DESTROTUS 30 mg /10 Ml Syrup

Зміст інструкції

1. DESTROTUS 30 mg/10 ml syrup, 15 mg/ml oral drops, solution
   1. What is DESTROTUS and what is it used for
   2. What you need to know before taking DESTROTUS
   3. How to take DESTROTUS
   4. Possible side effects
   5. How to store DESTROTUS
   6. Package Contents and Other Information

DESTROTUS 30 mg/10 ml syrup, 15 mg/ml oral drops, solution

Destrometorfano bromidrato

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after 5 days.

Contents of this leaflet:

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

1. What is DESTROTUS and what is it used for

DESTROTUS contains the active ingredient dextromethorphan, which belongs to the group of medicines
used for the treatment of dry cough.
See a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before taking DESTROTUS

Do not take DESTROTUS

• if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from breathing problems (bronchial asthma, chronic obstructive pulmonary disease);
• if you have difficulty breathing (including respiratory depression);
• if you have pneumonia, a lung infection;
• if you suffer from blood circulation and heart diseases (cardiovascular diseases);
• if you have high blood pressure (hypertension);
• if you suffer from thyroid disorders (hyperthyroidism);
• if you have diabetes;
• if you have an eye disorder (such as glaucoma);
• if you suffer from prostate problems (prostatic hypertrophy);
• if you suffer from disorders of the stomach, intestines or urinary tract (such as stenosis of the gastrointestinal and urogenital tract causing a pathological narrowing of the caliber of these organs);
• if you suffer from epilepsy;
• if you have severe liver disease;
• if the patient is a child under 12 years of age;
• if you are taking medicines used for the treatment of depression (MAO inhibitors);
• if it has only been two weeks since taking antidepressant medications (see section “Other medicines and DESTROTUS”);
• if you are in the first trimester of pregnancy;
• if you are breastfeeding.

Warnings and precautions
See a doctor or pharmacist before taking DESTROTUS.
The duration of treatment with this medicine should not be longer than 5-7 days.
The use of DESTROTUS, especially for prolonged treatments, can cause a decrease
in effectiveness and the need to continue using the medicine (habituation, tolerance,
mental and physical dependence). Therefore, short-term treatment and close
medical supervision are recommended, especially if you are predisposed to developing such
condition.
This medicine is not indicated for the treatment of persistent cough (chronic cough), which
may be due to smoking or lung disorders (emphysema) or breathing (asthma). If you have
a persistent cough, stop treatment and see a doctor, as it may be
a symptom of some respiratory disorders (asthma).
If you have a cough accompanied by abundant mucus, do not take this medicine. If your cough
causes pain and discomfort (irritating cough) and is accompanied by mucus, see a doctor who
will carefully assess the need for treatment with this medicine. If the doctor deems the
treatment essential, they will monitor you during therapy.
Take this medicine with caution and only on medical advice if you also experience
fever, skin irritation (rash), headache, nausea and vomiting.
You can only start treatment with DESTROTUS after a careful assessment by the doctor and
under close supervision if:

• you suffer from blood circulation and heart diseases (cardiovascular diseases);
• you have high blood pressure (hypertension);
• you suffer from thyroid disorders (hyperthyroidism);
• you have diabetes;
• you have an eye disorder (such as glaucoma);
• you suffer from prostate problems (prostatic hypertrophy);
• you suffer from disorders of the stomach, intestines or urinary tract (stenosis of the gastrointestinal and urogenital tract);
• you suffer from epilepsy;
• you have severe liver disease;
• you are taking medicines used for the treatment of depression (MAO inhibitors); before taking DESTROTUS, at least two weeks must have passed since taking antidepressant medications. In all of the above situations, taking this medicine is not recommended and is reserved only for cases of absolute necessity (see section “Do not take DESTROTUS”).

For those who engage in sports, the use of DESTROTUS 15 mg/ml oral drops, solution containing
ethanol (ethyl alcohol) may result in a positive doping test in relation to the limits of
blood alcohol concentration indicated by some sports federations.

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.

