BECHILAR 3 mg /Ml Syrup

Зміст інструкції

1. BECHILAR 3 mg/ml syrup
   1. What is Bechilar and what is it used for
   2. What you need to know before you take Bechilar
   3. How to take Bechilar
   4. Possible side effects
   5. How to store Bechilar
   6. Contents of the pack and other information
2. BECHILAR 3 mg/ml syrup
   1. What is Bechilar and what is it used for?
   2. What you need to know before you take Bechilar
   3. How to take Bechilar
   4. Possible side effects
   5. How to store Bechilar
   6. Contents of the pack and other information

BECHILAR 3 mg/ml syrup

Dextromethorphan bromhydrate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Bechilar and what is it used for

Bechilar syrup is indicated for the treatment of cough in adults.

2. What you need to know before you take Bechilar

Do not take Bechilar

• If you are allergic to Dextromethorphan bromohydrate or any of the other ingredients of this medicine listed in section 6.
• If you suffer from chronic (persistent) respiratory disorders.
• If you are already taking medicines belonging to the class of monoamine oxidase inhibitors (MAOIs), used for the treatment of depression and anxiety, or if you have stopped taking them less than two weeks ago (see Bechilar and other medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bechilar if:

• you suffer from or have suffered from asthma (a disease that causes narrowing and inflammation of the bronchi);
• you suffer from liver problems;
• you are taking medicines such as some antidepressants or antipsychotics (used to treat mental disorders), see “Other medicines and Bechilar”. Bechilar may interact with these medicines and changes in mental status may occur, e.g. agitation, hallucinations, coma (deep unconscious state) and other effects such as fever, tachycardia (increased heart rate), high blood pressure, muscle rigidity, lack of coordination, nausea, vomiting, diarrhea.
• the concomitant use of Bechilar with sedative medicines such as hypnotics (medicines that induce sleep), sedatives (calmants), anxiolytics (which reduce anxiety) increases the risk of drowsiness, difficulty breathing, coma and can be life-threatening. Tell your doctor about all sedative medicines you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends or family

so that they are aware of the signs and symptoms described above. If you experience these
symptoms contact your doctor.
Cases of dextromethorphan abuse have been reported.
If you have a tendency to abuse or become dependent on medicines, narcotics or alcohol, you should take
Bechilar for short periods and under strict medical supervision.
This medicine can lead to dependence. Therefore, treatment should be of short duration.

Do not use in children and adolescents.
Other medicines and Bechilar
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription.
Contact your doctor if you are being treated with:
medicines to treat depression, such as fluoxetine, paroxetine, sertraline and
bupropion (see “Do not take Bechilar” and “Warnings and precautions”);
medicines to treat mental disorders (haloperidol, thioridazine, perphenazine);
medicines that induce sleep (hypnotics);
calmants (sedatives);
medicines that reduce anxiety (anxiolytics).
The concomitant use of Bechilar and sedative or sleeping medicines (such as benzodiazepines)
increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be
life-threatening. For this reason, concomitant use should only be considered
if other treatment alternatives are not possible.
However, if your doctor prescribes Bechilar together with sedative medicines, the dose and duration of
concomitant treatment must be limited by the doctor. Tell your doctor about all sedative medicines
you are taking and carefully follow the recommendations on dosage. It may be helpful to
inform friends or family so that they are aware of the signs and symptoms described above.
Contact your doctor when these symptoms occur.
Tell your doctor if you are using:
medicines to treat severe pain or to reduce withdrawal symptoms in cases of narcotic
dependence (methadone);
medicines to treat heart rhythm disorders (amiodarone, quinidine, flecainide,
propafenone);
medicines to reduce the amount of calcium in the blood (cinacalcet);
medicines used for the treatment of fungal infections such as terbinafine.

Bechilar with alcohol
Avoid taking alcoholic beverages at the same time.
The concomitant use of Bechilar and alcohol can accentuate the undesirable effects of both.

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 use Bechilar during pregnancy and breastfeeding, unless in case of actual necessity and under
direct medical supervision.

Driving and using machines
Bechilar can cause drowsiness, therefore the ability to drive vehicles and use machines may be
reduced. Take particular care if you have to perform these activities.

Bechilar contains fructose
If your doctor has told you that you are intolerant to certain sugars, or if you have a diagnosis of hereditary
fructose intolerance, a rare genetic disease in which patients cannot break down
fructose, talk to your doctor before taking this medicine.

