Frenadol Junior 10 sobres

Label information

• You should not take more than the recommended dose in section 3. How to take FRENADOL® Junior. 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. They should also be cautious not to take more than 6 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.

You should consult your doctor or pharmacist before starting to take FRENADOL® Junior:

• Patients with kidney, heart, or lung diseases and patients with anemia.
• Patients with liver diseases (with or without liver failure) or viral hepatitis, as it increases the risk of hepatotoxicity.
• Patients with asthma 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 (high eye pressure), hyperthyroidism, bladder neck obstruction, prostate hyperplasia with residual urine formation. Elderly patients who may be more sensitive to the side effects of this medication.
• Patients with atopic dermatitis.
• 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.
• Patients who are slow metabolizers of CYP2D6 or who are using CYP2D6 inhibitors.

 

During treatment with FRENADOL® Junior, inform your doctor immediately if:

You have serious illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in the blood and fluids) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol along with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, a feeling of discomfort (nausea), and vomiting.

This medication may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while being treated with this medication, as they may enhance this effect. Consult the sections “Taking FRENADOL Junior with other medications” and “Taking FRENADOL Junior with food, beverages, and alcohol.”

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

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

Serious 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 serious skin reactions, and the use of the medication should be discontinued at the first appearance of a rash or any other sign of hypersensitivity.