DESTROMETORFANO 7.65 mg Жевательная таблетка

Содержание инструкции

1. DESTROMETORFANO BROMIDRATO SELLA 7.65 mg chewable tablets
   1. What is DESTROMETORFANO BROMIDRATO SELLA and what is it used for
   2. What you need to know before taking DESTROMETORFANO BROMIDRATO SELLA
   3. How to take DESTROMETORFANO BROMIDRATO SELLA
   4. Possible side effects
   5. How to store DESTROMETORFANO BROMIDRATO SELLA
   6. Contents of the pack and other information
2. DESTROMETORFANO BROMIDRATO SELLA 30 mg/10 ml syrup
   1. What is DESTROMETORFANO BROMIDRATO SELLA and what is it used for
   2. What you need to know before taking DESTROMETORFANO BROMIDRATO SELLA
   3. How to take DESTROMETORFANO BROMIDRATO SELLA
   4. Possible side effects
   5. How to store DESTROMETORFANO BROMIDRATO SELLA
   6. Contents of the pack and other information
3. DESTROMETORFANO BROMIDRATO SELLA 15 mg/ml oral drops, solution
   1. What is DESTROMETORFANO BROMIDRATO SELLA and what is it used for
   2. What you need to know before you take DESTROMETORFANO BROMIDRATO SELLA
   3. How to take DESTROMETORFANO BROMIDRATO SELLA
   4. Possible side effects
   5. How to store DESTROMETORFANO BROMIDRATO SELLA
   6. Contents of the pack and other information

DESTROMETORFANO BROMIDRATO SELLA 7.65 mg chewable tablets

Destrometorfano bromidrato

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 a few days.

Contents of this leaflet:

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

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

DESTROMETORFANO BROMIDRATO SELLA contains the active ingredient Destrometorfano which belongs to the
group of medicines used for the treatment of dry cough.
See a doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking DESTROMETORFANO BROMIDRATO SELLA

Do not take DESTROMETORFANO BROMIDRATO SELLA

• if you are allergic to destrometorfano or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from breathing problems (bronchial asthma, chronic obstructive bronchopneumonia);
• if you have difficulty breathing (including respiratory depression);
• if you have pneumonia, a lung infection;
• if you suffer from blood and heart circulation 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 disorders of the stomach, intestines or urinary tract (stenosis of the gastrointestinal and urogenital tract);
• if you suffer from epilepsy;
• if you have severe liver disease;
• if the patient is a child under the age of 12 years;
• if you are taking medicines used for the treatment of depression (MAO inhibitors); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary that

two weeks have passed since taking the antidepressant medicines (see section “Other
medicines and DESTROMETORFANO BROMIDRATO SELLA”);

• if you are in the first trimester of pregnancy and if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROMETORFANO BROMIDRATO SELLA.
The duration of treatment with this medicine should not be longer than 5-7 days.

This medicine can lead to dependence. Therefore, treatment should be of short duration.
The use of DESTROMETORFANO BROMIDRATO SELLA, especially for prolonged treatments, can cause
a decrease in effectiveness and the need to continue using the medicine (habituation,
tolerance, mental and physical dependence). Therefore, short-term treatment and under
strict medical control is recommended, especially if you are predisposed to developing this condition.
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 (asthma). If you have a persistent cough
stop treatment and see your doctor, as it may be a symptom of some 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, see your doctor who will assess
the need for treatment with this medicine. If the doctor deems the treatment
essential, they will monitor you during therapy.
Take this medicine with caution if you experience fever, skin irritation (rash), headache,
nausea and vomiting.
You can only start treatment with DESTROMETORFANO BROMIDRATO SELLA after a careful evaluation
by your doctor and under strict control if:

• you suffer from blood and heart circulation 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 disorders of the stomach, intestines or urinary tract (stenosis of the gastrointestinal and urogenital tract);
• you suffer from epilepsy;
• you have severe liver disease;
• you are taking medicines used for the treatment of depression (MAO inhibitors); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary that two weeks have passed since taking the antidepressant medicines. In all the situations above, taking this medicine is not recommended, and is reserved only for cases of absolute necessity (see section “Do not use DESTROMETORFANO BROMIDRATO SELLA”).

Talk to your doctor or pharmacist before taking DESTROMETORFANO BROMIDRATO SELLA if you are
taking medicines such as some antidepressants or antipsychotics. DESTROMETORFANO BROMIDRATO SELLA
can interact with these medicines and alterations in mental status (e.g.
agitation, hallucinations, coma) and other effects such as body temperature above 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.

