Aricodil cough

Package leaflet: Information for the user

ARICODILTOSSE 15 mg/ml oral drops, solution

Dextromethorphan hydrobromide
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 told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, 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 5–7 days.

Contents of this leaflet:

1. What ARICODILTOSSE is and what it is 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

1. What ARICODILTOSSE is and what it is used for

ARICODILTOSSE contains the active substance dextromethorphan, a cough suppressant, and is indicated for the symptomatic treatment of non-productive cough (dry cough).
Consult your doctor if you do not feel better or 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 substance 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 lung disease), breathing difficulties, respiratory depression, cardiovascular diseases, hypertension (high blood pressure), hyperthyroidism (increased thyroid activity), diabetes, glaucoma (eye disease), prostate enlargement (prostatic hypertrophy), narrowing (stenosis) of the gastrointestinal or urogenital tract, epilepsy, or severe liver disease;
• if you are taking or have taken within the last two weeks antidepressant MAO inhibitors;
• if you are in the first trimester of pregnancy or breastfeeding (see "Pregnancy, breastfeeding and fertility");
• if the person to be treated is under 2 years of age.

Warnings and precautions
This medicine may lead to dependence. Therefore, treatment should be short-term only.
Talk to your doctor or pharmacist before taking ARICODILTOSSE if you are taking medicines such as certain antidepressants or antipsychotics: ARICODILTOSSE 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, diarrhoea).
Consult your doctor or pharmacist before using ARICODILTOSSE.
Chronic cough may be an early symptom of asthma; therefore, dextromethorphan is not indicated for the suppression of chronic or persistent cough, for example due to smoking, emphysema (a lung disease), or asthma. Dextromethorphan should be administered with particular caution and only on medical advice if cough is accompanied by other symptoms such as fever, rash (skin eruption), headache, nausea, and vomiting. ARICODILTOSSE must not be taken if cough is accompanied by abundant secretion.
In cases of irritating cough with significant 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 may cause dependence. After prolonged use, patients may develop tolerance to the medicine, as well as psychological and physical dependence (see section 4 "Possible side effects"). Patients with a tendency to abuse or dependence should take ARICODILTOSSE only for short periods and under strict medical supervision.
During treatment with ARICODILTOSSE, consumption of alcoholic beverages is not recommended.

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 bacterial infections;
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, anxiolytics (medicines that reduce anxiety);
cinacalcet (used to reduce calcium levels in the blood);
cimetidine, a medicine used to treat stomach lesions (ulcers);
ritonavir (used for the treatment of HIV);
mucolytics (expectorants);
terbinafine (used for the treatment of fungal infections, mycoses).

ARICODILTOSSE with food and drinks
Grapefruit juice may increase the absorption of ARICODILTOSSE and increase its toxicity. Grapefruit juice should be avoided during treatment.
Concomitant use of ARICODILTOSSE with 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 ARICODILTOSSE 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 follow carefully his or her recommendations regarding 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 and alcohol
Avoid consuming alcoholic beverages at the same time.
Concomitant use of ARICODILTOSSE and alcohol may increase the central nervous system depressant (sedative) effects of both substances.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
ARICODILTOSSE must not be used during the first trimester of pregnancy.
Moreover, since administration of high doses of dextromethorphan hydrobromide, even for short periods, may cause respiratory depression in newborns, in later months the medicine should be taken only if clearly needed and after careful assessment of benefits and risks. As it is unknown whether the medicine is excreted in breast milk and a risk of respiratory depression in the newborn cannot be excluded, ARICODILTOSSE is contraindicated during breastfeeding.

Driving and using machines
ARICODILTOSSE may impair your ability to drive or operate machinery, as it may cause drowsiness. This effect is increased if alcohol is consumed at the same time.

ARICODILTOSSE contains 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 disease in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine.

ARICODILTOSSE contains 5.8 mg of alcohol (ethanol) per drop. The amount in a full adult dose (54 drops) corresponds to a blood alcohol concentration (BAC) of 0.75 mg/100 ml, 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 contains less than 1 mmol (23 mg) of sodium per dose (54 drops), i.e. it is essentially "sodium-free".

3. How to take ARICODILTOSSE

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.

Dosage

Adults and adolescents aged 12 years and older
The recommended dose ranges from 10 mg to 20 mg (equivalent to 27–54 drops), up to 4 times daily, 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, divided into 3–4 doses, with a minimum interval of 6 hours between doses.
Dosage selection must be based on body weight, especially when the child's age does not correspond to the weight indicated in the dosing table.

