Propalgina plus oral solution powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Propalgina Plus powder for oral solution

Paracetamol / Chlorphenamine maleate / Phenylephrine hydrochloride /
Dextromethorphan hydrobromide / Ascorbic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days of treatment in the case of fever, or 5 days in the case of pain.

Contents of the leaflet

1. What Propalgina Plus is and what it is used for
2. What you need to know before taking Propalgina Plus
3. How to take Propalgina Plus
4. Possible side effects
5. How to store Propalgina Plus
6. Contents of the pack and other information

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

Propalgina Plus is a combination of paracetamol, effective for reducing pain and fever; dextromethorphan, which suppresses the cough reflex; chlorpheniramine, an antihistamine with drying effect on nasal mucosa; phenylephrine, a nasal decongestant; and vitamin C.

This medicine is indicated for the symptomatic relief of catarrhal and influenza-like conditions associated with mild to moderate pain, fever, non-productive cough, nasal congestion, and nasal discharge in adults and adolescents aged 12 years and older.

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

2. What you need to know before taking Propalgina Plus

Do not take Propalgina Plus

• If you are allergic to paracetamol, chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide, vitamin C (ascorbic acid), tartrazine, or any of the other components of this medicine (listed in section 6). Cross-sensitivity 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 severe lung disease.
• If you have asthmatic cough.
• If you suffer from asthma.
• If you have a cough accompanied by abundant secretions.
• If you are currently being treated, or have been treated within the previous 2 weeks, with a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson’s disease, or other conditions, or if you are being treated with serotonin reuptake inhibitors (SSRIs). (See section "Taking other medicines").
• If you have severe renal or hepatic insufficiency.
• If you have cardiovascular insufficiency or ischemic heart disease (angina pectoris, myocardial infarction).
• If you have pneumonia.
• If you have respiratory insufficiency.
• If you have arterial hypertension (high blood pressure).
• If you have hyperthyroidism (increased activity of the thyroid gland).
• If you have glaucoma (increased eye pressure).
• If you have bladder neck obstruction or urinary retention.
• If you are undergoing combination therapy with oral anticoagulants (medicines to prevent blood clots).
• If you have oxalate urolithiasis (formation of oxalate stones in the urinary tract) or hyperoxaluria (urinary oxalic acid or oxalate concentration higher than normal).
• If you have or have had nephrolithiasis (kidney stones).
• If you have haemochromatosis (a condition in which excess iron accumulates in the body).

Warnings and precautions

• Do not take more medicine than the recommended dose stated in section 3. How to take Propalgina Plus.
• Chronic alcoholics should take care not to exceed 4 sachets of this medicine in 24 hours.
• If you are undergoing treatment for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol.
• Avoid using this medicine simultaneously with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Avoid taking this medicine with alcoholic beverages.
• Patients sensitive to one antihistamine may also be sensitive to others.
• If you notice skin redness, rash, blisters, or peeling, stop treatment and consult your doctor.

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

Patients should consult their doctor before using this medicine if they have:

• Kidney, liver, heart, or lung disease, or anemia,
• Asthma sensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• Gilbert's syndrome (a hereditary condition characterized by high bilirubin levels),
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia),
• Genetic liver diseases,
• Chronic or persistent cough, such as that caused by smoking. In children, chronic cough could be an early sign of asthma,
• Atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in childhood in individuals with hereditary allergic predisposition),
• Sedation, weakness, or are bedridden.
• Consult your doctor or pharmacist if you have any of the following conditions: pheochromocytoma (a rare tumor causing increased hormone production), cardiovascular diseases, diabetes mellitus, prostate hypertrophy (enlarged prostate), pancreatitis (inflammation of the pancreas), pyloroduodenal obstruction (intestinal obstruction), thyroid disorders, pulmonary and renal diseases, or anemia, as phenylephrine may worsen the condition and interact with medicines commonly used to treat them.
• Patients being treated with tricyclic antidepressants, maprotiline, or other medicines with anticholinergic action (medicines used to relieve stomach, intestinal, or bladder spasms) 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 them, 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, arterial hypertension, 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 develop serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Cases of abuse with medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section If you take more Propalgina Plus than you should).

