Leaflet: Information for the User

Dolostop Pediatric 100 mg/ml Oral Solution

Paracetamol

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

Follow exactly the administration instructions for 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 your condition worsens or does not improve after 3 days. If the fever persists for more than 3 days or the pain for more than 3 days in children (2 days for sore throat).

1.What is Dolostop Pediatric and for what it is used

2.What you need to know before starting to take Dolostop Pediatric

3.How to take Dolostop Pediatric

4.Possible side effects

5.Storage of Dolostop Pediatric

6.Contents of the pack and additional information

Paracetamolbelongs to a group of medicines called analgesics and antipyretics.

This medication is indicated in full-term newborns, infants, and children, for the treatment of febrile states and for the relief of mild or moderate pain.

Do not takeDolostop Pediatric

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• Do not exceed the recommended dose in section 3. Check that no other medications containing paracetamol are being taken simultaneously.
• Patients with mild or moderate liver disease should consult their doctor before taking the medication.
• Patients with kidney, heart, or lung diseases, anemia (decreased hemoglobin levels in the blood, due or not to decreased red blood cells), and patients with chronic malnutrition or dehydration should consult their doctor before taking the medication.
• Consuming alcoholic beverages may cause paracetamol to damage the liver.
• If the pain persists for more than 3 days (2 days for sore throat) or fever for more than 3 days, or worsens or new symptoms appear, discontinue treatment and consult your doctor. Avoid prolonged treatments.

Inform your doctor immediately during treatment with Dolostop if:

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 have malnutrition, chronic alcoholism, or 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 respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Consult your doctor before administering this medication to children under 2 years old.

Use of Dolostop Pediatric with other medications

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

Do notusewithothermedicationstotreatpainorfever(analgesics/antipyretics) lessthanyourdoctorindicates.

Paracetamol may increase the toxicity of chloramphenicol.

Barbiturates may potentiate the toxicity of paracetamol.

In cases of anticoagulant oral treatments, paracetamol can be administered occasionally as the preferred analgesic.

In particular, if you are using medications that contain any of the following active principles, it may be necessary to modify the dose or discontinue treatment of any of them:

• Oral anticoagulants (acenocoumarol, warfarin).
• Anticonvulsants (lamotrigine, phenytoin, phenobarbital, methylphenobarbital, primidone).
• Antituberculars (isoniazid, rifampicin).
• Colestiramine (used to reduce blood cholesterol levels).
• Medications used to treat gout (antigout) (probencid).
• Some diuretics of the loop type, such as those in the furosemide group.
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol used to treat high blood pressure (hypertension) and cardiac arrhythmias.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (denominated metabolic acidosis with high anionic imbalance) that must be treated urgently (see section 2).

Interference with analytical tests:

Inform your doctor that you are taking this medication, as it may alter the results of these tests.

Use of Dolostop Pediatric with foods, beverages, and alcohol

This medication can be taken with or without food and administered directly or diluted with water, milk, or fruit juice.

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day) may damage the liver.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Oral paracetamol does not produce undesirable effects in the pregnant woman, the fetus, or the newborn. Reproduction studies do not show malformations or toxic effects. If necessary, paracetamol can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever do not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, although there have been no reports of adverse effects in children. Therefore, it can be used in women breastfeeding if the recommended dose is not exceeded. Be cautious in cases of prolonged use.

Driving and operating machinery

It may reduce your ability to drive or operate machinery, as it contains propylene glycol, which can cause symptoms similar to those of alcohol.

Dolostop Pediatric contains propylene glycol (E-1520) and glucose

This medication contains 2.72 mg of propylene glycol per ml.

If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

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

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 or pharmacist.

Remember to take your medication.

Your doctor will indicate the duration of treatment. Do not discontinue treatment beforehand, as this would not yield the expected results. Similarly, do not use this medication for a longer period than indicated by your doctor.

The dosing of the solution is performed in ml (100 mg/ml), using the oral syringe of 2 or 5 ml.

Use in children

In children under 2 years, the dose must always be established by your doctor.

Children from 0 to 10 years:

The recommended daily dose of paracetamol is 60 mg/kg/day, that is, 10 mg/kg every 4 hours (up to 6 doses/day) or 15 mg/kg every 6 hours (up to 4 doses in 24 hours). In children under 1 year, doses of 10 mg/kg are preferred.

To administer 10 mg/kg with a minimum interval of 4 hours, the recommended schedule is as follows:

To perform a direct calculation, you can also multiply the child's weight in kg by 0.10. The result is the ml of solution to administer.

These doses can be repeated every 4 hours.

Alternatively, doses of 15 mg/kg with a minimum interval of 6 hours can be administered. In this case, for a direct calculation, you can multiply the child's weight in kg by 0.15. The result is the ml of solution to administer.

The administration of the preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, discontinue this medication.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Form of use and route of administration

Oral route

Instructions for use:

1.- Open the bottle following the instructions indicated on the cap (in the first opening the seal will break).

2.- Insert the oral syringe, pressing on the orifice of the perforated cap.

3.- Invert the bottle and remove the necessary dose.

4.- Administer directly or dilute with water, milk, or fruit juice.

5.- The oral syringe must be washed with water after each dose.

Close the bottle well after each administration.

If you take more Dolostop Pediátrico than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If an overdose has been ingested, go to a Medical Center immediately, even if there are no symptoms, as severe symptoms often do not appear until 3 days after ingestion, even in cases of severe intoxication. The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

A paracetamol overdose is considered to be the ingestion of a single dose of more than 6 g in adults and more than 100 mg/kg of body weight in children.The treatment of an overdose is more effective if initiated within 4 hours of medication ingestion.

In the case of patients undergoing barbiturate treatment or suffering from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

If you forgot to take Dolostop Pediátrico

Do not take a double dose to compensate for the missed doses.

If you have forgotten a dose, take another as soon as possible and continue with the usual schedule. However, if the next dose is due soon, skip the missed dose and take the next dose at the usual time.

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

This medication can produce the following adverse effects:

• Rare (may affect up to 1 in 1,000 people): discomfort, increased levels of liver transaminases, and decreased blood pressure.
• Very rare (may affect up to 1 in 10,000 people): severe skin reactions, liver alterations (such as jaundice), decreased glucose, blood alterations (thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia), cloudy urine, and kidney alterations.
• Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

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

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

Store the bottle in the outer packaging to protect it from light.

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.

Once opened, the contents of the bottle must be used within 6 months.

Medicines should not be disposed of through drains or in the trash. Dispose of empty containers and unused medications at your local pharmacy's SIGRE drop-off point.Ask your pharmacist how to dispose of empty containers and unused medications if you are unsure. By doing so, you will help protect the environment.

Composition of Dolostop Pediatric

• The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other components (excipients) are: macrogol 600, glycerol (E-422), sucralose (E-955), flavor enhancer (contains propylene glycol (E-1520)), strawberry aroma (contains propylene glycol (E-1520)), red cochineal (E-120) (contains glucose) and water.

Appearance of the product and content of the container

Dolostop Pediatric 100 mg/ml oral solution is presented in the form of a transparent, red-colored solution with a characteristic strawberry odor.

Container of 30 ml:

Plastic (PET) transparent bottle with 30 ml of oral solution, with a plastic (LDPE) adapter for inserting the dosing syringe and closed with a plastic (HDPE) cap. A plastic syringe of 2 ml is included.

Container of 60 ml:

Plastic (PET) transparent bottle with 60 ml of oral solution. With a plastic (LDPE) adapter for inserting the dosing syringe and closed with a plastic (HDPE) cap. A plastic syringe of 5 ml is included.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 202 5

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .