Package leaflet: Information for the patient

KOFITUSS MUCOLYTIC 2.7g/10ml syrup

carbocisteine lysine salt monohydrate
Equivalent medicine
Please read 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 have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What KOFITUSS MUCOLYTIC is and what it is used for
What you need to know before taking KOFITUSS MUCOLYTIC
How to take KOFITUSS MUCOLYTIC
Possible side effects
How to store KOFITUSS MUCOLYTIC
Contents of the pack and other information

1. What KOFITUSS MUCOLYTIC is and what it is used for

This medicinal product contains the active substance carbocisteine lysine salt monohydrate, which belongs to a group of medicines called mucolytics, which work by liquefying mucus in the airways, thus facilitating its elimination. KOFITUSS MUCOLYTIC is indicated to facilitate the elimination of mucus (mucolytic effect) in acute and chronic respiratory tract diseases.

2. What you need to know before taking KOFITUSS MUCOLITICO

Do not take KOFITUSS MUCOLITICO

if you are allergic to carbocysteine lysine salt monohydrate or to any of the other ingredients of this medicine (listed in section 6);
if you have a stomach or intestinal condition called gastroduodenal ulcer;
if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
if the person taking this medicine is a child under 11 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking KOFITUSS MUCOLITICO.
There are no known phenomena of reduced efficacy of the medicine after prolonged treatment or dependence (need to continue taking the medicine) with the use of KOFITUSS MUCOLITICO.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, debilitated patients, those with a history of gastroduodenal ulcers, or 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
KOFITUSS MUCOLITICO must not be administered to children under 11 years of age (see section “Do not take KOFITUSS MUCOLITICO”).
Other medicines and KOFITUSS MUCOLITICO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No disturbances due to interactions with medicines used for the treatment of upper and lower respiratory tract diseases are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not take KOFITUSS MUCOLITICO during pregnancy.
Breastfeeding
The use of KOFITUSS MUCOLITICO is not recommended if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.
Driving and using machines
There is no available information to determine the effect of this medicine on the ability to drive vehicles or operate machinery.
KOFITUSS MUCOLITICO contains sucrose, methyl parahydroxybenzoate, and ethanol.
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars (such as hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency), contact your doctor before taking this medicine.
In addition, if you take this medicine for two or more weeks, it may be harmful to the teeth.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Alcohol
This medicine contains 96 mg of alcohol (ethanol) per dose (10 ml). The amount in 10 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to take KOFITUSS MUCOLYTIC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 1 single-dose container per day.
Your doctor will determine the duration of treatment and may decide to adjust the required dose and frequency of administration.

If you take more KOFITUSS MUCOLYTIC than you should
In case of overdose, the following may occur: headache, nausea, vomiting, diarrhoea, stomach pain (gastralgia), skin irritations (cutaneous reactions), and altered sensory perceptions (sensory system disturbances).
In case of accidental ingestion or overdose of KOFITUSS MUCOLYTIC, contact your doctor immediately or go to the nearest hospital.

If you forget to take KOFITUSS MUCOLYTIC
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of KOFITUSS MUCOLYTIC, 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:

Skin irritations and skin disorders (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin eruption, skin rash, urticaria, erythema, dermatitis), possibly with spots, blisters or vesicles (exanthema, exanthema/erythematous blistering), itching, swelling due to fluid accumulation around the mouth and eyes, possibly causing breathing difficulties (angioedema) (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
Abdominal pain, nausea, vomiting, diarrhoea, gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
Dizziness;
Flushing;
Difficulty breathing (dyspnoea).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report them directly via the national reporting system at: 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 KOFITUSS MUCOLYTIC

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.
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 used. This will help protect the environment.

6. Package contents and other information

What KOFITUSS MUCOLITICO contains

The active substance is carbocisteine lysine salt monohydrate: one 10 ml single-dose container of syrup contains 2.7 g of carbocisteine lysine salt.
The other components are: ethanol (96%), sucrose, strawberry flavour, vanilla flavour, methyl parahydroxybenzoate, purified water.

Description of the appearance of KOFITUSS MUCOLITICO and package contents
Carton pack containing 6 single-dose containers of 10 ml.
MARKETING AUTHORISATION HOLDER
POOL-PHARMA S.r.l.
Via Basilicata 9 – 20098 San Giuliano Milanese (MI)
MANUFACTURER
Francia Farmaceutici – Industria Farmaco Biologica S.r.l.
Via dei Pestagalli, 7
20138 Milano
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY – MM/YYYY