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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Paracetamol / Dextromethorphan / Chlorphenamine

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the administration instructions 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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).

Contents of the leaflet

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. How to store Farsicold
6. Contents of the pack and other information

1. What Farsicold is and what it is used for

Farsicold is a medicine containing three active substances in combination: paracetamol, which reduces fever and relieves pain; dextromethorphan, which is a cough suppressant; and chlorpheniramine, which reduces nasal secretions.

It is indicated in adults and adolescents aged 14 years and older, for the symptomatic relief of colds and influenza-like conditions accompanied by mild to moderate pain such as headache, fever, non-productive cough (irritative cough, nervous cough), and runny nose.

You should consult your doctor if your condition worsens or does not improve after 5 days of treatment in adults, or 3 days in adolescents, or if 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 substances or to any of the other components of this medicine listed in section 6,
• you suffer from respiratory insufficiency, asthmatic cough, or cough accompanied by expectoration,
• you have severe liver or kidney disease,
• you are or have recently been treated with other medicines, such as: antidepressants, medicines for Parkinson's disease, treatment with linezolid (an antibiotic) or procarbazine (for cancer treatment). (See section "Other medicines and Farsicold"),
• 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 Farsicold".

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

• you have kidney, heart, or lung diseases,
• you have anemia,
• you suffer from liver diseases (with or without hepatic insufficiency) 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 also be sensitive to others (such as chlorphenamine),
• you have hypertension (high blood pressure), glaucoma (increased intraocular pressure), hyperthyroidism, vesical neck obstruction, symptomatic prostatic hypertrophy, or urinary retention,
• you suffer from atopic dermatitis.

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

Do not take this medicine if you have persistent or chronic cough, such as that caused by smoking, asthma, or emphysema, especially when cough is accompanied by abundant secretions, as it may impair expectoration and thereby increase airway resistance.

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

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

Chronic alcoholics should take care not to exceed 3 sachets per day (2 g of paracetamol).

Do not take this medicine simultaneously with other products containing paracetamol, as this could lead to paracetamol overdose and potential liver damage.

This medicine causes sedation. Avoid consuming alcoholic beverages and certain medications during treatment, as they may enhance this effect. Sedated, weakened, or bedridden patients must not take this medicine.

Rarely, severe skin reactions may occur, such as redness, blisters, or rashes. If you notice any of these symptoms, stop treatment immediately and consult your doctor.

Other medicines and Farsicold

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 for tuberculosis (isoniazid, rifampicin).
• Medicines 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 causing potassium loss (such as diuretics 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 cardiac arrhythmias, such as amiodarone or quinidine.
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Administration of Farsicold must be separated by at least 14 days after stopping treatment with certain antidepressants (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion); medicines used to treat Parkinson's disease (selegiline); and medicines used for other conditions such as cancer (procarbazine) and infections (linezolid, furazolidone).
• Medicines for depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for schizophrenia (such as haloperidol).
• Medicines that cause central nervous system depression, such as those used for insomnia or anxiety, Parkinson's disease, or allergies.
• Medicines that have the adverse effect of damaging the ear (ototoxic).
• Medicines that cause photosensitivity as an adverse effect (photosensitizers).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap), which requires urgent treatment 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, or when 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 them 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Interference with diagnostic tests:

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

Taking Farsicold with food, drinks, and alcohol

While taking this medicine, do not consume alcoholic beverages, as they may enhance the occurrence of adverse effects.

Using medicines containing paracetamol (such as Farsicold) in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

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

Pregnancy and breastfeeding

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. Taking medicines during pregnancy may be dangerous for the embryo or fetus and must be supervised by your doctor.

This medicine must 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 must not take Farsicold.

Use in children

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

Driving and using machines

Farsicold may cause drowsiness, affecting mental and/or physical performance. If you experience these effects, avoid driving or operating machinery.

Farsicold contains sodium:

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

Farsicold contains sucrose:

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

Farsicold contains Sunset Yellow FCF (E-110):

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

3. How to take Farsicold

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed 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 disorders (accelerated heart rate), coordination problems, psychosis with visual hallucinations, and hyperexcitability.

Additional symptoms in case of massive overdose may include: coma, severe breathing problems, and seizures.

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

Farsicold is a medicine intended for oral use.

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

Always use the lowest dose that is effective.

Recommended dose:

Adults and adolescents aged 14 years and over: 1 sachet every 6 or 8 hours (3 or 4 times daily), as needed. Preferably take 1 sachet before going to bed. Do not take more than 4 sachets per day.

Patients with hepatic impairment: 1 sachet every 8 hours. Do not take more than 3 sachets per day. Consult your doctor.

Patients with renal impairment: must not take this medicine due to the dose of paracetamol 650 mg.

Begin treatment as soon as the first symptoms appear and discontinue as symptoms subside.

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

If you take more Farsicold 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 the overdose has been ingested, even in cases of severe poisoning.

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

Treatment of overdose is most effective if started within 4 hours of taking the medicine. 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 this is not possible, contact the Toxicology Information Service (telephone: 91 5620420), stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of the combination of paracetamol, chlorpheniramine, and dextromethorphan, although their exact frequency could not be established:

• Frequently: drowsiness and somnolence.
• Rarely: nightmares, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more commonly observed in children and elderly patients. 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 sunlight; dry mouth; sore throat; and difficulty urinating. Skin rashes and serious allergic reactions have also been reported, 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 treatment may be hepatotoxic.

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 or pharmacist, 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: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Farsicold Storage

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

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Farsicold

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

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

Appearance of the medicine and contents of the pack

Yellow granules for oral solution with a lemon flavour.

Each pack 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 most recent revision of this leaflet: October 2022

Other sources of information

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