In children, serious adverse events, including neurological disturbances, may occur in the case of overdose.
Caregivers should not exceed the recommended dose.
When and for how long
Do not use ARICODILTOSSE for longer than 5–7 days.
Consult your doctor if you do not notice any improvement or if symptoms worsen after 5–7 days.
Instructions for opening the bottle
To open the dropper bottle, press the plastic cap and turn it counterclockwise. To close, repeat the procedure, turning in the opposite direction.
If you take more ARICODILTOSSE than you should
If you ingest or take an excessive dose of ARICODILTOSSE, contact your doctor immediately or go to the nearest hospital.
If you take more ARICODILTOSSE 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 heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Additional symptoms in the 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 ARICODILTOSSE
Do not take a double dose to make up for the 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.
The following are side effects whose frequency is unknown (frequency cannot be determined from the available data):
drowsiness
fatigue
dizziness
nystagmus (rhythmic, involuntary eye movement)
dystonia (alteration of muscular or nervous tone)
vertigo
mental confusion
foul speech
serotonin syndrome characterized by: nausea, hypotension (low blood pressure), neuromuscular hyperactivity (tremor, clonic spasm, myoclonus, increased reflex response, and pyramidal-origins rigidity), autonomic nervous system hyperactivity characterized by diaphoresis (sweating), fever, tachycardia (increased heart rate), tachypnea (increased respiratory rate), mydriasis (dilation of the pupils), and altered mental state (agitation, excitement, confusion), up to cardiac arrest and death.
psychosis
hallucinations
psychological dependence
abuse
severe allergic reactions (anaphylactic and anaphylactoid reactions)
hyperpyrexia (fever)
hyperthermia (elevated body temperature)
diabetes mellitus
nausea
vomiting
gastrointestinal disturbances
loss of appetite
asthenia
skin allergic reactions
skin rashes
angioedema (swelling of the skin or mucous membranes)
urticaria (skin irritation)
pruritus
erythema (redness of the skin)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can 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.

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 stated on the packaging. The expiry date refers to the last day of that month and to the product in its original, unopened packaging stored correctly.
No special storage precautions are required.
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 ARICODILTOSSE contains
100 ml of medicinal product contain:
Active substance: dextromethorphan hydrobromide 1,500 mg.
Other components: sodium saccharin, fructose, citric acid monohydrate, 95% ethyl alcohol, sodium citrate
dihydrate, sweet orange extract, purified water.
Description of the appearance of ARICODILTOSSE and package contents
Oral drops, solution.
25 ml glass bottle equipped with a "child-proof" safety cap.
Marketing Authorization 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.

Patient Information Leaflet: Information for the User

ARICODILTOSSE 3 mg/ml syrup

Dextromethorphan hydrobromide
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.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 taking 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 ARICODILTOSSE is and what it is used for
ARICODILTOSSE contains the active substance dextromethorphan, a cough suppressant (antitussive), and is indicated for the symptomatic treatment of non-productive cough (dry cough).
Consult your doctor if you do not feel better or if you feel worse after 5–7 days.

2. What you should know before taking ARICODILTOSSE

Do not take ARICODILTOSSE

• if you are allergic to the active substance 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 lung disease), breathing difficulties, respiratory depression, cardiovascular diseases, hypertension (high blood pressure), hyperthyroidism (increased thyroid activity), diabetes, glaucoma (eye disease), prostatic hyperplasia (enlarged prostate), stenosis (narrowing) of the gastrointestinal and urogenital tracts, epilepsy, severe liver disease;
• if you are taking or have taken within the last two weeks monoamine oxidase inhibitor (MAOI) antidepressants; if you are in the first trimester of pregnancy or breastfeeding (see "Pregnancy, breastfeeding and fertility");
• if the patient to be treated is under 12 years of age.

Warnings and precautions
This medicine may lead to dependence. Therefore, treatment should be short-term.
Talk to your doctor or pharmacist before taking ARICODILTOSSE if you are taking medicines
such as certain antidepressants or antipsychotics: ARICODILTOSSE 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, diarrhea).
Consult your doctor or pharmacist before using ARICODILTOSSE.
Chronic cough may be an early symptom of asthma, and therefore dextromethorphan is not indicated for
the suppression of 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 cough is accompanied by other symptoms such as: fever, rash (skin eruption), headache, nausea and vomiting. ARICODILTOSSE must not be taken in case of cough associated with abundant secretion.
In case of irritating cough with significant mucus production, treatment with dextromethorphan should be administered with particular caution and only on medical advice after careful risk-benefit assessment.
Consult your doctor if you have liver or kidney problems, especially if you have severe kidney problems.
Dextromethorphan may cause habituation. After 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, consumption of alcoholic beverages is not recommended.

