“Composition
Active ingredients
xylometazoline hydrochloride. 1 ml of nasal spray, solution contains 1 mg of xylometazoline hydrochloride. Each dose (approximately 0.09 ml of solution) contains 0.09 mg of xylometazoline hydrochloride.
Excipients
purified sea water, monobasic potassium phosphate, purified water.
Directions
Xylometazoline EG 1 mg/ml nasal spray is used for short-term treatment of nasal congestion with runny nose caused by colds or sinusitis in children from 12 years of age and in adults.
Method of administration and dosage
Blow your nose gently before using the nasal spray. It is recommended to use the last dose every day before bedtime.
After removing the protective cap, insert the nozzle into the nostril and press the dispenser once. When spraying, breathe gently through the nose. Repeat the procedure for the other nostril. After use, wipe the nozzle thoroughly with a clean paper towel before replacing the cap.
Remove the plastic cap from the nozzle. When using the spray for the first time, press the empty dispenser at least five times until a uniform mist is released. For subsequent uses, the dispenser will be ready for immediate use. However, the procedure will have to be repeated if the spray has not been used for several days. Please note the following:
4–14 days of non-use: 1 empty can;
more than 14 days of non-use: 5 empty sprays.
For hygiene reasons and to avoid contamination, each spray should only be used by one person.
The recommended dose for children aged 12 years and over and adults is 1 spray of Xylometazoline EG nasal spray in each nostril up to three times a day.
The use of Xylometazoline EG 1 mg/ml is not recommended for children under 12 years of age.
Warnings
There have been isolated reports of serious adverse reactions (mainly respiratory arrest) occurring after the use of therapeutic doses. Overdose should be avoided. Before using xylometazoline EG, consult a doctor or pharmacist if:
Have had a severe reaction to sympathomimetic drugs (such as adrenaline) in the past. In this case, the use of xylometazoline EG may cause insomnia, dizziness, tremor, irregular heartbeat or increased blood pressure. If you have any doubts, consult a doctor or pharmacist;
are taking monoamine oxidase inhibitors (MAOIs) or other drugs that can cause increased blood pressure;
suffer from increased eye pressure, especially narrow-angle glaucoma;
suffer from severe cardiovascular diseases (e.g. coronary artery disease, long QT syndrome) and high blood pressure (hypertension);
have a tumor of the adrenal gland (pheochromocytoma);
have metabolic disorders such as an overactive thyroid gland (hyperthyroidism) and diabetes (diabetes mellitus);
have an enlarged prostate;
suffer from porphyria (a metabolic disorder).
Avoid direct contact with the eyes.
With long-term treatment with xylometazoline, swelling of the nasal mucosa may recur after stopping therapy. To avoid this, the duration of treatment should be as short as possible.
If you think you have a bacterial infection, consult a doctor as it must be treated accordingly. This medicine should not be used by more than one person at a time to prevent the risk of spreading infections.
Contraindications
Do not use xylometazoline EG:
If you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine;
if you suffer from a certain form of chronic cold (dry rhinitis);
if you have recently had brain surgery through your nose and mouth (transsphenoidal hypophysectomy) or other surgery that exposes the outer covering (dura mater) of the brain.”
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