DEXTROMETHORPHAN HYDROBROMIDE FARMAKOPEA

Patient Information Leaflet

DEXTROMETHORPHAN HYDROBROMIDE FARMAKOPEA 30 mg/10 ml syrup

Dextromethorphan
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.

• Keep this leaflet. You may need to read it again.
• If you would like more 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 FARMAKOPEA is and what it is used for
2. What you need to know before taking DESTROMETHORFAN HYDROBROMIDE FARMAKOPEA
3. How to take DESTROMETHORFAN HYDROBROMIDE FARMAKOPEA
4. Possible side effects
5. How to store DESTROMETHORFAN HYDROBROMIDE FARMAKOPEA
6. Package contents and other information

1. What is DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA and what is it used for?

DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA 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 need to know before taking DESTROMETHORPHAN HYDROBROMIDE

FARMAKOPEA
Do not take DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA

• 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 bronchopneumopathy);
• 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 inhibitor antidepressants); at least two weeks must have passed since stopping such antidepressant medicines before taking DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA (see section “Other medicines and DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA”);
• 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 FARMAKOPEA.
This medicine may lead to dependence. Therefore, treatment should be short-term.
The duration of treatment with this medicine should not exceed 5–7 days.
The use of DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA, especially for prolonged treatment, may cause reduced effectiveness and the need to continue using the medicine (tolerance and 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 certain respiratory disorders (e.g. 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, or vomiting.
You may start treatment with DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA 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 inhibitor antidepressants); at least two weeks must have passed since stopping such 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 take DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA”).
  For individuals engaged in sports, the use of DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA containing ethyl alcohol may result in a positive doping test, depending on the blood alcohol concentration limits set by certain sports federations.

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA
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 such antidepressant medicines before taking DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA.
In particular, inform your doctor or pharmacist if you are taking or have recently taken:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section 2 “Do not take DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of addiction (methadone);
• medicines to treat psychiatric disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat cardiac arrhythmias (flecainide);
• medicines to reduce calcium levels in the blood and treat dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet; medicines used to prevent fungal growth (terbinafine).

Pay special attention 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 when taken together with DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA, they may cause a potentially fatal condition called serotonin syndrome, whose symptoms include: nausea; low blood pressure; tremors and muscle disorders (clonus, myoclonus, increased reflex response and pyramidal rigidity); nervous system disorders (autonomic hyperactivity, fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), dilation of the black part of the eye (mydriasis)); 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);
• 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 Farmakopea with benzodiazepines or related drugs:
The concomitant use of Destromethorphan Hydrobromide Farmakopea and sedative medicines such as benzodiazepines or related drugs 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 Farmakopea together with sedative medicines, the dose and duration of concomitant treatment must be determined by your doctor.
Inform your doctor about all sedative medicines you are taking and carefully follow the dosage recommendations provided by your doctor. It may be helpful to inform friends or family members to watch for the signs and symptoms described above. Contact your doctor if such symptoms occur.
Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA:

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

DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA with food and alcohol
Avoid drinking grapefruit juice during treatment with this medicine, as it may increase toxic effects or reduce the medicine’s effectiveness.
Avoid consuming alcohol during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, 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 if absolutely necessary 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 during breastfeeding.
Driving and using machines
DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA 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 FARMAKOPEA with food and alcohol”).
DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA, ethanol, sucrose and methyl p-
hydroxybenzoate
This medicine contains 8.02% vol ethanol (alcohol), i.e. up to 400 mg per dose, equivalent to 9.63 ml of beer or 4.01 ml of wine per dose. It may be harmful for alcoholics. This should be considered in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains methyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to take DESTROMETORFANO BROMIDRATO FARMAKOPEA

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 (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 FARMAKOPEA than you should
If you take more DESTROMETORFANO BROMIDRATO FARMAKOPEA than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, cardiac disturbances (accelerated heartbeat), coordination 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 FARMAKOPEA
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 estimated from the available data)

• drowsiness, fatigue;
• involuntary and rapid eye movements (nystagmus);
• movement difficulties (dystonia);
• dizziness;
• confusion and behavioural changes (foul speech);
• serotonin syndrome (see section “Warnings and precautions”), characterised by nausea, low blood pressure, tremors and muscle disorders (clonic, myoclonus, increased reflex response and pyramidal-origins rigidity), nervous system disorders (autonomic nervous system hyperactivity), sweating (diaphoresis), fever, increased heart rate (tachycardia), shortness of breath (tachypnea), dilation of the black part of the eye (mydriasis), 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);
• fever;
• diabetes mellitus;
• nausea and vomiting;
• stomach and intestinal disorders, loss of appetite;
• skin allergic reactions (rash).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 FARMAKOPEA

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 its original packaging 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. Contents of the pack and other information

What DESTROMETORFANO BROMIDRATO FARMAKOPEA contains

• The active substance is bromhexine hydrobromide. 10 ml of syrup contain 30 mg of bromhexine hydrobromide.
• The other components are: ethyl alcohol, glycerol, sucrose, sodium citrate, anhydrous citric acid, methyl p-hydroxybenzoate, star anise essential oil, polysorbate 20, purified water.

Description of the appearance of DESTROMETORFANO BROMIDRATO FARMAKOPEA and contents of the pack
Pack containing one 150 ml bottle.
Marketing Authorization Holder
Farmakopea S.p.A., Via Aldo Moro, 11 – 20080 Carpiano (MI).
Manufacturer
AEFFE Farmaceutici S.r.l., Via Torino, 448, 10032 – Brandizzo (TO)

Patient Information Leaflet

DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA 15 mg/ml oral drops, solution

Dextromethorphan
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to.

