Package Leaflet: Information for the User

FRENADOL?Decongestant Hard Capsules

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

Follow exactly the administration instructions 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 your doctor if you get worse or do not improve after5 days of treatment(3 days for fever and for adolescents).

1. What is FRENADOL?Decongestant and its use

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. Contents of the pack and additional information

FRENADOL?Decongestantis an association of paracetamol that reduces fever and relieves pain, dextromethorphan which is an antitussive, chlorphenamine that helps to reduce nasal secretion and sneezing, and pseudoephedrine that relieves nasal congestion.

This medication is indicated for symptomatic relief of colds and flu that are accompanied by mild or moderate pain such as headache, fever, unproductive cough (irritative cough, nervous cough), nasal secretion and congestion, and sneezingfor adults and adolescents aged 12 years and above.

You should consult your doctor if you worsen or do not improveafter 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.

Do not take FRENADOL?Decongestant

• If you are allergic to the active principles of sympathomimetics such as antihistamines or any of the other components of this medication 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 by medication

-If you have severe, acute (sudden) or chronic (long-term) kidney disease, or kidney failure

• If you are in the first trimester of pregnancy.
• If you have a severe liver disease.
• If you have severe renal insufficiency or are undergoing hemodialysis.
• If you have respiratory insufficiency, asthma, or cough with excessive sputum production.
• If you are being treated with a class of medications called "monoamine oxidase inhibitors" (MAOIs) or within two weeks of stopping treatment with these medications. Concomitant use increases the risk of serotonin syndrome and may cause increased blood pressure and/or hypertensive crisis.
• If you are or have recently been treated with other medications, such as antidepressants or Parkinson's disease medications, with linezolid, an antibiotic, or with procarbazine, a cancer medication (see "Taking FRENADOL?Decongestant with other medications"),
• Children under 7 years old cannot take this medication due to the dose of its active principles.

Warnings and precautions

• Do not take more than the recommended dose in section 3. Taking more than the recommended dose (overdose) may cause liver damage. If you experience an overdose, seek medical help immediately. Prompt medical attention is critical for adults as well as for children, even if you do not perceive any symptoms or signs.
• Chronic alcoholics should ask their doctor if they can take paracetamol, other analgesics, or medications that reduce fever. Additionally, they should be careful not to take more than 4 capsules per day (2g of paracetamol) and consult their doctor if they should take paracetamol or other fever reducers (adult products).
• Patients who regularly consume alcohol (3 or more alcoholic beverages - beer, wine, liquor, etc. - per day) may experience liver damage when taking this medication.
• Do not take other medications that contain paracetamol while taking this medication, as it may cause a paracetamol overdose that can damage the liver. Do not use more than one medication that contains paracetamol without consulting your doctor.
• You should not take other medications that contain decongestants.Seek medical attention immediately in case of an overdose. Prompt medical attention is critical for both adults and children, even if you do not observe any symptoms or signs.
• If small pustules, primarily non-follicular, appear, which may or may not be accompanied by fever and widespread edematous erythema, primarily located in skin folds, the trunk, and upper limbs, especially within the first two days of treatment, you may be experiencing generalized acute pustular exanthema, which should be medically monitored.
• If you suddenly experience abdominal pain, rectal bleeding, or other symptoms of developing ischemic colitis, discontinue treatment and consult a doctor.Severe skin reactions, such as generalized acute pustular exanthema (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been rarely reported in patients receiving paracetamol. Patients should be informed about the signs of severe skin reactions, and the use of the medication should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
• Reversible posterior leukoencephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medications containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop usingFRENADOL?Decongestant immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects").

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

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

Patients with a persistent respiratory condition such as emphysema, chronic bronchitis, asthma, or cough with excessive sputum production, glaucoma, benign prostatic hyperplasia with residual urine, should consult their doctor before using this product.

