active XYLO-COMOD 1 mg nasal spray ingredients

• 1 mg xylometazoline hydrochloride

XYLO-COMOD 1 mg nasal spray excipients

• disodium edetat-2 water
• Sodium dihydrogen phosphate-2 water
• disodium hydrogen phosphate-12 water
• sorbitol
• water, purified

Indication/ XYLO-COMOD 1 mg nasal spray Application

• The preparation is a drug for use in the nose (rhinological agent) and contains the alpha sympathomimetic xylometazoline.
• Xylometazoline has vasoconstrictive properties and thereby causes a decongestion of the mucous membrane.
• The medicine is used:
  • for short-term therapy for swelling (congestion) of the nasal mucosa
• The preparation is intended for adults and school children.

XYLO-COMOD 1 mg nasal spray dosage

• Always use the preparation exactly as directed. Please check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, the usual dose is:
  • In adults and school children, one spray is injected into each nostril up to 3 times a day as needed.

• duration of use
  • Do not use the preparation for more than 7 days without medical advice.
  • 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 of the medicine 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 with the preparation 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 discoloration of the skin due to the decrease in the oxygen content in the blood (cyanosis), palpitations, cardiac arrest, respiratory depression and respiratory arrest (apnea), pulmonary oedema, 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 have any further questions on the use of the medicine, ask your doctor or pharmacist.

XYLO-COMOD 1 mg nasal spray way

• The medicinal product is intended for nasal use.
• Important: When using for the first time, press the spray mechanism several times until a fine mist comes out.
• Then insert the nose adapter into one nostril at a time and create a spray.

side effects

• Like all medicines, the preparation can have side effects, although not everyone gets them.
• The evaluation of side effects is based on the following frequency information:
  • Very common: more than 1 in 10 people treated
  • Common: less than 1 in 10 but more than 1 in 100 people treated
  • Uncommon: less than 1 in 100 but more than 1 in 1000 people treated
  • Rare: less than 1 in 1,000 but more than 1 in 10,000 people treated
  • Very rare: affects less than 1 in 10,000 people or unknown
• The following side effects may occur during use:
  • nervous system:
    • Very rare:
      • restlessness, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (primarily in children).
  • Cardiovascular system:
    • Rarely:
      • Palpitations, increased heart rate (tachycardia), increase in blood pressure.
    • Very rare:
      • cardiac arrhythmias.
  • Respiratory tract:
    • Often:
      • Burning and dryness of the nasal mucosa, sneezing.
    • Occasionally:
      • after the effect has worn off, a stronger feeling of a "blocked" nose, nosebleeds.
  • Muscular and skeletal system:
    • Very rare:
      • Convulsions (especially in children).
  • Immune system:
    • Occasionally:
      • Hypersensitivity reactions (rash, itching, swelling of the skin and mucous membranes).
• Please tell your doctor or pharmacist if any of the listed side effects gets serious, or if you notice any side effects that are not listed.

XYLO-COMOD 1 mg nasal spray interactions

• When using the preparation with other medicines
  • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
  • If the preparation is 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 heart and circulatory functions.

Contraindications

• The drug must not be used
  • if you are allergic (hypersensitive) to xylometazoline hydrochloride or any of the other ingredients of the preparation
  • 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 XYLO-COMOD 1 mg nasal spray 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 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.
• Ask your doctor or pharmacist for advice before taking/using any medicine.

patient XYLO-COMOD 1 mg nasal spray notes

• Special care is required when using the drug
  • In the following diseases and situations, you may only use the product after consulting your doctor:
    • if you have increased intraocular pressure, especially angle-closure glaucoma
    • in severe cardiovascular diseases (e.g. coronary heart disease) and high blood pressure (hypertension)
    • if you are being treated with monoamine oxidase inhibitors (MAOIs) and other drugs that can potentially increase blood pressure
    • if you have a tumor of the adrenal gland (pheochromocytoma)
    • in metabolic disorders such as B. Overactive thyroid (hyperthyroidism) and diabetes (diabetes mellitus)
    • in prostate enlargement
    • in metabolic disease porphyria.
  • Long-term use of decongestant nasal spray 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.

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