PATIENT INFORMATION LEAFLET

PROPALCOF 15 mg/ml Oral Solution

Dextromethorphan hydrobromide

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

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

• Keep this leaflet as you may need to read it again.
• 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 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.

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 that is not accompanied by expectoration (irritative cough, nervous cough) in adults and children aged 2 years and older.

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 sectionUse of Propalcof with other medications).
• Children under 2 years old cannot take this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Propalcof.

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. 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).
• 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 section “If you take more Romilar than you should”).This product may also be addictive, so its use at high doses or for a prolonged period may cause 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 of time.

Children and adolescents

Do not use in children under 2 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.

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 interrupt treatment:

• Amiodarone and quinidine (used to treat heart arrhythmias)
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)
• CNS 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.

Pregnancy,Lactation, and fertility

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

Pregnant 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 propylene glycol (E-1520), ricinoleate of macrogolglycerol, anhydrous ethanol, parahydroxybenzoate of methyl (E-218), and parahydroxybenzoate of propyl (E-216) and sodium

This medication contains 400 mg of propylene glycol in each ml of solution. If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication. If you have liver or kidney failure, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication. If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

This medication may cause stomach discomfort and diarrhea because it contains ricinoleate of macrogolglycerol.

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl (E-218) and parahydroxybenzoate of propyl (E-216).

This medication contains 0.74 mg of alcohol (ethanol) in each ml. The amount of alcohol in 1 ml of this medication is equivalent to less than 19 ml of beer or 8 ml of wine.

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

This medication contains less than 23 mg of sodium (1 mmol) per ml of solution; it is essentially “sodium-free”.

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: 1 ml (20 drops) (15 mg of dextromethorphan) every 4 hours, or 2 ml (40 drops) (30 mg) every 6-8 hours depending on the intensity of the cough. Do not exceed a daily dose of 120 mg (8 ml or 160 drops).

?Children 6 to 12 years:0.5 ml (10 drops) (7.5 mg) every 4 hours, or 1 ml (20 drops) (15 mg) every 6-8 hours depending on the intensity of the cough. Do not exceed a daily dose of 60 mg (4 ml or 80 drops).

?Children 2 to 6 years:0.25 ml (5 drops) (3.75 mg) every 4 hours, or 0.5 ml (10 drops) (7.5 mg) every 6-8 hours depending on the intensity of the cough. Do not exceed a daily dose of 30 mg (2 ml or 40 drops).

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.

The drops can be dissolved in a little water, fruit juices (except orange or grapefruit juice, seeTaking Propalcof with food and drinks), milk, tea, etc.

Place the bottle in a vertical position with the opening downwards. If the solution does not drip immediately, shake it or gently tap it with your hand or invert it several times.

The concomitant intake of this medication with other foods or beverages does not affect its efficacy.

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

Use in children and adolescents

Do not administer to children under 2 years.

If you take more Propalcof than you should

If you take morePropalcofthan 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 (tachycardia), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

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

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

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents, which may lead to severe adverse effects, such as tachycardia, lethargy, hypertension or hypotension, mydriasis, agitation, vertigo, gastrointestinal disturbances, hallucinations, mumbling speech, nystagmus, fever, tachypnea, brain damage, ataxia, convulsions, respiratory depression, loss of consciousness, arrhythmias, and death.

In case of intoxication, you will be treated with appropriate treatments for the symptoms, which may include intravenous naloxone injection and gastric 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 forgot 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 cause adverse effects, although not everyone will 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
• Immune 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 sectionif 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.

Do not freeze.

Do not use this medication after the expiration date that appears on the box and on the label, 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 containers 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 containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofPropalcof:

Each milliliter of the solution (= 20 drops) contains:

-The active ingredient is: Dextromethorphan hydrobromide, 15 mg.

-The other components (excipients) are: propylene glycol, anhydrous ethanol, flavorings (coriander oil, sweet orange essential oil, tetraroma lemon), macrogolglycerol ricinoleate (cremophor EL), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium saccharin, citric acid monohydrate, sodium hydroxide, purified water.

Appearance of the product and content of the container

This medication is presented in the form of oral drops in solution. It is presented in containers containing a glass vial with 20 ml, provided with a dropper. Each milliliter of solution is equivalent to 20 drops.

Holder of the marketing authorization:

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona) Spain

Responsible for manufacturing:

KVP Pharma + Veterinar – Produkte GmBH

Projensdorfer Str, 324 (Kiel) – D – 24106 – Germany

Date of the last review of this leaflet: October 2019

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.es/