LISOMUCIL COUGH MUCOLYTIC UNIDIE

Patient Information Leaflet

Lisomucil Tosse Mucolitico Unidie 2.7 g granules for oral solution

Carbocysteine
Generic medicine
Please read this leaflet carefully before 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 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 your symptoms worsen.

Contents of this leaflet:

1. What Lisomucil Tosse Mucolitico Unidie is and what it is used for
2. What you need to know before taking Lisomucil Tosse Mucolitico Unidie
3. How to take Lisomucil Tosse Mucolitico Unidie
4. Possible side effects
5. How to store Lisomucil Tosse Mucolitico Unidie
6. Contents of the pack and other information

1. What Lisomucil Tosse Mucolitico Unidie 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, used to facilitate the elimination of mucus from the respiratory tract.
Lisomucil Tosse Mucolitico Unidie is indicated for the treatment of cough in acute and chronic respiratory diseases.

2. What you need to know before taking Lisomucil Tosse Mucolitico Unidie

Do not take Lisomucil Tosse Mucolitico Unidie

• 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 suffer from 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 (see section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lisomucil Tosse Mucolitico Unidie.
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 medications known to cause gastrointestinal bleeding. You must stop treatment with carbocysteine if gastrointestinal bleeding occurs.
This medicine should not be used in combination with cough suppressants and/or medicines that inhibit bronchial secretion.
There are no known effects of reduced efficacy after prolonged treatment or phenomena of dependence (need to continue taking the medicine) associated with the use of Lisomucil Tosse Mucolitico Unidie.
This medicine does not affect body weight, so you may take it if you are on a low-calorie diet or if you have diabetes.
Children
Lisomucil Tosse Mucolitico Unidie must not be given to children under 11 years of age.
Other medicines and Lisomucil Tosse Mucolitico Unidie
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 to treat diseases of the upper and lower respiratory tract are known.
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.
Pregnancy
Do not take Lisomucil Tosse Mucolitico Unidie during pregnancy.
Breastfeeding
If you are breastfeeding, do not take Lisomucil Tosse Mucolitico Unidie, as it is unknown whether this medicine passes into breast milk.
Driving and using machines
Lisomucil Tosse Mucolitico Unidie does not impair the ability to drive or operate machinery.
Lisomucil Tosse Mucolitico Unidie contains aspartame
This medicine contains 30 mg of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body's inability to properly metabolize it.

3. How to take Lisomucil Tosse Mucolitico Unidie

Take this medicine exactly as stated in this leaflet or according to your doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.
Do not mix Lisomucil Tosse Mucolitico Unidie with other products.
Instructions for use: dissolve the contents of the sachet in about half a glass of water and mix well.
The recommended dose is 1 sachet per day.
Duration of treatment: if symptoms persist beyond 14 days, the patient should consult their physician.
If you have kidney or liver problems, you may still take Lisomucil Tosse Mucolitico Unidie, as it is well tolerated.
If you take more Lisomucil Tosse Mucolitico Unidie than you should
In case of overdose, symptoms such as headache, nausea, vomiting, diarrhoea, stomach pain (gastralgia), skin irritations (cutaneous reactions), and altered sensory perceptions (sensory system disturbances) may occur.
In case of accidental ingestion or intake of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Lisomucil Tosse Mucolitico Unidie
Do not take a double dose to make up for the forgotten dose.
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 will experience them.
Contact your doctor if you experience any of the following side effects:

Frequency not known (frequency cannot be estimated from the available data)

• Skin irritations and skin disorders (skin rash, urticaria, erythema, dermatitis), possibly with spots, blisters or bullae (exanthema, bullous exanthema/erythema), severe skin reactions often with blisters or mucosal lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, erythema multiforme); toxic skin eruption, pruritus, swelling due to fluid accumulation around the eyes, mouth, tongue and throat, possibly causing breathing difficulties (angioedema) (in such cases, discontinue treatment and consult your doctor to initiate appropriate therapy);
• Abdominal pain, nausea, vomiting, diarrhoea, gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to initiate appropriate therapy);
• Dizziness;
• Flushing;
• Breathing difficulties (dyspnoea).

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/segnalazione-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lisomucil Tosse Mucolitico Unidie

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 store above 30°C.
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 Lisomucil Tosse Mucolitico Unidie 2.7 g oral solution granules contains

• The active substance is carbocisteine lysine salt monohydrate: each 5 g sachet contains 2.7 g of carbocisteine lysine salt.
• The other components are: mannitol, citric acid, povidone, aspartame (E951), cedar flavour, orange flavour, granular orange.

Description of the appearance of Lisomucil Tosse Mucolitico Unidie and the contents of the pack
Oral solution granules.
Pack sizes: 10 and 30 sachets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
Mipharm S.p.A., Via B. Quaranta, 12 – Milan, Italy