PATIENT INFORMATION LEAFLET

Dololavi1 g tablets

Paracetamol

Paracetamol is effective in reducing pain and fever.

It is indicated for the relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (muscle cramps) or back pain (lumbago) and in febrile states.

Dololavi is indicated for adults.

Do not take Dololavi:

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 before starting to take this medication.

• Do not take more than the recommended amount in the section 3. How to take Dololavi.
• Avoid using this medication with other medications that contain paracetamol, for example, medications for the flu and cold, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 g of paracetamol in 24 hours.

• Patients with liver, kidney, heart, or lung diseases, and patients with anemia (should consult with your doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments with paracetamol.
• Patients with asthma sensitive to acetylsalicylic acid should consult with your doctor before taking this medication.

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

During treatment with Dololavi, 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 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

Do not use in children under 18 years.

Other medications and Dololavi

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

In particular, if you are using any of the following medications, as 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 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 of the loop, 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 imbalance (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

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 systematically if you are taking another medication. In the case of oral anticoagulants, it may be possible to administer Dololavi 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 Dololavi with food, drinks, and alcohol:

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor) may cause liver damage.

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

Pregnancy, breastfeeding, and fertility

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

IMPORTANT FOR WOMEN

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

Breastfeeding

Small amounts of paracetamol may appear in breast milk, therefore, 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, ask your doctor or pharmacist.

The recommended dose is:

Adults:

take 1 tablet (1 g of paracetamol) every 6 – 8 hours, 3 times a day.Do not take more than3 g (3tablets)in 24 hours.

Always use the lowest effective dose

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, the medication is not indicated for this group of patients.

This medication should be taken orally.

The tablets can be swallowed whole or broken in half, with the help of a liquid, preferably water.

The groove is only for breaking the tablet if it is difficult to swallow whole

It should be avoided to use high daily doses of paracetamol for prolonged periods of time, as this increases the risk of adverse effects such as liver damage.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be discontinued.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, the patient should consult their doctor and reevaluate the clinical situation

Use in children and adolescents:

Do not use this medication in children or adolescents under 18 years old.

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

If you take more Dololavi than you should:

You should 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 should go immediately to a medical center, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of the overdose, 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.

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

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

If you forgot to take Dololavi:

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 between doses.

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

Rare adverse effects that may occur (in 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 (in 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). Paracetamol can damage the liver when taken in high doses or prolonged treatments. Rarely, severe skin reactions have been reported.

Adverse effects of 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 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 a possible adverse effect that does not appear in this leaflet. 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 about the safety of this medication

Keep out of the sight and reach of children.

This medication does not require special conservation conditions.

Do not use this medication after the expiration date appearing 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 trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Dololavi:

The active principle is paracetamol.

The other components are: pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable origin magnesium stearate.

Appearance of the product and content of the packaging:

Dololavi is presented in the form of oral tablets, in packaging of 10 tablets. The tablets are scored, which allows them to be split in half to facilitate swallowing.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí 08970 – Barcelona

Spain

Responsible for manufacturing:

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses 2, 28108 Alcobendas,

Madrid

Spain

or

FARMALIDER, S.A.

C/ Aragoneses 2, 28108 Alcobendas,

Madrid

Spain

Last review date of this prospectus: February 2025

"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/ ”