PATIENT INFORMATION LEAFLET

FRENADOL?Junior granulated oral solution

Paracetamol/Chlorphenamine/Dextromethorphan

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 given 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 after3 days.

1. What is FRENADOL?Junior and for what it is used.

2. What you need to know before starting to take FRENADOL?Junior.

3. How to take FRENADOL?Junior.

4. Possible side effects.

5. Storage of FRENADOL?Junior.

6. Contents of the pack and additional information.

FRENADOL?Junior is a combination of paracetamol that reduces fever and relieves pain, dextromethorphan which is an antitussive and chlorphenamine that helps to reduce nasal secretion.

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) and nasal secretionin children over 6 years and adolescents.

You should consult your doctor if it worsens, or if the symptoms persist after 3 days of treatment.

Do not take FRENADOL?Junior

• If you are allergic to the active ingredients or any of the other components of this medication listed in section 6.
• If you have a severe liver or kidney disease.
• If you are being treated with a class of medications called monoamine oxidase inhibitors (MAOIs) or after 2 weeks of having completed treatment with these medications.
• If you have respiratory insufficiency, asthma, or cough with expectoration.
• If you are or have recently been treated with other medications, such as antidepressants or Parkinson's disease medications, with linezolid, which is an antibiotic, or with procarbazine, which is a cancer medication (see the section “Taking FRENADOL?Junior with other medications”).
• Children under 6 years old cannot take this medication.

Warnings and precautions

• Do not take more than the recommended dose listed in section3. How to take FRENADOL?Junior.Taking more than the recommended dose (overdose) may 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. They should also be careful not to take more than 6 packets per day (2 gof paracetamol).
• While taking this medication, do not take other medications that contain paracetamol, as it may cause 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 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 (elevated blood pressure), glaucoma (elevated intraocular pressure), hyperthyroidism, urinary obstruction, benign prostatic hyperplasia with residual urine. 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, asthma, or cough with excessive secretions, glaucoma, or difficulty urinating due to benign prostatic hyperplasia.
• Patients who are slow metabolizers of CYP2D6 or who use CYP2D6 inhibitors.

During treatment with FRENADOL?Junior, inform your doctor immediately 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 if you 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, drowsiness, feeling unwell (nausea), and vomiting.

This medication may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while taking this medication, as they may potentiate this effect. See the sections “Taking FRENADOL?Junior with other medications” and “Taking FRENADOL?Junior with food, beverages, and alcohol”.

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 notice any of these symptoms, discontinue treatment and consult your doctor.

Severe skin reactions, such as generalized pustular psoriasis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported rarely 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.

Taking FRENADOL?Junior with other medications

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

Particularly, if you are using any 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 for preventing blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medications used to increase urine elimination (diuretics of the loop such as those in the furosemide group, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for treating hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used for treating gout (probencid).
• Medications used for treating high blood pressure (hypertension), such as propranolol and arrhythmias (abnormal heart rhythms), such as amiodarone or quinidine.
• Medications for lowering cholesterol levels in the blood (cholestyramine).
• Medications used for treating depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline) or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidine). The administration of FRENADOL?Junior should be separated from these medications by at least 14 days after completing treatment.
• Other medications for treating depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications for schizophrenia (such as haloperidol).
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Medications ototoxic (that damage the ear as an adverse effect).
• Medications photosensitizing (that cause allergic reactions to light).
• Medications used for pain relief and inflammation (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Metoprolol, used for treating cardiovascular diseases (hypertension, acute myocardial infarction).
• Isoconazole, used for treating invasive aspergillosis and mucormycosis.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Interference with diagnostic tests:

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

Taking FRENADOL?Junior with food, beverages, and alcohol

While taking this medication, do not consume alcoholic beverages, as they 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.

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. The consumption of medications during pregnancy may be hazardous to 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 women in the lactation period should not takeFRENADOL?Junior.

Driving and operating machinery

FRENADOL?Juniormay cause drowsiness, affecting mental and/or physical ability. If you notice these effects, avoid driving vehicles or operating machinery.

FRENADOL?Junior contains sodium:

This medication contains 77 mg of sodium (main component of table salt/for cooking) in each . This is equivalent to 3.94% of the maximum daily sodium intake recommended for an adult. Consult your doctor or pharmacist if you need one or more packets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

FRENADOL?Junior 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. Patients with diabetes mellitus should note that this medication contains 4.12 g of sucrose per packet.

FRENADOL?Junior contains Yellow S (E-110):

This medication may cause allergic reactions because it contains Yellow S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

FRENADOL?Junior contains soy oil:

This medication contains soy oil . It should not be used in case of soy allergy.

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 granule contained in the FRENADOL®Junior sachets is for oral administration.

The recommended dose is:

Children aged6 to12 years:(weight between21.5 kgand43 kg) 1 sachet every 6 or 8 hours (3 or 4 times a day) as needed.

Over 12 years (weight over44 kg) 2 sachets 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 per day.

This medication is contraindicated in children under 6 years.

Always use the lowest effective dose.

Start treatment as soon as the first symptoms appear and discontinue as they disappear.

The medication should not be used for more than 3 consecutive days without consulting a doctor. (see section 1. What is FRENADOL?Junior and what it is used for).

How to take:

This medication is taken orally.

Empty the contents of one sachet into a half glass of water and stir until dissolved.

If you take more FRENADOL?Junior than you should

Go immediately to a medical center 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, vomiting, confusion, excitement, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, states of somnolence, or alterations in gait.

Severe adverse effects have been reported with abuse of medications containing dextromethorphan, including agitation, confusion, conversion disorders, hallucinations, ataxia (uncoordinated movements), coma, decreased consciousness, dysarthria (speech difficulty), apathy, dystonia, nystagmus (uncontrolled and involuntary eye movements), convulsions, serotonin syndrome, tremor, depression, and central nervous system excitation, miosis, and mydriasis (pupil constriction and dilation), respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

The symptoms of chlorphenamine overdose may include central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel 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.

The treatment of overdose is more effective if initiated within 4 hours of medication ingestion. Patients on 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 medications, FRENADOL?Junior, can produce adverse effects, although not all people may 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.

During the period of use of the association of paracetamol, dextromethorphan, and chlorphenamine, the following adverse effects have occurred, whose frequency could not be established with precision: Anaphylactic reaction, hypersensitivity, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more common in children and the elderly.

The following gastrointestinal disturbances, such as abdominal pain, diarrhea, nausea, vomiting, and indigestion (dyspepsia), angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin eruption, skin lesions after taking the medication (fixed drug exanthema), as well as increased transaminases.

Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

The simultaneous consumption of alcohol during treatment may exacerbate the appearance of adverse effects. Do not consume alcoholic beverages during the same period.

Reporting of 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 System of Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears 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 unused medications at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of FRENADOL ? Junior

The active principles are: paracetamol 300 mg, dextromethorphan 15 mg (as hydrobromide) and chlorphenamine 2 mg (as maleate).

The other components (excipients) are: sucrose, sodium saccharin, titanium dioxide (E-171), anhydrous citric acid, polysorbate 80, sodium cyclamate, tangerine durarome flavor (contains traces of soybean oil), yellow quinoline (E-104), sunset yellow (E-110).

Appearance of the product and content of the packaging

Yellow-colored oral granule with orange flavor .

Each package contains 10 sachets.

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/.