Mucosolvan Anti-cough syrup for children 15 mg/5 ml x 100 ml Sanofi

MUCOSOLVAN syrup 15 mg / 5 ml for children
Leaflet: information for the user
MUCOSOLVAN 15 mg/5 ml syrup
Ambroxol hydrochloride
MUCOSOLVAN 15 mg/5 ml syrup
Ambroxol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

 Keep this leaflet. You may need to read it again.
 If you need further information or advice, ask your pharmacist.
 If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
 If you do not feel better after 4-5 days or your condition worsens, you should seek medical attention.

What this leaflet contains
1) What is MUCOSOLVAN and what is it used for?
2) What you need to know before taking MUCOSOLVAN
3) How to take MUCOSOLVAN
4) Possible side effects
5) How to store MUCOSOLVAN
6) Package contents and additional information
1. What MUCOSOLVAN is and what it is used for
Ambroxol, the active ingredient of MUCOSOLVAN, promotes mucus secretion in the respiratory tract, facilitates expectoration and relieves coughing.
MUCOSOLVAN is used for secretolytic treatment of acute and chronic diseases of the bronchi and lungs, occurring with abnormal bronchial secretion and impaired transport of secretions (phlegm).
2. What you need to know before you take MUCOSOLVAN Do not take MUCOSOLVAN if

 you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOSOLVAN

 If you have impaired kidney function or severely impaired liver function.

There have been reports of severe skin reactions associated with the use of ambroxol hydrochloride. If you develop a skin rash (including lesions of the mucous membranes, e.g. mouth, throat, nose, eyes, genitals), stop using MUCOSOLVAN and contact your doctor immediately.
Other medicines and MUCOSOLVAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The use of ambroxol hydrochloride with cough suppressants is not recommended.
No clinically significant adverse interactions with other medicinal products have been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
The use of MUCOSOLVAN is not recommended during pregnancy, especially during the first three months of pregnancy.
The use of MUCOSOLVAN is not recommended in breastfeeding women, as ambroxol hydrochloride passes into breast milk.
Driving and using machines
There is no evidence from post-marketing data regarding an effect on the ability to drive and use machines. No studies have been performed on the effects on the ability to drive and use machines.
3. How to take MUCOSOLVAN
Always take this medicine exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Children 6-12 years: 5 ml 2-3 times daily
Children 2-5 years: 2.5 ml 3 times daily
Children under 2 years: 2.5 ml 2 times daily
It is recommended that MUCOSOLVAN syrup for children be used in children under 2 years of age after consultation with a doctor or pharmacist.
If in the case of an acute respiratory illness, your symptoms do not improve after 4-5 days of treatment with MUCOSOLVAN, you should seek medical attention.
MUCOSOLVAN can be taken with or without food.
If you take more MUCOSOLVAN than you should
If you have taken more than the required dose of MUCOSOLVAN, contact your doctor or pharmacist for advice. No specific symptoms of overdose in humans have been reported so far. The symptoms observed in reports of accidental overdose or misuse correspond to the known adverse reactions to the use of MUCOSOLVAN at recommended doses, and may require symptomatic treatment.
If you forget to take MUCOSOLVAN
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
If you stop taking MUCOSOLVAN
Mucosolvan should be taken only when needed, and its use should be discontinued after symptoms subside.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)

 change in taste sensations;
 decreased sensitivity in the throat;
 nausea;
 decreased sensitivity in the mouth and tongue.

Uncommon (may affect up to 1 in 100 people)

diarrhea;
vomiting;
 digestive disorders;
 dry mouth;
 stomach pain.

Rare (may affect up to 1 in 1,000 people)

 hypersensitivity reactions;
rash;
 urticaria (hives).

Not known (frequency cannot be estimated from the available data):

 anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal layer) and pruritus;
 severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
 Dry throat.

Reporting side effects
If you get any side effects, please tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly by:
Executive Agency for Medicines
8 Damyan Gruev Street, 1303 Sofia
Tel.:+359 2 8903417
website: www.bda.bg.
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store MUCOSOLVAN
Keep out of the reach of children. Store below 30°C.
Do not use MUCOSOLVAN after the expiry date which is stated on the carton after „EXP“.
The expiry date corresponds to the last day of the month stated. The expiry date after first opening the packaging is 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information What MUCOSOLVAN contains

 The active substance is: ambroxol hydrochloride (5 ml syrup contains 15 mg ambroxol hydrochloride)
 The other ingredients are: sucralose, benzoic acid, hydroxyethylcellulose, berry flavor, vanilla flavor, purified water.

What MUCOSOLVAN looks like and what the pack contains
MUCOSOLVAN is a clear to almost clear, colorless to almost colorless, slightly viscous syrup. 100 ml dark glass bottle of PG hydrolytic grade with a polypropylene cap. The package contains a polypropylene measuring cup, graduated in measures of 1.25 ml, 2.5 ml and 5 ml.
Marketing Authorisation Holder
SANOFI BULGARIA EOOD, Bulgaria
Manufacturers
Delpharm Reims, France
or
Boehringer Ingelheim, Spain
or
Sanofi, Italy
This leaflet was last revised in: January 2019.