Destrotus

Italy
Brand name Destrotus
Form syrup
Active substance / Dosage
Dextromethorphan Hydrobromide
Prescription type Non-prescription – not available over the counter
ATC code
R05DA09
Registration number 029902
Manufacturer AEFFE FARMACEUTICI SRL

Table of Contents

Patient Information Leaflet

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

Dextromethorphan bromide

Please read all of 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 to do.

  • 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, 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 DESTROTUS is and what it is 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. Contents of the pack and other information

1. What DESTROTUS is and what it is used for

DESTROTUS contains the active substance dextromethorphan, which belongs to the group of medicines used 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 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 disorders (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 circulatory or 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 stomach, intestinal, or urinary tract disorders (such as gastrointestinal or genitourinary stenosis causing pathological narrowing of the lumen 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 to treat depression (MAO inhibitor antidepressants);
  • if less than two weeks have passed since stopping antidepressant medicines (see section “Other medicines and DESTROTUS”);
  • if you are in the first trimester of pregnancy;
  • if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking DESTROTUS.
The duration of treatment with this medicine should not exceed 5–7 days.
The use of DESTROTUS, especially for prolonged treatment, may lead to reduced effectiveness and the need to continue using the medicine (habituation, tolerance, mental and physical dependence). Therefore, short-term treatment under strict medical supervision is recommended, especially if you are predisposed to such conditions.
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 disorders (asthma). If you have a persistent cough, stop treatment and consult your doctor, as it may be a symptom of respiratory disorders (e.g. asthma).
Do not take this medicine if your cough is accompanied by abundant mucus. If your cough causes pain and discomfort (irritating cough) and is associated with mucus, consult your doctor, who will carefully assess whether treatment with this medicine is necessary. If your doctor considers treatment essential, you must be closely monitored during therapy.
Take this medicine with caution and only on medical advice if you also experience fever, skin rash, headache, nausea, or vomiting.
You may start treatment with DESTROTUS only after careful evaluation by your doctor and under close medical supervision if:

  • you suffer from circulatory or 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 stomach, intestinal, or urinary tract disorders (gastrointestinal or genitourinary stenosis);
  • you suffer from epilepsy;
  • you have severe liver disease;
  • you are taking medicines used to treat depression (MAO inhibitor antidepressants); at least two weeks must have passed since stopping antidepressant medicines before taking DESTROTUS. In all the above situations, taking this medicine is not recommended and should be reserved only for cases of absolute necessity (see section “Do not take DESTROTUS”).

For those engaged in sports, the use of DESTROTUS 15 mg/ml oral drops, solution containing ethanol (ethyl alcohol), may result in a positive doping test, depending on the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and DESTROTUS
Inform 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 to treat depression (MAO inhibitor antidepressants); at least two weeks must have passed since stopping antidepressant medicines before taking DESTROTUS.
In particular, inform 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 dependence (methadone);
  • medicines to treat psychiatric disorders (haloperidol, thioridazine, perphenazine);
  • medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
  • medicines to treat cardiac arrhythmias (flecainide);
  • medicines to reduce calcium levels in the blood and treat dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet;
  • medicines used to prevent fungal growth (terbinafine);
  • medicines used to treat insomnia and anxiety (hypnotics, sedatives, and anxiolytics);
  • cimetidine, a medicine used to treat stomach disorders due to high acidity;
  • ritonavir, a medicine used to treat AIDS;
  • medicines used to help clear mucus (secretolytic agents);
  • antidepressant medicines (MAO inhibitor antidepressants);
  • linezolid, a medicine used to treat bacterial infections;
  • sibutramine, a medicine used to treat obesity.

MAO inhibitor antidepressants, linezolid, and sibutramine, when taken together with DESTROTUS, may cause a condition that can be fatal, called "serotonin syndrome," whose symptoms include:

  • nausea;
  • low blood pressure (hypotension);
  • tremors, disturbances, seizures, and involuntary muscle contractions and relaxations (clonic spasms, myoclonus, increased reflex response, and pyramidal tract rigidity);
  • disturbances of the nervous system such as hyperactivity, fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis);
  • excessive sweating (diaphoresis);
  • mental disturbances (agitation, excitement, confusion);
  • heart block (cardiac arrest) and death.

