• 1 mg xylometazoline hydrochloride

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

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 the swelling of the nasal mucosa in the event of a cold, runny nose that occurs in attacks (vasomotor rhinitis), allergic rhinitis (allergic rhinitis).
  • The medicine is suitable for school children over 6 years old and adults. It must not be used in children in the age group below 6 years.
  • If you do not feel better or if you feel worse after 7 days, contact your doctor.

dosage

• 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, one drop is placed in each nostril up to 3 times a day for adults and school children 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 as a result of significant overdose or accidental ingestion of the drug.
  • The clinical picture of intoxication with this preparation can be confusing, since phases of stimulation can alternate with phases of suppression of the central nervous and cardiovascular systems.
  • 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 discoloration of the skin due to 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, heartbeat too fast/too slow.
  • 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 medicinal product 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 (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.

interactions

• Use together with other medicines
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including those obtained without a prescription.
  • When used at the same time as certain mood-enhancing drugs (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) and drugs that increase blood pressure, an increase in blood pressure can occur due to effects on cardiovascular functions.
  • Please note that this information may also apply to medicines that have been used recently.

Contraindications

• The drug 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 children under 6 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 should only use the medicine 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 medicine.
    • 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.
      • Long-term use of decongestant nose drops can lead to chronic swelling and ultimately to atrophy of the nasal mucosa.
  • children
    • The drug must not be used in children under 6 years of age.

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