DOLOSTOP 500 MG ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Dolostop 500 mg Oral Solution

Paracetamol

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 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 your symptoms worsen or if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the Package Leaflet

1. What is Dolostop and what is it used for
2. What you need to know before taking Dolostop
3. How to take Dolostop
4. Possible side effects
5. Storage of Dolostop
6. Contents of the pack and further information

1. What is Dolostop and what is it used for

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

It is used for the relief of mild or moderate occasional pain, such as headache, dental, muscular (cramps), or back pain (lumbago), as well as in febrile conditions in adults and children weighing over 33 kg (10-12 years, approximately).

2. What you need to know before taking Dolostop

Do not take Dolostop

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take the medicine.

• Do not take more medicine than recommended in section 3. How to take Dolostop.
• Avoid simultaneous use of this medicine with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 g/24 hours of paracetamol.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia (decreased hemoglobin level in the blood, due to or not due to a decrease in red blood cells), or those patients who suffer from chronic malnutrition or dehydration, should consult their doctor before taking this medicine.
• When being treated with certain medications for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with Dolostop, inform your doctor immediately if:

If you have 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 suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties 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 other presentations may be available with doses suitable for these patients.

Other medicines and Dolostop

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis (isoniazid, rifampicin).
• Medicines to treat depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Do not use with other pain relievers (medicines that reduce pain) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

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

Use of Dolostop with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

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

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

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

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

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

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains ammonium sulfite caramel.

This medicine contains glucose (in potato maltodextrin). If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Dolostop

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

The recommended dose is:

Adults:

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

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

Always take the lowest effective dose.

Taking this medicine is subject to the appearance of pain or fever. As they disappear, treatment should be suspended.

Avoid using high daily doses of paracetamol for prolonged periods, as the risk of adverse effects such as liver damage increases.

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

For throat pain, do not take the medicine for more than 2 consecutive days without consulting your doctor.

Patient with kidney disease:

Before taking this medicine, they must consult their doctor.

Take a maximum of 1 sachet per dose.

According to their disease, their doctor will indicate whether they should take their medicine with a minimum interval of 6 or 8 hours.

Patient with liver disease:

Must consult their doctor before starting to take this medicine.

Should take the amount of medicine prescribed by their doctor, with a minimum interval between each dose of 8 hours.

Should not take more than 2 g of paracetamol (4 sachets) 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 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

It is necessary to respect the dosages defined according to weight.The age of the child according to weight is given for information purposes.

• Children between 33 kg and 42 kg in weight (from 10 to 12 years, approximately): 1 sachet per dose, every 6 hours, up to a maximum of 4 sachets per day.
• Children between 42 kg and 50 kg in weight (from 12 to 14 years, approximately): 1 sachet per dose, every 4-6 hours as needed, up to a maximum of 5 sachets per day.

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

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

Method of administration

This medicine is taken orally.

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

Once the sachet is opened, consume its entire contents.

If you take more Dolostop than you should

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 (telephone 91 562 04 20), indicating the medicine 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 should go immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of ingestion of the medicine.

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Dolostop

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Side effects of unknown frequency (cannot be estimated from the available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol may damage the liver when taken in high doses or for prolonged periods.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dolostop

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dolostop

• The active ingredient is paracetamol. Each sachet contains 500 mg of paracetamol.
• The other ingredients are: propylene glycol (E1520), macrogol 400, povidone K12, sorbitol (E420), ammonium sulfite caramel (E150-d) (containing potato maltodextrin), masking SC274292 (containing sucralose (E955), potato maltodextrin, and mono-ammonium glycyrrhizinate), neohesperidin dihydrochalcone (E959), orange flavor (containing ethanol), citric acid monohydrate (for pH adjustment), and purified water.

Appearance of Dolostop and contents of the pack

Brown oral solution, packaged in single-dose sachets.

Each pack contains 10 and 20 sachets, packaged in heat-sealed sachets formed by an aluminum complex (polyester/aluminum/polyethylene, polyester, and polyethylene).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/