PROSPECTO: INFORMATION FOR THE USER

FRENADOL?COMPLEX granulated for oral solution

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

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult your doctor if you worsen or do not improve after5 days of treatment(3 days for fever and for adolescents).

1. What is FRENADOL?Complexand how it is used

2. What you need to know before starting to takeFRENADOL?Complex

3. How to takeFRENADOL?Complex

4. Possible adverse effects

5. Storage ofFRENADOL?Complex

6. Contents of the package and additional information

FRENADOL?Complex is an association of paracetamol that reduces fever and relieves pain, dextromethorphan which is an antitussive, chlorphenamine that helps to reduce nasal secretion and sneezing, and caffeine that counteracts the fatigue that usually accompanies the common cold. It also contains ascorbic acid or vitamin C.

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 you worsen or if symptoms 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?Complex

• 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 have respiratory insufficiency, asthma, or cough with excessive sputum production.
• If you are being treated with a class of medications called "monoamine oxidase inhibitors" (MAOIs) or have stopped taking these medications within the past two weeks.
• If you are taking or have recently taken other medications, such as antidepressants or medications for Parkinson's disease, linezolid, or procarbazine (see section "Taking FRENADOL?Complex with other medications").
• If you have a medical condition associated with iron retention, such as hemochromatosis, thalassemia, or sideroblastic anemia.
• Children under 14 years old should not take this medication due to the dose of its active ingredients.

Warnings and precautions

• Do not take more than the recommended dose listed in section3. How to takeFRENADOL?Complex.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 as well as children, even if you do not experience any symptoms or signs.

• Chronic alcoholics should consult their doctor before taking paracetamol, other analgesics, or medications that reduce fever. Additionally, they should be careful not to take more than 3 packets per day (2 g 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.

You should consult your doctor or pharmacist before starting to take FRENADOL?Complex:

• Patients with kidney, lung, stomach diseases, and anemia.
• Patients with diabetes, as caffeine and ascorbic acid may elevate blood sugar levels.
• Patients who have had kidney stones or gout or excessive iron in the blood, as ascorbic acid may worsen these conditions. Ascorbic acid should not be administered in doses exceeding 1 gram (1000 mg) in patients with renal lithiasis.
• 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 sensitive to theophylline or aminophylline.
• Patients with hypertension (elevated blood pressure), glaucoma (elevated intraocular pressure), hyperthyroidism, urinary obstruction, benign prostatic hyperplasia, or urinary retention.
• Older 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 use CYP2D6 inhibitors.

Patients with a persistent respiratory condition such as emphysema, chronic bronchitis, asthma, or cough with excessive sputum production, glaucoma, benign prostatic hyperplasia with residual urine formation, are recommended to consult their doctor before using this product.

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

During treatment withFRENADOL?Complex, inform your doctor immediately:

If you have serious 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 also taking flucloxacillin (an antibiotic). A serious 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 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.

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?Complex with other medications" and "Taking FRENADOL?Complex with foods, beverages, and alcohol".

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

Limit the use of caffeine-containing products during treatment, whether they are medications, foods, or beverages.

Rarely, severe skin reactions called acute generalized pustular psoriasis (AGPP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been associated with the use of paracetamol. If you experience the first sign of rash or hypersensitivity, discontinue treatment and consult your doctor.

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?Complex than you should").

Taking FRENADOL?Complex with other medications

Inform your doctor or pharmacist if you are taking or have taken recently 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, metharbital, primidone).
• Medications used to treat HIV-infected individuals, such as indinavir.
• Medications for treating tuberculosis (isoniazid, rifampicin).
• Medications for preventing blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medications used to increase urine production (diuretics such as furosemide, 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 (amiodarone, quinidine).
• Medications for lowering cholesterol levels in the blood (cholestyramine).
• Tricyclic and tetracyclic antidepressants (such as maprotiline) and other medications for treating depression and bipolar disorder (lithium).
• Medications for treating mental alterations (such as haloperidol).
• Medications that depress the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Ototoxic medications (that cause hearing damage).
• Phototoxic medications (that cause allergic reactions to light).
• Medications used to relieve pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Medications used to reduce iron and aluminum levels, such as deferoxamine.
• Metoprolol, used to treat cardiovascular diseases (hypertension, acute myocardial infarction).
• Isoconazole, used to treat invasive aspergillosis and mucormycosis.
• Antibiotic flucloxacillin, due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Do not take this medication during treatment, or within two weeks after treatment with the following medications, as it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Medications for treating depression, MAOIs (moclobemide, tranilcipromine), serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Medication used to quit smoking (bupropion).
• Medication used to treat infections (isoniazid).
• Medication used as an antibacterial (linezolid).
• Medication used to treat high blood pressure (pargilina).
• Medication used to treat cancer (procarbazine).
• Medication used to treat Parkinson's disease (selegiline).

