XIMERAL nasal spray 1mg / ml.10ml.

Abbott

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1. WHAT XIMERAL IS AND WHAT IT IS USED FOR
The active substance in this medicine is xylometazoline. It constricts the blood vessels in the nasal mucosa, thus reducing swelling for various reasons, and facilitates breathing through the nose.
Ximeral is used for the short-term treatment of nasal congestion in children between the ages of 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 medicine;
  • if your child has recently had brain surgery through the nose or mouth.

Take special care with Ximeral
Ask your doctor or pharmacist for advice before taking this medicine if your child has:

  • tendency to hypersensitivity to sympathomimetics (drugs such as adrenaline); Ximeral may cause insomnia, dizziness, tremor, arrhythmia, or increased blood pressure;
  • cardiovascular disease (heart disease, high blood pressure);
  • hyperthyroidism (overactive thyroid gland);
  • diabetes;
  • pheochromocytoma (a tumor in the medullary part of the adrenal glands that produces hormones);
  • prostate hypertrophy (enlarged prostate);
  • hereditary disease caused by defective enzymes (porphyria);
  • treatment with a drug for depression (MAO inhibitors);
  • increased intraocular pressure (narrow-angle glaucoma);
  • chronic cold with scanty or no secretion.

Swelling of the mucous membranes (swelling of the inner lining of the nose) may occur when long-term treatment with xylometazoline is stopped. To prevent this, the treatment period should be as short as possible .
If you think you may have a bacterial infection, please consult your doctor, as the infection must 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 a doctor before using Ximeral.



Using other medicines
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

The use of this medicine with certain antidepressants is not recommended, for example:

  • tri- or tetracyclic antidepressants;
  • MAO inhibitors (monoamine oxidase inhibitors), or if your child has been taking MAO inhibitors in the last two weeks.

The use of this medicine is also not recommended:

  • in combination with antihypertensive drugs (eg methyldopa) due to the potential hypertensive effects of xylometazoline;
  • with other drugs with a potential hypertensive effect (eg doxapram, ergotamine, oxytocin), as they may potentiate their hypertensive effects.

Pregnancy and lactation
This concentration of Ximeral is intended for use in children, but the information relates to the active substance xylometazoline.
Pregnant women or nursing mothers should consult their doctor before using this medicine.


Pregnancy:
Please consult your doctor before using this medicine when you are pregnant. Use this medicine only when your doctor has determined that it is safe for you.


Lactation:
It is not known whether xylometazoline is excreted in human milk. The presence of a risk to the infant cannot be ruled out. A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Ximeral, taking into account the benefit of breast-feeding for the child and the benefit of treatment for the mother. As overdose may lead to a decrease in breast milk production, the recommended dose of xylometazoline should not be exceeded during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.


Driving and using machines
When taken correctly, this medicine does not affect your ability to drive or use machines, but if you feel drowsy or drowsy while using the medicine, you should not drive or use machines.


3. HOW TO USE XIMERAL
Before the first application it is necessary to spray several times (4 times) in the air to achieve a uniform dose. The bottle must be in a vertical position. If the product has not been used for several days, at least one test spray in the air must be made in order to achieve a uniform dose.
Ximeral 1 mg / ml is indicated for the treatment of nasal congestion in children aged 2 to 10 years.


Dosage
The usual dose for children is one injection in each nostril every 10 to 12 hours (no more than three times a day) for a maximum of 5 days .

Ximeral 1mg / ml is not recommended for children under 2 years of age .
The safety and efficacy of Ximeral 1 mg / ml in children under 2 years of age have not yet been established.
Patients over 10 years of age should use Ximeral 1 mg / ml.


Duration of treatment The
duration of treatment should be as short as possible. After prolonged treatment, recurrence of mucosal edema (inner lining of the nose) is possible. Do not exceed the recommended dose. You should consult a doctor if you do not feel better, or if you feel worse after 3 days of continuous treatment.


If your child's symptoms do not improve
Contact your doctor if your child's symptoms persist or worsen after 5 days.
Your doctor may give you different dosing instructions than those provided in this patient information leaflet. Always use Ximeral exactly as instructed in this leaflet or as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.


Instructions for use
The spray should be applied to the child while he is upright. Therefore, it is best for young children to sit on your lap during the application.
Blow your child's nose before using this medicine. Remove the cap.
Hold the bottle between your index finger and middle finger while holding the bottom of the bottle with your thumb. Push the pump down to inject.
When using this medicine for the first time, spray several times (4 times) in the air to get a fine spray. It is also a good idea to test the pump by pushing it down at least once.
Insert the pump into the nostrils. Push the pump down and at the same time make the child inhale through the nose while you gently press the other nostril with the index finger of your free hand. Release the pump and remove it from the nostrils. Repeat this procedure in the other nostril.
Wipe the pump and replace the plastic cap after use.


Note: if the same bottle is used by several people, it can cause the infection to spread.


If your child has taken more Ximeral than you should
If your child (or anyone else) has taken an overdose of this medicine, see your doctor immediately. Overdose may cause central nervous system depression, dry mouth, sweating and symptoms caused by stimulation of the sympathetic nervous system (accelerated arrhythmia and increased blood pressure).


If you forget to use Ximeral
If you forget to take a dose of this medicine, skip the missed dose and continue with the dosing regimen. Do not take a double dose to make up for a forgotten 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.


The following side effects have been reported:
Common side effects - may affect 1 to 10 users in 100:

  • itching or burning in the nose and throat;
  • dry nasal mucosa.

Uncommon side effects - may affect 1 to 10 users in 1,000:

  • systemic allergic reactions;
  • increase in swelling of the nasal mucosa after stopping treatment;
  • epistaxis (nosebleeds).

Rare side effects - may affect 1 to 10 users in 10,000:

  • palpitations and rapid pulse;
  • nausea;
  • high blood pressure.

Very rare side effects - may affect less than 1 in 10,000 people:

  • nervousness;
  • insomnia;
  • fatigue;
  • headache;
  • arrhythmia;
  • mainly in children and after overdose: drowsiness / drowsiness, nervousness, insomnia, hallucinations and convulsions. Cases of irregular breathing have been reported in infants and newborns.

Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.


5. HOW TO STORE XIMERAL
Keep out of the reach and sight of children.
Do not use Ximeral after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
To be used within 3 months after opening.
Do not freeze. This medicine does not require any special storage conditions.
Medicines should not be disposed of via 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
What Ximeral
contains The active substance is
xylometazoline hydrochloride, 1 ml of solution containing 1 mg. 1 injection of Ximeral 1 mg / ml (= 180 microliters) contains 90 micrograms of xylometazoline hydrochloride.
The other ingredients are: purified sea water, potassium dihydrogen phosphate and purified water.