Leaflet: information for the user

Propalgina Plus powder for oral solution

Paracetamol/ Chlorphenamine maleate/ Phenylephrine hydrochloride/

Dextromethorphan hydrobromide/ Ascorbic acid

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

- 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if your condition worsens or does not improve after 3 days of treatment, in the case of fever, or 5 days,in the case of pain.

1. What is Propalgina Plus and what it is used for

2. What you need to know before starting to take Propalgina Plus

3. How to take Propalgina Plus

4. Possible side effects

5. Storage of Propalgina Plus

6. Contents of the pack and additional information

This is an association of paracetamol, effective in reducing pain and fever; dextromethorphan, which inhibits the cough reflex; chlorphenamine, which is an antihistamine, with a mucosal decongestant effect in the nose; phenylephrine, which is a nasal decongestant, and vitamin C.

This medication is indicated for symptomatic relief of catarrhal and influenza-like processes that are accompanied by mild or moderate pain, fever, unproductive cough, congestion, and nasal secretion, in adults and adolescents aged 12 years and above.

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment, in the case of fever, or 5 days, in the case of pain.

Do not take Propalgina Plus

• If you are allergic to paracetamol, chlorphenamine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide, vitamin C (ascorbic acid), tartrazine, or any of the other components of this medication (listed in section 6). You may experience cross-reactivity hypersensitivity reactions in patients sensitive to other antihistamines or sympathomimetic amines.
• If you have respiratory depression (weak breathing).
• Children under 12 years old.
• 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 past 2 weeks, with a monoamine oxidase inhibitor (MAOI) medication, used to treat depression or Parkinson's disease or other conditions, or if you are being treated with selective serotonin reuptake inhibitors (SSRIs). (See section Use of other medications).
• If you have severe renal or hepatic insufficiency.
• If you have cardiovascular insufficiency or ischemic cardiopathy (angina pectoris, myocardial infarction).
• If you have pneumonia.
• If you have respiratory insufficiency.
• If you have high blood pressure (hypertension).
• If you have hyperthyroidism (increased activity of the thyroid gland).
• If you have glaucoma (increased eye pressure).
• If you have urinary tract obstruction or urinary retention.
• If you are being treated with oral anticoagulants (blood clotting medications).
• If you have oxalate urolithiasis (formation of oxalate stones in the urinary tract) or hyperoxaluria (concentrated oxalic acid or oxalates in the urine).
• If you have kidney stones (nephrolithiasis).
• If you have hemochromatosis (a condition in which excess iron accumulates in the body).

Warnings and precautions

• Do not take more medication than recommended in section 3. How to take Propalgina Plus.
• Chronic alcoholics should be careful not to take more than 4 packets of this medication in 24 hours.
• When being treated for epilepsy, consult a doctor before taking this medication, as it may reduce the effectiveness and increase the risk of liver toxicity of paracetamol.
• Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not take more than one medication that contains paracetamol without consulting a doctor.
• Avoid taking this medication with alcoholic beverages.
• Patients sensitive to one antihistamine may be sensitive to others.
• If you experience skin redness, rash, blisters, or peeling, discontinue treatment and consult a doctor.

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

Consult a doctor before using this medication in patients:

• with kidney, liver, heart, or lung diseases, and patients with anemia,
• asthmatics sensitive to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• with Gilbert's syndrome (a hereditary condition characterized by high bilirubin levels),
• with glucose-6-phosphate dehydrogenase deficiency (G6PD) (may cause hemolytic anemia),
• with genetic liver diseases,
• with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough may be an early sign of asthma,
• 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, debilitated, or bedridden.
• Consult a doctor or pharmacist if you have any of the following conditions: phaeochromocytoma (rare tumor that causes increased hormone production), cardiovascular diseases, diabetes mellitus, prostatic hypertrophy (prostate enlargement), pancreatitis (inflammation of the pancreas), pyloric obstruction (intestinal obstruction), thyroid diseases, pulmonary and renal diseases, and anemia, as phenylephrine may exacerbate the condition and interact with medications commonly used to treat them.
• Patients being treated with tricyclic antidepressants, maprotiline, or other medications with anticholinergic action (medications used to relieve spasms or contractions of the stomach, intestines, and bladder) should inform their doctor or pharmacist as soon as possible if they experience gastrointestinal problems during treatment with Propalgina Plus, as they may develop paralytic ileus (intestinal obstruction).
• Older people may be more susceptible to the adverse effects of this medication, even at the usual adult dose.
• If you are taking other medications such as antidepressants or antipsychotics, Propalgina Plus may interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as elevated body temperature, increased heart rate, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Inform your doctor immediately if you have severe conditions, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe condition called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, somnolence, feeling unwell (nausea), and vomiting.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents; therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section If you take more Propalgina Plus than you should).

