Tusselim expectorant cough

Patient Information Leaflet

TUSSELIM FLUIDIFICANTE TOSSE 2.7 g granules for oral solution

Carbocisteine lysine salt monohydrate
Generic medicine
Please read all of 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 effect, including any 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 TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for
  2. What you need to know before taking TUSSELIM FLUIDIFICANTE TOSSE
  3. How to take TUSSELIM FLUIDIFICANTE TOSSE
  4. Possible side effects
  5. How to store TUSSELIM FLUIDIFICANTE TOSSE
  6. Contents of the pack and other information

1. What TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for

This medicinal product contains the active substance carbocisteine and is indicated to facilitate the elimination of mucus (mucolytic) 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 TUSSELIM FLUIDIFICANTE TOSSE

Do not take TUSSELIM FLUIDIFICANTE TOSSE

• if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lesion in the wall of the stomach or the first part of the intestine known as a peptic ulcer;
• if the child to be treated is under 11 years of age;
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
There are no known effects of reduced efficacy of the medicine after prolonged treatment or dependence (need to continue taking the medicine) with the use of TUSSELIM FLUIDIFICANTE TOSSE.
This medicine does not affect body weight, so it can be taken if you are on a low-calorie diet or if you have diabetes.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, debilitated patients, in those with a history of peptic ulcers, or in those taking medicines known to cause gastrointestinal bleeding. You must stop treatment with carbocysteine if gastrointestinal bleeding occurs.
This medicine must not be used in combination with cough suppressants and/or medicines that inhibit bronchial secretion.
Children
TUSSELIM FLUIDIFICANTE TOSSE must not be taken by children under 11 years of age (see section "Do not take TUSSELIM FLUIDIFICANTE TOSSE").
Other medicines and TUSSELIM FLUIDIFICANTE TOSSE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known with medicines used to treat upper and lower respiratory tract diseases.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take TUSSELIM FLUIDIFICANTE TOSSE during pregnancy.
Breastfeeding
The use of TUSSELIM FLUIDIFICANTE TOSSE is contraindicated if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.
Driving and using machines
No negative effects of the medicine on the ability to drive or operate machinery have been reported.
TUSSELIM FLUIDIFICANTE TOSSE contains aspartame
This medicine contains 30 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria: a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

3. How to take TUSSELIM FLUIDIFICANTE TOSSE

Take 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.
Dosage
The recommended dose is one sachet per day. Do not exceed the stated doses. Use only for short treatment periods.
TUSSELIM FLUIDIFICANTE TOSSE may also be taken for prolonged periods; in such cases, it is advisable to follow your doctor's advice.
Your doctor will determine the duration of treatment and may decide to change the required dose and frequency of administration.
Method of administration
Dissolve the contents of one sachet in about half a glass of water, stirring well.
If you take more TUSSELIM FLUIDIFICANTE TOSSE 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 overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take TUSSELIM FLUIDIFICANTE TOSSE
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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Contact your doctor if you experience any of the following adverse reactions:

• skin redness (rash);
• skin reactions (urticaria);
• skin redness (erythema);
• skin redness with blisters (bullous erythema);
• 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);
• skin irritations (dermatitis);
• skin rash (exanthema);
• itching;
• swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema);
• abdominal pain;
• gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• nausea;
• vomiting;
• diarrhoea;
• dizziness;
• flushing;
• difficulty breathing (dyspnoea).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store TUSSELIM FLUIDIFICANTE TOSSE

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.
Store below 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 TUSSELIM COUGH FLUIDIFIER 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, anhydrous citric acid, povidone, aspartame (E951), cedar flavour, orange flavour, granular orange.

Description of the appearance of TUSSELIM COUGH FLUIDIFIER and contents of the pack
TUSSELIM COUGH FLUIDIFIER is a granular formulation for oral solution.
Pack containing 10 sachets of 5 g.
Marketing Authorization Holder
Farmitalia S.r.l
Via Pinciana 25
00198 Rome
Manufacturer
Mipharm S.p.A.
Via B. Quaranta, 12 – 20139 Milan

Patient Information Leaflet

TUSSELIM FLUIDIFICANTE TOSSE 2.7 g granules for oral solution

Carbocysteine 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 others, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for
  2. What you need to know before taking TUSSELIM FLUIDIFICANTE TOSSE
  3. How to take TUSSELIM FLUIDIFICANTE TOSSE
  4. Possible side effects
  5. How to store TUSSELIM FLUIDIFICANTE TOSSE
  6. Contents of the pack and other information

1. What TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for

This medicine contains the active substance carbocisteine and is indicated for facilitating the elimination of mucus (mucolytic) in acute and chronic respiratory tract disorders.

