PROPALGINA PLUS POWDER FOR ORAL SOLUTION

2. What you need to know before taking Propalgina Plus

Do not take Propalgina Plus

• If you are allergic to paracetamol, chlorphenamine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide, vitamin C (ascorbic acid), or any of the other components of this medicine (listed in section 6). Cross-hypersensitivity reactions may occur in patients sensitive to other antihistamines or sympathomimetic amines.
• If you have respiratory depression (weak breathing).
• Children under 12 years of age.
• If you have a severe lung disease.
• If you have asthmatic cough.
• If you have asthma.
• If you have a cough with abundant secretions.
• If you are being treated, or have been treated in the last 2 weeks, with a monoamine oxidase inhibitor (MAOI) medication, used to treat depression or Parkinson's disease or other diseases, or if you are being treated with serotonin reuptake inhibitors (SSRI). (See section on Use of other medicines).
• If you have severe kidney or liver failure.
• If you have severe cardiovascular disease or ischemic heart disease (angina pectoris, myocardial infarction).
• If you have pneumonia.
• If you have respiratory failure.
• If you have high blood pressure.
• If you have hyperthyroidism (increased thyroid gland activity).
• If you have glaucoma (increased eye pressure).
• If you have obstruction of the bladder neck (bladder obstruction) or urinary retention.
• If you are undergoing combined therapy with oral anticoagulants (medicines to prevent blood clots).
• If you have oxalate urolithiasis (formation of oxalate stones in the urinary system) or hyperoxaluria (concentration of oxalic acid or oxalates in urine higher than normal).
• If you have had kidney stones.
• If you have hemochromatosis (a disease in which excess iron accumulates in the body).

Warnings and Precautions

• Do not take more than the recommended amount of medicine in section 3. How to take Propalgina Plus.
• Chronic alcoholics should be cautious not to take more than 4 sachets of this medicine in 24 hours.
• When being treated for epilepsy, consult your doctor before taking this medicine, as the efficacy may decrease and hepatotoxicity of paracetamol may increase when used together.
• Avoid taking this medicine with other medicines that contain paracetamol, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Avoid taking this medicine with alcoholic beverages.
• Patients sensitive to an antihistamine may be sensitive to others.
• If you observe redness of the skin, rash, blisters, or peeling, discontinue treatment and consult your doctor.

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

Patient groups that should consult their doctor before using this medicine include:

• those with kidney, liver, heart, or lung disease, and those with anemia,
• asthmatics sensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• those with Gilbert's syndrome (a hereditary disorder characterized by high bilirubin levels),
• those with glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia),
• those with genetic liver diseases,
• those with persistent or chronic cough, such as that caused by smoking. In children, chronic cough could be an early symptom of asthma,
• those with atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusts, and peeling, which begins in childhood in individuals with a hereditary allergic predisposition),
• those who are sedated, debilitated, or bedridden.
• Consult your doctor or pharmacist if you have any of the following diseases: pheochromocytoma (a rare tumor that causes increased hormone production), cardiovascular diseases, diabetes mellitus, prostatic hyperplasia (enlargement of the prostate), pancreatitis (inflammation of the pancreas), pyloroduodenal obstruction (intestinal obstruction), thyroid diseases, pulmonary and renal diseases, and anemia, as phenylephrine may worsen the disease and interact with medicines commonly used to treat them.
• Patient groups being treated with tricyclic antidepressants, maprotiline, or other medicines with anticholinergic action (medicines used to relieve stomach, intestine, or bladder spasms or contractions) should inform their doctor or pharmacist as soon as possible if they experience stomach problems during treatment with Propalgina Plus, as they may develop paralytic ileus (intestinal obstruction).
• Elderly people may be more susceptible to the adverse effects of this medicine, even at the usual adult dose.
• If you are taking other medicines such as antidepressants or antipsychotics, Propalgina Plus 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, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

During treatment with Propalgina Plus, inform your doctor immediately if you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

There have been cases of abuse with medicines containing dextromethorphan in adolescents; therefore, this possibility should be taken into account, as serious side effects can occur (see section If you take more Propalgina Plus than you should).

Children and Adolescents

Children under 12 years of age should not take this medicine; it is contraindicated in them.

