ARICODILTOSSE 15 mg /Ml Krople Doustne, Roztwór

Treść ulotki

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

ARICODILTOSSE 15 mg/ml oral drops, solution

Dextromethorphan hydrobromide

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 would like 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 5-7 days.

Contents of this leaflet:

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

1. What is ARICODILTOSSE and what is it used for?

ARICODILTOSSE contains the active ingredient dextromethorphan, a cough suppressant (calming) and is indicated for the symptomatic treatment of unproductive cough (dry cough).
Consult your doctor if you do not feel better or if you feel worse after 5-7 days.

2. What you need to know before taking ARICODILTOSSE

Do not take ARICODILTOSSE

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from bronchial asthma (narrowing and inflammation of the bronchi), COPD (chronic obstructive bronchopneumopathy), pneumonia (inflammatory disease of the lungs), difficulty breathing, respiratory depression, cardiovascular diseases, hypertension (high blood pressure), hyperthyroidism (increased thyroid activity), diabetes, glaucoma (eye disease), prostatic hypertrophy (enlargement of the prostate), stenosis (narrowing) of the gastrointestinal and urogenital tract, epilepsy, severe liver diseases;
• if you are taking or have taken within the last two weeks MAO inhibitor antidepressants;
• if you are in the first trimester of pregnancy or breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if the subject to be treated is under 2 years of age.

Warnings and precautions
This medicine can lead to dependence. Therefore, treatment should be of short duration.
Talk to your doctor or pharmacist before taking ARICODILTOSSE if you are taking medicines such as some antidepressants or antipsychotics: ARICODILTOSSE may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as a body temperature greater than 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 using ARICODILTOSSE.
A chronic cough may be an early symptom of asthma and therefore dextromethorphan is not indicated for suppressing chronic or persistent cough, for example due to smoking, emphysema (a lung disease) and asthma. Dextromethorphan should be administered with particular caution and only on medical advice if the cough is accompanied by other symptoms such as: fever, rash (skin eruption), headache, nausea and vomiting. ARICODILTOSSE should not be taken in case of cough accompanied by abundant secretion.
In case of irritating cough with considerable mucus production, treatment with dextromethorphan must be administered with particular caution and only on medical advice after careful evaluation of the risk-benefit ratio.
Consult your doctor if you have liver or kidney problems, especially if you have severe kidney problems.
Dextromethorphan can cause habituation. Following prolonged use, patients may develop tolerance to the medicine, as well as mental and physical dependence (see section 4 “Possible side effects”). Patients with a tendency to abuse or dependence should take ARICODILTOSSE for short periods and under strict medical supervision.
It is not recommended to drink alcoholic beverages during treatment with ARICODILTOSSE

Other medicines and ARICODILTOSSE
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:
antidepressants such as bupropion, MAO inhibitors, serotonin reuptake inhibitors (e.g. sertraline) and tricyclics;
Linezolid, an antibiotic, used to treat infections caused by bacteria;
sibutramine, to reduce appetite;
amiodarone, flecainide, propafenone, quinidine (medicines used for heart rhythm disorders);
methadone (used to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence);
haloperidol, thioridazine, perphenazine (medicines used to treat mental disorders);
hypnotics (medicines that induce sleep), sedatives (calming), anxiolytics (which reduce anxiety);
cinacalcet (used to reduce the amount of calcium in the blood);
cimetidine, a medicine used to treat stomach injuries (ulcers);
ritonavir (used for the treatment of HIV);
secretolytics (expectorants);
terbinafine (used for the treatment of fungal infections).

ARICODILTOSSE with food and drink
Grapefruit juice can increase the absorption of ARICODILTOSSE and increase its toxicity.
Consumption of grapefruit juice should be avoided during treatment.
The concomitant use of ARICODILTOSSE with 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 the doctor prescribes ARICODILTOSSE together with sedating medicines, the dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about any medicines with a sedative effect 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.

ARICODILTOSSE with alcohol
Avoid taking alcoholic beverages at the same time.
The concomitant use of ARICODILTOSSE and alcohol can increase the depressive (sedative) effects on the central nervous system of both substances.

Pregnancy, breastfeeding and fertility
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.
ARICODILTOSSE should not be used during the first trimester of pregnancy.
In addition, since the administration of high doses of dextromethorphan hydrobromide, even for short periods, can cause respiratory depression in newborns, in the following months the medicine should be taken only if absolutely necessary and after careful evaluation of the benefits and risks. Since the excretion of the medicine in breast milk is not known and a respiratory depression effect on the newborn cannot be excluded, ARICODILTOSSE is contraindicated during breastfeeding.