Children and adolescents

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

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Propalgina Plus with other medicines

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

In particular, if you are using any of the following medicines, dose adjustments or discontinuation of treatment may be necessary:

• 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 spasms or contractions of the stomach, intestine, and bladder: Anticholinergics (propantheline).
• Medicines to treat tuberculosis: Antituberculosis drugs (isoniazid, rifampicin).
• Medicines to treat depression and seizures: Barbiturates used as hypnotics, sedatives, and anticonvulsants.
• Tricyclic antidepressants (maprotiline), tetracyclic antidepressants (used to treat secondary depressive disorders in alcoholic patients), and serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine).
• Medicines used to lower cholesterol levels in the blood: Colestyramine.
• Medicines used to treat gout: Uricosurics (probenecid and sulfinpyrazone).
• Tetracycline (used to treat bacterial infections).
• Some diuretics used to increase urine output (loop diuretics such as furosemide).
• Antihypertensive medicines (used to treat high blood pressure): Rauwolfia alkaloids and medicines with mechanisms of action related to the sympathetic nervous system (such as propranolol, also used for heart rhythm disorders (cardiac arrhythmias)).
• Medicines used for heart conditions: Digitalis glycosides and antiarrhythmics.
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone, or tropisetron and granisetron (used in chemotherapy).
• Do not use this medicine with other analgesics, such as acetylsalicylic acid (pain-relieving medicines), without consulting your doctor.
• Monoamine oxidase inhibitors (MAOIs) used to treat depression (tranilcypramine, moclobemide) or Parkinson’s disease (selegiline), furazolidone or linezolid (antibacterial agents), and procarbazine (used to treat cancer). Serious adverse effects may occur, including severe headache, elevated blood pressure, sudden rise in body temperature, dizziness, palpitations, muscle contractions, and coma, among other symptoms. If you have taken any 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, childbirth, blood pressure, or other conditions).
• Beta-adrenergic blockers (for blood pressure and other conditions).
• General anesthetics.
• Atropine sulfate (for heart or digestive disorders).
• 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 conditions such as Parkinson’s disease, cocaine withdrawal syndrome, menstrual disorders such as amenorrhea (absence of menstruation), etc.).
• Ototoxic medicines (medicines that may damage the ear), such as certain antibiotics (aminoglycosides) and antitumor agents (bleomycin and cisplatin).
• Photosensitizing medicines (medicines that may cause photosensitivity reactions to light), such as certain antidepressants, antibiotics (sulfonamides), and some diuretics.
• Oral contraceptives containing estrogens.
• Deferoxamine (a medicine used to remove excess iron from the body).
• Cyclosporine (a medicine used to help the body accept a transplanted organ (such as kidney, liver, or heart)).
• Anti-inflammatory medicines (celecoxib, parecoxib, valdecoxib).
• CYP2D6 inhibitors (used to treat psychiatric disorders), such as haloperidol.
• Medicines that cause central nervous system depression (sedation or deeper effects), such as those used to treat insomnia or anxiety, antihistamines, or some used to treat Parkinson’s disease.
• Amiodarone and quinidine (to treat heart 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 blood and fluid imbalance (called metabolic acidosis) requiring 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 this medicine with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.

Taking this medicine with food, except for the above-mentioned items, does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

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

Propalgina Plus must not be taken during pregnancy or breastfeeding unless specifically prescribed by your doctor.

Driving and use of machines

The effect of Propalgina Plus on the ability to drive and operate machinery is moderate. This medicine may cause drowsiness or sedation; therefore, if you experience these symptoms, you must not drive or operate machinery.

Propalgina Plus contains sucrose and sodium

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

Patients 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 (main component of table/cooking salt) per sachet. This corresponds to 1.7% of the maximum daily recommended sodium intake for an adult.

3. How to take Propalgina Plus

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents over 14 years of age:

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

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

Patients with liver disease

Before taking this medicine, you must consult your doctor.

You should take the amount of medicine prescribed by your doctor, with a minimum interval of 8 hours between doses.

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

Patients with kidney disease

Before taking this medicine, you must consult your doctor.

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

Depending on your condition, your doctor will indicate whether you should take the medicine with a minimum interval of 6 or 8 hours.

This medicine is taken orally.

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

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

Always take the lowest effective dose.

Treatment with this medicine should only be initiated when symptoms of influenza or colds, for which this medicine is indicated, appear. As these symptoms resolve, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor.

For sore throat, do not take the medicine for more than 2 consecutive days without consulting your doctor.

If you take more Propalgina Plus than you should:

You must consult your doctor immediately.

If you take more Propalgina Plus than recommended, you may experience the following symptoms: dizziness, vomiting, loss of appetite, abdominal pain, nausea, occasionally diarrhea, yellowing of the skin and eyes (jaundice), sweating, general malaise, fear, agitation, excitability, restlessness, nervousness, insomnia, psychosis with hallucinations (seeing or hearing things that are not present), mental confusion, irritability, dizziness, headache, blurred vision, miosis (pupil constriction), clumsiness or instability, intense drowsiness, severe dryness of the mouth, nose, or throat, facial flushing, dyspnea (difficulty breathing), vasodilation and hyperventilation, tremors, and effects on the cardiovascular system such as cerebral hemorrhage and pulmonary edema, peripheral vasoconstriction (reduction in blood vessel diameter), reduced blood flow to vital organs, possibly decreasing renal perfusion, reduced urine output, metabolic acidosis (decreased blood alkaline reserve), paresthesias (sensory disturbances in body areas). With prolonged use, plasma volume depletion (decreased blood volume) may occur.

