BECHILAR

Package leaflet: Information for the user

BECHILAR 3 mg/ml syrup

Dextromethorphan hydrobromide
Please read this leaflet carefully before you start using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to 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 using 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 Bechilar is and what it is used for

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

2. What you need to know before taking Bechilar

Do not take Bechilar

• If you are allergic to dextromethorphan hydrobromide or to any of the other ingredients of this medicine listed in section 6.
• If you suffer from chronic (persistent) respiratory disorders.
• If you are currently taking medicines belonging to the class of monoamine oxidase inhibitors (MAOIs), used to treat depression and anxiety, or if you have discontinued 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 have or have had asthma (a condition causing narrowing and inflammation of the bronchi);
• You have liver problems;
• You are taking medicines such as certain antidepressants or antipsychotics (used to treat mental disorders), see "Other medicines and Bechilar". Bechilar may interact with these medicines and cause changes in mental status, e.g. agitation, hallucinations, coma (a state of deep unconsciousness), and other effects such as fever, tachycardia (increased heart rate), high blood pressure, muscle rigidity, lack of coordination, nausea, vomiting, diarrhea.
• Concomitant use of Bechilar with sedative medicines such as hypnotics (medicines that induce sleep), sedatives (calming agents), anxiolytics (which reduce anxiety) increases the risk of drowsiness, breathing difficulties, coma, and may be life-threatening. Inform your doctor about all sedative medicines you are taking and carefully follow their recommendations regarding dosage. It may be helpful to inform friends or family members so 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, drugs, or alcohol, you should take Bechilar only for short periods and under strict medical supervision.
• This medicine may lead to dependence. Therefore, treatment should be short-term. Do not use in children and adolescents.

Other medicines and Bechilar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Contact your doctor if you are being treated with:

• Medicines for depression, such as fluoxetine, paroxetine, sertraline, and bupropion (see "Do not take Bechilar" and "Warnings and precautions");
• Medicines for mental disorders (haloperidol, thioridazine, perphenazine);
• Medicines that induce sleep (hypnotics);
• Calming agents (sedatives);
• Medicines that reduce anxiety (anxiolytics).

Concomitant use of Bechilar and sedative or sleep medicines (e.g., benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if no other treatment alternatives are available.

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 about all sedative medicines you are taking and carefully follow dosage recommendations. It may be helpful to inform friends or family members so they are aware of the above-described signs and symptoms. Contact your doctor if such symptoms occur.

Inform your doctor if you are using:

• Medicines for severe pain or to reduce withdrawal symptoms in cases of drug dependence (methadone);
• Medicines for heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone);
• Medicines to reduce blood calcium levels (cinacalcet);
• Medicines used to treat fungal infections (mycoses) such as terbinafine.

Bechilar and alcohol
Avoid consuming alcoholic beverages while taking this medicine.
Concomitant use of Bechilar and alcohol may intensify the adverse effects of both.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Bechilar during pregnancy and breastfeeding unless strictly necessary and under direct medical supervision.

Driving and using machines
Bechilar may cause drowsiness; therefore, your ability to drive or operate machinery may be impaired. Exercise particular caution if you need to perform such activities.

Bechilar contains fructose
If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.

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

Bechilar contains sodium
This medicine contains 55.8 mg of sodium (a component of common table salt) per dose. This corresponds to 3% of the maximum daily recommended dietary intake for an adult.

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

3. How to take Bechilar

Use this medicine exactly 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 only.
Use the dosing cup provided with the package.
Consult a doctor if symptoms do not improve after 5-7 days of continuous use, or if they worsen.
Use in children and adolescents
Do not use in children and adolescents.
If you take more Bechilar than you should
If Bechilar is taken in excess, the following symptoms may occur: nausea and vomiting,
involuntary muscle contractions, agitation, confusion, drowsiness, unresponsiveness to stimuli
for waking, involuntary and rapid eye movements, cardiac disorders (accelerated heartbeat),
coordination disturbances, psychosis (thought disturbances) with visual hallucinations (seeing
things that do not exist), and hyperexcitability.
Additional symptoms in case of massive overdose may include: coma (deep unconscious state),
severe respiratory problems, seizures (involuntary, sudden and uncontrollable muscle movements),
and gastrointestinal disturbances.
Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.
If you have any doubts 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 gets them.
Side effects are rare. The following may occur:
Nervous system disorders:

• somnolence;
• dizziness.

Gastrointestinal disorders:

• gastrointestinal disorders;
• nausea;
• vomiting;
• abdominal discomfort.

