Parlatos 2.6 mg/ml oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Parlatos 2.6 mg/ml oral solution

Dextromethorphan hydrobromide

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

Follow exactly the instructions for use provided 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment, or if cough is accompanied by high fever, skin rash, or persistent headache.

Contents of the leaflet

1. What Parlatos is and what it is used for

2. What you need to know before taking Parlatos

3. How to take Parlatos

4. Possible side effects

5. Storage of Parlatos

6. Contents of the pack and other information

1. What Parlatos is and what it is used for

Dextromethorphan, the active ingredient in this medicine, is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry cough (non-productive cough, irritative cough, nervous cough) in adults and children from 2 years of age.

You should consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

2. What you need to know before taking Parlatos

Do not take Parlatos

• If you are allergic to dextromethorphan or to any of the other components of this medicine (listed in section 6).
• In case of persistent or chronic cough, such as that caused by smoking, asthma, or emphysema, or when 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 insufficiency.
• If you have respiratory depression.
• If you are breastfeeding.
• If you have cough accompanied by abundant secretions (e.g., in patients with conditions such as bronchiectasis (a disease in which the bronchi are dilated and filled with pus) or cystic fibrosis).
• If you are currently taking or have taken within the previous 2 weeks any monoamine oxidase inhibitor (MAOI) medicine used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitor medicines used to treat depression such as fluoxetine and paroxetine; or bupropion, a medicine used to stop smoking; or linezolid, an antibacterial medicine (see section "Other medicines and Parlatos").

Warnings and precautions

Talk to your doctor or pharmacist before taking Parlatos:

• If you suffer from persistent or chronic cough, such as that due to smoking. Particularly in children, chronic cough may be an early symptom of asthma.
• If you are taking serotonergic medicines (other than MAOIs), such as tricyclic antidepressants (see section "Other medicines and Parlatos").
• In patients with neurological diseases associated with markedly 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 "Other medicines and Parlatos").
• If you have liver or kidney disease.
• If you have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in childhood in individuals with hereditary allergic predisposition) and/or mastocytosis (increased mast cells in blood).
• If you are sedated, weakened, or bedridden.
• Dextromethorphan has a low potential for addiction. Prolonged use (e.g., exceeding the recommended duration) may lead to tolerance or mental and physical dependence. Individuals with a tendency to abuse or dependence should only take this medicine under strict medical supervision and for short periods.
• If you have respiratory insufficiency.
• If you have cough accompanied by expectoration.

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

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as serious adverse effects may occur (see section "If you take more Parlatos than you should").

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

Talk to your doctor, pharmacist, or nurse before taking Parlatos:

• If you are taking other medicines such as antidepressants or antipsychotics, Parlatos may interact with these medicines 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Paediatric population

Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must not exceed the recommended dose.

Do not administer to children under 2 years of age.

Other medicines and Parlatos

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

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine).
• Serotonin reuptake inhibitor antidepressants (such as fluoxetine or paroxetine).
• Bupropion (used to stop 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 medicine, consult your doctor if you are using any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

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

Taking Parlatos with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

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

Consult your doctor or pharmacist before using any medicine. Breastfeeding women should not take this medicine without consulting their doctor.

Pregnant women should not take this medicine without consulting their doctor.

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Driving and operating machinery

Rarely, during treatment, mild drowsiness and dizziness may occur. If you experience these symptoms, you should not drive cars or operate heavy machinery.

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

This medicinal product contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicinal product may cause allergic reactions, as it contains carmine red A. It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.

This medicinal product contains less than 1 mmol of sodium (23 mg) per ml and is therefore essentially "sodium-free".

3. How to take Parlatos

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

The recommended dose is:

Adults and adolescents aged 12 years and older: Take 4 to 7 ml (equivalent to 10.4 mg – 19.5 mg of dextromethorphan hydrobromide), depending on the severity of cough, every 4–6 hours.

Do not exceed 6 doses per day.

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

Use in children

Children aged 6–11 years: Take 2 to 3.5 ml (equivalent to 5.2 mg – 9.1 mg of dextromethorphan hydrobromide), depending on the severity of cough, every 4–6 hours.

Do not exceed 6 doses per day.

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

Children aged 2–5 years: Take 1 to 1.5 ml (equivalent to 2.6 mg – 3.9 mg of dextromethorphan hydrobromide), depending on the severity of cough, every 4–6 hours.

Do not exceed 6 doses per day.

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

Children under 2 years of age:

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

How to take:

The medicine is taken orally. Take the corresponding amount of oral solution according to the recommended dose, measured using the syringe provided.

Do not exceed the recommended dose.

It can be taken with or without food.

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

If symptoms worsen or if cough persists for more than 7 days of treatment, or if accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more Parlatos than you should

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

Furthermore, restlessness and excitability may turn into agitation as overdose increases. Additionally, symptoms such as decreased concentration and consciousness, up to coma as a sign of severe intoxication, mood changes such as dysphoria and euphoria, psychotic disorders such as disorientation and delusions up to states of confusion or paranoia, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (involuntary and uncontrollable eye movements), and visual disturbances may occur. Respiratory depression, changes in blood pressure (high or low), and tachycardia (increased heart rate) may also 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, disturbances in consciousness, rapid and involuntary eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.

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

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

If you forget to take Parlatos

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent adverse effects: may affect up to 1 in 10 patients.

• Dizziness
• Nausea
• Vomiting
• Gastrointestinal discomfort
• Fatigue

Very rare adverse effects: may affect up to 1 in 10,000 patients.

• Hallucinations
• Somnolence
• Dependence in individuals 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.
• Drug eruption (fixed drug eruption, FDE)
• Confusion, headache, constipation.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide further information on the safety of this medicine.

5. Storage of Parlatos

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

Do not freeze.

Do not use Parlatos after the expiry date stated on the packaging after EXP:. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Parlatos

The active substance 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 flavour, cochineal red A (E-124), and water.

Appearance of the product and contents of the container

Bottle containing 200 ml of oral solution. Each container is supplied with an oral dosing syringe with a scale ranging from 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 most recent review of this leaflet: June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/