Other medicines and DESTROTUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take this medicine if you are taking medicines used for the treatment of
depression (MAO inhibitors); at least two weeks must have passed since taking antidepressant medications before taking DESTROTUS.
In particular, tell your doctor if you are taking or have recently taken:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline, bupropion (see section 2. “Do not take DESTROTUS”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of addiction (methadone);
• medicines to treat mental illnesses (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat heart rhythm abnormalities (flecainide);
• medicines to reduce calcium levels in the blood and treat a dysfunction of the body due to reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
• medicines used to prevent the development of fungi (terbinafine);
• medicines used to treat insomnia and anxiety (hypnotic, sedative and anxiolytic medicines);
• cimetidine, a medicine used to treat stomach disorders due to high acidity,
• ritonavir, a medicine used to treat AIDS;
• medicines used to facilitate the elimination of mucus (expectorant medicines);
• antidepressant medicines (MAO inhibitors);
• linezolid, a medicine used to treat infections caused by bacteria;
• sibutramine, a medicine used to treat obesity.

MAO inhibitors, linezolid and sibutramine, when taken simultaneously with
DESTROTUS, can cause a condition, which can also be fatal, called “serotonin
syndrome” whose symptoms are:

• nausea;
• decrease in blood pressure (hypotension);
• tremors, disturbances, convulsions and involuntary contractions and extensions of the muscles (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity);
• nervous system disorders such as hyperactivity, fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis);
• profuse sweating (diaphoresis);
• mental disorders (agitation, excitement, confusion);
• heart block (cardiac arrest) and death.

The concomitant use of DESTROTUS and sedative medicines such as benzodiazepines or medicines related
to them increases the risk of drowsiness, difficulty breathing (respiratory depression),
coma and can be life-threatening. For this reason, concomitant use should be
considered only when other treatment options are not possible.
However, if your doctor prescribes you sedative medicines while you are using DESTROTUS, the dose and
duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow
the doctor's dosage recommendations. It may be helpful to inform friends or family members to pay
attention to the signs and symptoms listed above. See a doctor if these symptoms occur.

DESTROTUS with drinks and alcohol
Avoid taking grapefruit juice during treatment with this medicine because
they can increase toxic effects and decrease the effect of the medicine.
Avoid drinking alcohol during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Do not takethis medicine in the first three months of pregnancy.
After the third month of pregnancy, you can take this medicine only in cases of absolute
necessity and under strict medical supervision, as breathing problems may occur
in the newborn (respiratory depression), especially at high doses and even for short periods of
treatment.
Do not take this medicine during breastfeeding, as a respiratory depression effect in the newborn cannot be excluded. DESTROTUS is not indicated during
breastfeeding.

Driving and using machines
DESTROTUS can alter your ability to drive vehicles or use machinery, as it can induce
drowsiness, especially if you drink alcohol at the same time (see section “DESTROTUS
with drinks and alcohol”).

DESTROTUS 30 mg/10 ml syrup contains sucrose and parabens
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with
diabetes, or an intolerance to certain sugars, or are following a diet, contact
them before taking this medicine.
This medicine contains antimicrobial preservatives such as sodium benzoate and parabens
(methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate) which can
cause allergic reactions, even delayed ones.

DESTROTUS 15 mg/ml oral drops, solution contains ethanol
This medicine contains small amounts of ethanol (ethyl alcohol) less than 100 mg per dose.
For those who engage in sports, the use of medicines containing ethyl alcohol may determine
positive doping tests in relation to the limits of blood alcohol concentration indicated by some
sports federations.
The container of this medicine is made of latex rubber, which can cause serious
allergic reactions.

3. How to take DESTROTUS

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

DESTROTUS 30 mg/10 ml syrup
To open the bottle, press and unscrew simultaneously.
In adults and adolescents (12 to 18 years), the recommended dose ranges from 10 mg of dextromethorphan (an amount equal to one teaspoon of syrup, which corresponds to approximately 3 ml) to 20 mg of dextromethorphan (equal to 2 teaspoons of syrup, which corresponds to 6 ml), every 6 hours.
The maximum recommended daily dose is 80 mg of dextromethorphan (equal to 8 teaspoons of syrup per day).
To close the bottle, screw on tightly while pressing.

