Frenadol Forte granules for oral solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Frenadol Forte granules for oral solution

Paracetamol/Chlorpheniramine/Dextromethorphan

Read the entire leaflet carefully before you start taking this medicine, because 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 5 days of treatment (3 days for fever and for adolescents).

Contents of the leaflet:

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

1. What Frenadol Forte is and what it is used for

Frenadol Forte is a combination of paracetamol, which reduces fever and relieves pain, chlorpheniramine, which helps reduce nasal discharge and sneezing, and dextromethorphan, which is a cough suppressant.

This medicine is indicated for the symptomatic relief of colds and flu accompanied by mild to moderate pain such as headache, fever, dry cough (irritant cough, nervous cough), nasal discharge, and sneezing, in adults and adolescents aged 14 years and older.

You should consult your doctor if your condition worsens or if symptoms persist for more than 5 days in adults or 3 days in adolescents, or if fever lasts for more than 3 days.

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

Do not take FRENADOL® Forte

• if you are allergic to the active substances or to any of the other ingredients of this medicine listed in section 6,
• if you have severe liver disease,
• if you have severe renal failure or are undergoing hemodialysis,
• if you are being treated with a class of medicines called monoamine oxidase inhibitors (MAOIs), or within two weeks of stopping treatment with these medicines.
• if you suffer from 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 medicine for cancer) (see section “Taking FRENADOL® Forte with other medicines”). Children under 6 years of age must not take this medicine due to the dosage of its active ingredients.

Warnings and precautions

• Do not exceed the recommended dose stated in section 3, “How to take FRENADOL® Forte”. 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 you do not notice any signs or symptoms.

• Chronic alcoholics should consult their doctor before taking paracetamol, other analgesics, or antipyretic medicines. In addition, they should take care not to take more than 3 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 and potential liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Patients should consult their doctor or pharmacist before starting FRENADOL® Forte:

• Patients with kidney, heart, or lung disease, and patients with anemia.
• Patients with liver disease (with or without hepatic insufficiency) or viral hepatitis, as this increases the risk of hepatotoxicity.
• Asthmatic patients who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to others (such as chlorphenamine).
• Patients with hypertension (high blood pressure), glaucoma (elevated intraocular pressure), hyperthyroidism, bladder neck obstruction, prostate hyperplasia with urinary retention.
• Elderly patients who may be more sensitive to the side effects of this medicine.
• Patients with atopic dermatitis.
• Patients who are slow metabolizers of CYP2D6 or who are taking CYP2D6 inhibitors.
• Patients with chronic respiratory conditions such as emphysema, chronic bronchitis, bronchial asthma, or cough with excessive secretions, glaucoma, or difficulty urinating due to prostate hyperplasia.

This medicine may cause dependence. Therefore, treatment should be short-term.

This medicine may increase the sedative effects of central nervous system (CNS) 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.

During treatment with FRENADOL® Forte, 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 in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty 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. Refer to the sections “Taking FRENADOL® Forte with other medicines” and “Taking FRENADOL® Forte with food, drinks, and alcohol”.

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

Severe skin reactions, such as Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and 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 medicine must be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Cases of abuse of medicines containing dextromethorphan have been described in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section “If you take more FRENADOL® Forte than you should”).

Taking FRENADOL® Forte with other medicines

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

In particular, if you are using any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines to treat epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines to treat 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 to treat hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid).
• Medicines used to treat high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson’s disease (selegiline), or other conditions such as cancer (procarbazine), infections (linezolid, furazolidone). Administration of FRENADOL® Forte 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 cause central nervous system depression (such as those used for insomnia or anxiety, Parkinson’s disease, or allergies).
• Ototoxic medicines (those with adverse effects damaging to the ear).
• Photosensitizing medicines (those that cause light allergy as an adverse effect).
• Medicines used for relief of pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Metoprolol, used to treat cardiovascular diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used to treat invasive aspergillosis and invasive mucormycosis.
• The antibiotic flucloxacillin, due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Interference with diagnostic tests:

If you are scheduled to undergo any diagnostic tests (including blood and 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®Forte 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 medication.

Moreover, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, liquor, etc., per day) may cause liver damage.

Do not take this medicine together with grapefruit juice or bitter orange juice, as they may enhance the effects of one of its components (dextromethorphan).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

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®Forte.

Driving and operating machinery

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

FRENADOL®Forte contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, it is essentially “sodium-free”.

FRENADOL®Forte contains sucrose:

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 8.87 g of sucrose per sachet.

FRENADOL®Forte contains sunset yellow (E-110):

This medicine may cause allergic reactions because it contains sunset yellow (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

FRENADOL®Forte contains corn maltodextrin:

This medicine contains corn maltodextrin. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Frenadol Forte

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The granules contained in Frenadol Forte sachets are for oral administration.

Recommended dose:

Adults and adolescents aged 14 years and older: 1 sachet every 6 or 8 hours (3 or 4 times daily), as needed. Preferably take 1 sachet before going to bed. Do not exceed 4 sachets (equivalent to 2.6 g of paracetamol) per day. See section “Warnings and precautions”.

Patients with hepatic impairment: 1 sachet every 8 hours. Do not exceed 3 sachets (equivalent to 1.95 g of paracetamol) per day. Consult your doctor.

Patients with renal impairment: This medicine must not be taken due to the 650 mg paracetamol dose.

Use in children

This medicine is contraindicated in individuals under 14 years of age due to the dosage of its active substances.

Always use the lowest effective dose.

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

If symptoms do not improve or worsen after 5 consecutive days of treatment (3 days for fever or in adolescents), consult your doctor. (See section 1. “What Frenadol Forte is and what it is used for”).

How to take:

This medicine is taken orally.

Empty the contents of one sachet into half a glass of water and stir until dissolved. Sugar or honey may be added according to personal preference. At night, preferably take before going to bed.

If you take more Frenadol Forte than you should

Go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until 3 days after overdose ingestion, 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.

Other symptoms in cases of massive overdose may include: coma, severe respiratory problems, and seizures.

Contact your doctor or hospital immediately if you experience any of the symptoms listed.

Cases of abuse have been reported with medications containing dextromethorphan in adolescents, 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 chlorpheniramine overdose 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 experiencing prolonged agitation, coma, or seizures may rarely develop rhabdomyolysis and renal failure.

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

In case of overdose or accidental ingestion, go immediately to a medical center or, if not possible, contact the Toxicology Information Service (telephone: 91 5620420), stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Frenadol Forte may produce adverse effects, although not everyone experiences 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.

The following adverse reactions have been reported with unknown frequency: anaphylactic reaction, hypersensitivity, insomnia, nervousness and restlessness (psychomotor hyperactivity), abdominal pain, diarrhoea, nausea, vomiting, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin eruptions, 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 enhance 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es

5. Storage of Frenadol Forte

Keep this medicine out of 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 should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If 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® Forte

Active substances: paracetamol 650 mg, chlorphenamine 4 mg (as maleate) and dextromethorphan 20 mg (as hydrobromide).

Other components (excipients): sucrose, titanium dioxide (E-171), anhydrous citric acid, polysorbate 80, sodium citrate, povidone K 30, lemon flavour (containing corn maltodextrin), quinoline yellow (E-104), orange yellow (E-110).

Appearance of the product and contents of the pack

Yellow granules for oral solution with lemon flavour.

Each pack contains 10 sachets.

Date of last review of this leaflet: February 2025

The detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.