Package leaflet: Information for the patient

Sinuzolin, 0,5 mg/ml, nasal drops, solution
Oxymetazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed 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 7 days, or if you feel worse, consult your doctor.

Table of contents

What Sinuzolin is and what it is used for
Important information before using Sinuzolin
How to use Sinuzolin
Possible side effects
How to store Sinuzolin
Contents of the pack and other information

1. What Sinuzolin is and what it is used for

Sinuzolin contains the active substance oxymetazoline hydrochloride, which is a local
vasoconstrictor that relieves inflammation-related congestion of the nasal and sinus mucous membranes.
Sinuzolin is used for symptomatic treatment of acute rhinitis, allergic rhinitis, vasomotor rhinitis,
sinusitis, and otitis in association with rhinitis.
Sinuzolin may also be used to reduce mucosal swelling for diagnostic purposes.
Sinuzolin nasal drops are intended for use in adults and children over 6 years of age.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. 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 conditions around the nostrils or nasal mucosa (atrophic rhinitis);
in patients who have undergone transsphenoidal removal of the pituitary gland or other surgical procedures involving exposure of the meninges.

Do not use Sinuzolin if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting to use Sinuzolin, discuss with a doctor if any of the following apply to the patient:

very high blood pressure;
severe heart or vascular disease;
metabolic disorders (diabetes, hyperthyroidism);
pheochromocytoma;
prostate enlargement (of the prostate gland);
metabolic disorder (porphyria);
increased intraocular pressure, especially in cases of closed-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 longer than 7 days, as nasal mucosal congestion may recur after stopping prolonged use of this medicine. This is known as rebound congestion.
Prolonged use of Sinuzolin may also cause drug-induced rhinitis. If symptoms worsen or do not improve after 7 days, contact a doctor. Do not exceed the recommended dose.
Children and adolescents
Consult a doctor or pharmacist before giving Sinuzolin to a child.
Sinuzolin should not be used in children under 6 years of age.
Sinuzolin and other medicines
Tell the 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.
In particular, inform the doctor if the patient is taking:

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

Ask a doctor or pharmacist if unsure whether the patient is taking any of these medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use Sinuzolin during pregnancy or breastfeeding unless advised by a doctor.
Driving and operating machinery
Using preparations containing oxymetazoline in excessive doses or for prolonged periods may lead to systemic cardiovascular effects. In such cases, the ability to drive or 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 millilitre of solution.

3. How to use Sinuzolin

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 a 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 daily, as needed.
Doses of Sinuzolin should not be administered more frequently than 3 times per day into each nostril.
Sinuzolin nasal drops are intended for short-term use only (usually 3 to 5 days). Do not use this medicine for longer than 7 days unless otherwise advised by a doctor.
Use in children
Before administering Sinuzolin nasal drops to a child, consult a doctor or pharmacist. Do not use Sinuzolin in children under 6 years of age.
Method of administration
For nasal use.
Overdose of Sinuzolin
If more than the recommended dose is taken, seek immediate medical advice from a doctor or the nearest hospital. Take the medicine’s packaging with you so the doctor knows which medicine has been taken.
Missed dose of Sinuzolin
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Common adverse effects (may occur in less than 1 in 10 people):

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

Uncommon adverse effects (may occur in less than 1 in 100 people):

Palpitations, increased heart activity (tachycardia), increased blood pressure.

Rare adverse effects (may occur in less than 1 in 1000 people):

Headache, anxiety, difficulty sleeping, fatigue, drowsiness, sedation.
Rebound nasal mucosa congestion after discontinuation 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 of adverse effects

If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Sinuzolin

Keep this medicine 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 stated month. After first opening, do not use for longer than 1 year.
After first opening, store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sinuzolin contains

The active substance is oxymetazoline hydrochloride. 1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride.
The other components 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, colourless or slightly yellowish solution.
The medicine is available in a polyethylene bottle containing 10 ml of solution, with a dropper and a cap with a tamper-evident seal, packed in a cardboard box.
Marketing Authorisation Holder: Importer:
Farmak International Sp. z o.o. Farmak International Sp. z o.o.
ul. Koszykowa 65 ul. Chełmżyńska 249
00-667 Warsaw 04-458 Warsaw
tel. +48 22 822 93 06
This medicinal product is authorised in the European Economic Area countries under the following names:
Sinuzolin: Poland
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