Inform your doctor or pharmacist immediately if you experience any of the following during treatment with FRENADOL?Decongestant:

If you have severe diseases, 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 are also taking flucloxacillin (an antibiotic). A severe disease 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.

Frenadol Decongestant may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking Frenadol Decongestant and seek medical attention immediately. See section 4.

This medication may cause dependence. Therefore, treatment should be of short duration. Special caution is recommended for adolescents and young adults, as well as for patients with a history of substance abuse or use of psychoactive substances.

This medication may cause sedation. Avoid consuming alcoholic beverages and certain medications while taking this medication, as they may potentiate this effect. See the sections "Taking FRENADOL?Decongestant with other medications" and "Taking FRENADOL?Decongestant with foods, beverages, and alcohol".

Patients over 60 years old may be especially sensitive to the medication's adverse effects due to the presence of pseudoephedrine, a sympathomimetic amine. An overdose of sympathomimetic amines in these patients, over 60 years old, may cause hallucinations, central nervous system depression, seizures, and death.

Patients who are sedated, debilitated, or bedridden should not take this medication.

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

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

You should discontinue treatment with this medication at least 24 hours before surgery.

Children

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

Taking FRENADOL?Decongestant with other medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

In particular, 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 for treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medications for treating tuberculosis (isoniazid, rifampicin).
• Medications used to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medications used to increase urine elimination (diuretics of the loop such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probenecid).
• Medications used to treat high blood pressure (hypertension) or to promote urine elimination (beta-blockers such as propranolol, ACE inhibitors, rauwolfia alkaloids such as reserpine, metildopa, guanetidina), and heart rhythm alterations (arrhythmias) such as amiodarone or quinidine.
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications that inhibit monoamine oxidase (MAOIs) used to treat depression (moclobemide, tranilcipromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidine). If you are being treated with any of them, you should separate their administration from the administration of FRENADOL?Decongestant by at least 15 days, both before and after. If not, due to the presence of pseudoephedrine, you may experience severe hypertension, high fever, and headache.
• Other medications for treating depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications for treating schizophrenia (such as haloperidol).
• Medications that cause central nervous system depression (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medications (that cause hearing damage).
• Phototoxic medications (that cause light allergy).
• Medications used to relieve pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Alkalizing medications for urine (sodium bicarbonate, citrates).
• Anesthetic medications by inhalation.
• Medications that stimulate the nervous system (amphetamine, xanthines).
• Medications used for heart disease (digitalis glycosides).
• Medications used for thyroid disease (thyroid hormones).
• Medication used for Parkinson's disease (levodopa).
• Medications used for angina pectoris (nitrates).
• Cocaine, which, in addition to stimulating the nervous system, its use with pseudoephedrine may increase its effects on the heart.
• Other medications belonging to the pseudoephedrine group (sympathomimetic medications), as they may potentiate the adverse effects of this medication.
• Medications that inhibit selective serotonin reuptake, as they may cause serotonin syndrome.
• Metoprolol, used to treat cardiovascular system diseases (hypertension, acute myocardial infarction).
• Isoconazole, used to treat invasive aspergillosis and mucormycosis.
• Flucloxacillin, an antibiotic, due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

Interference with diagnostic tests:

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

Taking FRENADOL?Decongestant with foods, beverages, and alcohol

You should not take alcoholic beverages while taking this medication, as it may potentiate the appearance of adverse effects of this medication.

Additionally, the use of medications containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic beverages - beer, wine, liquor, etc. - per day) may cause liver damage.

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. The consumption of medications during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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

The 4 active principles of this medication are excreted in breast milk, so women in the lactation period should not takeFRENADOL?Decongestant unless the benefits of the treatment for the mother outweigh the possible risks to the infant.

Driving and operating machinery

FRENADOL?Decongestant may cause drowsiness. If you experience these effects, avoid driving vehicles or operating machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in 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.Take 1 capsule preferably before going to bed. Do not take more than 4 capsules (equivalent to 2 g of paracetamol) per day.See the "Warnings and precautions" section.

