MUCOSOLVAN

MUCOSOLVAN cough syrup sachets 30 mg/5 ml

Important notes (mandatory information)

Mucosolvan 1-a-day sustained-release capsules 75 mg hard capsule, sustained-release. Active ingredient: Ambroxol hydrochloride. Areas of application: Mucus solution in respiratory diseases with viscous mucus (expectorant).

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


PACKAGE LEAFLET: INFORMATION FOR USERS

MUCOSOLVAN 1-a-day sustained-release capsules
For use in adults and adolescents aged 12 and over
Active ingredient: Ambroxol hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

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

What this package leaflet contains

1. WHAT ARE MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES?
3. HOW TO TAKE MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES AND WHAT ARE THEY USED FOR?

MUCOSOLVAN 1-a-day sustained-release capsules are a medicine for mucus solution in respiratory diseases with viscous mucus (expectorant). MUCOSOLVAN 1-a-day sustained-release capsules are used for the mucus-dissolving treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES?

MUCOSOLVAN 1-a-day sustained-release capsules must not be taken,

• if you are hypersensitive (allergic) to the active substance ambroxol hydrochloride or any of the other ingredients of this medicine listed in section 6.
• by children under 12 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before taking this medicine.

There have been reports of serious skin reactions 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 MUCOSOLVAN 1-a-day sustained-release capsules and seek medical advice immediately.

Patients with impaired renal and hepatic function

If you have impaired renal function or severe liver disease, MUCOSOLVAN 1-a-day sustained-release capsules should only be taken on the instructions of a doctor. As with any medicine that is metabolised by the liver and then excreted via the kidneys, accumulation of the metabolites of ambroxol formed in the liver can be expected in the presence of severely impaired renal function.

In some rare diseases of the bronchi that are associated with excessive mucus accumulation (e.g. malignant ciliary syndrome), MUCOSOLVAN 1-a-day sustained-release capsules should only be used under medical supervision due to a possible mucus congestion.

Children

MUCOSOLVAN 1-a-day sustained-release capsules are not suitable for children under 12 years of age due to the high active ingredient content. MUCOSOLVAN children's juice 30 mg/5 ml and MUCOSOLVAN drops 30 mg/2 ml are available for this age group.

Taking MUCOSOLVAN 1-a-day sustained-release capsules 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

In the case of combined use of MUCOSOLVAN 1-a-day sustained-release capsules and cough suppressants (antitussives), a (dangerous) mucus congestion can occur in patients with existing respiratory diseases that are associated with increased mucus production, such as cystic fibrosis or bronchiectasis, due to the reduced cough reflex.

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 taking this medicine.

Pregnancy

Ambroxol reaches the unborn child. Clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the unborn child. Nevertheless, you should not take this medicine during pregnancy, especially not during the first 3 months.

Breast-feeding

The active substance ambroxol passes into breast milk in animal studies. Even if no harmful effects on the child are to be expected, use during breast-feeding is not recommended.

Fertility

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

Driving and using machines

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

3. HOW TO TAKE MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES?

Always take 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 adolescents aged 12 and over: 1 sustained-release capsule once a day (equivalent to 75 mg ambroxol hydrochloride/day).

Method and duration of use

MUCOSOLVAN 1-a-day sustained-release capsules are taken with or without food, swallowed whole with plenty of liquid (e.g. water, tea or fruit juice).

If your condition worsens or does 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 MUCOSOLVAN 1-a-day sustained-release capsules is too strong or too weak.

If you have taken more MUCOSOLVAN 1-a-day sustained-release capsules than you should

Specific symptoms of an overdose have not been reported to date. The symptoms observed in the event of accidental overdose or drug mix-up 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 may be necessary.

If you forget to take MUCOSOLVAN 1-a-day sustained-release capsules

If you forget to take MUCOSOLVAN 1-a-day sustained-release capsules once, or if you have taken too little, please continue taking MUCOSOLVAN 1-a-day sustained-release capsules at the next time as described in the dosage instructions.

If you stop taking MUCOSOLVAN 1-a-day sustained-release capsules

Premature discontinuation of treatment may worsen symptoms.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, MUCOSOLVAN 1-a-day sustained-release capsules 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 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Side effects

Immune system disorders

Rare: Hypersensitivity reactions
Not known: Allergic reactions up to 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: Skin rash, hives
Not known: Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis)

Gastrointestinal disorders

Common: Nausea
Uncommon: Vomiting, diarrhoea, indigestion, abdominal pain
Very rare: increased salivation

Respiratory, thoracic and mediastinal disorders

Not known: Shortness of breath (as a sign of a hypersensitivity reaction)

General disorders and administration site conditions

Uncommon: Fever, mucous membrane reactions

Countermeasures

At the first signs of a hypersensitivity reaction, MUCOSOLVAN 1-a-day sustained-release capsules must not be taken again.

Reporting of side effects

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

5. HOW SHOULD MUCOSOLVAN 1-A-DAY SUSTAINED-RELEASE CAPSULES 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 blister and carton after "Use by". The expiry date refers to the last day of the month indicated.

Storage conditions

Do not store above 30 °C.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What MUCOSOLVAN 1-a-day sustained-release capsules contain

The active substance is: Ambroxol hydrochloride.

1 sustained-release hard capsule contains 75 mg ambroxol hydrochloride.

The other ingredients are

Capsule contents

Crospovidone
Carnauba wax
Stearyl alcohol
Magnesium stearate

Capsule shell

Gelatine
Purified water
Titanium dioxide (E 171)
Iron oxides (E 172)

Capsule inscription

Shellac
Titanium dioxide (E 171)

How MUCOSOLVAN 1-a-day sustained-release capsules look like and contents of the pack

Hard capsules with orange lower part and reddish-brown upper part with the inscription "MUC 01"

MUCOSOLVAN 1-a-day sustained-release capsules are available in packs of 10 sustained-release hard capsules, 20 sustained-release hard capsules and 50 sustained-release hard capsules.

Pharmaceutical entrepreneur

A. Nattermann & Cie. GmbH
Brüningstraße 50
65929 Frankfurt am Main
Telephone: 0800 56 56 010
Telefax: 0800 56 56 011

Manufacturer

Delpharm Reims
10 Rue Colonel Charbonneaux
51100 Reims
France

This package leaflet was last revised in July 2023.

Source: Information from the package leaflet
Status: 09/2024
Active ingredient: Ambroxol hydrochloride. Areas of application: Mucus solution in respiratory diseases with viscous mucus (expectorant).