Interference with Laboratory Tests:

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Taking Propalgina Plus with Other Medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicines to prevent blood clots: Oral anticoagulants (warfarin, acenocoumarol, phenytoin).
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines used to relieve stomach, intestine, or bladder spasms or contractions: Anticholinergics (propantheline).
• Medicines to treat tuberculosis: Antituberculars (isoniazid, rifampicin).
• Medicines to treat depression and convulsions: Barbiturates used as hypnotics, sedatives, and anticonvulsants.
• Tricyclic antidepressants (maprotiline), tetracyclic (used to treat depressive disorders in alcoholic patients) and serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Medicines used to lower cholesterol levels in the blood: Cholestyramine.
• Medicines used to treat gout: Antigout (probenecid and sulfinpyrazone).
• Tetracycline (used to treat bacterial infections).
• Some medicines used to increase urine elimination (loop diuretics such as furosemide).
• Antihypertensive medicines (used to treat high blood pressure): Rauwolfia alkaloids and medicines with a mechanism of action related to the sympathetic nervous system (such as propranolol, also used in cardiac arrhythmias).
• Medicines used for the heart: Digitalis glycosides and antiarrhythmics.
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone or tropisetron and granisetron (used in chemotherapy).
• Also, do not use with other analgesics, such as acetylsalicylic acid (pain-relieving medicines) without consulting your doctor.
• Monamine oxidase inhibitors (MAOIs), used to treat depression (tranylcypromine, moclobemide) or Parkinson's disease (selegiline), furazolidone, or linezolid (antibacterial) and procarbazine (used to treat cancer). Serious side effects can occur, manifested as severe headache, high blood pressure, and sudden increase in temperature, dizziness, palpitations, muscle contractions, and coma, among other symptoms. If you have taken one of these medicines, wait at least 15 days before taking Propalgina Plus. If you are unsure whether your medication contains an MAOI, consult your doctor or pharmacist before taking Propalgina Plus.
• Alpha-adrenergic blockers (medicines for migraine or other conditions such as childbirth, blood pressure, or other diseases).
• Beta-adrenergic blockers (for blood pressure or other conditions).
• General anesthetics.
• Atropine sulfate (for heart or digestive diseases).
• Caffeine (used to treat fatigue, lack of vigor, drowsiness, headache, etc.).
• Thyroid hormones (used to treat goiter).
• Indomethacin (a medicine used to reduce inflammation and pain).
• Bromocriptine (a medicine used to treat diseases such as Parkinson's, cocaine withdrawal syndrome, menstrual disorders such as amenorrhea, etc.).
• Ototoxic medicines (medicines that can damage the ear), such as some antibiotics (aminoglycosides) and antitumorals (bleomycin and cisplatin).
• Photosensitizing medicines (medicines that can cause photosensitivity reactions to light), such as some antidepressants, antibiotics (sulfonamides), some diuretics, etc.
• Oral contraceptives with estrogens.
• Deferoxamine (a medicine used to remove excess iron from the body).
• Cyclosporin (a medicine used to help the body accept a transplanted organ, such as a kidney, liver, or heart).
• Anti-inflammatory medicines (celecoxib, parecoxib, valdecoxib).
• CYP2D6 inhibitors (used to treat mental disorders), such as haloperidol.
• Medicines that produce depression (sedation or a deeper effect) on the central nervous system (such as those used to treat insomnia or anxiety or antihistamines, some of which can be used to treat Parkinson's disease).
• Amiodarone and quinidine (for cardiac arrhythmias).
• Sibutramine (used to treat obesity).
• Bupropion (used to quit smoking).
• Expectorants and mucolytics (used to eliminate phlegm and mucus).
• Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Propalgina Plus with Food, Drinks, and Alcohol

Alcoholic beverages should not be consumed during treatment, as they may cause side effects.

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

Taking this medicine with food, except for the aforementioned, does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

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

Propalgina Plus should not be taken during pregnancy or breastfeeding, unless prescribed by your doctor.

Driving and Using Machines

The influence of Propalgina Plus on the ability to drive and use machines is moderate. This medicine may cause drowsiness or sedation, so if you experience these symptoms, you should not drive or operate machines.

Propalgina Plus Contains Sucrose and Sodium

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.

Patient groups with diabetes mellitus should be aware that this medicine contains 3.67 g of sucrose per sachet.

This medicine contains 34.44 mg of sodium (the main component of table salt) per sachet. This is equivalent to 1.7% of the maximum daily sodium intake recommended for an adult.

