DESTROMETORFANO 15 mg /5 Ml Syrup

Зміст інструкції

1. DESTROMETORFANO EG 15 mg/5 ml syrup
   1. What is DESTROMETORFANO EG and what is it used for?
   2. What you need to know before you use DESTROMETORFANO EG
   3. How to take DESTROMETORFANO EG
   4. Possible side effects
   5. How to store DESTROMETORFANO EG
   6. Package contents and other information
2. DESTROMETORFANO EG 10 mg tablets
   1. What is DESTROMETORFANO EG and what is it used for
   2. What you need to know before using DESTROMETORFANO EG
   3. How to take DESTROMETORFANO EG
   4. How to store DESTROMETORFANO EG
   5. Contents of the pack and other information

DESTROMETORFANO EG 15 mg/5 ml syrup

destromethorphan bromhydrate

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 told you to.

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

Contents of this leaflet:

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

1. What is DESTROMETORFANO EG and what is it used for?

DESTROMETORFANO EG is a medicine that contains dextromethorphan and is indicated for the
treatment of dry cough.
See a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before you use DESTROMETORFANO EG

This medicine can lead to dependence. Therefore, it should be of short duration.
Do not use DESTROMETORFANO EG

• If you are allergic to dextromethorphan hydrobromide or to any of the other ingredients of this medicine (listed in section 6);
• If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
• If you suffer from bronchial asthma (a disease that causes inflammation and constriction of the bronchi);
• If you suffer from respiratory problems (respiratory failure, chronic obstructive bronchopneumonia, respiratory depression, lung infection);
• If you are taking antidepressants (MAO inhibitors) at the same time and for two weeks after stopping such treatment (see “Other medicines and DESTROMETORFANO EG”);
• If the subject to be treated is under 6 years of age (see “How to take DESTROMETORFANO EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROMETORFANO EG if you are
taking medicines such as some antidepressants or antipsychotics: DESTROMETORFANO EG can
interact with these medicines and 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, exaggeration of reflexes, muscle rigidity,
lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting,
diarrhea) may occur.
See your doctor or pharmacist before taking DESTROMETORFANO EG:

• if you suffer from a blood disease (mastocytosis);
• if you have a chronic cough (not recent onset);
• if you have a productive cough (with phlegm);
• if you suffer from a disease that causes obstruction of the bronchi due to excessive mucus production (bronchiectasis or cystic fibrosis);
• if you suffer from neurological diseases associated with a reduction in the cough reflex (such as stroke, Parkinson's disease and dementia).

Pay particular attention with DESTROMETORFANO EG and inform your doctor:
Dextromethorphan can cause habituation: following prolonged use (e.g. exceeding beyond
the recommended treatment period), tolerance to the medicine can develop, as well as
mental and physical dependence. If you have a tendency to abuse or dependence, you should take
DESTROMETORFANO EG for short periods and under strict medical supervision.
Cases of dextromethorphan abuse have been reported.

Other medicines and DESTROMETORFANO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Contact your doctor if you are being treated with:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline, fluvoxamine, and bupropion (see section 2 “Do not take DESTROMETORFANO EG”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence (methadone);
• medicines to treat mental disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone);
• medicines used to lower blood pressure such as clonidine;
• medicines to reduce the amount of calcium in the blood (cinacalcet);
• medicines used for the treatment of fungal infections (terbinafine);
• medicines used to reduce pain (opioid analgesics);
• medicines against allergies (antihistamines);
• sedatives (calming) such as barbiturates,
• medicines that reduce anxiety (anxiolytics)
• medicines used to reduce anxiety and for insomnia such as benzodiazepines;
• medicines to induce sleep (hypnotics);
• other cough suppressants;
• medicines to dissolve phlegm (mucolytics). The concomitant use of DESTROMETORFANO EG and sedating medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes DESTROMETORFANO EG together with sedating medicines, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor about any sedating medicine you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends and family so that they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.

