Dolostop 1 g tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Dolostop 1 g 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 taking the medicine as described in this leaflet or as directed 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 effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet.
- You should consult a doctor if symptoms worsen or if fever persists for more than 3 days or pain for more than 5 days.
Leaflet contents:
- 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
Dolostop 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 spasms), or back pain (lumbago), as well as for feverish conditions in adults and adolescents over 15 years of age.
You should consult a doctor if symptoms worsen or do not improve after 3 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 or pharmacist or nurse before starting to take this medicine.
- 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, such as 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 disease, or those with anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), or those suffering from chronic malnutrition or dehydration, should consult their doctor before taking this medicine.
- If you are being treated with medication for epilepsy, you must consult your doctor before taking this medicine, because when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially with high-dose paracetamol treatment.
- 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 fluids) has been reported in patients under these conditions 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 breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Children and adolescents
For children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for these patients may be available.
Interference with laboratory tests
If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.
Paracetamol may alter the analytical values of uric acid and glucose measurements.
Use of Dolostop with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
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:
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Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
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Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
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Medicines to treat tuberculosis: (isoniazid, rifampicin)
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Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
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Medicines to reduce cholesterol levels in the blood: (cholestyramine)
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Medicines used to increase urine elimination (loop diuretics such as furosemide)
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Medicines used to treat gout (probenecid and sulfinpyrazone)
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Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
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Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
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Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).
Do not use with other analgesics (medicines that relieve pain) 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 any other medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.
Use of Dolostop with food, drinks and alcohol
The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day – beer, wine, liquor, etc. per day) may cause liver damage. |
Taking this medicine with food does not affect its efficacy.
Pregnancy and lactation
Pregnancy
Consult your doctor or pharmacist before using any medicine.
IMPORTANT FOR WOMEN
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and must be monitored by your doctor.
If necessary, Dolostop may be used during pregnancy. The lowest possible dose that reduces pain or fever should be used, and for the shortest possible duration. Contact your doctor if pain or fever do not decrease, or if you need to take the medicine more frequently.
Lactation
Consult your doctor or pharmacist before using any medicine.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.
Driving and operating machinery
The influence of paracetamol on the ability to drive and operate machinery is none or negligible.
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 recommended dose is:
Adults and adolescents over 15 years of age and weighing more than 50 kg:
Take 1 tablet (1 g of paracetamol) every 6–8 hours, 3 times a day. Do not exceed 3 g (3 tablets) in 24 hours.
For adults and adolescents with low body weight (less than 50 kg), a daily dose of 2 g of paracetamol (2 tablets) is recommended.
Always take the lowest dose that provides effective relief.
This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.
Avoid using high daily doses of paracetamol for prolonged periods, 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, you must stop treatment and consult your doctor.
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 several doses.
Patients with kidney disease: This medicine does not meet the dosing recommendations for these patients.
If you take more Dolostop 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.
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
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.
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.
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) are: malaise, low 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), hypoglycaemia (low blood sugar), and severe 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 serious underlying diseases who use paracetamol (see section 2).
Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
5. Storage of Dolostop
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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 1 g of paracetamol.
- The other components are: pregelatinized corn starch, stearic acid, and povidone.
Appearance of the product and contents of the pack
Dolostop is presented as oral tablets. The tablets are white, oblong, and scored on one side. The packs contain 4 or 10 tablets in PVC/aluminum blisters.
Marketing Authorization Holder and Manufacturer
Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Date of the most recent revision 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 Health Products (AEMPS) http://www.aemps.gob.es/ .