2. What you need to know before taking TUSSELIM FLUIDIFICANTE TOSSE

Do not take TUSSELIM FLUIDIFICANTE TOSSE

• if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lesion of the stomach or first part of the intestine wall known as a peptic ulcer;
• if the child to be treated is under 11 years of age;
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking TUSSELIM FLUIDIFICANTE TOSSE.
There are no known phenomena of reduced effectiveness of the medicine after prolonged treatment (tolerance) or dependence (need to continue taking the medicine) with the use of TUSSELIM FLUIDIFICANTE TOSSE.
This medicine does not affect body weight, so it can be taken if you are on a low-calorie diet or if you have diabetes.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, debilitated patients, in those with a history of peptic ulcers, or in those taking medicines known to cause gastrointestinal bleeding. You must stop treatment with carbocysteine if gastrointestinal bleeding occurs.
This medicine must not be used in combination with cough suppressants and/or medicines that inhibit bronchial secretion.

Children
TUSSELIM FLUIDIFICANTE TOSSE must not be taken by children under 11 years of age (see section “Do not take TUSSELIM FLUIDIFICANTE TOSSE”).

Other medicines and TUSSELIM FLUIDIFICANTE TOSSE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known with medicines used to treat upper and lower respiratory tract diseases.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take TUSSELIM FLUIDIFICANTE TOSSE during pregnancy.

Breastfeeding
TUSSELIM FLUIDIFICANTE TOSSE is contraindicated if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Driving and using machines
No negative effects of the medicine on the ability to drive vehicles or operate machinery have been reported.

TUSSELIM FLUIDIFICANTE TOSSE contains aspartame
This medicine contains 30 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.

3. How to take TUSSELIM FLUIDIFICANTE TOSSE

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Dosage
The recommended dose is 1 sachet per day. Your doctor will determine the duration of treatment and may decide
to adjust the required dose and frequency of administration based on your clinical condition.
Method of administration
Dissolve the contents of one sachet in about half a glass of water, stirring well.
If you take more TUSSELIM FLUIDIFICANTE TOSSE 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.
If you accidentally ingest or take an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital.
If you forget to take TUSSELIM FLUIDIFICANTE TOSSE
Do not take a double dose to make up for the missed 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 experiences them.
Contact your doctor if you experience any of the following side effects:

• skin redness (rash);
• skin reactions (urticaria);
• redness of the skin (erythema);
• skin redness with blisters (bullous erythema);
• 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);
• skin irritation (dermatitis);
• skin rash (exanthema);
• itching;
• swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema);
• abdominal pain;
• gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• nausea;
• vomiting;
• diarrhoea;
• dizziness;
• flushing;
• difficulty breathing (dyspnoea).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: 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 TUSSELIM FLUIDIFICANTE TOSSE

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.
Store below 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 TUSSELIM FLUIDIFICANTE TOSSE 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, anhydrous citric acid, povidone, aspartame (E951), cedar flavour, orange flavour, granular orange.

Description of the appearance of TUSSELIM FLUIDIFICANTE TOSSE and the contents of the pack
TUSSELIM FLUIDIFICANTE TOSSE is a granular preparation for oral solution.
Pack containing 30 sachets of 5 g.
Marketing Authorization Holder
Farmitalia S.r.l
Via Pinciana 25
00198 Rome
Manufacturer
Mipharm S.p.A.
Via B. Quaranta, 12 – 20139 Milan

Package leaflet: information for the patient

TUSSELIM FLUIDIFICANTE COUGH 90 mg/ml syrup

Carbocysteine lysine salt monohydrate
Equivalent 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.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effect, 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 TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for
2. What you need to know before taking TUSSELIM FLUIDIFICANTE TOSSE
3. How to take TUSSELIM FLUIDIFICANTE TOSSE
4. Possible side effects
5. How to store TUSSELIM FLUIDIFICANTE TOSSE
6. Contents of the pack and other information

1. What TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for

This medicine contains the active substance carbocisteine and is indicated to facilitate the elimination of mucus (mucolytic) in acute and chronic respiratory tract disorders.
Consult a doctor if you do not feel better or if you feel worse.

