Coryfin cough mucolytic

Package leaflet: Information for the patient

CORYFIN TOSSE MUCOLITICO 250 mg/5 ml syrup

carbocisteine
Please read all of this leaflet carefully before you start using 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 to do.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days for children and 14 days for adults.

Contents of this leaflet:

1. What CORYFIN TOSSE MUCOLITICO is and what it is used for
2. What you need to know before using CORYFIN TOSSE MUCOLITICO
3. How to use CORYFIN TOSSE MUCOLITICO
4. Possible side effects
5. How to store CORYFIN TOSSE MUCOLITICO
6. Contents of the pack and other information

1. What CORYFIN COUGH MUCOLYTIC is and what it is used for

CORYFIN COUGH MUCOLYTIC contains carbocisteine, a substance belonging to the group of medicines known as "mucolytics". It works, in respiratory disorders, by liquefying mucus secretions in the airways. By reducing mucus viscosity, these medicines promote its elimination from the body.
Consult your doctor if you do not feel better or feel worse after 14 days, or if your child does not feel better or feels worse after 7 days.

2. What you need to know before using CORYFIN COUGH MUCOLYTIC

Do not use CORYFIN COUGH MUCOLYTIC

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach or intestinal ulcer;
• if you are pregnant or breastfeeding;
• in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using CORYFIN COUGH MUCOLYTIC.
If your condition occurs repeatedly or if you have noticed any recent changes in its characteristics, consult your doctor.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, 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
Do not use this medicine in children under 2 years of age, as their respiratory tracts are not yet fully developed and this medicine may cause obstruction of their bronchi (bronchial obstruction), leading to breathing difficulties (see section 2 “Do not use CORYFIN COUGH MUCOLYTIC”).
Other medicines and CORYFIN COUGH MUCOLYTIC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine must not be used during pregnancy or breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
CORYFIN COUGH MUCOLYTIC contains:

• methyl parahydroxybenzoate: may cause allergic reactions (including delayed-type reactions).
• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. This medicine contains 6.3 g of sucrose per dose (15 ml). This should be taken into account in patients with diabetes mellitus.
• sodium: this medicine contains 36.85 mg of sodium (main component of table salt) per 5 ml dose and 110.55 mg of sodium per 15 ml dose. This corresponds to 1.84% and 5.53%, respectively, of the maximum daily dietary intake recommended for an adult.

3. How to use CORYFIN TOSSE MUCOLITICO

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults is 15 ml three times daily.
Use in children
The recommended dose in children aged 2 to 5 years is 5 ml twice daily.
The recommended dose in children aged 5 to 10 years is 15 ml twice daily.
Warning: Do not exceed the stated doses. Use only for short-term treatment.
CORYFIN TOSSE MUCOLITICO may also be taken for prolonged periods. However, if symptoms do not improve after 2 weeks of treatment in adults and after 7 days of treatment in children, it is recommended to consult a doctor.
Instructions for use:

For opening the bottle: press the cap downwards while unscrewing counterclockwise. For closing the bottle: screw the cap fully in clockwise direction.

If you use more CORYFIN TOSSE MUCOLITICO than you should
If you have taken an excessive dose of CORYFIN TOSSE MUCOLITICO syrup, inform your doctor immediately or go to the nearest hospital.
In case of overdose, you may experience headache, nausea, diarrhoea, or stomach ache (gastralgia).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
If any of the following side effects occur, stop treatment and contact your doctor immediately:

• swelling of the face and/or throat, itching, sudden drop in blood pressure (anaphylactic reaction);
• appearance of red spots or raised bumps (skin rash), which may be a sign of an allergic reaction;
• appearance of round red lesions with well-defined borders (fixed erythema).

If any of the following side effects occur, reduce the dose or discontinue treatment:

• dizziness;
• stomach discomfort (upper abdominal pain), nausea, diarrhea.

Bronchial obstruction (bronchial obstruction) may occur with this medicine, causing breathing difficulties.

• Skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption). In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.
• 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 https://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 CORYFIN TOSSE MUCOLITICO

Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CORYFIN COUGH MUCOLYTIC contains

• The active substance is carbocisteine. 5 ml of syrup contain 250 mg of carbocisteine.
• The other components are disodium phosphate dodecahydrate, methyl 4-hydroxybenzoate, sucrose, raspberry flavour, caramel, sodium hydroxide, purified water.

Description of the appearance of CORYFIN COUGH MUCOLYTIC and package contents
CORYFIN COUGH MUCOLYTIC is supplied in a dark glass bottle containing 200 ml of syrup, with a child-resistant closure cap and a graduated oral dosing dispenser.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 – 27035 Mede (PV).
Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Provinciale per Lecco, 78 - 22038 Tavernerio (CO).