Xylometazoline Nasal drops 0.05 % x10 ml Polpharma

XYLOMETAZOLIN / XYLOMETAZOLIN 0.05% description:
Xylometazoline is a derivative of imidazoline. It has a sympathomimetic effect. Applied to the nasal mucosa, it causes constriction of blood vessels, 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 secretion (vasomotor rhinitis), allergic rhinitis (allergic rhinitis).
Application:
Children from 2 to 12 years: Locally 1-2 drops of 0.05% solution in each nostril 1-2 times a day. Re-application should only be carried out if treatment has been interrupted for several days. Therapy should not be continued for more than 3-5 days without consulting a doctor. Do not apply doses higher than recommended. For hygiene reasons, one package should be used by only one patient. With prolonged use, there is a risk of atrophy of the nasal mucosa and therefore the application is limited to 7 days.
 
Composition:
Active ingredient: 0.5 mg Xylometazoline hydrochloride. Excipients: Sodium dihydrogen phosphate; H2O, disodium hydrogen phosphate; 12 H2O, sodium chloride, sorbitol, disodium EDTA, benzalkonium chloride, distilled water.
Patient information leaflet Read the leaflet carefully, it contains important information for the patient. To achieve a good therapeutic effect, the product XYLOMETASOLINE WZF 0.05% must be applied carefully and according to the information contained in the leaflet. ¦ Keep this leaflet. You may need to read it again. ¦ If you have any further questions or need advice, please contact your doctor or pharmacist. ¦ If symptoms worsen or persist for more than 3-5 days, contact your doctor. XYLOMETAZOLIN WZF 0.05% nasal drops, solution XYLOMETAZOLIN WZF 0.05% nasal drops, solution Xylometazoline hydrochloride Contents of the leaflet: 1. What is XYLOMETAZOLIN WZF 0.05% and what is it used for 2. Before using XYLOMETAZOLIN WZF 0.05% 3. How to use XYLOMETAZOLIN WZF 0.05% 4. Possible side effects 5. Storage of XYLOMETAZOLIN WZF 0.05% 6. Additional information 1. What is XYLOMETAZOLIN WZF 0.05% nasal drops, solution and what is it used for Xylometazoline is a derivative of imidazoline. It has a sympathomimetic effect. Applied to the nasal mucosa, it causes blood vessel constriction, removes edema, suppresses hyperemia of the nasopharyngeal mucosa and reduces the amount of secretion. To reduce edema of the nasal mucosa in acute rhinitis, attacks of profuse nasal secretion (vasomotor rhinitis), allergic rhinitis (allergic rhinitis). 2. Before using XYLOMETASOLINE WZF 0.05% Do not use XYLOMETASOLINE WZF 0.05% if any of the following conditions have been reported; ¦ Proven hypersensitivity to the active substance or any of the excipients. ¦ Narrow-angle glaucoma. ¦ Hypophysectomy or other cranial intervention. ¦ Dry atrophic rhinitis (rhinitis sicca). Use XYLOMETASOLINE WZF 0t05% with caution; ¦ In young children – if agitation or sleep disturbances occur, the drug should be stopped. ¦ In patients in whom the following symptoms have been observed after the administration of sympathomimetics: insomnia, dizziness, tremor, arrhythmias or hypertension. ¦ In patients with circulatory disorders (arterial hypertension, angina pectoris), diabetes, glaucoma, prostatic hypertrophy, hyperthyroidism. Patients with such diseases should consult a doctor before starting treatment with XYLOMETASOLINE WZF 0.05%. With prolonged use, there is a risk of atrophy of the nasal mucosa and therefore the use is limited to 7 days. Special attention in some special groups using the drug Use of XYLOMETASOLINE WZF0.05% in children: Do not use in children under 2 years of age. In children under 6 years of age, the drug is dispensed on prescription. Pregnancy and lactation: Due to the lack of indicative 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 lactation. 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 excluded, which may impair the ability to drive and operate machinery. Important information about some ingredients of the product XYLOMETASOLINE WZF0,05% Due to the content of benzalkonium chloride, the drug may cause local irritation of the nasal mucosa. Use of other drugs: Do not use the drug during treatment with tricyclic antidepressants or MAO inhibitors (drugs used to treat depression), due to reports of rare cases of interactions. Simultaneous use with other sympathomimetics (ephedrine, pseudoephedrine) should be avoided. Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed to you. 3. How to use XYLOMETASOLIN WZF 0.05% One 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 only be carried out in case the treatment is interrupted for several days. Therapy should not be continued for more than 3 - 5 days without consulting a doctor. Doses higher than recommended should not be applied. For hygiene reasons, one package should only be used by one patient. If you take more XYLOMETASOLINE WZF 0.05% than you should Significant overdose or accidental oral intake 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 (rinitis medicamentosa). In case of overdose, a doctor should be consulted. Sympathetic 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, XYLOMETASOLINE WZF 0.05% may cause side effects. General disorders and those related to nasal administration: Rare: local irritation, burning, unpleasant dryness of the nasal mucosa. Very rare: weakness, nausea. Respiratory and chest disorders: Rare: Sneezing. Nervous system disorders: Very rare: headache, drowsiness or pronounced sedation after overdose. Cardiovascular system disorders: Very rare: palpitations, increased blood pressure. Some people may experience other side effects during the use of XYLOMETASOLINE WZF 0.05%. Please inform your doctor if you notice any side effects not mentioned in this leaflet. 5. Storage of XYLOMETASOLINE WZF 0.05% Keep out of the reach of children. Store below 25°C. Protect from light. The shelf life after opening the package is 12 weeks. Do not use XYLOMETASOLINE WZF 0.05% after the expiry date stated on the package. 6. Further information 1 ml of the solution contains: Active substance: 0.5 mg Xylometazoline hydrochloride Excipients: Sodium dihydrogen phosphate * H2O, disodium hydrogen phosphate • 12 H2O, sodium chloride, sorbitol, disodium EDTA, benzalkonium chloride, distilled water. Name and address of the marketing authorisation holder: Warsaw Pharmaceutical Works Polfa SA.