Bechilar contains methyl hydroxybenzoate and propyl hydroxybenzoate
May cause allergic reactions (including delayed reactions).

Bechilar contains sodium
This medicine contains 55.8 mg of sodium (the main component of table salt) per dose.
This is equivalent to 3% of the recommended maximum daily intake with the diet of an adult.

Bechilar contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially
“potassium-free”.

3. How to take Bechilar

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
Adults: The recommended dose is 30 mg (corresponding to 10 ml) up to 4 times a day, if necessary,
with an interval of at least 6 hours
The maximum daily dose is 120 mg. Do not exceed the maximum daily dose.
For oral use.
Use the measuring cup provided in the package.
Consult a doctor if after 5-7 days of continuous use you do not improve or if you notice a worsening.

Use in children and adolescents
Do not use in children and adolescents

If you take more Bechilar than you should
If you take more Bechilar than you should, the following symptoms may occur: nausea and vomiting,
involuntary muscle contractions, agitation, confusion, drowsiness, unresponsiveness in case
of stimulation to wake up, involuntary and rapid eye movements, heart disorders (fast
heartbeat), coordination disorders, psychosis (thought disorders) with visual hallucinations
(seeing things that do not exist) and hyperexcitability.
Other symptoms in case of massive overdose may be: coma (deep unconsciousness
state), severe breathing problems and convulsions (involuntary, sudden and uncontrolled
muscle movements) and gastrointestinal disorders.
Contact your doctor or hospital immediately if you experience any of the above symptoms.
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.
Side effects are rare. They may include:

Nervous system disorders:

• drowsiness;
• dizziness. Gastrointestinal disorders:
• gastrointestinal disturbances;
• nausea;
• vomiting;
• abdominal discomfort.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 to provide more information
about the safety of this medicine.

5. How to store Bechilar

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 label. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and 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 Bechilar contains

• The active ingredient is dextromethorphan hydrobromide. 100 ml of syrup contains 300 mg Dextromethorphan hydrobromide.
• The other ingredients are Fructose, Glycerol, Citric acid monohydrate, Sodium hydroxide, Cherry aroma, Potassium acesulfame, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Purified water.

Description of the appearance of Bechilar and contents of the pack
Syrup in a glass bottle of 100 ml with a polypropylene measuring cup.

Marketing Authorisation Holder
MONTEFARMACO OTC S.p.A.- Via IV Novembre, 92 - 20021 Bollate (MI)

Manufacturer
Istituto De Angeli Srl, Località Prulli , 50066 Reggello (FI)

BECHILAR 3 mg/ml syrup

Dextromethorphan bromhydrate

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

• Keep this leaflet. You may need to read it again.
• If you would like 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 worsen after 5-7 days.

Contents of this leaflet:

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

2. What is Bechilar and what is it used for?

Bechilar syrup is indicated for the treatment of cough in adults.

2. What you need to know before you take Bechilar

Do not take Bechilar

• If you are allergic to Dextromethorphan bromhydrate or any of the other ingredients of this medicine listed in section 6.
• If you suffer from chronic (persistent) respiratory disorders.
• If you are already taking medicines belonging to the class of monoamine oxidase inhibitors (MAOIs), used for the treatment of depression and anxiety, or if you have stopped taking them less than two weeks ago (see Bechilar and other medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bechilar if:

• You suffer from or have suffered from asthma (a disease that causes narrowing and inflammation of the bronchi);
• You suffer from liver problems
• You are taking medicines such as some antidepressants or antipsychotics (used to treat disorders of the mind), see “Other medicines and Bechilar”. Bechilar may interact with these medicines and changes in mental status may occur, e.g. agitation, hallucinations, coma (deep unconscious state) and other effects such as fever, tachycardia (increased heart rate), high blood pressure, muscle rigidity, lack of coordination, nausea, vomiting, diarrhea.
• The concomitant use of Bechilar with sedative medicines such as hypnotics (medicines that induce sleep), sedatives (calmants), anxiolytics (which reduce anxiety)

increases the risk of drowsiness, difficulty breathing, coma and can be life-threatening.
Inform your doctor of all sedative medicines you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends or family members so that they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.
Cases of dextromethorphan abuse have been reported.
If you have a tendency to abuse or become dependent on medicines, narcotics or alcohol, you should take Bechilar for short periods and under strict medical supervision.
This medicine can lead to dependence. Therefore, treatment should be of short duration.
Do not use in children and adolescents.

