FRENADOL DESCONGESTIVO Hard Capsules

Introduction

Package Leaflet: Information for the User

FRENADOL?Decongestant Hard Capsules

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

Follow the instructions for administration of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or does not improve after 5 days of treatment (3 days for fever and for adolescents).

Contents of the Package Leaflet

1. What is FRENADOL? Decongestant and what is it used for
2. What you need to know before taking FRENADOL? Decongestant
3. How to take FRENADOL? Decongestant
4. Possible side effects
5. Storage of FRENADOL? Decongestant
6. Package Contents and Additional Information

1. What is FRENADOL (Decongestant and what is it used for

FRENADOL? Decongestant is an association of paracetamol that reduces fever and relieves pain, dextromethorphan that is a cough suppressant, chlorphenamine that helps reduce nasal secretion and sneezing, and pseudoephedrine that relieves nasal congestion.

This medicine is indicated for the symptomatic relief of colds and flu that present with mild or moderate pain such as headache, fever, unproductive cough (irritative cough, nervous cough), nasal secretion, and congestion, and sneezing for adults and adolescents from 12 years old.

You should consult your doctor if your condition worsens or does not improve after 5 days of treatment in adults or 3 days in adolescents, or if the fever persists for more than 3 days, or if the cough is accompanied by rash or persistent headache.

2. What you need to know before taking FRENADOL (Decongestant

Do not take FRENADOL?Decongestant

• if you are allergic to the active substances or to sympathomimetics such as antihistamine medicines or to any of the other components of this medicine listed in section 6.

• If you have severe hypertension (high blood pressure) or severe coronary artery disease.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure
  • If you are in the first trimester of pregnancy.
  • If you have severe liver disease.
  • If you have severe kidney failure or are undergoing hemodialysis.
  • If you have respiratory failure, asthmatic cough, or cough accompanied by expectoration.
  • If you are being treated with a class of medicines called "monoamine oxidase inhibitors" (MAOIs) or after two weeks of stopping treatment with these medicines. Concomitant use increases the risk of serotonin syndrome and can cause an increase in blood pressure and/or hypertensive crisis,
  • If you are or have recently been treated with other medicines, such as medicines for depression or Parkinson's disease, with linezolid, which is an antibiotic, or with procarbazine, which is a medicine for cancer (see section "Taking FRENADOL? Decongestant with other medicines"),
  • Children under 7 years old cannot take this medicine due to the dose of its active ingredients.

Warnings and Precautions

• Do not take more than the recommended dose in section 3. How to take FRENADOL? Decongestant. Taking more than the recommended dose (overdose) can result in liver damage. In case of overdose, seek medical help immediately. Prompt medical attention is critical for adults, as well as for children, even if you do not perceive any signs or symptoms.
• Chronic alcoholics should ask their doctor if they can take paracetamol, other pain relievers, or fever-reducing medicines. Additionally, they should be cautious not to take more than 4 capsules per day (2g of paracetamol) and should consult their doctor if they need to take paracetamol or other fever reducers (adult products).
• Patients who habitually consume alcohol (3 or more alcoholic beverages - beer, wine, liquor, ... - per day) may experience liver damage when taking this medicine.
• While taking this medicine, you cannot take other medicines that contain paracetamol because it could cause a paracetamol overdose that could damage the liver. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• You also cannot take other medicines that contain nasal decongestants. In case of overdose, seek medical attention immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are observed.
• If small pustules form, mainly non-follicular, which may or may not be accompanied by fever and a disseminated edematous erythema, mainly localized in skin folds, trunk, and upper limbs, especially in the first 2 days of treatment. You may be suffering from acute generalized exanthematous pustulosis that requires medical monitoring.
• If you suddenly experience abdominal pain, rectal bleeding, or other symptoms of ischemic colitis development. You should discontinue treatment and consult a doctor. Severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been rarely reported in patients taking paracetamol. Patients should be informed about the signs of severe skin reactions, and the use of the medicine should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
• There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medicines containing pseudoephedrine. PRES and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using FRENADOL? Decongestant immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to know the symptoms, see section 4 "Possible side effects").