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

Other medicines and DESTROMETORFANO BROMIDRATO 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 for the treatment of depression
(MAO inhibitors); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary
that two weeks have passed since taking the antidepressant medicines.
Be particularly careful and see your doctor if you are taking:

• antidepressant medicines (MAO inhibitors);
• linezolid, a medicine used to treat infections caused by bacteria;
• sibutramine, a medicine used to treat obesity; as if taken simultaneously with DESTROMETORFANO BROMIDRATO SELLA they can cause a condition, which can also be fatal, called serotonin syndrome whose symptoms are:
• nausea;
• decrease in blood pressure;
• tremors and muscle disorders (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity);
• nervous system disorders (hyperactivity of the autonomic nervous system, fever, acceleration of the heartbeat (tachycardia), short breath (tachypnea), pupil dilation (mydriasis);
• profuse sweating (diaphoresis);
• mental disorders (agitation, excitement, confusion);
• heart block (cardiac arrest) and death.

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

• medicines used for the treatment of insomnia and anxiety (hypnotic, sedative and anxiolytic medicines);
• medicines used for the treatment of some heart disorders (amiodarone, quinidine, propafenone);
• medicines to treat heart rhythm abnormalities (flecainide);
• medicines used for the treatment of depression (fluoxetine, paroxetine, sertraline, bupropion);
• antipsychotic medicines used for the treatment of some mental disorders (haloperidol, thioridazine, perphenazine);
• medicine to treat severe pain or to reduce withdrawal symptoms in cases of addiction (methadone);
• medicines to reduce calcium levels in the blood and treat a dysfunction of the body 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 (mycetes) (terbinafine);
• cimetidine, a medicine used to treat stomach disorders due to high acidity;
• ritonavir, a medicine used to treat AIDS;
• medicines used to facilitate the elimination of mucus (secretolytic medicines).

The concomitant use of DESTROMETORFANO BROMIDRATO SELLA and sedative medicines such as
benzodiazepines or medicines related to them increases the risk of drowsiness, difficulty breathing (respiratory
depression), coma and can be life-threatening. For this reason, concomitant use should be
considered only when other treatment options are not possible.
However, if your doctor prescribes DESTROMETORFANO BROMIDRATO SELLA together with sedative medicines, the
dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow
the doctor's dosage recommendation. It may be helpful to inform friends or family to pay attention to
the above signs and symptoms.
See your doctor if you experience these symptoms.

DESTROMETORFANO BROMIDRATO SELLA with drinks and alcohol
Avoid taking grapefruit juice during treatment with this medicine because it can occur
an increase in toxic effects or a decrease in effect.
Avoid drinking alcohol during treatment with this medicine.

Pregnancy and breastfeeding
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 taking this medicine.
Do not take this medicine in the first three months of pregnancy.
After the third month of pregnancy, you can take this medicine only in cases of absolute necessity and under
strict medical control because respiratory problems may occur in the newborn (respiratory
depression), especially at high doses and even for short periods of treatment.
Do not take this medicine during breastfeeding.

Driving and using machines
DESTROMETORFANO BROMIDRATO SELLA can alter your ability to drive vehicles or use machinery,
as it can cause drowsiness, especially if you take it at the same time as alcohol (see section
“DESTROMETORFANO BROMIDRATO SELLA with drinks and alcohol”).

DESTROMETORFANO BROMIDRATO 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 that you (or your child) are intolerant to some sugars, or if you have a
diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot
transform fructose, talk to your doctor before you (or your child) take this medicine. It can
cause gastrointestinal problems and have a mild laxative effect.

3. How to take DESTROMETORFANO BROMIDRATO SELLA

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
In adults and adolescents (from 12 to 18 years), the recommended dose ranges from 1 tablet to 3
tablets, every 6 hours.
The maximum achievable dose in 24 hours is 10-11 tablets.

