БРОНКЕНОЛО ТОССЕ 1,54 МГ/МЛ Сироп

Содержание инструкции

1. BRONCHENOLO TOSSE 1.54 mg/ml syrup
   1. What is BRONCHENOLO TOSSE and what is it used for?
   2. What you need to know before taking BRONCHENOLO TOSSE
   3. How to take BRONCHENOLO TOSSE
   4. Possible side effects
   5. How to store BRONCHENOLO TOSSE
   6. Contents of the pack and other information

BRONCHENOLO TOSSE 1.54 mg/ml syrup

Dextromethorphan bromhydrate

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 5-7 days of treatment.

Contents of this leaflet:

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

1. What is BRONCHENOLO TOSSE and what is it used for?

This medicine contains dextromethorphan hydrobromide, an active ingredient belonging to the
class of cough suppressant medicines.
BRONCHENOLO TOSSE is used to soothe coughs.
Consult your doctor if you do not feel better or if you feel worse after 5-7 days of treatment.

2. What you need to know before taking BRONCHENOLO TOSSE

Do not take BRONCHENOLO TOSSE if:

• you are allergic to dextromethorphan hydrobromide 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 having breathing problems (respiratory failure), for example, you have chronic obstructive airway diseases, pneumonia, an ongoing asthma attack or worsening of asthma. Do not use BRONCHENOLO TOSSE in children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking BRONCHENOLO TOSSE 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 is accompanied by phlegm;
• the 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 some antidepressants or antipsychotics. BRONCHENOLO TOSSE may interact with these medicines and changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as a body temperature above 38° C, increased heart rate, unstable blood pressure, exaggeration of reflexes, muscle stiffness, 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 TOSSE 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 (profound unconsciousness) and may 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 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 TOSSE for short periods and under strict medical supervision. It is not recommended to consume alcoholic beverages during treatment with BRONCHENOLO TOSSE. Children and adolescentsSerious side effects such as difficulty breathing and sedation may occur in children. If these signs appear, contact your doctor.

Other medicines and BRONCHENOLO TOSSE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
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 side effects”).
In particular, tell your doctor if you are taking or have recently taken:

• medicines to treat depression such as selective serotonin reuptake inhibitors, tricyclic antidepressants, fluoxetine, paroxetine, sertraline and bupropion (see section 2. “Do not take BRONCHENOLO TOSSE if”);
• 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 disturbances (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 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 TOSSE and sedating medicines such as benzodiazepines, or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may 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 TOSSE together with sedating medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all 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 TOSSE with alcohol
Do not consume alcohol during treatment with this medicine, as this may cause or
worsen certain side effects, such as drowsiness.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy and breastfeeding
Clinical data on the risk in pregnancy and during breastfeeding are not available.
BRONCHENOLO TOSSE should only be used if absolutely necessary and under the direct
supervision of the doctor.
Fertility
No data are available.

Driving and operating machinery
BRONCHENOLO TOSSE can cause drowsiness and dizziness, therefore it can alter the ability to
drive vehicles and operate machinery. Be particularly careful if you have to perform these
activities.

BRONCHENOLO TOSSE contains:

• Liquid sucrose; contains 17.2 g of sucrose (sugar) per dose (15 ml). This should be taken into account in people with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
• methyl parahydroxybenzoates, may cause allergic reactions (even delayed);
• ethyl alcohol. This medicine contains 576 mg of alcohol (ethanol) per dose (15 ml). The amount in 15 ml of this medicine is equivalent to 14 ml of beer and 6 ml of wine. The amount of alcohol in this medicine does not appear 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 dependence, talk to your doctor before taking this medicine.
• Sodium. This medicine contains less than 1 mmol of sodium (23 mg), which is to be considered essentially sodium-free.

3. How to take BRONCHENOLO TOSSE

Take this medicine following exactly as indicated in this leaflet or as instructed 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 of age
The recommended dose is 15 ml 3 – 4 times a day with a minimum interval between doses of 4 hours.
The maximum daily dose is 60 ml. Do not exceed the recommended maximum daily dose.

Children between 6 and 12 years of age
The recommended dose is 7.5 ml 3 – 4 times a day with a minimum interval between doses of 4 hours.
The maximum daily dose is 30 ml. Do not exceed the recommended maximum daily dose.
1 ml of syrup contains: 1.54 mg of dextromethorphan hydrobromide.
Do not use BRONCHENOLO TOSSE 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 TOSSE syrup must be taken orally, using the measuring cup
(measuring spoon), as follows:

• 1. Open the bottle by pressing and rotating the cap counterclockwise simultaneously.
• 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.
• 5. Wash the measuring spoon after each use.

If you take more BRONCHENOLO TOSSE than you should
If you take more BRONCHENOLO TOSSE 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 (fast heartbeat),
coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe breathing problems
(respiratory depression) and convulsions. Seek medical attention or go to hospital immediately if
you experience any of the aforementioned symptoms.

If you forget to take BRONCHENOLO TOSSE
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 TOSSE 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 in mental status, increased

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 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 TOSSE

Keep this medicine out of the sight and reach of children.
No special storage precautions are necessary.
Do not use this medicine after the expiry date which is stated on the packaging after Scad. The
expiry date refers to the last day of that month.
After first opening, use the medicine within 12 months.
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 TOSSE contains
The active ingredient is: dextromethorphan hydrobromide.
100 ml of syrup contains: 154 mg dextromethorphan hydrobromide.
The other ingredients are: sodium citrate; citric acid monohydrate; ethyl alcohol; liquid sucrose;
lemon aroma; mint aroma; methyl parahydroxybenzoate; purified water.

Description of the appearance of BRONCHENOLO TOSSE and contents of the pack
150 ml glass bottle with child-resistant closure, containing syrup, and 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.

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