Bronchenolo cough sedative and fluidifier

Patient and user information leaflet

BRONCHENOLO SEDATIVE AND EXPECTORANT, 1.5 mg/ml + 10 mg/ml, syrup

Dextromethorphan hydrobromide, Guaifenesin
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 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 5 days of treatment.

Contents of this leaflet:

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

1. What BRONCHENOLO SEDATIVE AND EXPECTORANT is and what it is used for

This medicinal product contains 2 active substances:

• dextromethorphan hydrobromide, which helps to suppress cough;
• guaifenesin, which works by liquefying phlegm.

These belong to the class of medicines known as cough suppressants and expectorants. BRONCHENOLO SEDATIVE AND EXPECTORANT is used for the symptomatic treatment of cough, helping to suppress cough and to make phlegm more fluid, thus easier to eliminate. Consult your doctor if you do not feel better or if you feel worse after 5 days of treatment.

2. What you need to know before taking BRONCHENOLO SEDATIVE AND EXPECTORANT

Do not take BRONCHENOLO SEDATIVE AND EXPECTORANT if:

• you are allergic to dextromethorphan hydrobromide, guaifenesin, or any of the other ingredients of this medicine (listed in section 6);
• you are taking or have taken within the last two weeks medicines used to treat depression called monoamine oxidase inhibitors (MAOIs);
• you have or are at risk of respiratory problems (respiratory failure), for example, chronic obstructive pulmonary disease, pneumonia, an ongoing asthma attack, or worsening of asthma. Do not use BRONCHENOLO SEDATIVE AND EXPECTORANT in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCHENOLO SEDATIVE AND EXPECTORANT if:

• you have long-term (chronic or persistent) cough, such as that occurring in asthma (a condition causing narrowing and inflammation of the bronchi) or emphysema (a lung disease causing breathing difficulties);
• your cough does not improve or worsens despite treatment, or if it is accompanied by high fever, skin rash, or headache;
• you have severe liver or kidney problems;
• you are taking medicines such as certain antidepressants or antipsychotics. BRONCHENOLO SEDATIVE AND EXPECTORANT may interact with these medicines and cause changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea);
• you are taking other cough or cold medicines. The concomitant use of BRONCHENOLO SEDATIVE AND EXPECTORANT with sedative medicines such as benzodiazepines, hypnotics (medicines that induce sleep), sedatives (calming agents), or anxiolytics (medicines that reduce anxiety) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma (a state of deep unconsciousness), and may be life-threatening. Inform your doctor about all sedative medicines you are taking and follow their dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor. Cases of abuse and dependence have been reported. Dextromethorphan may lead to habituation: prolonged use (e.g. beyond the recommended treatment period) may result in tolerance to the medicine, as well as mental and physical dependence (leading to use of higher doses than recommended or repeated over time). If you have a tendency to abuse or become dependent on medicines, drugs, or alcohol, you should take BRONCHENOLO SEDATIVE AND EXPECTORANT only for short periods and under strict medical supervision. The consumption of alcoholic beverages is not recommended during treatment with BRONCHENOLO SEDATIVE AND EXPECTORANT.

Children and adolescents
In children, serious adverse effects such as breathing difficulties and sedation may occur. If these signs appear, contact your doctor.

Other medicines and BRONCHENOLO SEDATIVE AND EXPECTORANT
Do not take this medicine if you are taking or have taken within the last two weeks medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), as this increases the risk of adverse reactions, even severe ones, such as serotonin syndrome, which manifests as changes in mental status, increased blood pressure, agitation, brief and involuntary muscle contractions, increased reflexes, excessive sweating, chills, and tremors (see "Warnings and precautions" and "Possible side effects").
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking or have recently taken:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline, and bupropion (see section 2. "Do not take BRONCHENOLO SEDATIVE AND EXPECTORANT if");
• medicines used for colds such as phenylpropanolamine;
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines to treat psychiatric disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat cardiac arrhythmias (flecainide);
• medicines to reduce calcium levels in the blood and treat dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet;
• medicines used to prevent fungal (mycotic) growth (terbinafine). The concomitant use of BRONCHENOLO SEDATIVE AND EXPECTORANT with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes BRONCHENOLO SEDATIVE AND EXPECTORANT together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all sedative medicines you are taking and follow their dosage recommendations carefully. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

BRONCHENOLO SEDATIVE AND EXPECTORANT and laboratory tests
This medicine may cause alterations (false positives) in tests measuring the concentration of vanillylmandelic acid in urine.
If your doctor has prescribed this type of urine test, inform them about your use of BRONCHENOLO SEDATIVE AND EXPECTORANT.

BRONCHENOLO SEDATIVE AND EXPECTORANT with alcohol
Do not consume alcohol during treatment with this medicine, as it may cause or worsen certain side effects, such as drowsiness.

