FRENADOL FORTE GRANULADO FOR ORAL SOLUTION

Warnings and precautions

• Do not take more than the recommended dose in section 3. "How to take FRENADOL? Forte". 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 analgesics, or medications that reduce fever. Additionally, they should be cautious not to take more than 3 sachets per day (2 g of paracetamol).
• While taking this medication, you cannot take other medications that contain paracetamol because a paracetamol overdose could occur, which could damage the liver. Do not use more than one medication that contains paracetamol without consulting your doctor.

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

• Patient with kidney, heart, 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 vesical neck, prostate hyperplasia with urine formation. Elderly patients who may be more sensitive to the secondary effects of this medication.
• Patient with atopic dermatitis.
• Patient slow metabolizers of CYP2D6 or using CYP2D6 inhibitors.
• Patient with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough accompanied by excessive secretions, glaucoma, or difficulty urinating due to prostate hyperplasia.

This medication can cause dependence. Therefore, treatment should be short-term.

This medicine can increase the sedative effects of central nervous system depressants, including alcohol, sedatives, and tranquilizers. Therefore, it is recommended to avoid drinking alcohol or taking central nervous system depressants (barbiturates, tranquilizers, MAOIs) while taking this medicine.

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

If you have serious 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 if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

This medication can cause drowsiness. Avoid consuming alcoholic beverages and certain medications while taking this medication, as they can potentiate this effect. Consult the sections "Taking FRENADOL? Forte with other medications" and "Taking FRENADOL? Forte with food, beverages, and alcohol".

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

Severe skin reactions, such as generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been very 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 suspended at the first appearance of skin rash or any other sign of hypersensitivity.

Cases of abuse with medications containing dextromethorphan have been described in adolescents, which can cause serious adverse effects (see section "If you take more FRENADOL? Forte than you should").

Taking FRENADOL? Forte 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 any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medications to treat epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medications to treat tuberculosis (isoniazid, rifampicin).
• Medications to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medications 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).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probenecid).
• Medications used to treat high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medications to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidone). The administration of FRENADOL? Forte should be separated by a minimum of 14 days after finishing treatment.
• Other medications for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications for schizophrenia (such as haloperidol).
• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of producing allergy to light).
• Medications used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Metoprolol, used to treat cardiovascular system diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used to treat 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 test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking/using this medication, as it may alter the results.

Taking FRENADOL

While taking this medication, you cannot drink alcoholic beverages, as it can potentiate the appearance of adverse effects of this medication.

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

Do not take the medication with grapefruit or bitter orange juice, as it can potentiate the effects of one of its components (dextromethorphan).

Pregnancy and lactation

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

This medication should not be taken during pregnancy unless your doctor considers it strictly necessary.

The 3 active ingredients of this medication are excreted in breast milk, so breastfeeding women should not take FRENADOL? Forte.

Driving and using machines

FRENADOL? Forte can cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

FRENADOL? Forte contains sodium:

This medication contains less than 23 mg of sodium (1 mmol) per sachet; this is, essentially "sodium-free".

FRENADOL? Forte contains sucrose:

This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patient with diabetes mellitus should be aware that this medication contains 8.87 g of sucrose per sachet.

FRENADOL? Forte contains orange yellow (E-110):

This medication can cause allergic reactions because it contains orange yellow (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

FRENADOL? Forte contains corn maltodextrin

This medication contains corn maltodextrin. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Frenadol Forte

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

The granules contained in the sachets of Frenadol Forte are for oral administration.

The recommended dose is:

Adults and adolescents from 14 years old:1 sachet every 6 or 8 hours (3 or 4 times a day), as needed. Preferably take 1 sachet before bedtime. Do not take more than 4 sachets (equivalent to 2.6 g of paracetamol) per day. See section "Warnings and precautions".

Patient with liver insufficiency:1 sachet every 8 hours. Do not take more than 3 sachets (equivalent to 1.95 g of paracetamol) per day. Consult your doctor.

Patient with renal insufficiency:You cannot take this medication due to the dose of paracetamol 650 mg.

Use in children

This medication is contraindicated in children under 14 years old due to the dose of its active ingredients.

Always use the lowest effective dose.

Start treatment when the first symptoms appear and suspend it as they disappear.

If you do not improve or worsen after 5 consecutive days of treatment (3 for fever or adolescents), you should consult your doctor. (See section 1. "What Frenadol Forte is and what it is used for").

How to take:

This medication is taken orally.

Pour the contents of a sachet into a half glass of water and stir until dissolved. You can add sugar or honey according to your preferences. At night, take preferably before bedtime.

If you take more Frenadol Forte than you should

Go immediately to a medical center, even if you do not have symptoms, as they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The most serious effect of an overdose of this medication is liver damage caused by paracetamol. You may feel dizzy, vomit, confused, excited, restless, nervous, irritable, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, states of drowsiness or alterations in gait.

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.

Cases of abuse with medications containing dextromethorphan have been described in adolescents, which can cause serious adverse effects, such as agitation, confusion, conversion disorders, hallucinations, ataxia (uncoordinated movements), coma, decreased consciousness, dysarthria (difficulty speaking), apathy, dystonia, nystagmus (involuntary and uncontrolled eye movement), convulsions, serotonin syndrome, tremor, depression, and central nervous system excitement, miosis, and mydriasis (contraction and dilation of the eye pupil), respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

The symptoms of an overdose of chlorphenamine may be central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased intestinal sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, convulsions, or arrhythmias. Patients with prolonged agitation, coma, or convulsions may rarely develop rhabdomyolysis and renal failure.

Treatment of overdose is more effective if started within 4 hours of taking the medication. Patients treated 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 medication and the amount ingested.

4. Possible adverse effects

Like all medications, Frenadol Forte can cause adverse effects, although not all people experience them.

The following adverse effects were reported in at least 1 in 100 subjects during clinical trials with chlorphenamine: drowsiness, dry mouth, dizziness, restlessness, pharyngitis, and dyspepsia.

The following adverse reactions were reported with an unknown frequency: anaphylactic reaction, hypersensitivity, insomnia, nervousness, and restlessness (psychomotor hyperactivity), abdominal pain, diarrhea, nausea, vomiting, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin eruptions, skin lesions after taking the medication (fixed drug eruption), as well as increased transaminases.

Frequency not known (cannot be estimated from available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with serious disease using paracetamol (see section 2).

Simultaneous consumption of alcohol during treatment can accentuate the appearance of adverse effects. Do not ingest alcoholic beverages during the same.

Reporting 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 Medications. Website: www.notificaram.es

5. Storage of Frenadol Forte

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofFRENADOL?Forte

The active ingredients are: paracetamol 650 mg, chlorphenamine 4 mg (as maleate) and dextromethorphan 20 mg (as hydrobromide).

The other components (excipients) are: sucrose, titanium dioxide (E-171), anhydrous citric acid, polysorbate 80, sodium citrate, povidone K 30, lemon flavor (containing corn maltodextrin), quinoline yellow (E-104), orange yellow (E-110).

Appearance of the Product and Package Contents

Yellow-colored oral solution granules with a lemon flavor.

Each package contains 10 sachets.

Date of the Last Revision of this Leaflet:February 2025

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