Active ingredients: Dextromethorphan (Dextromethorphan hydrobromide)
ARICODILTOSSE 3 mg / ml syrup
Aricodiltosse package inserts are available for pack sizes:- ARICODILTOSSE 3 mg / ml syrup
- ARICODILTOSSE 15 mg / ml oral drops, solution
Why is Aricodiltosse used? What is it for?
ARICODYLTOSSE contains the active ingredient dextromethorphan and is a cough suppressant. This medicine is used in adults and children over 2 years of age for the symptomatic treatment of non-productive cough (dry cough). Dry cough is a symptom that frequently accompanies colds and flu states; it is due to the inflammatory state of the respiratory tract and is not accompanied by the production of mucus and / or phlegm. Dry cough increases in frequency and intensity during the night, when the patient is lying down, disturbing his sleep and worsening the inflammation of the airways. The presence of dry air, open mouth breathing and the supine position stimulate coughing fits. To prevent such accesses, it is advisable to properly humidify the rooms and promote nasal breathing.
Talk to your doctor if you don't feel better or if you feel worse after 5-7 days.
Contraindications When Aricodiltosse should not be used
Do not take ARICODILTOSSE
- If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
- If you have or are at risk of developing respiratory failure, for example if you have chronic obstructive airway disease or pneumonia (inflammatory lung disease), ongoing asthma attack or exacerbation (worsening) of asthma;
- If you are taking or have taken monoamine oxidase inhibitor antidepressants (MAOIs) within the last two weeks (see "Other medicines and ARICODYLTOSSE");
- In pregnancy and lactation (see "Pregnancy, lactation and fertility"). ARICODILTOSSE should not be used in children under 2 years of age.
Precautions for use What you need to know before taking Aricodiltosse
Talk to your doctor or pharmacist before taking ARICODYLTOSSE.
Take ARICODYLTOSSE with caution:
- in case of an irritating cough with a considerable production of mucus and only on medical advice;
- if you have "impaired liver function (liver)".
Avoid drinking alcoholic beverages which may change the effect of the medicine while taking ARICODYLTOSSE (see "ARICODYLTOSSE and alcohol").
Cases of dextromethorphan abuse have been reported, including cases in adolescents and children. The majority of reported cases involved patients with a history of alcoholism and / or drug abuse (overuse) and / or psychiatric disorders (mental disorders) (see "If you take more ARICODYLTOSSE than you should").
Children and adolescents
The use of ARICODYLTOSSE is not recommended in children under 2 years of age. In children between 2 and 12 years of age, the product should only be administered in case of real need and under the direct supervision of a doctor.
Interactions Which drugs or foods can modify the effect of Aricodiltosse
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid taking ARICODILTOSSE concurrently with antidepressant drugs belonging to the class of monoamine oxidase inhibitors (MAOIs), eg phenelzide or selegiline, which could induce severe effects on the central nervous system (eg excitement, high fever, alterations in functions respiratory and circulatory) including serotonin syndrome (a condition characterized by an excessive increase in the concentration of serotonin, a neurotransmitter, in the central nervous system). If you have stopped taking MAOIs for less than two weeks, the use of dextromethorphan it is however contraindicated (see "Do not take ARICODILTOSSE").
In particular, tell your doctor if you are taking or have recently taken:
- tricyclic antidepressant medicines (e.g. clomipramine, amitriptyline, trazodone) or serotonin reuptake inhibitors (e.g. citalopram, paroxetine, fluoxetine, sertraline), which may increase the effects of dextromethorphan causing a serotonin syndrome with changes in mental status, hypertension, agitation, myoclonus (short and rapid contraction of the muscle), hyperreflexia (exaggeration of reflexes), diaphoresis (intense sweating), tremors (sudden agitation caused by strong emotion) and tremors;
- medicines to treat heart rhythm abnormalities (amiodarone, quinidine, flecainide, propafenone);
- medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section do not take ARICODYLTOSSE);
- medicines to treat severe pain or to reduce withdrawal symptoms in cases of drug addiction (methadone);
- medicines to treat psychiatric diseases (haloperidol, thioridazine, perphenazine;
- medicines to reduce the level of calcium in the blood and treat hyperparathyroidism, a disease characterized by an "alteration in the secretion of the hormone that regulates calcium levels in the body" (cinacalcet);
- medicines used to prevent the development of fungi (fungi) such as terbinafine.
