Xilometazolin Vzf 0,05%

Package Leaflet: Information for the Patient

XYLOMETAZOLIN WZF 0.05%, 0.5 mg/ml, Nasal Drops, Solution
Xylometazoline Hydrochloride

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or More Information, Ask your Pharmacist.
• If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor or Pharmacist. See Section 4.
• If there is no Improvement or you Feel Worse after 3 to 5 Days, Contact your Doctor.

Table of Contents of the Leaflet

• 1. What is Xylometazolin WZF 0.05% and what is it Used for
• 2. Important Information Before Using Xylometazolin WZF 0.05%
• 3. How to Use Xylometazolin WZF 0.05%
• 4. Possible Side Effects
• 5. How to Store Xylometazolin WZF 0.05%
• 6. Package Contents and Other Information

1. What is Xylometazolin WZF 0.05% and what is it Used for

Xylometazolin WZF 0.05% is a Medication in the Form of Nasal Drops, Containing Xylometazoline Hydrochloride as the Active Substance, Belonging to a Group of Medications Called Sympathomimetics.
Xylometazolin WZF 0.05% Applied to the Nasal Mucosa Reduces its Swelling and Congestion, Reduces the Amount of Secretion and Facilitates its Flow from the Sinuses. This Reduces the Feeling of a Stuffy Nose and Sinuses.
Xylometazolin WZF 0.05% is Used:

• for Acute Rhinitis Caused by Viruses or Bacteria,
• for Acute or Chronic Exacerbating Sinusitis,
• for Allergic Rhinitis,
• for Acute Otitis Media (to Open the Eustachian Tube in the Ear).

2. Important Information Before Using Xylometazolin WZF 0.05%

When not to Use Xylometazolin WZF 0.05%:

• If the Patient is Allergic (Symptoms, e.g., Rash, Swelling of the Face and Throat, Shortness of Breath) to Xylometazoline Hydrochloride or any of the other Ingredients of this Medication (Listed in Section 6).
• If the Patient has had their Pituitary Gland Removed or has Undergone other Neurosurgical Operations.
• If the Patient has Defects or Changes in the Nasal Mucosa.

Warnings and Precautions

Before Starting to Use Xylometazolin WZF 0.05%, Discuss it with your Doctor or Pharmacist.

• If, During the Use of the Medication in Children, Excitement or Difficulty Falling Asleep Occurs, it Should be Discontinued.
• If, During the Use of the Medication, Symptoms such as Insomnia, Dizziness, Tremors, Irregular Heartbeat, or Increased Blood Pressure Occur, the Medication Should be Discontinued. This Applies Especially to Patients who have Previously Experienced such Symptoms when Using other Similar Medications.
• The Patient Should Consult a Doctor Before Using the Medication if they have:
• Heart Disease (e.g., Long QT Syndrome),
• High Blood Pressure,
• Angina Pectoris (Symptoms: e.g., Chest Pain During Exercise) or other Cardiovascular Diseases,
• Diabetes (Increased Blood Sugar Levels),
• Glaucoma with Closed Angle (Increased Eye Pressure),
• Prostate Enlargement,
• Hyperthyroidism.
• The Medication is not Recommended for Children Under 2 Years of Age.
• Xylometazolin WZF 0.05% Should not be Used for More than 5 Days, as Prolonged Use may Cause Difficult-to-Treat Changes in the Nasal Mucosa.

Xylometazolin WZF 0.05% and other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking, have Recently Taken, or Plan to Take.

• Xylometazolin WZF 0.05% Should not be Used During Treatment with Antidepressant Medications Called Tricyclic Antidepressants and MAO Inhibitors.

It is Recommended to Avoid Taking Xylometazolin WZF 0.05% with Medications such as Ephedrine, Pseudoephedrine (which are Ingredients in Medications Used for the Common Cold).

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant or are Planning to have a Child, Consult your Doctor or Pharmacist Before Using this Medication.
Xylometazolin WZF 0.05% Should not be Used During Pregnancy.
Breastfeeding Women Should Consult a Doctor Before Using the Medication.

Driving and Operating Machinery

If Xylometazolin WZF 0.05% is Used as Described in this Leaflet, it Usually Does not Affect Driving or Operating Machinery.
If Xylometazolin WZF 0.05% is Used for a Long Time or in High Doses, Side Effects may Occur in the Patient, such as those Described in Section 4 (e.g., Rapid and Irregular Heartbeat, Increased Blood Pressure, Headache, Drowsiness). In this Case, do not Drive or Operate Machinery until these Symptoms have Resolved.

