Dextromethorphan EG

Patient Information Leaflet

DESTROMETORFAN EG 15 mg/5 ml syrup

dextromethorphan hydrobromide
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

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

1. What DESTROMETORFANO EG is and what it is 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 should know before using DESTROMETHORPHAN EG

This medicine may lead to dependence. Therefore, treatment should be short-term only.
Do not use DESTROMETHORPHAN 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 causing inflammation and narrowing of the bronchial tubes);
• If you have respiratory disorders (respiratory failure, chronic obstructive pulmonary disease, respiratory depression, lung infection);
• If you are taking antidepressant medicines (MAO inhibitors) or within two weeks after stopping such treatment (see "Other medicines and DESTROMETHORPHAN EG");
• If the person to be treated is under 6 years of age (see "How to take DESTROMETHORPHAN EG").

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROMETHORPHAN EG if you are taking
medicines such as certain antidepressants or antipsychotics: DESTROMETHORPHAN EG may
interact with these medicines and may 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).
Contact your doctor or pharmacist before taking DESTROMETHORPHAN EG:

• if you have a blood disorder (mastocytosis);
• if you have chronic cough (not recently developed);
• if you have productive cough (with phlegm);
• if you suffer from a disease causing obstruction of the bronchi due to excessive mucus production (bronchiectasis or cystic fibrosis);
• if you suffer from neurological diseases associated with reduced cough reflex (such as stroke, Parkinson’s disease, and dementia).

Take special care with DESTROMETHORPHAN EG and inform your doctor:
Dextromethorphan may cause addiction: prolonged use (e.g. beyond the recommended treatment duration) may lead to tolerance to the medicine, as well as psychological and physical dependence. If you have a tendency to abuse or dependence, you should take DESTROMETHORPHAN EG only for short periods and under strict medical supervision.
Cases of dextromethorphan abuse have been reported.
Other medicines and DESTROMETHORPHAN EG
Inform 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 for depression such as fluoxetine, paroxetine, sertraline, fluvoxamine, and bupropion (see section 2 "Do not take DESTROMETHORPHAN EG");
• medicines for severe pain or to reduce withdrawal symptoms in cases of drug dependence (methadone);
• medicines for mental disorders (haloperidol, thioridazine, perphenazine);
• medicines for heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone);
• medicines used to lower blood pressure such as clonidine;
• medicines used to reduce calcium levels in the blood (cinacalcet);
• medicines used for fungal infections (mycosis) (terbinafine);
• medicines used to relieve pain (opioid analgesics);
• allergy medicines (antihistamines);
• sedatives (tranquilizers) such as barbiturates;
• medicines to reduce anxiety (anxiolytics);
• medicines used to reduce anxiety and for insomnia such as benzodiazepines;
• medicines to induce sleep (hypnotics);
• other cough suppressants;
• medicines to liquefy phlegm (mucolytics). The concomitant use of DESTROMETHORPHAN EG and sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes DESTROMETHORPHAN EG together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about any sedative medicine you are taking and carefully follow their dosage recommendations. 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.

DESTROMETHORPHAN EG and alcohol
Avoid consuming alcoholic beverages. The concomitant use of DESTROMETHORPHAN EG and alcohol may increase the sedative effects of both substances.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
DESTROMETHORPHAN EG must not be used during pregnancy and breastfeeding (see "Do not take DESTROMETHORPHAN EG").
Use during the last months of pregnancy, even for a short period, may cause respiratory depression in the newborn.
Dextromethorphan passes into breast milk and may cause decreased muscle tone (hypotonia) and breathing pauses in the infant.
Driving and using machines
DESTROMETHORPHAN EG may affect your ability to drive or operate machinery, as it may cause drowsiness, dizziness, and altered reaction times. These effects are intensified if alcohol or other medicines are taken at the same time.
DESTROMETHORPHAN EG contains:
Methyl and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).
24 mg of sucrose (sugar) per maximum daily dose. This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
3640 mg of sorbitol per maximum daily dose, equivalent to 72.8 mg/kg in adults and adolescents over 12 years. 1820 mg of sorbitol per maximum daily dose, equivalent to 113.75 mg/kg in children aged 6 to 12 years. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, talk to your doctor before you (or the child) take this medicine.