If you take more DESTROMETORFANO BROMIDRATO SELLA than you should
If you take more DESTROMETORFANO BROMIDRATO SELLA than you should, 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
disorders, psychosis with visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe respiratory problems and
convulsions and decreased urine output.
Contact your doctor or hospital immediately if you experience any of the aforementioned symptoms .
If you forget to take DESTROMETORFANO BROMIDRATO SELLA
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask 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 available data)

• drowsiness, fatigue;
• involuntary and rapid eye movements (nystagmus);
• difficulty of movement (dystonia);
• dizziness;
• mental confusion and behavioral changes (scurrilous language);
• serotonin syndrome (see section “Warnings and precautions”), characterized by nausea, decreased blood pressure, tremors and muscle disorders (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity), nervous system disorders (hyperactivity of the autonomic nervous system), fever, accelerated heartbeat (tachycardia), rapid breathing (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disorders (agitation, excitement, confusion), heart block (cardiac arrest) and death;
• mental disorders (psychosis), hallucinations;
• need to continue taking the medicine (psychic dependence);
• severe allergic reactions (anaphylaxis);
• high fever, even very high;
• diabetes mellitus;
• nausea and vomiting;
• stomach and intestinal disorders, loss of appetite;
• allergic skin reactions (skin rashes).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 DESTROMETORFANO BROMIDRATO SELLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expires:”. The expiry
date refers to the last day of that month.
Keep the medicine in its well-closed packaging, protected from moisture and in its original packaging to protect from
light.
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 DESTROMETORFANO BROMIDRATO SELLA contains

• The active ingredient is destrometorfano bromidrato. 1 tablet contains 7.65 mg of destrometorfano bromidrato.
• The other ingredients are sorbitol (E420), rice starch, magnesium trisilicate, magnesium stearate, mint flavour.

Description of the appearance of DESTROMETORFANO BROMIDRATO SELLA and contents of the pack
Pack containing 20 tablets

Marketing authorisation holder and manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)

DESTROMETORFANO BROMIDRATO SELLA 30 mg/10 ml syrup

Destrometorfano bromidrato

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 a few days.

Contents of this leaflet:

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

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

DESTROMETORFANO BROMIDRATO SELLA contains the active ingredient Destrometorfano which belongs to the
group of medicines used for the treatment of dry cough.
See a doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking DESTROMETORFANO BROMIDRATO SELLA

Do not take DESTROMETORFANO BROMIDRATO SELLA

• if you are allergic to destrometorfano or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from respiratory disorders (bronchial asthma, chronic obstructive bronchopneumonia);
• if you have difficulty breathing (including respiratory depression);
• if you have pneumonia, a lung infection;
• if you suffer from diseases of the blood circulation and heart (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 disorders of the stomach, intestines or urinary tract (stenosis of the gastrointestinal and urogenital tract);
• if you suffer from epilepsy;
• if you have severe liver disease;
• if the patient is a child under the age of 12;
• if you are taking medicines used for the treatment of depression (MAO inhibitors); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary that

two weeks have passed since taking the antidepressant medicines (see section “Other
medicines and DESTROMETORFANO BROMIDRATO SELLA”);

• if you are in the first trimester of pregnancy and if you are breastfeeding.

Warnings and precautions
Consult your doctor or pharmacist before taking DESTROMETORFANO BROMIDRATO SELLA.
The duration of treatment with this medicine should not exceed 5-7 days.

This medicine can lead to dependence. Therefore, treatment should be of short duration.
The use of DESTROMETORFANO BROMIDRATO SELLA, especially for prolonged treatments, may cause
a decrease in effectiveness and the need to continue using the medicine (habituation,
tolerance, mental and physical dependence). Therefore, short-term treatment and under
strict medical supervision is recommended, especially if you are predisposed to developing this condition.
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 (asthma). If you have a persistent cough
stop treatment and see your doctor, as it may be a symptom of some 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 evaluate
the need for treatment with this medicine. If the doctor deems treatment
necessary, they will monitor you during therapy.
Take this medicine with caution if you experience fever, skin irritation (rash), headache,
nausea and vomiting.
You can only start treatment with DESTROMETORFANO BROMIDRATO SELLA after a careful evaluation
by your doctor and under strict supervision if:

• you suffer from diseases of the blood circulation and heart (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 disorders of the stomach, intestines or urinary tract (stenosis of the gastrointestinal and urogenital tract);
• you suffer from epilepsy;
• you have severe liver disease;
• you are taking medicines used for the treatment of depression (MAO inhibitors); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary that two weeks have passed since taking the antidepressant medicines. In all the situations indicated above, taking this medicine is not recommended, and is reserved only for cases of absolute necessity (see section “Do not use DESTROMETORFANO BROMIDRATO SELLA”).

Talk to your doctor or pharmacist before taking DESTROMETORFANO BROMIDRATO SELLA if you are
taking medicines such as some antidepressants or antipsychotics. DESTROMETORFANO BROMIDRATO SELLA
can interact with these medicines and alterations in mental status (e.g.
agitation, hallucinations, coma) and other effects such as body temperature above 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.

