Nasal spray for kids-children xylometazoline hydrochloride

• 0.50 mg xylometazoline hydrochloride

• Citric acid monohydrate
• Sodium citrate-2-water
• Glycerol 85%
• Water for injections

Nasal spray for kids-children xylometazoline hydrochloride Indication / application

• The preparation is a means for use in the nose (rhinological agent) and contains the alpha-sympathomimetic xylometazoline.
• Xylometazoline has vasoconstricting properties and thus causes the mucous membrane to decongest.
• The medicine is used
  • for the decongestion of the nasal mucosa (short-term treatment) in the event of a cold, runny nose (rhinitis vasomotorica) or allergic rhinitis (allergic rhinitis)
  • to facilitate the discharge of secretions in the case of inflammation of the paranasal sinuses and catarrh of the tubular middle ear in connection with rhinitis.
• The preparation is intended for children between 2 and 6 years of age.

Nasal spray for kids-children xylometazoline hydrochloride dosage

• Always use the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by your doctor, the usual dose is
  • In children between the ages of 2 and 6, 1 spray is applied to each nostril as required - but no more than 3 times a day.

• Duration of application
  • The preparation must not be used for longer than 7 days, unless directed to do so by a doctor.
  • A renewed application should only take place after a break of several days.
  • Because of the risk of shrinkage of the nasal mucous membrane, it may only be used for chronic rhinitis under medical supervision.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• If you use more than you should
  • The following effects may occur as a result of a significant overdose or accidental ingestion of the drug:
    • Dilation or constriction of the pupil
    • Nausea and vomiting
    • Pallor, blueing of the skin and lips
    • Fever, sweating or a drop in body temperature
    • Cardiovascular disorders such as slow, fast or irregular heartbeat, rise or fall in blood pressure
    • Stop breathing
    • Lethargy, drowsiness, and coma
    • Anxiety, agitation, hallucinations, and convulsions
  • After an overdose, especially in children, convulsions and coma, slow heartbeat, cessation of breathing and an increase in blood pressure, which can be followed by a drop in blood pressure, often occur.
  • In the event of poisoning, you must inform your doctor immediately; monitoring and therapy in the hospital are necessary.

• If you forget to use it
  • Next time, do not use a double dose to make up for a forgotten dose, but continue using as described in the dosage instructions.

• If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

Nasal spray for kids-children xylometazoline hydrochloride way

• Insert the spray port into the nostril and pump once. Breathe in gently through your nose while spraying.
• It is advisable to blow your nose thoroughly before using the preparation. The last application on each day of treatment should preferably be done before bedtime.
• For reasons of hygiene and to avoid the transmission of pathogens, each spray should only be used by one and the same person.

Side effects

• Like all medicines, the preparation can cause side effects, although not everybody gets them.
• When evaluating side effects, the following frequencies are used as a basis:
  • very common: more than 1 in 10 patients
  • common: affects 1 to 10 users in 100
  • uncommon: affects 1 to 10 users in 1,000
  • rare: affects 1 to 10 users in 10,000
  • very rare: less than 1 patient in 10,000
  • not known: frequency cannot be estimated from the available data
• immune system
  • Occasionally:
    • Hypersensitivity reactions (rash, itching, swelling of the skin and mucous membranes)
• Nervous system
  • Very rare:
    • Restlessness, insomnia, tiredness, headache, dizziness, nausea, hallucinations (primarily in children)
• Cardiovascular system
  • Rarely:
    • Palpitations, increased heartbeat, increase in blood pressure
  • Very rare:
    • Arrhythmia
• Airways and chest
  • Frequently:
    • temporary mild irritation (burning or dryness of the nasal mucosa, sneezing)
  • Occasionally:
    • After the effects have subsided, stronger feeling of a "blocked" nose, nosebleeds
• Skeletal muscles, connective tissue and bones
  • Very rare:
    • Convulsions (especially in children)
• Please inform your doctor or pharmacist if any of the listed side effects gets serious, or if you notice side effects that are not listed.

Nasal spray for kids-children xylometazoline hydrochloride Interactions

• When using the preparation with other drugs
  • Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
  • With simultaneous use of the preparation and certain mood-enhancing drugs (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) and blood pressure-increasing drugs, an increase in blood pressure can occur due to effects on cardiovascular functions.

Contraindications

• The drug must not be used
  • if you are allergic (hypersensitive) to xylometazoline or any of the other ingredients of the preparation for children.
  • if you suffer from a certain form of chronic runny nose (rhinitis sicca, dry inflammation of the nasal mucous membrane with crust formation).
  • after surgical removal of the pineal gland through the nose (transsphenoidal hypophysectomy) or other surgical procedures that expose the meninges.
  • in infants and young children under 2 years of age.

Nasal spray for kids-children xylometazoline hydrochloride pregnancy and breast feeding period

• Since the safety of using the drug during pregnancy and breastfeeding has not been sufficiently proven, you may only use the product on the advice of your doctor and only after he has carefully weighed the benefits and risks. The recommended dose must not be exceeded during pregnancy and breastfeeding, as overdosing can impair the blood supply to the unborn child or reduce milk production.

Nasal spray for kids-children xylometazoline hydrochloride Patient information

• Special care is required when using the drug
  • if you are being treated with certain mood-enhancing medicines (monoamine oxidase inhibitors [MAOIs]) and other medicines that may increase blood pressure.
  • if you suffer from increased pressure in the eye, especially narrow-angle glaucoma.
  • if you suffer from severe cardiovascular diseases (e.g. coronary artery disease [CHD], high blood pressure).
  • if you have a tumor of the adrenal gland (pheochromocytoma).
  • if you have metabolic disorders such as B. Overactive thyroid (hyperthyroidism) or diabetes (diabetes mellitus).
  • if you have an enlarged prostate.
  • if you suffer from the metabolic disease porphyria.
• The long-term use of cold medicines to decongest the mucous membrane can lead to chronic swelling and ultimately to shrinkage of the nasal mucosa.
• children
  • The preparation must not be used in infants and young children under 2 years of age.

• Driving and using machines
  • If used as intended, no adverse effects are to be expected.