XYLOMETAZOLINE sol 0.05% 10ml
Leaflet: patient information
XYLOMETHAZOLINE WZF 0.05% , nasal drops, solution
Xylometazoline hydrochloride
XYLOMETHAZOLIN WZF 0.05%, nasal drops, solution
Xylometazoline hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your pharmacist
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet.
- If you do not feel better or your condition worsens after 3-5 days, you should seek medical attention.
What this leaflet contains:
- What Xylometazoline WZF 0.05% is and what it is used for
- What you need to know before you take Xylometazoline WZF 0.05%
- How to take Xylometazoline WZF 0.05%
- Possible side effects
- How to store Xylometazoline WZF 0.05%
- Package contents and additional information
- What Xylometazoline WZF 0.05% is and what it is used for
Xylometazoline is an imidazoline derivative. It has a sympathomimetic effect. Applied to the mucous membrane of the nose, it causes constriction of blood vessels, removes edema, suppresses hyperemia of the mucous membrane of the nasopharynx and reduces the amount of secretion.
To reduce swelling of the nasal mucosa in acute runny nose, attacks of copious nasal discharge (vasomotor rhinitis), allergic runny nose (allergic rhinitis).
- What you need to know before you use Xylometazoline WZF 0.05%
Do not use Xylometazoline WZF 0.05%
- if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in item 6);
- if you have angle-closure glaucoma;
- if you have had a hypophysectomy or other cranial intervention
- if you have dry atrophic rhinitis (rhinitis sicca).
Warnings and precautions
Talk to your doctor or pharmacist before using Xylometazoline WZF 0.05%
- In small children - if agitation or sleep disturbances occur, the drug should be stopped;
- In patients in whom the following symptoms were observed after administration of sympathomimetics: insomnia, dizziness, tremors, arrhythmias or hypertension;
- In patients with circulatory disorders (arterial hypertension, angina pectoris), diabetes, glaucoma, prostatic hypertrophy, hyperthyroidism.
With prolonged use, there is a risk of atrophy of the nasal mucosa, and therefore the application is limited to 7 days.
Warnings in special populations using the drug
Use of Xylometazoline WZF 0.05% in children:
Do not use in children under 2 years of age.
For children under 6 years of age, the drug is prescribed by a doctor with a prescription.
Other medicines and Xylometazoline WZF 0.05%
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Do not administer the product during treatment with tricyclic antidepressants or MAO inhibitors (medicines used to treat depression), due to reports of rare cases of interactions. Concomitant use with other sympathomimetics (ephedrine, pseudoephedrine) should be avoided.
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Due to the lack of indicative studies on the effects of the product on the fetus and since it is not known whether the medicinal substance is excreted in breast milk, it should not be used during pregnancy and breastfeeding.
Driving and using machines:
The product is intended for short-term treatment, but with long-term use and in high doses, systemic effects on the cardiovascular system are not excluded, which may impair the ability to drive and operate machinery.
Xylometazoline WZF 0.05% contains benzalkonium chloride
Since the drug contains benzalkonium chloride, the treatment may cause local irritation of the nasal mucosa.
- How to use Xylometazoline WZF 0.05%
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Each drop contains 0.025 mg xylometazoline hydrochloride.
Children from 2 to 12 years
Locally, 1 - 2 drops of 0.05% solution in each nostril 1 - 2 times a day.
Re-use should be carried out only in case the treatment is interrupted for several days.
Treatment should not last more than 3-5 days without consulting a doctor.
Do not apply doses higher than recommended.
For hygienic reasons, one package should only be used by one patient.
If you take more Xylometazoline WZF 0.05% than you should
A significant overdose or accidental oral intake of the product, especially by children, can cause drowsiness, visual disturbance, headache, nervousness, irregular heartbeat, insomnia.
Long-term use can lead to treatment-resistant secondary rhinitis (rhinitis medicamentosa).
In case of overdose, a doctor's consultation is necessary.
Symptomatic treatment is carried out according to the appointment of the doctor. Gastric lavage is done only in case of accidental oral ingestion.
- Possible adverse drug reactions and
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Side effects may be: very common (affects more than 1 in 10 people), common (affects ≥ 1/100 to < 1/10 people), uncommon (affects ≥ 1/1000 to < 1/100 people), rare (affecting ≥ 1/10,000 to < 1/1,000 people), very rare (affecting < 1/10,000 people), with an unknown frequency (cannot be estimated from the available data).
General disorders and those related to nasal administration:
Rare: local irritation, burning, unpleasant dryness of the nasal mucosa;
Very rare: weakness, malaise.
Respiratory and chest disorders
Rare: sneezing.
Disorders of the nervous system
Very rare: headache, drowsiness or pronounced sedation after overdose.
Disorders of the cardiovascular system
Rare: palpitations, increase in blood pressure.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system listed in the Medicines Executive Agency
8 Damyan Gruev St
1303, Sofia
Phone: +35 928903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
- How to store Xylometazoline WZF 0.05%
Keep out of the reach of children.
To be stored below 25°C. Keep away from light.
Shelf life after opening the package - 12 weeks.
Do not use this medicine after the expiry date which is stated on the pack.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
- Contents of the package and additional information
What Xylometazoline WZF 0.05% contains
- The active substance is xylometazoline hydrochloride . Each ml of the solution contains 0.5 mg xylometazoline hydrochloride.
- Other ingredients are: Sodium dihydrogen phosphate .H2O, disodium hydrogen phosphate .12 H2O, sodium chloride, sorbitol, disodium-EDTA, benzalkonium chloride, purified water.
What Xylometazolin WZF 0.05% looks like and contents of the pack
Polyethylene bottle (10 ml) with a pipette and a cap with a guarantee ring. Each vial is placed in a cardboard box with the necessary markings and a leaflet.
Marketing Authorization Holder and Manufacturer
Warsaw Pharmaceutical Works Polfa SA,
22/24 Karolkowa Str.; 01-207 Warsaw, Poland.
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
"Z.F. POLPHARMA S.A. - "Bulgaria" branch
"Simeonovsko Shose" St., No. 85, Floor 3, Office 3, Studentski Grad
Sofia 1734, Bulgaria
Phone: 02/4400843
Date of last revision of leaflet
