DOLOSTOP 650 MG TABLETS

Introduction

Prospectus: Information for the user

Dolostop650 mgtablets

Paracetamol

Read the entire prospectus carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions of the medication contained in this prospectus or as indicated by your doctor, pharmacist, or nurse.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.
• You should consult a doctor if the symptoms worsen or if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the prospectus:

1. What is Dolostop and what is it used for
2. What you need to know before taking Dolostop
3. How to take Dolostop
4. Possible side effects
5. Storage of Dolostop
6. Package contents and additional information

1. What is Dolostop and what is it used for

Dolostop is effective in reducing pain and fever.

It is indicated for the relief of occasional mild or moderate pain, such as headache, dental, muscle (cramps) or back (lumbago) pain, and in febrile states in adults and children over 9 years old.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before taking Dolostop

Do not takeDolostop

• If you are allergic to paracetamol or any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take this medication.

• Do not take more medication than recommended in section 3. How to take Dolostop.
• The simultaneous use of this medication with other medications that contain paracetamol, such as flu and cold medications, should be avoided, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 grams/24 hours of paracetamol.
• Patients with kidney, liver, heart, or lung disease, and patients with anemia (decreased hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), or those who suffer from chronic malnutrition or dehydration, should consult their doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

During treatment with Dolostop, inform your doctor immediately if:

If you have severe illnesses, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and adolescents

In children and adolescents under 15 years old, consult your doctor or pharmacist, as other presentations may be available with doses that are suitable for these patients.

Interference with analytical tests

If you are going to have any analytical tests (including blood, urine, etc.), inform your doctor that you are taking/using this medication, as it may alter the results.

Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Use ofDolostopwith other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and convulsions: Barbiturics (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.

• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that must be treated urgently (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Use ofDolostopwith food, drinks, and alcohol

Taking this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

If necessary, Dolostop can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

3. How to take Dolostop

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

The recommended dose is:

Adults:

Take half to 1 tablet (325 mg to 650 mg of paracetamol) every 4-6 hours, 3 times a day. Do not take more than 3 grams (4 tablets) in 24 hours.

In adults and adolescents of low weight (less than 50 kg), a daily dose of 2 grams of paracetamol (3 tablets) is recommended.

Always take the lowest effective dose.

Taking this medication is subject to the appearance of pain or fever. As they disappear, treatment should be suspended.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens, or other symptoms appear, treatment should be interrupted and your doctor consulted.

Patient with liver disease:

Before taking this medication, they must consult their doctor.

They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.

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

Patient with kidney disease:

Before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Depending on their illness, their doctor will indicate whether they should take their medication with a minimum interval of 6 or 8 hours.

Children:

It is necessary to respect the dosages defined according to weight.The age of the child according to weight is given for information purposes. The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

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

This medication should not be used in children weighing less than 27 kg (approximately 9 years) because the dose of this presentation does not adapt to this group of patients.

Do not use in children over 27 kg for more than 3 days without evaluating the clinical situation.

Whole, broken, or crushed tablets should be taken with the help of a glass of liquid, preferably water.

If you take moreDolostopthan you should

You should consult 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 medication and the amount ingested.

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

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice symptoms, as they often do not manifest until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of ingestion of the medication.

Patient being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

4. Possible side effects

Like all medications, Dolostop can cause side effects, although not everyone will experience them.

Rare side effects that may affect up to 1 in 1,000 people are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

Very rare side effects that may affect up to 1 in 10,000 people are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), hypoglycemia (low blood sugar), and severe skin reactions.

Side effects of unknown frequency (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or for prolonged treatments.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of Dolostop

Keep out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofDolostop:

• The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other components are: pregelatinized cornstarch, stearic acid, and povidone.

Appearance of the product and package contents

Dolostop is presented in tablets for oral administration. The tablets are white, oblong, and scored on one side. The boxes are of 4, 12, or 20 tablets packaged 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 last revision of this prospectus: February 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.