neo-bronchol® cough lozenges
Product Characteristics
Patient information
Please read this leaflet carefully, because it contains important information that you should be aware of when taking this medicine. If you have any questions, or if you are not sure about anything, please ask your doctor or pharmacist.
neo-bronchol®
Active ingredient: ambroxol hydrochloride
Composition:
1 lozenge contains:
Active ingredient:
ambroxol hydrochloride 15.0 mg
Excipients :
Sorbitol solution 70%, non crystallising, acacia, light liquid paraffin, saccharin sodium, flavouring, water.
Note for diabetics: 1 lozenge contains 922.2 mg dry matter from sorbitol solution 70%, non crystallising, (equivalent to approx. 0.08 carbohydrate units).
Presentation and contents:
Pack of 20 lozenges.
Indications/Mode of action:
Medication for liquefaction of mucus in respiratory tract diseases with viscous mucus (expectorant).
Divapharma-Knufinke
Arzneimittelwerk GmbH
12274 Berlin
Tel. 030/72002-266
Indications:
For the mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.
Ambroxol-containing drugs must be administered to children below 2 years of age only under medical supervision.
Contraindications:
In which cases is it not indicated to use neo-bronchol®?
Do not use neo-bronchol® in the presence of a known hypersensitivity to ambroxol hydrochloride, the active ingredient in neo-bronchol®, or to any of the other ingredients.
In which cases is it indicated to use neo-bronchol® only after consulting your doctor?
The following describes when neo-bronchol® should be taken only under certain circumstances and only with particular caution. Please ask your doctor for advice. You should also do so if this information has ever applied to you.
If you suffer from renal dysfunction or a serious liver disease, particular caution is required when taking neo-bronchol® (e.g. longer ingestion intervals or a lower dose).
In a number of rare bronchial diseases associated with a build-up of excess secretion (e.g. malignant ciliary syndrome), neo-bronchol® should be used with particular caution, i.e. under medical supervision, because of possible secretion retention.
This medicinal product contains sorbitol. If taken as directed, each dose delivers up to 1.84 g sorbitol.
In babies and infants, sorbitol-containing drugs should be used only after consulting the treating physician because of the possibility of a hitherto unrecognised congenital fructose intolerance. A health risk also exists in adolescents and adults with hereditary fructose intolerance. These patients should use the drug only after consulting the treating physician.
What must you be aware of during pregnancy and breast-feeding?
During pregnancy, particularly the first three months, and when breast-feeding, neo-bronchol® should be used only after a careful assessment of the risk-to-benefit ratio, because insufficient experience has been obtained to date in human subjects.
What should you be aware of in children?
neo-bronchol® is not suitable for children below 6 years of age because of the high active-ingredient content. Medication in the form of juices/syrups with a lower active-ingredient content is available for this age group.
Drug interactions:
What other medication affects the action of neo-bronchol®?
Please note that this information may also apply to recently used drugs.
Concomitant use of neo-bronchol® and cough-suppressing medication may cause dangerous secretion retention because of the impairment of the coughing reflex, so combination treatment should be administered only if strictly indicated.
What other drugs are affected by neo-bronchol®?
Concomitant ingestion of neo-bronchol® and antibacterial agents (amoxicillin, cefuroxim, erythromycin, doxycycline) may enhance penetration of the antibiotics into the lung tissue.
Dosage instructions, mode and duration of administration:
The following information applies unless your doctor has otherwise prescribed neo-bronchol®. Please adhere to the directions, otherwise neo-bronchol® will not be able to work properly.
How often and in what quantities should you take neo-bronchol®?
Children from 6 to 12 years of age:
Generally, 1 lozenge should be sucked 2 - 3 times daily (equivalent to 15 mg ambroxol hydrochloride 2 - 3 times daily).
Adults and children over 12 years of age:
Generally, 2 lozenges should be sucked 3 times daily for the first 2 - 3 days (equivalent to 30
mg ambroxol hydrochloride 3 times daily), thereafter 1 lozenge 3 times daily (equivalent to 15 mg ambroxol hydrochloride 3 times daily).
Note for diabetics:
1 lozenge contains 922.2 mg dry matter from sorbitol solution 70 %, non-crystallising, (equivalent to approx. 0.08 carbohydrate units).
N.B.:
If you suffer from renal dysfunction or a serious liver disease, neo-bronchol® must be taken at longer intervals or at a lower dose.
When and how should you take neo-bronchol®?
The lozenges are sucked after meals.
N.B.:
The mucolytic effect of neo-bronchol® is enhanced by fluid intake.
For how long should you take neo-bronchol®?
The duration of administration depends on the type and severity of the condition and should be decided by the treating physician.
Do not take neo-bronchoI® for more than 4 - 5 days without medical advice.
Overdosage and other ingestion errors:
What should you do if you have taken too much neo-bronchol® (intentional or accidental overdosage)?
No symptoms of intoxication have been observed with ambroxol overdosage. Short-lived restlessness and diarrhoea have been reported. In the case of accidental or intentional extreme overdosage, increased salivation, retching, vomiting and hypertension may occur.
Consult a doctor. Acute measures, such as induction of vomiting and washing out of the stomach, are not generally indicated and should be considered only in cases of extreme overdosage. Treatment of the symptoms of the overdosage is recommended.
What must you do if you have taken too little neo-bronchol® or forgotten to take a dose?
If you have forgotten to take neo-bronchol® or have taken too little, continue to take as directed from the next dose onwards.
Side effects:
What side effects may occur with use of neo-bronchol®?
The following side effects may occur in rare cases:
Gastrointestinal disorders (e.g. nausea and abdominal pain), intolerance reactions (allergic reactions) of the skin and mucous membranes (e.g. swelling, rash, redness, itching), shortness of breath, facial swelling, raised temperature with shivering.
Dryness of the mouth and airways, increased saliva flow, increased nasal secretions, constipation and difficult urination may also occur in rare cases after administration of neo-bronchol®.
In single cases, sudden, severe hypersensitivity reactions associated with severe circulatory disturbances may occur (anaphylactic shock). In this case, immediate medical advice must be sought.
There has been one report of allergic skin inflammation (contact dermatitis).
If you notice any side effects not mentioned in this package leaflet, please inform your doctor or pharmacist.
What countermeasures should be taken if side effects occur?
neo-bronchol® must be discontinued at the first signs of a hypersensitivity reaction. Tell your doctor, so that he or she can assess the severity and decide what further action, if any, should be taken.
Storage information:
The shelf-life of this pack is printed on the box and the blister pack. Do not use this pack after this date.
How should you store neo-bronchol®?
Protect neo-bronchol® from light and do not store above 25° C.
Store away from children!
Date of information: September 2000
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neo-bronchol® cough lozenges is available in the following countries:
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