PATIENT INFORMATION LEAFLET

Frenadol Forte oral granule 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 after5 days of treatment(3 days for fever and for adolescents).

1. What is Frenadol Forte and how to use it

2. What you need to know before starting to take Frenadol Forte

3. How to take Frenadol Forte

4. Possible side effects

5. Storage of Frenadol Forte

6. Contents of the pack and additional information

FrenadolForte is a combination of paracetamol that reduces fever and relieves pain, clorfenamina that helps to reduce nasal secretion and sneezing, and dextrometorfano that is an antitussive.

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), nasal secretion, and sneezingfor adults and adolescents 14 years and older.

You should consult your doctor if symptoms worsen or persist after5 days of treatment in adults or 3 days in adolescents or if fever persists for more than 3 days.

Do not take FRENADOL?Fort

• 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 serious liver disease,
• If you have severe kidney failure or are undergoing hemodialysis,
• If you are being treated with a class of medications called monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping treatment with these medications.
• If you have respiratory insufficiency, asthma, or cough with expectoration.

If you are taking or have recently taken other medications, such as antidepressants or Parkinson's disease medications, linezolid, or procarbazine (see section "Taking FRENADOL Forte with other medications"). Children under 6 years old cannot take this medication due to the dose of its active ingredients.

Warnings and precautions

• Do not take more than the recommended dose in section 3. "How to take FRENADOL Forte". Taking more than the recommended dose (overdose) may cause liver damage. If you suspect an overdose, seek medical help immediately. Prompt medical attention is critical for adults and children, even if you do not perceive any symptoms or signs.

• 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 3 packets per day (2g of paracetamol).
• While taking this medication, do not take other medications that contain paracetamol, as it may cause a paracetamol overdose that can damage the liver. Do not use more than one medication that contains paracetamol without consulting your doctor.

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 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 urinary retention. 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, asthma, or cough with excessive secretions, glaucoma, or difficulty urinating due to benign prostatic hyperplasia.

This medication may cause dependence. Therefore, treatment should be of short duration.

This medication 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 medication.

Inform your doctor immediately if you experience:

Severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are 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 sections "Taking FRENADOL Forte with other medications" and "Taking FRENADOL Forte with food, drinks, and alcohol".

Sedated, weakened, or bedridden patients should not take this medication.

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 discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Cases of abuse with medications containing dextromethorphan in adolescents have been reported, so this possibility should be taken into account, as it may cause severe adverse effects (see section "If you take more FRENADOL Forte than you should").

Taking FRENADOL Forte with other medications

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

In particular, if you are using some 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 hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probenecid).
• Medications used to treat high blood pressure (hypertension), such as propranolol and arrhythmias (abnormal heart rhythms), such as amiodarone or quinidine.
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidine). The administration of FRENADOL Forte should be separated from these medications by at least 14 days after stopping 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 that are ototoxic (that damage the ear).
• Medications that are photosensitizing (that cause an allergic reaction to light).
• Medications used to relieve pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Metoprolol, used to treat cardiovascular diseases (hypertension, acute myocardial infarction).
• Isoconazole, used to treat invasive aspergillosis and mucormycosis.
• Flucloxacillin, an antibiotic, due to a serious risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (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 Forte with food, drinks, 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, consult your doctor or pharmacist before using this medication. The use 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 take FRENADOL Forte.

Driving and operating machinery

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

FRENADOL Forte contains sodium:

This medication contains less than 23 mg of sodium (1 mmol) per sachet, which is essentially "sodium-free".

FRENADOL Forte contains saccharose:

This medication contains saccharose. If your doctor has told you 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 8.87 g of saccharose per sachet.

FRENADOL Forte contains yellow-orange (E-110):

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

FRENADOL Forte contains corn maltodextrin:

This medication contains corn maltodextrin. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

The recommended dose is:

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

Patients with liver insufficiency:1 sachet every 8 hours. Do not take more than 3 sachets (equivalent to 1.95 g of paracetamol) per day. Consult your doctor.

Patients with renal insufficiency:You cannot take this medication due to the paracetamol dose of 650 mg.

Use in children

This medication is contraindicated in children under 14 years old, due to the dose of its active principles.

Always use the lowest effective dose.

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

If you do not improve or worsen after 5 consecutive days of treatment (3 for fever or adolescents), you must consult your doctor. (see section 1. "What is Frenadol Forte and what it is used for").

How to take:

This medication is taken orally.

Pour the contents of one sachet into a half glass of water and stir until dissolved. You can add sugar or honey according to your preferences. Take preferably before going to bed at night.

If you take more Frenadol Forte than you should

Go immediately to a medical center, even if you do not have symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe intoxication.

The most severe effect of an overdose of this medication is liver damage caused by paracetamol. You may feel dizziness, vomiting, confusion, excitement, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, states of somnolence, or alterations in gait.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

Cases of abuse with medications containing dextromethorphan in adolescents have been reported, which may lead to severe adverse effects, such as agitation, confusion, conversion disorders, hallucinations, ataxia (uncoordinated movements), coma, decreased consciousness, dysarthria (speech difficulty), apathy, dystonia, nystagmus (uncontrolled and involuntary eye movement), 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 be 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 an overdose is more effective if initiated within 4 hours of medication ingestion. Patients undergoing 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 Forte 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.

The following adverse reactions were reported with unknown frequency: Anaphylactic reaction, hypersensitivity, insomnia, nervousness, and restlessness (psychomotor hyperactivity), abdominal pain, diarrhea, nausea, vomiting, angioedema (swelling of certain skin areas), pruritus, urticaria, rash, pruritic rash, skin eruptions, skin lesions after taking the medication (Fixed drug eruption) as well as increased transaminases.

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

The simultaneous consumption of alcohol during treatment may exacerbate the appearance 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 SIGRE collection point at the pharmacy. 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 ? Forte

The active principles are: paracetamol 650 mg, chlorphenamine 4 mg (as maleate) and dextromethorphan 20 mg (as hydrobromide).

The other components (excipients) are: sucrose, titanium dioxide (E-171), anhydrous citric acid, polysorbate 80, sodium citrate, povidone K 30, lemon aroma (which contains corn maltodextrin), yellow quinoline (E-104), yellow-orange (E-110).

Appearance of the product and contents of the packaging

Yellow-colored granule for oral solution with a lemon flavor.

Each package contains 10 sachets.

Last review date of this prospectus: 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/.