PROPALCOF 15 mg/5 ml SYRUP

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PROPALCOF 15 mg/5 ml syrup

Dextromethorphan hydrobromide

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

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

Contents of the package leaflet:

1. What is Propalcof and what is it used for
2. What you need to know before taking Propalcof
3. How to take Propalcof
4. Possible side effects
5. Storage of Propalcof

1. Package contents and additional information

1. What is Propalcof and what is it used for

Dextromethorphan, the active substance of this medicine, 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 6 years of age.

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

2. What you need to know before taking Propalcof

Do not take Propalcof:

• If you are allergic (hypersensitive) to dextromethorphan hydrobromide or any of the other components of this medicine (listed in section 6).
• If you have a severe lung disease.
• If you have asthma.
• If you have a cough accompanied by abundant secretions.
• If you are being treated or have been treated in the last 2 weeks with a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used to treat depression, such as fluoxetine and paroxetine; or with bupropion, which is a medicine used to quit smoking, or with linezolid, which is an antibacterial medicine. (See section Use of Propalcof with other medicines).
• Children under 6 years of age should not take this medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Propalcof if you are a patient.

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

Especially, patients with the following conditions should consult their doctor before using this medicine:

• Chronic or persistent cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma,
• Liver or kidney disease,
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with a hereditary allergic predisposition),
• Those who are sedated, debilitated, or bedridden,
• With CYP2D6 polymorphism (genetic alteration that affects the activity of this liver enzyme),
• Concomitant use with alcohol should be avoided,
• If you are taking other medicines such as antidepressants or antipsychotics, Propalcof 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, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

There have been reports of abuse with medicines containing dextromethorphan in adolescents, which can cause serious side effects. This product can also be addictive, so its use at high doses or for a prolonged period can lead to tolerance and mental and physical dependence. In patients with a tendency to abuse or dependence, it should only be administered under strict medical control and for short periods.

Children and adolescents

Do not use in children under 6 years of age.

Use of Propalcof with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

Note that these instructions may also apply to medicines that have been used before or may be used after.

Do not take this medicine during treatment or in the 2 weeks following treatment with the following medicines, as it can cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• MAOIs (moclobemide, tranylcypromine, clorgyline, iproniazid, and isocarboxazid)
• Serotonin reuptake inhibitors (fluoxetine, sibutramine, sertraline, or paroxetine)
• Bupropion (used to quit smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)

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

• Amiodarone and quinidine (to treat heart arrhythmias)
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib)
• Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.)
• Expectorants and mucolytics (used to eliminate phlegm and mucus).
• CYP2D6 inhibitors such as haloperidol (used to treat mental illnesses)

Taking Propalcof with food and drinks

Alcoholic beverages should not be consumed during treatment, as they can cause adverse reactions.

Do not take with grapefruit or orange juice during treatment, as they can increase the adverse effects of this medicine.

Fertility, pregnancy, and lactation

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

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

Driving and using machines

During treatment with this medicine, drowsiness, dizziness, fatigue, dystonia (involuntary muscle contractions), and visual hallucinations may occur, which should be taken into account when driving or using hazardous machinery.

Propalcof contains sucrose, sorbitol, ethanol, sodium benzoate (E-211), and glucose

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

This medicine contains 650 mg of sorbitol solution in 5 ml of syrup. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult with your doctor before taking this medicine.

This medicine contains 0.925 mg of alcohol (ethanol) in each dose (5 ml). The amount of alcohol in a dose of this medicine is equivalent to less than 24 ml of beer or 10 ml of wine.

The small amount of alcohol in this medicine has no significant effect.

This medicine contains 12.5 mg of sodium benzoate in 5 ml of syrup. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Propalcof

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

? Adults and adolescents from 12 years of age: 5 ml (1 measuring spoon) (15 mg of dextromethorphan hydrobromide) every 4 hours, or 10 ml (2 measuring spoons) (30 mg) every 6-8 hours, depending on the intensity of the cough. Do not exceed the dose of 120 mg/day (8 measuring spoons).

? Children from 6 to 12 years of age: 2.5 ml (half a measuring spoon) (7.5 mg) every 4 hours or 5 ml (1 measuring spoon) (15 mg) every 6-8 hours, depending on the intensity of the cough. Do not exceed the dose of 60 mg/day (4 measuring spoons).

Do not exceed 6 doses per day.

Pediatric population

Severe side effects can occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

Method of administration:

Oral route.

It cannot be dissolved or taken with grapefruit or orange juice or with alcoholic beverages. See Taking Propalcof with food and drinks.

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

Use in children and adolescents

Do not administer to children under 6 years of age.

If you take more Propalcof than you should

If you take more Propalcof than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid involuntary 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.

There have been reports of abuse with medicines containing dextromethorphan in adolescents, which can cause serious side effects, such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension, mydriasis (pupil dilation), agitation, vertigo, gastrointestinal disorders, hallucinations, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of poisoning, appropriate treatments should be applied to the symptoms, which may include intravenous naloxone injection and stomach lavage.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Propalcof

Do not take a double dose to make up for forgotten doses. If you have forgotten a dose, take it as soon as possible and continue with your usual schedule, as indicated in the section 3. How to take Propalcof.

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

4. Possible side effects

Like all medicines, Propalcof can cause side effects, although not everyone gets them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency cannot be established with certainty:

• Nervous system disorders: drowsiness, dizziness, fatigue, involuntary muscle contractions, and more rarely mental confusion and headache.
• Gastrointestinal disorders: nausea, vomiting, gastrointestinal disorders such as stomach pain, constipation.
• Ear and labyrinth disorders: vertigo
• Immune system disorders: hypersensitivity and anaphylactic reaction, including symptoms such as: skin rash, urticaria, edema, pruritus, and cardio-respiratory difficulty.
• Psychiatric disorders: visual hallucinations and confusion. These effects are much more pronounced with overdose (see section If you take more Propalcof than you should).
• Skin and subcutaneous tissue disorders: skin rash, urticaria, pruritus, erythema, allergic dermatitis.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Propalcof

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

No special storage conditions are required.

Do not freeze.

Do not use this medicine after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Propalcof:

Each 5 ml of syrup (1 measuring spoon) contains:

-The active substance is dextromethorphan hydrobromide, 15 mg.

-The other components (excipients) are: sucrose, sodium benzoate (E-211), sorbitol 70% solution, sweet orange oil, lemon tetrarome, coriander oil, citric acid monohydrate, caramel color (E-150 c), anhydrous ethanol, purified water.

Appearance of the product and package contents

This medicine is presented in a plastic bottle.

The package contents are 200 ml. It includes a 5 ml plastic measuring spoon with a mark at 2.5 ml.

Marketing authorization holder:

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona) Spain

Manufacturer:

Delpharm Bladel B.V.

Industrieweg 1, 5531 AD

Bladel, Netherlands

Date of last revision of this leaflet: October 2019

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