Frenadol Junior granules for oral solution

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FRENADOL? Junior Granules for Oral Solution

Paracetamol/Chlorpheniramine/Dextromethorphan

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the instructions for use provided 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or do not improve after 3 days.

Leaflet Contents:

1. What FRENADOL? Junior is and what it is used for.
2. What you need to know before taking FRENADOL? Junior.
3. How to take FRENADOL? Junior.
4. Possible side effects.
5. How to store FRENADOL? Junior.
6. Contents of the pack and other information.

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

FRENADOL® Junior is a combination medicine containing paracetamol, which reduces fever and relieves pain; dextromethorphan, a cough suppressant; and chlorpheniramine, which helps reduce nasal secretions.

This medicine is indicated for the symptomatic relief of colds and flu accompanied by mild to moderate pain, such as headache, fever, dry (irritating, nervous) cough, and runny nose, in children over 6 years of age and adolescents.

You should consult your doctor if your condition worsens or if symptoms persist for more than 3 days of treatment.

2. What you need to know before taking FRENADOL® Junior

Do not take FRENADOL® Junior

• If you are allergic to the active substances or to any of the other components of this medicine listed in section 6.
• If you have severe liver or kidney disease.
• If you are being treated with a class of medicines called monoamine oxidase inhibitors (MAOIs), or within 2 weeks after stopping treatment with these medicines.
• If you have respiratory insufficiency, asthmatic cough, or cough accompanied by expectoration.
• If you are or have recently been treated with other medicines, such as medicines for depression or Parkinson's disease, linezolid (an antibiotic), or procarbazine (a cancer medicine) (see section “Taking FRENADOL® Junior with other medicines”).
• Children under 6 years of age must not take this medicine.

Warnings and precautions

• Do not exceed the recommended dose stated in section 3. How to take FRENADOL® Junior. Taking more than the recommended dose (overdose) may result in liver damage. In case of overdose, seek immediate medical help. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.
• Chronic alcoholics should consult their doctor before taking paracetamol or other analgesics and antipyretics. They should also take care not to exceed 6 sachets per day (2 g of paracetamol).
• While taking this medicine, do not take other products containing paracetamol, as this could lead to a paracetamol overdose, which may damage the liver.

Patients should consult their doctor or pharmacist before starting FRENADOL® Junior if they:

• Have kidney, heart, or lung disease, or anemia.
• Have liver disease (with or without hepatic insufficiency) or viral hepatitis, as this increases the risk of hepatotoxicity.
• Are asthmatic patients sensitive to acetylsalicylic acid.
• Are sensitive (allergic) to an antihistamine, as they may also be sensitive to others (such as chlorphenamine).
• Have hypertension (high blood pressure), glaucoma (increased intraocular pressure), hyperthyroidism, bladder neck obstruction, or benign prostatic hyperplasia with residual urine formation. Elderly patients may be more sensitive to the side effects of this medicine.
• Have atopic dermatitis.
• Have a chronic respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough with excessive secretions, glaucoma, or difficulty urinating due to benign prostatic hyperplasia.
• Are slow metabolizers of CYP2D6 or are taking CYP2D6 inhibitors.

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

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

This medicine may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while being treated with this medicine, as they may enhance this effect. See sections “Taking FRENADOL® Junior with other medicines” and “Taking FRENADOL® Junior with food, drinks and alcohol”.

Sedated, weakened, or bedridden patients must not take this medicine.

Rarely, severe skin reactions may occur, such as redness, blisters, or rashes. If you notice any of these symptoms, stop treatment and consult your doctor.

Serious skin reactions, such as Acute 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 medicine must be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Taking FRENADOL® Junior with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

• Medicines for epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines for tuberculosis (isoniazid, rifampicin).
• Medicines to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other potassium-wasting diuretics (such as diuretics used for hypertension or other conditions).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid).
• Medicines used for high blood pressure (hypertension), such as propranolol, and for cardiac arrhythmias, such as amiodarone or quinidine.
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression (moclobemide, tranilcypramine, fluoxetine, paroxetine, bupropion), Parkinson’s disease (selegiline), or other conditions such as cancer (procarbazine), infections (linezolid, furazolidone). Administration of FRENADOL® Junior must be separated by at least 14 days after stopping treatment.
• Other medicines for depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for schizophrenia (such as haloperidol).
• Medicines that depress the central nervous system (such as those used for insomnia or anxiety, Parkinson’s disease, or allergies).
• Ototoxic medicines (those that have ear damage as an adverse effect).
• Photosensitizing medicines (those that cause light allergy as an adverse effect).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Metoprolol, used for cardiovascular diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used for the treatment of invasive aspergillosis and invasive mucormycosis.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap), which requires urgent treatment (see section 2).

