Mucosolvan 7,5 mg / 1 ml - solution

Ambroxol hydrochloride, the active ingredient in Mucosolvan 7.5 mg / 1 ml - solution, dissolves congested and tenacious secretions from the bronchial wall and facilitates coughing.

Application

What is Mucosolvan and what is it used for?

Ambroxol hydrochloride, the active ingredient in Mucosolvan 7.5 mg / 1 ml - solution, dissolves congested and tenacious secretions from the bronchial wall and facilitates coughing.

Mucosolvan 7.5 mg / 1 ml - solution is used together with plenty of fluids for mucolytic treatment in acute and chronic diseases of the bronchi and lungs.

How is it used?

What is Mucosolvan and what is it used for?

Ambroxol hydrochloride, the active ingredient in Mucosolvan 7.5 mg / 1 ml - solution, dissolves congested and tenacious secretions from the bronchial wall and facilitates coughing.

Mucosolvan 7.5 mg / 1 ml - solution is used together with plenty of fluids for mucolytic treatment in acute and chronic diseases of the bronchi and lungs.

What should you consider before taking it?

What should you consider before using Mucosolvan?

Mucosolvan 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 Mucosolvan,

• if you suffer from severe kidney or liver dysfunction.

In these cases, you may only use Mucosolvan 7.5 mg / 1 ml - solution after consulting your doctor.

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 7.5 mg / 1 ml - solution and seek medical advice immediately.

Use of Mucosolvan together with other medicines
Tell 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 studies, the simultaneous administration of ambroxol hydrochloride, the active ingredient in Mucosolvan 7.5 mg / 1 ml - solution and certain medicines for 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 breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
The use of Mucosolvan 7.5 mg / 1 ml - solution during pregnancy, especially during the first 3 months, is not recommended.

Ambroxol hydrochloride passes into breast milk. The use of Mucosolvan 7.5 mg /
1 ml - solution is therefore not recommended during breastfeeding.

Driving and using machines
Based on data available after marketing, there is no evidence of an effect on driving and using machines. No studies on the effects on driving and using machines have been performed.

Mucosolvan contains benzalkonium chloride
Mucosolvan 7.5 mg / 1 ml - solution contains the preservative benzalkonium chloride. When inhaled, benzalkonium chloride can cause bronchospasm.

Mucosolvan 7.5 mg / 1 ml - solution contains 42.8 mg sodium in the recommended daily dose. If you need to follow a controlled low-sodium diet, you should take this into account.

How should the medicine be taken?

How to use Mucosolvan?

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

For oral and inhalation use.

The recommended dose is:

For oral use

Adults and
On the first 2-3 days of treatment 4 ml 3 times a day, then 3 times a day Adolescents over 12 years:
2 ml.
In severe cases, taking 4 ml 3 times a day can be continued after consulting your doctor.

Children from 6 to 12 years:	2-3 times a day 2 ml
Children from 2 to 6 years:	3 times a day 1 ml
Toddlers up to 2 years:	2 times a day 1 ml

Children
Mucosolvan 7.5 mg / 1 ml - solution should only be used in children under 2 years of age on medical advice.

Use the enclosed measuring cup with milliliter (ml) graduation to measure. The
solution can be diluted with tea, fruit juice, milk or water. You can
Mucosolvan 7.5 mg / 1 ml - solution regardless of meals.

Patients with impaired renal and/or hepatic function
In case of severe renal impairment or severe hepatic impairment, you must consult your doctor before taking it, as your doctor may reduce the dose or extend the dose interval accordingly.

Duration of use
If your condition worsens or does not improve after 4-5 days, you should see a doctor.

Note
The mucolytic effect of Mucosolvan 7.5 mg / 1 ml - solution is supported by plenty of fluid intake.

For inhalation

Adults, adolescents

and children over 6 years:	1-2 inhalations with 2-3 ml solution per day
Toddlers and children
under 6 years:	1-2 inhalations with 2 ml solution per day

You must not mix Mucosolvan 7.5 mg / 1 ml - solution with solutions containing cromoglycic acid or with saline solutions for inhalation (e.g. Emser Salz).

You can administer Mucosolvan 7.5 mg / 1 ml - solution with all modern inhalation devices (except steam inhalers). Please also refer to the operating instructions for your nebulizer.

When using Mucosolvan 7.5 mg / 1 ml - solution with a nebulizer with
breathing mask, you can add physiological saline solution to the solution in a ratio of 1:1, which results in optimal humidification of the breathing air.

Before inhaling, you should warm Mucosolvan 7.5 mg / 1 ml - solution to body temperature. If you have asthma, you should first use your asthma medication before inhaling.

Inhalation can trigger a cough. Therefore, you should breathe in and out without straining.

If only one inhalation per day is possible, Mucosolvan 7.5 mg / 1 ml - solution should also be administered orally.

If you have used more Mucosolvan than you should

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

If you suspect an overdose of Mucosolvan 7.5 mg / 1 ml - solution, a doctor should be consulted immediately.

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

If you forget to use Mucosolvan
Continue using it at the next time. Do not use double the amount if you have forgotten the previous application.

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

What side effects are possible?

How to store Mucosolvan?

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 label and carton after "use by:". The expiry date refers to the last day of the month indicated.

Usable for 1 year after opening.

Do not use Mucosolvan 7.5 mg / 1 ml - solution if you notice the following:

• a significant coloration.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage instructions

How to store Mucosolvan?

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 label and carton after "use by:". The expiry date refers to the last day of the month indicated.

Usable for 1 year after opening.

Do not use Mucosolvan 7.5 mg / 1 ml - solution if you notice the following:
­ a significant coloration.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Mucosolvan contains

• The active ingredient is: ambroxol hydrochloride. 1 ml solution contains 7.5 mg ambroxol hydrochloride.
• The other ingredients are: benzalkonium chloride, citric acid,
  sodium monohydrogen phosphate dihydrate, sodium chloride, purified water

How Mucosolvan looks like and contents of the pack
Clear, colorless to slightly brownish solution

Brown glass bottles with polyethylene closure to 100 ml. A measuring cup made of polystyrene with milliliter (ml) graduation is enclosed.