ARAFRIOL POWDER FOR ORAL SOLUTION

2. What you need to know before taking ARAFRIOL

Do not take ARAFRIOL if

• you are allergic (hypersensitive) to the active ingredients or to any of the other components of ARAFRIOL (included in section 6).
• you have arterial hypertension.
• you have hyperthyroidism.
• you have diabetes mellitus.
• you have tachycardias (rapid heartbeats).
• you are being treated with a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• you are being treated with sympathomimetic medications (medications used to treat asthma or medications to accelerate heart rate).
• you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: Taking ARAFRIOL with other medications).
• you have glaucoma (elevated eye pressure).
• you have a serious heart or arterial disease (such as coronary disease or angina pectoris).
• you have a serious liver or kidney disease.

Patients under 12 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ARAFRIOL.

• Do not take more medication than recommended in section 3: How to take ARAFRIOL.
• Avoid simultaneous use of this medication 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.
• Chronic alcoholics should be cautious not to take more than 2 g/24 hours of paracetamol.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as it may decrease the efficacy and potentiate the hepatotoxicity of paracetamol, especially in high-dose treatments.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

• 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 medication for: prostate hypertrophy, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid disease, patient sensitive to sedative effects of some medications.
• If being treated with tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as ileus (stop of normal bowel movements) may occur.

During treatment with Arafriol, inform your doctor immediately if:

• You have serious diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) 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. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and adolescents

Interference with analytical tests:

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

Taking ARAFRIOL with other medications

Inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that must be treated urgently (see section 2)

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take 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:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for tuberculosis: (isoniazid, rifampicin)
• Medications for depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine oxidase inhibitors (MAOIs). ARAFRIOL administration should be separated by a minimum of 15 days after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat arterial diseases).
• Medications for depression (tricyclic and tetracyclic antidepressants).
• General anesthetic medications.
• Antihypertensives (medications to lower blood pressure).
• Medications used for the heart such as cardiac glycosides, antiarrhythmics, and beta-adrenergic blockers.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases (atropine sulfate).
• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of producing allergy to light).

Taking ARAFRIOL with food, drinks, and alcohol

While being treated with this medication, you should not take alcoholic beverages, as it may potentiate the appearance of adverse effects of this medication.

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

The medication can be taken with or without food.

Pregnancy and lactation

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 produce adverse effects in the baby.

Driving and using machines

This medication may produce drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

3. How to take ARAFRIOL

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

It is not recommended to take more than one sachet per dose.

The recommended dose is:

Adultsand adolescents from 12 years old: 1 sachet every 6-8 hours if necessary (3 or 4 times a day). Do not exceed 4 sachets (equivalent to 2 grams of paracetamol) in 24 hours. The maximum daily dose of paracetamol should not exceed 3 grams every 24 hours (see section 4.4).

Patient with renal insufficiency:

Consult your doctor.

Your doctor will indicate if you can take the medication every 6 or 8 hours.

Patient with hepatic insufficiency:

Consult your doctor.

In case of hepatic insufficiency or Gilbert's syndrome, do not exceed 2 g/24 hours and the minimum interval between doses will be 8 hours.

Use in children

Children between 6 and 12 years old cannot take this medication due to the dose of 500 mg of paracetamol.

Use in elderly patients

Elderly patients cannot take this medication without consulting their doctor, as it may affect them especially with some adverse 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 are also more likely to present adverse 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

ARAFRIOL is taken orally.

Dissolve the contents of one sachet in half a glass or cup of hot milk or water.

Always take the smallest effective dose.

Treatment with this medication is subject to the appearance of symptoms. As they disappear, treatment should be suspended.

If the fever persists for more than 3 days of treatment, the pain or other symptoms persist for more than 5 days, or worsen or new ones appear, consult your doctor.

If you take moreARAFRIOLthan you should

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

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 (the latter especially in children). Dryness of mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). In prolonged use, it can produce depletion of plasma volume (decrease in blood volume).

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

4. Possible Adverse Effects

Like all medicines, ARAFRIOL can cause adverse effects, although not all people suffer from them.

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

• The adverse effects that may appear most 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 tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dry nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• The adverse effects that may appear with low frequency (rare) are:

Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually with high doses, and more frequent in the elderly and children), which can include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may appear with low frequency are: chest tension, lung noises, rapid or irregular heartbeats (usually with overdose), liver disorders (which can be presented with stomach pain 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 blood cell formula, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), alterations in the ears, impotence, menstrual alterations.

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

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

• The adverse effects whose frequency of appearance is not known(cannot be estimated from the available data), are: A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2), 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 (severe bradycardia), reduction of the caliber of blood vessels (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low 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.

Reporting of Adverse Effects

If you experience any of the adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines Website: www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of ARAFRIOL

Keep out of sight and reach of children.

Do not use ARAFRIOL after the expiration date that appears on the packaging, after CAD or Expiration Date. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C and protected from humidity.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE point of 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 ofARAFRIOL

Each sachet contains:

• As active ingredients: 500 mg of paracetamol, 10 mg of phenylephrine hydrochloride, and 4 mg of chlorphenamine maleate.
• The other components (excipients) are: Lemon flavor, Polysorbate 80, Isomaltose, and Sucralose.

Appearance of the Product and Content of the Packaging

Sachets containing white or almost white powder, with a slight lemon odor.

Boxes with 10 and 20 sachets.

Marketing Authorization Holder and Manufacturer

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo (Guadalajara). Spain

Date of the Last Revision of this Prospectus:

December 2024.

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/