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

Pregnancy and breastfeeding
Clinical data on risk during pregnancy and breastfeeding are not available.
BRONCHENOLO SEDATIVE AND EXPECTORANT should only be used if clearly needed and under direct medical supervision.

Fertility
No data are available.

Driving and using machines
BRONCHENOLO SEDATIVE AND EXPECTORANT may cause drowsiness and dizziness, thus possibly impairing your ability to drive or operate machinery. Exercise particular caution if you need to perform such activities.

BRONCHENOLO SEDATIVE AND EXPECTORANT contains:

• Sucrose liquid. Contains 7.35 g of sucrose (sugar) per dose. This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine;
• Propyl and methyl para-hydroxybenzoates, which may cause allergic reactions (including delayed ones);
• Ethanol (alcohol). This medicine contains 480 mg of alcohol (ethanol) per dose (10 ml). The amount in 10 ml of this medicine is equivalent to 12 ml of beer and 5 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effects in children are not evident. However, some effects may occur in very young children, for example, feeling sleepy. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, talk to your doctor before taking this medicine.
• Sodium. This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to take BRONCHENOLO SEDATIVE AND FLUIDIFYING

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Use should be limited to the shortest possible duration and the lowest possible dose.

Adults and adolescents over 12 years of age:
The recommended dose is 10 ml 2 to 4 times daily, with a minimum interval of 6 hours between doses.
The maximum daily dose is 40 ml.
Do not exceed the recommended maximum daily dose.

Children between 6 and 12 years of age:
The recommended dose is 5 ml 3 to 4 times daily, with a minimum interval of 6 hours between doses.
The maximum daily dose is 20 ml.
Do not exceed the recommended maximum daily dose.

1 ml of syrup contains: 1.5 mg of dextromethorphan hydrobromide and 10 mg of guaifenesin.

Do not use BRONCHENOLO SEDATIVE AND FLUIDIFYING for more than 5 days.
Consult your doctor if you do not feel better or if you feel worse after 5 days of treatment.

Method of administration
BRONCHENOLO SEDATIVE AND FLUIDIFYING syrup must be taken orally using the dosing cup (measuring device) as described below:

1. Open the bottle by pressing and turning the cap counterclockwise simultaneously.
2. For accurate dosing, it is recommended to keep the measuring cup horizontal and fill it up to the mark corresponding to the required dose.
3. Immediately drink the syrup directly from the measuring cup.
4. Close the bottle by pressing firmly and screwing the cap back on (fig.2).
5. Wash the measuring cup after each use.

If you take more BRONCHENOLO SEDATIVE AND FLUIDIFYING than you should:
If you take more BRONCHENOLO SEDATIVE AND FLUIDIFYING than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, cardiac disorders (accelerated heartbeat), coordination disturbances, psychosis with visual hallucinations and hyperexcitability.

Additional symptoms in case of massive overdose may include: coma, severe respiratory problems (respiratory depression), and seizures.
If taken in excessive amounts, guaifenesin may cause kidney stone formation (renal calculi).
Contact your doctor or go to hospital immediately if any of the above-mentioned symptoms occur.

If you forget to take BRONCHENOLO SEDATIVE AND FLUIDIFYING
Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Inform your doctor if, during treatment with BRONCHENOLO SEDATIVE AND FLUIDIFYING, you notice:

Uncommon side effects (may affect up to 1 in 100 people)

• drowsiness and dizziness;
• abdominal, stomach or intestinal disorders, nausea, vomiting;

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• serotonin syndrome, presenting with changes in mental status, increased blood pressure, agitation, brief and involuntary muscle contractions, increased reflexes, excessive sweating, chills and tremors;
• agitation
• headache
• hypersensitivity (allergy)
• rash (skin eruption)
• urticaria (skin irritation)
• angioedema (swelling of the face, eyes, lips, throat, which may cause breathing and swallowing difficulties)
• confusion
• insomnia (difficulty sleeping)
• diarrhoea

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:
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 BRONCHENOLO SEDATIVE AND FLUIDIFYING

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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 you no longer use. This will help protect the environment.
Dispose of the measuring spoon according to local regulations for plastic household waste.

6. Package contents and other information

What BRONCHENOLO SEDATIVE AND EXPECTORANT contains
The active substances are: dextromethorphan hydrobromide and guaifenesin.
100 ml of syrup contain: 0.15 g dextromethorphan hydrobromide and 1.00 g guaifenesin.
Other components are: pine bud essential oil; citric acid monohydrate; alcohol; glycerol; liquid sucrose; sweet orange essence; propyl parahydroxybenzoate; methyl parahydroxybenzoate; sodium saccharin; purified water.

