Patient Information Leaflet

NIROLEX COUGH DRY 30 mg/10 ml syrup

Dextromethorphan hydrobromide
Please read all of this leaflet carefully before you start 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, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

What NIROLEX COUGH DRY is and what it is used for
What you need to know before taking NIROLEX COUGH DRY
How to take NIROLEX COUGH DRY
Possible side effects
How to store NIROLEX COUGH DRY
Contents of the pack and other information

1. What NIROLEX TOSSE SECCA is and what it is used for

NIROLEX TOSSE SECCA contains the active substance destromethorphan hydrobromide, which belongs to
the group of medicines used to suppress cough.
NIROLEX TOSSE SECCA is indicated in adults and adolescents from 12 years of age onwards, for the treatment of
symptoms of dry cough.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before taking NIROLEX TOSSE SECCA

Do not take NIROLEX TOSSE SECCA

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 (glaucoma);
if you have prostate problems (prostatic hypertrophy);
if you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary tract stenosis);
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); at least two weeks must have passed since stopping such antidepressants before taking NIROLEX TOSSE SECCA (see section “Other medicines and NIROLEX TOSSE SECCA”);
if you are in the first trimester of pregnancy or are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking NIROLEX TOSSE SECCA.
The duration of treatment with this medicine should not exceed 5–7 days.
The use of NIROLEX TOSSE SECCA, especially for prolonged treatment, may lead to reduced effectiveness and the need to continue using the medicine (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 certain 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 evaluate whether treatment with this medicine is necessary. If your doctor considers treatment essential, you must be closely monitored during therapy.
Use this medicine with caution if you experience fever, skin irritation (rash), headache, nausea, or vomiting.
This medicine may lead to dependence. Therefore, treatment should be short-term.
You may start treatment with NIROLEX TOSSE SECCA only after careful evaluation by your doctor and under strict 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 (glaucoma);
you have prostate problems (prostatic hypertrophy);
you suffer from stomach, intestinal or urinary tract disorders (gastrointestinal and genitourinary tract 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 such antidepressants before taking NIROLEX TOSSE SECCA.
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 NIROLEX TOSSE SECCA”).

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and NIROLEX TOSSE SECCA
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 antidepressants (MAO inhibitors); at least two weeks must have passed since stopping such antidepressants before taking NIROLEX TOSSE SECCA.
Talk to your doctor or pharmacist before taking NIROLEX TOSSE SECCA:

if you are taking medicines such as certain antidepressants or antipsychotics: NIROLEX TOSSE SECCA may interact with these medicines, leading to changes in mental state (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).

Pay particular attention and consult your doctor if you are taking:

antidepressant medicines (MAO inhibitors);
linezolid, a medicine used to treat bacterial infections;
sibutramine, a medicine used to treat obesity.

If taken together with NIROLEX TOSSE SECCA, these medicines may cause a potentially fatal condition called serotonin syndrome, whose symptoms include:

nausea;
low blood pressure;
tremors and muscle disorders (clonus, myoclonus, increased reflex response and pyramidal-origin rigidity);
nervous system disorders (autonomic nervous system hyperactivity), fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), dilation of the black part of the eye (mydriasis);
mental disorders (agitation, excitement, confusion);
heart block (cardiac arrest) and death.

In particular, inform your doctor if you are taking or have recently taken:

medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section 2 “Do not take NIROLEX TOSSE SECCA”);
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 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 facilitate mucus elimination (secretolytic medicines).

Concomitant use of NIROLEX TOSSE SECCA 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 be considered only when no other treatment options are available.
However, if your doctor prescribes NIROLEX TOSSE SECCA together with sedative medicines, 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 you experience any of these symptoms.
NIROLEX TOSSE SECCA with food and alcohol
Avoid consuming grapefruit juice during treatment with this medicine, as it may increase toxic effects or reduce efficacy.
Avoid consuming alcohol during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or 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 in cases of absolute necessity 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.
Driving and using machines
NIROLEX TOSSE SECCA 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 “NIROLEX TOSSE SECCA with food and alcohol”).
NIROLEX TOSSE SECCA contains sucrose, sodium benzoate (E 211) and sodium
This medicine contains 5.5 g of sucrose per 10 ml. This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 4.5 mg of sodium benzoate per minimum dose of 10 mg (equivalent to 3 ml) and 36 mg per maximum daily dose of 80 mg (equivalent to 24 ml).
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose of 80 mg (equivalent to 24 ml), i.e. essentially 'sodium-free'.

3. How to take NIROLEX TOSSE SECCA

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.
In adults and adolescents (12 to 18 years of age), the recommended dose ranges from 10 mg (one teaspoonful, equivalent to approximately 3 ml) to 20 mg (two teaspoonfuls, equivalent to 6 ml) every 6 hours.
The maximum recommended daily dose is 80 mg.
If you take more NIROLEX TOSSE SECCA than you should
If you take more NIROLEX TOSSE SECCA than recommended, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, cardiac disorders (accelerated heartbeat), coordination disturbances, psychosis with visual hallucinations and hyperexcitability, dizziness, excitement, muscle disorders (increased muscle tone), low blood pressure (hypotension), reduced urine output, and breathing problems (respiratory depression) in the most severe cases.
Additional symptoms in case of massive overdose may include: coma, severe breathing problems, and seizures.
Seek immediate medical attention from your doctor or go to the hospital if any of the symptoms listed above occur.
If you forget to take NIROLEX TOSSE SECCA
Do not take a double dose to make up for the missed dose.
If you have any questions 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 everybody will experience them.
Not known (frequency cannot be established from the available data)

drowsiness, fatigue;
involuntary and rapid eye movements (nystagmus);
movement difficulties (dystonia);
dizziness;
mental confusion and behavioural changes (foul language);
serotonin syndrome (see section “Warnings and precautions”), characterised by nausea, decreased blood pressure, tremors and muscle disorders (clonus, myoclonus, increased reflex response and pyramidal rigidity), nervous system disturbances (autonomic nervous system hyperactivity), fever, increased heart rate (tachycardia), shortness of breath (tachypnea), dilation of the black part of the eye (midriasis), disturbances of the mind (agitation, excitement, confusion), heart block (cardiac arrest) and death;
mental disorders (psychosis), hallucinations;
need to continue taking the medicine (psychic dependence);
severe allergic reactions (anaphylaxis);
fever;
diabetes mellitus;
nausea and vomiting;
stomach and intestinal disorders, decreased appetite;
allergic skin reactions (skin rashes).

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 NIROLEX TOSSE SECCA

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, tightly closed, away from sources of heat, in the original packaging to protect 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. Package contents and other information

What NIROLEX COUGH DRY contains
NIROLEX COUGH DRY

The active substance is dextromethorphan hydrobromide. 10 ml of syrup contain 30 mg of dextromethorphan hydrobromide.
The other ingredients are sucrose, glycerol, sodium benzoate (E 211), citric acid, sodium citrate, purified water.

Description of the appearance of NIROLEX COUGH DRY and the contents of the pack
Pack containing one 150 ml bottle.
Marketing Authorization Holder
Almus Srl - Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]
Manufacturer
Laboratorio Chimico Farmaceutico A. Sella Srl - Via Vicenza, 67 - 36015 Schio (VI)