Dextromethorphan bromide Sella

Italy
Brand name Dextromethorphan bromide Sella
Form tablets, chewable
Active substance / Dosage
Dextromethorphan Hydrobromide
Prescription type Non-prescription – not available over the counter
ATC code
R05DA09
Registration number 029788
Manufacturer LABORATORIO CHIMICO FARMACEUTICO A. SELLA S.R.L.
Dextromethorphan bromide Sella tablets, chewable

Table of Contents

Patient Information Leaflet

DEXTROMETHORPHAN HYDROBROMIDE SELLA 7.65 mg chewable tablets

Dextromethorphan hydrobromide
Please read this entire 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 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  • Contact your doctor if you do not notice any improvement, or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What DESTROMETORFANO BROMIDRATO SELLA is and what it is used for

DESTROMETORFANO BROMIDRATO SELLA contains the active substance dextromethorphan, which belongs to the group of medicines used for the treatment of dry cough.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before taking DESTROMETHORPHAN HYDROBROMIDE SELLA

Do not take DESTROMETHORPHAN HYDROBROMIDE SELLA

  • if you are allergic to dextromethorphan or to any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from breathing disorders (bronchial asthma, chronic obstructive pulmonary disease);
  • if you have difficulty breathing (including respiratory depression);
  • if you have pneumonia, a lung infection;
  • if you suffer from circulatory and heart diseases (cardiovascular diseases);
  • if you have high blood pressure (hypertension);
  • if you suffer from thyroid gland disorders (hyperthyroidism);
  • if you have diabetes;
  • if you have an eye disorder (glaucoma);
  • if you suffer from prostate problems (prostatic hypertrophy);
  • if you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary stenosis);
  • if you suffer from epilepsy;
  • if you have severe liver disease;
  • if the patient is a child under 12 years of age;
  • if you are taking medicines used to treat depression (MAO inhibitor antidepressants); before taking DESTROMETHORPHAN HYDROBROMIDE SELLA, at least two weeks must have passed since stopping treatment with these antidepressant medicines (see section “Other medicines and DESTROMETHORPHAN HYDROBROMIDE SELLA”);
  • if you are in the first trimester of pregnancy or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE SELLA.
The duration of treatment with this medicine should not exceed 5–7 days.
This medicine may lead to dependence. Therefore, treatment should be short-term.
The use of DESTROMETHORPHAN HYDROBROMIDE SELLA, especially for prolonged treatments, may lead to reduced effectiveness and the need to continue using the medicine (habituation, tolerance, mental and physical dependence). Therefore, short-term treatment under strict medical supervision is recommended, especially if you are predisposed to developing such conditions.
This medicine is not indicated for the treatment of persistent cough (chronic cough), which may be due to smoking or lung disorders (emphysema) or breathing disorders (asthma). If you have a persistent cough, stop treatment and consult your doctor, as it may be a symptom of certain respiratory disorders (asthma).
Do not take this medicine if you have a cough with abundant mucus. If your cough causes pain and discomfort (irritating cough) and is accompanied by mucus, consult your doctor, who will carefully evaluate whether treatment with this medicine is necessary. If your doctor considers treatment essential, you must be closely monitored during therapy.
Take this medicine with caution if you experience fever, skin irritation (rash), headache, nausea, and vomiting.
You may start treatment with DESTROMETHORPHAN HYDROBROMIDE SELLA only after careful evaluation by your doctor and under strict medical supervision if:

  • you suffer from circulatory and heart diseases (cardiovascular diseases);
  • you have high blood pressure (hypertension);
  • you suffer from thyroid gland disorders (hyperthyroidism);
  • you have diabetes;
  • you have an eye disorder (glaucoma);
  • you suffer from prostate problems (prostatic hypertrophy);
  • you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary stenosis);
  • you suffer from epilepsy;
  • you have severe liver disease;
  • you are taking medicines used to treat depression (MAO inhibitor antidepressants); at least two weeks must have passed since stopping treatment with these antidepressant medicines. In all the above situations, taking this medicine is not recommended and should be reserved only for cases of absolute necessity (see section “Do not use DESTROMETHORPHAN HYDROBROMIDE SELLA”).

Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE SELLA if you are taking medicines such as certain antidepressants or antipsychotics. DESTROMETHORPHAN HYDROBROMIDE SELLA may interact with these medicines and may 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, diarrhoea).

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.

Other medicines and DESTROMETHORPHAN HYDROBROMIDE SELLA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking medicines used to treat depression (MAO inhibitor antidepressants); at least two weeks must have passed since stopping treatment with these antidepressant medicines.
Be particularly careful and consult your doctor if you are taking:

  • antidepressant medicines (MAO inhibitors);
  • linezolid, a medicine used to treat bacterial infections;
  • sibutramine, a medicine used to treat obesity; as taking these together with DESTROMETHORPHAN HYDROBROMIDE SELLA may cause a condition, which can even be fatal, called serotonin syndrome, whose symptoms include:
    • nausea;
    • decreased blood pressure;
    • tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response and pyramidal-origin rigidity);
    • nervous system disorders (autonomic nervous system hyperactivity, fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis));
    • excessive sweating (diaphoresis);
    • mental disorders (agitation, excitement, confusion);
    • heart block (cardiac arrest) and death.

Consult your doctor and take this medicine with caution if you are taking:

  • medicines used to treat insomnia and anxiety (hypnotic, sedative and anxiolytic medicines);
  • medicines used to treat certain heart disorders (amiodarone, quinidine, propafenone);
  • medicines to treat cardiac arrhythmias (flecainide);
  • medicines used to treat depression (fluoxetine, paroxetine, sertraline, bupropion);
  • antipsychotic medicines used to treat certain mental disorders (haloperidol, thioridazine, perphenazine);
  • a medicine used to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
  • medicines to reduce calcium levels in the blood and to treat dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet;
  • medicines used to prevent fungal (mould) growth (terbinafine);
  • cimetidine, a medicine used to treat stomach disorders due to high acidity;
  • ritonavir, a medicine used to treat AIDS;
  • medicines used to facilitate mucus elimination (secretolytic medicines).

Concomitant use of DESTROMETHORPHAN HYDROBROMIDE SELLA with sedative medicines such as benzodiazepines or related substances 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 DESTROMETHORPHAN HYDROBROMIDE SELLA 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 the doctor's 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 any of these symptoms.

DESTROMETHORPHAN HYDROBROMIDE SELLA with food and alcohol
Avoid drinking grapefruit juice during treatment with this medicine, as it may increase toxic effects or reduce efficacy.
Avoid alcohol during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the first three months of pregnancy.
After the third month of pregnancy, you may take this medicine only in cases of absolute necessity and under strict medical supervision, as breathing problems in the newborn (respiratory depression) may occur, especially at high doses and even after short treatment periods.
Do not take this medicine while breastfeeding.

Driving and using machines
DESTROMETHORPHAN HYDROBROMIDE SELLA may affect your ability to drive or operate machinery, as it may cause drowsiness, especially if you also consume alcohol (see section “DESTROMETHORPHAN HYDROBROMIDE SELLA with food and alcohol”).

DESTROMETHORPHAN HYDROBROMIDE SELLA contains sorbitol
This medicine contains 640 mg of sorbitol, a type of sugar, per dose. Sorbitol is a source of fructose. If your doctor has told you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine. It may cause gastrointestinal problems and has a mild laxative effect.

3. How to take DESTROMETORFANO BROMIDRATO SELLA

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.
In adults and adolescents (aged 12 to 18 years), the recommended dose ranges from 1 to 3 tablets every 6 hours.
The maximum daily dose over 24 hours is 10–11 tablets.

If you take more DESTROMETORFANO BROMIDRATO SELLA than you should
If you take more DESTROMETORFANO BROMIDRATO SELLA 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 problems, psychosis with visual hallucinations, and hyperexcitability.
Additional symptoms in case of massive overdose may include: coma, severe respiratory problems, seizures, and reduced urine output.
Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.

