Leaflet: Information for the User

Dolostop 500 mg Oral Solution

Paracetamol

Read this leaflet carefully before you start taking this medicine, as 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. See section 4.
• You should consult a doctor if symptoms worsen or if fever persists for more than 3 days or pain for more than 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

5. Storage of Dolostop

6. Contents of the pack and additional information

Dolostop contains paracetamol. Paracetamol is effective in reducing pain and fever.

It is used for the relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (muscle spasms) or back pain (lower back pain), as well as in febrile states in adults and children with a body weight of more than 33 kg (approximately 10-12 years old).

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 the medication.

• No take more medication than the recommended amount in 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 may 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, and patients with anemia (decrease in hemoglobin levels in the blood, due or not to a decrease in red blood cells), or those patients who suffer from chronic malnutrition or dehydration, should consult their doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as when taken together, it may decrease the effectiveness and increase the hepatotoxicity of paracetamol, 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:

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 suffer from malnutrition, chronic 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

In children and adolescents under 10-12 years, consult your doctor or pharmacist as there may be other presentations available with doses adapted to these patients.

Other medications and Dolostop

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 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 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 (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.

• Flucloxacillin (antibiotic), due to a serious 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 medications) without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist systematically if you are taking another medication. In the case of oral anticoagulants, it may be administered occasionally as the preferred analgesic.

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, etc…), inform your doctor that you are taking this medication, as it may alter the results.

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

Use of Dolostop with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day – beer, wine, liquor… per day) may cause liver damage.

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

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.

Dolostop contains sorbitol (E-420), propylene glycol (E-1520), sulfites, glucose, and ethanol

This medication contains 2,000 mg of sorbitol in each sachet. If your doctor has indicated that you (or your child) suffer from intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication contains 2,500 mg of propylene glycol in each sachet.

If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney failure, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) due to the presence of ammonium sulfite caramel.

This medication contains glucose (in maltodextrin from potato). If your doctor has indicated that you suffer from intolerance to certain sugars, consult with them before taking this medication.

This medication contains 0.2% ethanol (alcohol), which corresponds to 18.2 mg per sachet.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor.In case of doubt, ask your doctor, pharmacist, or nurse..

The recommended dose is:

Adults:

Take 1 tablet (500 mg of paracetamol) every 4-6 hours as needed. If necessary, 2 tablets can be taken every 8 hours.

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

Always take the lowest effective dose.

The use of this medication is subject to the appearance of pain or fever. As these symptoms 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 pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, treatment should be interrupted and your doctor consulted.

For sore throat, do not take the medication for more than 2 consecutive days without consulting a doctor.

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 disease.

Patients with liver disease:

You must consult your doctor before starting to take this medication.

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 g of paracetamol (4 tablets) in 24 hours, divided into several doses.

Children

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, that is,15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

You mustrespect the dosages defined according to weight.The child's age according to weight is given for information 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 4-6 hours as needed,up to a maximum of 5 tablets per day.

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

Do not use in children weighing less than 33 kg (approximately 10-12 years old). It is recommended to use other presentations more suitable for the treatment of this group of patients.

Administration form

This medication is taken orally.

The contents of the tablet can be taken diluted in a liquid, preferably water, or taken directly.

Once the tablet is opened, consume all its contents.

If you take more Dolostop than you should

You must 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 (phone 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 must 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 barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to take Dolostop

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

Like all medications, this medication 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 increased 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) and 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 treatments.

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 for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below 30°C.

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 drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications.By doing so, you will help protect the environment.

Composition of Dolostop

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

• The other components are: propylene glycol (E1520), macrogol 400, povidone K12, sorbitol (E420), ammonium sulphite caramel (E150-d) (containing corn starch), masking SC274292 (containing sucralose (E955), potato starch and mono-ammonium glycyrrhizinate), neohesperidin dihydrochalcone (E959), orange aroma (containing ethanol), citric acid monohydrate (for pH adjustment) and purified water.

Appearance of Dolostopand contents of the packaging

Orange-coloured oral solution, packaged in single-dose sachets.

Each package contains 10 and 20 sachets, packaged in heat-sealed sachets made of a complex of aluminium (polyester/aluminium/polyethylene, polyester and polyethylene).

Only some package sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

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/