You should consult your doctor or pharmacist before starting to take FRENADOL? Decongestant:

• Patient with kidney disease, pre-existing heart disease (such as arrhythmias or coronary disease) or lung disease, and patients with anemia.
• Patient with liver disease (with or without liver failure) or viral hepatitis, as it increases the risk of hepatotoxicity.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to others (such as chlorphenamine).
• Patient with hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, obstruction of the neck of the bladder, symptomatic prostatic hyperplasia, difficulty urinating, and urinary obstruction or retention.
• Patient with atopic dermatitis.
• Patient with diabetes mellitus.
• Patient with thyroid disease
• Patient with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough accompanied by excessive secretions.
• Patient with difficulty urinating and/or prostatic hyperplasia.
• Patient with a CYP2D6 slow metabolizer or using CYP2D6 inhibitors.

Patient with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough accompanied by excessive secretions, glaucoma, prostatic hyperplasia with residual urine formation, is recommended to consult a doctor before using this product.

During treatment with FRENADOL? Decongestant, inform your doctor immediately if:

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 the 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. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

With Frenadol Decongestant, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Frenadol Decongestant and contact your doctor or seek immediate medical attention. See section 4.

This medicine may cause dependence. Therefore, treatment should be short-term. Special caution is recommended in adolescents and young adults, as well as in patients with a history of drug abuse or use of psychoactive substances.

This medicine may produce sedation. Avoid consuming alcoholic beverages and certain medicines while being treated with this medicine, as they may potentiate this effect. Consult the sections "Taking FRENADOL? Decongestant with other medicines" and "Taking FRENADOL? Decongestant with food, beverages, and alcohol".

Patient over 60 years old may be especially sensitive to the adverse effects of the medicine because it contains pseudoephedrine, which is a sympathomimetic amine. Overdose of sympathomimetic amines in these patients, over 60 years old, can cause hallucinations, central nervous system depression, convulsions, and death.

Sedated, debilitated, or bedridden patients should not take this medicine.

In rare cases, severe skin reactions with redness, blisters, or rashes may occur. If you notice any of these symptoms, discontinue treatment and consult your doctor.

It is recommended not to take this medicine at the same time as other medicines for cough or nasal congestion. Consult "Taking FRENADOL? Decongestant with other medicines".

If you are going to undergo surgery, you should discontinue treatment with this medicine at least 24 hours in advance.

Children

Children under 12 years old cannot take this medicine due to the dose of its active ingredients.

Taking FRENADOL?Decongestant with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take 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 for treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines for treating tuberculosis (isoniazid, rifampicin).
• Medicines for preventing blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics that produce potassium loss (such as diuretics for treating hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used for treating gout (probenecid).
• Medicines used for treating high blood pressure (hypertension) or for promoting urine elimination (such as beta-blockers like propranolol, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine), and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines used to lower cholesterol levels in the blood (cholestyramine).
• Medicines that inhibit monoamine oxidase (MAOIs) used for treating depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidone). If you are being treated with any of these, you should separate their administration from the administration of FRENADOL? Decongestant by at least 15 days, both before and after. If not, because it contains pseudoephedrine, it can cause a severe increase in blood pressure, very high fever, and headache.
• Other medicines for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for treating schizophrenia (such as haloperidol).
• Medicines that produce central nervous system depression (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which have the adverse effect of producing allergy to light).
• Medicines used for relieving pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Medicines that alkalize urine (sodium bicarbonate, citrates).
• Inhaled anesthetic medicines.
• Medicines that stimulate the central nervous system (amphetamines, xanthines).
• Medicines used for heart conditions (digitalis glycosides).
• Medicines used for thyroid diseases (thyroid hormones).
• Medicine used for treating Parkinson's disease (levodopa).
• Medicines used for treating angina pectoris (nitrates).
• Cocaine, which, in addition to stimulating the central nervous system, can increase the effects on the heart when used with pseudoephedrine.
• Other medicines belonging to the pseudoephedrine group (sympathomimetic medicines), as they can potentiate the adverse effects of this medicine.
• Medicines that selectively inhibit serotonin reuptake, as they can cause serotonin syndrome.
• Metoprolol, used for treating cardiovascular system diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used for treating invasive aspergillosis and invasive mucormycosis.
• Flucloxacillin antibiotic due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2)