If you forget to take DESTROMETORFANO BROMIDRATO SELLA
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.
Not known (frequency cannot be estimated from the available data)

  • drowsiness, fatigue;
  • involuntary and rapid eye movements (nystagmus);
  • movement difficulties (dystonia);
  • dizziness;
  • mental confusion and behavioural changes (foul language);
  • serotonin syndrome (see section “Warnings and precautions”), characterised by nausea, low blood pressure, tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response and pyramidal rigidity), nervous system disorders (autonomic nervous system hyperactivity), fever, increased heart rate (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disorders (agitation, excitement, confusion), cardiac arrest and death;
  • mental disorders (psychosis), hallucinations;
  • need to continue taking the medicine (psychic dependence);
  • severe allergic reactions (anaphylaxis);
  • fever, sometimes very high;
  • nausea and vomiting;
  • stomach and intestinal disorders, loss of appetite;
  • skin allergic reactions (rashes).

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can 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 DESTROMETORFANO BROMIDRATO SELLA

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 "Expires:". The expiry date refers to the last day of that month.
Store the medicine in its original, tightly closed packaging, protected from moisture and light.
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 DESTROMETORFANO BROMIDRATO SELLA contains

  • The active substance is bromhexine hydrobromide. Each tablet contains 7.65 mg of bromhexine hydrobromide.
  • The other ingredients are sorbitol (E420), rice starch, magnesium trisilicate, magnesium stearate, peppermint flavour.

Description of the appearance of DESTROMETORFANO BROMIDRATO SELLA and package contents
Carton pack containing 20 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)

Patient information leaflet

DEXTROMETHORPHAN HYDROBROMIDE SELLA 30 mg/10 ml syrup

Dextromethorphan hydrobromide
Read this entire 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 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 improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What DESTROMETORFANO BROMIDRATO SELLA is and what it is used for

DESTROMETORFANO BROMIDRATO SELLA contains the active substance dextromethorphan, which belongs to the group of medicines used to treat dry cough.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before taking DESTROMETHORPHAN HYDROBROMIDE SELLA

Do not take DESTROMETHORPHAN HYDROBROMIDE SELLA

  • if you are allergic to dextromethorphan or to any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from breathing disorders (bronchial asthma, chronic obstructive bronchopulmonary disease);
  • if you have difficulty breathing (including respiratory depression);
  • if you have pneumonia, a lung infection;
  • if you suffer from circulatory and heart disorders (cardiovascular diseases);
  • if you have high blood pressure (hypertension);
  • if you suffer from thyroid disorders (hyperthyroidism);
  • if you have diabetes;
  • if you have an eye disorder (glaucoma);
  • if you suffer from prostate problems (prostatic hypertrophy);
  • if you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary stenosis);
  • if you suffer from epilepsy;
  • if you have severe liver disease;
  • if the patient is a child under 12 years of age;
  • if you are taking medicines used to treat depression (MAO-inhibiting antidepressants); at least two weeks must have passed since stopping these antidepressant medicines before taking DESTROMETHORPHAN HYDROBROMIDE SELLA (see section “Other medicines and DESTROMETHORPHAN HYDROBROMIDE SELLA”);
  • if you are in the first trimester of pregnancy or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE SELLA.
The duration of treatment with this medicine should not exceed 5–7 days.
This medicine may lead to dependence. Therefore, treatment should be short-term.
The use of DESTROMETHORPHAN HYDROBROMIDE SELLA, especially for prolonged treatment, may cause reduced effectiveness and the need to continue using the medicine (habituation, tolerance, mental and physical dependence). Therefore, short-term treatment under strict medical supervision is recommended, particularly if you are predisposed to such conditions.
This medicine is not indicated for the treatment of persistent cough (chronic cough), which may be due to smoking or lung disorders (emphysema) or breathing disorders (asthma). If you have a persistent cough, stop treatment and consult your doctor, as it may be a symptom of certain respiratory disorders (asthma).
Do not take this medicine if your cough is accompanied by abundant mucus. If your cough causes pain and discomfort (irritating cough) and is associated with mucus, consult your doctor, who will carefully assess whether treatment with this medicine is necessary. If your doctor considers treatment essential, you must be closely monitored during therapy.
Take this medicine with caution if you experience fever, skin rash, headache, nausea, and vomiting.
You may start treatment with DESTROMETHORPHAN HYDROBROMIDE SELLA only after careful evaluation by your doctor and under close medical supervision if:

