Fricold granules for oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

fricoldgranulado for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorpheniramine maleate

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens, does not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

Leaflet Contents

1. What fricold is and what it is used for
2. What you need to know before taking fricold
3. How to take fricold
4. Possible adverse effects
5. How to store fricold
6. Contents of the pack and other information

1. What fricold is and what it is used for

It is a combination of paracetamol, chlorpheniramine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents over 15 years of age for the relief of symptoms of colds and flu associated with fever or mild to moderate pain, nasal congestion, and nasal discharge.

You should consult a doctor if symptoms worsen or do not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

2. What you need to know before taking fricold

Do not take fricold

• 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 high blood pressure (hypertension).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitors (MAOIs), such as certain antidepressant medicines or medicines used to treat Parkinson's disease.
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma, or medicines to increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see: Taking fricold with other medicines).
• If you have glaucoma (increased pressure in the eye).
• If you have a severe heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have severe liver or kidney disease.
• Children under 15 years of age must not take this medicine.

Warnings and precautions

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

• Do not take more medicine than recommended in section 3: How to take fricold.
• Chronic alcoholics should take care not to take more than 2 g of paracetamol (3 sachets) per day of fricold.
• Avoid using this medicine simultaneously with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Patients should consult their doctor before taking this medicine if they:

• Have kidney, liver, heart, or lung disease, or if they have anemia.
• Are asthmatic and sensitive to acetylsalicylic acid.
• Are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).
• Are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between the stomach and intestine), thyroid diseases, or if they are sensitive to the sedative effects of certain medicines.
• Are being treated with tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems; in such cases, stop taking this medicine immediately and consult a doctor, as you may develop paralytic ileus (cessation of normal intestinal movements).
• Have glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

Children and adolescents

This medicine must not be given to children under 15 years of age.

Interference with diagnostic tests:

If you are due to have any diagnostic tests (including blood or urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking fricold with other medicines:

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 to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: (isoniazid, rifampicin).
• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicine to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or others), and other diuretics that cause potassium loss (such as diuretics used to treat hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Medicines used to lower cholesterol levels in the blood (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). fricold must not be taken within at least 15 days after stopping treatment with these medicines.
• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat high blood pressure or other conditions (alpha-adrenergic blocking medicines).
• Alpha- and beta-adrenergic blocking medicines (labetalol and carvedilol) used for heart conditions or arterial diseases.
• Medicines used to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetics.
• Antihypertensives (medicines to lower blood pressure).
• Medicines of the type of cardiac glycosides, antiarrhythmics, and beta-adrenergic blockers used for heart conditions.
• Medicines containing thyroid hormones (used to treat thyroid diseases).
• Medicines used for heart diseases or digestive disorders such as atropine sulfate.
• Medicines that depress the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which have the adverse effect of causing light allergy).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

During treatment with Fricold granules for oral solution, inform your doctor immediately:

If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Taking fricold with food, drinks, and alcohol

While being treated with this medicine, do not consume alcoholic beverages, as they may increase the risk of adverse effects of this medicine.

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

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

This medicine must not be taken during breastfeeding, as it may cause adverse effects in the infant.

Driving and using machines

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

fricold contains mannitol (E-421)

This medicine may cause a mild laxative effect because it contains mannitol.

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

3. How to take fricold

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents over 15 years of age: The usual 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 2,600 mg of paracetamol per day). Do not exceed 3 grams of paracetamol in any 24-hour period (see section “Warnings and precautions”).

Patients with renal impairment: This medicine must not be administered to such patients, as it contains 650 mg of paracetamol and is formulated as a granule. Since the maximum single dose for these patients is 500 mg, the contents of the sachet cannot be divided to achieve the appropriate dose.

Patients with hepatic impairment: In cases of hepatic impairment or Gilbert’s syndrome, do not exceed 3 sachets in 24 hours, and the minimum interval between doses must be 8 hours.

Use in children

This medicine must not be administered to children and adolescents under 15 years of age.

Use in elderly patients

Elderly patients must not use this medicine without consulting a doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorphenamine. They may also be more likely to experience adverse effects such as sedation, confusion, hypotension, or agitation, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

This medicine is taken orally.

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

Always take the lowest effective dose. Treatment with this medicine should be initiated only upon the onset of symptoms. As symptoms subside, treatment should be discontinued.

If you take more fricold than you should

If you have ingested an overdose, you must go immediately to a medical center even if you do not feel any symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output, metabolic acidosis (decreased blood alkaline reserve). With prolonged use, plasma volume depletion (reduced blood volume) may occur.

Overdose may also cause: coagulation disorders (blood clots and hemorrhages).

Treatment of overdose is most effective if initiated within 4 hours of ingestion.

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 call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

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

The following adverse effects have been reported during the use of paracetamol, phenylephrine and chlorphenamine, the frequency of which has not been accurately established:

• The adverse effects that may occur more frequently are: Mild drowsiness, dizziness, muscle weakness; these adverse effects may disappear after 2–3 days of treatment. Difficulty in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision or other visual disturbances.

• The adverse effects that may occur less frequently (rare) are: Malaise, drop in blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary oedema (increased fluid volume in the lungs), and cerebral haemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses, and more common in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even seizures. Other adverse effects that may occur less frequently are: chest tightness, lung sounds, rapid or irregular heartbeat (generally with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorphenamine. Blood disorders (changes in blood cell counts, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, oedema (swelling), ear disturbances, impotence, menstrual disorders.

• The adverse effects that may occur very rarely (very rare) are: Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.

Very rare cases of skin reactions have been reported.

• The adverse effects whose frequency of occurrence is unknown 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 heartbeat (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance, particularly affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, pallor, piloerection (goosebumps), increased blood sugar (hyperglycaemia), low blood potassium, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). With high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur.
• Frequency not known (cannot be estimated from available data): A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fricold

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of fricold

Each sachet contains:

• Active substances: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine), and 4 mg of chlorpheniramine maleate (equivalent to 2.8 mg of chlorpheniramine).
• Other components (excipients): Mannitol (E-421), sodium saccharin (E-954), anhydrous colloidal silica, orange flavour (containing maltodextrin, which is a derivative of maize starch), and povidone.

Description of the product and contents of the pack

fricold is a white or yellowish-white granule for oral solution with an orange flavour. It is supplied in sachets packed in cardboard boxes containing 10 sachets.

Marketing Authorization Holder

FARLINE COMERCIALIZADORA DE PRODUCTOS FARMACÉUTICOS S.A.
C/ Sta. Engracia, 31
28010 Madrid
Spain

Manufacturer

ALCALÁ FARMA, S.L.
Avenida de Madrid, 82
Alcalá de Henares 28802 (Madrid)
Spain

Date of the most recent revision of this leaflet: February 2025

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