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

Patients with liver insufficiency: Consult your 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.

Patients with renal insufficiency: Consult your doctor. The recommended dose is 1 capsule every 6 or 8 hours, depending on the degree of insufficiency.

Use in children

• Children under 12 years cannot take this medication, due to the dose of its active principles.

Use in people over 60 years

People over 60 years are more prone to the stimulating effects of one of the components of this medication (pseudoephedrine), so the dose may need to be reduced. Consult 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.

The treatment will be discontinued as symptoms disappear.

Consult your doctor if symptoms worsen or 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 to a medical center immediately, even if you have no symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The most severe effect of overdose is liver damage caused by paracetamol. You may feel dizziness, confusion, excitement, restlessness, nervousness, irritability, insomnia, dilated pupils, anxiety, agitation, hallucinations, tremors, convulsions, difficulty urinating, gastrointestinal discomfort, abdominal pain, general feeling of discomfort, nausea, and vomiting, loss of appetite, rapid breathing, and difficulty breathing, increased blood pressure, palpitations, arrhythmias, tachycardia, and bradycardia, visual disturbances, yellowing of the skin and eyes (jaundice). In children, states of somnolence, or gait disturbances. In severe cases, it can cause: hypokalemia, altered perception of reality (psychosis), convulsions, coma, hypertensive crisis, arrhythmias, intracerebral hemorrhage, myocardial infarction, rhabdomyolysis, and ischemic intestinal infarction.

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

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

Cases of abuse of medicines containing dextromethorphan have been reported, with the possibility of serious adverse effects such as agitation, confusion, conversion disorder, mixed hallucinations, ataxia, clumsiness, coma, decreased level of consciousness, dysarthria, dystonia, lethargy, nystagmus, convulsions, serotoninergic syndrome (neuromuscular disorders), tremors, miosis, mydriasis, respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

Pseudoephedrine overdose can cause nausea, vomiting, sympathomimetic symptoms, including stimulation of the central nervous system, insomnia, tremors, mydriasis, anxiety, agitation, hallucinations, convulsions, palpitations, tachycardia, hypertension, and bradycardia. Other effects may include arrhythmias, hypertensive crisis, intracerebral hemorrhage, myocardial infarction, psychosis, rhabdomyolysis, hypokalemia, and ischemic intestinal infarction. Somnolence has been reported in children in cases of overdose.

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.

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

Like all medicines, FRENADOL?Decongestant, can cause side effects, although not everyone will experience them.

Unknown frequency: cannot be estimated from available data

- Severe diseases affecting the blood vessels in the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).

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

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

• Sudden onset of severe headache

• Malaise

• Vomiting

• Confusion

• Seizures

• Changes in vision

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

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

Severe allergic reactions, such as anaphylactic reaction, hypersensitivity, anxiety, euphoric mood, hallucinations, visual hallucinations, restlessness, cerebrovascular accident, headache, paresthesia, and numbness in the extremities, nervousness, and hyperactivity (psychomotor hyperactivity), tremor, 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 medication (fixed drug exanthema), acute generalized exanthematous pustulosis, dysuria (difficulty urinating), and urinary retention.

The same frequency as general disorders such as irritability, increased blood pressure, increased transaminases, and decreased blood flow to the optic nerve (ischemic optic neuropathy).

Concurrent consumption of alcohol during treatment may increase the occurrence of side effects. Do not consume alcoholic beverages during treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 of Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es

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

Do not store at a temperature above 86°F (30°C).

Do not use this medication 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 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.This will help protect the environment.

The active principles 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), yellow quinoline (E-104), titanium dioxide (E-171), iron oxide black (E-172)

Appearance of the product and contents of the packaging

They are hard gelatin capsules of red and white opaque color, with the name "Frenadol decongestant" printed

Each package contains 16 capsules.

Last review date of this leaflet: February 2025

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/