Interference with diagnostic tests:

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

Taking FRENADOL® Junior with food, drinks, and alcohol

While taking this medicine, you must not consume alcoholic beverages, as they may increase the likelihood of adverse effects from this medicine.

In addition, the use of medicines containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

This medicine should not be taken together with grapefruit juice or bitter orange juice, as it may enhance the effects of one of its components (dextromethorphan).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be under medical supervision.

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

The three active ingredients in this medicine are excreted in breast milk; therefore, women who are breastfeeding should not take FRENADOL® Junior.

Driving and operating machinery

FRENADOL® Junior may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving vehicles or operating machinery.

FRENADOL® Junior contains sodium:

This medicine contains 77 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 3.94% of the maximum daily sodium intake recommended for an adult. Consult your doctor or pharmacist if you need one or more sachets daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

FRENADOL® Junior contains sucrose:

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 4.12 g of sucrose per sachet.

FRENADOL® Junior contains Sunset Yellow FCF (E-110):

This medicine may cause allergic reactions because it contains Sunset Yellow FCF (E-110). It may trigger asthma, particularly in patients allergic to acetylsalicylic acid.

FRENADOL® Junior contains soybean oil:

This medicine contains soybean oil. It must not be used if you are allergic to soy.

3. How to take FRENADOL® Junior

Follow exactly the dosing instructions for this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The granules contained in FRENADOL® Junior sachets are for oral administration.

The recommended dose is:

Children aged 6 to 12 years (weighing between 21.5 kg and 43 kg): 1 sachet every 6 or 8 hours (3 or 4 times daily), as needed.

Patients over 12 years of age (weighing more than 44 kg): 2 sachets every 6 or 8 hours (3 or 4 times daily), as needed.

It is preferable to take one dose before going to bed. Do not exceed 4 doses per day.

This medicine is contraindicated in children under 6 years of age.

Always use the lowest effective dose.

Begin treatment at the onset of the first symptoms and discontinue as symptoms subside.

This medicine should not be used for more than 3 consecutive days without consulting a doctor. (See section 1. What FRENADOL® Junior is and what it is used for).

How to take it:

This medicine is taken orally.

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

If you take more FRENADOL® Junior than you should

Seek immediate medical attention even if there are no symptoms, as symptoms often do not appear until 3 days after overdose, even in cases of severe intoxication. The most serious effect of overdose is liver damage caused by paracetamol. You may experience dizziness, vomiting, confusion, excitability, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, drowsiness or disturbances in gait may occur.

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

Symptoms of overdose with chlorpheniramine may include central nervous system (CNS) depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or arrhythmias. Patients with prolonged agitation, coma, or seizures may rarely develop rhabdomyolysis and renal failure.

Treatment of overdose is most effective when initiated within 4 hours of ingestion. Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, seek immediate medical attention or, if not possible, contact the Toxicology Information Service (telephone: 91 5620420), indicating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, FRENADOL® Junior may cause adverse effects, although not everyone experiences them.

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

During the period of use of the combination of paracetamol, dextromethorphan, and chlorpheniramine, the following adverse effects have occurred, although their frequency cannot be accurately determined: anaphylactic reaction, hypersensitivity, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more commonly observed in children and elderly patients.

Similarly: 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 rash, skin lesions after taking the medicine (fixed drug eruption), as well as increased transaminases.

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Concomitant consumption of alcohol during treatment may increase the occurrence of adverse effects. Do not consume alcoholic beverages during treatment.

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 not listed in this leaflet. You may also report them directly through the Spanish System of Pharmacovigilance for Human Medicinal Products. Website: www.notificaram.es

5. Storage of FRENADOL( Junior

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of FRENADOL® Junior

The active substances are: paracetamol 300 mg, dextromethorphan 15 mg (as hydrobromide), and chlorpheniramine 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 flavour (contains traces of soybean oil), quinoline yellow (E-104), sunset yellow (E-110).

Appearance of the medicinal product and contents of the pack

Yellow granules for oral solution with an orange flavour.

Each pack contains 10 sachets.

Date of the last revision of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.