Package Leaflet: Information for the User

Farsicold 650 mg/20 mg/4 mg Granule for Oral Solution EFG

Paracetamol/Dextromethorphan/Chlorphenamine

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

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

1. What Farsicold is and what it is 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. Contents of the pack and additional information

Farsicold is a medication that contains three active ingredients in association: paracetamol, which reduces fever and relieves pain, dextromethorphan, which is an antitussive, and chlorphenamine, which reduces nasal secretion.

It is indicated in adults and adolescents aged 14 and over, 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) and nasal secretion.

Consult your doctor if symptoms worsen or do not improve after 5 days of treatment in adults, or 3 days in adolescents, or if fever persists for more than 3 days.

Do not take Farsicold if:

-You are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication included in section 6,

-You have respiratory insufficiency, asthma, or cough accompanied by expectoration.

-You have a severe liver or kidney disease,

-You are or have recently been treated with other medications, such as: medications for depression, medications for Parkinson's treatment, treatment with linezolid (antibiotic) or with procarbazina (for cancer treatment). (See section “Other medications and Farsicold”).

-Children under 14 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 Farsicold”.

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

-You have kidney, heart, or lung diseases,

-In patients with anemia,

-You have liver diseases (with liver insufficiency or without it) or viral hepatitis, because it increases the risk of hepatotoxicity,

-You are asthmatic and sensitive to acetylsalicylic acid,

-You are allergic (sensitive) to an antihistamine, because you may be sensitive to others (such as chlorphenamine),

-You have hypertension (elevated blood pressure), glaucoma (elevated intraocular pressure), hyperthyroidism, urethral obstruction, benign prostatic hyperplasia, urinary retention,

-You have atopic dermatitis.

Older patients may be more sensitive to the side effects of this medication.

Do not take this medication 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 the expectoration and increase the resistance of the respiratory tract.

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

See sections “Other medications and Farsicold” and “Intake of Farsicold with food, drinks, and alcohol”.

Chronic alcoholics should be careful not to take more than 3 packets a day (2 g of paracetamol).

Do not take this medication simultaneously with others that contain paracetamol, as it may cause a paracetamol overdose that could damage the liver.

This medication produces sedation. Avoid consuming alcoholic beverages and certain medications while taking this medication, as they may potentiate this effect. Patients who are sedated, weakened, or bedridden should not take this medication.

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

Other medications and Farsicold

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication. Especially if you arecurrently using some of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medications to treat epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medications to treat tuberculosis (isoniazid, rifampicin).
• Medications to prevent 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 (probencid).
• Medications used to treat high blood pressure (hypertension), such as propranolol and heart rhythm disturbances (arrhythmias), such as amiodarone or quinidine.
• Medications to reduce blood cholesterol levels (cholestyramine).
• It is necessary to separate the administration of Farsicold for at least 14 days after completing treatment with some medications to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion); medications used to treat Parkinson's disease (selegiline), and medications to treat other diseases, such as cancer (procarbazina), and infections (linezolid, furazolidine).
• Medications to treat depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications to treat 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, or for allergies.
• Medications that have as an adverse effect that damage the ear (ototoxic).
• Medications that, as an adverse effect, produce allergy to light (photosensitizing).
• Medications used to relieve pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and that may occur particularly in severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood that causes damage to organs), 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 medications such as antidepressants or antipsychotics, Farsicold may interact with these medications and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, hypertension, and exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

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 this medication, as it may alter the results.

Intake of Farsicold with food, drinks, and alcohol

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

The use of medications that contain paracetamol (such as Farsicold) 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 bitter lemon juice, as it may potentiate the effects of one of its components (dextromethorphan).

Pregnancy and lactation

If you are pregnant or breastfeeding, 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 lactation should not take Farsicold.

Use in children

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

Driving and operating machinery

Farsicoldmay cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or operating machinery.

Farsicold contains sodium:

Patients with low-sodium diets should be aware that this medication contains 26.3 mg (1.1 nmoles) of sodium per tablet.

Farsicold contains saccharose:

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

Farsicold containsyellow orange S(E-110):

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

If you take more Farsicold 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 (acceleration of heart rate), coordination disturbances, psychosis with visual hallucinations and hyperexcitability.

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.

Farsicold is a medication intended for oral use.

The contents of one sachet should be poured into a half glass of water and stirred until dissolved. Sugar or honey may be added according to preference.Take preferably before going to bed at night.

Always use the lowest effective dose.

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. Take 1 sachet preferably before going to bed. Do not take more than 4 sachets a day.

Patients with liver insufficiency: 1 sachet every 8 hours. Do not take more than 3 sachets a day. Consult your doctor.

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

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

If there is no improvement or worsening after 5 consecutive days of treatment (3 for fever or adolescents), consult your doctor. (See section 1. “What is Farsicold and what it is used for”).

If you take more Farsicold than you should:

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

The most severe effect of overdose is liver damage caused by paracetamol. You may feel dizzy, vomit, confused, excited, restless, nervous, irritable, visual disturbances, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, states of somnolence, or gait disturbances.

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, immediately go 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, this medication may produce adverse effects, although not everyone will experience them.

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

• Frequently: drowsiness and somnolence.
• 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 discomfort, 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. Skin eruptions and severe allergic reactions, such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain skin areas), pruritus, urticaria, rash, and increased transaminases have also been described. High doses or prolonged treatment are toxic to the liver.

The simultaneous consumption of alcohol during treatment may exacerbate the appearance of adverse effects. Do not consume alcoholic beverages during treatment.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 30 °C

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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Farsicold

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

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

Appearance of the product and contents of the packaging

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

Each package contains 10 sachets.

Holder of the marketing authorization

Farmasierra Laboratorios, S.L

Ctra. de Irún km 26,200

San Sebastián de los Reyes, 28709 (Madrid)

Spain

Responsible for manufacturing

Farmasierra Manufacturing S.L.

Ctra. de Irún km 26,200

San Sebastián de los Reyes, 28709 (Madrid)

Spain

Last review date of this leaflet: October 2022

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/