Children and adolescents

Children under 12 years old cannot take this medication, it is contraindicated in them.

Interference with laboratory tests:

Inform your doctor if you are undergoing any laboratory tests (including blood, urine, etc.) as this medication may alter the results.

Taking Propalgina Plus with other medications

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

Particularly, if you are using some of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Medications to prevent blood clots: Oral anticoagulants (warfarin, acenocoumarol, phenitoin).
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenitoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications used to relieve spasms or contractions of the stomach, intestines, and bladder: Anticholinergics (propantelina).
• Medications to treat tuberculosis: Antituberculosos (isoniazida, rifampicina).
• Medications to treat depression and seizures: Barbiturates used as hypnotics, sedatives, and anticonvulsants.
• Tricyclic antidepressants (maprotiline), tetracyclic antidepressants (used to treat secondary depressive disorders in alcoholics), and selective serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Medications used to lower cholesterol levels in the blood: Colestiramina.
• Medications used to treat gout: Antigotosos (probenecid and sulfinpirazona).
• Tetracycline (used to treat bacterial infections).
• Diuretics of the loop (such as furosemide).
• Antihypertensive medications (used to treat high blood pressure): Alkaloids of rauwolfia and medications with a mechanism of action related to the sympathetic nervous system (such as propranolol, also used for arrhythmias).
• Medications used for the heart: Digitalis glycosides and antiarrhythmics.
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone or tropisetron and granisetron (used in chemotherapy).
• Do not use with other analgesics, such as acetylsalicylic acid (pain-relieving medications) without consulting a doctor.
• MAOIs (used to treat depression) such as tranilcipromina, moclobemida, selegilina (used to treat Parkinson's disease), furazolidona, or linezolid (antibiotic), and procarbazina (used to treat cancer). Severe adverse effects may occur, such as severe headache, elevated blood pressure, and elevated body temperature, dizziness, palpitations, muscle contractions, and coma, among other symptoms. If you have taken one of these medications, 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 (medications for migraine or other conditions).
• Beta-adrenergic blockers (for hypertension and other conditions).
• General anesthetics.
• Atropine sulfate (for the heart or digestive diseases).
• Caffeine (used to treat fatigue, lack of energy, somnolence, headache, etc.).
• Thyroid hormones (used to treat goiter).
• Indometacina (used to reduce inflammation and pain).
• Bromocriptina (used to treat conditions such as Parkinson's disease, cocaine withdrawal syndrome, menstrual disorders, etc.).
• Ototoxic medications (medications that can damage the ear), such as some antibiotics (aminoglycosides) and antitumor medications (bleomycin and cis-platinum).
• Phototoxic medications (medications that can cause photosensitivity reactions to light), such as some antidepressants, antibiotics (sulfonamides), some diuretics, etc.
• Oral contraceptives with estrogens.
• Deferoxamina (used to remove excess iron from the body).
• Ciclosporina (used to help the body accept a transplanted organ).
• Anti-inflammatory medications (celecoxib, parecoxib, valdecoxib).
• CYP2D6 inhibitors (used to treat mental disorders), such as haloperidol.
• Medications that cause 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 may be used to treat Parkinson's disease).
• Amiodarona and quinidina (for arrhythmias).
• Sibutramina (used to treat obesity).
• Bupropión (used to quit smoking).
• Expectorants and mucolíticos (used to eliminate mucus and phlegm).
• Flucloxacilina (antibiotic), due to a severe risk of blood and fluid alteration (metabolic acidosis) that requires urgent treatment (see section 2).

Taking Propalgina Plus with food, drinks, and alcohol

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

Do not take with orange or bitter lemon juice, as they may increase the adverse effects of this medication.

Taking this medication with food, except for the above-mentioned, 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 medication.

Propalgina Plus should not be taken during pregnancy or breastfeeding, unless your doctor prescribes it.

