Leaflet: Information for the User

Dolostop 650 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 the symptoms worsen or if the fever persists for more than 3 days or the 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 cramps) or back pain (lumbago) and in febrile states in adults and adolescents over 14 years old and weighing more than 43 kg.

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.

• Do not take more 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 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 of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung diseases, or patients with anemia (decreased hemoglobin levels in the blood, due or not due 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 taking them together may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• 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 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 respiratory distress with deep and rapid breathing, somnolence, feeling unwell (nausea), and vomiting.

Children and adolescents

Consult your doctor or pharmacist if you are under 14 years old, as there may be other presentations available with doses adapted to these patients.

Taking Dolostop with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, if you are taking 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 medications (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 (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a high 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 taken occasionally as the preferred analgesic.

Interference with laboratory tests

Inform your doctor if you are undergoing any laboratory tests (including blood, urine, etc.) as this medication may affect the results.

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

Use of Dolostop with food, drinks, and alcohol

Taking this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist if you are pregnant, breastfeeding, or think you may be pregnant, or if you plan to become pregnant, before using this medication.

Consuming medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

If necessary, Dolostop may 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 pain or fever do 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.

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

Driving and operating machinery

Paracetamol has no or insignificant influence on the ability to drive and operate machinery.

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

Sorbitol

This medication contains 2,000 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (a rare genetic disease in which the patient cannot break down fructose), consult your doctor before taking this medication.

Propylene glycol

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

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

Do not take this medication unless recommended by your doctor if you have liver or kidney insufficiency. Your doctor may perform additional checks while you are taking this medication.

Sulfites

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

Glucose

This medication contains glucose (in maltodextrin from potato and corn). If your doctor has indicated that you have a fructose intolerance, consult your doctor before taking this medication.

It may cause tooth decay.

Ethanol

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 and adolescents over 14 years old and weighing more than 43 kg:

Take 1 tablet (650 mg of paracetamol) every 4-6 hours as needed.

Do not take more than 3 grams of paracetamol (4 tablets) in 24 hours.

Take the smallest 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 the doctor consulted.

For sore throat, the medication should not be taken for more than 2 consecutive days without consulting a doctor.

Patients with kidney disease:

Before taking this medication, they must consult their doctor.Due to the dose, they should not use this medication.

Patients with liver disease:

They must consult their doctor before starting to take this medication.

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

They should not take more than 2 grams of paracetamol (3 tablets) in 24 hours, divided into several doses.

Children and adolescents:

Do not use in children and adolescents under 14 years old or weighing less than 43 kg.

Administration form

This medication is taken orally.

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

Once the packet 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 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, 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, 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.

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 prospectus. 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 on the safety of this medication.

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

Store below 30°C.

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. Dispose of packaging and unused medications at the SIGRE collection pointof 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 650 mg of paracetamol.
• The other components are: propylene glycol (E1520), macrogol 400, povidone K12, sorbitol (E420), ammonium sulphite caramel (E150-d) (containing maize maltodextrin), masking SC274292 (containing sucralose (E955), potato maltodextrin and mono-ammonium glycyrrhizinate), neohesperidin dihydrochalcone (E959), orange aroma (containing ethanol), citric acid monohydrate (for pH adjustment) and purified water.

Appearance of the product and contents of the packaging

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

Each package contains 10 and 20 sachets, packaged in thermosealed sachets formed by a complex of aluminium (polyester/aluminium/polyethylene, polyester and polyethylene).

Only some package sizes may be marketed.

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/.