Mucolase
Italy
Table of Contents
Package leaflet: Information for the patient
MUCOLASE 1.5 g granules for oral solution
Carbocisteine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms.
- Contents of this leaflet:
- What MUCOLASE is and what it is used for
- What you need to know before taking MUCOLASE
- How to take MUCOLASE
- Possible side effects
- How to store MUCOLASE
- Contents of the pack and other information
1. What MUCOLASE is and what it is used for
MUCOLASE contains the active substance carbocisteine, which belongs to the class of medicines known as mucolytics (substances that dissolve mucus, facilitating its elimination).
MUCOLASE is used as a mucolytic and fluidifying agent in acute and chronic respiratory tract disorders.
Consult your doctor if you do not feel better or if you feel worse.
2. What you need to know before taking MUCOLASE
Do not use MUCOLASE
- if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6).
- if you have gastroduodenal ulcer (stomach and intestinal ulcer).
- during pregnancy and breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOLASE.
An increase in sputum (phlegm), which may occur from the first few days and indicates the breakdown of pathological secretions, decreases rapidly.
Other medicines and MUCOLASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines have been reported.
Pregnancy and breastfeeding
The use of MUCOLASE is contraindicated during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
MUCOLASE does not affect the ability to drive vehicles or operate machinery.
MUCOLASE contains:
- sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
- sodium. This medicine contains 14 mmol (or 322 mg) of sodium per maximum adult dose; this should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.
3. How to take MUCOLASE
Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 sachets per day (one in the morning and one in the evening) during the acute phase,
to be subsequently reduced to one sachet per day according to the doctor's judgment.
Dissolve the contents of one sachet in half a glass of still (non-carbonated) water.
If you take more MUCOLASE than you should
Symptoms due to overdose may include: headache, stomach ache, nausea, diarrhoea.
In case of overdose, induce vomiting and, if necessary, perform gastric lavage followed by specific supportive therapy.
If you or someone else has accidentally taken an excessive dose of MUCOLASE, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following may occur: dizziness, stomach upset, nausea, diarrhoea. In such cases, the dosage should be reduced.
Additionally, allergic skin rashes and anaphylactic reactions, as well as fixed erythema, may occur. In such cases, discontinue treatment and consult a doctor to establish appropriate therapy.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the following address:
https://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store MUCOLASE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the product in its original, undamaged packaging, properly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What MUCOLASE contains
- The active substance is carbocysteine. Each sachet contains 1.5 g of carbocysteine.
- The other components are: Glycine, Sodium bicarbonate, Sodium saccharin, Orange flavour, Lemon flavour, E 110, Sucrose.
Description of the appearance of MUCOLASE and package contents
Granules for oral solution – 20 sachets.
Marketing Authorization Holder
LAMPUGNANI FARMACEUTICI S.p.A.
Nerviano (MI) - Via Gramsci, 4.
Manufacturer
FINE FOODS & PHARMACEUTICALS NTM S.p.A. - Brembate (BG)
Patient Information Leaflet
MUCOLASE 50 mg/ml syrup
Carbocysteine
Read this entire leaflet carefully before taking this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen.
- Contents of this leaflet:
- What MUCOLASE is and what it is used for
- What you need to know before taking MUCOLASE
- How to take MUCOLASE
- Possible side effects
- How to store MUCOLASE
- Package contents and other information
1. What MUCOLASE is and what it is used for
MUCOLASE contains the active substance carbocisteine, which belongs to the class of medicines known as mucolytics (substances that dissolve mucus, facilitating its elimination).
MUCOLASE is used as a mucolytic and liquefying agent in acute and chronic respiratory tract disorders.
Consult your doctor if you do not feel better or if you feel worse.
2. What you should know before taking MUCOLASE
Do not use MUCOLASE
- if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6).
- if you have gastroduodenal ulcers (stomach or intestinal ulcers).
- during pregnancy or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOLASE.
An increase in sputum (phlegm), which may occur from the first few days and indicates the breakdown of pathological secretions, usually decreases rapidly.
Other medicines and MUCOLASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines have been reported.
Pregnancy and breastfeeding
The use of MUCOLASE is contraindicated during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
MUCOLASE does not affect the ability to drive vehicles or operate machinery.
MUCOLASE contains:
- sucrose. This medicine contains 22.5 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus;
- methyl parahydroxybenzoate. May cause allergic reactions (including delayed reactions);
- sodium. This medicine contains 7.5 mmol (or 172 mg) of sodium per daily dose for adults. This should be taken into account in patients with impaired renal function or those on a low-sodium diet.
3. How to take MUCOLASE
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults:
The recommended dose is 2–3 tablespoons per day. This dose may be increased according to medical prescription.
If you take more MUCOLASE than you should
Symptoms of overdose may include: headache, stomach ache, nausea, diarrhoea.
In case of overdose, induce vomiting and, if necessary, perform gastric lavage followed by specific supportive therapy.
In the event of accidental ingestion/overdose of an excessive amount of MUCOLASE, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following may occur: dizziness, stomach discomfort, nausea, diarrhoea. In such cases, the dosage should be reduced.
In addition, allergic skin rashes and anaphylactic reactions, as well as fixed erythema, may occur. In such cases, treatment must be discontinued and a doctor should be consulted to establish appropriate therapy.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at the website https://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store MUCOLASE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the product in its original packaging, properly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What MUCOLASE contains
- The active substance is carbocisteine. 100 ml contain 5 g of carbocisteine.
- The other components are: Sodium hydrate, Sucrose, Citric acid, Natural cherry flavour, Methyl p-hydroxybenzoate, Purified water.
Description of the appearance of MUCOLASE and contents of the pack
50 mg/ml syrup – 200 ml bottle.
Marketing Authorization Holder
LAMPUGNANI FARMACEUTICI S.p.A.
Nerviano (MI) - Via Gramsci, 4.
Manufacturer
COSMO S.p.A. – Via C. Colombo, 1 – Lainate (MI)