active AMBROXOL, ambroxol hydrochloride, Aristo cough syrup ingredients

• 30 mg ambroxol hydrochloride

AMBROXOL, ambroxol hydrochloride, Aristo cough syrup excipients

• 10 mg benzoic acid
• Sodium hydroxide for pH adjustment
• Sodium hydroxide for pH adjustment
• Raspberry flavor, liquid, 203580, Symrise
• water, purified
• Hyetellosis
• Citric acid monohydrate
• Sorbitol 70
• Glycerol 85%
• sodium cyclamate

AMBROXOL, ambroxol hydrochloride, Aristo cough syrup indication

• The preparation is a medicinal product for dissolving mucus in respiratory diseases with tough mucus (expectorant).
• It is used for mucolytic treatment in acute and chronic diseases of the bronchi and lungs with thick mucus.

dosage AMBROXOL, ambroxol hydrochloride, Aristo cough syrup

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The recommended dose is:
  • Children up to 2 years: only on medical advice
    • 1.25 ml solution is taken twice a day (equivalent to 15 mg ambroxol hydrochloride/day).
  • Children from 2 to 5 years:
    • 1.25 ml solution is taken 3 times a day (equivalent to 22.5 mg ambroxol hydrochloride/day).
  • Children from 6 to 12 years:
    • 2.5 ml solution is taken 2-3 times a day (equivalent to 30-45 mg
      ambroxol hydrochloride/day).
  • Adults and young people aged 12 and over:
    • As a rule, during the first 2-3 days, 5 ml of the solution (equivalent to 90 mg ambroxol hydrochloride/day) is taken 3 times a day, then 5 ml of the solution (equivalent to 60 mg ambroxol hydrochloride/day) is taken twice a day.
    • With the dosage for adults and adolescents from 12 years of age, it is possible to increase the effectiveness by administering 10 ml of solution twice a day (equivalent to 120 mg ambroxol hydrochloride/day).
  • dosing regimen
    • Age: 0 - 2 years
      • Daily dose: Only on medical advice 2 x 1.25 ml
    • Age 2 - 5 years:
      • Daily dose: 3 x 1.25 ml
    • Age 6 - 12 years:
      • Daily dose: 2 - 3 x 2.5 ml
    • Age from 12 years:
      • daily dose:
        • On the first 2 - 3 days 3 x 5 ml
        • afterwards: 2 x 5 ml
• If your condition worsens or does not improve after 4-5 days, you should consult a doctor.
• 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 take more than you should
  • Specific symptoms of overdose have not been reported to date. The signs of illness seen in accidental overdose or drug mix-up are consistent with the side effects that may occur at the recommended dosage.
  • In the event of an overdose, please contact a doctor as treatment of the symptoms may be necessary.

• If you forget to take a dose
  • If you forget to take the medicine or have taken too little, please continue taking it at the next time as described in the dosing instructions.

• If you stop taking it
  • Symptoms may worsen if treatment is stopped prematurely.

way

• The medicine is an oral solution.
• The medicine is taken with or without meals using the enclosed dosing aid.
• Please clean the dosing aid after use by rinsing it out with warm water.

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The frequency of side effects is based on the following categories:
  • Very common: affects more than 1 in 10 people
  • 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: affects less than 1 in 10,000 people
  • Not known: frequency cannot be estimated from the available data
• side effects
  • diseases of the immune system
    • Rare: Hypersensitivity reactions
    • Not known: Allergic reactions up to anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or tissue under the mucous membrane) and itching
  • Skin and subcutaneous tissue disorders
    • Rare: rash, hives
    • Not known: Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
  • Diseases of the nervous system
    • Common: taste disturbances
  • Diseases of the gastrointestinal tract
    • Common: nausea, numbness in the mouth
    • Uncommon: vomiting, diarrhea, indigestion, abdominal pain, dry mouth
    • Rare: dry throat
    • Very rare: increased salivation
  • Respiratory, thoracic and mediastinal disorders
    • Common: numbness in the throat
    • Not known: shortness of breath (as a sign of hypersensitivity reaction)
  • General disorders and administration site conditions
    • Uncommon: fever, mucosal reactions
• countermeasures
  • At the first sign of a hypersensitivity reaction, the drug should not be taken again.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

• Please tell your doctor or pharmacist if you are taking/using other medicines, have recently taken/used other medicines or intend to take/use other medicines.
• Ambroxol/Antitussives
  • If the drug and cough suppressants (antitussives) are used at the same time, a dangerous build-up of secretion can occur due to the restricted cough reflex, so that the simultaneous use should only take place after careful benefit-risk assessment.

Contraindications

• The drug must not be taken
  • if you are allergic (hypersensitive) to the active substance ambroxol hydrochloride or any of the other ingredients of this medicine.

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 taking this medicine.
• pregnancy
  • Ambroxol reaches the unborn child. You should not take this medicine during pregnancy, especially during the first 3 months.
• lactation
  • In animal experiments, the active ingredient ambroxol passes into breast milk. Use during lactation is not recommended.
• fertility
  • Non-clinical studies have not revealed any harmful effects on fertility or fertility.

patient notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine.
  • There have been reports of severe skin reactions associated with the use of ambroxol hydrochloride. If you develop a skin rash (including lesions in the lining of the mouth, throat, nose, eyes and genitals), please stop using the medicine and seek medical advice immediately.
  • Patients with impaired kidney and liver function
    • If you suffer from impaired kidney function or severe liver disease, the medicine may only be taken on medical advice. As with any drug that is metabolized by the liver and then excreted by the kidneys, in the presence of severe renal impairment, an accumulation of hepatic metabolites of ambroxol can be expected.
  • In some rare diseases of the bronchi that are associated with excessive accumulation of secretion (e.g. malignant ciliary syndrome), the drug should only be used under medical supervision because of a possible accumulation of secretion.
• children
  • The medicine may only be used in children under 2 years of age on medical advice.

• Ability to drive and use machines
  • There is no evidence that it affects the ability to drive or use machines; corresponding studies have not been carried out.