FRENADOL COMPLEX GRANULATED ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FRENADOL?COMPLEX granules for oral solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve after 5 days of treatment (3 days for fever and for adolescents).

Contents of the package leaflet:

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

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

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

This medicine is indicated for the symptomatic relief of colds and flu that present with mild or moderate pain such as headache, fever, unproductive cough (irritative cough, nervous cough), nasal secretion, and sneezing for adults and adolescents from 14 years of age.

You should consult your doctor if your symptoms worsen or if the symptoms persist after 5 days of treatment in adults or 3 days in adolescents, or if the 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 kidney failure or are undergoing hemodialysis.
• If you have respiratory failure, asthmatic cough, and cough accompanied by expectoration
• 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 are or have recently been treated with other medicines, such as medicines for depression or Parkinson's disease, with linezolid which is an antibiotic, or with procarbazine, which is a medicine for cancer (see section "Taking FRENADOL? Complex with other medicines").
• If you suffer from a medical condition associated with iron retention, such as hemochromatosis, thalassemia, or sideroblastic anemia.
• Children under 14 years of age cannot take this medicine, due to the dose of its active ingredients.

Warnings and precautions

• Do not take more than the recommended dose in section 3. How to takeFRENADOL®Complex.Taking more than the recommended dose (overdose) can result in liver damage. In case of overdose, seek medical help immediately. Prompt medical attention is critical for adults, as well as for children, even if you do not perceive any signs or symptoms.

• Chronic alcoholics should ask their doctor if they can take paracetamol, other pain relievers, or fever-reducing medicines. Additionally, they should be cautious not to take more than 3 sachets per day (2 g of paracetamol).
• While taking this medicine, you cannot take other medicines that contain paracetamol because a paracetamol overdose could occur, which could damage the liver. Do not use more than one medicine that contains paracetamol without consulting your doctor.

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

• Patient with kidney, lung, stomach diseases, and patients with anemia.
• Patient with diabetes, as caffeine and ascorbic acid can raise blood sugar levels.
• Patient who has had kidney stones or gout or excess iron in the blood, as ascorbic acid can worsen these conditions. Ascorbic acid should not be administered at doses higher than 1 gram (1000 mg) in patients with kidney stones.
• Patient with liver disease (with or without liver failure) or viral hepatitis, as it increases the risk of hepatotoxicity
• Patient with asthma sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to others (such as chlorphenamine)
• Patient sensitive to theophylline or aminophylline.
• Patient with hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, obstruction of the neck of the bladder, symptomatic prostatic hyperplasia, urinary retention
• Patient of advanced age who may be more sensitive to the side effects of this medicine.
• Patient with atopic dermatitis.
• Patient who are slow metabolizers of CYP2D6 or who use CYP2D6 inhibitors.

Patient with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or in which they suffer from cough accompanied by excessive secretions, glaucoma, prostatic hyperplasia with residual urine formation, it is recommended that they consult their doctor before using this product.

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

During treatment with FRENADOL®Complex, inform your doctor immediately:

If you have 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 suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

This medicine 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 central nervous system depressants (barbiturates, tranquilizers, MAOIs) while taking this medicine.

This medicine can cause drowsiness. Avoid consuming alcoholic beverages and certain medicines while being treated with this medicine, as they can potentiate this effect. Consult the sections "Taking FRENADOL? Complex with other medicines" and "Taking FRENADOL? Complex with food, beverages, and alcohol".

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

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

Very rarely, cases of severe skin reactions called acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported, associated with the use of paracetamol. At the first symptom of skin rash or hypersensitivity, discontinue treatment and consult your doctor.

Cases of abuse with medicines containing dextromethorphan have been described in adolescents; therefore, this possibility should be taken into account, as serious side effects can occur (see section "If you take more FRENADOL? Complex than you should").