2. What you need to know before taking TUSSELIM FLUIDIFICANTE TOSSE

Do not take TUSSELIM FLUIDIFICANTE TOSSE

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lesion in the wall of the stomach or the first part of the intestine known as a gastroduodenal ulcer;
• if the child is under 2 years of age (see section “Children”); if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”)

Warnings and precautions

No reduction in the effectiveness of the medicine after prolonged treatment or dependency (need to continue taking the medicine) has been reported with the use of TUSSELIM FLUIDIFICANTE TOSSE.
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 stop treatment with carbocisteine if gastrointestinal bleeding occurs. This medicine must not be used concomitantly with cough suppressants and/or medicines that inhibit bronchial secretion.
For those engaged in sports activities: the use of medicines containing ethyl alcohol may result in a positive result in anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.

Children
TUSSELIM FLUIDIFICANTE TOSSE must not be administered to children under 2 years of age, because mucus may block the bronchi and interfere with normal breathing.

Other medicines and TUSSELIM FLUIDIFICANTE TOSSE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known with medicines used to treat upper and lower respiratory tract diseases.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take TUSSELIM FLUIDIFICANTE TOSSE during pregnancy.
Breastfeeding
Use of TUSSELIM FLUIDIFICANTE TOSSE is contraindicated during breastfeeding, as it is unknown whether this medicine passes into breast milk.

Driving and using machines
No negative effects of the medicine on the ability to drive or operate machinery have been reported.

TUSSELIM FLUIDIFICANTE TOSSE contains sucrose, methyl parahydroxybenzoate, and ethanol
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars (such as hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or saccharase-isomaltase deficiency), contact your doctor before taking this medicine.
TUSSELIM FLUIDIFICANTE TOSSE contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
TUSSELIM FLUIDIFICANTE TOSSE contains 0.65 vol.% ethanol (alcohol), i.e. up to 100 mg per 15 ml dose, equivalent to 2 ml of beer and 1 ml of wine per dose. This may be harmful for individuals suffering from alcoholism.
This should be taken into account in pregnant or breastfeeding women, children, and high-risk individuals, such as patients with liver problems or epilepsy.
If used chronically (i.e. for two weeks or more), TUSSELIM FLUIDIFICANTE TOSSE may be harmful to teeth (promotes the development of dental caries).

3. How to take TUSSELIM FLUIDIFICANTE TOSSE

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.
Take this medicine within 15 days from the first opening of the bottle.
Do not mix TUSSELIM FLUIDIFICANTE TOSSE with other products.
Instructions for use: the package includes a dosing cup with markings indicating the quantity in ml.
The recommended dose for adults is 15 ml 2-3 times daily.
Do not exceed the recommended doses. Use only for short-term treatment.
TUSSELIM FLUIDIFICANTE TOSSE may also be taken for prolonged periods; in such cases, it is advisable to follow your doctor's advice. Your doctor will determine the duration of treatment and may decide to adjust the required dose and frequency of administration.
Use in children over 5 years of age
The recommended dose is 5 ml 2-3 times daily.
Use in children from 2 to 5 years of age
The recommended dose is 2.5 ml 2-3 times daily.
If you take more TUSSELIM FLUIDIFICANTE TOSSE 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.
If you accidentally ingest or take an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take TUSSELIM FLUIDIFICANTE TOSSE
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Contact your doctor if you experience any of the following adverse effects:

• Skin redness (rash);
• Skin reactions (urticaria);
• Skin flushing (erythema);
• 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.)
• Skin rash (exanthema);
• Itching;
• Swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema);
• Abdominal pain;
• Gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• Nausea;
• Vomiting;
• Diarrhea;
• Dizziness;
• Flushing;
• Difficulty breathing (dyspnea);
• Bronchial obstruction (bronchial occlusion).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store TUSSELIM FLUIDIFICANTE TOSSE

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.
The product should be used within 15 days of first opening the bottle. Any remaining product should be
discarded.
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 TUSSELIM FLUIDIFICANTE TOSSE contains

• The active substance is carbocisteine lysine salt monohydrate: 100 ml of syrup contain 9 g of carbocisteine lysine salt.
• The other components are: methyl 4-hydroxybenzoate, sucrose, cherry flavour, ethanol, purified water.

Description of the appearance of TUSSELIM FLUIDIFICANTE TOSSE and package contents
TUSSELIM FLUIDIFICANTE TOSSE is an oral syrup.
Pack containing 1 bottle of 200 ml and a graduated dosing cup.

