Mucocis
Italy
Table of Contents
Package leaflet: Information for the patient
MUCOCIS Children 20mg/ml Syrup, Adults 50mg/ml Syrup
carbocisteine
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for 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, talk to your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not notice any improvement or if your symptoms worsen.
Contents of this leaflet:
- What MUCOCIS is and what it is used for
- What you need to know before taking MUCOCIS
- How to take MUCOCIS
- Possible side effects
- How to store MUCOCIS
- Contents of the pack and other information
1. What MUCOCIS is and what it is used for
MUCOCIS contains the active substance carbocisteine.
Carbocisteine belongs to a group of medicines called mucolytics, which help to liquefy mucus in the bronchi.
MUCOCIS is used in acute and chronic respiratory tract disorders.
2. What you need to know before taking MUCOCIS
Do not take MUCOCIS:
- if you are allergic to carbocysteine or to any of the other ingredients of this medicine listed in section 6;
- if you have gastrointestinal tract lesions (gastro-duodenal ulcers);
- if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").
MUCOCIS Children 20 mg/ml Syrup
Do not give this medicine to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOCIS.
Caution is recommended in elderly patients, in asthmatic patients with a history of severe respiratory disorders, in debilitated patients, in those with a history of gastroduodenal ulcers, or in those taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocysteine if gastrointestinal bleeding occurs.
This medicine must not be used concomitantly with cough suppressants and/or medicines that inhibit bronchial secretion.
Children
Mucolytic medicines such as carbocysteine may cause bronchial obstruction in children under 2 years of age. Therefore, MUCOCIS must not be administered to children under 2 years of age (see "Do not take MUCOCIS").
Other medicines and MUCOCIS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Based on current knowledge, no interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use MUCOCIS if you are or think you may be pregnant or if you are breastfeeding.
Driving and using machines
No effects of MUCOCIS on the ability to drive or operate machinery have been reported.
MUCOCIS contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
MUCOCIS contains methyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
3. How to take MUCOCIS
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:
MUCOCIS Adults 50 mg/ml Syrup
2 or 3 tablespoons per day.
These doses may be increased according to the doctor's prescription.
MUCOCIS Children 20 mg/ml Syrup
Children from 2 to 5 years: 1 teaspoon 2–3 times daily.
Children over 5 years: 1 teaspoon 3–4 times daily, depending on age.
These doses may be increased according to the doctor's prescription.
If you take more MUCOCIS than you should
If you have accidentally taken too much MUCOCIS, contact your doctor immediately or go to the nearest hospital.
Taking large amounts of carbocisteine may cause headache, nausea, diarrhoea, and abdominal pain. If you experience these symptoms, your doctor may advise you to induce vomiting and may perform gastric lavage.
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.
Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):
- Upper abdominal pain, nausea, diarrhoea.
Frequency not known (frequency cannot be estimated from the available data):
- Severe allergic reactions (anaphylactic reactions, allergic skin rashes, fixed drug eruption);
- Skin irritations and skin disorders (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme; toxic skin eruption, skin rash). (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.)
- Breathing difficulties due to bronchial obstruction. (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
- Epigastric discomfort;
- Dizziness;
- Vomiting, gastrointestinal bleeding. (In such cases, discontinue treatment and consult your 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 or pharmacist. You can also report side effects
directly through the national reporting system at the following website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store MUCOCIS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after {Exp.}. The expiry date refers to the last day of that month.
Store this medicine at room temperature.
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 MUCOCIS contains
The active substance is carbocisteine.
100 ml of MUCOCIS Adults 50 mg/ml Syrup contain 5 g of carbocisteine.
The other components are:
Sodium benzoate, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-
hydroxybenzoate, sucrose, vanillin, bur-caramel flavor, caramel E 150, purified water.
100 ml of MUCOCIS Children 20 mg/ml Syrup contain 2 g of carbocisteine.
The other components are:
Sodium benzoate, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate,
sucrose, vanillin, bur-caramel flavor, purified water.
Description of the appearance of MUCOCIS and contents of the pack
Carton pack containing one 200 ml glass bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome)
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy
Patient Information Leaflet
MUCOCIS 300 mg Granules for oral suspension
carbocysteine
Equivalent medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for 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 your symptoms worsen.
Contents of this leaflet:
- What MUCOCIS is and what it is used for
- What you need to know before taking MUCOCIS
- How to take MUCOCIS
- Possible side effects
- How to store MUCOCIS
- Contents of the pack and other information
7. What MUCOCIS is and what it is used for
MUCOCIS contains the active substance carbocisteine.
Carbocisteine belongs to a group of medicines called mucolytics, which help to liquefy mucus in the bronchi.
MUCOCIS is used in acute and chronic respiratory tract disorders.
8. What you need to know before taking MUCOCIS
Do not take MUCOCIS:
- if you are allergic to carbocisteine or to any of the other ingredients of this medicine listed in section 6;
- if you have gastrointestinal tract lesions (gastro-duodenal ulcers);
- if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding"). Do not give this medicine to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOCIS.
Caution is recommended in elderly patients, in asthmatic patients with a history of severe respiratory disorders, in debilitated patients, in those with a history of gastroduodenal ulcers, or in those taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine if gastrointestinal bleeding occurs.
This medicine must not be used concomitantly with cough suppressants and/or medicines that inhibit bronchial secretion.
Children
Mucolytic medicines such as carbocisteine may cause bronchial obstruction in children under 2 years of age. Therefore, MUCOCIS must not be administered to children under 2 years of age (see "Do not take MUCOCIS").
Other medicines and MUCOCIS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Based on current knowledge, no interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use MUCOCIS if you are or think you may be pregnant or if you are breastfeeding.
Driving and using machines
No effects of MUCOCIS on the ability to drive or operate machinery have been reported.
MUCOCIS contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.
9. How to take MUCOCIS
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:
Adults: 1 sachet 3–4 times daily.
Children: 1/2–1 sachet twice daily.
Dissolve the recommended doses in a glass containing two fingers’ width of water, stirring with a teaspoon.
If you take more MUCOCIS than you should
If you have accidentally taken an excessive dose of MUCOCIS, contact your doctor immediately or go to the nearest hospital.
Taking large amounts of carbocisteine may cause headache, nausea, diarrhoea, and abdominal pain. If you experience these symptoms, your doctor may advise you to induce vomiting and may perform gastric lavage.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
10. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):
- upper abdominal pain, nausea, diarrhoea.
Frequency not known (frequency cannot be estimated from the available data):
- dizziness;
- severe allergic reactions (anaphylactic reactions, allergic skin rashes, drug-induced fixed eruption);
- skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption; skin rash);
- breathing difficulties due to bronchial obstruction (bronchial obstruction); (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
- epigastric discomfort;
- vomiting;
- gastrointestinal bleeding (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.
11. How to store MUCOCIS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after {Exp}. The expiry date refers to the last day of that month.
Store this medicine at room temperature.
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.
12. Package contents and other information
What MUCOCIS contains
The active substance is carbocysteine.
One 5 g sachet of MUCOCIS 300 mg oral suspension granules contains 300 mg of carbocysteine.
The other components are:
Sodium bicarbonate, citric acid, colloidal silica, orange flavour, lemon flavour,
saccharin, sucrose.
Description of the appearance of MUCOCIS and contents of the pack
Carton containing 30 paper/aluminium/polyethylene laminate sachets of 5 g granules (300 mg active substance).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 - Pomezia (Rome)
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy