MUCOSOLVAN

MUCOSOLVAN Inhalation Solution 15 mg Solution for Nebulizer

Important notes (mandatory information)

Mucosolvan Inhalation Solution 15 mg/2 ml solution for a nebuliser. Active ingredient: Ambroxol hydrochloride. Areas 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.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucosolvan Inhalation Solution 15 mg/2 ml solution for a nebuliser
Active ingredient: Ambroxol hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 4 - 5 days, talk to your doctor.

What this package leaflet contains

1. WHAT IS MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML?
3. HOW IS MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML AND WHAT IS IT USED FOR?

Mucosolvan Inhalation Solution 15 mg/2 ml is a medicine for thinning mucus in respiratory diseases with viscous mucus (expectorant). Mucosolvan Inhalation Solution 15 mg/2 ml is used for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML?

Mucosolvan Inhalation Solution 15 mg/2 ml must not be used if you are hypersensitive (allergic) to the active ingredient 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 this medicine. Since there is generally a risk of the respiratory muscles going into spasm during inhalation, Mucosolvan Inhalation Solution 15 mg/2 ml should not be used in patients with known hypersensitivity of the bronchial system and/or a known tendency to allergies. There have been reports of severe skin reactions in connection with the use of ambroxol hydrochloride. If you develop a rash (including damage to the mucous membranes in the mouth, throat, nose, eyes and genital area), please stop using Mucosolvan Inhalation Solution 15 mg/2 ml and seek medical advice immediately.

Patients with impaired kidney and liver function

If you have impaired kidney function or severe liver disease, Mucosolvan Inhalation Solution 15 mg/2 ml may only be used on the instructions of a doctor. As with any medicine that is metabolised by the liver and then excreted via the kidneys, an accumulation of the metabolites of ambroxol formed in the liver can be expected in the presence of severely impaired kidney function. In some rare diseases of the bronchi that are accompanied by excessive secretion accumulation (e.g. malignant ciliary syndrome), Mucosolvan Inhalation Solution 15 mg/2 ml should only be used under medical supervision due to a possible mucus blockage.

Children

Mucosolvan Inhalation Solution 15 mg/2 ml may only be used in children under 6 years of age on the instructions of a doctor. There is insufficient knowledge regarding a dosage recommendation for children under 6 years of age for inhalation of ambroxol. Mucosolvan Children's Juice 30 mg/5 ml and Mucosolvan Drops 30 mg/2 ml are available for children under 6 years of age.

Use of Mucosolvan Inhalation Solution 15 mg/2 ml together with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used or intend to take/use any other medicines.

Ambroxol/Antitussives

If Mucosolvan Inhalation Solution 15 mg/2 ml and cough suppressants (antitussives) are used at the same time, a dangerous mucus blockage can occur due to the restricted cough reflex, so that the two should only be used together after careful consideration of the benefits and risks.

Pregnancy, breast-feeding and

fertility

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

Pregnancy

Ambroxol reaches the unborn child. You should not use this medicine during pregnancy, especially not during the first 3 months.

Breast-feeding

The active ingredient ambroxol passes into breast milk in animal studies. Use during breast-feeding is not recommended.

fertility

Non-clinical studies have shown no evidence of harmful effects on fertility.

Driving and using machines

There is no evidence of an effect on driving and using machines; no corresponding studies have been carried out.

Mucosolvan Inhalation Solution 15 mg/2 ml contains benzalkonium chloride

Benzalkonium chloride can cause bronchospasms (spasmodic constrictions of the airways).