Interference with analytical tests:

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

Taking FRENADOL

While taking this medicine, you cannot consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medicine.

Additionally, the use of medicines that contain paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor,... per day) may cause liver damage.

You should not take this medicine with grapefruit or bitter orange juice, as it may potentiate the adverse effects of some of its components, dextromethorphan and pseudoephedrine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The use of medicines during pregnancy can be hazardous for the embryo or fetus and should be monitored by your doctor.

This medicine is contraindicated in the first trimester of pregnancy and should not be taken during the remaining period of pregnancy unless your doctor considers it strictly necessary.

The 4 active ingredients of this medicine are excreted in breast milk; therefore, breastfeeding women should not take FRENADOL? Decongestant unless the benefits of treatment for the mother outweigh the possible risks for the infant.

Driving and Using Machines

FRENADOL? Decongestant may produce sedation. If you notice these effects, avoid driving vehicles or using machines.

3. How to take FRENADOL (Decongestant)

Follow the administration instructions of the medicine 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: 1 capsule every 6 or 8 hours (3 or 4 times a day), as needed. Preferably take 1 capsule before bedtime. Do not take more than 4 capsules (equivalent to 2 g of paracetamol) per day. See section "Warnings and precautions".

Adolescents between 12 and 18 years: 1 capsule every 6 or 8 hours (3 or 4 times a day) as needed. Preferably take 1 dose before bedtime. Do not exceed 4 doses (equivalent to 2 g of paracetamol) per day.

Patient with liver failure: Must consult with their doctor. The recommended dose is 1 capsule every 8 hours. Do not take more than 4 capsules (equivalent to 2 g of paracetamol) per day.

Patient with kidney failure: Consult with your doctor. The recommended dose is 1 capsule every 6 or 8 hours, depending on the degree of kidney failure.

Use in children

• Children under 12 years cannot take this medicine due to the dose of its active ingredients.

Use in people over 60 years

People over 60 years are often more prone to the stimulating effects of one of the components of this medicine (pseudoephedrine), so sometimes the dose should be reduced. Consult with your doctor.

How to take

It is taken orally.

Take the capsule with the help of a glass of water.

Always use the smallest effective dose.

Treatment will be discontinued as symptoms disappear.

Consult your doctor if symptoms worsen or if symptoms persist after 5 days of treatment in adults or 3 days in adolescents, or if fever persists for more than 3 days, or if cough is accompanied by rash or persistent headache.

If you take more FRENADOL?Decongestant than you should

Go immediately to a medical center, even if there are no symptoms, since they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The most serious effect of overdose of the medicine is liver damage caused by paracetamol. You may feel dizziness, confusion, excitability, restlessness, nervousness, irritability, insomnia, dilation of the pupils, anxiety, agitation, hallucinations, tremors, convulsions, difficulty urinating, gastrointestinal upset, abdominal pain, feeling of general discomfort, nausea and vomiting, loss of appetite, rapid breathing and difficulty breathing, increased blood pressure, palpitations, alteration of heart rhythm (arrhythmias), tachycardia and reflex bradycardia, visual disturbances, yellowing of the skin and eyes (jaundice). In children, states of drowsiness or alterations in gait. In more severe cases, it can cause: decrease in potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, hypertensive crisis, arrhythmias, cerebral hemorrhage, myocardial infarction, rhabdomyolysis, and intestinal ischemic infarction.