Driving and operating machinery
ARICODILTOSSE can impair the ability to drive vehicles or operate machinery, as it can cause drowsiness. This effect is accentuated in case of concomitant intake of alcohol.

ARICODILTOSSE contains fructose.
If your doctor has told you that you (or your child) are intolerant to certain 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 your child) take this medicine.

ARICODILTOSSEcontains 5.8 mg of alcohol (ethanol) in each drop. The amount in a dose of this medicine for an adult (54 drops) equal to 0.75 mg/100 ml of blood alcohol concentration (BAC) is equivalent to less than 8 ml of beer or 3.13 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

ARICODILTOSSE containsless than 1 mmol (23 mg) of sodiumper dose (54 drops), i.e. it is essentially “sodium-free”.

3. How to take ARICODILTOSSE

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

How much

Adults and adolescents from 12 years of age
The recommended dose ranges from 10 mg to 20 mg (corresponding to 27 – 54 drops), up to 4 times a day, every
6 hours.
The maximum daily dose is 80 mg.
One drop contains 0.37 mg of dextromethorphan.

Children
The recommended daily dose is 1 mg/kg/day in 3-4 administrations with a minimum interval between doses
of 6 hours.
When choosing the dosage, it is necessary to refer to the weight if the child's age does not correspond to the
weight indicated in the dosage schedule.
In children, in case of overdose, serious adverse events, including neurological disorders, may occur. People
caring for patients should not exceed the recommended dose.

When and for how long
Do not use ARICODILTOSSE for more than 5-7 days.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5-7 days.

Instructions for opening the bottle
To open the drop bottle, press the plastic cap while rotating it counterclockwise. To close, repeat the operation
rotating in the opposite direction.

If you take more ARICODILTOSSE than you should
In case of ingestion/taking an excessive dose of ARICODILTOSSE, immediately inform your
doctor or go to the nearest hospital.
If you take more ARICODILTOSSE 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 (rapid 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 ARICODILTOSSE
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 everybody gets them.
Below are listed side effects for which the frequency is unknown (the frequency cannot be
defined based on available data):
drowsiness
fatigue
dizziness
nystagmus (rhythmic and involuntary eye movements)
dystonia (alteration of muscle or nervous tone)
giddiness
mental confusion
foul language
serotonin syndrome characterized by: nausea, hypotension (low blood pressure), hyperactivity
neuromuscular (tremor, clonic spasm, myoclonus, increased reflex response and rigidity of pyramidal
origin), hyperactivity of the autonomic nervous system characterized by diaphoresis (sweating), fever,
tachycardia (increased heart rate), tachypnea (increased breathing rate),
mydriasis (pupil dilation) and altered mental status (agitation, excitement, confusion), up to
cardiac arrest and death.
psychosis
hallucinations
psychic dependence
abuse
severe allergic reactions (anaphylactic and anaphylactoid reactions)
hyperpyrexia (fever)
hyperthermia (increased body temperature)
diabetes mellitus
nausea
vomiting
gastrointestinal disorders
loss of appetite
asthenia
allergic skin reactions
skin rashes
angioedema (swelling of the skin or mucous membranes),
urticaria (skin irritation)
itching
erythema (skin redness)

Reporting of side effects
If you get any side effects, talk to 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 ARICODILTOSSE

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. The expiry date refers to the last day of that month and to the product in intact packaging, correctly
stored.
No special storage precautions are necessary.
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 ARICODILTOSSE contains
100 ml of the medicine contains:

Active ingredient: dextromethorphan hydrobromide 1.500 mg.

Other components:sodium saccharin, fructose, citric acid monohydrate, ethyl alcohol 95%, sodium citrate
dihydrate, sweet orange extract, purified water.

Description of the appearance of ARICODILTOSSE and contents of the pack
Oral drops, solution.
Glass bottle of 25 ml equipped with a child-resistant closure cap.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi n. 3, Florence.

Manufacturer
Berlin Chemie AG, Glienicker Weg 125 D-12489 Berlin, Germany.

• A. Menarini Manufacturing Logistic and Services s.r.l., Via Sette Santi 3 Florence, Italy.

ARICODILTOSSE 3 mg/ml syrup

Dextromethorphan bromhydrate
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 5-7 days.