These medicines can, in fact, increase the levels of dextromethorphan in the blood, inhibiting its metabolism.
ARICODILTOSSE and alcohol
Avoid the simultaneous intake of alcoholic beverages and medicines containing alcohol.
The concomitant use of dextromethorphan and alcohol may increase the sedative effects on the central nervous system of both substances. The effect on alertness can make driving or use of machines dangerous (see "Driving and using machinery ").
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use ARICODYLTOSSE during pregnancy and breastfeeding. Use should also be avoided if you suspect that you are pregnant or wish to plan a maternity leave (see "Do not take ARICODYLTOSSE").
Driving and using machines
As the medicine may decrease alertness and cause drowsiness, the ability to drive and use machines may be reduced, especially in conjunction with the intake of alcohol or other medicines that may reduce reaction times (see "ARICODYLTOSSE and alcohol").
ARICODILTOSSE 3 mg / ml syrup contains fructose
This medicine contains 2.25g of fructose per 5ml (1 scoop). To be taken into consideration in people with diabetes mellitus (see "Do not take ARICODILTOSSE").
ARICODILTOSSE 3 mg / ml syrup contains sorbitol
It may have a mild laxative effect. The caloric value of sorbitol is 2.6 kcal / g.
Dose, Method and Time of Administration How to use Aricodiltosse: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Each ml of syrup is equivalent to 3 mg of dextromethorphan hydrobromide.
A 5 ml measuring cup is attached to the package with notches corresponding to 1/2 (equal to 2.5 ml) and 1/4 (equal to 1.25 ml).
To open the package, remove the seal, press the cap firmly and turn counterclockwise at the same time.
How many
Adults
The recommended dose is 10 ml (equal to 30 mg of dextromethorphan hydrobromide), equivalent to 2 scoops, one to four times a day.
Children and adolescents
Warning: do not exceed the indicated doses without medical advice. Do not exceed the maximum recommended daily dose.
When and for how long
It is advisable to take the drug during or after the main meals.
Do not use for more than 7 days.
After 5-7 days of treatment without appreciable results, consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
If you forget to take ARICODYLTOSSE
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much aricodyl cough
An overdose of dextromethorphan can cause nausea, vomiting, urinary retention (a condition in which the patient is unable to voluntarily or completely empty the bladder), shallow breathing (fast, shallow breathing), excitement, confusion, drowsiness, dizziness , ataxia (lack of muscle and movement coordination), blurred vision, nystagmus (rapid and repetitive involuntary movement of the eyes).
In extreme cases, urinary retention and respiratory depression (dysfunction) can occur.
The accidental ingestion of large doses can cause respiratory depression, convulsions, coma.
In case of ingestion / intake of an excessive dose of ARICODILTOSSE, notify your doctor immediately or go to the nearest hospital.
Emergency interventions in case of ingestion / intake of an excessive dose of ARICODYLTOSSE include emptying the stomach and supporting vital functions.
In the event of a severe overdose, administration of naloxone may be useful, particularly in patients with respiratory depression.
Side Effects What are the side effects of Aricodiltosse
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Occasionally, physical and mental weakness, asthenia (lack of strength), confusion, nausea, vomiting, dizziness and sleepiness may occur, especially in the event of an overdose (see "If you take more ARICODYLTOSSE than you should") or in very old age or in case of diseases that already in themselves tend to cause drowsiness: in these cases it is generally sufficient to reduce the doses.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Italian Medicines Agency, Website: www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 package. The expiry date refers to the last day of that month and to the product in intact packaging, correctly stored.
