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.