Contents of this leaflet:

1. What is ARICODILTOSSE and what it is used for

2. What you need to know before you take ARICODILTOSSE

3. How to take ARICODILTOSSE

4. Possible side effects

5. How to store ARICODILTOSSE

6. Contents of the pack and other information

1. What is ARICODILTOSSE and what it is used for

ARICODILTOSSE contains the active ingredient dextromethorphan, a cough suppressant (calming) and is
indicated
for the symptomatic treatment of non-productive cough (dry cough).
See a doctor if you do not feel better or if you feel worse after 5-7 days.

2. What you need to know before taking ARICODILTOSSE

Do not take ARICODILTOSSE

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine(listed in section 6);
• if you suffer from bronchial asthma (narrowing and inflammation of the bronchi), COPD(chronic obstructive pulmonary disease), pneumonia (inflammatory disease of the lungs), breathing difficulties, respiratory depression, cardiovascular diseases, hypertension (high blood pressure),hyperthyroidism (increased thyroid activity), diabetes, glaucoma (eye disease), prostatic hypertrophy (enlargement of the prostate), stenosis (narrowing) of the gastrointestinal andurogenital tract, epilepsy, severe liver diseases;
• if you are taking or have taken in the last two weeks MAO inhibitor antidepressants; if you are in the first trimester of pregnancy or breastfeeding (see “Pregnancy,breastfeeding and fertility”);
• if the subject to be treated is under 12 years of age.

Warnings and precautions
This medicine can lead to dependence. Therefore, treatment should be of short duration.
Talk to your doctor or pharmacist before taking ARICODILTOSSE if you are taking medicines
such as some antidepressants or antipsychotics: ARICODILTOSSE can interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects
such as a 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 using ARICODILTOSSE.
A chronic cough may be an early symptom of asthma and therefore dextromethorphan is not indicated for
suppressing chronic or persistent cough, e.g. due to smoking, emphysema (a lung disease) and asthma. Dextromethorphan should be administered with particular caution and only on
medical advice if the cough is accompanied by other symptoms such as: fever, rash (skin eruption), headache, nausea and vomiting. ARICODILTOSSE should not be taken in case of cough
accompanied by abundant secretion.
In case of irritating cough with considerable mucus production, treatment with dextromethorphan should be administered with particular caution and only on medical advice after careful assessment of the
risk-benefit ratio.
Consult your doctor if you have liver or kidney problems, especially if you have severe kidney problems.
Dextromethorphan can cause habituation. Following prolonged use, patients may develop
tolerance to the medicine, as well as mental and physical dependence (see section 4 “Possible side effects”). Patients with a tendency to abuse or dependence should take ARICODILTOSSE for
short periods and under strict medical supervision.
During treatment with ARICODILTOSSE, it is not recommended to consume alcoholic beverages
Other medicines and ARICODILTOSSE
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:
antidepressants such as bupropion, MAO inhibitors, serotonin reuptake inhibitors (e.g.
sertraline) and tricyclics;
Linezolid, an antibiotic, used to treat infections caused by bacteria;
sibutramine, a medicine used to reduce appetite;
amiodarone, flecainide, propafenone (medicines used for heart rhythm disorders);
methadone (used to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence);
haloperidol, thioridazine, perphenazine (medicines used to treat mental disorders);
hypnotics (medicines that induce sleep), sedatives (calming), anxiolytics (that reduce anxiety);
cinacalcet (used to reduce the amount of calcium in the blood);
cimetidine, a medicine used to treat stomach injuries (ulcers);
ritonavir (used for the treatment of HIV);
secretolytics (expectorants).
ARICODILTOSSE with food and drink
Grapefruit juice can increase the absorption of ARICODILTOSSE and increase its toxicity.
During treatment, consumption of grapefruit juice should be avoided.
The concomitant use of ARICODILTOSSE with 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 the doctor prescribes ARICODILTOSSE together with sedatives, the dose and
duration of concomitant treatment must be limited by the 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.
ARICODILTOSSE with alcohol
Avoid the simultaneous consumption of alcoholic beverages.
The concomitant use of ARICODILTOSSE and alcohol can increase the depressive (sedative) effects on the central nervous system of both substances.
Pregnancy, breastfeeding and fertility
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.
ARICODILTOSSE should not be used during the first trimester of pregnancy. Furthermore, as the
administration of high doses of dextromethorphan hydrobromide, even for short periods, can cause
respiratory depression in newborns, in the following months the medicine should only be taken if
absolutely necessary and after careful evaluation of the benefits and risks. Since the excretion of
the medicine in breast milk is not known and a respiratory depressant effect on the
newborn cannot be ruled out, ARICODILTOSSE is contraindicated during breastfeeding.
Driving and operating machinery
ARICODILTOSSE can alter the ability to drive vehicles or operate machinery, as it can induce
drowsiness. This effect is accentuated in case of concomitant consumption of alcohol.
ARICODILTOSSE 3 mg/ml syrup contains fructose. This medicine contains 2.25 g of fructose per
5 ml (1 measuring cup). If your doctor has diagnosed you with intolerance to certain sugars, contact him before
taking this medicine.
ARICODILTOSSE 3 mg/ml syrup contains sorbitol. It may have a mild laxative effect. The caloric value of sorbitol is 2.6 kcal/g.

