DOLOLAVI 1 G TABLETS

Patient Information Leaflet

Introduction

PATIENT INFORMATION LEAFLET

Dololavi 1 g tablets

Paracetamol

Package leaflet contents:

1. What Dololavi is and what it is used for
2. What you need to know before taking Dololavi
3. How to take Dololavi
4. Possible side effects
5. Storage of Dololavi
6. Contents of the pack and other information

1. What Dololavi is and what it is used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle strains) or back pain (lumbago), and for feverish conditions.

Dololavi is indicated for use in adults.

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

Do not take Dololavi:

If you are allergic (hypersensitive) to paracetamol or to 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 indicated in section 3, How to take Dololavi.
• Avoid using this medicine simultaneously with other medicines containing paracetamol, for example, cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
• Patients with liver, kidney, heart, or lung disease, or those with anemia, should consult their doctor before taking this medicine.
• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as using them together may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments.
• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and re-evaluate your clinical condition.

During treatment with Dololavi, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

Do not use in individuals under 18 years of age.

Other medicines and Dololavi

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

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose of some of them or discontinue treatment:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: (isoniazid, rifampicin)
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine output (loop diuretics such as furosemide)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (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 advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood and urine tests, 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 drinks per day: beer, wine, spirits) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

IMPORTANT FOR WOMEN

If necessary, paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Breastfeeding

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The effect of paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to take Dololavi

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult 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.

Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Before taking this medicine, you must consult your doctor.

Maximum dose per intake: 500 milligrams.

Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this patient group.

This medicine is for oral use.

The tablets can be taken directly or split in half, with a glass of liquid, preferably water.

The score line is provided solely to facilitate splitting the tablet if you have difficulty swallowing it whole.

Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects such as liver damage.

This medicine should only be administered when pain or fever occur. Treatment should be discontinued as symptoms resolve.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you must consult your doctor to reassess your clinical condition.

Use in children and adolescents:

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

When doses lower than 1 g of paracetamol per dose are required, other paracetamol formulations appropriate for the required dosage should be used.

If you take more Dololavi than you should:

Contact 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 ingested.

If you have ingested an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours of ingestion of the medicine.

Patients undergoing treatment with barbiturates or who suffer 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 missed doses. Simply take the missed dose as soon as you remember, and take the following doses at the recommended intervals between doses.

4. Possible adverse effects

Like all medicines, Dololavi may cause adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Paracetamol may cause liver damage when taken in high doses or during prolonged treatment. Very rare cases of serious skin reactions have been reported.

Adverse effects with unknown frequency (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dololavi

Keep out of sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dololavi:

The active substance is paracetamol.

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

Appearance of the medicinal product and contents of the pack:

Dololavi is presented as tablets for oral administration, in packs of 10 tablets. The tablets are scored, allowing them to be split 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 the most recent revision of this summary: February 2025

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”