DESTROMETORFANO EG with alcohol
Avoid taking alcohol at the same time. The concomitant use of
DESTROMETORFANO EG and alcohol can increase the sedative effects of both substances.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
DESTROMETORFANO EG should not be used during pregnancy and breastfeeding (see “Do not take DESTROMETORFANO EG”).
Use in the last months of pregnancy, even for a short period, can cause respiratory depression in the newborn.
Dextromethorphan passes into breast milk and can cause decreased muscle tone (hypotonia) and pauses in breathing in the infant.

Driving and using machines
DESTROMETORFANO EG can impair your ability to drive vehicles or use machines, as
it can cause drowsiness, dizziness and alter reaction times. These effects are accentuated in case of
concomitant use of alcohol or other medicines.

DESTROMETORFANO EG contains:
methyl and propyl para-hydroxybenzoate: may cause allergic reactions (including
delayed reactions).
24 mg of sucrose(sugar) per maximum daily dose. This should be taken into account in
people with diabetes mellitus. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.
3640 mg of sorbitolper maximum daily dose, equivalent to 72.8 mg/kg in adults and
adolescents over 12 years of age. 1820 mg of sorbitol per maximum daily dose equivalent to
113.75 mg/kg in children from 6 to 12 years of age. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before you (or the child) take this
medicine.

3. How to take DESTROMETORFANO EG

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

Adults and adolescents over 12 years
The recommended dose is 30 mg (corresponding to 10 ml) up to 4 times a day, if necessary, with
an interval of at least 6 hours. The maximum daily dose is 120 mg.
Do not exceed the maximum daily dose.

Children and adolescents from 6 to 12 years
The recommended dose is 15 mg (corresponding to 5 ml) up to 4 times a day, if necessary, with
an interval of at least 6 hours. The maximum daily dose is 60 mg.
Do not exceed the maximum daily dose.
DESTROMETORFANO EG is contraindicated in children under 6 years of age (see “Do not use
DESTROMETORFANO EG”).
Duration of treatment
Treatment should not exceed 5 days.
Method of administration
The dose should preferably be taken after meals. Do not dilute.
The package includes a dosing spoon.

Instructions for opening the bottle
The bottle is equipped with a “child-proof” safety closure cap. To open the bottle, it is
necessary to press the cap against the capsule and unscrew. To close the bottle, screw the cap back on.

Elderly patients and patients with liver or kidney problems
Consult your doctor if you are elderly or have liver or kidney problems. The doctor will assess your
condition and adjust the dose to be taken and the time interval between doses.
In children, in case of overdose, serious adverse events, including neurological disorders, may occur. People who care for patients should not exceed the
recommended dose.

If you take more DESTROMETORFANO EG than you should
If you take more DESTROMETORFANO EG than you should, you may experience the following symptoms:
nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive
disorders, involuntary and rapid eye movements, cardiac disorders (fast heartbeat),
coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in case of massive overdose may include: coma, severe breathing problems, and
seizures.
Contact your doctor or hospital immediately if you experience any of the above symptoms.

If you forget to take DESTROMETORFANO EG
Do not take a double dose to make up for a missed dose.
If you have any doubts 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 everyone will experience them.

Very common (may affect more than 1 in 10 people)

• nausea, vomiting, constipation;
• drowsiness, dizziness. Common (may affect up to 1 in 10 people)
• itching;
• confusional state;
• fatigue. Very rare (may affect up to 1 in 10,000 people)
• abuse (frequent or prolonged use or with excessive doses);
• dependence (need to continue taking the medicine). Frequency not known(the frequency cannot be estimated on the basis of the available data):
• skin rash;
• severe allergic reaction (anaphylactic reaction);
• swelling of the face, lips, mouth, tongue and throat that can cause problems with breathing and swallowing (angioedema);
• skin irritation (urticaria);
• drug eruption;
• constriction of the bronchi (bronchospasm);
• pupil dilation (mydriasis), following the intake of high doses;
• difficulty in speaking (dysarthria);
• oscillating, rhythmic and involuntary eye movements (nystagmus);
• alteration of muscle tone (dystonia), especially in children;
• agitation, following the intake of high doses;
• vertigo;
• perception of non-existent things in reality (hallucinations);
• severe alteration of mental balance (psychotic disorder).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform 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 EG