Xylometazolin WZF 0.05% Contains Benzalkonium Chloride

The Medication Contains 0.1 mg of Benzalkonium Chloride per ml of Solution. Benzalkonium Chloride may Cause Irritation or Swelling Inside the Nose, Especially if Used for a Long Time.

3. How to Use Xylometazolin WZF 0.05%

This Medication Should Always be Used Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist. If you are Unsure, Consult your Doctor or Pharmacist.

• The Medication Should be Used Exclusively for the Nose (also in the Case of Otitis Media).
• For Hygiene Reasons, the Medication Packaging Should be Used by one Patient Only.
• The Medication Should not be Used for More than 3 to 5 Days. If there is no Improvement or you Feel Worse after 3 to 5 Days, Consult your Doctor.
• Do not Use Higher Doses than those Specified Below.

Children Aged 2 to 12 Years:
1 to 2 Drops into Each Nostril Once or Twice a Day, Every 8 to 10 Hours. Do not Administer More than 3 Doses into Each Nostril per Day.

Using a Higher Dose of Xylometazolin WZF 0.05% than Recommended

If you have Used a Higher Dose than Recommended (Overdosed) or Accidentally Taken the Medication Orally, Especially if a Child has Done so, Contact your Doctor Immediately.
Seek Medical Attention Immediately if you Experience any of the Following Symptoms, as they may Indicate an Overdose or Accidental Ingestion by a Child:

• Rapid and Irregular Heartbeat,
• Increased Blood Pressure (Symptoms: e.g., Persistent, Severe Headache - Especially in the Back of the Head; Weakness, Malaise),
• Drowsiness,
• Irregular Breathing or Difficulty Breathing,
• Impaired Consciousness,
• Excessive Sedation in Children.

Missing a Dose of Xylometazolin WZF 0.05%

Do not Take a Double Dose to Make up for a Missed Dose.

4. Possible Side Effects

Like all Medications, Xylometazolin WZF 0.05% can Cause Side Effects, although not Everybody gets them.
If you Experience Allergic Reactions, such as Swelling of the Face, Lips, Tongue, Throat, Causing Difficulty Breathing or Swallowing, Shortness of Breath, Stop Using the Medication and Seek Medical Attention Immediately. Such Reactions are Very Rare.
Uncommon (Occurring in Less than 1 in 100 People):

• Nosebleeds.

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 People with Cardiovascular Diseases).

The Following may Also Occur: Irritation and Dryness in the Nose, Burning Sensation in the Nose and Throat, Sneezing.
Using the Medication for a Longer Period than Recommended and/or in Higher Doses than Recommended may Cause Difficult-to-Treat Changes in the Nasal Mucosa.

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Medication.

5. How to Store Xylometazolin WZF 0.05%

Store in a Temperature Below 25°C.
Keep the Bottle Tightly Closed in the Outer Packaging to Protect from Light.
Store the Medication out of Sight and Reach of Children.
Do not Use this Medication after the Expiry Date Stated on the Carton and Bottle after: EXP.
The Expiry Date Refers to the Last Day of the Specified Month.
After First Opening the Bottle, the Medication Should not be Used for More than 12 Weeks.
Medications Should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Xylometazolin WZF 0.05% Contains

• The Active Substance of the Medication is Xylometazoline Hydrochloride. Each ml of Solution Contains 0.5 mg of Xylometazoline Hydrochloride. Each Drop Contains 0.025 mg of Xylometazoline Hydrochloride.
• The other Ingredients are: Disodium Phosphate Dodecahydrate; Sodium Dihydrogen Phosphate Monohydrate; Sodium Chloride; Sorbitol; Disodium Edetate; Benzalkonium Chloride Solution; Purified Water.

What Xylometazolin WZF 0.05% Looks Like and what the Package Contains

Xylometazolin WZF 0.05% is a Nasal Drop in the Form of a Colorless or Almost Colorless, Clear Liquid.
The Packaging Contains a Polyethylene Bottle with a Dropper and a Tamper-Evident Cap, Containing 10 ml of Solution, in a Cardboard Box.

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Date of Last Update of the Leaflet:December 2024