PATIENT INFORMATION LEAFLET

PROPALCOF 15 mg/5 ml syrup

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, 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 any 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 your cough is accompanied by high fever, skin eruptions or persistent headache.

6. Contents of the pack and additional information

The dextromethorphan, active ingredient of this medication, is an antitussive 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 aged 6 years and above.

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

Do not take Propalcof:

• If you are allergic (hypersensitive) to dextromethorphan hydrobromide or to any of the other components of this medication (listed in section 6).
• If you have a serious 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 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 the section onUse of Propalcof with other medications).
• Children under 6 years old cannot take this medication.

Warnings and precautions

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

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

Especially, patients with persistent or chronic cough, such as that due to smoking, should consult their doctor before using this medication. Especially in children, chronic cough could be an early sign of asthma,

• with liver or kidney disease,
• with atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition),
• who are sedated, weakened, or bedridden,
• with CYP2D6 polymorphism (genetic alteration affecting the activity of this liver enzyme),
• alcohol consumption should be avoided,
• if you are taking other medications such as antidepressants or antipsychotics, Propalcof 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).

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

Children and adolescents

Do not use in children under 6 years old.

Use of Propalcof with other medications

Inform your doctor or pharmacist if you are taking,have taken recentlyor may need to take any other medication.

These instructions may also apply to medications that have been used before or may be used afterwards.

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):

• MAOIs (moclobemide, tranylcypromine, clorgiline, iproniazid, and isocarboxazid)
• SSRIs (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 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:

• Amiodarone and quinidine (used to treat heart arrhythmias)
• Anti-inflammatory medications (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)

Propalcof with food and beverages

Do not consume alcoholic beverages during treatment, as they may cause adverse reactions.

Do not take this medication with orange or grapefruit juice during treatment, as it may increase the adverse effects of this medication.

Fertility, pregnancy, and breastfeeding

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

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

Driving and operating machinery:

During treatment with this medication, you may experience mild drowsiness and dizziness, fatigue, dystonia (involuntary muscle contractions), and visual hallucinations, which should be taken into account when driving or operating hazardous machinery.

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

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

This medication 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 medication.

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

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

This medication 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 old).

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

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

Children 6 to 12 years:2.5 ml (half spoonful)(7.5 mg) every 4 hours or 5 ml (1 spoonful) (15 mg) every 6-8 hours depending on the intensity of the cough. Do not exceed the dose of 60 mg/day (4 spoonfuls).

Do not exceed 6 daily doses.

Pediatric population

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

Administration form:

Oral route.

It will not be possible to dissolve or take with orange or grapefruit juice or alcoholic beverages, seeTaking Propalcof with food and drinks.

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

Use in children and adolescents

Do not administer to children under 6 years.

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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (accelerated heart rate), coordination disturbances, 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.

Cases of abuse with medications containing dextromethorphan have been reported in adolescents, which may lead to severe adverse effects, such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (discoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of intoxication, you will be administered appropriate treatments for 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 medication and the amount ingested.

If you forget to take Propalcof

Do not take a double dose to compensate for the missed doses. If you have forgotten a dose, take it as soon as possible and continue with your regular schedule, as indicated in the section3. How to take Propalcof.

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

Like all medications,Propalcofmay have adverse effects, although not all people may experience them.

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency has not been established with precision:

• Nervous System Disorders:drowsiness, dizziness, fatigue, involuntary muscle contractions, and less frequently mental confusion and headache.
• Gastrointestinal Disorders:nausea, vomiting, gastrointestinal discomfort such as stomach pain, constipation.
• Vestibular and Labyrinthine Disorders:vertigo
• Immunological System Disorders:hypersensitivity and anaphylactic reaction, including symptoms such as: skin rash, urticaria, edema, pruritus, and respiratory-cardiovascular 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).
• Dermatological and Subcutaneous Tissue Disorders:skin rash, urticaria, pruritus, erythema, allergic dermatitis.

If you consider that any of the adverse effects you are experiencing are severe, or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not freeze.

Do not use this medication after the expiration date shown 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Propalcof:

Each 5 ml of syrup (1 spoonful) contains:

-The active ingredient is Dextromethorphan hydrobromide, 15 mg.

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

Appearance of the product and contents of the packaging

This medicine is presented in a plastic bottle.

The contents of the packaging are 200 ml. It contains a plastic spoon with a capacity of 5 ml and a mark at 2.5 ml.

Holder of the marketing authorization:

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona) Spain

Responsible for manufacturing:

Delpharm Bladel B.V.

Industrieweg 1, 5531 AD

Bladel- Holland

Date of the last review of this leaflet: October 2019

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