Prospecto: Information for the User

Dolocatil1 gtablets EFG

paracetamol

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

1.Whatis Dolocatil andwhat it is used for

2.What you need to know before starting totake Dolocatil

3.How to take Dolocatil

4.Possible adverse effects

5.Storage of Dolocatil

6. Contents of the pack and additional information.

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

It is usedfor the treatment of symptoms of pain and fever.

Do not take Dolocatil

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

Warnings and precautions

Do not take more than the recommended dose in section 3. How to take Dolocatil.

In patients with asthma sensitive to acetylsalicylic acid, consult a doctor before taking this medication.

If you have any liver, kidney, heart, or lung disease, or have anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medication.

When undergoing treatment with any medication for epilepsy, consult a doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is potentiated, especially in high-dose paracetamol treatments.

In chronic alcoholics, be careful not to take more than 2 g/24 hours of paracetamol.

If the pain persists for more than 5 days, fever for more than 3 days, or the pain or fever worsen or other symptoms appear, consult a doctor and reevaluate the clinical situation.

In children under 15 years, consult your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.

During treatment with Dolocatil, immediately inform your doctor 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 chronic 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, somnolence, feeling unwell (nausea), and vomiting.

Other medications and Dolocatil:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: (colestiramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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

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

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Dolocatil 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... per day) may cause liver damage.

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

Pregnancy and lactation:

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

The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

In case of need, Dolocatil may 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 the pain or fever do not decrease or if you need to take the medication more frequently.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery:

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication. Dolocatil mustbe taken orally.

According to your preferences, the tablets can be taken directly or split in half, with the help of a liquid container, preferably water.

The groove is only for being able to split and facilitate swallowing but not to divide into equal doses.

Consult your doctor or pharmacist if you have doubts.

The recommended dose is:

Adults and adolescents over 15 years old: the usual dose is 1 tablet (1 gof paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. No more than 4 tablets (4 g) should be taken in 24 hours.

Patients with liver disease: before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, is not indicated for this group of patients.

Older patients: they must consult their doctor.

Use in children and adolescents

Do not use in children under 15 years old.

If it is estimated that the medication's action is too strong or too weak, inform your doctor or pharmacist.

When requiring the administration of doses lower than 1 gram of paracetamol per dose, other paracetamol presentations should be used that adapt to the required dosage.

If you takemoreDolocatilthan you should

You must consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you have ingested an overdose, you must go immediately to a medical center even if you do not notice the symptoms, as they often do not manifest 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), abdominal painand inflammation of the pancreas (pancreatitis).

The treatment of overdose is more effective if it is initiated within 4 hours of medication ingestion.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to takeDolocatil

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 interval (at least 4 hours).

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rare adverse effects that may occur (affecting up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (affecting up to 1 in 10,000 people) are: 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). Rarely, severe skin reactions have been reported.

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

Adverse effects of unknown frequency (cannot be estimated from available data): A severe disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting Adverse Effects

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

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

This medication does not require special storage conditions.

Do not use this medicationafterthe expiration date that appears on the packaging (after CAD.). The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dolocatil

• The active principle is paracetamol.
• The other components are:povidone, magnesium stearate, anhydrous colloidal silica, sodium glycolate starch (Type A) (origin: potato) and pregelatinized starch (origin: corn).

Appearanceof Dolocatiland content of the packaging

Oblong tablets, white in color and scored, in packaging of 20 and 40 tablets.

The tablets are scored, which allows them to be split in half.

Holder of the marketing authorization

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 - Barcelona

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan XXIII, 10

08950 – Esplugues de Llobregat (Barcelona)

or

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 - Sant Cugat del Vallés (Barcelona)

Date of the last review of this prospectus: 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/