BRONCHENOLO 1,5 MG/ML + 10 MG/ML Syrop

Treść ulotki

1. BRONCHENOLO SEDATIVO E FLUIDIFICANTE, 1.5 mg/ml + 10 mg/ml, syrup
   1. What is BRONCHENOLO SEDATIVO E FLUIDIFICANTE and what is it for?
   2. What you need to know before taking BRONCHENOLO SEDATIVO E FLUIDIFICANTE
2. BRONCHENOLO SEDATIVO E FLUIDIFICANTE should only be used in case of actual
   1. How to take BRONCHENOLO SEDATIVO E FLUIDIFICANTE
   2. Possible side effects
   3. How to store BRONCHENOLO SEDATIVO E FLUIDIFICANTE
   4. Contents of the pack and other information
3. BRONCHENOLO SEDATIVO E FLUIDIFICANTE, 7.5 mg + 55 mg, mint-flavored pastilles
   1. What is BRONCHENOLO SEDATIVO E FLUIDIFICANTE and what is it for?
   2. What you need to know before taking BRONCHENOLO SEDATIVO E FLUIDIFICANTE
4. BRONCHENOLO SEDATIVO E FLUIDIFICANTE should only be used in case of actual
   1. How to take BRONCHENOLO SEDATIVO E FLUIDIFICANTE
   2. Possible side effects
   3. How to store BRONCHENOLO SEDATIVO E FLUIDIFICANTE
   4. Contents of the pack and other information

BRONCHENOLO SEDATIVO E FLUIDIFICANTE, 1.5 mg/ml + 10 mg/ml, syrup

Dextromethorphan hydrobromide, Guaifenesin

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 5 days of treatment.

Contents of this leaflet:

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

1. What is BRONCHENOLO SEDATIVO E FLUIDIFICANTE and what is it for?

This medicine contains 2 active ingredients:

• dextromethorphan hydrobromide, which serves to calm the cough;
• guaifenesin, which acts by fluidifying the mucus. These belong to the class of cough sedatives and expectorant medicines. BRONCHENOLO SEDATIVO E FLUIDIFICANTE is used for the symptomatic treatment of cough, it serves to calm the cough and to make the mucus more fluid, therefore more easily eliminated. 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 SEDATIVO E FLUIDIFICANTE

Do not take BRONCHENOLO SEDATIVO E FLUIDIFICANTE 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 risk having breathing problems (respiratory failure), for example you have chronic obstructive airway disease, pneumonia, a current asthma attack or worsening of asthma. Do not use BRONCHENOLO SEDATIVO E FLUIDIFICANTE in children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking BRONCHENOLO SEDATIVO E
FLUIDIFICANTE if:

• you have a long-lasting (chronic or persistent) cough, such as that which occurs in the case of asthma (a disease that causes narrowing and inflammation of the bronchi) or emphysema (a lung disease that causes difficulty breathing);
• the cough does not improve or worsens despite treatment or if it is accompanied by high fever, skin rash or headache;
• you have serious problems with the liver or kidneys;
• you are taking medicines such as some antidepressants or antipsychotics. BRONCHENOLO SEDATIVO E FLUIDIFICANTE may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as a body temperature higher than 38° C, increased heart rate, unstable blood pressure, exaggeration of reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) may occur;
• you are taking other medicines for cough or cold. The concomitant use of BRONCHENOLO SEDATIVO E FLUIDIFICANTE with sedating medicines such as benzodiazepines, such as hypnotics (medicines that induce sleep), sedatives (calmants), anxiolytics (which reduce anxiety) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma (deep unconscious state) and can be life-threatening. Inform your doctor of all sedating medicines you are taking and carefully follow their recommendations on dosage. 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 can cause habituation: following prolonged use (e.g. exceeding the recommended treatment period), tolerance to the medicine may develop, as well as mental and physical dependence (which causes the 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 SEDATIVO E FLUIDIFICANTE for short periods and under strict medical supervision. It is not recommended to consume alcoholic beverages during treatment with BRONCHENOLO SEDATIVO E FLUIDIFICANTE.

Children and adolescents
Serious adverse effects such as difficulty breathing and
sedation may occur in children. If these signs appear, contact your doctor.