Shelf life of the medicine after first opening: 6 months.
Store in the original container and outer carton.
No special storage precautions are required.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What ARICODYLTOSSE contains
100 ml of syrup contain:
- Active ingredient: dextromethorphan hydrobromide 300 mg.
- Other components: fructose, non-crystalline liquid sorbitol, glycerol, sodium benzoate, forest fruit flavor, vanilla flavor, citric acid monohydrate, purified water.
Description of the appearance of ARICODILTOSSE and contents of the pack
Syrup. ARICODILTOSSE is presented in the form of a syrup, colorless or slightly yellow, for oral use in a glass bottle of 100 ml.
A measuring cup is associated with the package.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ARICODILTOSSE 3 MG / ML SYRUP
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of syrup contain:
active principle: dextromethorphan hydrobromide 300 mg.
Excipients with known effects:
fructose 45 g
sorbitol 15 g
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Syrup.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of non-productive coughs.
04.2 Posology and method of administration
Adults: 10 ml (equal to 30 mg), equivalent to 2 scoops, one to four times a day
Children (2-5 years): 2.5 ml (equivalent to 7.5 mg), equivalent to half a scoop, one to four times a day
Children (6-11 years): 5 ml (equal to 15 mg), equivalent to one scoop, one to four times a day
Each ml of syrup is equivalent to 3 mg of dextromethorphan hydrobromide.
A 5 ml measuring cup with notches corresponding to ½ and ¼ is attached to the syrup package.
It is advisable to take the drug during or after main meals.
The use of ARICODYLTOSSE 3 mg / ml syrup is not recommended in children under two years of age due to insufficient data on safety and efficacy
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with respiratory failure or at risk of developing respiratory failure (eg patients with chronic obstructive airway disease or pneumonia, patients with ongoing asthma attack or exacerbation of asthma).
Children under the age of 2, pregnant and breastfeeding.
Patients who are taking or have taken monoamine oxidase inhibitor antidepressants (MAOIs) within the last two weeks.
04.4 Special warnings and appropriate precautions for use
The use of ARICODYLTOSSE is not recommended in children below two years of age due to insufficient data on safety and efficacy. In children between 2 and 12 years of age, the product should be administered only in case of real need and under the direct supervision of the doctor.
In case of an irritating cough with considerable mucus production, treatment with ARICODYLTOSSE as a cough suppressant should be given with particular caution and only on medical advice.
Administer with caution in subjects with impaired hepatic function.
During treatment with ARICODILTOSSE it is not recommended to drink alcoholic beverages.
Cases of dextromethorphan abuse have been reported, including cases in adolescents and children. Special care is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. The majority of reported cases involved patients with a history of alcoholism and / or psychiatric disorders.
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. Approximately 10% of the population metabolise CYP2D6 slowly. In poor metabolisers and patients with concomitant use of CYP2D6 inhibitors, exaggerated and / or prolonged effects of dextromethorphan may occur. patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5).
ARICODILTOSSE contains fructose and sorbitol: this should be taken into account in the case of diabetes and low-calorie diets. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
The product should not be used simultaneously with or within 2 weeks of treatment with monoamine oxidase inhibitor antidepressants (MAOIs), as serious adverse reactions, including serotonin syndrome, have been reported (see "Contraindications").
Patients should consult their physician before taking dextromethorphan in the following situations:
Concomitant use of dextromethorphan with selective serotonin reuptake inhibitor antidepressants or tricyclic antidepressants
It can cause serotonin syndrome with changes in mental status, hypertension, agitation, myoclonus, hyperreflexia, diaphoresis, tremors and tremors (see "Warnings and precautions");
• CYP2D6 inhibitors
Dextromethorphan is metabolised by CYP2D6 and has extensive first pass metabolism. Concomitant use of potent inhibitors of the CYP2D6 enzyme can increase dextromethorphan concentrations in the body to levels many times above normal. This increases the patient's risk of the toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea and respiratory depression) and of developing serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan are increased up to 20-fold, resulting in increased CNS adverse effects of the agent. Also amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is required, the patient should be monitored and the dose of dextromethorphan may need to be reduced;
Concomitant use of dextromethorphan and alcohol
It can increase the central nervous system depressant effects of both substances.
