Leaflet: Information for the User

Dolostop 500 mg 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 fever worsens or does not improve after 3 days and the pain after 5 days.

1.What is Dolostop and what it is used for

2.What you need to know before starting to take Dolostop

3.How to take Dolostop

4.Possible side effects

5Storage of Dolostop

6.Contents of the pack and additional information

Paracetamol is effective in reducing pain and fever.

It is indicated for symptomatic relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (spasms) or back pain (lumbago), as well as in febrile states in adults and children with a weight of over 33 or 42 kg (approximately 10-12 years old).

Consult a doctor if fever worsens or does not improve after 3 days and pain after 5 days.

Do not take Dolostop

• 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 Dolostop.

• Do not take more medication than recommended in section 3, Taking Dolostop.
• Avoid using this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication containing 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, and patients with anemia, should consult their doctor before taking this medication.
• Patients undergoing treatment for epilepsy should consult their doctor before taking this medication, as it may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially at high doses.
• Patients with asthma 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 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 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.

Use of Dolostop with other medications

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

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

-Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

-Medications to treat epilepsy: Antiepileptic drugs (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 blood cholesterol levels (colestiramine).

-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 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).

Interference with laboratory tests

Inform your doctor that you are taking/using this medication if you are to undergo any laboratory tests (including blood, urine, etc.), as it may affect the results.

Use of Dolostop with food, drink, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

Inform your doctor or pharmacist if you are pregnant, breastfeeding, or plan to become pregnant before using this medication.

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

In case of need, Dolostop can be used during pregnancy. 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.

Paracetamol passes into breast milk, so breastfeeding women 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 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 grams (6 tablets) in 24 hours. Doses should be spaced at least 4 hours apart.

Always take the smallest effective dose.

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

Avoid using high daily doses of paracetamol for prolonged periods of time 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 pain or fever worsen or other symptoms appear, discontinue treatment and consult your doctor.

For throat pain, do not take the medication for more than 2 consecutive days without consulting a 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 (4 tablets) of this medication in 24 hours, divided into several doses.

Patients with kidney disease:

Before taking this medication, you must consult your doctor.

Take a maximum of 1 tablet 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 purposes only.

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

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

Whole tablets, broken or crushed, should be taken with the help of a 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 ingested an overdose, you should go to a medical center immediately, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dolostop

Do not take a double dose to compensate for the missed doses.

If you discontinue treatment with Dolostop

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

Like all medications, Dolostop may produce 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 severe 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 treatments.

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

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

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

Do not dispose of medications through the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dolostop

-The active ingredient is Paracetamol. Each tablet contains 500 mg of paracetamol.

-The other components are pregelatinized cornstarch, stearic acid, and povidone.

Appearance of the product and contents of the packaging

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

They are presented in PVC/aluminum blisters packaged in boxes of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2025

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