3. How to take DESTROMETORFANO EG

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

Adults and adolescents over 12 years
The recommended dose is 30 mg (corresponding to 10 ml) up to 4 times daily, 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 aged 6 to 12 years
The recommended dose is 15 mg (corresponding to 5 ml) up to 4 times daily, 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.
A dosing spoon is provided with the package.

Instructions for opening the bottle
The bottle is equipped with a "child-proof" safety cap. To open, press down on the cap while turning it counterclockwise. To close, screw the cap back on securely.

Elderly patients and patients with liver or kidney problems
Consult your doctor if you are elderly or have liver or kidney problems. Your doctor will evaluate your condition and adjust the dose and dosing interval accordingly.

In children, overdose may lead to serious adverse events, including neurological disorders. Caregivers must not exceed the recommended dose.

If you take more DESTROMETORFANO EG than you should
If you take more DESTROMETORFANO EG 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 (increased heart rate), coordination problems, psychosis with visual hallucinations and hyperexcitability.

Additional symptoms in case of massive overdose may include: coma, severe respiratory problems, and seizures.

Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.

If you forget to take DESTROMETORFANO EG
Do not take a double dose to make up for the forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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;
• confusion;
• fatigue. Very rare (may affect up to 1 in 10,000 people)
• abuse (frequent or prolonged use, or use of excessive doses);
• dependence (need to continue taking the medicine). Frequency not known (frequency cannot be estimated from the available data):
• skin rash;
• severe allergic reaction (anaphylactic reaction);
• swelling of the face, lips, mouth, tongue, and throat, which may cause breathing or swallowing difficulties (angioedema);
• skin irritation (urticaria);
• drug-induced skin rash;
• bronchial constriction (bronchospasm);
• pupil dilation (mydriasis), following ingestion of high doses;
• difficulty speaking (dysarthria);
• rhythmic, involuntary, oscillating eye movements (nystagmus);
• changes in muscle tone (dystonia), especially in children;
• agitation, following ingestion of high doses;
• dizziness;
• perception of things not present in reality (hallucinations);
• severe disturbance of mental equilibrium (psychotic disorder). Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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 stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Store below 25°C.
Keep the bottle tightly closed and protected from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What DESTROMETORFANO EG contains

• The active substance is dextromethorphan hydrobromide. 100 ml of syrup contain 0.3 g of dextromethorphan hydrobromide.
• The other components are: sucrose, sorbitol 70% (E 420), methyl parahydroxybenzoate, propyl parahydroxybenzoate, orange flavour, purified water.

Description of the appearance of DESTROMETORFANO EG and package contents
DESTROMETORFANO EG is a syrup for oral use.
The package contains a 100 ml bottle with a safety cap and a dosing spoon.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Unither Liquid Manufacturing - Colomiers site (France)

Patient Information Leaflet: Information for the patient

DESTROMETORFANO EG 10 mg tablets

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

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any of the 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 5 days.

Contents of this leaflet:

1. What DESTROMETORFANO EG is and what it is used for
2. What you need to know before taking 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 DESTROMETORFANO EG is and what it is 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 feel worse after 5 days.

2. What you need to know before using DESTROMETHORPHAN EG

Do not use DESTROMETHORPHAN 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 condition causing inflammation and narrowing of the bronchial tubes);
• If you have respiratory problems (respiratory insufficiency, chronic obstructive pulmonary disease, respiratory depression, lung infection);
• If you are taking antidepressant medicines (MAO inhibitors) or within two weeks after stopping such treatment (see "Other medicines and DESTROMETHORPHAN EG");
• If the person to be treated is under 12 years of age (see "How to take DESTROMETHORPHAN EG").

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

• If you have a blood disorder (mastocytosis);
• If you have chronic cough (not recently developed);
• If you have productive cough (with phlegm);
• If you suffer from a disease causing obstruction of the bronchi due to excessive mucus production (bronchiectasis or cystic fibrosis);
• If you suffer from neurological diseases associated with reduced cough reflex (such as stroke, Parkinson's disease, and dementia).

Exercise particular caution with DESTROMETHORPHAN EG and inform your doctor:
Dextromethorphan may cause dependence: prolonged use (e.g. beyond the recommended treatment duration) may lead to tolerance to the medicine, as well as psychological and physical dependence. If you have a tendency to abuse or dependence, you should take DESTROMETHORPHAN EG only for short periods and under strict medical supervision.
Cases of dextromethorphan abuse have been reported.

