AMBROXOL Inhalat Lösung für einen Vernebler

Important notes (mandatory information)

Ambroxol Inhalat 15 mg/2 ml - solution for a nebuliser, pack of 20 x 2 ml Active ingredient: Ambroxol hydrochloride, area of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!

Patient information: Information for the user
Ambroxol Inhalat 15 mg/2 ml - solution for a nebuliser, pack of 20 x 2 ml
Active ingredient: Ambroxol hydrochloride

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, Ambroxol Inhalat must be used as directed in order to achieve the best possible treatment results.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If your symptoms worsen or do not improve after 4 - 5 days, you must consult a doctor.
- If any of the listed side effects affect you severely or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS AMBROXOL INHALAT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING AMBROXOL INHALAT?
3. HOW SHOULD AMBROXOL INHALAT BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD AMBROXOL INHALAT BE STORED?
6. FURTHER INFORMATION

1. WHAT IS AMBROXOL INHALAT AND WHAT IS IT USED FOR?
Ambroxol Inhalat is a medicine for dissolving mucus in respiratory diseases with viscous mucus (expectorant).

Area of application
- for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus

2. WHAT SHOULD YOU CONSIDER BEFORE USING AMBROXOL INHALAT?
Ambroxol Inhalat must not be used if you are hypersensitive (allergic) to the active ingredient ambroxol hydrochloride or any of the other ingredients of Ambroxol Inhalat.

Special care should be taken when using Ambroxol Inhalat,
- since there is generally a risk of the respiratory muscles going into spasm during inhalation. Therefore, the solution should not be used for inhalation in patients with known hypersensitivity of the bronchial system and/or a known tendency to allergies.
- Very rarely, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome has been reported in temporal connection with the use of Ambroxol. If skin and mucous membrane changes occur for the first time, medical advice should be sought immediately and the use of Ambroxol should be discontinued.
- Caution is advised in patients with histamine intolerance. Long-term therapy should be avoided in these patients, as Ambroxol Inhalat influences histamine metabolism and can lead to intolerance symptoms (e.g. headache, runny nose, itching).
- In patients with impaired renal and hepatic function. If you suffer from impaired renal function or severe liver disease, Ambroxol Inhalat may only be used with special caution (i.e. at longer intervals or in reduced doses). (see also section 3.2). In severe renal insufficiency, accumulation of the degradation products of Ambroxol formed in the liver must be expected.
- In some rare diseases of the bronchi, which are associated with excessive mucus accumulation (e.g. malignant ciliary syndrome), Ambroxol Inhalat should only be used under medical supervision due to a possible mucus congestion.
- Children
Ambroxol Inhalat may only be used in children under 2 years of age on doctor's orders.

When using Ambroxol Inhalat with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.

Ambroxol/Antitussives
When Ambroxol Inhalat and cough suppressants (antitussives) are used in combination, a dangerous mucus congestion can occur due to the restricted cough reflex, so that the indication for this

combination treatment should be made with particular care.
The simultaneous administration of Ambroxol and antibacterial substances (amoxicillin, cefuroxime, erythromycin, doxycycline) leads to an improved transfer of these antibiotics into the lung tissue.

When using Ambroxol Inhalat together with food and drink
There are no special features to be observed.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using any medicine.

Pregnancy
Since there is insufficient experience in humans to date, you should only use Ambroxol Inhalat during pregnancy on the orders of your doctor and only after your doctor has carefully weighed the benefits and risks.

Breast-feeding
The active ingredient in Ambroxol Inhalat passes into breast milk in animals. Since there is insufficient experience in humans to date, you should only use Ambroxol Inhalat during breast-feeding on the orders of your doctor.

Driving and operating machinery

There are no special features to be observed.

Important information about certain other ingredients of Ambroxol Inhalat
No information is necessary, as the other ingredients are only sodium chloride and water.

3. HOW SHOULD AMBROXOL INHALAT BE USED?

Always use Ambroxol Inhalat exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

- Children aged 0 - 2 years: 1 - 2 times a day 1 ml solution (= ½ single-dose container with 2 ml inhalation solution, corresponding to 7.5 - 15 mg ambroxol hydrochloride/day)
- Children aged 2 - 6 years: 1 - 2 times a day 2 ml solution (= 1 single-dose container with 2 ml inhalation solution, corresponding to 15 - 30 mg ambroxol hydrochloride/day)
- Children over 6 years of age and adults: 1 - 2 times a day 2 - 3 ml solution (= 1 - 1½ single-dose containers with 2 ml inhalation solution, corresponding to 15 - 45 mg ambroxol hydrochloride/day).
In the adult dosage, the effectiveness can be increased if necessary by administering 60 mg ambroxol hydrochloride twice a day (corresponding to 120 mg ambroxol hydrochloride/day). For the exact measurement of 1 ml and 3 ml, please use the enclosed measuring cup.

