Leaflet: Information for the User

Dolostop1 g tablets

Paracetamol

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.
• 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.

1.What isDolostopand how it is used

2.What you need to know before starting to takeDolostop

3.How to takeDolostop

4.Possible side effects

5.Storage ofDolostop

6.Contents of the pack and additional information

Dolostopis effective in reducing pain and fever.

It is indicated for the relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (muscle spasms) or back pain (lumbago) and in febrile states in adults and adolescents over 15 years old.

Consult a doctor if it worsens or does not improve after 3 days.

Do not takeDolostop

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

Warnings and precautions

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

• Do not take more of the medication than recommended in section 3, Taking Dolostop.
• Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses can cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 g/24 hours of paracetamol.
• Patients with kidney, liver, heart, or lung diseases, or patients with anemia (decreased hemoglobin levels in the blood, due or not to a decrease in red blood cells), or patients with chronic malnutrition or dehydration should consult their doctor before taking this medication.
• Patients undergoing treatment with epilepsy medications should consult their doctor before taking this medication, as when used together, the efficacy is decreased and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

Inform your doctor immediately if you experience:

Severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

Consult your doctor or pharmacist, as there may be other presentations available with doses adapted to these patients.

Interference with analytical tests

Inform your doctor that you are taking/using this medication, as it may alter the results of any analytical tests (including blood, urine, etc…).

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

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.

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

• Medications 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 seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (diuretics of the loop, such as furosemide)
• Medications used to treat gout (probencid 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 severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) 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 inform your doctor or pharmacist if you are taking another medication. In the case of oral anticoagulants, Dolostop may be administered occasionally as the preferred analgesic.

Use ofDolostopwith food, drinks, and alcohol

The taking of 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 consumption of medications during pregnancy can be hazardous to the embryo or fetus, and should be monitored by your doctor.

In case of need, Dolostop may 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 do 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 women in the lactation period should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

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

The recommended dose is:

Adults and adolescents over 15 years old and weighing more than 50 kg:

Take 1 tablet (1 g of paracetamol) every 6 – 8 hours, 3 times a day. Do not take more than 3 g (3 tablets) in 24 hours.

It is recommended for adults and adolescents with low weight (less than 50 kg) a daily dose of 2 g of paracetamol (2 tablets).

Always take the smallest dose that is effective.

The use of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be discontinued.

It is recommended to avoid the use of high daily doses of paracetamol for prolonged periods of time as this increases the risk of adverse effects such as liver damage.

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

Patients with liver disease:Before taking this medication, you must consult your doctor.

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

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

Patients with kidney diseases: This medication does not follow the recommended dosage for these patients.

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 Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration 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 the symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The treatment of overdose is more effective if it is initiated within 4 hours of medication ingestion.

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

Like all medications,Dolostopmay cause adverse effects, although not all people will experience them.

Rare adverse effects that may affect up to 1 in 1,000 people are: discomfort, low blood pressure (hypotension), and elevated levels of transaminases in the blood.

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

Adverse effects of unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keepout of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDolostop

• The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.
• The other components are: maize pregelatinized starch, stearic acid and povidone.

Appearance of the product and content of the packaging

Dolostop is presented in oral tablets. The tablets are white, oblong and scored on one face.The boxes are of 4 or 10 tablets conditioned in PVC/aluminium blister.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last review of this leaflet: February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.