DOLOSTOP 650 MG ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Dolostop 650 mg Oral Solution

Paracetamol

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

Follow the instructions for administration 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 you start 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 (lumbago) pain, and in febrile conditions in adults and adolescents over 14 years and weighing more than 43 kg.

2. What you need to know before you start 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 than the recommended dose 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 levels in the blood, due to or not due to a decrease in red blood cells), or those 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 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 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 are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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 14 years, consult your doctor or pharmacist, as other presentations may be available with doses suitable for these patients.

Taking Dolostop with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis: (isoniazid, rifampicin).
• Medicines for treating depression and convulsions: Barbiturics (used as hypnotics, sedatives, and anticonvulsants).
• Medicines for reducing cholesterol levels in the blood: (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used for treating gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used for treating 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 requires urgent treatment (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 analytical tests

If you are going to have any analytical test (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

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 hazardous to the embryo or fetus and should be monitored by your doctor.

If necessary, Dolostop can 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 medicine more frequently.

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

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.

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

Sorbitol

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

Sorbitol is a source of fructose. 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.

Propylene glycol

This medicine also 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.

Sulfites

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

Glucose

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

It may cause cavities.

Etanol

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

3. How to take Dolostop

Follow the instructions for administration 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 and adolescents over 14 years and weighing more than 43 kg:

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

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

Always take the lowest effective dose.

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

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 discontinue 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. Due to the dose, they should not use this medicine.

Patient with liver disease:

Must consult their doctor before starting to take this medicine.

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

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

Children and adolescents:

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

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 to a medical center or call the Toxicological 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 to a medical center immediately, 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 barbiturics 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 serious 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 treatment.

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 (AEMPS) 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, 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 650 mg of paracetamol.
• The other ingredients are: propylene glycol (E1520), macrogol 400, povidone K12, sorbitol (E420), ammonium sulfite caramel (E150-d) (containing corn maltodextrin), masking SC274292 (containing sucralose (E955), potato maltodextrin, and monoammonium glycyrrhizinate), neohesperidin dihydrochalcone (E959), orange flavor (containing ethanol), citric acid monohydrate (for pH adjustment), and purified water.

Appearance of the product and packaging contents

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).

Only certain 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 the 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/.