  • you suffer from circulatory and heart disorders (cardiovascular diseases);
  • you have high blood pressure (hypertension);
  • you suffer from thyroid disorders (hyperthyroidism);
  • you have diabetes;
  • you have an eye disorder (glaucoma);
  • you suffer from prostate problems (prostatic hypertrophy);
  • you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary stenosis);
  • you suffer from epilepsy;
  • you have severe liver disease;
  • you are taking medicines used to treat depression (MAO-inhibiting antidepressants); at least two weeks must have passed since stopping these antidepressant medicines.

In all the above situations, taking this medicine is not recommended and should be reserved only for cases of absolute necessity (see section “Do not use DESTROMETHORPHAN HYDROBROMIDE SELLA”).

Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE SELLA if you are taking medicines such as certain antidepressants or antipsychotics. DESTROMETHORPHAN HYDROBROMIDE SELLA may interact with these medicines and may cause changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable arterial pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.

Other medicines and DESTROMETHORPHAN HYDROBROMIDE SELLA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking medicines used to treat depression (MAO-inhibiting antidepressants); at least two weeks must have passed since stopping these antidepressant medicines before taking DESTROMETHORPHAN HYDROBROMIDE SELLA.
Be particularly careful and consult your doctor if you are taking:

  • antidepressant medicines (MAO inhibitors);
  • linezolid, a medicine used to treat bacterial infections;
  • sibutramine, a medicine used to treat obesity;

as taking them together with DESTROMETHORPHAN HYDROBROMIDE SELLA may cause a condition, which can even be fatal, called serotonin syndrome, whose symptoms include:

  • nausea;
  • low blood pressure;
  • tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response, and pyramidal-origins muscle rigidity);
  • nervous system disorders (autonomic nervous system hyperactivity, fever, increased heart rate (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis));
  • excessive sweating (diaphoresis);
  • mental disorders (agitation, excitement, confusion);
  • heart block (cardiac arrest) and death.

Consult your doctor and take this medicine with caution if you are taking:

  • medicines used to treat insomnia and anxiety (hypnotic, sedative, and anxiolytic medicines);
  • medicines used to treat certain heart disorders (amiodarone, quinidine, propafenone);
  • medicines to treat cardiac arrhythmias (flecainide);
  • medicines used to treat depression (fluoxetine, paroxetine, sertraline, bupropion);
  • antipsychotic medicines used to treat certain mental disorders (haloperidol, thioridazine, perphenazine);
  • a medicine used to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
  • 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 (mould) growth (terbinafine);
  • cimetidine, a medicine used to treat stomach disorders due to high acidity;
  • ritonavir, a medicine used to treat AIDS;
  • medicines used to facilitate mucus elimination (secretolytic medicines).

Concomitant use of DESTROMETHORPHAN HYDROBROMIDE SELLA 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 no other treatment options are available.
However, if your doctor prescribes DESTROMETHORPHAN HYDROBROMIDE SELLA 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 carefully follow 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.

DESTROMETHORPHAN HYDROBROMIDE SELLA with grapefruit juice and alcohol
Avoid consuming grapefruit juice during treatment with this medicine, as it may increase toxic effects or reduce efficacy.
Avoid consuming alcohol during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the first three months of pregnancy.
After the third month of pregnancy, you may take this medicine only in cases of absolute necessity and under strict medical supervision, as breathing problems in the newborn (respiratory depression) may occur, especially at high doses and even after short treatment periods.
Do not take this medicine while breastfeeding.

