PARLATOS 2.6 mg/ml ORAL SOLUTION

Introduction

Prospectus

Parlatos 2.6 mg/ml oral solution

Dextromethorphan hydrobromide

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment, or if the cough is accompanied by high fever, skin rashes, or persistent headache.

Contents of the prospectus

1. What Parlatos is and what it is used for
2. What you need to know before starting to take Parlatos
3. How to take Parlatos
4. Possible adverse effects

5 Conservation of Parlatos

1. Contents of the package and additional information

1. What Parlatos is and what it is used for

Dextromethorphan, the active ingredient of this medication, is a cough suppressant that inhibits the cough reflex.

It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritative cough, nervous cough) in adults and children from 2 years of age.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before starting to take Parlatos

Do not takeParlatos

• If you are allergic to dextromethorphan or any of the other components of this medication (included in section 6).

• In case of persistent or chronic cough, such as that due to tobacco, asthma, or chronic obstructive pulmonary disease (COPD), or when the cough is accompanied by abundant secretions.
• Children under 2 years of age.
• If you have bronchial asthma.
• If you have chronic obstructive pulmonary disease (COPD).
• If you have pneumonia.
• If you have respiratory failure.
• If you have respiratory depression.
• If you are breastfeeding.
• If you have a cough accompanied by abundant secretions (for example, in patients with diseases such as bronchiectasis (a lung disease where the bronchi are dilated and with pus) or cystic fibrosis).
• If you are being treated or have been treated during the previous 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication (see section on other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Parlatos:

• If you have persistent or chronic cough, such as that due to tobacco. Especially in children, chronic cough could be an early symptom of asthma.
• If you are taking serotonergic medications (different from MAOIs) such as tricyclic antidepressants (see section on other medications and Parlatos).
• In patients with neurological diseases associated with a notably reduced cough reflex (such as stroke, Parkinson's disease, and dementia), treatment with Parlatos should be administered with special caution and only after carefully evaluating the benefit-risk ratio (see section on other medications and Parlatos).
• If you have liver or kidney disease.
• If you have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition) and/or mastocytosis (an increase in mast cells in the blood).
• If you are sedated, debilitated, or bedridden.
• Dextromethorphan has a mild addictive potential. Prolonged use (for example, if the recommended time period is exceeded) may produce tolerance or mental and physical dependence. People with a tendency to abuse or dependence should only take it under strict medical control and for short periods of time.
• If you have respiratory failure
• If you have a cough accompanied by expectoration

Patients with liver diseases should consult their doctor before using this medication.

There have been reports of abuse with medications containing dextromethorphan in adolescents; therefore, this possibility should be taken into account, as serious adverse effects may occur (see section "If you take more Parlatos than you should").

This medication may cause dependence. Therefore, treatment should be short-term.

Consult your doctor or pharmacist or nurse before taking Parlatos:

• If you are taking other medications such as antidepressants or antipsychotics, Parlatos may interact with these medications, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Pediatric population

Severe adverse effects may occur in children in case of overdose, including neurological alterations. Caregivers should not exceed the recommended dose.

Do not administer to children under 2 years of age.

Other medications and Parlatos

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. Do not take this medication during treatment or in the 2 weeks following treatment with the following medications, as excitement, high blood pressure, and fever above 40°C (hyperpyrexia) may occur:

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranilcipromine).
• Serotonin reuptake inhibitor antidepressants (such as fluoxetine or paroxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial medication).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).
• Terbinafine (used as an antifungal medication).

Before taking this medication, you should consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Medications to treat heart arrhythmias, such as amiodarone, quinidine, flecainide, and propafenone.
• Anti-inflammatory medications, such as celecoxib, parecoxib, or valdecoxib.
• Central nervous system depressant medications used to treat mental illnesses, allergies, or Parkinson's disease.
• Medications used to eliminate phlegm and mucus, expectorants, and mucolytics, especially if you have a chest disease such as bronchiectasis (a lung disease where the bronchi are dilated and with pus) or cystic fibrosis.
• Medications for the treatment of psychosis (states of mind in which there is a loss of contact with reality), such as haloperidol and thioridazine.
• Medications for the treatment of HIV, such as ritonavir.
• Plant-based medications, such as berberine.
• Medications for the treatment of hyperparathyroidism, such as cinacalcet.
• Antifungal medications, such as terbinafine.
• Medications for the treatment of stomach acidity, such as cimetidine.