Interference with diagnostic tests:

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

Taking FRENADOL?Complex with foods, 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 withorange or grapefruit juiceas it may potentiate the effects of one of its components (dextromethorphan).

Coffee, tea, chocolate, or cola beverages 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, or if you think you may be 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 active ingredients of this medication are excreted in breast milk, so women in the lactation period should not takeFRENADOL?Complex.

Driving and operating machinery

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

FRENADOL?Complex 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 8.19 g of saccharose per sachet.

FRENADOL?Complex contains benzyl alcohol:

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

FRENADOL?Complex contains yellow-orange S (E-110):

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

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 recommended dose is:

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

Always use the lowest effective dose.

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

Patients with renal insufficiency:Cannot take this medication due to its content of 650 mg paracetamol.

Use in children and adolescents

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

Use in elderly patients

Elderly patients cannot use this medication without consulting a doctor.

Because they may be especially affected by some medication side effects such as slow heart rate (bradycardia) or reduced cardiac output, due to the content of chlorphenamine. They may also be more likely to present side effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take:

This medication is taken orally

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

Medication should start as soon as the first symptoms appear, and should be discontinued as symptoms disappear.

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

If you take more FRENADOL Complex?Complexthan you should

Go immediately to a medical center, even if there are no symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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

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

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

The most severe effect of overdose is liver damage caused by paracetamol.The symptoms of overdose may be:dizziness, vomiting, confusion, excitability, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathingarrhythmias (rapid or irregular heartbeats), nervous stimulation (hallucinations, convulsions), these latter symptoms may appear late, hypotension (dizziness).

Taking very high doses of this medication may cause in children a state of drowsiness, nervousness, nausea, vomiting, or disturbances in gait.

There have been cases of abuse with medications containing dextromethorphan in adolescents, which may cause severe side effects, such as tachycardia (rapid heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal disturbances, hallucinations, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), ischemic colitis, and death.

The treatment of 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 ? Complex, may produce adverse effects, although not all people will experience them.

The most frequent adverse effects are sedation and somnolence.

During the period of use of the association of paracetamol, dextromethorphan, chlorphenamine, caffeine, and ascorbic acid, the following adverse effects have been produced, whose frequency has not been established with precision:

In rare cases, they may produce nightmares, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more common in children and the elderly. Dizziness and hypotension, especially in the elderly.

Very rarely, gastrointestinal disturbances, such as abdominal pain, diarrhea, nausea, vomiting, gastrointestinal irritation, and indigestion (dyspepsia), elevated blood glucose levels, confusion, dizziness, visual disturbances, increased sensitivity to the sun, dry mouth, sore throat, and difficulty urinating. Very rarely, severe skin reactions have been reported. Also, cases of agitation, moderate delirium, palpitations, and tachycardia have been reported. Skin eruptions and severe allergic reactions, such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, have also been described. Elevated transaminases. High doses or prolonged treatment are toxic to the liver. Kidney stone formation, acute gout attacks in predisposed individuals, allergic asthma syndrome presenting as hives, urticaria, edema, pruritus, and anaphylactic shock.

Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (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 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 of 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 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? Complex

The active principles are: paracetamol, 650 mg, dextromethorphan, 20 mg (as hydrobromide) and 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 flavor (which contains traces of benzyl alcohol and sodium), yellow quinoline (E-104), yellow-orange S (E-110).

Appearance of the product and contents of the packaging

Orange-colored granule for oral solution 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/.