Driving and using machines
DESTROMETHORPHAN HYDROBROMIDE SELLA may affect your ability to drive or operate machinery, as it may cause drowsiness, especially if you consume alcohol at the same time (see section “DESTROMETHORPHAN HYDROBROMIDE SELLA with grapefruit juice and alcohol”).

DESTROMETHORPHAN HYDROBROMIDE SELLA contains sucrose, sodium, sodium benzoate, and parahydroxybenzoates
This medicine contains 3 g of sucrose (sugar) per dose. This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.
This medicine contains 9 mg of benzoate salt per dose.
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to take DESTROMETORFANO BROMIDRATO SELLA

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.
DESTROMETORFANO BROMIDRATO SELLA
In adults and adolescents (12 to 18 years of age), the recommended dose ranges from 10 mg (one teaspoonful, equivalent to approximately 3 ml) to 20 mg (two teaspoonfuls, equivalent to 6 ml) every 6 hours.
The maximum recommended dose is 80 mg per day.
If you take more DESTROMETORFANO BROMIDRATO SELLA than you should
If an excessive amount of DESTROMETORFANO BROMIDRATO SELLA is taken, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), coordination disturbances, psychosis with visual hallucinations and hyperexcitability.
Additional symptoms in case of massive overdose may include coma, severe respiratory problems, convulsions, and reduced urine output.
Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.
If you forget to take DESTROMETORFANO BROMIDRATO SELLA
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 will experience them.

Not known (frequency cannot be established from available data)

  • drowsiness, fatigue;
  • involuntary and rapid eye movements (nystagmus);
  • movement difficulties (dystonia);
  • dizziness;
  • mental confusion and behavioural changes (foul language);
  • serotonin syndrome (see section “Warnings and precautions”), characterised by nausea, low blood pressure, tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response and pyramidal-origins rigidity), nervous system disorders (autonomic nervous system hyperactivity), fever, increased heart rate (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disturbances (agitation, excitement, confusion), cardiac arrest and death;
  • psychiatric disorders (psychosis), hallucinations;
  • need to continue taking the medicine (psychic dependence);
  • severe allergic reactions (anaphylaxis);
  • fever, sometimes very high;
  • diabetes mellitus;
  • nausea and vomiting;
  • stomach and intestinal disturbances, loss of appetite;
  • skin allergic reactions (rash).

Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please inform 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 DESTROMETORFANO BROMIDRATO SELLA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expires:". The expiry date refers to the last day of that month.
Store the medicine in its original packaging, tightly closed, to protect it from light.
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 DESTROMETORFANO BROMIDRATO SELLA contains

  • The active substance is bromhexine hydrobromide. Each 10 ml of syrup contains 30 mg of bromhexine hydrobromide.
  • The other components are: sodium benzoate (E211), citric acid monohydrate, sucrose, methyl parahydroxybenzoate (E218), raspberry flavour, purified water.

Description of the appearance of DESTROMETORFANO BROMIDRATO SELLA and the contents of the pack
Pack containing one 150 ml bottle.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)

Patient Information Leaflet

DESTROMETHORPHAN HYDROBROMIDE SELLA 15 mg/ml oral drops, solution

Dextromethorphan hydrobromide
Please 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 instructed you.

  • Keep this leaflet. You may need to read it again.
  • If you would like more information or advice, please consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What DESTROMETORFANO BROMIDRATO SELLA is and what it is used for

DESTROMETORFANO BROMIDRATO SELLA contains the active substance Dextromethorphan, which belongs to the group of medicines used for the treatment of dry cough.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking DESTROMETHORPHAN HYDROBROMIDE SELLA

