FRENADOL COMPLEX GRANULES FOR ORAL SOLUTION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FRENADOL®COMPLEX effervescent granules for oral solution

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed 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).

Leaflet contents:

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

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

FRENADOL Complex is a combination medicine containing paracetamol, which reduces fever and relieves pain; dextromethorphan, a cough suppressant; chlorpheniramine, which helps reduce nasal discharge and sneezing; and caffeine, which counteracts the fatigue commonly associated with the common cold. It also contains ascorbic acid (vitamin C).

This medicine is indicated for the symptomatic relief of colds and flu accompanied by mild to moderate pain, such as headache, fever, non-productive cough (irritating cough, nervous cough), runny nose, 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 persists for more than 3 days.

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

Do not take FRENADOL® Complex

• 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 disease,
• if you have severe renal impairment or are undergoing hemodialysis,
• if you suffer from respiratory insufficiency, asthmatic cough, or cough with expectoration,
• if you are being treated with a class of medicines called “monoamine oxidase inhibitors” (MAOIs), or within two weeks after stopping treatment with such medicines,
• if you are or have recently been treated with other medicines, such as antidepressants or Parkinson’s disease medications, with linezolid (an antibiotic), or with procarbazine (a cancer medication) (see section “Taking FRENADOL® Complex with other medicines”),
• if you have a medical condition associated with iron retention, such as hemochromatosis, thalassemia, or sideroblastic anemia,
• children under 14 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® Complex. 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, other analgesics, or antipyretic medicines. They should also take care not to exceed 3 sachets per day (2 g of paracetamol).

• While taking this medicine, do not take other products containing paracetamol, as this may lead to paracetamol overdose and potential liver damage. Do not use more than one paracetamol-containing medicine without consulting your doctor.

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

• Patients with kidney, lung, or stomach disorders, or those with anemia,
• Patients with diabetes, as caffeine and ascorbic acid may increase blood glucose levels,
• Patients who have previously had kidney stones (calculi), gout, or excess iron in the blood, as ascorbic acid may worsen these conditions. Ascorbic acid should not be administered at doses exceeding 1 gram (1000 mg) in patients with renal lithiasis,
• Patients with liver disease (with or without hepatic insufficiency) or viral hepatitis, due to increased risk of hepatotoxicity,
• Asthmatic patients sensitive to acetylsalicylic acid,
• Patients sensitive (allergic) to an antihistamine, as they may also be sensitive to others (such as chlorpheniramine),
• Patients sensitive to theophylline or aminophylline,
• Patients with hypertension (high blood pressure), glaucoma (increased intraocular pressure), hyperthyroidism, bladder neck obstruction, symptomatic prostatic hypertrophy, or urinary retention,
• Elderly patients, who may be more sensitive to the side effects of this medicine,
• Patients with atopic dermatitis,
• Patients who are poor metabolizers of CYP2D6 or who are taking CYP2D6 inhibitors.

Patients with chronic respiratory conditions such as emphysema, chronic bronchitis, bronchial asthma, or those experiencing cough with excessive secretions, as well as patients with glaucoma, prostatic hyperplasia with residual urine formation, are advised to consult their doctor before using this product.

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

During treatment with FRENADOL® Complex, 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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period 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 enhance the sedative effects of central nervous system (CNS) depressants, including alcohol, sedatives, and tranquilizers. Therefore, it is recommended to avoid alcohol consumption or taking CNS depressants (barbiturates, tranquilizers, MAOIs) while taking this medicine.

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

Sedated, debilitated, or bedridden patients should not take this medicine.

Limit the use of caffeine-containing products during treatment, whether in medicines, food, or drinks.

Very rarely, serious skin reactions have been reported with paracetamol use, including generalized exanthematous pustulosis (GEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). At the first sign of a skin rash or hypersensitivity, discontinue treatment and consult your doctor.

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

Taking FRENADOL® Complex 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, dosage adjustments or discontinuation of treatment may be necessary:

• Medicines for epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone),
• Medicines used to treat HIV infection, such as indinavir,
• Medicines for tuberculosis (isoniazid, rifampicin),
• Medicines to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin,
• Medicines used to increase urine output (loop diuretics such as furosemide, or other diuretics), and other potassium-depleting diuretics (such as those 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 heart rhythm disorders (cardiac arrhythmias), such as amiodarone, quinidine,
• Medicines used to lower blood cholesterol levels (cholestyramine),
• Tricyclic and tetracyclic antidepressants (such as maprotiline) and other medicines for depression and bipolar disorder (lithium),
• Medicines for psychiatric disorders (such as haloperidol),
• Medicines causing central nervous system depression (such as those used for insomnia or anxiety, Parkinson’s disease, or allergies),
• Ototoxic medicines (those with adverse effects damaging the ear),
• Photosensitizing medicines (those causing light allergy as an adverse effect),
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib),
• Medicines used to increase mucus secretion,
• Medicines used to reduce iron and aluminum levels, such as deferoxamine,
• Metoprolol, used for cardiovascular diseases (hypertension, acute myocardial infarction),
• Isavuconazole, used for the treatment of invasive aspergillosis and invasive mucormycosis,
• The antibiotic flucloxacillin, due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) requiring urgent treatment (see section 2).

