Label information
• You should 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. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
• Chronic alcoholics should ask their doctor if they can take paracetamol, other pain relievers, or medicines that reduce fever. Additionally, they should be cautious not to take more than 3 sachets a day (2 g of paracetamol).
• While taking this medication, you cannot take others that contain paracetamol because it could lead to a paracetamol overdose that 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:
Patients with kidney, heart, or lung diseases and patients with anemia.
• Patients with liver diseases (with or without liver failure) or viral hepatitis, because it increases the risk of hepatotoxicity.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to an antihistamine, because they may be sensitive to others (such as chlorphenamine).
• Patients with hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, bladder neck obstruction, prostate hyperplasia with urine formation. Elderly patients who may be more sensitive to the side effects of this medication.
• Patients with atopic dermatitis.
• Patients who are slow metabolizers of CYP2D6 or who use CYP2D6 inhibitors.
• Patients 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 may cause dependence. Therefore, treatment should be of short duration.
This medicine may increase the sedative effects of central nervous system depressants, including alcohol, sedatives, and tranquilizers. Therefore, it is recommended to avoid drinking alcohol or taking CNS depressants (barbiturates, tranquilizers, MAOIs) while taking this medicine.
This medication may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while you are being treated with this medication, as they may enhance this effect. Consult the sections “Taking FRENADOL® Forte with other medications” and “Taking FRENADOL® Forte with food, beverages, and alcohol.”
Patients who are sedated, weakened, or bedridden 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 reported very rarely 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 a rash or any other sign of hypersensitivity.
Cases of abuse with medications containing dextromethorphan have been described in adolescents, so this possibility should be taken into account, as it may lead to serious adverse effects (see section “If you take more FRENADOL® Forte than you should”).
Safety visual aids
We recommend that you read the package leaflet before using the product for safety warnings.
Manufacturer details
Details of the manufacturer can be found in the package leaflet.
Authorised EU Representative
Details of the manufacturer and, if applicable, the EU Responsible Party can be found in the package leaflet.
