Dolostop 650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dolostop 650 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 effects, consult your doctor, pharmacist, or nurse, even if they are effects 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:

1. What Dolostop is and what it is used for
2. What you need to know before taking Dolostop
3. How to take Dolostop
4. Possible adverse effects
5. Storage of Dolostop
6. 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), and for febrile conditions in adults and children over 9 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 starting to take Dolostop

Do not take Dolostop

• If you are allergic to paracetamol or to any of the other components 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 (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 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 any medication 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.
• 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 in these situations 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 difficulties 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 diagnostic 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 affect the analytical results 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, dose adjustments or discontinuation of treatment may be necessary:

• 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 in the treatment of 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 metabolic acidosis with high anion gap) that requires urgent treatment (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 used as the analgesic of choice.

Use of Dolostop with food, drinks and alcohol

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breastfeeding

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 should 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.

Breastfeeding

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 use of machines

The influence of paracetamol on the ability to drive and use machines is none or negligible.

3. How to take Dolostop

Follow these instructions unless your doctor has given you different ones. Consult your doctor or pharmacist if you have any doubts.

Recommended dose:

Adults:

Take half to 1 tablet (325 mg to 650 mg of paracetamol) every 4–6 hours, 3 times a day. Do not exceed 3 g (4 tablets) in 24 hours.

For adults and adolescents with low body weight (less than 50 kg), a daily dose of 2 g of paracetamol (3 tablets) is recommended.

Always take the lowest effective dose.

This medicine should only be taken when pain or fever occurs. 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 a doctor consulted.

Patients with liver disease:

Must consult their doctor before taking this medicine.

They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

They must not take more than 2 grams of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease:

Must consult their doctor before taking this medicine.

Maximum dose per intake: 500 milligrams.

Depending on their condition, their doctor will advise whether the medicine should be taken with a minimum interval of 6 or 8 hours.

Children:

Dosing must be based on body weight. The child's age corresponding to body weight is provided for informational purposes only. The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day; that is, 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Weighing between 27 and 43 kg (approximately 9 to 12 years): Half a tablet every 4 hours, up to a maximum of 6 doses per day (3 tablets).
• Weighing between 43 and 50 kg (approximately 12 to 15 years): One tablet every 6 hours, up to a maximum of 4 doses per day (4 tablets).

This medicine must not be used in children weighing less than 27 kg (approximately 9 years) because the dosage of this formulation is not suitable for this patient group.

Do not use in children weighing more than 27 kg for longer than 3 days without reassessing the clinical condition.

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. 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 an overdose has been ingested, immediate medical attention is required even if no symptoms are present, as symptoms often do not appear until 3 days after ingestion, 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 will experience them.

Rare adverse effects (may affect up to 1 in 1,000 people): malaise, low 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 seriously ill patients using paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or with prolonged treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for 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 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 should not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. 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 650 mg of paracetamol.
• The other components are: pregelatinized maize starch, stearic acid, and povidone.

Appearance of the product and contents of the pack

Dolostop is presented as tablets for oral administration. The tablets are white, oblong, and scored on one side. The packs contain 4, 12 or 20 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 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 Health Products (AEMPS) http://www.aemps.gob.es/ .