Description of the appearance of BRONCHENOLO SEDATIVE AND EXPECTORANT and contents of the pack
Glass bottle of 150 ml with child-resistant cap, containing syrup, and a graduated dosing cup.

Marketing Authorization Holder
Perrigo Italia S.r.l. – Viale dell’Arte, 25 – 00144 Rome
Manufacturer
Farmaclair – 440 Avenue du General de Gaulle - Herouville Saint Clair – France.
Omega Pharma Manufacturing GmbH & Co. KG – 71083 Benzstr. 25 – Herrenberg - Germany

are provided in the following section>

Patient and user information leaflet

BRONCHENOLO SEDATIVE AND FLUIDIFYING, 7.5 mg + 55 mg, peppermint-flavored tablets

Dextromethorphan hydrobromide, Guaifenesin
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 any adverse reactions occur, 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 5 days of treatment.

Contents of this leaflet:

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

1. What BRONCHENOLO SEDATIVE AND EXPECTORANT is and what it is used for

This medicinal product contains 2 active substances:

• dextromethorphan hydrobromide, which helps to suppress cough;
• guaifenesin, which acts by liquefying mucus. BRONCHENOLO SEDATIVE AND EXPECTORANT is used for the symptomatic treatment of cough, helping to suppress cough and to make mucus more fluid, thus easier to expel. Consult your doctor if you do not feel better or if you feel worse after 5 days of treatment.

2. What you need to know before taking BRONCHENOLO SEDATIVE AND EXPECTORANT

Do not take BRONCHENOLO SEDATIVE AND EXPECTORANT if:

• you are allergic to dextromethorphan hydrobromide, guaifenesin, or any of the other ingredients of this medicine (listed in section 6);
• you are taking or have taken within the last two weeks medicines used to treat depression called monoamine oxidase inhibitors (MAOIs);
• you have or are at risk of respiratory problems (respiratory failure), for example, chronic obstructive pulmonary disease, pneumonia, an ongoing asthma attack or worsening asthma. Do not use BRONCHENOLO SEDATIVE AND EXPECTORANT in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCHENOLO SEDATIVE AND
EXPECTORANT if:

• you have a long-term (chronic or persistent) cough, such as that occurring in asthma (a disease causing narrowing and inflammation of the bronchi) or emphysema (a lung disease causing breathing difficulties);
• your cough does not improve or worsens despite treatment, or if it is accompanied by high fever, skin rash, or headache;
• you have severe liver or kidney problems;
• you are taking medicines such as certain antidepressants or antipsychotics. BRONCHENOLO SEDATIVE AND EXPECTORANT may interact with these medicines and cause changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea);
• you are taking other cough or cold medicines. The concomitant use of BRONCHENOLO SEDATIVE AND EXPECTORANT with sedative medicines such as benzodiazepines, hypnotics (medicines that induce sleep), sedatives (calming agents), anxiolytics (reducing anxiety) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma (deep unconscious state), and may be life-threatening. Inform your doctor about all sedative medicines you are taking and follow carefully his/her dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor. Cases of abuse and dependence have been reported. Dextromethorphan may cause dependence: prolonged use (e.g. exceeding the recommended treatment period) may lead to tolerance to the medicine, as well as mental and physical dependence (leading to use of higher doses than recommended or repeated over time). If you have a tendency to abuse or become dependent on medicines, narcotics, or alcohol, you should take BRONCHENOLO SEDATIVE AND EXPECTORANT only for short periods and under strict medical supervision. Alcohol consumption is not recommended during treatment with BRONCHENOLO SEDATIVE AND EXPECTORANT. Children and adolescents In children, serious adverse effects such as breathing difficulties and sedation may occur. If these signs appear, contact your doctor.

Other medicines and BRONCHENOLO SEDATIVE AND EXPECTORANT
Do not take this medicine if you are taking or have taken within the last two weeks
medicines used to treat depression called monoamine oxidase inhibitors (MAOIs),
as this increases the risk of adverse reactions, even severe ones, such as serotonin
syndrome, which manifests as changes in mental status, increased blood pressure,
agitation, brief and involuntary muscle contractions, increased reflexes, excessive
sweating, chills, and tremors (see "Warnings and precautions" and "Possible
side effects").
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicine.
In particular, inform your doctor if you are taking or have recently taken:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline, and bupropion (see section 2. "Do not take BRONCHENOLO SEDATIVE AND EXPECTORANT if");
• medicines used for colds such as phenylpropanolamine;
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines to treat psychiatric disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat cardiac arrhythmias (flecainide);
• medicines to reduce calcium levels in the blood and treat dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet;
• medicines used to prevent fungal (mycete) growth (terbinafine). The concomitant use of BRONCHENOLO SEDATIVE AND EXPECTORANT and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not feasible. However, if your doctor prescribes BRONCHENOLO SEDATIVE AND EXPECTORANT together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking, and follow carefully the doctor's dosage recommendations. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