04.6 Pregnancy and breastfeeding
There are no adequate data regarding the use of dextromethorphan in pregnant women. Animal studies are insufficient to highlight effects on pregnancy, embryonic / fetal development, parturition or postnatal development. The potential risk for humans is not known. ARICODILTOSSE should not be used during pregnancy and lactation.
04.7 Effects on ability to drive and use machines
ARICODYLTOSSE has minor effects on the ability to drive or use machines.
04.8 Undesirable effects
The administration of ARICODILTOSSE can occasionally give rise to asthenia, confusion, nausea, vomiting, dizziness and somnolence, especially in the event of an overdose or in patients of very old age or carriers of conditions that already tend to cause drowsiness in themselves: in these in cases it is usually sufficient to reduce the doses.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose
Signs and symptoms
Intake of high doses of dextromethorphan may cause nausea, vomiting, urinary retention, shallow breathing, excitement, mental confusion, drowsiness, dizziness, ataxia, blurred vision, nystagmus. Accidental ingestion of large doses can cause respiratory depression, convulsions and coma.
Treatment
Emergency interventions include emptying the stomach and supporting vital functions.
In the event of a severe overdose, administration of naloxone may be useful, particularly in patients with respiratory depression.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough suppressants - Opium alkaloids and its derivatives ATC code: R05DA09
Dextromethorphan hydrobromide is a morphinic type alkaloid which acts on the cough center by raising the threshold of excitation to toxigenic stimuli; at therapeutic doses it is devoid of analgesic, euphoric or narcotic effects. In large doses it can cause respiratory depression.
05.2 Pharmacokinetic properties
Dextromethorphan hydrobromide is rapidly absorbed from the gastrointestinal tract. The maximum plasma level is achieved approximately 2 hours after oral administration. Dextromethorphan is metabolised in the liver and eliminated by the kidney. Less than 2.5% of the administered dose in the unmodified form and up to 30% in the metabolised form is eliminated within 24 hours.
Dextromethorphan undergoes rapid and extensive first pass metabolism in the liver following oral administration. Genetically controlled O-demethylation (CYD2D6) is the major determinant of the pharmacokinetics of dextromethorphan in human volunteers.
It appears that there are distinct phenotypes for this oxidation process, resulting in highly variable pharmacokinetics between subjects. Unmetabolized dextromethorphan and the three demethylated metabolites of morphinan, dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3-hydroxymorphinan and 3-methoxymorphinane, have been identified as conjugated products in urine.
Dextrorphan, which also has an antitussive action, is the main metabolite. In some subjects, metabolism proceeds more slowly and unchanged dextromethorphan predominates in the blood and urine.
05.3 Preclinical safety data
There is no information, deriving from preclinical data, of significant importance to the physician that has not already been reported in the other sections of the Summary of Product Characteristics.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Fructose, non-crystalline liquid sorbitol, glycerol, sodium benzoate, berry flavor, vanilla flavor, citric acid monohydrate, purified water
06.2 Incompatibility
Not relevant
06.3 Period of validity
48 months
Validity after first opening: 6 months
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
100 ml type III amber glass bottle with child-proof resistant polypropylene cap with expanded polyethylene / polyethylene seal.
A polypropylene measuring cup is associated with the package.
06.6 Instructions for use and handling
No special instructions.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Florence.
08.0 MARKETING AUTHORIZATION NUMBER
3 mg / ml syrup, 100 ml bottle - A.I.C. n. 011680079
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: August 2010
10.0 DATE OF REVISION OF THE TEXT
February 2017