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

Other medicines and DESTROMETORFANO BROMIDRATO 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 for the treatment of depression
(MAO inhibitors); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary
that two weeks have passed since taking the antidepressant medicines.
Be particularly careful and consult your doctor if you are taking:

• antidepressant medicines (MAO inhibitors);
• linezolid, a medicine used to treat infections caused by bacteria;
• sibutramine, a medicine used to treat obesity; as if taken at the same time with DESTROMETORFANO BROMIDRATO SELLA they can cause a condition, which can also be fatal, called serotonin syndrome whose symptoms are:
• nausea;
• decrease in blood pressure;
• tremors and muscle disorders (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity);
• nervous system disorders (hyperactivity of the autonomic nervous system, fever, accelerated heartbeat (tachycardia), short breath (tachypnea), pupil dilation (mydriasis);
• profuse 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 for the treatment of insomnia and anxiety (hypnotic, sedative and anxiolytic medicines);
• medicines used for the treatment of some heart disorders (amiodarone, quinidine, propafenone);
• medicines to treat heart rhythm abnormalities (flecainide);
• medicines used for the treatment of depression (fluoxetine, paroxetine, sertraline, bupropion);
• antipsychotic medicines used for the treatment of some mental disorders (haloperidol, thioridazine, perphenazine);
• medicine to treat severe pain or to reduce withdrawal symptoms in cases of addiction (methadone);
• 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 (mycetes) (terbinafine);
• cimetidine, a medicine used to treat stomach disorders due to high acidity;
• ritonavir, a medicine used to treat AIDS;
• medicines used to facilitate the elimination of mucus (secretolytic medicines).

The concomitant use of DESTROMETORFANO BROMIDRATO SELLA and sedative medicines such as benzodiazepines
or medicines related to them increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be
considered only when other treatment options are not possible.
However, if your doctor prescribes DESTROMETORFANO BROMIDRATO SELLA together with sedative medicines, the
dose and duration of concomitant treatment must be limited by the doctor.
Inform the doctor about all the sedative medicines you are taking and carefully follow
the doctor's recommendation on the dose. It may be helpful to inform friends or relatives to pay attention to
the signs and symptoms listed above.
Consult your doctor if you experience these symptoms.

DESTROMETORFANO BROMIDRATO SELLA with drinks and alcohol
Avoid taking grapefruit juice during treatment with this medicine because it may occur
an increase in toxic effects or a decrease in effect.
Avoid drinking alcohol during treatment with this medicine.

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

Driving and operating machinery
DESTROMETORFANO BROMIDRATO SELLA may impair the ability to drive vehicles or use machinery,
as it may cause drowsiness, especially if taken at the same time as alcohol (see section
“DESTROMETORFANO BROMIDRATO SELLA with drinks and alcohol”).

DESTROMETORFANOBROMIDRATOSELLAcontainssucrose,sodium,sodiumbenzoateand
parahydroxybenzoates
This medicine contains 3 g of sucrose (sugar) per dose. To be taken into
consideration in people affected by diabetes mellitus. If your doctor has diagnosed you with an intolerance to
some 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 sodium benzoate per dose.
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate) which may cause allergic reactions (even delayed).

3. How to take DESTROMETORFANO BROMIDRATO SELLA

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

DESTROMETORFANO BROMIDRATO SELLA
In adults and adolescents (from 12 to 18 years), the recommended dose ranges from 10 mg (one teaspoonful, equivalent to approximately 3 ml) to 20 mg (2 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 you take more DESTROMETORFANO BROMIDRATO SELLA than you should, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive impairment, involuntary and rapid eye movements, heart disorders (accelerated heartbeat), coordination disorders, psychosis with visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may include: coma, severe respiratory problems and
convulsions and decreased urine output.
Seek medical attention or go to the hospital immediately if you experience any of the aforementioned symptoms.

If you forget to take DESTROMETORFANO BROMIDRATO SELLA
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 available data)

• drowsiness, fatigue;
• involuntary and rapid eye movements (nystagmus);
• difficulty of movement (dystonia);
• dizziness;
• mental confusion and behavioral changes (scurrilous language);
• serotonin syndrome (see section “Warnings and precautions”), characterized by nausea, decreased blood pressure, tremors and muscle disorders (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity), nervous system disorders (hyperactivity of the autonomic nervous system), fever, accelerated heartbeat (tachycardia), rapid breathing (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disorders (agitation, excitement, confusion), heart block (cardiac arrest) and death;
• mental disorders (psychosis), hallucinations;
• need to continue taking the medicine (psychic dependence);
• severe allergic reactions (anaphylaxis);
• high fever, even very high;
• diabetes mellitus;
• nausea and vomiting;
• stomach and intestinal disorders, loss of appetite;
• allergic skin reactions (skin rashes).