BRONCHENOLO SEDATIVE AND EXPECTORANT and laboratory tests
This medicine may cause alterations (false positives) in tests measuring the
concentration of vanillylmandelic acid in urine.
If your doctor has prescribed this type of urine test, inform him/her about the use of
BRONCHENOLO SEDATIVE AND EXPECTORANT.
BRONCHENOLO SEDATIVE AND EXPECTORANT with alcohol
Do not consume alcohol during treatment with this medicine, as it could
cause or worsen certain side effects, such as drowsiness.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy and breastfeeding
No clinical data are available on the risk during pregnancy and breastfeeding.
BRONCHENOLO SEDATIVE AND EXPECTORANT should be used only if clearly needed and under direct medical supervision.
Fertility
No data are available.
Driving and using machines
BRONCHENOLO SEDATIVE AND EXPECTORANT may cause drowsiness and dizziness; therefore, it may impair your ability to drive vehicles and operate machinery. Exercise particular caution if you perform such activities.
BRONCHENOLO SEDATIVE AND EXPECTORANT contains:

• sucrose; If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
• aspartame. This medicine contains 23 mg of aspartame per tablet. 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 properly eliminate it.

3. How to take BRONCHENOLO SEDATIVE AND FLUIDIFYING

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.
Use should be limited to the shortest possible duration and the lowest possible dose.

Adults and adolescents over 12 years of age
The recommended dose is 3–6 tablets per day to be dissolved in the mouth, with a minimum interval of 4 hours between doses.
The maximum daily dose is 6 tablets.
Do not exceed the recommended maximum daily dose.

Children aged 6 to 12 years
The recommended dose is 2–3 tablets per day to be dissolved in the mouth, with a minimum interval of 8 hours between doses.
The maximum daily dose is 3 tablets.
Do not exceed the recommended maximum daily dose.
It is recommended to supervise the child while taking the tablet.

Do not use BRONCHENOLO SEDATIVE AND FLUIDIFYING for more than 5 days.
Consult your doctor if you do not feel better or if you feel worse after 5 days of treatment.

Method of administration
Take BRONCHENOLO SEDATIVE AND FLUIDIFYING tablets by allowing them to dissolve in the mouth (oral use).

If you take more BRONCHENOLO SEDATIVE AND FLUIDIFYING than you should
If you take more BRONCHENOLO SEDATIVE AND FLUIDIFYING than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, cardiac disturbances (accelerated heartbeat), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Additional symptoms in case of massive overdose may include: coma, severe respiratory problems (respiratory depression), and seizures.
If taken in excessive amounts, guaifenesin may cause kidney stone formation (renal calculi).
Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.

If you forget to take BRONCHENOLO SEDATIVE AND FLUIDIFYING
Do not take a double dose to make up for the forgotten dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Inform your doctor if, during treatment with BRONCHENOLO SEDATIVE AND FLUIDIFYING, you notice:

Uncommon adverse reactions (may affect up to 1 in 100 people)

• drowsiness and dizziness;
• abdominal, stomach or intestinal disorders, nausea, vomiting;

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data)

• serotonin syndrome, manifested by changes in mental status, increased blood pressure, agitation, brief and involuntary muscle contractions, increased reflexes, excessive sweating, chills and tremors;
• agitation;
• headache;
• hypersensitivity (allergy);
• rash (skin eruption);
• urticaria (skin irritation);
• angioedema (swelling of the face, eyes, lips, throat which may cause breathing and swallowing difficulties);
• confusion;
• insomnia (difficulty sleeping);
• diarrhoea.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following address:
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 BRONCHENOLO SEDATIVE AND FLUIDIFYING

Keep this medicine out of the sight and reach of children.
No special storage precautions are required.
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 in use. This will help protect the environment.

6. Package contents and other information

What BRONCHENOLO SEDATIVE AND EXPECTORANT contains
The active substances are: dextromethorphan hydrobromide and guaifenesin.
Each tablet contains: 7.5 mg dextromethorphan hydrobromide and 55 mg guaifenesin.
The other components are: essential oil of pine mugo; magnesium trisilicate; aspartame;
magnesium stearate; sucrose; peppermint flavour.
Description of the appearance of BRONCHENOLO SEDATIVE AND EXPECTORANT and pack
contents
BRONCHENOLO SEDATIVE AND EXPECTORANT tablets are available in a carton containing 20
peppermint-flavoured tablets.
Marketing Authorization Holder
Perrigo Italia S.r.l. – Viale dell’Arte, 25 – 00144 Rome
Manufacturer
Famar Italia S.p.A. - Via Zambeletti 25 - Baranzate (MI).