Dolocatil 1 g tablets EFG
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
Dolocatil 1 g tablets EFG
paracetamol
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for 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 effects not listed in this leaflet. See section 4.
Leaflet Contents:
- What Dolocatil is and what it is used for
- What you need to know before taking Dolocatil
- How to take Dolocatil
- Possible adverse effects
- How to store Dolocatil
- Contents of the pack and other information
1. What Dolocatil is and what it is used for
Dolocatil belongs to a group of medicines called analgesics and antipyretics.
It is used to treat symptoms of pain and fever.
2. What you need to know before taking Dolocatil
Do not take Dolocatil
- If you are allergic (hypersensitive) to paracetamol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Do not take more than the recommended dose indicated in section 3, How to take Dolocatil.
In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
If you have liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
If you are undergoing treatment with medications for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol in 24 hours.
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 reassess the clinical situation.
For children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.
During treatment with Dolocatil, 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 body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Other medicines and Dolocatil:
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.
Paracetamol may interact with the following medicines:
- 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 elimination (loop diuretics such as furosemide)
- Medicines used in the treatment of gout (probenecid and sulfinpyrazone)
- Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
- Medicines used for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring 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 patients taking oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.
Interference with diagnostic tests:
If you are scheduled to undergo any laboratory 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 Dolocatil with food, drinks, and alcohol
Using paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.
If necessary, Dolocatil may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.
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 Dolocatil
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine. Dolocatil should be taken orally.
Depending on your preference, the tablets may be taken whole or split in half, with a glass of liquid, preferably water.
The score line is intended only to facilitate splitting the tablet and swallowing, but not for dividing it into equal doses.
Consult your doctor or pharmacist if you have any doubts.
Recommended dose:
Adults and adolescents over 15 years of age: the usual dose is 1 tablet (1 g of paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.
Patients with liver disease: you must consult your doctor before taking this medicine. 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: you must consult your doctor before taking this medicine.
Take a maximum of 500 milligrams per dose.
Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this patient group.
Elderly patients: you should consult your doctor.
Use in children and adolescents
Do not use in children under 15 years of age.
If you feel the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.
When lower doses than 1 gram of paracetamol per dose are required, other paracetamol formulations adapted to the required dosage should be used.
If you take more Dolocatil 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 name of the medicine and the amount ingested.
If you have taken 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), abdominal pain, and inflammation of the pancreas (pancreatitis).
Treatment of overdose is most effective if started within 4 hours after ingestion of the medicine.
Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
If you forget to take Dolocatil
Do not take a double dose to make up for a missed dose. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare adverse effects (may affect up to 1 in 1,000 people) are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (may affect 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). Very rare cases of severe skin reactions have been reported.
Paracetamol may damage the liver when taken at high doses or during prolonged treatment.
Adverse effects with frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in critically ill patients receiving paracetamol (see section 2).
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Dolocatil
Keep this medicine out of the 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 must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dolocatil
- The active substance is paracetamol.
- The other components are: povidone, magnesium stearate, anhydrous colloidal silica, sodium starch glycolate (Type A) (source: potato) and pregelatinized starch (source: maize).
Appearance of Dolocatil and contents of the pack
Oblong, white, scored tablets, in packs of 20 and 40 tablets.
The tablets are scored, which allows them to be divided into two equal parts.
Marketing Authorization Holder
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028 - Barcelona
Manufacturer
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 most recent review of this leaflet: February 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/