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 “Scad”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Keep the bottle tightly closed and protected from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What DESTROMETORFANO EG contains

• The active ingredient is dextromethorphan hydrobromide. 100 ml of syrup contains 0.3 g of dextromethorphan hydrobromide.
• The other ingredients are: sucrose, sorbitol70% ( E 420), methyl parahydroxybenzoate, propyl parahydroxybenzoate, orange flavour, purified water.

Description of the appearance of DESTROMETORFANO EG and package contents
DESTROMETORFANO EG is presented as an oral syrup.
The package contents are a 100 ml bottle with a safety cap and measuring spoon.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milano

Manufacturer
Unither Liquid Manufacturing - Officina di Colomiers (France)

DESTROMETORFANO EG 10 mg 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 get worse after 5 days.

Contents of this leaflet:

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

1. What is DESTROMETORFANO EG and what is it used for

DESTROMETORFANO EG is a medicine containing dextromethorphan and is indicated for the
treatment of dry cough.
Consult your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using DESTROMETORFANO EG

Do not use DESTROMETORFANO EG

• If you are allergic to dextromethorphan hydrobromide or any of the other ingredients of this medicine (listed in section 6);
• If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
• If you suffer from bronchial asthma (a disease that causes inflammation and constriction of the bronchi);
• If you suffer from respiratory problems (respiratory failure, chronic obstructive bronchopneumopathy, respiratory depression, lung infection);
• If you are taking antidepressants (MAO inhibitors) at the same time and for the two weeks following discontinuation of such treatment (see “Other medicines and DESTROMETORFANO EG”);
• if the subject to be treated is under 12 years of age (see “How to take

DESTROMETORFANO EG”).

Warnings and precautions
Consult your doctor or pharmacist before taking DESTROMETORFANO EG.
Talk to your doctor or pharmacist before taking LisomuilTosse Sedativo if you are
taking medicines such as some antidepressants or antipsychotics: DESTROMETORFANO EG may
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.
Consult your doctor or pharmacist before taking DESTROMETORFANO EG:

• if you suffer from a blood disease (mastocytosis);
• if you have a chronic cough (not recent onset);
• if you have a productive cough (with phlegm);
• if you suffer from a disease that causes obstruction of the bronchi due to excessive mucus production (bronchiectasis or cystic fibrosis);
• if you suffer from neurological diseases associated with a reduction in the cough reflex (such as stroke, Parkinson's disease and dementia).

Pay particular attention with DESTROMETORFANO EG and inform your doctor:
Dextromethorphan can cause habituation: following prolonged use (e.g. exceeding beyond
the recommended treatment period), tolerance to the medicine, as well as
mental and physical dependence can develop. If you have a tendency to abuse or dependence you should take
DESTROMETORFANO EG for short periods and under strict medical supervision.
Cases of dextromethorphan abuse have been reported.

Other medicines and DESTROMETORFANO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Contact your doctor if you are being treated with:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline, fluvoxamine, and bupropion (see section 2 “Do not take DESTROMETORFANO EG”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence (methadone);
• medicines to treat mental disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone);
• medicines used to lower blood pressure (clonidine);
• medicines to reduce the amount of calcium in the blood (cinacalcet);
• medicines used for the treatment of fungal infections (terbinafine);
• medicines used to reduce pain (opioid analgesics);
• medicines against allergies (antihistamines);
• sedatives (calming) such as barbiturates;
• medicines that reduce anxiety (anxiolytics);
• medicines used to reduce anxiety and for insomnia such as benzodiazepines;
• medicines to induce sleep (hypnotics);
• other cough suppressants;
• medicines to dissolve phlegm (mucolytics). The concomitant use of DESTROMETORFANO EG and sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes DESTROMETORFANO EG together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about any sedatives you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends and family so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.