Other symptoms in case of massive overdose may be: 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 of medicines containing dextromethorphan, with the possibility of serious adverse effects such as agitation, confusion, conversion disorder, mixed hallucinations, ataxia (uncoordinated movements), clumsiness, coma, decreased level of consciousness, dysarthria (alteration in the articulation of words), dystonia, lethargy, nystagmus (involuntary and uncontrolled movement of the eyes), convulsions, serotonin syndrome (neuromuscular disorders), tremors, miosis, mydriasis (pupil dilation), respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

Overdose of pseudoephedrine can cause nausea, vomiting, sympathomimetic symptoms, including stimulation of the central nervous system, insomnia, tremors, mydriasis, anxiety, agitation, hallucinations, convulsions, palpitations, tachycardia, hypertension, and reflex bradycardia (slowdown of heartbeats). Other effects may include arrhythmias, hypertensive crisis, cerebral hemorrhage, myocardial infarction, psychosis, rhabdomyolysis (breakdown of muscle tissue), hypokalemia, and intestinal ischemic infarction. Drowsiness has been reported in overdose in children.

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.

In case of overdose or accidental ingestion, go immediately to a medical center or, if not possible, consult the Toxicology Information Service (telephone: 91 5620420), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, FRENADOL? Decongestant may cause adverse effects, although not all people suffer from them.

Frequency not known: cannot be estimated from available data

• Serious diseases affecting the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Stop using FRENADOL? Decongestant immediately and seek urgent medical attention if you present symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision

The most frequent adverse effects are sedation and somnolence. The following adverse effects were reported in at least 1 in 100 subjects during clinical trials with chlorphenamine, chlorphenamine/paracetamol/pseudoephedrine/ single ingredient pseudoephedrine and paracetamol/pseudoephedrine: Asthenia, dizziness, dry mouth, dyspepsia, restlessness, insomnia, nausea, nervousness, pharyngitis, and somnolence.

During the period of use of the association of paracetamol, chlorphenamine, dextromethorphan, and pseudoephedrine, the following other adverse effects have occurred, whose frequency cannot be established with precision:

Severe allergic reactions, such as anaphylactic reaction, hypersensitivity, anxiety, euphoric mood, hallucinations, visual hallucinations, restlessness, stroke, headache, tingling and numbness in the limbs, nervousness and nervousness (psychomotor hyperactivity), tremors, arrhythmia, myocardial infarction, palpitations, tachycardia, abdominal pain, ischemic colitis, diarrhea, vomiting, severe skin reaction (acute generalized exanthematous pustulosis), angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin lesions after taking the medicine (fixed drug eruption), acute generalized exanthematous pustulosis, dysuria (difficulty urinating), and urinary retention. With the same frequency, general disorders such as irritability, increased blood pressure, increased transaminases, and decreased blood flow to the optic nerve (ischemic optic neuropathy).

The simultaneous consumption of alcohol during treatment may increase the appearance of adverse effects. Do not ingest alcoholic beverages during the same.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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. Website: www.notificaram.es

5. Conservation of FRENADOL (Decongestant)

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medicine after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that are no longer needed in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

The active ingredients are: paracetamol 500 mg, chlorphenamine 2 mg (as maleate), dextromethorphan 15 mg (as hydrobromide), and pseudoephedrine 30 mg (as hydrochloride)

The other components (excipients) are: pregelatinized cornstarch, colloidal silicon dioxide, magnesium stearate, gelatin, erythrosine (E-127), quinoline yellow (E-104), titanium dioxide (E-171), black iron oxide (E-172)

Appearance of the product and package contents

They are hard gelatin capsules, red and white opaque, with the name "Frenadol decongestant" serigraphed.

Each package contains 16 capsules.

Date of the last revision of this prospectus:February 2025

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