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 DESTROMETORFANO BROMIDRATO SELLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expires:”. 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 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 DESTROMETORFANO BROMIDRATO SELLA contains

• The active ingredient is destromethorphan bromhydrate. Each 10 ml of syrup contains 30 mg of destromethorphan bromhydrate.
• The other ingredients are: sodium benzoate (E211), citric acid monohydrate, sucrose, methylparaben (E218), raspberry aroma, purified water.

Description of the appearance of DESTROMETORFANO BROMIDRATO SELLA and contents of the pack
Pack containing a 150 ml bottle.

Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)

DESTROMETORFANO BROMIDRATO SELLA 15 mg/ml oral drops, solution

Destrometorfano bromidrato

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 a few days.

Contents of this leaflet:

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

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

DESTROMETORFANO BROMIDRATO SELLA contains the active ingredient Destrometorfano which belongs to the
group of medicines used for the treatment of dry cough.
See a doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before you take DESTROMETORFANO BROMIDRATO SELLA

Do not take DESTROMETORFANO BROMIDRATO SELLA

• if you are allergic to destrometorfano or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from respiratory disorders (bronchial asthma, chronic obstructive broncho-pneumonia);
• if you have difficulty breathing (including respiratory depression);
• if you have pneumonia, a lung infection;
• if you suffer from blood and heart circulation 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 disorders of the stomach, intestines or urinary tract (stenosis of the gastrointestinal and urogenital tract);
• 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 for the treatment of depression (MAO inhibitors antidepressants); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary that

two weeks have passed since taking the antidepressant medicines (see section “Other
medicines and DESTROMETORFANO BROMIDRATO SELLA”);

• if you are in the first trimester of pregnancy and if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROMETORFANO BROMIDRATO SELLA.
The duration of treatment with this medicine should not exceed 5-7 days.

This medicine can lead to dependence. Therefore, treatment should be of short duration.
The use of DESTROMETORFANO BROMIDRATO SELLA, especially for prolonged treatments, may cause
a decrease in effectiveness and the need to continue using the medicine (habituation,
tolerance, mental and physical dependence). Therefore, short-term treatment and under
strict medical supervision is recommended, especially if you are predisposed to developing this condition.
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 (asthma). If you have a persistent cough
stop treatment and see your doctor, as it may be a symptom of some 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, see your doctor who will assess
the need for treatment with this medicine. If the doctor deems treatment
essential, they will monitor you during therapy.
Take this medicine with caution if you experience fever, skin irritation (rash), headache,
nausea and vomiting.
You can only start treatment with DESTROMETORFANO BROMIDRATO SELLA after a careful assessment
by your doctor and under strict supervision if:

• you suffer from blood and heart circulation 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 disorders of the stomach, intestines or urinary tract (stenosis of the gastrointestinal and urogenital tract);
• if you suffer from epilepsy;
• if you have severe liver disease;
• if you are taking medicines used for the treatment of depression (MAO inhibitor antidepressants); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary that two weeks have passed since taking the antidepressant medicines. In all the situations above, taking this medicine is not recommended, and is reserved only for cases of absolute necessity (see section “Do not use DESTROMETORFANO BROMIDRATO SELLA”).

Talk to your doctor or pharmacist before taking DESTROMETORFANO BROMIDRATO SELLA if you are
taking medicines such as some antidepressants or antipsychotics. DESTROMETORFANO BROMIDRATO SELLA
may interact with these medicines and changes in mental status (e.g.
agitation, hallucinations, coma) and other effects such as a 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, diarrhea) may occur.

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

Other medicines and DESTROMETORFANO BROMIDRATO 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 for the treatment of depression
(MAO inhibitor antidepressants); before taking DESTROMETORFANO BROMIDRATO SELLA it is necessary
that two weeks have passed since taking the antidepressant medicines.
Be particularly careful and see your doctor if you are taking:

• antidepressant medicines (MAO inhibitors);
• linezolid, a medicine used to treat infections caused by bacteria;
• sibutramine, a medicine used to treat obesity; as if taken at the same time with DESTROMETORFANO BROMIDRATO SELLA they can cause a condition, which can also be fatal, called serotonin syndrome whose symptoms are:
• nausea;
• decrease in blood pressure;
• tremors and muscle disorders (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity);
• nervous system disorders (hyperactivity of the autonomic nervous system, fever, accelerated heartbeat (tachycardia), short breath (tachypnea), pupil dilation (mydriasis);
• excessive sweating (diaphoresis);
• mental disorders (agitation, excitement, confusion);
• heart block (cardiac arrest) and death.