Concomitant use of DESTROTUS and sedative medicines such as benzodiazepines or related substances 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 sedative medicines while you are using DESTROTUS, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if such symptoms occur.
DESTROTUS with food and alcohol
Avoid consuming grapefruit juice during treatment with this medicine, as it may increase toxic effects and reduce the medicine’s effectiveness.
Avoid consuming alcohol during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the first three months of pregnancy.
After the third month of pregnancy, you may take this medicine only if absolutely necessary and under strict medical supervision, as breathing problems in the newborn (respiratory depression) may occur, especially at high doses and even after short treatment periods.
Do not take this medicine while breastfeeding, as respiratory depression in the newborn cannot be ruled out. DESTROTUS is not indicated during breastfeeding.
Driving and using machines
DESTROTUS may impair your ability to drive or operate machinery, as it may cause drowsiness, especially if you consume alcohol at the same time (see section “DESTROTUS with food and alcohol”).
DESTROTUS 30 mg/10 ml syrup contains sucrose and parahydroxybenzoates
This medicine contains sucrose, a type of sugar. If you have been diagnosed with diabetes, sugar intolerance, or are on a weight-reducing diet, contact your doctor before taking this medicine.
This medicine contains antimicrobial preservatives such as sodium benzoate and parahydroxybenzoates (methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate), which may cause allergic reactions, including 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 engaged in sports, the use of medicines containing ethyl alcohol may result in a positive doping test, depending on the blood alcohol concentration limits set by certain sports federations.
The container of this medicine contains latex rubber, which may cause severe allergic reactions.

3. How to take DESTROTUS

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

DESTROTUS 30 mg/10 ml syrup
To open the bottle, press down and unscrew at the same time.
In adults and adolescents (from 12 to 18 years of age), the recommended dose ranges from 10 mg of dextromethorphan (an amount equal to one teaspoon of syrup, corresponding to approximately 3 ml) to 20 mg of dextromethorphan (equal to two teaspoons of syrup, corresponding 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 the cap tightly while pressing down.

DESTROTUS 15 mg/ml oral drops, solution
To open the dropper bottle, press down and unscrew simultaneously.
In adults and adolescents (from 12 to 18 years of age), the recommended dose ranges from 10 mg of dextromethorphan (approximately 14 drops) to 20 mg (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 problems (ataxia);
  • dizziness;
  • excitement, mental confusion;
  • muscle disorders (increased muscle tone);
  • decreased blood pressure (hypotension);
  • increased heart rate (tachycardia);
  • reduced urine output and breathing difficulties (respiratory depression) in more severe cases.

If you have taken an excessive amount of this medicine, contact 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 the missed dose.

If you stop taking DESTROTUS
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 gets them.
The frequency of side effects is not known (i.e. cannot be estimated from the available data). Individual side effects are listed below:

  • drowsiness, fatigue;
  • involuntary and rapid eye movements (nystagmus);
  • movement difficulties (dystonia);
  • dizziness;
  • mental confusion and behavioural changes (foul language);
  • mental disorders (psychosis), hallucinations;
  • need to continue taking the medicine (psychic dependence);
  • severe allergic reactions (anaphylactic) 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;
  • skin allergic reactions (rashes);
  • "serotonin syndrome" (see section “Warnings and precautions”), characterised by nausea, decreased blood pressure (hypotension), tremors, disturbances, seizures, and involuntary contractions and relaxations of muscles (clonic spasms, myoclonus, increased reflex response and pyramidal origin rigidity), nervous system disorders such as hyperactivity, fever, increased heart rate (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disorders (agitation, excitement, confusion), up to cardiac arrest and death.

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
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 stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store the medicine in the original packaging to protect it from light.
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. Contents of the pack and other information

What DESTROTUS contains
DESTROTUS 30 mg/10 ml syrup

  • The active substance is brompheniramine hydrobromide. Each 10 ml of syrup contains 30 mg of brompheniramine hydrobromide. The other components are: sucrose, sodium benzoate and parahydroxybenzoates (methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate (which may cause allergic reactions, including delayed reactions)), sodium hydroxide, propylene glycol, peppermint essential oil, citric acid, cedar flavour, purified water. (see section “Driving and use of machines”) Brompheniramine 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 substance is brompheniramine hydrobromide. Each ml of solution contains 15 mg of brompheniramine hydrobromide. The other components are: ethanol (ethyl alcohol), peppermint essential oil, purified water. This medicinal product contains small amounts of ethanol (ethyl alcohol), less than 100 mg per dose. The container of this medicinal product is made of latex rubber, which may cause severe allergic reactions. (see section “Driving and use of machines”)

Description of the appearance of DESTROTUS and contents of the pack
DESTROTUS 30 mg/10 ml syrup
Pack containing one 150 ml glass bottle.
DESTROTUS 15 mg/ml oral drops, solution
Pack containing one 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)
Marketing Authorisation Holder
G.S.M. Srl – via Duca Degli Abruzzi, 166 Varese