FRICOLD GRANULADO FOR ORAL SOLUTION

2. What you need to know before taking fricold

Do not takefricold

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have high blood pressure.
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) medication (such as certain antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or medications to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: Taking fricold with other medications).
• If you have glaucoma (increased eye pressure).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have a serious liver or kidney disease.
• Children under 15 years old should not take this medication.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take fricold.

• Do not take more than the recommended dose of medication (see section 3: How to take fricold).
• Chronic alcoholics should not take more than 2g of paracetamol (3 sachets) per day of fricold.
• Avoid taking this medication simultaneously with other medications that contain paracetamol, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

The following patients should consult their doctor before taking this medication:

• Patient with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heart rate, low blood pressure, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid disease, patients sensitive to the sedative effects of certain medications.
• If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (stoppage of normal bowel movements).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

Children and Adolescents

This medication should not be administered to children under 15 years old.

Interference with Laboratory Tests

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking fricold with Other Medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication.

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

• Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for tuberculosis: (isoniazid, rifampicin).
• Medications for convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics such as furosemide, or others), 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 and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine Oxidase Inhibitors (MAOIs)). You should wait at least 15 days after finishing treatment with these medications before taking fricold.
• Medications used to treat migraines; medications taken for childbirth; medications taken for high blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blocking medications (labetalol and carvedilol) used for the heart or to treat arterial diseases.
• Medications for depression (tricyclic and tetracyclic antidepressants).
• General anesthetics.
• Antihypertensives (medications to lower blood pressure).
• Medications for the heart, such as cardiac glycosides, antiarrhythmics, and beta blockers.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases, such as atropine sulfate.
• Medications that depress the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (which can damage the ear as a side effect).
• Photosensitizing medications (which can cause light allergy as a side effect).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

During treatment with Fricold granules for oral solution, 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 organ damage), 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 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 unwell (nausea) and vomiting.

Taking fricold with food, drinks, and alcohol

While being treated with this medication, you should not consume alcoholic beverages, as it may increase the risk of side effects.

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

Taking this medication with food does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be taken during pregnancy unless your doctor considers it strictly necessary.

This medication should not be taken during breastfeeding, as it may cause side effects in the baby.

Driving and Using Machines

This medication may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or using machines.

fricold contains mannitol (E-421)

This medication may have a mild laxative effect because it contains mannitol.

This medication contains less than 23 mg of sodium (1mmol) per unit dose, which is essentially "sodium-free".

3. How to Take fricold

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 15 years old: The normal dose is 1 sachet every 6-8 hours (3-4 sachets per day), as needed. Do not take more than 4 sachets per day (equivalent to 2.6g of paracetamol per day). Do not take more than 3 grams of paracetamol every 24 hours (see "Warnings and Precautions" section).

Patient with kidney failure: This medication should not be administered to these patients, as it contains 650 mg of paracetamol and its pharmaceutical form is granules. Since the maximum dose per intake for these patients is 500 mg, the sachet content cannot be divided to achieve the appropriate dose.

Patient with liver failure: In case of liver failure or Gilbert's syndrome, do not exceed 3 sachets in 24 hours, and the minimum interval between doses will be 8 hours.

Use in Children

This medication should not be administered to children and adolescents under 15 years old.

Use in Elderly Patients

Elderly patients should not use this medication without consulting their doctor, as they may be more susceptible to certain side effects, such as bradycardia (slow heart rate) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine. They are also more likely to experience 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.

Pour the entire contents of the sachet into approximately half a glass of water. Stir and drink immediately.

Always take the smallest effective dose. The intake of this medication is subject to the appearance of symptoms. As they disappear, treatment should be discontinued.

If you take more fricold than you should

If you have ingested an overdose, go to a medical center immediately, even if you do not notice symptoms, as they may not appear until 3 days after ingestion, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, decreased urine output, metabolic acidosis (decrease in blood alkalinity). In case of prolonged use, it may cause depletion of plasma volume (decrease in blood volume).

Overdose can also cause: coagulation disorders (blood clots and bleeding).

Treatment of overdose is more effective if started within 4 hours after taking the overdose of the medication.

Patient being 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 to a medical center immediately or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

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

• Adverse effects that may appear more frequently are: Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and paresthesias, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• Adverse effects that may appear with low frequency (rare) are: Malaise, lowering of blood pressure (hypotension), and increase in blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung fluid volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally with high doses, and is more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which can be presented with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood alterations (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; lowering or rising blood pressure, edema (swelling), alterations in the ears, impotence, menstrual alterations.

• Adverse effects that may appear with very low frequency (very rare) are:Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowish skin discoloration), blood alterations (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

Very rare cases of skin reactions have been reported.

• Adverse effects whose frequency of appearance is not known are: Anxiety, irritability, weakness, increase in blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, paleness, hair standing on end, increase in blood sugar (hyperglycemia), decrease in potassium in the blood, metabolic acidosis (metabolism alteration), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.
• Frequency not known (cannot be estimated from the 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).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or 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: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Fricold

Keep this medication out of sight and reach of children.

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.

No special storage conditions are required.

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

6. Content of the Packaging and Additional Information

Composition of Fricold

Each sachet contains:

• As active ingredients: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).
• The other components (excipients) are: Mannitol (E-421), sodium saccharin (E-954), anhydrous colloidal silica, orange flavor (containing maltodextrin, which is a corn starch derivative) and povidone.

Appearance of the Product and Content of the Packaging

Fricold is a white or yellowish-white granulate for oral solution with an orange flavor, presented in sachets that are packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder

FARLINE COMERCIALIZADORA DE PRODUCTOS FARMACÉUTICOS S.A.

C/ Sta. Engracia, 31

28010 Madrid

Manufacturer

ALCALÁ FARMA, S.L

Avenida de Madrid, 82

Alcalá de Henares 28802 (Madrid)

Date of the Last Revision of this Prospectus: February 2025

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