Ambroxol hydrochloride, the active ingredient in Ambroxol Genericon, loosens congested and tenaciously adhering secretions from the bronchial wall, making it easier to cough them up.

Application

1. WHAT IS AMBROXOL GENERICON AND WHAT IS IT USED FOR?

Ambroxol hydrochloride, the active ingredient in Ambroxol Genericon, loosens congested and tenaciously adhering secretions from the bronchial wall, making it easier to cough them up.

Ambroxol Genericon is used for the expectorant treatment of acute and chronic diseases of the respiratory tract (bronchi and lungs) with thick mucus.
If you do not feel better or even worse after 5 days, consult your doctor.

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How is it applied?

WHAT IS AMBROXOL GENERICON AND WHAT IS IT USED FOR?

Ambroxol hydrochloride, the active ingredient in Ambroxol Genericon, loosens congested and tenaciously adhering secretions from the bronchial wall, making it easier to cough them up.

Ambroxol Genericon is used for the expectorant treatment of acute and chronic diseases of the respiratory tract (bronchi and lungs) with viscous mucus.
If you do not feel better or even worse after 5 days, consult your doctor.

What should you pay attention to before taking it?

What SHOULD YOU BE AWARE OF BEFORE TAKING AMBROXOL GENERICON ?

Ambroxol Genericon must not be taken,

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• If you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine listed in section 6.
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• of children under 12 years of age due to the high active substance content.

Warnings and precautions.
Please talk to your doctor or pharmacist before taking Ambroxol Genericon,
- if you have severe kidney or liver dysfunction.

In these cases, you must only take Ambroxol Genericon after consulting your doctor.

Very rarely, the occurrence of severe skin reactions in temporal relation to the treatment of ambroxol has been reported. These included extensive skin rashes associated with itching, flu-like symptoms (fever, chills, joint pain, cough, cold, sore throat), skin peeling and changes in blood counts (Stevens-Johnson syndrome and toxic epidermal necrolysis). If you develop a skin rash (including mucous membrane damage in the mouth, throat, nose, eyes and genital area), please stop using Ambroxol Genericon and seek medical advice immediately.
In some rare bronchial diseases associated with excessive accumulation of secretions (e.g. malignant cilia syndrome), Ambroxol Genericon must only be used under medical supervision because of a possible build-up of secretions.

Children
Ambroxol Genericon 60 mg soluble tablets are not suitable for children under 12 years of age because of the high content of the active substance. For this purpose, Ambroxol Genericon is available in the form of juice and solution with a lower active substance content.

Taking Ambroxol Genericon with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

No significant interactions are known.

In laboratory tests, the simultaneous administration of ambroxol hydrochloride, the active ingredient of Ambroxol Genericon 60 mg soluble tablets, and certain medicines against infections (the antibiotics amoxicillin, cefuroxime, doxycycline and erythromycin) leads to a higher antibiotic concentration in the bronchial mucus and sputum.

Pregnancy and breastfeeding.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

The use of Ambroxol Genericon is not recommended during pregnancy, especially during the first 3 months.

Ambroxol hydrochloride passes into breast milk. The use of Ambroxol Genericon is therefore not recommended during breast-feeding.

Driving ability and ability to operate machinery.
There is no evidence to suggest that the ability to drive or operate machinery is affected.

Ambroxol Genericon contains sodium.
One soluble tablet of Ambroxol Genericon contains 5.50 mmol (126.54 mg) of sodium. This corresponds to 6.33 % of the maximum daily dietary sodium intake recommended for an adult. If you have to follow a low-salt diet, you should take this into account.

Ambroxol Genericon contains lactose and sorbitol.
This medicine contains lactose and sorbitol. Therefore, please only take Ambroxol Genericon after consulting your doctor if you know that you suffer from a sugar intolerance.

How should the medicine be taken?

HOW TO TAKE AMBROXOL GENERICON?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults and adolescents over 12 years of age
is ½ tablet 2 to 3 times daily (corresponding to 30 mg ambroxol hydrochloride 2 to 3 times daily)
.glich 30 mg Ambroxolhydrochlorid)
It may be possible to increase the effect by taking 1 tablet 2 times daily (corresponding to 60 mg Ambroxolhydrochlorid 2 times daily).
Use in children
Ambroxol Genericon 60 mg soluble tablets are not suitable for children under 12 years of age because of the high content of active substance. For this purpose, Ambroxol Genericon is available in the form of juice and solution with a lower active substance content.

Use in patients with impaired renal and/or hepatic function
In cases of severe renal impairment or severe hepatic impairment, you must consult your doctor before use, as your doctor may reduce the dose accordingly or increase the interval between applications.

Mode of administration
To be taken by dissolving.
The tablet may be divided into equal doses.

Ambroxol Genericon is dissolved in a glass of water and may be taken with meals or independently.

Note:
The expectorant effect of Ambroxol Genericon is improved by hydration (juice, tea, water).

If you have taken a larger amount of Ambroxol Genericon than you should
To date, no particular symptoms have been reported in the event of overdose.

Note to doctor:
For overdose information, see the end of the leaflet.

If you forget to take Ambroxol Genericon
Continue taking it at the next time. Do not take double the amount if you have forgotten to take it before.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

HOW TO STORE AMBROXOL GENERICON?

Do not store above 30 °C. Close the tubes tightly immediately after use until the cap clearly clicks into place!

Store this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube bottom after "Use by:". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. HOW TO STORE AMBROXOL GENERICON?

Do not store above 30 °C. Close the tubes tightly immediately after use until the cap clearly clicks into place!

Store this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the bottom of the tube after "EXP". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

PACKAGE CONTENTS AND FURTHER INFORMATION

What Ambroxol Genericon contains

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• The active ingredient is: ambroxol hydrochloride.
  Each soluble tablet contains 60 mg ambroxol hydrochloride.
• The other ingredients are: Anhydrous citric acid, sodium hydrogen carbonate,
  anhydrous sodium carbonate, saccharin sodium, sodium cyclamate, sodium chloride,
  sodium citrate dihydrate, anhydrous lactose, mannitol (E421), sorbitol (E420), cherry flavouring "ALH" code 801, simeticon
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What Ambroxol Genericon looks like and contents of the pack.
Ambroxol Genericon are white, round tablets with a break notch on one side for making an oral solution.
Ambroxol Genericon is available in original packs of 20.