FARSICOLD 650 MG/20 MG/4 MG ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Farsicold 650 mg/20 mg/4 mg granules for oral solution EFG

Paracetamol/Dextromethorphan/Chlorphenamine

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

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment (3 days for fever and for adolescents).

Package Leaflet Contents

1. What is Farsicold and what is it used for
2. What you need to know before taking Farsicold
3. How to take Farsicold
4. Possible side effects
5. Storage of Farsicold
6. Package Contents and Additional Information

1. What is Farsicold and what is it used for

Farsicold is a medicine that contains three active ingredients in combination: paracetamol, which reduces fever and relieves pain, dextromethorphan, which is a cough suppressant, and chlorphenamine, which reduces nasal secretion.

It is indicated for adults and adolescents from 14 years of age, 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), and nasal secretion.

You should consult your doctor if your symptoms worsen or do not improve 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 Farsicold

Do not take Farsicold if:

• you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medicine listed in section 6,
• you suffer from respiratory failure, asthmatic cough, and cough accompanied by expectoration.
• you suffer from severe liver or kidney disease,
• you are or have recently been treated with other medicines, such as: medicines for depression, medicines for the treatment of Parkinson's disease, treatment with linezolid (antibiotic) or with procarbazine (for the treatment of cancer). (See section "Other medicines and Farsicold").
• 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 take Farsicold".

Before starting to take Farsicold, you should consult your doctor or pharmacist if:

• you have kidney, heart, or lung disease,
• you have anemia,
• you suffer from liver disease (with or without liver failure) or viral hepatitis, as this increases the risk of hepatotoxicity,
• you are asthmatic and sensitive to acetylsalicylic acid,
• you are sensitive (allergic) to an antihistamine, as you may be sensitive to others (such as chlorphenamine),
• you have high blood pressure (hypertension), glaucoma (increased eye pressure), hyperthyroidism, obstruction of the vesical neck, symptomatic prostatic hyperplasia, urinary retention,
• you suffer from atopic dermatitis.

Elderly patients may be more sensitive to the secondary effects of this medicine.

Do not take this medicine in case of persistent or chronic cough, such as that due to smoking, asthma, or emphysema when the cough is accompanied by abundant secretions, as it may worsen expectoration and increase the resistance of the respiratory tract.

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

Consult the sections "Other medicines and Farsicold" and "Taking Farsicold with food, drinks, and alcohol".

Chronic alcoholics should be cautious not to take more than 3 sachets per day (2 grams of paracetamol).

Do not take this medicine simultaneously with others that contain paracetamol, as this could lead to a paracetamol overdose that could damage the liver.

This medicine causes sedation. Avoid consuming alcoholic beverages and certain medicines while being treated with this medicine, as they may potentiate this effect. Sedated, weakened, or bedridden patients should not take this medicine.

In rare cases, severe skin reactions with redness, blisters, or rashes may occur. If you notice any of these symptoms, stop treatment and consult your doctor.

Other medicines and Farsicold

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicine. Especially 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 for treating tuberculosis (isoniazid, rifampicin).
• Medicines for preventing 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 for treating gout (probenecid).
• Medicines used for treating high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines for reducing cholesterol levels in the blood (cholestyramine).
• The administration of Farsicold should be separated by a minimum of 14 days after finishing treatment with certain medicines for treating depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion); medicines used for treating Parkinson's disease (selegiline), and medicines for treating other diseases, such as cancer (procarbazine), and infections (linezolid, furazolidone).
• Medicines for treating depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for treating schizophrenia (such as haloperidol).
• Medicines that have a depressant effect on the central nervous system, such as those used for insomnia or anxiety, for Parkinson's disease, or for allergies.
• Medicines that have ototoxicity as a side effect.
• Medicines that have photosensitization as a side effect.
• Medicines used for relieving pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that should be treated urgently and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Consult your doctor or pharmacist before taking Farsicold:

• If you are taking other medicines such as antidepressants or antipsychotics, Farsicold may interact with these medicines, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Interference with analytical tests:

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

Taking Farsicold with food, drinks, and alcohol

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

The use of medicines containing paracetamol (such as Farsicold) by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) may cause liver damage.

Do not take the medicine with grapefruit or bitter orange juice, as it may potentiate the effects of one of its components (dextromethorphan).

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 hazardous to 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, so breastfeeding women should not take Farsicold.

Use in children

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

Driving and using machines

Farsicold may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Farsicold contains sodium:

Patients on low-sodium diets should note that this medicine contains 26.3 mg (1.1 nmoles) of sodium per sachet.

Farsicold 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.

Farsicold containsorange yellow S (E-110):

This medicine may 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 Farsicold

Follow the administration instructions for this medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

If you take more Farsicold than indicated, you may experience the following symptoms: nausea and vomiting, muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

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.

Farsicold is a medicine intended for oral use.

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. At night, take preferably before bedtime.

Always use the lowest effective dose.

The recommended dose is:

Adults and adolescents from 14 years of age: 1 sachet every 6 or 8 hours (3 or 4 times a day), as needed. Preferably take 1 sachet before bedtime. Do not take more than 4 sachets per day.

Patient with liver failure: 1 sachet every 8 hours. Do not take more than 3 sachets per day. Consult your doctor.

Patient with kidney failure: cannot take this medicine due to the dose of paracetamol 650 mg.

Start treatment when the first symptoms appear and stop as they disappear.

If you do not improve or worsen after 5 consecutive days of treatment (3 for fever or adolescents), you should consult a doctor. (See section 1. "What is Farsicold and what is it used for").

If you take more Farsicold than you should:

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

The most serious effect of an overdose of this medicine is liver damage caused by paracetamol. You may feel dizzy, vomit, confused, excited, restless, nervous, irritable, have visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, states of drowsiness or alterations in gait.

Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine. Patients treated 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, consult the Toxicology Information Service (telephone: 91 5620420), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

During the use of the combination of paracetamol, chlorphenamine, and dextromethorphan, the following side effects have occurred, whose frequency cannot be established with precision:

• Frequently: sedation and drowsiness.
• Rarely, nightmares, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity) may occur, more common in children and the elderly. Dizziness and hypotension, especially in the elderly.
• Very rarely, gastrointestinal disorders, such as abdominal pain, diarrhea, nausea, vomiting, and indigestion (dyspepsia), confusion, dizziness, visual disturbances, increased sensitivity to the sun, dry mouth, sore throat, and difficulty urinating. Also, skin rashes and severe allergic reactions, such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, as well as increased transaminases. High doses or prolonged treatments are toxic to the liver.

The simultaneous consumption of alcohol during treatment may accentuate the appearance of side effects. Do not consume alcoholic beverages during the same.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Farsicold

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Farsicold

The active ingredients are: paracetamol 650 mg, chlorphenamine maleate 4 mg, and dextromethorphan hydrobromide 20 mg.

The other components (excipients) are: sucrose, sodium cyclamate, sodium citrate, orange yellow S (E-110), sodium saccharin, anhydrous citric acid, polysorbate 80, povidone K 30, titanium dioxide (E-171), lemon flavor, quinoline yellow (E-104).

Appearance of the product and package contents

Granules for oral solution, yellow in color and lemon-flavored.

Each package contains 10 sachets.

Marketing Authorization Holder

Farmasierra Laboratorios, S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes, 28709 (Madrid)

Spain

Manufacturer

Farmasierra Manufacturing S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes, 28709 (Madrid)

Spain

Date of the last revision of this package leaflet: October 2022

Other sources of information

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