Other medicines and BRONCHENOLO SEDATIVO E FLUIDIFICANTE
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 serious ones, such as serotonin
syndrome, which manifests with 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
adverse effects”).
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell 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 SEDATIVO E FLUIDIFICANTE if”);
• medicines used to treat colds such as phenylpropanolamine;
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines to treat mental illnesses (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 a dysfunction of the organism due to a reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
• medicines used to prevent the development of fungi (terbinafine). The concomitant use of BRONCHENOLO SEDATIVO E FLUIDIFICANTE and sedating medicines such as benzodiazepines, or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes BRONCHENOLO SEDATIVO E FLUIDIFICANTE together with sedating medicines, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about all the sedating medicines you are taking, and carefully follow the doctor's recommendations on dosage. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE and laboratory tests
This medicine can cause alterations (false positives) in tests that measure the
concentration of vanilmandelic acid in urine.
If your doctor has prescribed this type of urine test, report the use of
BRONCHENOLO SEDATIVO E FLUIDIFICANTE.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE with alcohol
Do not consume alcohol during treatment with this medicine, as this may cause or
worsen certain adverse effects, such as drowsiness.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.
Pregnancy and breastfeeding
No clinical data are available on the risk in pregnancy and during breastfeeding.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE should only be used in case of actual

need and under the direct control of the doctor.
Fertility
No data are available.

Driving and operating machinery
BRONCHENOLO SEDATIVO E FLUIDIFICANTE can cause drowsiness and dizziness, therefore
it may impair the ability to drive vehicles and operate machinery. Pay particular attention
if you have to perform these activities.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE contains:

• saccharoseliquid. Contains 7.35 g of saccharose (sugar) per dose. This should be taken into consideration in people affected by diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
• propyl and methyl para-hydroxybenzoates, which may cause allergic reactions (including delayed ones);
• ethyl 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 does not seem to have an effect on adults and adolescents and its effects in children are not evident. Some effects may occur in 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 have an alcohol addiction, 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 SEDATIVO E FLUIDIFICANTE

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Use should be limited to the shortest possible period and at the lowest possible dose.

Adults and adolescents over 12 years of age:
The recommended dose is 10 ml 2-4 times a day, with a minimum interval between doses of 6 hours.
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 3-4 times a day, with a minimum interval between doses of 6 hours.
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 SEDATIVO E FLUIDIFICANTE 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 SEDATIVO E FLUIDIFICANTE syrup must be taken orally using the
measuring cup (measuring spoon) as indicated below:

• 1. Open the bottle by pressing and turning the cap counterclockwise at the same time.
• 2. For correct dosage, it is recommended to keep the measuring spoon horizontal and fill it up to the level mark corresponding to the dose to be taken.
• 3. Drink the syrup immediately directly from the measuring spoon.
• 4. Close the bottle by pressing firmly and screwing on the cap (fig.2).
• 5. Wash the measuring spoon after each use.

If you take more BRONCHENOLO SEDATIVO E FLUIDIFICANTE than you should:
If you take more BRONCHENOLO SEDATIVO E FLUIDIFICANTE than you should, you may
experience the following symptoms: nausea and vomiting, involuntary muscle contractions,
agitation, confusion, drowsiness, cognitive impairment, involuntary and rapid eye movements,
cardiac disorders (accelerated heartbeat), coordination disorders, psychosis with
visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe
respiratory problems (respiratory depression) and convulsions.
If taken in excessive quantities, guaifenesin can cause kidney stones. Contact your
doctor or hospital immediately if you experience any of the above symptoms.

If you forget to take BRONCHENOLO SEDATIVO E FLUIDIFICANTE
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if during treatment with BRONCHENOLO SEDATIVO E FLUIDIFICANTE
you notice:

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

• drowsiness and dizziness;
• disorders of the abdomen, stomach or intestine, nausea, vomiting; Side effects not known(frequency cannot be estimated based on available data)
• serotonin syndrome which manifests with alterations of mental state, 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 that can cause difficulty breathing and swallowing)
• Confusion
• Insomnia (difficulty sleeping)
• Diarrhea

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects directly
through 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 BRONCHENOLO SEDATIVO E FLUIDIFICANTE

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C
Do not use this medicine after the expiry date which is reported on the packaging after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.
Dispose of the measuring cup according to local regulations for plastic household waste.

