IMIDIN nasal drops for children 10 ml Xylometazoline hydrochloride

Aristo Pharma GmbH

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IMIDIN nasal drops for children 10 ml Xylometazoline hydrochloride

Imidin ® for children, Xylometazoline hydrochloride

Active ingredients : Xylometazoline hydrochloride .
Areas of application: For decongesting the nasal mucous membrane in the event of a cold, runny nose (rhinitis vasomotorica), allergic rhinitis (allergic rhinitis). Imdin for children is intended for children between 2 and 6 years of age.
Note: Contains benzalkonium chloride.



Imidin ® for children, Xylometazoline hydrochloride For information on risks and side effects, please read the package insert or ask your doctor or pharmacist.

 To reduce swelling of the nasal mucosa in case of a cold.

active IMIDIN nasal drops for children 10 ml Xylometazoline hydrochloride ingredients

  • 0.5 mg xylometazoline hydrochloride

IMIDIN nasal drops for children 10 ml Xylometazoline hydrochloride excipients

  • 0.2 mg benzalkonium chloride
  • water, purified
  • Sodium citrate-2 water
  • Citric acid monohydrate
  • Glycerol 85%

indication

  • The drug is a drug for use in the nose (rhinological agent) and contains the alpha sympathomimetic agent xylometazoline.
  • Xylometazoline has vasoconstrictive properties and thereby causes a decongestion of the mucous membrane.
  • It is applied
    • For reducing swelling of the nasal mucosa in the event of a cold, paroxysmal runny nose (vasomotor rhinitis) and allergic rhinitis (allergic rhinitis).
  • The medicine is intended for children between 2 and 6 years of age.
  • If you do not feel better or worse after 7 days, contact your doctor.

 

dosage IMIDIN nasal drops for children 10 ml Xylometazoline hydrochloride

 

  • Always use this medicine exactly as described here or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • The recommended dose is
    • Unless otherwise prescribed by the doctor, in children aged 2-6 years, 1 drop is placed in each nostril up to 3 times a day as needed.

 

  • duration of use
    • The drug should not be used for more than 7 days unless directed by a doctor. It should only be used again after a break of several days.
    • Due to the risk of atrophy of the nasal mucosa, it may only be used for chronic colds under medical supervision.
    • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

 

  • If you use more than you should
    • you should inform your doctor immediately.
    • Poisoning can occur from significant overdose or from accidental ingestion of the drug.
    • The clinical picture of intoxication can be confusing, since phases of stimulation can alternate with phases of suppression of the central nervous system and the cardiovascular system.
    • Especially in children, overdosing often leads to central nervous effects with spasms and coma, slow heartbeat, respiratory arrest and an increase in blood pressure, which can be replaced by a drop in blood pressure.
    • Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations and convulsions.
    • Symptoms resulting from central nervous system inhibition are low body temperature, lethargy, drowsiness and coma.
    • The following additional symptoms may occur: constriction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, paleness, bluish discolouration of the skin as a result of the decrease in the oxygen content in the blood (cyanosis), palpitations, respiratory depression and cessation of breathing (apnea), nausea and vomiting, psychogenic disorders, increase or decrease in blood pressure, irregular heartbeat, too fast/too slow heartbeat.
    • In case of poisoning, a doctor must be informed immediately, monitoring and therapy in the hospital are necessary.

 

  • If you forgot the application
    • Do not apply a double dose if you have forgotten the previous application, but continue to use according to the dosing instructions.

 

  • If you cancel the application
    • You can cancel the application.

 

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

way

  • The preparation is intended for nasal use.
  • Instill the nose drops in each nostril with the head tilted back.

side effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • possible side effects
    • Common: may affect up to 1 in 10 people
      • Burning and dryness of the nasal mucosa, sneezing
    • Uncommon: may affect up to 1 in 100 people
      • After the effect has worn off, a stronger feeling of a "blocked" nose, nosebleeds, hypersensitivity reactions (skin rash, itching, swelling of the skin and mucous membranes)
    • Rare: may affect up to 1 in 1,000 people
      • Palpitations, increased heart rate (tachycardia), increase in blood pressure
    • Very rare: may affect up to 1 in 10,000 people
      • restlessness, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (primarily in children)
      • cardiac arrhythmias
      • Respiratory arrest in young infants and newborns
      • convulsions (especially in children)
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

 

IMIDIN nasal drops for children 10 ml Xylometazoline hydrochloride interactions

 

  • Use together with other medicines
    • Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
    • Concomitant use of this preparation and certain mood-enhancing medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) and medicines that increase blood pressure can cause an increase in blood pressure due to effects on heart and circulatory functions.
    • Please note that this information may also apply to recently used medicines.

Contraindications

    • The preparation must not be used
      • if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine.
      • in a certain form of chronic cold (rhinitis sicca);
      • if you have had surgery to remove the pineal gland through the nose (transsphenoidal hypophysectomy) or other surgical procedures that expose the meninges;
      • in infants and young children up to 2 years of age.

 

pregnancy and breast feeding period

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
  • Since the safety of use during pregnancy and lactation has not been sufficiently proven, you may only use the preparation on the advice of your doctor and only after he has carried out a careful risk/benefit assessment. The recommended dosage must not be exceeded during pregnancy and lactation, as an overdose can impair the blood supply to the unborn child or reduce milk production.

patient notes

  • Warnings and Precautions
    • Please talk to your doctor before using the preparation.
    • In the following diseases and situations, you may only use the product after consulting your doctor:
      • with increased intraocular pressure, especially angle-closure glaucoma;
      • severe cardiovascular disease (e.g. coronary artery disease) and high blood pressure (hypertension);
      • if you have a heart condition (e.g. long QT syndrome);
      • if you are being treated with monoamine oxidase inhibitors (MAOIs) and other potentially blood pressure-increasing medicines;
      • tumor of the adrenal gland (pheochromocytoma);
      • metabolic disorders such as B. Overactive thyroid (hyperthyroidism) and diabetes (diabetes mellitus);
      • prostate enlargement;
      • Metabolic disease porphyria.
      • The long-term use of decongestant nose drops can lead to chronic swelling and ultimately to atrophy of the nasal mucosa.
    • children
      • The medicine must not be used in infants and small children up to 2 years of age.

 

  • Ability to drive and use machines
    • If used as intended, no impairments are to be expected.