Package Leaflet: Information for the user

Dolostop650 mgtablets

Paracetamol

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor, or 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, or 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 for what 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 (spasms) or back pain (lumbago) and in febrile states in adults and children over 9 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 (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 of the medication than recommended in the section 3. How to take 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 antiepileptic 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.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

Inform your doctor immediately if you experience any of the following during treatment with Dolostop:

Severe diseases, such as severe renal insufficiency 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 for children and adolescents under 15 years old, 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 if you are to undergo any analytical test (including blood, urine, etc. tests), as it may alter the results.

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

Use of Dolostop with other medications

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

• 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 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 (hypertension) 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 of Dolostop with food, drinks, and alcohol

The taking of this medication with food does not affect its efficacy.

Pregnancy and lactation

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 does not decrease or if you need to take the medication more frequently.

Lactation

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:

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 g(4 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 (3 tablets).

Always take the lower 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.

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

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

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 disease:

Before taking this medication, you must consult your doctor.

Take a maximum of 500 milligrams per dose.

Your doctor will indicate whether you should take your medication with a minimum interval of 6 or 8 hours, depending on your condition.

Children:

You mustrespect the dosages defined according to weight.The child's age according to weight is given for information only. The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 daily doses, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Between 27 and 43 kg of weight (9 to 12 years): Takehalf a tabletevery 4 hours,up to a maximum of 6 doses a day (3 tablets).
• Between 43 and 50 kg of weight (12 to 15 years): Take one tablet every 6 hours,up to a maximum of 4 doses a day (4 tablets).

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

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

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

If you take moreDolostopthan you should

You should consult your doctor or pharmacist immediately. Incase 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 intoxication.

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

Patients undergoing barbiturate treatment 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 prospectus. 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 is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keepout of 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.

Medicines should not be disposed of through drains or in the trash. Disposeiof the packaging and unused medicines at the SIGREpoint of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect theenvironment.

Composition ofDolostop:

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

Appearance of the product and content of the packaging

Dolostopispresentedinoral tablets for administration. The tablets arewhite, oblong, and scored on one face.The boxes are of 4, 12, or 20 tablets conditioned in PVC/aluminum blister.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72- Colón II Industrial Estate

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2025

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