3. How to take Propalgina Plus

Follow the administration instructions of this medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 14 years old :

Take 1 sachet every 4 to 6 hours (6 to 4 times a day), as needed. Under no circumstances should more than 6 sachets (3g of paracetamol) be taken in 24 hours. See the Warnings and Precautions section.

Adolescents between 12 and 14 years old :Administer 1 sachet every 6 hours. Under no circumstances should more than 4 sachets (2g of paracetamol) be taken in 24 hours.

Patients with liver disease

Before taking this medication, they must consult their doctor.

They should take the amount of medication prescribed by their doctor, with a minimum interval of 8 hours between each dose.

They should not take more than 3 sachets (1.5g of paracetamol) in 24 hours, divided into 3 doses.

Patients with kidney disease

Before taking this medication, they must consult their doctor.

Take a maximum of 1 sachet (0.5g of paracetamol) per dose.

Depending on their illness, their doctor will indicate whether they should take their medication with a minimum interval of 6 or 8 hours.

This medication is taken orally.

Dissolve the contents of the sachet completely in a glass of water (cold or hot).

Taking the medication with food and drinks, except for grapefruit or bitter orange juice and alcoholic beverages, does not affect its efficacy.

Always take the lowest effective dose.

Taking the medication is subject to the appearance of flu or cold symptoms for which this medication is indicated. As these symptoms disappear, treatment should be suspended.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen, or other symptoms appear, treatment should be interrupted and a doctor consulted.

For throat pain, the medication should not be taken for more than 2 consecutive days without consulting a doctor.

If you take more Propalgina Plus than you should:

You should consult your doctor immediately.

If you take more Propalgina Plus than you should, you may notice the following symptoms: dizziness, vomiting, loss of appetite, abdominal pain, nausea, occasional diarrhea, yellowing of the skin and eyes (jaundice), sweating, general discomfort, fear, agitation, excitability, restlessness, nervousness, insomnia, psychosis with hallucinations (visions or hearings that are not present), mental confusion, irritability, vertigo, headache, blurred vision, miosis (contraction of the pupil of the eye), clumsiness or instability, intense drowsiness, severe dryness of the mouth, nose, or throat, flushing of the face, difficulty breathing, vasodilation, and hyperventilation, tremors, and effects on the cardiovascular system such as cerebral hemorrhage and pulmonary edema, peripheral vasoconstriction (reduction of blood vessel thickness), reduction of blood flow to vital organs, which can decrease renal perfusion, decreased urine output, metabolic acidosis (decrease in blood alkaline reserve), paresthesias (sensitivity alterations in body areas). Prolonged use can lead to depletion of plasma volume (decrease in blood volume).

Taking very high amounts of this medication can cause children to experience hallucinations, drowsiness, rashes, nausea, nervousness, involuntary eye movements, and gait disturbances, among other symptoms.

If you take more Propalgina Plus than indicated, you may experience the following symptoms due to dextromethorphan: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, consciousness disorders, rapid involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

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

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

Due to paracetamol, overdose can also cause: coagulation disorders (blood clots and bleeding).

There have been cases of abuse with medications like Propalgina Plus, which contain dextromethorphan, and severe adverse effects may appear, such as: anxiety, panic, memory loss, tachycardia (accelerated heartbeats), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, slurred speech, nystagmus (involuntary eye movement), fever, tachypnea (rapid shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

Mild symptoms have been reported after withdrawal from medications like Propalgina Plus, which contain dextromethorphan, in cases of daily and prolonged use, such as restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, and chills.

In cases of severe poisoning, stupor or coma (especially if the medication has been ingested with alcohol), liver and kidney failure may occur.

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, since they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours after ingestion of the medication.

Patients treated with barbiturates or chronic alcoholics may be more susceptible to paracetamol overdose toxicity.

It is recommended to take the medication packaging and prospectus to the healthcare professional.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Propalgina Plus

If you forgot to take Propalgina Plus and the symptoms continue, do not take a double dose to make up for the missed dose. If necessary, take the medication again as indicated in section 3. How to take Propalgina Plus.

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

4. Possible adverse effects

Like all medications, Propalgina Plus can cause adverse effects, although not all people experience them.

Rare adverse effects that may affect up to 1 in 1,000 people are:

Discomfort, hypotension (decreased blood pressure), increased liver transaminase levels (markers of liver function).