Taking Parlatos with food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment, as they may increase the occurrence of adverse effects.

Do not take with grapefruit or bitter orange juice, as they may increase the adverse effects of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication. Women who are breastfeeding should not take this medication without consulting their doctor.

Women who are pregnant should not take this medication without consulting their doctor.

Driving and using machines

On rare occasions, during treatment, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

Parlatos contains sucrose, cochineal red A (E-124), and sodium

This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains cochineal red A. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 1 mmol of sodium (23 mg) per ml; that is, it is essentially "sodium-free".

3. How to take Parlatos

Follow the administration instructions for the medication indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years of age: take 4 to 7 ml (equivalent to 10.4 mg - 19.5 mg of dextromethorphan hydrobromide), depending on the intensity of the cough, every 4-6 hours.

Do not exceed 6 daily doses.

The maximum amount that can be taken in 24 hours is 45 ml, divided into several doses.

Use in children

Children between 6-11 years of age: take 2 to 3.5 ml (equivalent to 5.2 mg - 9.1 mg of dextromethorphan hydrobromide), depending on the intensity of the cough, every 4-6 hours.

Do not exceed 6 daily doses.

The maximum amount that can be taken in 24 hours is 21 ml, divided into several doses.

Children between 2-5 years of age: take 1 to 1.5 ml (equivalent to 2.6 mg - 3.9 mg of dextromethorphan hydrobromide), depending on the intensity of the cough, every 4-6 hours.

Do not exceed 6 daily doses.

The maximum amount that can be taken in 24 hours is 9 ml, divided into several doses.

Children under 2 years of age:

This medication is contraindicated in children under 2 years of age.

How to take:

The medication is taken orally. Take the corresponding amount of oral solution, according to the recommended dose, measured with the help of the syringe included.

Do not exceed the recommended dose.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section "Taking Parlatos with food, drinks, and alcohol").

If it worsens or if the cough persists for more than 7 days of treatment, or if it is accompanied by high fever, skin rashes, or persistent headache, consult your doctor.

If you take more Parlatos than you should

If you take more Parlatos than recommended, you may especially notice in children and adolescents or in case of abuse: nausea, vomiting, gastrointestinal discomfort, dizziness, fatigue, drowsiness, and hallucinations.

Similarly, restlessness and excitability can transform into agitation with increased overdose. Additionally, symptoms such as decreased concentration and consciousness up to coma as a symptom of severe intoxication, changes in mood such as dysphoria and euphoria, psychotic disorders such as disorientation and delirium up to confused or paranoid states, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (involuntary and uncontrolled eye movement), and visual disturbances, as well as respiratory depression, changes in blood pressure (high or low blood pressure), and tachycardia (accelerated heart rate) may occur.

Dextromethorphan may increase the risk of serotonin syndrome, and this risk is increased in cases of overdose, especially if taken with other serotonergic agents.

If you take more Parlatos than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, consciousness disorders, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

In cases of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Parlatos

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication may cause adverse effects, although not all people experience them.

Frequent adverse effects: may affect up to one in ten patients.

• Dizziness
• Nausea
• Vomiting
• Gastrointestinal discomfort
• Fatigue

Very rare adverse effects: may affect up to one in ten thousand patients.

• Hallucinations
• Drowsiness
• Dependence in people who have abused dextromethorphan.

Adverse effects with unknown frequency (cannot be estimated from available data).

• Hypersensitivity reactions, including anaphylactic reactions, angioedema, urticaria, pruritus, rash, and erythema.
• Fixed drug eruption (FDE)
• Mental confusion, headache, constipation.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Parlatos

Keep this medication out of the sight and reach of children.

Do not freeze

Do not use Parlatos after the expiration date that appears on the packaging after CAD:. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

6. Contents of the package and additional information

Composition of Parlatos

The active ingredient is dextromethorphan hydrobromide. Each ml of oral solution contains 2.6 mg of dextromethorphan hydrobromide.

The other components (excipients) are:

Sucrose, sodium saccharin, sodium hydroxide, sorbic acid (E-200), disodium edetate, peppermint essence, cochineal red A (E-124), and water.

Appearance of the product and contents of the package

Bottle with 200 ml of oral solution. Each package is provided with a dosing syringe with a scale of 0.5 ml to 5 ml

Marketing authorization holder and manufacturer

Marketing authorization holder:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

Manufacturer:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the last revision of this prospectus:June 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/