Other medicines and Bechilar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
Contact your doctor if you are being treated with:
medicines for treating depression, such as fluoxetine, paroxetine, sertraline and bupropion (see “Do not take Bechilar” and “Warnings and precautions”);
medicines for treating mental disorders (haloperidol, thioridazine, perphenazine);
medicines that induce sleep (hypnotics);
calmants (sedatives);
medicines that reduce anxiety (anxiolytics).
The concomitant use of Bechilar and sedative or sleeping medicines (e.g. benzodiazepines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered if other treatment alternatives are not possible.
However, if your doctor prescribes Bechilar together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor of all sedative medicines you are taking and carefully follow the recommendations on dosage. It may be helpful to inform friends or family members so that they are aware of the signs and symptoms described above.
Contact your doctor when these symptoms occur.
Tell your doctor if you are using:
medicines for treating severe pain or to reduce withdrawal symptoms in cases of narcotic dependence (methadone);
medicines for treating heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone);
medicines to reduce the amount of calcium in the blood (cinacalcet);
medicines used for the treatment of fungal infections such as terbinafine.

Bechilar with alcohol
Avoid the simultaneous consumption of alcoholic beverages.
The concomitant use of Bechilar and alcohol can accentuate the undesirable effects of both.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Bechilar during pregnancy and breastfeeding unless absolutely necessary and under direct medical supervision.

Driving and operating machinery
Bechilar can cause drowsiness, therefore your ability to drive vehicles and operate machinery may be reduced. Take particular care if you have to perform these activities.

Bechilar contains fructose
If your doctor has told you that you are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients are unable to metabolize fructose, talk to your doctor before taking this medicine.

Bechilar contains methyl hydroxy benzoate and propyl hydroxy benzoate
May cause allergic reactions (including delayed reactions).

Bechilar contains sodium
This medicine contains 55.8 mg of sodium (the main component of table salt) per dose.
This is equivalent to 3% of the recommended maximum daily intake of salt with the diet of an adult.

Bechilar contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium-free”.

4. How to take Bechilar

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

Adults
The recommended dose is 30 mg (corresponding to 10 ml) up to 4 times a day, if necessary, with
an interval of at least 6 hours. The maximum daily dose is 120 mg. Do not exceed the maximum
daily dose.
For oral use.
Use the measuring cup supplied with the pack.
Consult a doctor if you do not improve after 5-7 days of continuous use or if you notice a worsening.

Use in children and adolescents
Do not use in children and adolescents.

If you take more Bechilar than you should
If you take more Bechilar than you should, the following symptoms may occur: nausea and vomiting,
involuntary muscle contractions, agitation, confusion, drowsiness, unresponsiveness in case
of stimulation to wake up, involuntary and rapid eye movements, cardiac disorders (fast
heartbeat), coordination disorders, psychosis (thought disorders) with visual hallucinations
(seeing things that do not exist) and hyperexcitability.
Other symptoms in case of massive overdose may be: coma (deep unconsciousness
state), severe breathing problems and convulsions (sudden, abrupt and uncontrollable
muscle movements) and gastrointestinal disorders.
Seek medical attention or go to the hospital immediately if you experience any of the above symptoms.
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.
Side effects are rare. They may include:

Nervous system disorders:

• drowsiness;
• dizziness. Gastrointestinal disorders:
• gastrointestinal disturbances;
• nausea;
• vomiting;
• abdominal discomfort.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 Bechilar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and 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 Bechilar contains

• The active ingredient is dextromethorphan hydrobromide. 100 ml of syrup contains 300 mg Dextromethorphan hydrobromide.
• The other ingredients are Fructose, Glycerol, Citric acid monohydrate, Sodium hydroxide, Amarena flavour, Acesulfame potassium, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Purified water.

Description of the appearance of Bechilar and contents of the pack
Syrup in a glass bottle of 95 ml with a polypropylene measuring cup.

Marketing Authorisation Holder
MONTEFARMACO OTC S.p.A.- Via IV Novembre, 92 - 20021 Bollate (MI)

Manufacturer
Istituto De Angeli Srl, Località Prulli , 50066 Reggello (FI)