Do not take this medicine during treatment or within 2 weeks after stopping treatment with the following medicines, as it may cause excitation, high blood pressure, and fever above 40°C (hyperpyrexia):

• Antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine), serotonin reuptake inhibitors (paroxetine, fluoxetine),
• Medicines used to stop smoking (bupropion),
• Medicines used to treat infections (isoniazid),
• Antibacterial medicine (linezolid),
• Medicine used for high blood pressure (pargyline),
• Medicine used for cancer treatment (procarbazine),
• Medicine used for Parkinson’s disease (selegiline)

Interference with diagnostic tests:

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

Taking FRENADOL® Complex with food, beverages, and alcohol

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

In addition, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, 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).

Coffee, tea, chocolate, and cola drinks are sources of caffeine. Therefore, it is recommended to moderate the consumption of these products while taking FRENADOL® Complex.

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 active substances in this medicine are excreted in breast milk; therefore, women who are breastfeeding should not take FRENADOL® Complex.

Driving and operating machinery

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

FRENADOL® Complex contains sucrose:

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

Patients with diabetes mellitus should be aware that this medicine contains 8.19 g of sucrose per sachet.

FRENADOL® Complex contains benzyl alcohol:

This medicine contains 0.02 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

FRENADOL® Complex contains sodium:

This medicine contains less than 1 mmol (23 mg) of sodium per sachet; this is essentially "sodium-free".

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

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

3. How to take FRENADOL® Complex

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:

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

Always use the lowest effective dose.

Patients with hepatic impairment: 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 impairment: This medicine must not be used due to its paracetamol content (650 mg).

Use in children and adolescents

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

Use in elderly patients

Elderly patients must not use this medicine without first consulting a doctor.

They may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of chlorpheniramine. They may also be more likely to experience adverse effects such as sedation, confusion, hypotension, or agitation, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take:

This medicine is taken orally.

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

Treatment should begin at the onset of the first symptoms and should be discontinued as symptoms resolve.

Consult your doctor if fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new symptoms appear.

If you take more FRENADOL® Complex 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 poisoning.

If you take more Frenadol Complex than recommended, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations and hyperexcitability, ischemic colitis, and hypertension.

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

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

The most serious consequence of overdose is liver damage caused by paracetamol. Symptoms of overdose may include: dizziness, vomiting, confusion, excitability, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, difficulty breathing, cardiac arrhythmias (rapid or irregular heartbeat), nervous stimulation (hallucinations, seizures); these latter symptoms may appear later, and hypotension (feeling of fainting).

Taking very high amounts of this medicine may cause children to become drowsy, nervous, nauseous, vomit, or have difficulty walking.

Cases of abuse with medicines containing dextromethorphan have been reported in adolescents, potentially leading to serious adverse effects such as tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil of the eye), agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), ischemic colitis, and death.

Treatment of overdose is most effective if 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, go immediately to a medical center or, if not possible, contact the Toxicology Information Service (telephone: 91 5620420), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, FRENADOL®Complex may produce adverse effects, although not everyone experiences them.

The most frequent adverse effects are drowsiness and somnolence.

During the period of use of the combination of paracetamol, dextromethorphan, chlorpheniramine, caffeine, and ascorbic acid, the following adverse effects have been reported, although their frequency could not be accurately determined:

Rarely, nightmares, insomnia, excitation, nervousness, and restlessness (psychomotor hyperactivity) may occur, more commonly in children and elderly patients. Dizziness and hypotension, especially in the elderly.

Very rarely, gastrointestinal discomfort such as abdominal pain, diarrhea, nausea, vomiting, gastrointestinal irritation, and indigestion (dyspepsia), elevated blood glucose levels, confusion, dizziness, visual disturbances, increased sensitivity to sunlight, dry mouth, sore throat, and difficulty urinating. Very rare cases of serious skin reactions have been reported. Cases of agitation, moderate delirium, palpitations, and tachycardia may also occur. Skin rashes and severe allergic reactions such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain areas of the skin), pruritus, urticaria, and rash have also been described. Increased transaminase levels. High doses or prolonged treatment may be hepatotoxic. Kidney stone formation, acute gout attacks in predisposed individuals, and allergic asthma syndrome presenting as rashes, urticaria, edema, pruritus, and anaphylactic shock.

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 alcohol consumption during treatment may increase the likelihood 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 via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es

5. FRENADOL( Complex Storage

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. Instead, dispose of unused medicines and their containers at the Sigre Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of FRENADOL® Complex

The active substances are: paracetamol, 650 mg, dextromethorphan, 20 mg (as hydrobromide), chlorphenamine, 4 mg (as maleate), caffeine citrate, 30 mg and ascorbic acid, 250 mg.

The other components (excipients) are: sucrose, titanium dioxide (E-171), citric acid, polysorbate 80, orange flavour (containing traces of benzyl alcohol and sodium), quinoline yellow (E-104), orange yellow S (E-110).

Appearance of the product and contents of the pack

Orange-coloured granules for oral solution with an orange flavour.

Presented in packs containing 10 and 18 sachets.

Date of the last revision of this leaflet: February 2025

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