Very rare adverse effects that may affect up to 1 in 10,000 people are:

Alterations in blood cell count (such as thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia), sterile pyuria (cloudy urine), kidney failure, hypoglycemia (decreased blood glucose levels), hypersensitivity reactions, ranging from a simple skin rash or urticaria to anaphylactic shock (a very severe allergic reaction that can cause death), severe skin reactions, hepatotoxicity (jaundice: yellowing of the skin and eyes).

Due to the different active ingredients of this medication, the following adverse effects may appear, whose frequency cannot be established with accuracy:

Dizziness, vertigo, and drowsiness, headache, restlessness, anxiety, nervousness, weakness, dizziness, tremors, insomnia, irritability, involuntary facial movements, tremors, tingling or numbness, and even mental confusion. With high doses, convulsions and psychosis with hallucinations may occur, clumsiness, and paradoxical excitement, especially with high doses and in children or the elderly, characterized by restlessness, insomnia, tremors, nervousness, delirium, palpitations, and even convulsions; skin reactions such as rash, pallor, hair standing on end, increased sweating, flushing of the skin, allergic dermatitis, itching, and edema (swelling); severe hypersensitivity reactions such as severe generalized pustular eruptions, outbreaks, such as erythema multiforme, Stevens-Johnson syndrome (an acute inflammatory disease), toxic epidermal necrolysis (a severe skin disease characterized by blistering); effects on the respiratory system, such as dryness of the nose and throat, thickening of mucus, wheezing (noise in the lungs), bronchospasm (narrowing of the bronchi), and asthma, including analgesic asthma syndrome or pulmonary edema (fluid accumulation in the lungs), usually at high doses, or in susceptible individuals; hypersensitivity reactions (allergic), such as cough, difficulty swallowing, rapid heartbeat, swelling of the eyelids or around the eyes, face, tongue, difficulty breathing, fatigue, rash, angioedema (swelling under the skin), photosensitivity (sensitivity to sunlight), cross-sensitivity with medications related to chlorphenamine, etc.; gastrointestinal discomfort such as nausea, vomiting, diarrhea, abdominal pain, constipation, stomach discomfort, such as pain in the upper part of the stomach and stomach cramps, dry mouth, loss of appetite, alterations in taste or smell; adverse effects on the liver, such as cholestasis (decreased bile flow), liver failure, hepatitis, dose-dependent liver failure; chronic administration can lead to liver fibrosis and cirrhosis, which can be fatal; adverse effects on the kidneys, especially in cases of overdose, such as decreased urine output, urinary retention, or difficulty urinating. Due to its vitamin C content, there is a risk of stone formation in the urinary tract or gout attacks in predisposed individuals; cardiac disorders, such as myocardial infarction, tachycardias, chest pain or discomfort, severe bradycardia (very slow heartbeats), possible induction or exacerbation of heart failure associated with heart disease; vascular disorders, such as cerebral hemorrhage, hypertension, and hypotension (high or low blood pressure), peripheral vasoconstriction (reduction of blood vessel thickness); cold in the extremities, flushing; with prolonged use, a decrease in blood volume may occur; metabolic disorders, such as hyperglycemia (elevated blood sugar), hypokalemia (low potassium levels in the blood), and metabolic acidosis (produced when the body produces too much acid or the kidneys do not eliminate enough acid from the body); vision disorders, such as blurred vision or double vision; alterations in the ear, such as tinnitus or inflammation and irritation of the ear; impotence or menstrual disorders have also been reported.

Adverse effects of unknown frequency (cannot be estimated from available data) are:

A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting adverse effects:

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

5. Conservation of Propalgina Plus

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Propalgina Plus after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information.

Composition of Propalgina Plus

• The active ingredients are: 500mg of paracetamol, 10mg of dextromethorphan hydrobromide, 2mg of chlorphenamine maleate, 7.5mg of phenylephrine hydrochloride, and 200mg of ascorbic acid.
• The other components (excipients) are: sodium saccharin, sodium cyclamate, anhydrous citric acid, mannitol (E-421), sucrose, disodium edetate, anhydrous colloidal silica, povidone, and cola flavor-colorant.

Appearance of the product and package contents

Propalgina Plus is a uniform granulate, yellowish-pink in color.

Propalgina Plus is presented in sachets composed of Paper/Aluminum/Polyethylene.

It is presented in cardboard boxes containing 10 or 20 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chaussee 1

06803 Bitterfeld-Wolfen

Germany

Date of the last revision of this prospectus:March 2025

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.gob.es.