Do not take DESTROMETHORPHAN HYDROBROMIDE SELLA

  • if you are allergic to dextromethorphan or to any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from respiratory disorders (bronchial asthma, chronic obstructive pulmonary disease);
  • if you have difficulty breathing (including respiratory depression);
  • if you have pneumonia, a lung infection;
  • if you suffer from circulatory and heart diseases (cardiovascular diseases);
  • if you have high blood pressure (hypertension);
  • if you suffer from thyroid disorders (hyperthyroidism);
  • if you have diabetes;
  • if you have an eye disorder (glaucoma);
  • if you suffer from prostate problems (prostatic hypertrophy);
  • if you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary tract stenosis);
  • if you suffer from epilepsy;
  • if you have severe liver disease;
  • if the patient is a child under 12 years of age;
  • if you are taking medicines used to treat depression (MAO inhibitor antidepressants); before taking DESTROMETHORPHAN HYDROBROMIDE SELLA, at least two weeks must have passed since stopping these antidepressant medicines (see section “Other medicines and DESTROMETHORPHAN HYDROBROMIDE SELLA”);
  • if you are in the first trimester of pregnancy or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE SELLA.
The duration of treatment with this medicine should not exceed 5–7 days.
This medicine may lead to dependence. Therefore, treatment should be short-term.
The use of DESTROMETHORPHAN HYDROBROMIDE SELLA, especially for prolonged treatments, may cause reduced effectiveness and the need to continue using the medicine (habituation, tolerance, mental and physical dependence). Therefore, short-term treatment under strict medical supervision is recommended, especially if you are predisposed to such conditions.
This medicine is not indicated for the treatment of persistent cough (chronic cough), which may be due to smoking or lung disorders (emphysema) or breathing disorders (asthma). If you have a persistent cough, stop treatment and consult your doctor, as it may be a symptom of respiratory disorders (asthma).
If you have a cough accompanied by abundant mucus, do not take this medicine. If your cough causes pain and discomfort (irritating cough) and is accompanied by mucus, consult your doctor, who will carefully assess whether treatment with this medicine is necessary. If your doctor considers treatment essential, you must be closely monitored during therapy.
Take this medicine with caution if you experience fever, skin rash, headache, nausea and vomiting.
You may start treatment with DESTROMETHORPHAN HYDROBROMIDE SELLA only after careful evaluation by your doctor and under close medical supervision if:

  • you suffer from circulatory and heart diseases (cardiovascular diseases);
  • you have high blood pressure (hypertension);
  • you suffer from thyroid disorders (hyperthyroidism);
  • you have diabetes;
  • you have an eye disorder (glaucoma);
  • you suffer from prostate problems (prostatic hypertrophy);
  • you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary tract stenosis);
  • you suffer from epilepsy;
  • you have severe liver disease;
  • you are taking medicines used to treat depression (MAO inhibitor antidepressants); at least two weeks must have passed since stopping these antidepressant medicines. In all the above situations, taking this medicine is not recommended and should be reserved only for cases of absolute necessity (see section “Do not use DESTROMETHORPHAN HYDROBROMIDE SELLA”).

Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE SELLA if you are taking medicines such as certain antidepressants or antipsychotics. DESTROMETHORPHAN HYDROBROMIDE SELLA may interact with these medicines and may 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).

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.

Other medicines and DESTROMETHORPHAN HYDROBROMIDE SELLA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take this medicine if you are taking medicines used to treat depression (MAO inhibitor antidepressants); at least two weeks must have passed since stopping these antidepressant medicines before taking DESTROMETHORPHAN HYDROBROMIDE SELLA.
Be especially careful and consult your doctor if you are taking:

  • antidepressant medicines (MAO inhibitors);
  • linezolid, a medicine used to treat bacterial infections;
  • sibutramine, a medicine used to treat obesity; as taking them together with DESTROMETHORPHAN HYDROBROMIDE SELLA may cause a condition, which can even be fatal, called serotonin syndrome, whose symptoms include:
    • nausea;
    • low blood pressure;
    • tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response and pyramidal-origin stiffness);
    • nervous system disorders (autonomic nervous system hyperactivity, fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis));
    • excessive sweating (diaphoresis);
    • mental disturbances (agitation, excitement, confusion);
    • heart block (cardiac arrest) and death.