3. HOW IS MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults and children aged 6 years and over: Usually 1 - 2 times a day with 2 - 3 ml of inhalation solution (corresponding to 1 - 2 times a day 15 - 22.5 mg ambroxol hydrochloride) is inhaled. Notes: Mucosolvan Inhalation Solution 15 mg/2 ml is a solution for inhalation. Mucosolvan Inhalation Solution 15 mg/2 ml can be administered with all modern inhalation devices (e.g. compressor and ultrasonic nebulisers) that do not work on the steam boiler principle. Heating the solution to 80°C for 10 minutes does not affect the effect of the medicine. The inhalation solution is miscible with physiological saline solution and beta-sympathomimetics. Mucosolvan Inhalation Solution 15 mg/2 ml should not be mixed with cromoglicic acid. In order to achieve optimum humidification of the respiratory air, especially when used in a respirator, Mucosolvan Inhalation Solution 15 mg/2 ml should be mixed with physiological saline solution 1:1. Mucosolvan Inhalation Solution 15 mg/2 ml (pH value 5.0) should not be mixed with alkaline solutions (e.g. Emser salt solution), as this can lead to clouding or flocculation. 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. The inhalation solution should be warmed to body temperature before use. Please clean the measuring cup after use by rinsing it with warm water. If your symptoms worsen or if there is no improvement after 4 - 5 days, you should see a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Mucosolvan Inhalation Solution 15 mg/2 ml is too strong or too weak.

If you have used more Mucosolvan Inhalation Solution 15 mg/2 ml than you should

Specific symptoms of an overdose have not been reported to date. The symptoms of illness observed in the event of accidental overdose or medicinal product mix-ups correspond to the side effects that can occur at the recommended dosage (see section 4). In the event of an overdose, please contact a doctor, as treatment of the symptoms of illness may be necessary.

If you forget to use Mucosolvan Inhalation Solution 15 mg/2 ml

If you forget to use Mucosolvan Inhalation Solution 15 mg/2 ml once, or if you have used too little, please continue using Mucosolvan Inhalation Solution 15 mg/2 ml at the next time, as described in the dosage instructions.

If you stop using Mucosolvan Inhalation Solution 15 mg/2 ml

If treatment is stopped prematurely, the symptoms may worsen.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Mucosolvan Inhalation Solution 15 mg/2 ml can have side effects, although not everybody gets them.

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

Side effects

Immune system disorders:

• Rare: Hypersensitivity reactions.
• Not known: Allergic reactions up to and including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or tissue under the mucous membrane) and itching.

Skin and subcutaneous tissue disorders:

• Rare: Rash, hives.
• Not known: Severe skin reactions (including erythema multiforme, StevensJohnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Nervous system disorders:

• Common: Taste disturbances.

Gastrointestinal disorders:

• Common: Nausea, numbness in the mouth.
• Uncommon: Vomiting, diarrhoea, indigestion, abdominal pain, dry mouth.
• Rare: Dry throat.
• Very rare: Increased salivation.

Respiratory, thoracic and mediastinal disorders:

• Common: Numbness in the throat.
• Very rare: Shortness of breath and spasm of the respiratory muscles (mostly in patients with known hypersensitivity of the airways).
• Not known: Shortness of breath (as a sign of a hypersensitivity reaction).

General disorders and administration site conditions:

• Uncommon: Fever, mucous membrane reactions.

Countermeasures

Mucosolvan Inhalation Solution 15 mg/2 ml must not be used again at the first signs of a hypersensitivity reaction.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD MUCOSOLVAN INHALATION SOLUTION 15 MG/2 ML BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: This medicinal product does not require any special storage conditions. Note on shelf life after opening: The shelf life after opening the bottle is 6 months. Do not dispose of this medicine in waste water. Ask your pharmacist how to dispose of the medicine when you have finished using it. This helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mucosolvan Inhalation Solution 15 mg/2 ml contains

The active ingredient is: Ambroxol hydrochloride. 2 ml solution contain 15 mg ambroxol hydrochloride. The other ingredients are: Benzalkonium chloride, citric acid monohydrate, sodium monohydrogen phosphate dihydrate, sodium chloride, purified water.

What Mucosolvan Inhalation Solution 15 mg/2 ml looks like and contents of the pack

Mucosolvan Inhalation Solution 15 mg/2 ml is a clear, colourless to slightly brownish solution. Mucosolvan Inhalation Solution 15 mg/2 ml is available in original packs of 100 ml.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Sanofi Aventis
Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main
Telephone: 0800 56 56 010
Telefax: 0800 56 56 011
www.mucosolvan.de

Manufacturer

Istituto de Angeli, s.r.l.
Località Prulli, 103/c
50066 Reggello (Firenze)
Italy

This package leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Ambroxol hydrochloride. Areas of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.