PROPALCOF 15 mg/ml ORAL SOLUTION DROPS

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 medication (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 medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section Use of Propalcof with other medications).
• Children under 2 years of age cannot take this medication.

Warnings and precautions

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

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

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

• 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 redness, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition).
• Sedated, weakened, or bedridden patients.
• CYP2D6 polymorphism (genetic alteration that affects 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 body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

There have been reports of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects can occur (see section If you take more Propalcof than you should). 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 of time.

Children and adolescents

Do not use in children under 2 years of age.

Use of Propalcof with other medications

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

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

• 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 medication, you should 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 (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)

Taking Propalcof with food and drinks

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 using machines:

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

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

This medication contains 400 mg of propylene glycol per 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 of age, consult your doctor or pharmacist, especially if they have been given other medications containing propylene glycol or alcohol.

This medication can cause stomach upset and diarrhea because it contains macrogolglycerol ricinoleate.

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

This medication contains 0.74 mg of alcohol (ethanol) per 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".

3. How to take Propalcof

Follow the administration instructions for the medication 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: 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 the dose of 120 mg per day (8 ml or 160 drops).

? Children from 6 to 12 years of age: 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 the dose of 60 mg per day (4 ml or 80 drops).

? Children from 2 to 6 years of age: 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 the dose of 30 mg per day (2 ml or 40 drops).

Do not exceed 6 daily doses.

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.

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

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

Concomitant intake of this medication with other foods or drinks does not affect its efficacy.

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 2 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 include: 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 medications containing dextromethorphan in adolescents, which can lead to serious side effects, such as tachycardia (accelerated heart rate), lethargy, high or low blood pressure, mydriasis (pupil dilation), agitation, dizziness, gastrointestinal disorders, hallucinations, slurred speech, nystagmus (involuntary and uncontrolled eye movements), 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, you should receive treatment according 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 Toxicology 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 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 doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Propalcof can cause side effects, although not everyone will experience them.

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

• 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: dizziness
• 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 listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Propalcof

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

Do not freeze.

Do not use this medication after the expiration date shown on the box and label, after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Propalcof:

Each ml 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 and package contents

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

Marketing authorization holder:

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona) Spain

Manufacturer:

KVP Pharma + Veterinar – Produkte GmBH

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

Date of the last revision of this leaflet: October 2019

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