See 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 some heart disorders (amiodarone, quinidine, propafenone);
• medicines to treat heart rhythm abnormalities (flecainide);
• medicines used to treat depression (fluoxetine, paroxetine, sertraline, bupropion);
• antipsychotic medicines used to treat some mental disorders (haloperidol, thioridazine, perphenazine);
• medicine to treat severe pain or to reduce withdrawal symptoms in cases of addiction (methadone);
• 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 (mycetes) (terbinafine);
• cimetidine, a medicine used to treat stomach disorders due to high acidity;
• ritonavir, a medicine used to treat AIDS;
• medicines used to facilitate the elimination of mucus (secretolytic medicines).

The concomitant use of DESTROMETORFANO BROMIDRATO SELLA and sedative medicines such as benzodiazepines
or medicines related to them increases the risk of drowsiness, difficulty breathing (respiratory
depression), coma and can be life-threatening. For this reason, concomitant use should be
considered only when other treatment options are not possible.
However, if your doctor prescribes DESTROMETORFANO BROMIDRATO SELLA together with sedative medicines, the
dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow
the doctor's dosage recommendations. It may be helpful to inform friends or family to pay attention to
the above signs and symptoms.
See your doctor if you experience these symptoms.

DESTROMETORFANO BROMIDRATO SELLA with food and alcohol
Avoid taking grapefruit juice during treatment with this medicine because it may cause
an increase in toxic effects or a decrease in effect.
Avoid drinking alcohol during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
Do not take this medicine in the first three months of pregnancy.
After the third month of pregnancy, you can only take this medicine in cases of absolute necessity and under
strict medical supervision because respiratory problems may occur in the newborn (respiratory
depression), especially at high doses and even for short periods of treatment.
Do not take this medicine during breastfeeding.

Driving and operating machinery
DESTROMETORFANO BROMIDRATO SELLA may impair your ability to drive vehicles or operate machinery,
as it may cause drowsiness, especially if you take it at the same time as alcohol (see section
“DESTROMETORFANO BROMIDRATO SELLA with food and alcohol”).

DESTROMETORFANO BROMIDRATO SELLA contains methyl parahydroxybenzoate
May cause allergic reactions (including delayed reactions).

3. How to take DESTROMETORFANO BROMIDRATO SELLA

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
In adults and adolescents (from 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 DESTROMETORFANO BROMIDRATO SELLA than you should
If you take more DESTROMETORFANO BROMIDRATO SELLA 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 (accelerated heartbeat), coordination
disorders, psychosis with visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may include: coma, severe breathing problems and
convulsions and decreased urine output.
Seek medical attention or go to the hospital immediately if you experience any of the aforementioned symptoms.

If you forget to take DESTROMETORFANO BROMIDRATO SELLA
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 available data)

• drowsiness, fatigue;
• involuntary and rapid eye movements (nystagmus);
• difficulty with movement (dystonia);
• dizziness;
• mental confusion and behavioral changes (scurrilous language);
• serotonin syndrome (see section “Warnings and precautions”), characterized by nausea, decreased blood pressure, tremors and muscle disorders (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity), nervous system disorders (hyperactivity of the autonomic nervous system), fever, accelerated heartbeat (tachycardia), rapid breathing (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disorders (agitation, excitement, confusion), heart block (cardiac arrest) and death;
• mental disorders (psychosis), hallucinations;
• need to continue taking the medicine (psychic dependence);
• severe allergic reactions (anaphylaxis);
• high fever, even very high;
• diabetes mellitus;
• nausea and vomiting;
• stomach and intestinal disorders, loss of appetite;
• allergic skin reactions (skin rashes).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 DESTROMETORFANO BROMIDRATO SELLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expires:”. 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 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 DESTROMETORFANO BROMIDRATO SELLA contains

• The active ingredient is destrometorfano bromidrato. Each ml of solution (20 drops) contains 15 mg of destrometorfano bromidrato.
• The other ingredients are: glycerol, methyl parahydroxybenzoate (E218), purified water.

Description of the appearance of DESTROMETORFANO BROMIDRATO SELLA and contents of the pack
Pack containing a 20 ml bottle.

Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)