Xylometazoline nasal drops 0.1% 10 ml Polpharma

XYLOMETAZOLINE WZF 0.1% nasal drops, solution
Xylometazoline hydrochloride
 
XYLOMETAZOLIN WZF 0.1% 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 includes any possible side effects not listed in this leaflet. See section 4.
– If you do not feel better or your condition worsens after 3-5 days, you should seek medical attention.
 
 
What this leaflet contains:
1. What Xylometazoline WZF 0.1% is and what it is used for
2. What you need to know before you take Xylometazoline WZF 0.1%
3. How to take Xylometazoline WZF 0.1%
4. Possible side effects
5. How to store Xylometazoline WZF 0.1%
6. Contents of the pack and other information
 
 
1. What Xylometazoline WZF 0.1% is and what it is used for
 
Xylometazoline is an imidazoline derivative. It has a sympathomimetic effect. When applied to the nasal mucosa, it causes blood vessel constriction, eliminates edema, suppresses hyperemia of the nasopharyngeal mucosa, and reduces the amount of secretion.
To reduce swelling of the nasal mucosa in acute rhinitis, attacks of profuse nasal discharge (vasomotor rhinitis), allergic rhinitis (allergic rhinitis).
 
 
2. What you need to know before you use Xylometazoline WZF 0.1%
 
Do not use Xylometazoline WZF 0.1%
– if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
– if you have angle-closure glaucoma;
– if you have undergone a hypophysectomy or other cranial intervention;
– if you have dry atrophic rhinitis (rhinitis sicca).
 
Warnings and precautions
Talk to your doctor or pharmacist before taking Xylometazoline WZF 0.1%,
– if you suffer from heart disease (e.g. long QT syndrome).
– in patients in whom the following symptoms have been observed after administration of sympathomimetics: insomnia, dizziness, tremor, arrhythmias or hypertension.
– in patients with circulatory disorders (arterial hypertension, angina pectoris), diabetes, angle-closure glaucoma, prostatic hypertrophy, hyperthyroidism.
In young children – if agitation or sleep disturbances occur, the medication should be stopped.
 
                With prolonged use, there is a risk of atrophy of the nasal mucosa, and therefore use is limited to 7 days.
               
                Use in children:
                Do not use in children under 2 years of age.
               
                Other medicines and Xylometazoline WZF 0.1%
                Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
                Do not use 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, breastfeeding 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 conclusive studies on the effects of the product on the fetus and because it is not known whether the drug 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 prolonged use and in high doses, systemic effects on the cardiovascular system cannot be ruled out, which may impair the ability to drive and operate machinery.
 
Xylometazoline WZF 0.1% contains benzalkonium chloride
This medicine contains 0.1 mg benzalkonium chloride in each ml. Benzalkonium chloride may cause irritation or swelling of the nasal mucosa, especially if used for a long time.
 
 
3. How to use Xylometazoline WZF 0.1%
 
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 0.05 mg of xylometazoline hydrochloride.
 
Children over 12 years old and adults
Topically, 2-3 drops of 0.1% solution in each nostril 2-3 times daily.
 
Re-use should only be done if treatment has been interrupted for several days.
Treatment should not continue for more than 3-5 days without consulting a doctor.
Do not apply doses higher than recommended.
 
For hygiene reasons, one pack should only be used by one patient.
 
If you take more Xylometazoline WZF 0.1% than you should
Significant overdose or accidental oral ingestion of the product, especially by children, may cause drowsiness, visual disturbances, headache, nervousness, irregular heartbeat, insomnia.
Long-term use may lead to secondary rhinitis resistant to treatment (rhinitis medicamentosa).
In case of overdose, a doctor's consultation is necessary.
Symptomatic treatment is carried out according to the doctor's prescription. Gastric lavage is performed only in case of accidental oral ingestion.
 
4. Possible side effects
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.
 
                Uncommon side effects (may affect up to 1 in 100 people):
– nosebleed.
 
Rare side effects (may affect up to 1 in 1,000 people):
– local irritation, burning, unpleasant dryness of the nasal mucosa;
– sneezing.
 
Very rare side effects (may affect up to 1 in 10,000 people):
– weakness, nausea;
– headache, drowsiness or pronounced sedation after overdose;
– palpitations, increased blood pressure.
 
                Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Medicines Executive Agency.
8 Damyan Gruev Street
1303, Sofia
Tel.: +35 928903417
website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
 
 
5. How to store Xylometazoline WZF 0.1%
 
Keep out of the reach of children.
 
Store below 25°C. Protect from light.
Shelf life after opening the package – 12 weeks.
Do not use this medicine after the expiry date which is stated on the packaging.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
 
6. Contents of the pack and other information
 
What Xylometazoline WZF 0.1% contains
– The active substance is xylometazoline hydrochloride. Each ml of the solution contains 1.0 mg xylometazoline hydrochloride.
– The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, sorbitol, disodium edetate, benzalkonium chloride, purified water.
 
What Xylometazoline WZF 0.1% looks like and contents of the pack
Polyethylene vial (10 ml) with pipette and cap with protective ring. Each vial is placed in a cardboard box with the necessary markings and a leaflet.
 
Permit holder
Warsaw Pharmaceutical Works Polfa SA.
22/24 Karolkowa Str., 01-207 Warsaw, Poland
              
Use and manufacturer
Warsaw Pharmaceutical Works Polfa SA.
22/24 Karolkowa Str., 01-207 Warsaw, Poland
               
Zakłady Farmaceutyczne POLPHARMA SA.
Medan Branch in Sieradz
street Władysława Łokietka 10, 98-200 Sieradz, Poland
               
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
„"Z.F. POLPHARMA S.A. - Branch "Bulgaria"„
85 Simeonovsko Shose St., 3rd floor, office 3, Studentski Grad
Sofia 1734, Bulgaria
tel. 02/4400843