MUCOSOLVAN

MUCOSOLVAN Syrup 30 mg/5 ml

Important notes (mandatory information)

Mucosolvan Cough Syrup 30 mg/5 ml. Active ingredient: Ambroxol hydrochloride. Areas of application: is used for the 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 Cough Syrup 30 mg/5 ml, oral solution
Active ingredient: Ambroxol hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, because 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 if you feel worse after 4–5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS MUCOSOLVAN COUGH SYRUP 30 MG/5 ML AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOSOLVAN COUGH SYRUP 30 MG/5 ML?
3. HOW SHOULD MUCOSOLVAN COUGH SYRUP 30 MG/5 ML BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MUCOSOLVAN COUGH SYRUP 30 MG/5 ML BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MUCOSOLVAN COUGH SYRUP 30 MG/5 ML AND WHAT IS IT USED FOR?

Mucosolvan Cough Syrup 30 mg/5 ml is a medicine for dissolving mucus in respiratory diseases with viscous mucus (expectorant). Mucosolvan Cough Syrup 30 mg/5 ml is used for the mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOSOLVAN COUGH SYRUP 30 MG/5 ML?

Mucosolvan Cough Syrup 30 mg/5 ml must not be taken if you are hypersensitive (allergic) to the active ingredient ambroxol hydrochloride or any of the other ingredients listed in section 6 of this medicine.

Warnings and precautions

Please talk to your doctor or pharmacist before taking this medicine. In very rare cases, severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have been reported in temporal connection with the use of substances with mucolytic effect (expectorants) such as ambroxol hydrochloride. In most cases, these could be explained by the underlying disease of the patients and/or the concomitant medication. In addition, in the initial stage of Stevens-Johnson syndrome or TEN, non-specific flu-like symptoms such as fever, aching limbs, rhinitis, cough and sore throat may occur. Due to these non-specific initial flu-like symptoms, symptomatic treatment with cough and cold medicines may be started incorrectly. Therefore, if new skin or mucous membrane lesions occur, medical advice should be sought immediately and the use of ambroxol hydrochloride should be discontinued.

Patients with impaired renal and hepatic function

If you have impaired renal function or severe liver disease, Mucosolvan Cough Syrup 30 mg/5 ml should only be taken on medical advice. 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 secretion accumulation (e.g. malignant ciliary syndrome), Mucosolvan Cough Syrup 30 mg/5 ml should only be used under medical supervision due to a possible mucus congestion.

Children

Mucosolvan Cough Syrup 30 mg/5 ml should only be used in children under 2 years of age on medical advice.

Taking Mucosolvan Cough Syrup 30 mg/5 ml 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 Cough Syrup 30 mg/5 ml is used together with cough suppressants (antitussives), a dangerous mucus congestion may occur due to the restricted cough reflex, so that the concomitant use should only take place 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 taking this medicine.

Pregnancy

Ambroxol reaches the unborn child. You should not take 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 conducted.

Mucosolvan Cough Syrup 30 mg/5 ml contains sorbitol

This medicine contains approx. 1.2 g sorbitol per 5 ml (equivalent to 4.9 g per maximum recommended daily dose). Please only take Mucosolvan Cough Syrup 30 mg/5 ml after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW SHOULD MUCOSOLVAN COUGH SYRUP 30 MG/5 ML BE TAKEN?

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:

• Children up to 2 years: only on medical advice. 2.5 ml of solution are taken twice a day (equivalent to 15 mg ambroxol hydrochloride/day).
• Children from 2 to 5 years: 3 times a day, 1.25 ml of solution each (equivalent to 22.5 mg ambroxol hydrochloride/day).
• Children from 6 to 12 years: 2–3 times a day, 2.5 ml of solution each (equivalent to 30–45 mg ambroxol hydrochloride/day).
• Adults and adolescents from 12 years: Usually 3 times a day, 5 ml of solution each (equivalent to 90 mg ambroxol hydrochloride/day) are taken during the first 2–3 days, then 2 times a day, 5 ml of solution each (equivalent to 60 mg ambroxol hydrochloride/day) are taken.

