MUCOSOLVAN syr 30mg/5ml 100ml
MUCOSOLVAN 30 mg/5ml syrup
Ambroxol hydrochloride
MUCOSOLVAN® 30 mg/5ml 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, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet.
■ If you do not feel better or your condition worsens, you should seek medical attention.
1. What MUCOSOLVAN is and what it is used for
Ambroxol, the active ingredient of MUCOSOLVAN, supports the mucus secretion of the respiratory tract, facilitates expectoration and relieves coughing.
MUKOSOLVAN is used for the secretolytic treatment of acute and chronic diseases of the bronchi and lungs, occurring with abnormal bronchial secretion and impaired transportation of the secretion (sputum).
2. What you need to know before taking MUCOSOLVAN
Do not take MUCOSOLVAN if:
• you are allergic (hypersensitive) to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• you have rare congenital diseases that may lead to incompatibilities with any of the ingredients of this medicine (see also "MUCOSOLVAN contains sorbitol")
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOSOLVAN
• If you have impaired kidney function or severely impaired liver function.
Very rarely, serious and sometimes life-threatening drug reactions such as Stevens-Johnson Syndrome (a severe condition in which the top layer of the skin peels off) and toxic epidermal necrolysis (TEN, a severe disease accompanied by blistering of the skin) have been reported. It may affect also the eyes, mouth, throat and bronchial tree which are associated with taking mucolytics, such as ambroxol hydrochloride. If new skin or mucous membrane disorders appear, you should immediately seek medical advice and, as a precaution, stop using MUCOSOLVAN .
Other drugs 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 suppressant medicinal products is not recommended.
No clinically significant adverse interactions with other medicinal products have been reported.
Pregnancy and breastfeeding
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.
It is not recommended to use MUCOSOLVAN during pregnancy, especially during the first three months of pregnancy.
It is not recommended to use MUCOSOLVAN in breastfeeding women, because 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 conducted on the effects on the ability to drive and use machines.
MUCOSOLVAN contains sorbitol
Talk to your doctor before taking this medicine if you know you have an intolerance to some sugars.
5 ml of syrup contains 1.2 g of sorbitol, which corresponds to 4.9 g of sorbitol in the maximum recommended daily dose (20 ml). You should not take this medicinal product if you have a congenital intolerance to fructose.
3. How to take MUCOSOLVAN
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and children over 12 years: 10 ml 2 times a day.
This dosage is suitable for the treatment of acute diseases of the respiratory tract and for the initial therapy of chronic conditions for up to 14 days.
If, in the case of an acute respiratory disease, your symptoms do not improve during treatment with MUCOSOLVAN, you should seek medical help.
MUCOSOLVAN can be taken with or without food.
If you have taken more than the required dose of MUCOSOLVAN
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 improper use correspond to the known side effects when using MUCOSOLVAN in the recommended doses, and may require symptomatic treatment.
If you have forgotten to take MUKOSOLVLN
If you miss a dose, you can take it as soon as you remember. Do not take a double dose to make up for a missed dose. Take the next dose as usual.
If you have stopped taking MUCOSOLVAN
MUCOSOLVAN should be taken only when needed, and its use should be discontinued after the symptoms subside.
If you have any further questions related to 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 patients)
• change in taste sensations
• reduced sensitivity in the throat
• nausea
• reduced sensitivity in the mouth and tongue
Uncommon (may affect up to 1 in 100 patients)
• diarrhea
• vomiting
• digestive disorders
• dry mouth
• stomachache
Rare (may affect up to 1 in 1,000 patients)
• rash
• hives
Not known (frequency cannot be estimated from the available data):
• anaphylactic reactions (rapidly developing life-threatening allergic reaction), including anaphylactic shock (sudden, acute allergic reaction characterized by difficulty breathing, collapse of the circulatory system, sudden swelling).
• angioedema (sudden swelling of the skin or mucous membranes which may cause breathing difficulties)
• hypersensitivity
• itching
• dry throat
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.
5. How to store MUCOSOLVAN
Keep out of the reach of children. To be stored at a temperature below 30°C.
Do not use MUCOSOLVAN after the expiration date marked on the "Exp by:" card.
The expiration date corresponds to the last day of the specified month. The shelf life after first opening the package is 6 months.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What MUKOSOLVAN contains
• The active substance is: ambroxol hydrochloride (5 ml of syrup contain 30 mg of ambroxol hydrochloride)
• The other ingredients are: benzoic acid, hydroxyethylcellulose, acesulfame potassium, liquid sorbitol, glycerol 85%, strawberry flavoring, vanilla flavoring, purified water
Leaflet for the patient: 2020-07-01-119894q.pdf (bda.bg)