Consult your doctor and take this medicine with caution if you are taking:

  • medicines used to treat insomnia and anxiety (hypnotic, sedative and anxiolytic medicines);
  • medicines used to treat certain heart disorders (amiodarone, quinidine, propafenone);
  • medicines to treat heart rhythm disorders (flecainide);
  • medicines used to treat depression (fluoxetine, paroxetine, sertraline, bupropion);
  • antipsychotic medicines used to treat certain mental disorders (haloperidol, thioridazine, perphenazine);
  • a medicine used to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
  • medicines to reduce calcium levels in the blood and to treat organ dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet;
  • medicines used to prevent fungal (mould) growth (terbinafine);
  • cimetidine, a medicine used to treat stomach disorders due to high acidity;
  • ritonavir, a medicine used to treat AIDS;
  • medicines used to help eliminate mucus (secretolytic medicines).

Concomitant use of DESTROMETHORPHAN HYDROBROMIDE SELLA and sedative medicines such as benzodiazepines or related substances increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should be considered only when no other treatment options are available.
However, if your doctor prescribes DESTROMETHORPHAN HYDROBROMIDE SELLA 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 the doctor's dose 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 any of these symptoms.

DESTROMETHORPHAN HYDROBROMIDE SELLA with food and alcohol
Avoid consuming grapefruit juice during treatment with this medicine, as it may increase toxic effects or reduce effectiveness.
Avoid consuming alcohol during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during the first three months of pregnancy.
After the third month of pregnancy, you may take this medicine only in cases of absolute necessity and under strict medical supervision, as breathing problems in the newborn (respiratory depression) may occur, especially at high doses and even after short treatment periods.
Do not take this medicine while breastfeeding.

Driving and using machines
DESTROMETHORPHAN HYDROBROMIDE SELLA may affect your ability to drive or use machinery, as it may cause drowsiness, especially if you consume alcohol at the same time (see section “DESTROMETHORPHAN HYDROBROMIDE SELLA with food and alcohol”).

DESTROMETHORPHAN HYDROBROMIDE SELLA contains methyl 4-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to take DEXTROMETHORPHAN HYDROBROMIDE SELLA

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.
In adults and adolescents (aged 12 to 18 years), the recommended dose ranges from 10 mg (approximately 14 drops) to 20 mg (approximately 28 drops) every 6 hours.
The maximum recommended dose is 80 mg per day (approximately 110 drops).

If you take more DEXTROMETHORPHAN HYDROBROMIDE SELLA than you should
If you take more DEXTROMETHORPHAN HYDROBROMIDE SELLA 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 problems, psychosis with visual hallucinations, and hyperexcitability.
Additional symptoms in case of massive overdose may include: coma, severe breathing problems, seizures, and reduced urine output.
Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.

If you forget to take DEXTROMETHORPHAN HYDROBROMIDE SELLA
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 gets them.
Not known (frequency cannot be estimated from the available data)

  • drowsiness, fatigue;
  • involuntary and rapid eye movements (nystagmus);
  • movement difficulties (dystonia);
  • dizziness;
  • confusion and behavioural changes (foul language);
  • serotonin syndrome (see section “Warnings and precautions”), characterised by nausea, decreased blood pressure, tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response and pyramidal rigidity), nervous system disorders (autonomic nervous system hyperactivity), fever, increased heart rate (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disorders (agitation, excitement, confusion), heart block (cardiac arrest) and death;
  • psychiatric disorders (psychosis), hallucinations;
  • need to continue taking the medicine (psychic dependence);
  • severe allergic reactions (anaphylaxis);
  • fever, sometimes very high;
  • nausea and vomiting;
  • stomach and intestinal disturbances, reduced appetite;
  • skin allergic reactions (rashes).

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

5. How to store DESTROMETORFANO BROMIDRATO SELLA

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 "Expiry:". The expiry date refers to the last day of that month.
Store the medicine in the original packaging, tightly closed, to protect from light.
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 DESTROMETORFANO BROMIDRATO SELLA contains

  • The active substance is brompheniramine maleate. Each ml of solution (20 drops) contains 15 mg of brompheniramine maleate.
  • The other components are: glycerol, methyl parahydroxybenzoate (E218), purified water.

Description of the appearance of DESTROMETORFANO BROMIDRATO SELLA and package contents
Pack containing one 20 ml bottle.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)