A measuring cup is enclosed. The manufacturer of the measuring cup is

Hugo Meding GmbH
Kruppstraße 8
D-58543 Halver

Method of application
For inhalation. Ambroxol Inhalat can be administered with all modern inhalation devices (e.g. compressor and ultrasonic nebulisers) that do not operate on the steam boiler principle. The PARI eFlow rapid inhalation device is recommended.

Note
In 1:1 mixtures of Ambroxol Inhalat with basic solutions, precipitation of Ambroxol base may occur under certain circumstances. The inhalation solution is miscible with beta-sympathomimetics. The inhalation solution is extremely well tolerated by the mucous membranes. Nevertheless, coughing may occur if the aerosols are inhaled too deeply. Therefore, normal inhalation and exhalation should be used when inhaling.

Duration of use
The duration of use depends on the type and severity of the disease and should be decided by the attending physician. Do not use Ambroxol Inhalat for more than 4 - 5 days without medical or dental advice. If your symptoms worsen or do 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 Ambroxol Inhalat is too strong or too weak.

If you have used more Ambroxol Inhalat than you should
Serious symptoms of poisoning have not been observed in the case of overdose of Ambroxol, the active ingredient in Ambroxol Inhalat. Short-term restlessness and diarrhoea have been reported.
In the event of accidental or intentional extreme overdose, increased salivation, gagging, vomiting and a drop in blood pressure may occur.
Contact a doctor. Acute measures, such as inducing vomiting and gastric lavage, are not generally indicated and should only be considered in the event of extreme overdose. Treatment is recommended according to the signs of overdose that occur.

If you forget to use Ambroxol Inhalat
Do not use a double dose if you have forgotten the previous application. Please continue using Ambroxol Inhalat at the next time, as described in the dosage instructions.

If you stop using Ambroxol Inhalat
Please do not stop treatment with Ambroxol Inhalat without consulting your doctor. Your illness could worsen as a result.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Ambroxol Inhalat can have side effects, although not everybody gets them. The following frequency categories are used to evaluate side effects

The following frequency categories are used to evaluate side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Generalised disorders
Uncommon: Hypersensitivity reactions (skin rash, mucous membrane reactions, facial oedema, shortness of breath, itching), fever
Very rare: severe allergic (anaphylactic) reactions up to and including shock

Gastrointestinal tract
Uncommon: Gastrointestinal complaints: (nausea, vomiting, abdominal pain), dry mouth
Very rare: intestinal sluggishness, difficulty urinating

Respiratory tract
Very rare: Increased nasal secretion, dryness of the airways, shortness of breath and spasm of the respiratory muscles (mostly in patients with known hypersensitivity of the airways

Urogenital tract
Very rare: Difficulty urinating

Please inform your doctor or pharmacist if any of the listed side effects affect you severely or if you notice any side effects not listed in this leaflet. At the first signs of a hypersensitivity reaction, Ambroxol Inhalat must not be taken again.

5. HOW SHOULD AMBROXOL INHALAT BE STORED?
Keep medicines out of the reach of children. Do not use the medicine after the expiry date stated on the single-dose container and on the folding box after "Use by". The expiry date refers to the last day of the month.
Ambroxol Inhalat does not contain a preservative. Opened single-dose containers are intended for single use only and must not be stored. The remaining quantity in the single-dose container after application must be discarded.
Do not store above 25°C and in the closed packaging to protect the contents from light.

Storage conditions

Do not store the unopened single-dose container above 25ºC. Store the unopened single-dose containers in the outer carton to protect the contents from light. Discard any remaining contents after use.

6. FURTHER INFORMATION

What Ambroxol Inhalat contains

The active ingredient is: Ambroxol hydrochloride. 1 single-dose container with 2.0 ml contains 15.0 mg ambroxol hydrochloride. The other ingredients are: Sodium chloride, water.

What Ambroxol Inhalat looks like and contents of the pack

Clear solution filled into single-dose containers

Ambroxol Inhalat is available in packs of
- 10 single-dose containers each with 2.0 ml; solution for a nebuliser
- 20 single-dose containers each with 2.0 ml ; solution for a nebuliser
- 50 single-dose containers each with 2.0 ml; solution for a nebuliser
- 100 single-dose containers each with 2.0 ml; solution for a nebuliser
available.

Pharmaceutical entrepreneur and manufacturer

Pharma Stulln GmbH
Werksstrasse 3
D-92551 Stulln
Telephone: +49 9435 / 3008 - 0
Telefax: +49 9435 / 3008 - 99
Internet: www.pharmastulln.de
E-Mail: info@pharmastulln.de

Co-distributor

Penta Arzneimittel GmbH
Werksstrasse 3
D-92551 Stulln
Telephone: +49 9435 / 307138
Telefax: +49 9435 / 307139
Internet: www.penta-arzneimittel.de
E-Mail: info@penta-arzneimittel.de

This leaflet was last revised in May 2011.

Source: www.Information from the package leaflet
Status: 08/2015
Active ingredient: Ambroxol hydrochloride, area of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.