6. Contents of the pack and other information

What BRONCHENOLO SEDATIVO E FLUIDIFICANTE contains
The active ingredients are: dextromethorphan hydrobromide and guaifenesin.
100 ml of syrup contains: 0.15 g dextromethorphan hydrobromide and 1.00 g guaifenesin.
The other ingredients are: pine bud essential oil; citric acid monohydrate; alcohol;
glycerol; liquid sucrose; sweet orange essence; propyl para-hydroxybenzoate; methyl
para-hydroxybenzoate; sodium saccharin; purified water.

Description of the appearance of BRONCHENOLO SEDATIVO E FLUIDIFICANTE and contents of the
pack
150 ml glass bottle with child-resistant closure, containing syrup, and a
graduated measuring cup.

Marketing Authorisation Holder
Perrigo Italia S.r.l. – viale dell’Arte, 25 – 00144 Roma

Manufacturer
Farmaclair – 440 Avenue du General de Gaulle - Herouville Saint Clair – France.
Omega Pharma Manufacturing GmbH & Co. KG – 71083 Benzstr. 25 – Herrenberg - Germany

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BRONCHENOLO SEDATIVO E FLUIDIFICANTE, 7.5 mg + 55 mg, mint-flavored pastilles

Dextromethorphan hydrobromide, Guaifenesin

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 5 days of treatment.

Contents of this leaflet:

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

1. What is BRONCHENOLO SEDATIVO E FLUIDIFICANTE and what is it for?

This medicine contains 2 active ingredients:

• dextromethorphan hydrobromide, which is used to calm the cough;
• guaifenesin, which acts by fluidifying mucus. BRONCHENOLO SEDATIVO E FLUIDIFICANTE is used for the symptomatic treatment of cough, it serves to calm the cough and to make the mucus more fluid, therefore more easily eliminated. 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 SEDATIVO E FLUIDIFICANTE

Do not take BRONCHENOLO SEDATIVO E FLUIDIFICANTE 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 risk having breathing problems (respiratory failure), for example you have chronic obstructive airway disease, pneumonia, a current asthma attack or worsening of asthma. Do not use BRONCHENOLO SEDATIVO E FLUIDIFICANTE in children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking BRONCHENOLO SEDATIVO E
FLUIDIFICANTE if:

• you have a long-lasting (chronic or persistent) cough, such as that which occurs in the case of asthma (a disease that causes narrowing and inflammation of the bronchi) or emphysema (a lung disease that causes difficulty breathing);
• the cough does not decrease 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 some antidepressants or antipsychotics. BRONCHENOLO SEDATIVO E FLUIDIFICANTE may interact with these medicines and alterations in mental status (e.g. agitation, hallucinations, coma) and other effects such as a body temperature greater than 38° C, increased heart rate, unstable blood pressure, exaggeration of reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) may occur;
• you are taking other medicines for cough or cold. The concomitant use of BRONCHENOLO SEDATIVO E FLUIDIFICANTE with sedating medicines such as benzodiazepines, such as hypnotics (medicines that induce sleep), sedatives (calmants), anxiolytics (which reduce anxiety) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma (deep unconscious state) and can be life-threatening. Tell your doctor about all sedating medicines you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends or family 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 can cause habituation: following prolonged use (e.g. exceeding the recommended treatment period), tolerance to the medicine can develop, as well as mental and physical dependence (which causes the 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 SEDATIVO E FLUIDIFICANTE for short periods and under strict medical supervision. It is not recommended to consume alcoholic beverages during treatment with BRONCHENOLO SEDATIVO E FLUIDIFICANTE. Children and adolescentsSerious adverse effects such as breathing difficulties and sedation may occur in children. If these signs appear, contact your doctor.