DESTROMETORFANO EG with alcohol
Avoid taking alcoholic beverages at the same time.
The concomitant use of DESTROMETORFANO EG and alcohol can increase the sedative effects of both substances.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
DESTROMETORFANO EG should not be used during pregnancy and breastfeeding.
Do not take DESTROMETORFANO EG during pregnancy or during breastfeeding (see
“Do not take DESTROMETORFANO EG”).
Use in the last months of pregnancy, even for a short period, can cause
respiratory depression in the newborn.
Dextromethorphan passes into breast milk and can cause decreased muscle tone
(hypotonia) and pauses in breathing in the infant.

Driving and operating machinery
DESTROMETORFANO EG can alter the ability to drive vehicles or operate machinery, as
it can cause drowsiness, dizziness and alter reaction times. These effects are accentuated in case of
concomitant use of alcohol or other medicines.

DESTROMETORFANO EG contains:
16.3 g of sucrose(sugar) and 14.4 g of glucose: If your doctor has diagnosed you with an intolerance
to certain sugars, contact him before taking this medicine. To be considered in
people with diabetes mellitus.

3. How to take DESTROMETORFANO EG

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults and adolescents over 12 years:
The recommended dose is 1-2 tablets (corresponding to 10-20 mg) up to 6 times a day, if
necessary, with an interval of at least 4 hours. The maximum daily dose is 120 mg.
Do not exceed the maximum daily dose.
DESTROMETORFANO EG is contraindicated in children and adolescents under 12 years of age
(see “Do not use DESTROMETORFANO EG”).

Elderly patients and patients with liver or kidney problems
Consult your doctor if you are elderly or have liver or kidney problems. The doctor will assess your
condition and adjust the dose to be taken and the time interval between doses.
Duration of treatment
Treatment should not exceed 5 days.
Method of administration
Dissolve the tablets slowly in your mouth.

If you take more DESTROMETORFANO EG than you should
If you take more DESTROMETORFANO EG than you should, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive
disorders, involuntary and rapid eye movements, cardiac disorders (fast heartbeat),
coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in case of massive overdose may include: coma, severe breathing problems and
convulsions.
Contact your doctor or hospital immediately if you experience any of the above symptoms.

If you forget to take DESTROMETORFANO EG
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common (may affect more than 1 in 10 people)

• nausea, vomiting, constipation;
• drowsiness, dizziness. Common (may affect up to 1 in 10 people)
• itching;
• confusional state;
• fatigue. Very rare (may affect up to 1 in 10,000 people)
• abuse (frequent or prolonged use or with excessive doses);
• dependence (need to continue taking the medicine). Frequency not known (frequency cannot be estimated based on available data):
• skin rash;
• severe allergic reaction (anaphylactic reaction);
• swelling of the face, lips, mouth, tongue and throat which may cause problems with breathing and swallowing (angioedema);
• skin irritation (urticaria);
• drug rash;
• constriction of the bronchi (bronchospasm);
• pupil dilation (mydriasis), following the administration of high doses;
• difficulty speaking (dysarthria);
• oscillatory, rhythmic and involuntary eye movements (nystagmus);
• alteration of muscle tone (dystonia), especially in children;
• agitation, following the administration of high doses;
• vertigo;
• perception of non-existent things (hallucinations);
• severe mental imbalance (psychotic disorder).

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 the address: 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.

3. How to store DESTROMETORFANO EG

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 “Scad”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DESTROMETORFANO EG contains

• The active ingredient is dextromethorphan hydrobromide. Each tablet contains 10 mg of dextromethorphan hydrobromide.
• The other ingredients are: sucrose, magnesium trisilicate, glucoseliquid, citric acid monohydrate, pectoral flavour.

Description of the appearance of DESTROMETORFANO EG and contents of the pack
DESTROMETORFANO EG is available in the form of tablets for oral use.
The pack contains 24 tablets.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milano

Manufacturer
Pierre Fabre Medicament Production
Z.I. de la Coudette
F-32290 Aignan (France)