Other medicines and DESTROMETHORPHAN EG
Inform 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 for depression such as fluoxetine, paroxetine, sertraline, fluvoxamine, and bupropion (see section 2 "Do not take DESTROMETHORPHAN EG");
• Medicines for severe pain or to reduce withdrawal symptoms in cases of drug addiction (methadone);
• Medicines for mental disorders (haloperidol, thioridazine, perphenazine);
• Medicines for heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone);
• Medicines used to lower blood pressure (clonidine);
• Medicines used to reduce calcium levels in the blood (cinacalcet);
• Medicines used for fungal infections (mycoses) (terbinafine);
• Medicines used to relieve pain (opioid analgesics);
• Medicines for allergies (antihistamines);
• Sedatives (tranquilizers) 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 liquefy mucus (mucolytics).

Concomitant use of DESTROMETHORPHAN EG and sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes DESTROMETHORPHAN EG together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about any sedative medicines you are taking and carefully follow their dosage recommendations. 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.

DESTROMETHORPHAN EG and alcohol
Avoid consuming alcoholic beverages at the same time. Concomitant use of DESTROMETHORPHAN EG and alcohol may increase the sedative effects of both substances.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
DESTROMETHORPHAN EG must not be used during pregnancy or while breastfeeding.
Do not take DESTROMETHORPHAN EG during pregnancy or while breastfeeding (see "Do not take DESTROMETHORPHAN EG").
Use during the last months of pregnancy, even for a short period, may cause respiratory depression in the newborn.
Dextromethorphan passes into breast milk and may cause decreased muscle tone (hypotonia) and breathing pauses in the infant.

Driving and using machines
DESTROMETHORPHAN EG may affect your ability to drive or operate machinery, as it may cause drowsiness, dizziness, and altered reaction times. These effects are intensified if alcohol or other medicines are taken at the same time.

DESTROMETHORPHAN 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 them before taking this medicine. This should be taken into account in patients with diabetes mellitus.

3. How to take DESTROMETORFANO EG

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age:
The recommended dose is 1–2 tablets (corresponding to 10–20 mg) up to 6 times daily, if necessary, with an interval of at least 4 hours between doses. 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. Your doctor will evaluate your condition and adjust both the dose and the interval between doses accordingly.
Duration of treatment
Treatment should not exceed 5 days.
Method of administration
Allow the tablets to dissolve slowly in the mouth.
If you take more DESTROMETORFANO EG than you should
If you take more DESTROMETORFANO EG 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, and seizures.
Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.
If you forget to take DESTROMETORFANO EG
Do not take a double dose to make up for the missed dose.
If you have any doubts about using 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.
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;
• confusion;
• fatigue.
  Very rare (may affect up to 1 in 10,000 people)
• abuse (frequent or prolonged use, or excessive doses);
• dependence (need to continue taking the medicine).
  Frequency not known (frequency cannot be determined from available data):
• skin rash;
• severe allergic reaction (anaphylactic reaction);
• swelling of the face, lips, mouth, tongue, and throat, which may cause breathing or swallowing difficulties (angioedema);
• skin irritation (urticaria);
• drug-induced skin rash;
• bronchial constriction (bronchospasm);
• pupil dilation (mydriasis), following ingestion of high doses;
• difficulty speaking (dysarthria);
• rhythmic, oscillating, involuntary eye movements (nystagmus);
• alteration of muscle tone (dystonia), especially in children;
• agitation, following ingestion of high doses;
• vertigo;
• perception of things that do not exist in reality (hallucinations);
• severe disturbance of mental equilibrium (psychotic disorder).
  Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
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 EG contains

• The active substance is dextromethorphan hydrobromide. Each tablet contains 10 mg of dextromethorphan hydrobromide.
• The other components are: sucrose, magnesium trisilicate, liquid glucose, citric acid monohydrate, pectoral flavor.

Description of the appearance of DESTROMETORFANO EG and contents of the pack
DESTROMETORFANO EG is presented as oral tablets.
Pack contents: 24 tablets.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Pierre Fabre Medicament Production
Z.I. de la Coudette
F-32290 Aignan (France)