DOLOLAVI 1G TABLETS

2. What you need to know before taking Dololavi

Do not take Dololavi:

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

Warnings and precautions:

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

• Do not take more than the recommended dose in section 3. How to take Dololavi.
• Avoid simultaneous use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should avoid taking more than 2 g of paracetamol in 24 hours.

• Patient with liver, kidney, heart, or lung disease, and patients with anemia (should consult their doctor before taking this medicine.
• When being treated with certain medicines for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

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 reassess the clinical situation.

During treatment with Dololavi, inform your doctor immediately if:

If you have severe 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 are also taking flucloxacillin (an antibiotic). A severe 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 unwell (nausea) and vomiting.

Children and adolescents

Do not use in children under 18 years of age.

Other medicines and Dololavi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis: (isoniazid, rifampicin).
• Medicines for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines for lowering blood cholesterol levels: (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used for treating gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used for treating high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

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

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist 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 laboratory tests:

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

Taking Dololavi with food, drinks, and alcohol:

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

IMPORTANT FOR WOMEN

If necessary, paracetamol 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 if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

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

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or nonexistent.

3. How to take Dololavi

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 than 3 g (3 tablets) in 24 hours.

Always use the lowest effective dose.

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

Patient with kidney disease: before taking this medicine, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

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

This medicine should be taken orally.

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

The score line is only for breaking the tablet if you find it difficult to swallow whole.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

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

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 reassess the clinical situation.

Use in children and adolescents:

Do not use this medicine in children or adolescents under 18 years of age.

When lower doses of paracetamol are required, other presentations of paracetamol should be used that adapt to the required dosage.

If you take more Dololavi than you should

Consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you have ingested an overdose, go immediately to a medical center, even if you do not notice 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.

Treatment of overdose is more effective if started within 4 hours of taking the medicine.

Patient treated with barbiturates or suffering from chronic alcoholism may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Dololavi

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the indicated interval in each case.

4. Possible side effects

Like all medicines, Dololavi can cause side effects, although not everybody gets them.

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

Very rare side effects that may occur (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Paracetamol may damage the liver when taken in high doses or for prolonged periods. Very rare cases of serious skin reactions have been reported.

Side effects with unknown frequency (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).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dololavi

Keep out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging (after EXP.). The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dololavi:

The active ingredient is paracetamol.

The other ingredients are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the product and pack contents:

Dololavi is presented in the form of tablets for oral administration, in packs of 10 tablets. The tablets are scored, which allows them to be broken in half to facilitate swallowing.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí 08970 – Barcelona

Spain

Manufacturer:

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses 2, 28108 Alcobendas,

Madrid

Spain

or

FARMALIDER, S.A.

C/ Aragoneses 2, 28108 Alcobendas,

Madrid

Spain

Date of last revision of this leaflet:February 2025

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