3. How to take ARICODILTOSSE

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.
Each ml of syrup is equivalent to 3 mg of dextromethorphan hydrobromide.
The package includes a 5 ml dosing cup with markings corresponding to 1/2 (equal to 2.5 ml) and
1/4 (equal to 1.25 ml).
Quantity
Adults and adolescents from 12 years of age
The recommended dose is 10 ml (equal to 30 mg of dextromethorphan hydrobromide), equivalent to 2 measuring cups,
from one to four times a day.
Children up to 12 years
ARICODILTOSSE should not be used.
When and for how long
It is advisable to take ARICODILTOSSE during or after main meals.
Do not use ARICODILTOSSE for more than 5-7 days.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 5-7 days.
Instructions for opening the bottle
The bottle is equipped with a “child-proof” safety closure cap. To open the bottle, remove the
seal, press down firmly on the cap and rotate it counterclockwise simultaneously.
If you take more ARICODILTOSSE than you should
In case of ingestion/taking an excessive dose of ARICODILTOSSE, immediately notify your
doctor or go to the nearest hospital.
If you take more ARICODILTOSSE 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 be: coma, severe respiratory problems and
convulsions.
Seek medical attention or go to hospital immediately if you experience any of the above symptoms.
If you forget to take ARICODILTOSSE
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 everybody gets them.
Below are listed side effects for which the frequency is not known (the frequency cannot be
defined based on available data):
drowsiness
fatigue
nystagmus (rhythmic and involuntary eye movement)
dystonia (alteration of muscle or nervous tone)
dizziness
mental confusion
scurrilous language
serotonin syndrome characterized by: nausea, hypotension (low blood pressure), hyperactivity
neuromuscular (tremor, clonic spasm, myoclonus, increased reflex response and rigidity of pyramidal
origin), hyperactivity of the autonomic nervous system characterized by diaphoresis (sweating), fever,
tachycardia (increased heart rate), tachypnea (increased respiratory rate), mydriasis (pupil dilation) and altered mental status (agitation, excitement,
confusion), up to cardiac arrest and death
psychosis,
hallucinations
psychic dependence
abuse
severe allergic reactions (anaphylactic and anaphylactoid reactions)
hyperpyrexia (fever)
hyperthermia (increased body temperature)
diabetes mellitus
nausea
vomiting
gastrointestinal disorders
loss of appetite
asthenia
allergic skin reactions
skin rashes
angioedema (swelling of the skin or mucous membranes)
urticaria (skin irritation)
itching
erythema (redness of the skin)
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 ARICODILTOSSE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date
refers to the last day of that month and the product in intact packaging, correctly
stored.
Shelf life of the medicine after first opening: 6 months
Store in the original container and in the outer packaging.
No special storage precautions are required.
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 ARICODILTOSSE contains
100 ml of syrup contains:
Active substance: destromethorphan hydrobromide 300 mg.
Other components:fructose, non-crystallizing liquid sorbitol, glycerol, sodium benzoate, forest fruit flavour, vanilla flavour, citric acid monohydrate, purified water.
Description of the appearance of ARICODILTOSSE and contents of the pack
Syrup. ARICODILTOSSE is presented in the form of syrup, colourless or slightly yellow, for oral use in
100 ml glass bottle equipped with a child-resistant closure cap.
A measuring device is included in the pack.
Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi n. 3, Florence.

Manufacturer
Berlin Chemie AG, Glienicker Weg 125 D-12489 Berlin, Germany

• A. Menarini Manufacturing Logistic and Services s.r.l., Via Sette Santi 3 Florence, Italy.