DOLOSTOP 500 MG TABLETS

Introduction

Package Leaflet: Information for the User

Dolostop 500 mg Tablets

Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.
• You should consult a doctor if the fever worsens or does not improve after 3 days and the pain after 5 days.

Contents of the Package Leaflet:

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 Conservation of Dolostop

1. Contents of the package and additional information

1. What is Dolostop and what is it used for

Paracetamol is effective for reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild or moderate pain, such as headache, dental, muscular (contractures), or back (lumbago) pain, as well as in febrile states in adults and children weighing over 33 or 42 kg (10-12 years, approximately).

You should consult a doctor if the fever worsens or does not improve after 3 days and the pain after 5 days.

2. What you need to know before taking Dolostop

Do not take Dolostop

• If you are allergic to paracetamol or any of the other components 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 recommended in section 3. How to take Dolostop.
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 g/24 hours of paracetamol.
• Patients with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, 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 medicine.

During treatment with Dolostop, inform your doctor immediately if:

If you have severe diseases, 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 unwell (nausea), and vomiting.

Using Dolostop with other medicines

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medicine.

In particular, if you are using any of the following medicines, as it may be necessary to modify the dose of some of them or interrupt 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 convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood (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 and heart rhythm disorders (arrhythmias): Propranolol.

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

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 medicine, as it may alter the results.

Using Dolostop with food, drink, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking medicines during pregnancy can be dangerous for 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 medicine more frequently.

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

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 normal dose is:

Adults:

Take 1 tablet every 4-6 hours as needed. If necessary, you can take 2 tablets every 8 hours.

Do not take more than 3 g (6 tablets) in 24 hours. The doses should be spaced at least 4 hours apart.

Always take the lowest effective dose.

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

Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects such as liver damage.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen, or other symptoms appear, you should interrupt treatment and consult your doctor.

For throat pain, do not take the medicine for more than 2 consecutive days without consulting your doctor.

Patients with liver disease:

Before taking this medicine, they must consult their doctor.

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

They should 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, they must consult their doctor.

Take a maximum of 1 tablet per dose.

Depending on their disease, their doctor will indicate whether they should take their medicine 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.

• Children between 33 kg and 42 kg in weight (from 10 to 12 years, approximately): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
• Children between 42 kg and 50 kg in weight (from 12 to 14 years, approximately): 1 tablet per dose, every 4 hours, up to a maximum of 6 tablets per day.

Children under 33 kg should not take this medicine. The use of other presentations more suitable for the treatment of this group of patients is recommended.

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

If you take more Dolostop than you should

You should consult your doctor or pharmacist immediately.

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

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

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 forgotten doses.

If you stop taking Dolostop

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dolostop can cause side effects, although not everyone gets them.

Rare side effects that may affect up to 1 in 1,000 people are: discomfort, low blood pressure (hypotension), and increased levels of transaminases 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, leukopenia, neutropenia, hemolytic anemia), hypoglycemia (low blood sugar), and severe skin reactions.

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

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

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 leaflet, inform your doctor or pharmacist.

5. Conservation 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 expiration date that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Dolostop

• The active ingredient is Paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are pregelatinized cornstarch, stearic acid, and povidone.

Appearance of the product and package contents

Dolostop tablets are white, round, and have a notch on one side. The tablet can be divided into two equal halves.

They are presented in PVC/aluminum blisters packaged 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 last revision of this leaflet: February 2025

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