Ambrobene® 7,5 mg/ml - Lösung

Ambroxol hydrochloride, the active substance in Mucosolvan 7.5 mg / 1 ml - solution, dissolves congested and stubbornly adhering secretions from the bronchial wall and makes coughing up easier.

Application

What is Ambrobene 7.5 mg/ml - solution and what is it used for? Ambroxol hydrochloride, the active substance in Ambrobene 7.5 mg/ml – solution, dissolves congested and stubbornly adhering secretions from the bronchial wall and makes coughing up easier.

Ambrobene 7.5 mg/ml – solution is used together with plenty of fluids for the mucolytic treatment of acute and chronic diseases of the bronchi and lungs.

If you do not feel better or even feel worse after 4 to 5 days, contact your doctor.

What should you consider before taking it?

What should you consider before using Ambrobene 7.5 mg/ml - solution?

Ambrobene must not be used,

- if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Ambrobene,  

- if you suffer from a stomach and/or intestinal ulcer,

- if you suffer from severe kidney or liver dysfunction.

In these cases, you may only use Ambrobene 7.5 mg/ml - solution after consulting your doctor.

Severe skin reactions have been reported in connection with the use of ambroxol hydrochloride. If you develop a skin rash (including damage to the mucous membranes in the mouth, throat, nose, eyes and genital area), please stop using Ambrobene 7.5 mg/ml - solution and seek medical advice immediately. During the early phase of some of these serious skin diseases, non-specific flu-like symptoms such as fever, body aches, runny nose, cough and sore throat may appear first. If you experience such symptoms, consult a doctor immediately.

Using Ambrobene 7.5 mg/ml - solution with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. No significant interactions are known. In general, it is not recommended to combine expectorants such as ambroxol with antitussives due to the risk of secretion congestion.

In laboratory tests, the simultaneous administration of ambroxol hydrochloride, the active substance in Ambrobene 7.5 mg/ml - solution, 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, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Ambroxol hydrochloride passes into the placenta. The use of Ambrobene 7.5 mg/ml - solution during pregnancy, especially during the first 3 months, is not recommended.

Breast-feeding

Ambroxol hydrochloride passes into breast milk in animal studies. The use of Ambrobene 7.5 mg/ml - solution is therefore not recommended during breast-feeding.

Driving and using machines

There is no evidence of an effect on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been conducted.

How to take the medicine?

How to use Ambrobene 7.5 mg/ml - solution?

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

For oral use and inhalation.

The recommended dose is:

For oral use

Adults and adolescents over 12 years:	On the first 2 to 3 days of treatment, 4 ml 3 times daily, then 2 ml 3 times daily. In severe cases, taking 4 ml 3 times daily can be continued after consulting your doctor.
Children from 6 to 12 years:	2 ml 2 to 3 times daily
Children from 2 to 6 years:	1 ml 3 times daily
Infants up to 2 years:	1 ml 2 times daily

Children

Ambrobene 7.5 mg/ml - solution may only be used in infants under 2 years of age on medical advice. Use the enclosed measuring cup with milliliter (ml) graduations for measuring. The solution can be diluted with tea, fruit juice, milk or water. You can use Ambrobene 7.5 mg/ml - solution independently of meals.

Patients with impaired kidney and/or liver function

In case of severe kidney impairment or severe liver impairment, you must consult your doctor before use.

Duration of use

If your symptoms worsen or if there is no improvement after 4 to 5 days, consult a doctor.

Note: The mucolytic effect of Ambrobene 7.5 mg/ml - solution is supported by plenty of fluid intake.

For inhalation

Adults, adolescents and children over 6 years:	1 to 2 inhalations with 2 to 3 ml of solution per day
Infants and children under 6 years:	1 to 2 inhalations with 2 ml of solution per day

Inhale using a suitable inhalation device (observe instructions for use).

Before inhaling, you should warm Ambrobene 7.5 mg/ml - solution to body temperature. If you suffer from asthma, you should use your asthma medication before inhaling.

Inhaling can trigger a cough reflex. Therefore, you should breathe in and out without effort.

If only one inhalation per day is possible, Ambrobene 7.5 mg/ml - solution should additionally be administered orally.

If you have taken more Ambrobene 7.5 mg/ml - solution than you should

Based on reports of accidental overdose and/or incorrect use, the observed symptoms are consistent with the known side effects at the recommended dosage.

If an overdose of Ambrobene 7.5 mg/ml - solution is suspected, contact a doctor immediately.

Note for healthcare professionals

Information on overdose can be found at the end of the package leaflet.

If you forget to use Ambrobene 7.5 mg/ml - solution

Continue the application at the next scheduled time. Do not use a double amount if you forgot the previous application.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What side effects are possible?

Common (may affect up to 1 in 10 people):

- changes in taste perception

- numbness in the throat

- nausea, numbness in the mouth

Uncommon (may affect up to 1 in 100 people):

- vomiting, diarrhea, indigestion (dyspepsia), abdominal pain, dry mouth, constipation

Rare (may affect up to 1 in 1,000 people):

- hypersensitivity reactions, such as skin rash, mucosal reactions,

- temperature increase with chills

- runny nose, skin rash, hives

- difficulty urinating

- headache, weakness

Not known (frequency cannot be estimated from the available data):

- allergic reactions (sudden wheezing, skin rash, fainting, difficulty swallowing, shortness of breath), anaphylactic shock

- angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or tissue under the mucous membrane, especially of the face, lips, tongue, throat)

- itching

- skin redness with blistering or peeling of the skin. Possibly severe blistering and bleeding on the lips, eyes, mouth, nose and genitals. These can be signs of serious skin conditions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis.

- dryness of the throat

Reporting of side effects

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can

also report side effects directly via the
Federal Office for Safety in Health Care
Traisengasse 5
1200 VIENNA
AUSTRIA
Fax: + 43 (0) 50 555 36207
Website: www.basg.gv.at
By reporting side effects, you can help provide more information on the safety of this medicine.

Special storage instructions

How to store Ambrobene 7.5 mg/ml - solution?

This medicine does not require any special storage conditions. Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton/label after: "EXP:". The expiry date refers to the last day of that month.

Can be used for 1 year after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Special notes on content

Contents of the pack and other information

What Ambrobene 7.5 mg/ml - solution contains

- The active substance is ambroxol hydrochloride. 1 ml of solution (= approx. 14 drops) contains 7.5 mg of ambroxol hydrochloride.

- The other ingredients are: potassium sorbate, hydrochloric acid 25%, purified water.

What Ambrobene 7.5 mg/ml - solution looks like and contents of the pack

Clear, colorless, odorless solution for oral use or for a nebulizer.

Packs of 40 and 100 ml. A measuring cup with graduations for 1, 2, 3, 4, 5 and 6 ml is enclosed.