Other medicines and BRONCHENOLO SEDATIVO E FLUIDIFICANTE
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 serious ones, such as serotonin
syndrome, which manifests with alterations 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”).
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell 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 SEDATIVO E FLUIDIFICANTE if”);
• medicines used to treat 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 rhythm abnormalities (flecainide);
• medicines to reduce calcium levels in the blood and treat a dysfunction of the organism due to a reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
• medicines used to prevent the development of fungi (terbinafine). The concomitant use of BRONCHENOLO SEDATIVO E FLUIDIFICANTE and sedating medicines such as benzodiazepines, or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes BRONCHENOLO SEDATIVO E FLUIDIFICANTE together with sedating medicines, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor about all the sedating medicines you are taking, and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or family to pay attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE and laboratory tests
This medicine may cause alterations (false positives) in tests that measure
vanilmandelic acid concentration in the urine.
If your doctor has prescribed this type of urine test, report the use of
BRONCHENOLO SEDATIVO E FLUIDIFICANTE.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE with alcohol
Do not consume alcohol during treatment with this medicine, as this could
cause or worsen some side effects, such as drowsiness.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.
Pregnancy and breastfeeding
No clinical data are available on the risk in pregnancy and during breastfeeding.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE should only be used in case of actual

need and under the direct control of the doctor.
Fertility
No data are available.

Driving and operating machinery
BRONCHENOLO SEDATIVO E FLUIDIFICANTE may cause drowsiness and dizziness, therefore
it may alter the ability to drive vehicles and operate machinery. Pay particular attention
if you have to perform these activities.

BRONCHENOLO SEDATIVO E FLUIDIFICANTE contains:

• sucrose; If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 disease that causes the accumulation of phenylalanine because the body cannot eliminate it correctly.

3. How to take BRONCHENOLO SEDATIVO E FLUIDIFICANTE

Take this medicine following exactly as indicated in this leaflet or
by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use should be limited to the shortest possible period and the lowest possible dose.

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

Children from 6 to 12 years
The recommended dose is 2-3 tablets per day to be dissolved in the mouth, with a minimum
interval between doses of 8 hours.
The maximum daily dose is 3 tablets.
Do not exceed the recommended maximum daily dose.
It is recommended to supervise the child during tablet intake.
Do not use BRONCHENOLO SEDATIVO E FLUIDIFICANTE 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 SEDATIVO E FLUIDIFICANTE tablets allowing them to dissolve in your mouth
(oral route).

If you take more BRONCHENOLO SEDATIVO E FLUIDIFICANTE than you should
If you take more BRONCHENOLO SEDATIVO E FLUIDIFICANTE than you should, the following symptoms may
occur: nausea and vomiting, involuntary muscle contractions,
agitation, confusion, drowsiness, cognitive disorders, involuntary and rapid eye movements,
cardiac disorders (rapid heartbeat), coordination disorders, psychosis with
visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe
respiratory problems (respiratory depression) and seizures.
If taken in excessive quantities, guaifenesin may cause kidney stones.
Contact your doctor or hospital immediately if you experience any of the above symptoms.

If you forget to take BRONCHENOLO SEDATIVO E FLUIDIFICANTE
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor if during treatment with BRONCHENOLO SEDATIVO E FLUIDIFICANTE
you notice:

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

• drowsiness and dizziness;
• disorders of the abdomen, stomach or intestines, nausea, vomiting; Side effects not known (frequency cannot be estimated based on available data)
• serotonin syndrome which manifests with alterations of mental state, 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 can cause difficulty in breathing and swallowing)
• Confusion
• Insomnia (difficulty sleeping)
• Diarrhea

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects directly
through 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 BRONCHENOLO SEDATIVO E FLUIDIFICANTE

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 which is stated on the packaging after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRONCHENOLO SEDATIVO E FLUIDIFICANTE contains
The active ingredients are: dextromethorphan hydrobromide and guaifenesin.
1 lozenge contains: 7.5 mg dextromethorphan hydrobromide and 55 mg of guaifenesin.
The other ingredients are: pine bud essential oil; magnesium trisilicate; aspartame;
magnesium stearate; sucrose; mint flavour.

Description of the appearance of BRONCHENOLO SEDATIVO E FLUIDIFICANTE and contents of the
pack
BRONCHENOLO SEDATIVO E FLUIDIFICANTE lozenges are available in a pack containing 20
lozenges with a mint flavour.

Marketing Authorisation Holder
Perrigo Italia S.r.l. – viale dell’Arte, 25 – 00144 Roma

Manufacturer
Famar Italia S.p.A. - Via Zambeletti 25 - Baranzate (MI).