Other medicines and ARICODILTOSSE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Inform 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, anxiolytics (reduce anxiety);
cinacalcet (used to reduce calcium levels in the blood);
cimetidine, a medicine used to treat stomach lesions (ulcers);
ritonavir (used for the treatment of HIV);
mucolytics (expectorants).

ARICODILTOSSE with food and drinks
Grapefruit juice may increase the absorption of ARICODILTOSSE and increase its toxicity.
During treatment, consumption of grapefruit juice should be avoided.
Concomitant use of ARICODILTOSSE with 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 ARICODILTOSSE 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 recommendations regarding 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 and alcohol
Avoid taking alcoholic beverages at the same time.
Concomitant use of ARICODILTOSSE and alcohol may increase the depressant (sedative) effects on the central nervous system of both substances.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
ARICODILTOSSE must not be used during the first trimester of pregnancy. Furthermore, since high doses of dextromethorphan hydrobromide, even for short periods, may cause respiratory depression in newborns, in the following months the medicine should only be taken when strictly necessary and after careful assessment of benefits and risks. As it is not known whether the medicine is excreted in breast milk and a respiratory depressant effect on the newborn cannot be excluded, ARICODILTOSSE is contraindicated during breastfeeding.

Driving and using machines
ARICODILTOSSE may affect your ability to drive or operate machinery, as it may cause drowsiness. This effect is increased if alcohol is taken at the same time.

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 an intolerance to certain sugars, contact him/her 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 exactly as stated 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 contains 3 mg of dextromethorphan hydrobromide.
The pack includes a dosing cup of 5 ml with markings corresponding to 1/2 (equal to 2.5 ml) and 1/4 (equal to 1.25 ml).

Dosage
Adults and adolescents from 12 years of age
The recommended dose is 10 ml (equivalent to 30 mg of dextromethorphan hydrobromide), equal to 2 dosing cups, one to four times daily.

Children under 12 years of age
ARICODILTOSSE must not be used.

When and for how long
It is advisable to take ARICODILTOSSE during or after main meals.
Do not use ARICODILTOSSE for longer than 5–7 days.
Consult your doctor if you do not notice improvement or if symptoms worsen after 5–7 days.

Instructions for opening the bottle
The bottle is equipped with a "child-proof" safety cap. To open, remove the seal, press down firmly on the cap and simultaneously turn it counterclockwise.

If you take more ARICODILTOSSE than you should
If you take too much ARICODILTOSSE, contact your doctor immediately or go to the nearest hospital.
If you take more ARICODILTOSSE than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, heart problems (fast heartbeat), coordination difficulties, psychosis with visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may include: coma, severe breathing 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 ARICODILTOSSE
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 everyone gets them.
The side effects listed below have a frequency that is unknown (frequency cannot be estimated from the
available data):
drowsiness
fatigue
nystagmus (rhythmic, involuntary eye movement)
dystonia (alteration of muscular or nervous tone)
dizziness
mental confusion
inappropriate or offensive language
serotonin syndrome characterized by: nausea, hypotension (low blood pressure), neuromuscular
hyperactivity (tremor, clonic spasms, myoclonus, increased reflex response, and pyramidal-origins
rigidity), autonomic nervous system hyperactivity characterized by diaphoresis (sweating), fever,
tachycardia (increased heart rate), tachypnea (increased respiratory rate), mydriasis (dilated pupils),
and altered mental status (agitation, excitement, confusion), progressing in severe cases to cardiac arrest
and death
psychosis
hallucinations
psychological dependence
abuse
severe allergic reactions (anaphylactic and anaphylactoid reactions)
hyperpyrexia (high fever)
hyperthermia (elevated body temperature)
diabetes mellitus
nausea
vomiting
gastrointestinal disturbances
loss of appetite
asthenia
skin allergic 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 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
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 stated on the packaging. The expiry date refers to the
last day of that month and applies to the product in its original, unopened packaging, stored correctly.
Shelf life after first opening: 6 months
Store in the original container and outer packaging.
No special storage precautions are required.
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 ARICODILTOSSE contains
100 ml of syrup contain:
Active substance: dextromethorphan hydrobromide 300 mg.
Other components: fructose, non-crystalline liquid sorbitol, glycerol, sodium benzoate, forest fruit flavour, vanilla flavour, citric acid monohydrate, purified water.

Description of the appearance of ARICODILTOSSE and the contents of the pack
Syrup. ARICODILTOSSE is an oral syrup, colourless or slightly yellow, supplied in a 100 ml glass bottle fitted with a child-resistant closure cap.
A dosing cup is included with the pack.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi n. 3, Florence, Italy.

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.