DESTROTUS 15 mg/ml oral drops, solution
To open the bottle with dropper, press and unscrew simultaneously.
In adults and adolescents (12 to 18 years), the recommended dose ranges from 10 mg of dextromethorphan (equal to approximately 14 drops) to 20 mg (equal to approximately 28 drops), every 6 hours.
The maximum recommended daily dose is 80 mg of dextromethorphan (approximately 110 drops per day).

If you take more DESTROTUS than you should
In case of overdose, symptoms may include:

• nausea, vomiting;
• visual disturbances;
• movement coordination disorders (ataxia);
• dizziness;
• excitation, mental confusion;
• muscle disorders (increased muscle tone);
• decreased blood pressure (hypotension);
• increased heart rate (tachycardia);
• decreased urine output and breathing problems (respiratory depression) in the most severe cases.

If you have ingested/taken an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital. If necessary, gastric lavage is recommended.

If you forget to take DESTROTUS
Do not take a double dose to make up for a missed dose.

If you stop taking DESTROTUS
If you have any doubts about the use of 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.

The frequency of side effects is not known(i.e. cannot be estimated from available data). Individual side effects are listed below:

• drowsiness, fatigue;
• involuntary and rapid eye movements (nystagmus);
• difficulty with movement (dystonia);
• dizziness;
• mental confusion and changes in behaviour (scurrilous language);
• mental disorders (psychosis), hallucinations;
• need to continue taking the medicine (psychic dependence);
• severe allergic (anaphylactic) reactions and anaphylactoid reactions (similar to anaphylactic reactions, but less severe);
• fever, even very high;
• diabetes mellitus;
• nausea and vomiting;
• stomach and intestinal disorders, loss of appetite;
• allergic skin reactions (skin rashes);
• “serotonin syndrome” (see section “Warnings and precautions”), characterised by nausea, decreased blood pressure (hypotension), tremors, disturbances, convulsions and involuntary contractions and extensions of muscles (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity), nervous system disorders such as hyperactivity, fever, accelerated heartbeat (tachycardia), rapid breathing (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disorders (agitation, excitement, confusion), up to cardiac arrest and death.

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 DESTROTUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Keep the medicine in the original package to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What DESTROTUS contains
DESTROTUS 30 mg/10 ml syrup

• The active ingredient is dextromethorphan hydrobromide. Each 10 ml of syrup contains 30 mg of dextromethorphan hydrobromide. The other components are: sucrose, sodium benzoate and parabens (methyl paraben, ethyl paraben, propyl paraben (which may cause allergic reactions, even delayed), sodium hydroxide, propylene glycol, peppermint essential oil, citric acid, lemon aroma, purified water. (see the “Driving and using machines” section) Dextromethorphan hydrobromide syrup contains 4.0 mg of sodium benzoate per dose, equivalent to 0.67 mg/ml.

DESTROTUS 15 mg/ml oral drops, solution

• The active ingredient is dextromethorphan hydrobromide. Each ml of solution contains 15 mg of dextromethorphan hydrobromide. The other components are: ethanol (ethyl alcohol), peppermint essential oil, purified water. This medicine contains small amounts of ethanol (ethyl alcohol) less than 100 mg per dose. The container of this medicine is made of latex rubber, which may cause serious allergic reactions. (see the “Driving and using machines” section)

Description of the appearance of DESTROTUS and package contents
DESTROTUS 30 mg/10 ml syrup
Package containing a 150 ml glass bottle.

DESTROTUS 15 mg/ml oral drops, solution
Package containing a 20 ml glass bottle with dropper.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
AEFFE FARMACEUTICI Srl – Piazza Sant’Angelo 1- 20121 Milano
Manufacturers
AEFFE FARMACEUTICI Srl - via Torino 448 Brandizzo (TO)
Sales distributor
G.S.M. Srl – via Duca Degli Abruzzi, 166 Varese