Dolostop 500 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Dolostop 500 mg tablets
Paracetamol
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet.
- You should consult a doctor if fever worsens or does not improve after 3 days, or if pain persists beyond 5 days.
Contents of the leaflet:
- What Dolostop is and what it is used for
- What you need to know before taking Dolostop
- How to take Dolostop
- Possible side effects
- How to store Dolostop
- Contents of the pack and other information
1. What Dolostop is and what it is used for
Paracetamol is effective in reducing pain and fever.
It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle strains), or back pain (lumbago), as well as for febrile conditions in adults and children weighing more than 33 or 42 kg (approximately 10–12 years of age).
You should consult a doctor if fever worsens or does not improve after 3 days, or if pain persists beyond 5 days.
2. What you need to know before taking Dolostop
Do not take Dolostop
- If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Dolostop.
- Do not take more medicine than the recommended dose stated in section 3, How to take Dolostop.
- The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, 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 kidney, liver, heart, or lung diseases, or those with anemia, should consult their doctor before taking this medicine.
- If you are being treated with any medication for epilepsy, you should consult your doctor before taking this medicine, because when used together, the effectiveness of paracetamol may be reduced and its hepatotoxicity increased, especially with high-dose paracetamol.
- Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
During treatment with Dolostop, 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 together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
Taking Dolostop with other medicines
Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:
- Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
- Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Medicines to treat tuberculosis (isoniazid, rifampicin).
- Medicines to treat 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 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 disturbances (called high anion gap metabolic acidosis), which requires urgent treatment (see section 2).
Interference with laboratory tests
If you are scheduled for any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.
Use of Dolostop with food, drink, and alcohol
The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks—beer, wine, spirits, etc.—per day) may cause liver damage.
Taking this medicine with food does not affect its effectiveness.
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.
Taking medicines during pregnancy may be harmful to the embryo or fetus and should be supervised by your doctor.
If necessary, Dolostop 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.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.
Driving and using machines
The effect of paracetamol on the ability to drive and operate machinery is negligible or none.
3. How to take Dolostop
Follow these instructions unless your doctor has given you different advice. Consult your doctor or pharmacist if you have any doubts.
The usual dose is:
Adults:
Take 1 tablet every 4–6 hours as needed. If necessary, 2 tablets may be taken every 8 hours.
Do not take more than 3 g (6 tablets) in 24 hours. Doses should be spaced at least 4 hours apart.
Always take the lowest effective dose.
This medicine should only be taken when pain or fever occur. As these symptoms subside, treatment should be discontinued.
Prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped and you should consult your doctor.
For sore throat, do not take this medicine for more than 2 consecutive days without consulting your doctor.
Patients with liver disease:
Before taking this medicine, you must consult your doctor.
Take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.
Do not take more than 2 grams (4 tablets) of this medicine in 24 hours, divided into several doses.
Patients with kidney disease:
Before taking this medicine, you must consult your doctor.
Take a maximum of 1 tablet per dose.
Depending on your condition, your doctor will advise whether doses should be taken at minimum intervals of 6 or 8 hours.
Children:
Dosages based on body weight must be strictly observed. The age ranges corresponding to these weights are provided for informational purposes only.
- Children weighing between 33 kg and 42 kg (approximately 10 to 12 years of age): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
- Children weighing between 42 kg and 50 kg (approximately 12 to 14 years of age): 1 tablet per dose, every 4 hours, up to a maximum of 6 tablets per day.
Children weighing less than 33 kg must not take this medicine. The use of other formulations more suitable for this patient group is recommended.
Whole, split, or crushed tablets should be taken with a glass of liquid, preferably water.
If you take more Dolostop than you should
Contact your doctor or pharmacist immediately.
Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
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.
Treatment for overdose is most effective if started within 4 hours of taking the medicine.
Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Dolostop
Do not take a double dose to make up for a missed dose.
If you stop treatment with Dolostop
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Dolostop may cause adverse effects, although not everyone experiences them.
Rare adverse effects (may affect up to 1 in 1,000 people): malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), and serious skin reactions.
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).
Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of Dolostop
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dolostop
- The active substance is Paracetamol. Each tablet contains 500 mg of paracetamol.
- The other components are pregelatinized corn starch, stearic acid, and povidone.
Appearance of the product and contents of the pack
Dolostop tablets are white, round, and have a score line on one side. The tablet can be divided into equal halves.
They are presented in PVC/aluminum blisters, packed in boxes of 20 tablets.
Marketing Authorization Holder and Manufacturer
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/