Marketing Authorization Holder
Farmitalia S.r.l
Via Pinciana 25
00198 Rome

Manufacturer
Francia Farmaceutici - Industria Farmaco Biologica S.r.l - Via Dei Pestagalli, 7 - 20138 Milan

Package leaflet: Information for the patient

TUSSELIM FLUIDIFICANTE TOSSE 2.7 g/10 ml syrup

Carbocisteine lysine salt monohydrate
Equivalent 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 effect, 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 TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for
2. What you need to know before taking TUSSELIM FLUIDIFICANTE TOSSE
3. How to take TUSSELIM FLUIDIFICANTE TOSSE
4. Possible side effects
5. How to store TUSSELIM FLUIDIFICANTE TOSSE
6. Package contents and other information

1. What TUSSELIM FLUIDIFICANTE TOSSE is and what it is used for

This medicinal product contains the active substance carbocisteine and is indicated to facilitate the elimination of mucus (mucolytic) in acute and chronic respiratory tract disorders.
Consult a doctor if you do not feel better or if you feel worse.

2. What you need to know before taking TUSSELIM FLUIDIFICANTE TOSSE

Do not take TUSSELIM FLUIDIFICANTE TOSSE

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lesion in the wall of the stomach or the first part of the intestine, known as a peptic ulcer;
• if the child to be treated is under 11 years of age;
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
There are no known effects of reduced efficacy of the medicine after prolonged treatment or dependency (need to continue taking the medicine) with the use of TUSSELIM FLUIDIFICANTE TOSSE.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, debilitated patients, those with a history of peptic ulcers, or those taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine in case of gastrointestinal bleeding. This medicine must not be used concomitantly with cough suppressants and/or medicines that inhibit bronchial secretion.

For those engaged in sports: the use of medicines containing ethanol may result in positive anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.

Children
TUSSELIM FLUIDIFICANTE TOSSE must not be taken by children under 11 years of age (see section "Do not take TUSSELIM FLUIDIFICANTE TOSSE").

Other medicines and TUSSELIM FLUIDIFICANTE TOSSE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known with medicines used to treat upper and lower respiratory tract diseases.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take TUSSELIM FLUIDIFICANTE TOSSE during pregnancy.

Breastfeeding
The use of TUSSELIM FLUIDIFICANTE TOSSE is contraindicated if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Driving and using machines
No adverse effects of the medicine on the ability to drive vehicles or operate machinery have been reported.

TUSSELIM FLUIDIFICANTE TOSSE contains sucrose, methyl parahydroxybenzoate, and ethanol
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars (such as hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or saccharase-isomaltase deficiency), contact your doctor before taking this medicine.
TUSSELIM FLUIDIFICANTE TOSSE contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
TUSSELIM FLUIDIFICANTE TOSSE contains 1 vol% ethanol (alcohol), e.g. up to 100 mg per dose, equivalent to 2 ml of beer or 1 ml of wine per dose. This may be harmful for people suffering from alcoholism.
This should be taken into consideration in pregnant or breastfeeding women, children, and high-risk individuals, such as patients with liver disease or epilepsy.
If used chronically (i.e. for two weeks or more), TUSSELIM FLUIDIFICANTE TOSSE may be harmful to teeth (promotes the development of dental caries).

3. How to take TUSSELIM FLUIDIFICANTE TOSSE

Take 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 for adults is 1 single-dose container per day.
Do not exceed the recommended doses. Use only for short-term treatment.
TUSSELIM FLUIDIFICANTE TOSSE may also be taken for prolonged periods; in such cases, it is advisable to follow your doctor's advice. Your doctor will determine the duration of treatment and may decide to adjust the required dose and frequency of administration.

If you take more TUSSELIM FLUIDIFICANTE TOSSE 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.
If you accidentally ingest or take an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take TUSSELIM FLUIDIFICANTE TOSSE
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of 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:

• skin redness (rash);
• skin reactions (urticaria);
• skin redness (erythema);
• skin redness with blisters (bullous erythema);
• 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);
• skin rash (exanthema);
• itching;
• swelling of the face, tongue, and throat, which may cause breathing difficulties (angioedema);
• abdominal pain;
• gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• nausea;
• vomiting;
• diarrhoea;
• dizziness;
• flushing;
• difficulty breathing (dyspnoea).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You may 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 TUSSELIM FLUIDIFICANTE TOSSE

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What TUSSELIM FLUIDIFICANTE TOSSE 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: ethyl alcohol (96%), sucrose, strawberry flavour, vanilla flavour, methyl parahydroxybenzoate, purified water.

Description of the appearance of TUSSELIM FLUIDIFICANTE TOSSE and contents of the pack
TUSSELIM FLUIDIFICANTE TOSSE is a syrup for oral use.
Pack containing 6 single-dose containers of 10 ml.
Marketing Authorization Holder
Farmitalia S.r.l
Via Pinciana 25
00198 Roma
Manufacturer
Francia Farmaceutici
Industria Farmaco Biologica S.r.l
Via Dei Pestagalli, 7 - 20138 Milano