DESLORATADINE TAD 5 mg film-coated tablets 20 pc

AD Pharma GmbH

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Desloratadine TAD ® 5 mg film-coated tablets

Active substance:
Desloratadine

Application areas:
Desloratadine TAD improves the symptoms of allergic rhinitis (e.g. hay fever or house dust mite allergy) in adults and adolescents from 12 years of age. These symptoms include sneezing, runny or itchy nose, itchy roof of the mouth, and itchy, red, or watery eyes. Desloratadine TAD is also used to relieve the symptoms of urticaria. These symptoms include itching and hives. If you don't feel better or even worse after 3 days, contact your doctor.

Warnings:
Medicinal product contains lactose. Note leaflet.

Status:
March 2018.

For DESLORATADINE information on risks and side effects, read the package insert and ask your doctor or pharmacist.

Active ingredients

  • 5 mg desloratadine

Auxiliary materials

  • Cellulose, microcrystalline
  • Hypromellose
  • Hydrochloric acid for pH adjustment
  • Sodium hydroxide
  • Cornstarch
  • Lactose-1 water
  • talc
  • Macrogol
  • Titanium dioxide
  • Indigo carmine

DESLORATADINE Indication / application

  • What is the medicine?
    • The preparation contains desloratadine, which is an antihistamine.
  • How does the medicine work?
    • It is an antiallergic medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
  • When should the medicine be used?
    • The preparation improves the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or house dust mite allergy) in adults and adolescents from 12 years of age. These symptoms include sneezing, runny or itchy nose, itchy roof of the mouth, and itchy, red, or watery eyes.
    • Desloratadine is also used to relieve symptoms associated with urticaria (skin condition caused by an allergy). These symptoms include itching and hives.
    • The elimination of these symptoms will last a full day and will help you get back to normal daily activity and sleep.

DESLORATADINE dosage

  • Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
  • Adults and adolescents (from 12 years):
    • The recommended dose is one tablet once a day with water, with or without food.

 

  • Duration of application
    • Regarding the length of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and then decide how long you should take desloratadine for.
    • If your allergic rhinitis is intermittent (symptoms occur less than 4 days a week or last for less than 4 weeks), your doctor will recommend a treatment regimen that will depend on your previous illness.
    • If your allergic rhinitis is persistent (symptoms appear 4 or more days a week and last for more than 4 weeks), your doctor may recommend longer treatment for you.
    • For urticaria, the duration of treatment can vary from patient to patient. Therefore, you should follow your doctor's instructions.

 

  • If you take more than you should
    • Only take desloratadine as prescribed for you. Accidental overdose is not likely to cause serious problems. If you take more desloratadine than you should, contact your doctor, pharmacist or nurse immediately.

 

  • If you forget to take desloratadine
    • If you forget to take your dose in time, take it as soon as possible and then go back to your normal treatment schedule.
    • Do not take a double dose to make up for a forgotten dose.

 

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

DESLORATADINE way

  • The recommended dose is one tablet once a day with water, with or without food.
  • This medicine is for oral use.
  • Swallow the tablet whole.

DESLORATADINE Side effects

  • Like all medicines, this medicine can have side effects, although not everybody gets them.
  • Cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) have been reported very rarely in the post-marketing experience of this medicine.
  • If you notice any of these serious side effects, stop taking the medicine and seek medical advice straight away.
  • In adult clinical trials, side effects were similar to placebo. However, more reports of tiredness (fatigue), dry mouth and headache were reported than with placebo. Headache was the most commonly reported side effect in adolescents.
  • In clinical studies with desloratadine, the following side effects were reported:
    • Common: the following side effects may affect 1 to 10 people in 100
      • chronic tiredness (fatigue)
      • Dry mouth
      • headache
  • adult
    • The following side effects have been reported during the marketing of desloratadine:
      • Very rare: the following side effects may affect less than 1 in 10,000 people
        • severe allergic reactions
        • Heart pounding
        • Vomit
        • dizziness
        • muscle pain
        • Restlessness with increased physical activity
        • skin rash
        • stomach pain
        • Upset stomach
        • Drowsiness
        • Hallucinations
        • Inflammation of the liver
        • Palpitations or irregular heartbeat
        • nausea
        • diarrhea
        • insomnia
        • Seizures
        • abnormal liver function tests
      • Not known: frequency cannot be estimated from the available data
        • extraordinary fatigue
        • Yellowing of the skin and / or eyes
        • increased sensitivity of the skin to sunlight, including hazy sunlight, and to UV (ultraviolet) light, e.g. B. UV lamps in a solarium
        • altered heartbeat
        • abnormal behavior
        • aggression
        • Weight gain
        • increased appetite
  • children
    • Not known: frequency cannot be estimated from the available data
      • slow heartbeat
      • abnormal behavior
      • altered heartbeat
      • aggression
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to side effects that are not specified.

DESLORATADINE Interactions

  • Taking with other medicines
    • There are no known interactions of desloratadine with other medicinal products.
    • Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.
  • Take with food, drink and alcohol
    • The medicine can be taken with or without food.
    • Alcohol should be consumed with caution during treatment.

DESLORATADINE Contraindications

  • Do not take the medicine
    • if you are allergic to desloratadine, any of the other ingredients of this medicine or loratadine.

DESLORATADINE pregnancy and breast feeding period

  • Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
  • The use of desloratadine is not recommended during pregnancy and breastfeeding.
  • Fertility / childbearing ability
    • Data on male fertility / female childbearing ability are not available.

DESLORATADINE Patient information

  • Warnings and Precautions
    • Talk to your doctor, pharmacist or nurse before taking this medicine
      • if you have impaired kidney function.
      • if you have a history of seizures or a family history of seizures.
    • Use in children and adolescents
      • Do not give this medicine to children under 12 years of age.

 

  • Driving and using machines
    • At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience sleepiness, it is recommended that you refrain from activities that require mental alertness, such as driving or using machines, until you have achieved personal response to the medicine.