Xylometazoline wzf 0.1%

Patient Information Leaflet

XYLOMETAZOLIN WZF 0.1%, 1 mg/ml, nasal drops, solution
Xylometazolini hydrochloridum
Please read all of this 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 patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 3 to 5 days, consult your doctor.

Leaflet Contents

1. What Xylometazolin WZF 0.1% is and what it is used for
2. Important information before using Xylometazolin WZF 0.1%
3. How to use Xylometazolin WZF 0.1%
4. Possible side effects
5. How to store Xylometazolin WZF 0.1%
6. Contents of the pack and other information

1. What Xylometazolin WZF 0.1% is and what it is used for

Xylometazolin WZF 0.1% is a nasal drop formulation containing xylometazoline hydrochloride as the active substance, belonging to a group of medicines called sympathomimetics.
When applied to the nasal mucosa, Xylometazolin WZF 0.1% reduces swelling and congestion, decreases mucus secretion, and facilitates drainage from the sinuses. As a result, it relieves the sensation of nasal and sinus congestion.
Xylometazolin WZF 0.1% is used:

• in acute viral or bacterial rhinitis (inflammation of the nasal mucosa),
• in acute or exacerbating chronic sinusitis,
• in allergic rhinitis,
• in acute otitis media (to clear the Eustachian tube in the ear).

2. Information before using Xylometazolin WZF 0.1%

When not to use Xylometazolin WZF 0.1%:

• If the patient is allergic (symptoms such as rash, facial and throat swelling, difficulty breathing) to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If the patient has had the pituitary gland removed or has undergone other neurosurgical procedures.
• If the patient has defects or changes in the nasal mucosa.

Warnings and precautions
Before starting treatment with Xylometazolin WZF 0.1%, consult a doctor or pharmacist.

• Discontinue use of the medicine if symptoms such as insomnia, dizziness, tremor, irregular heartbeat, or increased blood pressure occur. This is especially important for patients who previously experienced such symptoms after using similar medicinal products.
• The patient should consult a doctor before using the medicine if they have any of the following conditions:
• heart disease (e.g. long QT syndrome),
• high blood pressure,
• angina pectoris (chest pain during exertion) or other cardiovascular disorders,
• diabetes (elevated blood glucose),
• narrow-angle glaucoma (increased intraocular pressure),
• benign prostatic hyperplasia,
• hyperthyroidism.
• Xylometazolin WZF 0.1% should not be used for longer than 5 days, as prolonged use may lead to persistent changes in the nasal mucosa that are difficult to treat.

Xylometazolin WZF 0.1% and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient intends to use.

• Do not use Xylometazolin WZF 0.1% while being treated with antidepressant medicines known as tricyclic antidepressants or MAO inhibitors.

Concomitant use of Xylometazolin WZF 0.1% with medicines such as ephedrine or pseudoephedrine (components of cold medicines) should be avoided.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Xylometazolin WZF 0.1% should not be used during pregnancy.
Breastfeeding women should consult a doctor before using this medicine.
Driving and operating machinery
When Xylometazolin WZF 0.1% is used as directed in this leaflet, it usually does not affect the ability to drive or operate machinery.
However, if Xylometazolin WZF 0.1% is used for prolonged periods or in high doses, adverse effects described in section 4 (e.g. rapid and irregular heartbeat, increased blood pressure, headache, drowsiness) may occur. In such cases, driving and operating machinery should be avoided until these symptoms resolve.
Xylometazolin WZF 0.1% contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may cause nasal irritation or swelling, especially when used for prolonged periods.

3. How to use the medicine Xylometazolin WZF 0.1%

This medicine should always be used exactly as described in this patient leaflet or as advised by your
doctor. If in doubt, consult your doctor or pharmacist.

• The medicine should be used for nasal use only (also in cases of middle ear infection).
• For hygienic reasons, the medicine container should be used by only one patient.
• Do not use the medicine for longer than 3 to 5 days. If there is no improvement after 3 to 5 days, or if symptoms worsen, consult your doctor.
• Do not exceed the doses stated below.

Adults and adolescents over 12 years of age:
2 to 3 drops into each nostril every 8 to 10 hours. Do not administer more than 3 doses into
each nostril per day.

Use of a higher than recommended dose of Xylometazolin WZF 0.1%
If a patient has used more than the recommended dose (overdose) or has accidentally swallowed
the medicine, especially if a child has done so, seek immediate medical advice.
Seek immediate medical attention if any of the following symptoms occur, as they may indicate
an overdose or accidental oral ingestion by a child:

• rapid and irregular heartbeat,
• high blood pressure (symptoms: e.g. persistent, severe headache – especially in the back of the head; weakness, general malaise),
• drowsiness,
• irregular breathing or difficulty breathing,
• disturbances of consciousness,
• excessive sedation in children.

Missed dose of Xylometazolin WZF 0.1%
Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If the patient experiences allergic reactions such as swelling of the face, lips, tongue, or throat,
causing difficulty in breathing or swallowing, or shortness of breath, the use of the medicine must be discontinued
and medical advice must be sought immediately. Such reactions are very rare.
Uncommon (occurring in less than 1 in 100 people):

• nosebleeds.

Very rare (occurring in less than 1 in 10,000 people):

• nausea,
• headache,
• weakness,
• fatigue,
• drowsiness,
• visual disturbances,
• palpitations,
• rapid heartbeat,
• increased blood pressure (especially in patients with cardiovascular diseases).

The following may also occur: nasal irritation and dryness, burning sensation in the nose and throat, sneezing.
Prolonged use of the medicine beyond the recommended period and/or in doses higher than recommended may lead to persistent changes in the nasal mucosa that are difficult to treat.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 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 Xylometazolin WZF 0.1%

Store below 25°C.
Keep the bottle tightly closed in the outer packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the stated month.
After first opening the bottle, do not use the medicine for longer than 12 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Xylometazolin WZF 0.1% contains

• The active substance is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline hydrochloride. Each drop contains 0.05 mg of xylometazoline hydrochloride.
• The other ingredients are: disodium phosphate dodecahydrate; monosodium dihydrogen phosphate monohydrate; sodium chloride; sorbitol; disodium edetate; benzalkonium chloride, solution; purified water.

What Xylometazolin WZF 0.1% looks like and contents of the pack
Xylometazolin WZF 0.1% is a nasal drop solution in the form of a colourless or almost colourless,
transparent liquid.
The pack contains a polyethylene bottle with a dropper and a tamper-evident cap, containing 10 ml of solution, in a cardboard box.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Plant in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz