DEXTRO BOLDER 10.5 mg pastilles, 20 pcs

Instructions for use for DEXTRO BOLDER 10.5 mg pastilles, 20 pcs

Application instructions

Children aged 6-12	1 Pastille	several times a day (max. 6 lozenges per day)	at intervals of 4-6 hours, regardless of the meal
Young people aged 12 and over and adults	1-3 Lozenges	several times a day (max. 12 lozenges per day)	at intervals of 4-6 hours, regardless of the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient stops the urge to cough by shutting down the cough center in the brain. To prevent mucus from accumulating in the airways, the substance is only suitable if the cough is completely dry. Anyone who overdoses on the substance runs the risk of blocking the airways or having difficulty breathing.

Composition

Contraindications

What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Bronchial asthma
- Chronic obstructive respiratory disease (chronic respiratory disease with narrowing of the airways)
- Lung infection
- Weakness in breathing

Under certain circumstances - talk to your doctor or pharmacist about this:
- Impaired liver function
- Cough with heavy mucus formation
- Tendency to abuse medications

Which age group should be taken into account?
- Children under 6 years: The medicine should generally not be used in this group. There are preparations that are more suitable in terms of active ingredient strength and/or dosage form.

What about pregnancy and lactation?
- Pregnancy: Consult your doctor. Various considerations play a role in whether and how the medicine can be used during pregnancy.
- Breast-feeding: The medicine must not be used.

If you have been prescribed this medicine despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit may be greater than the risk associated with use if there is a contraindication.

Side effects

What adverse effects may occur?

- Gastrointestinal complaints
- Nausea
- Vomiting
- Fatigue
- Dizziness

If you notice any discomfort or change during treatment, contact your doctor or pharmacist.

The information provided here primarily takes into account side effects that occur in at least one in 1,000 treated patients.

Hints

What should you pay attention to?
- The ability to react can be impaired even when used as intended, especially in higher doses or in combination with alcohol. Pay particular attention when you drive or operate machines (including at home) that could cause you injury.
- Be careful if you are allergic to the sweetener cyclamate (E number E 952)!
- Be careful if you are allergic to the sweetener saccharin (E number E 954)!
- Be careful if you are allergic to dyes (e.g. quinoline yellow with the E number E 104)!
- Be careful if you have an intolerance to fructose (fruit sugar). If you have to follow a diabetes diet, you should consider the sugar content.
- There may be medicines that interact with. You should therefore generally tell your doctor or pharmacist before starting treatment with a new medicine that you are already using. This also applies to medicines that you buy yourself, only use occasionally or that were used some time ago.

Detailed instructions for DEXTRO BOLDER 10.5 mg pastilles, 20 pcs

Field of use

• The preparation is used for the symptomatic treatment of dry coughs.
• A dry cough is a dry cough in which no mucus is coughed up (unproductive cough).

Active ingredients / ingredients / ingredients

10.5 mg dextromethorphan hydrobromide
7.7 mg dextromethorphan
Arabic gum excipient (+)
168.5 mg Betadex excipient (+)
Quinoline yellow excipient (+)
Citric acid, anhydrous excipient (+)
0.5 mg levomenthol excipient (+)
Maltitol solution excipient (+)
851 mg maltitol excipient (+)
Sodium cyclamate excipient (+)
Paraffin, low-viscosity excipient (+)
Saccharin, sodium salt excipient (+)
Drinking water auxiliary (+)
Wax, bleached auxiliary (+)
23 mg total sodium ion excipient (+)
Total Sodium Ion Excipient (+)
Honey aroma excipient (+)
Lime flavor excipient (+)

Contraindications

• The medicine must not be taken,
  • if you are hypersensitive (allergic) to dextromethorphan hydrobromide or any of the other ingredients of this medicine.
  • if you are also taking so-called MAO-inhibitors (certain mood-enhancing drugs) or have taken them in the last two weeks.
  • in bronchial asthma.
  • in chronic obstructive respiratory disease.
  • with pneumonia (pneumonia).
  • in case of respiratory inhibition (respiratory depression).
  • with insufficient breathing activity (respiratory insufficiency).
  • if you are breastfeeding.
  • of children under 6 years
  • in rare cases of congenital intolerance to one of the components.

dosage

• Always take this medicine exactly as described or exactly as your doctor or pharmacist has told you.
• Do not take more or take it for longer than recommended.
• Cases of dextromethorphan abuse have been reported, including cases in children and adolescents.
• Check with your doctor or pharmacist if you are unsure.
• The recommended dose is:
  • Children from 6 to 12 years old
    • Single dose: 1 lozenge (equivalent to 10.5 mg dextromethorphan hydrobromide monohydrate) every 4 to 6 hours
    • Total daily dose: 6 lozenges (equivalent to 63 mg dextromethorphan hydrobromide monohydrate)
  • Young people over 12 years and adults
    • Single dose: 1 to 3 lozenges (equivalent to 10.5 to 31.5 mg dextromethorphan hydrobromide monohydrate) every 4 to 6 hours
    • Total daily dose: 12 lozenges (equivalent to 126 mg dextromethorphan hydrobromide monohydrate)
  • The preparation must not be taken by children under 6 years of age.

 

• Duration of application
  • Do not take the medicine for longer than 3 - 5 days without medical advice.
  • Even if prescribed by a doctor, the preparation should not be taken for longer than two to three weeks.
  • 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 have taken more than you should
  • If you take more than you should, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, restlessness, confusion, sleepiness, impaired consciousness, involuntary and rapid eye movements, disturbances in cardiac function (fast heartbeat), incoordination, psychosis with visual hallucinations and hyperexcitability.
  • Other symptoms in the event of a massive overdose may include: coma, severe breathing problems and convulsions.
  • Contact your doctor or hospital immediately if you experience any of the above symptoms.
  • If you are concerned that you have taken too high a dose, contact a doctor immediately.
  • Cases of poisoning with fatal outcomes have occurred in cases of simultaneous overdose of dextromethorphan and other drugs.
  • Under certain circumstances, intensive care monitoring with symptom-related therapy may be necessary. Naloxone can be used as an antagonist.

 

• If you forget to take it
  • Do not take a double dose if you forget to take the previous dose. Continue taking according to dosage recommendations.

Intake

• To be taken (sucked). Let the pastilles slowly melt in your mouth.

Patient information

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine.
  • Patients with
    • impaired liver function
    • impaired kidney function
    • Mastocytosis
  • you should only use the product after consulting your doctor. Patients with severe impairment of kidney or liver function should, after consulting their doctor, take a lower dose or increase the intervals between doses (dosing intervals).
  • Talk to your doctor or pharmacist before taking the product:
    • If you are taking medicines such as certain antidepressants or antipsychotics, the preparation may interact with these medicines and you may experience changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as an increase in body temperature above 38°C, Increase in heart rate, unstable blood pressure and exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).
  • A combined use of preparations with expectorant and antitussive effects can improve the therapy of productive coughs (coughs with sputum), whereby mucus solution is recommended during the day and cough suppression at night. In patients with a cough with significant mucus production (e.g. bronchiectasis or cystic fibrosis), as well as in patients with neurological diseases (stroke, Parkinson's disease, dementia) who have a significantly impaired cough reflex, the preparation should only be used after consulting a doctor because under these circumstances a lower sensitivity to cough stimuli with a decrease in cough frequency may be undesirable.
  • Chronic cough can be an early symptom of bronchial asthma, therefore this medicine is not indicated to suppress this cough - especially in children.
  • This medicine can cause dependence. Therefore, treatment should be short-term. For patients who are prone to drug abuse or drug dependence, treatment should therefore be carried out at short notice and under the strictest medical supervision.
  • Caution is also advised if you are prone to alcohol abuse or have suffered from psychiatric illnesses in the past.
  • Cases of dextromethorphan abuse, predominantly in adolescents, have been reported.
  • Children
    • Children under 6 years of age must not take the medicine. In children, serious adverse events, including neurological disorders, may occur in the event of an overdose. Caregivers must not exceed the recommended dose.

 

• Ability to drive and use machines
  • Even when used as intended, this medicine can often lead to slight tiredness and dizziness and can thereby change the ability to react to such an extent that the ability to actively participate in road traffic or to operate machines is impaired. This applies to an increased extent when combined with alcohol or medication, which in turn can impair the ability to react.

Pregnancy

• 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
  • Observations on humans have so far shown no evidence of fruit-damaging properties of dextromethorphan, but the available studies are not sufficient to make a final assessment of the safety of using dextromethorphan during pregnancy. Therefore, dextromethorphan may only be used after a strict benefit-risk assessment by the treating doctor and only in exceptional cases.
• Lactation
  • There are no studies on the transfer of dextromethorphan into breast milk. Since a respiratory inhibiting effect on the infant cannot be ruled out, dextromethorphan must not be used during breastfeeding.
• Reproductive ability
  • Non-clinical studies showed no effect of dextromethorphan on fertility.

Hints

Manufacturer:  Bolder Arzneimittel GmbH & Co. K, Rheinische Allee 11