Leaflet: information for the user

Fricoldpowder for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4.

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

1.What is Fricold and what it is used for

2.What you need to knowbefore starting to take Fricold

3.How to takeFricold

4.Possible side effects

5.Storage ofFricold

6.Contents of the pack and additional information

It is an association of paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents over 15 years old for the relief of symptoms of colds and flu that are accompanied by fever or mild to moderate pain, congestion, and nasal secretion.

Consult a doctor if symptoms worsen or do not improve or if fever persists for more than 3 days or pain or other symptoms persist for more than 5 days.

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 any 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 increase heart rate).

- If you are being treated with beta-blocker medications (medications for the heart or to treat blood vessel diseases) (see: Taking fricold with other medications).

- If you have glaucoma (elevated eye pressure).

- If you have severe heart or blood vessel disease (such as coronary artery disease or angina pectoris).

- If you have severe 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 takefricold

• Do not take more medication than recommended in section 3: How to take fricold.
• Chronic alcoholics should be careful not to take more than 2g of paracetamol (3 packets) per day of fricold.
• Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

You should consult your doctor before taking this medication:

• Patients with kidney, liver, heart, or lung diseases and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patients being treated with medications for: benign prostatic hyperplasia, asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer disease, pyloric obstruction, thyroid diseases, patients sensitive to the sedative effects of some medications.
• If you are being treated with tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (detention of normal intestinal movements).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

Children and adolescents

Do not administer to children under 15 years old.

Interference with laboratory tests:

Inform your doctor if you are taking/using this medication, as it may affect test results.

Taking fricold with other medications:

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for tuberculosis: (isoniazid, rifampicin).
• Medications for seizures 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 (probencid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arhythmias): Propranolol.
• Medications used to lower cholesterol levels in the blood (colestiramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine oxidase inhibitors (MAOIs)). You should separate the intake of fricold and these medications for at least 15 days after completing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure, or other diseases (alpha-blocker medications).
• Medications that block alpha and beta-adrenergic receptors (labetalol and carvedilol) used for the heart or to treat blood vessel diseases.
• Medications used to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetics.
• Anti-hypertensive medications.
• Medications used for the heart, such as cardiac glycosides, anti-arrhythmics, and beta-blockers.
• Medications that contain thyroid hormones (used to treat thyroid diseases).
• Medications used to treat heart or digestive diseases, such as atropine sulfate.
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (that can cause hearing damage).
• Phototoxic medications (that can cause light allergy).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and when using the maximum daily doses of paracetamol.

Taking fricold with food, drinks, and alcohol

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

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

The intake of 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 cannot be taken during breastfeeding, as it may cause adverse effects in the baby.

Driving and operating machinery

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

fricold contains mannitol (E-421)

This medication may cause a mild laxative effect due to the presence of mannitol.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 15 years old:The usual dose is 1 tablet every 6-8 hours (3-4 tablets a day), as needed. Do not take more than 4 tablets a day (equivalent to 2.6 g of paracetamol per day). Do not take more than 3 grams of paracetamol per 24 hours (see "warnings and precautions").

Patients with renal insufficiency:This medication cannot be administered to these patients, because it contains 650 mg of paracetamol and its pharmaceutical form is granulated. Since the maximum dose per intake for these patients is 500 mg, the content of the packet cannot be divided to obtain the appropriate dose.

Patients with liver insufficiency:In case of liver insufficiency or Gilbert's syndrome, do not exceed 3 tablets 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

People of advanced age cannot use this medication without consulting a doctor

because they may be especially affected by some side effects of the medication such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the content of phenylephrine and chlorphenamine. They may also be more likely to present 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.

Empty the contents of the packet into approximately half a glass of water. Shake and drink immediately.

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

If you take too much of this medication

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

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration 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 (this last one 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 reserve). In case of prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

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

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the overdose of the medication.

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

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

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

• The side effects that may appear most frequently are:Light drowsiness, dizziness, muscle weakness: these side 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 discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucosities, sweating, blurred vision, or other visual disturbances.

• The side effects that may appear with low frequency (rare) are:Uncomfortable feeling, low blood pressure, and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually 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 side effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (usually with overdose), liver disturbances (which may present 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) with related chlorphenamine medications. 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; low or high blood pressure, edema (swelling), ear alterations, impotence, menstrual alterations.

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

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

There have been very rare cases of skin reactions reported.

• The side effects whose frequency of appearance is unknown are:Anxiety, irritability, weakness, high blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), reduction in peripheral blood vessel diameter (vasoconstriction), reduction in heart function that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, sensation 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.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of fricold

Each sachet contains:

- As active principles: 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, a cornstarch derivative) and povidone.

Appearance of the product and content of the packaging

fricold is an oral granule solution of white or light yellow color and orange flavor, which is presented in sachets that are packaged in cardboard boxes with 10 sachets.

Holder of the marketing authorization

FARLINE COMERCIALIZADORA DE PRODUCTOS FARMACÉUTICOS S.A.

C/ Sta. Engracia, 31

28010 Madrid

Responsible for manufacturing

ALCALÁ FARMA, S.L

Avenida de Madrid, 82

Alcalá de Henares 28802 (Madrid)

Last review date of this leaflet: February 2025

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/