Leaflet: Information for the patient

Apiretal 24 mg/ml oral suspension

Paracetamol

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

• 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.
• 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 sore throat), fever for more than 3 days, or if the pain or fever worsen or other symptoms appear.

1. What is Apiretal and what it is used for

2. What you need to know before starting to take Apiretal

3. How to take Apiretal

4. Possible side effects

5. Storage of Apiretal

6. Contents of the pack and additional information

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

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

Do not take Apiretal:

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

Warnings and Precautions

Consult your doctor or pharmacist or nurse before starting to take Apiretal.

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

Inform your doctor immediately if during treatment with Apiretal:

• You have severe diseases, such as severe renal insufficiency 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 severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

For children under 2 years, consult your doctor to determine the dose to take.

Taking Apiretal with other medications

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

Particularly, if you are using medications that contain any of the following active ingredients, as you may need to adjust the dose or discontinue treatment with either of them:

• Antibiotics (flucloxacillin), due to a severe 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).
• Antituberculosos (isoniazid, rifampicin).
• Barbiturates (used as hypnotics, sedatives and anticonvulsants).
• Medications used to treat gout (probencid and sulfinpyrazone).
• Some medications used to increase urine elimination (diuretics such as furosemide).
• Propranolol used to treat high blood pressure (hypertension) and heart rhythm disturbances (arrhythmias).
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, causing AIDS).
• Colestiramine (used to reduce blood cholesterol levels).
• Metoclopramide and domperidone; used to prevent nausea and vomiting.

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist if you are being treated with another medication. In the case of oral anticoagulants, it may be possible to administer Apiretal occasionally as the preferred analgesic.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood and urine tests, etc.), inform your doctor that you are taking this medication, as it may affect 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.

The taking of this medication with food does not affect its efficacy.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medication.

Apiretal may be used during pregnancy if necessary. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor before taking this medication.

Driving and operating machinery

No effects have been described that modify the ability to drive and operate machinery.

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

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

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

This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-217).

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

It is necessary to respectthe defined dosages based on weight. The child's age based on weight is given for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 daily doses, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

For the administration of15 mg/kg every 6 hours, the schedule is the one in the following table, where the doses can be repeated with a minimum interval of 6 hours, without exceeding a total of 4 doses in 24 hours.

If, 3-4 hours after administration, the desired effects are not obtained, 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. Doses should be spaced at least 4 hours apart.Do not exceed 120 ml(3 gof paracetamol)per day.

Always use the smallest effective dose to control symptoms. Doses should be repeated while symptoms last.

Patients with liver disease:Consult your doctorbefore taking this medication.

You should take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

Patients with kidney disease:Consult your doctorbefore taking this medication.

Depending on your condition, your doctor will tell you if you should take your medication with a minimum interval of 6 or 8 hours.

Older patients:Consult your doctorbefore taking this medicationbecauseyou may need to reduce the dose.

Instructions for correct administration of the preparation

The suspension is for oral administration.

Use the oral dosing syringe included in the package for your dosing, and ingest the suspension alone, or diluted in water or another liquid, or incorporated into milk or pap:

1. Shake the container before use.

2. Insert the syringe, pressing the orifice of the perforated cap.

3. Invert the container and remove the necessary amount with the dosing syringe.

3. Wash the dosing syringe and close the container tightly after each use.

You can take it with food or without it. To get quick relief from pain, take the medication without food.

Medication administration is subject to the appearance of pain or fever. As these disappear, discontinue medication.

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

If you take moreApiretal than you should

If you have taken more Apiretal than you should,go to a medical center immediatelyeven if you have no symptoms, as 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, yellowing of the skin and eyes (jaundice), and abdominal pain.

A paracetamol overdose is considered to be the ingestion of a single dose of more than6 gin adults and more than 100 mg per kg of body weight in children. The treatment of an overdose is more effective if it is initiated within 4 hours of medication ingestion.

Patients undergoing barbiturate treatment 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 Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the container and the medication leaflet to the healthcare professional.

If you forget to take Apiretal

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated spacing (at least 4 hours).

If you interrupt treatment with Apiretal

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

Like all medications, apiretal can produce adverse effects, although not all people will experience them.

Paracetamol adverse reactions are generally rare(can affect up to 1 in 1,000 patients)or very rare(can 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. Elevated levels of some liver proteins (hepatic transaminases) may also be found in rare cases.

Very rarely, it may damage the liver at high doses or prolonged treatment. Very rarely, the following may also occur: Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Severe skin reactions have been reported very rarely.

Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this leaflet.

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

Do not use this medication after the expiration date indicated on the packaging 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

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 contents of the packaging

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

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing

Laboratorios INIBSA, S.A.

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

08185 Barcelona

Spain

Last review date of this leaflet:February 2025.

Other sources of information

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/.