Taking very high amounts of this medicine may cause the following symptoms in children: hallucinations, drowsiness, rashes, nausea, nervousness, involuntary eye movements, and gait disturbances, among others.

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, disturbances of consciousness, rapid and involuntary eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations and hyperexcitability.

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

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

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

Cases of abuse with medicines such as Propalgina Plus, which contain dextromethorphan, have been reported, potentially leading to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (increased heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

Mild withdrawal symptoms have been documented after discontinuation of medicines such as Propalgina Plus containing dextromethorphan, following daily and prolonged use, including restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, and chills.

In cases of severe intoxication, stupor or coma (especially if the medicine was taken with alcohol) may occur, along with liver and kidney failure.

If you have ingested an overdose, you must go immediately to a medical center, even if you do not feel symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe intoxication.

Treatment of overdose is most effective if started within 4 hours after ingestion of the medicine.

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

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

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

If you forget to take Propalgina Plus

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

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

4. Possible adverse effects

Like all medicines, Propalgina Plus can cause adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 1,000 people):

Malaise, hypotension (reduced blood pressure), increased levels of liver transaminases (markers of liver function).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Blood cell count abnormalities (such as thrombocytopenia, agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), sterile pyuria (cloudy urine), renal failure, hypoglycaemia (decreased blood glucose levels), hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock (a very severe allergic reaction which may be fatal), serious skin reactions, hepatotoxicity (jaundice: yellowing of the skin and eyes).

Due to the different active substances in this medicine, the following adverse effects may occur, for which the frequency cannot be precisely determined:

Dizziness, vertigo, and drowsiness, headache, restlessness, anxiety, nervousness, weakness, dizziness, tremors, insomnia, irritability, involuntary facial movements, tremor, tingling or numbness, and even mental confusion. At high doses, seizures and psychosis with hallucinations may occur; clumsiness may occur, and paradoxical excitation may be observed, especially with high doses and in children or elderly patients, characterized by restlessness, insomnia, tremors, nervousness, delirium, palpitations, and even seizures; skin reactions such as rash, pallor, piloerection (goosebumps), increased sweating, skin redness, allergic dermatitis, itching, and oedema (swelling); severe hypersensitivity reactions such as severe generalized pustular eruptions (containing pus), outbreaks such as erythema multiforme, Stevens-Johnson syndrome (acute inflammatory disease), toxic epidermal necrolysis (a serious skin condition characterized by the appearance of blisters); respiratory system effects such as dryness of the nose and throat, thickening of mucus, wheezing (lung noise), bronchospasm (narrowing of the bronchi), and asthma including analgesic-induced asthma syndrome or pulmonary oedema (fluid accumulation in the lungs), generally at high doses or in susceptible individuals; hypersensitivity (allergic) reactions such as cough, difficulty swallowing, rapid heartbeat, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, fatigue, rashes, allergic angioedema (swelling under the skin), photosensitivity (sensitivity to sunlight), cross-sensitivity with medicines related to chlorpheniramine, etc.; gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal pain, constipation, stomach discomfort including upper stomach pain and stomach cramps, dry mouth, loss of appetite, taste or smell disturbances; liver-related adverse effects such as cholestasis (reduced bile flow), liver failure, hepatitis, dose-dependent hepatic failure; chronic administration may lead to hepatic fibrosis and cirrhosis, which may result in fatal outcomes; kidney-related adverse 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 urinary tract stone formation or gout attacks in predisposed individuals; cardiac disorders such as myocardial infarction, tachycardia, chest pain or discomfort, severe bradycardia (very slow heart rate), possible induction or worsening of heart failure associated with heart disease; vascular disorders such as cerebral haemorrhage, hypertension and hypotension (high or low blood pressure), peripheral vasoconstriction (reduction in blood vessel diameter); cold extremities, flushing; prolonged use may lead to decreased blood volume; metabolic disorders such as hyperglycaemia (increased blood sugar), hypokalaemia (low potassium levels in blood), and metabolic acidosis (occurs when the body produces too much acid or the kidneys do not remove enough acid from the body); vision disorders such as blurred vision or double vision; ear-related disturbances such as tinnitus or ear inflammation and irritation; impotence or menstrual disorders have also been reported.

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

A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Propalgina Plus

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Propalgina Plus after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Propalgina Plus

• The active substances are: 500 mg paracetamol, 10 mg dextromethorphan hydrobromide, 2 mg chlorphenamine maleate, 7.5 mg phenylephrine hydrochloride and 200 mg 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 flavouring-colouring.

Appearance of the medicine and contents of the pack

Propalgina Plus is a uniform granulate with a yellowish-pink colour.

Propalgina Plus is supplied in sachets made of Paper/Aluminum/Polyethylene.

It is packaged 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 most recent review of this package leaflet: March 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.