• Keep this leaflet. You may need to read it again.
• If you would like more 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 DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA is and what it is used for
2. What you need to know before taking DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA
3. How to take DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA
4. Possible side effects
5. How to store DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA
6. Contents of the pack and other information

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

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

2. What you should know before taking DESTROMETHORPHAN HYDROBROMIDE

FARMAKOPEA
Do not take DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA

• 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 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 FARMAKOPEA,
  at least two weeks must have passed since stopping these antidepressant medicines (see section
  “Other medicines and DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA”);

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

Warnings and precautions
Consult your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE
FARMAKOPEA.
This medicine may lead to dependence. Therefore, treatment should be short-term.
The duration of treatment with this medicine should not exceed 5–7 days.
The use of DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA, especially for prolonged
treatment, may lead to reduced effectiveness, resulting in the need to continue using the medicine
(tolerance and mental and physical dependence). Therefore, short-term treatment under strict medical
supervision is recommended, especially if you are aware of a personal predisposition 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,
discontinue treatment and consult your doctor, as it may be a symptom of certain respiratory disorders (asthma).
If you have a cough with 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 the need for
treatment with this medicine. 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 FARMAKOPEA 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): In all the above situations, taking this medicine is not recommended and is reserved only for cases of absolute necessity (see section “Do not take DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA”).

For people engaged in sports, the use of DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA
containing ethyl alcohol may result in a positive anti-doping test, depending on the alcohol concentration
limits set by certain sports federations.
Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA
Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other
medicine.
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 FARMAKOPEA.
In particular, inform your doctor if you are taking or have recently taken:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section 2. “Do not take DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines to treat psychiatric disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat cardiac arrhythmias (flecainide);
• medicines to reduce calcium levels in the blood and treat organ dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet; medicines used to prevent fungal (mould) growth (terbinafine).

Exercise particular caution 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 their concomitant use with DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA may cause a condition, potentially fatal, called serotonin syndrome, whose symptoms include:
• nausea;
• low blood pressure;
• tremors and muscle disorders (clonic, myoclonic, increased reflex response and pyramidal-origin rigidity);
• disorders of the nervous system (autonomic nervous system hyperactivity), fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), dilation of the black part of the eye (mydriasis);
• mental disorders (agitation, excitement, confusion);
• 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);
• 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 Farmakopea with benzodiazepines or related drugs:
The concomitant use of Destromethorphan hydrobromide Farmakopea and sedative medicines such as benzodiazepines or
related drugs 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 possible.
However, if your doctor prescribes Destromethorphan hydrobromide Farmakopea together with sedative medicines, the dose and duration of concomitant treatment must be determined by your doctor.
Inform your doctor of all sedative medicines you are taking and carefully follow the dosage recommendations provided by your doctor. It may be helpful to inform friends or relatives to watch for the signs and symptoms described above. Consult your doctor if these symptoms occur.
Talk to your doctor or pharmacist before taking DESTROMETHORPHAN HYDROBROMIDE
FARMAKOPEA:

• if you are taking medicines such as certain antidepressants or antipsychotics: DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA may interact with these medicines and cause changes in mental state (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).

DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA 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, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist, as this medicine is not recommended during the first three months of pregnancy and during breastfeeding.
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 (respiratory depression) may occur in the newborn, especially at high doses and even after short treatment periods.
Driving and using machines
DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA may affect your ability to drive or operate machinery, as it may cause drowsiness, especially if you consume alcohol simultaneously (see section “DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA with food and alcohol”).
DESTROMETHORPHAN HYDROBROMIDE FARMAKOPEA contains ethanol and parahydroxybenzoates
This medicine contains 12.05 vol% ethanol (alcohol), i.e. up to 140 mg per dose, equivalent to 3.4 ml of beer or 1.4 ml of wine per dose. It may be harmful for alcoholics.
This should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
This medicine contains parahydroxybenzoates (methyl p-hydroxybenzoate, propyl p-hydroxybenzoate) which
may cause allergic reactions (including delayed reactions).

3. How to take DESTROMETORFANO BROMIDRATO FARMAKOPEA

Take this medicine exactly as stated in this leaflet or according to your doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.
In adults and adolescents (12 to 18 years of age), 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 FARMAKOPEA than you should
If you take more DESTROMETORFANO BROMIDRATO FARMAKOPEA 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 (rapid heartbeat), coordination problems, psychosis with visual hallucinations and hyperexcitability.
Additional symptoms in case of massive overdose may include: coma, severe respiratory problems, seizures, 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 FARMAKOPEA
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.

Unknown frequency (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, myoclonus, increased reflex response and pyramidal rigidity), nervous system disturbances (autonomic nervous system hyperactivity), sweating (diaphoresis), fever, increased heart rate (tachycardia), shortness of breath (tachypnea), dilation of the black part of the eye (midriasis), 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;
• diabetes mellitus;
• nausea and vomiting;
• stomach and intestinal disorders, reduced appetite;
• skin allergic reactions (rash).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 FARMAKOPEA

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 date".
The expiry date refers to the last day of that month.
Keep the bottle tightly closed and in the original packaging 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 FARMAKOPEA contains

• The active substance is bromhexine hydrobromide. Each ml of solution contains 15 mg of bromhexine hydrobromide.
• The other components are: anhydrous citric acid, propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, strawberry flavour, sodium saccharin, ethyl alcohol, purified water.

Description of the appearance of DESTROMETORFANO BROMIDRATO FARMAKOPEA and contents of the package
Pack containing one 20 ml bottle with dropper.
Marketing Authorization Holder
Farmakopea S.p.A., Via Aldo Moro, 11 – 20080 Carpiano (MI).
Manufacturer
AEFFE Farmaceutici S.r.l., Via Torino, 448, 10032 – Brandizzo (TO)