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WHAT XIMERAL AND WHAT IT IS USED
The active substance of this medication is xylometazoline. It constricts blood vessels in the nasal mucosa, and thus reduces swelling due to various reasons, and facilitate breathing through the nose.
Ksimeral used for short-term treatment of nasal congestion in children aged between 2 and 10 years.
2. BEFORE YOU USE XIMERAL
Do not use Ximeral:
if your child is allergic (hypersensitive) to xylometazoline or any of the other ingredients of the drug;
if your child has recently undergone brain surgery through the nose or mouth.
Take special care with Ximeral
Ask your doctor or pharmacist before taking this medicine if your child has:
tendency to hypersensitivity to sympathomimetic agents (drugs such as adrenalin); Ximeral can cause insomnia, dizziness, tremors, arrhythmias, or increase in blood pressure;
cardiovascular disease (heart disease, high blood pressure);
hyperthyroidism (overactive thyroid gland);
pheochromocytoma (tumor in the medullary portion of the adrenal glands, which produce hormones);
prostatic hypertrophy (enlarged prostate);
an inherited disease caused by defective enzymes (porphyria);
conducting drug treatment for depression (MAO inhibitors);
increased intraocular pressure (narrow-angle glaucoma);
chronic colds with scant or no secretion.
Mucosal edema (swelling of the lining of the nose) may occur upon termination of long-term treatment with xylometazoline. To prevent this, the period of treatment should be as short as possible.
If you think you have a bacterial infection, please consult your doctor as the infection should be treated promptly. This medicine should not be used by more than one person to prevent the risk of spreading infections.
If any of the above applies to your child, consult your doctor before taking Ksimeral.
Using other medicines
Tell your doctor or pharmacist if your child is taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is not recommended to use this drug with certain antidepressants, for example:
tri- or tetracyclic antidepressants;
MAOIs (monoamine oxidase inhibitors), or if your child is taking MAO inhibitors during the past two weeks.
Not recommended also using this medicine:
in combination with antihypertensive drugs (eg. methyldopa) due to potential hypertensive effects of xylometazoline;
with other drugs with a potential hypertensive effects (eg. doxapram, ergotamine, oxytocin), as they can potentiate their mutual hypertensive effects.
Pregnancy and lactation
This concentration of Ximeral is intended for use in children, but the information applies to the active ingredient xylometazoline.
Pregnant or nursing women should consult their doctor before taking this medicine.
Please consult your doctor before taking this drug when you are pregnant. Use this medicine only if your doctor has determined that it is safe for you.
It is not known if xylometazoline is excreted in breast milk. The risk to the infant can not be ruled out. It has to decide whether to discontinue nursing or to discontinue / do not use Ximeral, taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother. Since overdose can lead to reduced milk production, xylometazoline recommended dose should not be exceeded during lactation.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
When taken properly, this drug does not affect the ability to drive and use machines, but if you feel dopey or sleepy while using the drug should not drive or operate machinery.
3. HOW TO USE XIMERAL
Before the first administration is necessary to burst several times (4 times) in the air, in order to achieve a uniform dose. The bottle must be vertical. If the product is not used for several days, must be done at least one test spraying in the air in order to achieve a uniform dose.
Ximeral 0,5 mg / ml is intended for the treatment of nasal congestion in children aged 2-10 years.
The usual dose for children is one spray in each nostril every 10-12 hours (not more than three times a day) for a maximum of five days.
Ximeral 0,5 mg / ml is not recommended for children under two years.
The safety and efficacy of Ximeral 0,5 mg / ml in children under the age of 2 years have not yet been established
Patients aged over 10 years should use Ksimeral 1 mg / ml.
Duration of treatment
Treatment duration should be as short as possible. After continuous treatment is possible reoccurrence of edema of the mucosa (inner lining of the nose). Do not exceed the recommended dose. You should consult a doctor if you feel better or if you feel worse after three days of continuous treatment.
If symptoms of the disease your child does not improve
Contact your doctor if symptoms of the disease your child persist or worsen after five days.
The doctor may give you different dosage instructions as compared to the information provided in this leaflet with patient information. Always use Ximeral exactly as described in this leaflet or as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Instructions for use
The spray should be applied to the child while it is upright. So it's best young children to sit on your lap during application.
Blow your nose to your child before using this medicine. Remove the cap.
Hold the bottle between your index and middle finger while keeping the bottom of the bottle with his thumb. Injection prime the pump down.
When using this medicine for the first time, spray several times (4 times) in the air to get a fine spray. It is also good to test pump spray by pressing it down at least once.
Place pump spray in the nostril. Prime the pump down and at the same time take the child to breathe through your nose while you gently squeezing the other nostril with the index finger of his free hand. Release pump spray and remove it from the nostril. Repeat this procedure in the other nostril.
Wipe pump spray and place the plastic cap after use.
Note: If the same bottle is used by several people, this can cause spread of infection.
If your child has used more than the amount Ximeral
If your child (or anyone else) has taken an overdose of this medicine, see your doctor immediately. Overdosing can cause depression of the central nervous system, dry mouth, sweating and symptoms caused by stimulation of the sympathetic nervous system (rapid irregular heartbeat and blood pressure increase).
If you forget to use Ximeral
If you forget to give a dose of this medicine, skip the missed dose and continue with the dosage regime. Do not take a double dose to make up the missed dose.
If you stop using Ximeral
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ximeral can cause side effects, although not everybody gets them.
Reported the following adverse reactions:
Common side effects - may affect 1 to 10 users per 100 people:
itching or burning in the nose and throat;
dry nasal mucosa.
Uncommon side effects - can affect 1 to 10 users in 1000 people:
systemic allergic reactions;
increased swelling of the nasal mucosa after discontinuation of therapy;
Rare side effects - can affect 1 to 10 users in 10,000 people:
palpitations and rapid pulse;
high blood pressure.
Very rare side effects - may affect less than 1 in 10,000 people:
mainly in children after overdose: somnolence / drowsiness, nervousness, insomnia, hallucinations and convulsions. Cases of irregular breathing were recorded in infants and newborns.
5. HOW TO STORE XIMERAL
Keep out of reach of children.
Do not use Ximeral after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Use within 3 months after opening.
Do not freeze. This medicine does not require any special storage conditions.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance is ksilometazolinov hydrochloride, one milliliter of solution contains 0,5 mg. 1 injection Ximeral 0,5 mg / ml (= 90 microlitres) contains 45 micrograms ksilometazolinov hydrochloride.
The other ingredients are purified seawater, potassium dihydrogen phosphate and purified water.
Ximeral looks like and contents of the pack
Clear colorless solution.
Bottle of 10 ml.
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