For adults and adolescents from 12 years, the effectiveness can be increased if necessary by taking 2 times a day, 10 ml of solution each (equivalent to 120 mg ambroxol hydrochloride/day).

• 0–2 years: Only on medical advice 2 x 1.25 ml,
• 2–5 years: 3 x 1.25 ml,
• 6–12 years: 2–3 x 2.5 ml,
• From 12 years: 3 x 5 ml on the first 2–3 days, then

Type and duration of use

Mucosolvan Cough Syrup 30 mg/5 ml is an oral solution. Mucosolvan Cough Syrup 30 mg/5 ml is taken with or independently of meals using the enclosed dosing aid (measuring cup). 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 Cough Syrup 30 mg/5 ml is too strong or too weak.

If you have taken more Mucosolvan Cough Syrup 30 mg/5 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 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 of illness may be necessary.

If you forget to take Mucosolvan Cough Syrup 30 mg/5 ml

If you have forgotten to take Mucosolvan Cough Syrup 30 mg/5 ml once, or have taken too little, please continue taking Mucosolvan Cough Syrup 30 mg/5 ml at the next time, as described in the dosage instructions.

If you stop taking Mucosolvan Cough Syrup 30 mg/5 ml

If treatment is discontinued prematurely, the symptoms may worsen.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Mucosolvan Cough Syrup 30 mg/5 ml can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of 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, skin and subcutaneous tissue disorders

Rare: rash, hives.
Not known: swelling of the skin and mucous membranes, itching, severe allergic (anaphylactic) reactions up to shock, other hypersensitivity reactions.

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.
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 Cough Syrup 30 mg/5 ml must not be taken again at the first signs of a hypersensitivity reaction.

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 provide more information about the safety of this medicine.

5. HOW SHOULD MUCOSOLVAN COUGH SYRUP 30 MG/5 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: After opening the bottle, the shelf life is 6 months. Do not dispose of this medicine in waste water. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mucosolvan Cough Syrup 30 mg/5 ml contains

The active ingredient is: ambroxol hydrochloride. 5 ml of solution contain 30 mg of ambroxol hydrochloride. The other ingredients are: benzoic acid, sorbitol solution 70 % (non-crystallising), hydroxyethylcellulose, glycerol 85 %, acesulfame potassium, flavourings, purified water. Notes: Mucosolvan Cough Syrup 30 mg/5 ml is suitable for diabetics. 5 ml of solution correspond to 0.1 BE. Mucosolvan Cough Syrup 30 mg/5 ml does not contain alcohol.

What Mucosolvan Cough Syrup 30 mg/5 ml looks like and contents of the pack

Mucosolvan Cough Syrup 30 mg/5 ml is a colourless liquid with a fruity odour in a brown glass bottle with a child-resistant screw cap. Mucosolvan Cough Syrup 30 mg/5 ml is available in packs of 100 ml and 250 ml.

The enclosed dosing aid (measuring cup) is a medical device and bears the CE marking 0459. Manufacturer of the dosing aid: UNION PLASTIC, Z.A. Robert - B.P. 27, F-43140 Saint Didier en Velay.

Child-resistant bottle closure

1. Remove measuring cup from the cap
2. Press the cap down to open
3. Turn the cap in the direction of the arrow at the same time

Marketing Authorisation Holder

Boehringer Ingelheim Pharma GmbH & Co. KG
Thomae Sales Line
Binger Str. 173
55216 Ingelheim am Rhein
Telephone: 0 800/77 90 900
Telefax: 0 61 32/72 99 99
www.Mucosolvan.de

Manufacturer

Boehringer Ingelheim España S.A.
Prat de la Riba, 50
08174 Sant Cugat del Valles (Barcelona)
Spain

This package leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 09/2016
Active ingredient: Ambroxol hydrochloride. Areas of application: is used for the mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.