Driving and operating machinery

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

Propalgina Plus contains saccharose and sodium

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.

Patients with diabetes mellitus should note that this medication contains 3.67 g of saccharose per packet.

This medication contains 34.44 mg of sodium (main component of table salt/cooking salt) in each packet, which is equivalent to 1.7% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication contained in this leaflet or those 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 tablet every 4 to 6 hours (6 to 4 times a day), as needed. In no case should more than 6 tablets (3 g of paracetamol) be taken in 24 hours. See the Advertencias and precautions section.

Adolescents between 12 and 14 years old:Administer 1 tablet every 6 hours. In no case should more than 4 tablets (2 g 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 tablets (1.5 g of paracetamol) in 24 hours, divided into 3 doses.

Patients with kidney disease

Before taking this medication, they must consult their doctor.

Take, at most, 1 tablet (0.5 g of paracetamol) per dose.

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

This medication is taken orally.

Completely dissolve the contents of the tablet in a glass of water (cold or hot).

The taking of the medication with food and drinks, except for,orange or lemon juice and alcoholic beverages, does not affect its efficacy.

Always take the smallest effective dose.

The taking of the medication is subject to the appearance of the symptoms of the common cold or flu 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 the doctor consulted.

For sore throat, 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 experience 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, excitement, restlessness, nervousness, insomnia, psychosis with visual or auditory hallucinations, confusion, irritability, dizziness, headache, blurred vision, miosis (pupil constriction), clumsiness or instability, intense somnolence, severe dryness of the mouth, nose, or throat, severe facial redness, shortness of breath, vasodilation, and hyperventilation, tremors, and cardiovascular effects such as cerebral hemorrhage and pulmonary edema, peripheral vasoconstriction (reduction of blood vessel thickness), reduction of blood flow to vital organs, which may decrease renal perfusion, decreased urine output, metabolic acidosis (decrease in blood alkalinity reserve), paresthesias (sensory alterations in body areas). In prolonged use, plasma volume depletion (decrease in blood volume) may occur.

Taking very high doses of this medication may cause children to experience hallucinations, somnolence, 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, somnolence, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (accelerated heart rate), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose of dextromethorphan may be: coma, severe respiratory problems, and seizures.

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

Due to paracetamol, overdose may also cause: coagulation disturbances (blood clots and hemorrhages).

Cases of abuse with medications such as Propalgina Plus, which contain dextromethorphan, have been reported, and may cause severe adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heart rate), lethargy, hypertension or hypotension, mydriasis (pupil dilation), agitation, dizziness, gastrointestinal disturbances, mumbling speech, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (rapid and shallow breathing), cerebral damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

In cases of severe intoxication, stupor or coma (especially if the medication has been taken with alcohol doses) may occur, as well as liver and kidney insufficiency.

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

The treatment of overdose is more effective if initiated within 4 hours of medication ingestion.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

Incase of overdose or accidental ingestion, immediately 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 Propalgina Plus:

If you forgot to take Propalgina Plus and symptoms persist, do not take a double dose to compensate for the missed dose. If necessary, take the medication in the same way as indicated in the section 3. How to take Propalgina Plus.

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

Like all medicines, Propalgina Plus may cause side effects, although not everyone will experience them.

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

Discomfort, hypotension (low blood pressure), elevated liver enzyme levels (liver function markers).

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

Alterations in blood cell count (such as thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia), sterile pyuria (cloudy urine), renal insufficiency, hypoglycemia (low blood sugar), hypersensitivity reactions, ranging from a simple skin rash or urticaria to anaphylactic shock (severe allergic reaction that can be fatal), severe skin reactions, hepatotoxicity (jaundice: yellowing of the skin and eyes).

Due to the different active ingredients in this medication, the following side effects may occur, whose frequency cannot be established with precision:

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

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

Severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting of side effects:

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

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Propalgina Plus after the expiration date that appears 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 the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Propalgina Plus

• The active principles are: 500 mg of paracetamol, 10 mg of dextromethorphan hydrobromide, 2 mg of chlorphenamine maleate, 7.5 mg of phenylephrine hydrochloride, and 200 mg 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 content of the packaging

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

Propalgina Plus is presented in composite paper/aluminum/polyethylene sachets.

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

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chaussee 1

06803 Bitterfeld-Wolfen

Germany

Last review date of this leaflet:March 2025

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.gob.es.