APIRETAL 24 mg/mL ORAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Apiretal 24 mg/ml Oral Suspension

Paracetamol

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.
• You should consult a doctor and stop treatment if the pain persists for more than 3 days in children or 5 days in adults (2 days for throat pain), or if the fever persists for more than 3 days, or if the pain or fever worsens, or if other symptoms appear.

Contents of the Package Leaflet:

1. What Apiretal is and what it is used for
2. What you need to know before taking Apiretal
3. How to take Apiretal
4. Possible side effects
5. Storage of Apiretal
6. Package Contents and Additional Information

1. What Apiretal is and what it is used for

Apiretal belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated for the symptomatic treatment of febrile states and for the relief of mild or moderate pain.

2. What you need to know before taking Apiretal

Do not take Apiretal:

• If you are allergic (hypersensitive) to paracetamol or to any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Apiretal.

• Do not exceed the recommended dose in "Section 3 - How to take Apiretal". Check that you are not using other medicines that contain paracetamol at the same time.
• Patients with heart or lung disease and patients with anemia should consult their doctor before taking this medicine.
• If you have liver problems (including Gilbert's syndrome) or kidney problems, or if you suffer from chronic malnutrition or dehydration, consult your doctor, as you may need a reduction in the dose of paracetamol.
• If you are an asthmatic sensitive to acetylsalicylic acid, consult your doctor before using this medicine.
• In chronic alcoholics, caution should be exercised not to take more than 2 g of paracetamol per day.
• If the symptoms worsen or if the fever persists for more than 3 days or the pain for more than 3 days in children or 5 days in adults (2 days for throat pain), you should consult your doctor.

During treatment with Apiretal, inform your doctor immediately if:

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

Children

In children under 2 years of age, consult your doctor to indicate the dose to be taken.

Taking Apiretal with other medicines

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

In particular, if you are using medicines that contain any of the following active ingredients, as it may be necessary to modify the dose or interrupt treatment of either of them:

• Antibiotics (flucloxacillin), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

• Oral anticoagulants (acenocoumarol, warfarin).
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, primidone, carbamazepine).
• Antituberculars (isoniazid, rifampicin).
• Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Certain medicines used to increase urine elimination (loop diuretics such as furosemide).
• Propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, which causes AIDS).
• Colestyramine (used to decrease blood cholesterol levels).
• Metoclopramide and domperidone; used to prevent nausea and vomiting.

It should not be used with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to inform your doctor or pharmacist systematically if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

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

Taking Apiretal with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

In case of necessity, Apiretal can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before taking this medicine.

Driving and using machines

No effects have been described that modify the ability to drive and use machines.

Apiretal contains saccharose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-217), and azorubine (carmoisine) (E-122).

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 0.4 g of saccharose per ml.

It can cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-217).

This medicine may cause allergic reactions because it contains azorubine (carmoisine) (E-122). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Apiretal

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

It is necessary to respect the posologies defined according to weight. The child's age according to weight is given for information purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

For administration of 15 mg/kg every 6 hours, the schedule is as follows, where the doses can be repeated with a minimum interval of 6 hours, without exceeding a total of 4 doses in 24 hours.

If the desired effects are not achieved within 3-4 hours of administration, the dose can be advanced every 4 hours, in which case 10 mg/kg will be administered.

Adults and adolescents over 15 years:

The recommended dose is 20 ml to 40 ml per dose as needed every 4-6 hours. The doses should be spaced at least 4 hours apart. Do not exceed 120 ml(3 g of paracetamol) per day.

Always use the lowest effective dose to control symptoms. The doses should be repeated as long as symptoms persist.

Patients with liver disease:Consult your doctor before taking this medicine.

You should take the prescribed amount of medicine with a minimum interval of 8 hours between each dose.

Patients with kidney disease:Consult your doctor before taking this medicine.

Depending on your disease, your doctor will indicate whether you should take your medicine with a minimum interval of 6 or 8 hours.

Elderly patients:Consult your doctor before taking this medicine, as you may need a dose reduction.

Instructions for the correct administration of the preparation

The suspension is for oral administration.

Use the oral syringe included in the package to measure the dose, and take the suspension alone, or diluted in water or another liquid, or mixed with milk or pap.

1. Shake the bottle before use.
2. Insert the syringe, pressing on the perforated cap.
3. Invert the bottle and withdraw the necessary amount with the dosing syringe.
4. Wash the dosing syringe and close the bottle well after each use.

It can be taken with or without food. For rapid relief of pain, take the medicine without food.

Administration of the medicine is subject to the appearance of pain or fever. As they disappear, the medication should be suspended.

If the symptoms worsen or if the fever persists for more than 3 days or the pain for more than 3 days in children or 5 days in adults (2 days for throat pain), you should consult your doctor.

If you take more Apiretal than you should

If you have taken more Apiretal than you should, go to a medical center immediately, even if you do not have symptoms, as they often do 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.

Paracetamol overdose is considered to be a single dose of more than 6 gin adults and more than 100 mg/kg of body weightin children. Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patients being treated with barbiturates or chronic alcoholics may be more sensitive to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go to a medical center immediately or, if not possible, call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take Apiretal

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the following doses with the indicated separation between doses (at least 4 hours).

If you stop treatment with Apiretal

If you have any other doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Apiretal can cause side effects, although not everyone gets them.

Paracetamol's adverse reactions are, in general, rare (may affect up to 1 in 1,000 patients) or very rare (may affect up to 1 in 10,000 patients).

In rare cases, general discomfort or sudden discomfort due to a drop in blood pressure (hypotension) may occur. It is also rare to find elevated levels of certain liver proteins (liver transaminases).

Very rarely, it can damage the liver at high doses or prolonged treatments. Also, very rarely, the following may appear: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from 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).

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

5. Storage of Apiretal

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

Do not use this medicine after the expiration date indicated on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Apiretal

• The active ingredient is paracetamol. Each milliliter of suspension contains 24 mg of paracetamol.
• The other components (excipients) are: saccharose (0.4 g/ml), methyl parahydroxybenzoate (E-218) (0.9 mg/ml), propyl parahydroxybenzoate (E-217) (0.45 mg/ml), azorubine (carmoisine) (E-122) (0.25 mg/ml), tragacanth gum, raspberry flavor, sodium saccharin, and purified water.

Appearance of the product and package contents

Red/pink suspension with a sweet taste. It is presented in a glass bottle, amber in color, containing 120 ml of suspension, with a safety screw cap and an adapter for incorporating the oral syringe (5 ml), which is also included.

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer

Laboratorios INIBSA, S.A.

Crta. Sabadell a Granollers, Km 14.5 (Lliçà de Vall)

08185 Barcelona

Spain

Date of the last revision of this package leaflet:February 2025.

Other sources of information

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