acid monohydrate, sodium citrate, glycerol, benzalkonium chloride, water for injections.

What Sinuzolin looks like and contents of the pack

Sinuzolin is a clear, colorless or slightly yellowish solution.
The medicine is available in a 10 ml polyethylene bottle with a dropper and a tamper-evident cap, in a cardboard box.

Marketing authorization holder:

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06

Importer:

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sinuzolin: Poland
Date of last revision of the leaflet:May 2025
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: www.urpl.gov.pl