Taking FRENADOL®Complex with other medicines

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

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicines for treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines used to treat people infected with HIV, such as indinavir.
• Medicines for treating tuberculosis (isoniazid, rifampicin).
• Medicine 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 diuretics that cause potassium loss (such as diuretics for treating hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used to treat gout (probenecid).
• Medicines used to treat high blood pressure (such as propranolol) and heart rhythm disorders (such as amiodarone, quinidine)
• Medicines used to lower cholesterol levels in the blood (cholestyramine).
• Tricyclic and tetracyclic antidepressants (such as maprotiline) and other medicines for treating depression and bipolar disorder (lithium)
• Medicines for treating mental disorders (such as haloperidol).
• Medicines that produce depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies).
• Medicines that are ototoxic (which have the adverse effect of damaging the ear).
• Medicines that are photosensitizing (which have the adverse effect of producing allergy to light).
• Medicines used for pain relief and inflammation (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Medicines used to reduce the amount of iron and aluminum, such as deferoxamine.
• Metoprolol, used to treat cardiovascular system diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used to treat invasive aspergillosis and invasive mucormycosis.
• Flucloxacillin antibiotic, due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Do not take this medicine during treatment or in the 2 weeks following treatment with the following medicines, as it can cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Medicines for treating depression, monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine), serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Medicine used to quit smoking (bupropion)
• Medicine used to treat infections (isoniazid)
• Medicine used as an antibacterial (linezolid)
• Medicine used to treat high blood pressure (pargyline)
• Medicine used to treat cancer (procarbazine)
• Medicine used to treat Parkinson's disease (selegiline)

Interference with analytical tests:

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

Taking FRENADOL

While taking this medicine, you cannot drink alcoholic beverages, as it can potentiate the appearance of side effects of this medicine.

Additionally, the use of medicines containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) can cause liver damage.

Do not take the medicine with grapefruit or bitter orange juiceas it can potentiate the effects of one of its components (dextromethorphan).

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

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The consumption of medicines during pregnancy can 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 ingredients of this medicine are excreted in breast milk; therefore, women who are breastfeeding should not take FRENADOL® Complex.

Driving and using machines

FRENADOL® Complex can cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

FRENADOL?Complex contains sucrose:

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

Patient 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 in each sachet. Benzyl alcohol can cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side 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 orange yellow S (E-110):

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

3. How to take FRENADOL Complex

Follow the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 14 years old: 1 sachet every 6 or 8 hours (3 or 4 times a day), 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.

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

Patient with kidney failure: They cannot take this medication due to its paracetamol content of 650 mg.

Use in children and adolescents

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

Use in elderly patients

Elderly people cannot use this medication without consulting their doctor.

Because they can be especially affected by some adverse effects of the medication, such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the clorfenamina content. They are also more likely to experience adverse 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.

Pour the contents of a sachet into a half glass of water and stir until it is dissolved.

Medication should be started when the first symptoms appear, and as they disappear, the medication should be discontinued.

You should consult your doctor if the 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 than you should

Go immediately to a medical center, even if there are no symptoms, since they often do not manifest 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, somnolence, disorders of consciousness, involuntary and rapid eye movements, cardiac disorders (acceleration of heart rate), coordination disorders, 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 serious effect of overdose of the medication 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 breathing, arrhythmias (rapid or irregular heartbeats), nervous stimulation (hallucinations, convulsions), these last symptoms may appear late, hypotension (feeling of fainting).

Taking very high amounts of this medication can produce in children a state of drowsiness, nervousness, nausea, vomiting, or alterations in gait.

There have been cases of abuse with medications containing dextrometorfano in adolescents, which can lead to serious adverse effects, such as tachycardia (acceleration of heartbeats), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil), agitation, vertigo, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), ischemic colitis, and death.

Treatment of overdose is more effective if started within 4 hours after ingestion of the medication. Patients undergoing treatment with barbiturics 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.

4. Possible adverse effects

Like all medications, FRENADOL Complex can produce adverse effects, although not all people experience them.

The most frequent adverse effects are sedation and somnolence.

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

Rarely, nightmares, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity) may occur, more common in children and the elderly. Vertigo 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 the sun, dry mouth, sore throat, and difficulty urinating. Very rare cases of severe skin reactions have been reported. Agitation, moderate delirium, palpitations, and tachycardia may also occur. Erupciones cutáneas and severe allergic reactions, such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, have also been described. Increased transaminases. High doses or prolonged treatments are toxic to the liver. Kidney stone formation, acute gout attacks in predisposed individuals, allergic asthma syndrome, which presents as rashes, urticaria, edema, pruritus, and anaphylactic shock.

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Simultaneous consumption of alcohol during treatment may enhance the appearance of adverse effects. Do not ingest alcoholic beverages during the same.

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 Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es

5. Conservation of FRENADOL Complex

Keep this medication out of 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.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications that are no longer needed in the Sigre Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This way, you will help protect the environment.

6. Packaging content and additional information

Composition of FRENADOL Complex

The active ingredients are: paracetamol, 650 mg, dextrometorfano, 20 mg (as hydrobromide) and clorfenamina, 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), quinoline yellow (E-104), orange yellow S (E-110).

Appearance of the product and packaging content

Orange-colored and orange-flavored granulate for oral solution.

Each packaging contains 10 sachets.

Date of the last revision of this prospectus:February 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.