Leaflet: information for the user

Parlatos 2.6 mg/ml oral solution

Dextromethorphan hydrobromide

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment, or if your cough is accompanied by high fever, skin eruptions, or persistent headache.

1.What Parlatos is and for what it is used

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

3.How to take Parlatos

4.Possible side effects

5Storage of Parlatos

6.Contents of the pack and additional information

The dextromethorphan, active principle of this medication, is an antitussive that inhibits the cough reflex.

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

Consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not takeParlatos

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

- In case of persistent or chronic cough, such as that due to smoking, asthma, or emphysema, or when the cough is accompanied by abundant secretions.

- Children under 2 years old.

- If you have bronchial asthma.

- If you have chronic obstructive pulmonary disease (COPD).

- If you have pneumonia.

- If you have respiratory insufficiency.

- 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 disease where the bronchi are dilated and filled with pus) or cystic fibrosis).

- If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used for the treatment of 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 smoking. Especially in children, chronic cough may be an early symptom of asthma.
• If you are taking serotoninergic medications (other than MAOIs) such as tricyclic antidepressants (see section on Other medications and Parlatos).
• In patients with neurological diseases associated with a significantly reduced cough reflex (such as stroke, Parkinson's disease, and dementia), Parlatos treatment should be administered with special caution and only after careful evaluation of the benefit-risk ratio (see section on Other medications and Parlatos).
• If you have liver or kidney disease.
• If you have atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition) and/or mastocytosis (increase of mast cells in the blood).
• If you are sedated, weakened, or bedridden.
• Dextromethorphan has a mild potential for addiction. Prolonged use (for example, exceeding the recommended treatment period) may produce mental and physical dependence or tolerance. Individuals with a tendency to abuse or dependence should only take it under strict medical supervision and for short periods of time.
• If you have respiratory insufficiency
• If you have a cough accompanied by expectoration

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

Cases of abuse with dextromethorphan-containing medications have been described in adolescents, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section "If you take more Parlatos than you should").

This medication may cause dependence. Therefore, treatment should be of short duration.

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 high body temperature, increased heart rate, hypertension, and exaggerated reflexes, muscle rigidity, 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 old.

Other medications and Parlatos

Inform your doctor or pharmacist if you are using, have used recently, 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 it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Monoamine oxidase inhibitors (MAOIs) used for the treatment of depression, Parkinson's disease, or other diseases (moclobemide, tranylcypromine).

• Serotonin reuptake inhibitors used for the treatment of depression (such as fluoxetine or paroxetine).

• Bupropion (used to quit smoking).

• Linezolid (used as an antibacterial).

• Procarbazine (used to treat cancer).

• Selegiline (used to treat Parkinson's disease).

• Terbinafine (used as an antifungal).

Before taking this medication, 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 discontinue treatment:

• Medications used to treat heart arrhythmias such as amiodarone, quinidine, flecainide, and propafenone.

• Anti-inflammatory medications such as celecoxib, parecoxib, or valdecoxib.

• Medications used to treat mental illnesses, allergies, Parkinson's disease.

• Medications used to eliminate mucus and phlegm expectorants and mucolytics, especially if you have a lung disease such as bronchiectasis (a disease where the bronchi are dilated and filled with pus) or cystic fibrosis.

• Medications used to treat psychosis (states of mind in which there is a loss of contact with reality) such as haloperidol and thioridazine.

• Medications used to treat HIV such as ritonavir.

• Medications based on plants such as berberine.

• Medications used to treat hyperparathyroidism such as cinacalcet.

• Antifungal medications such as terbinafine.

• Medications used to treat stomach acid such as cimetidine.

Parlatos with food, beverages, and alcohol

Do not consume alcoholic beverages during treatment, as it may increase the risk of adverse effects.

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be 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 operating machinery

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

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

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

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

Follow exactly the medication administration instructions indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older: 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 doses per day.

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: 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 doses per day.

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

Children between 2-5 years: 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 doses per day.

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

Children under 2 years:

This medication is contraindicated in children under 2 years.

How to take:

The medication is taken orally. Take the corresponding oral solution amount, 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 eruptions, or persistent headache, consult your doctor.

If you take more Parlatos than you should

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

Furthermore, restlessness and excitement can transform into agitation with increased overdose. Additionally, symptoms such as decreased concentration and consciousness up to coma as a sign of severe poisoning, mood changes such as dysphoria and euphoria, psychotic disorders such as disorientation and delirium up to states of confusion or paranoia, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (uncontrolled and involuntary eye movements), 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 when taken with other serotonin 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 seizures.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

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

If you forgot to take Parlatos

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produceadverse effects, although not all people will experience them.

Frequent adverse effects: may affect up to one in 10 patients.

• Dizziness

• Nausea

• Vomiting

• Gastrointestinal discomfort

• Fatigue

Very rare adverse effects: may affect up to one in 10,000 patients.

• Hallucinations

• Drowsiness

• Dependence in individuals who have abused dextromethorphan.

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

• Hypersensitivity reactions including anaphylactic reactions, angioedema, urticaria, pruritus, urticaria, and erythema.

• Fixed drug eruption (FDE)

• 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 not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Parlatos

The active principle is dextromethorphan hydrobromide. Each milliliter 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, red cochineal A (E-124), and water.

Appearance of the product and contents of the packaging

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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

Responsible for manufacturing:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the last review of this leaflet:June 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/