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 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 stated on the label. The expiry date refers to the last day of that month.
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 Bechilar contains

• The active substance is brompheniramine maleate. 100 ml of syrup contain Brompheniramine maleate 300 mg.
• The other ingredients are Fructose, Glycerol, Citric acid monohydrate, Sodium hydroxide, Black cherry 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 100 ml amber glass bottle with a polypropylene dosing cup.
Marketing Authorization Holder
MONTEFARMACO OTC S.p.A. - Via IV Novembre, 92 - 20021 Bollate (MI)
Manufacturer
Istituto De Angeli Srl, Località Prulli, 50066 Reggello (FI)

Package leaflet: information for the user

BECHILAR 3 mg/ml syrup

Dextromethorphan hydrobromide
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any of the side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 Bechilar is and what it is used for

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

2. What you should know before taking Bechilar

Do not take Bechilar

• If you are allergic to dextromethorphan hydrobromide or to 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 to treat depression and anxiety, or if you have discontinued 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 or have suffered from asthma (a condition causing narrowing and inflammation of the bronchi);
• You have liver problems;
• You are taking medicines such as certain antidepressants or antipsychotics (used to treat mental disorders); see "Other medicines and Bechilar". Bechilar may interact with these medicines and may cause changes in mental status, e.g. agitation, hallucinations, coma (a state of deep unconsciousness), and other effects such as fever, tachycardia (increased heart rate), high blood pressure, muscle rigidity, lack of coordination, nausea, vomiting, diarrhoea.
• The concomitant use of Bechilar with sedative medicines such as hypnotics (medicines that induce sleep), sedatives (calming agents), anxiolytics (medicines that reduce anxiety)

increases the risk of drowsiness, breathing difficulties, coma and may be life-threatening.
Inform your doctor about all sedative medicines you are taking and carefully follow
his/her dosage recommendations. 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, drugs or alcohol, you should take
Bechilar only for short periods and under strict medical supervision.
This medicine may lead to dependence. Therefore, treatment should be short-term.
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 not requiring a prescription.

Contact your doctor if you are being treated with:
medicines for depression, such as fluoxetine, paroxetine, sertraline and
bupropion (see "Do not take Bechilar" and "Warnings and precautions");
medicines for mental disorders (haloperidol, thioridazine, perphenazine);
medicines that induce sleep (hypnotics);
calming agents (sedatives);
medicines that reduce anxiety (anxiolytics).

The concomitant use of Bechilar and sedative or sleep medicines (e.g. benzodiazepines)
increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be
life-threatening. For this reason, concomitant use should only be considered if no other treatment alternatives are 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 about all sedative medicines you are taking and carefully follow the dosage recommendations. 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 if you experience such symptoms.

Inform your doctor if you are taking:
medicines for severe pain or to reduce withdrawal symptoms in cases of drug dependence (methadone);
medicines for heart rhythm disorders (amiodarone, quinidine, flecainide,
propafenone);
medicines to reduce blood calcium levels (cinacalcet);
medicines used to treat fungal infections (mycoses) such as terbinafine.

Bechilar and alcohol
Avoid consuming alcoholic beverages while taking this medicine.
The concomitant use of Bechilar and alcohol may intensify the adverse effects of both.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Bechilar during pregnancy or breastfeeding unless clearly necessary and under direct medical supervision.

Driving and using machines
Bechilar may cause drowsiness; therefore, your ability to drive or operate machinery may be impaired. Exercise particular caution if you need to perform such activities.

Bechilar contains fructose
If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.

Bechilar contains methyl and propyl hydroxybenzoates
These may cause allergic reactions (including delayed reactions).

Bechilar contains sodium
This medicine contains 55.8 mg of sodium (a main component of table salt) per dose.
This corresponds to 3% of the maximum daily recommended dietary intake for an adult.

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

4. How to take Bechilar

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. 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 daily, 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 dosing cup supplied with the pack.
Consult a doctor if symptoms do not improve after 5-7 days of continuous use or if they worsen.
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 recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, unresponsiveness to stimuli for waking, involuntary and rapid eye movements, heart disorders (fast heartbeat), coordination problems, psychosis (thought disturbances) with visual hallucinations (seeing things that are not real) and hyperexcitability.
Additional symptoms in case of massive overdose may include: coma (deep unconsciousness), severe breathing problems, seizures (involuntary, sudden and uncontrolled muscle movements), and gastrointestinal disturbances.
Seek immediate medical advice or go to hospital if any of the above symptoms occur.
If you have any doubts 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 everyone experiences them.
Side effects are rare. The following may occur:
Nervous system disorders:

• somnolence;
• dizziness.

Gastrointestinal disorders:

• gastrointestinal disturbances;
• nausea;
• vomiting;
• abdominal discomfort.

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 Bechilar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bechilar contains

• The active substance is dextromethorphan hydrobromide. 100 ml of syrup contain dextromethorphan hydrobromide 300 mg.
• The other components are fructose, glycerol, citric acid monohydrate, sodium hydroxide, black cherry flavour, acesulfame potassium, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of Bechilar and package contents
Syrup in a 95 ml glass bottle with a polypropylene dosing cup.
Marketing Authorization Holder
MONTEFARMACO OTC S.p.A. - Via IV Novembre, 92 - 20021 Bollate (MI)
Manufacturer
Istituto De Angeli Srl, Località Prulli, 50066 Reggello (FI)