Dolostop 650 mg oral solution
Spain
Table of Contents
Package leaflet: Information for the user
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 exactly 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects 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.
Contents of the leaflet
- What Dolostop is and what it is used for
- What you need to know before taking Dolostop
- How to take Dolostop
- Possible side effects
- How to store Dolostop
- Contents of the pack and other information
1. What Dolostop is and what it is used for
Dolostop contains paracetamol. Paracetamol is effective in reducing pain and fever.
It is used for the relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), and in febrile conditions in adults and adolescents over 14 years of age and weighing more than 43 kg.
2. What you need to know before starting to take Dolostop
Do not take Dolostop
- If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take this medicine.
- Do not take more of the medicine than the recommended dose stated in section 3, How to take Dolostop.
- Avoid taking this medicine together with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
- Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
- Patients with kidney, liver, heart, or lung disease, or those with anemia (reduced hemoglobin levels in the blood, due to or unrelated to a decrease in red blood cells), or those suffering from chronic malnutrition or dehydration, should consult their doctor before taking this medicine.
- If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
- Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
During treatment with Dolostop, inform your doctor immediately if:
You have serious medical conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance in blood and fluid chemistry) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Children and adolescents
For children and adolescents under 14 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for these patients may be available.
Taking Dolostop with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:
- Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
- Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Medicines for tuberculosis: (isoniazid, rifampicin).
- Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
- Medicines to lower blood cholesterol levels: (cholestyramine).
- Medicines used to increase urine output (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 (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).
Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.
Interference with diagnostic tests
If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.
Paracetamol may affect the analytical results for 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 drinks per day – beer, wine, liquor, etc. 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.
Dolosptop may be used during pregnancy if necessary. Use the lowest possible dose that relieves 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 medicine more frequently.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.
Driving and use of machines
The influence of paracetamol on the ability to drive and operate machinery is none or negligible.
Dolostop contains sorbitol (E-420), propylene glycol (E-1520), sulphites, 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 informed you (or your child) that you have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child’s 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 recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.
If you have hepatic or renal impairment, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.
Sulphites
This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains ammonium sulphite caramel.
Glucose
This medicine contains glucose (in maltodextrin derived from potato and maize). If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
May cause dental caries.
Ethanol
This medicine contains 0.2% ethanol (alcohol), a small amount corresponding to 18.2 mg per sachet.
3. How to take Dolostop
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor. If in doubt, ask your doctor, pharmacist, or nurse.
Recommended dose:
Adults and adolescents over 14 years of age and weighing more than 43 kg:
Take 1 sachet (650 mg paracetamol) every 4–6 hours as needed.
Do not exceed 3 grams of paracetamol (4 sachets) in 24 hours.
Always take the lowest effective dose.
This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.
High daily doses of paracetamol should be avoided over prolonged periods, 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 new symptoms appear, discontinue treatment and consult your doctor.
For sore throat, do not take this medicine for more than 2 consecutive days without consulting your doctor.
Patients with kidney disease:
You must consult your doctor before taking this medicine. Due to the dosage, this medicine should not be used.
Patients with liver disease:
You must consult your doctor before starting to take this medicine.
You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.
Do 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 of age or weighing less than 43 kg.
Method of administration
This medicine is taken orally.
The contents of the sachet may be taken diluted in a liquid, preferably water, or directly.
Once opened, consume the entire contents of the sachet immediately.
If you take more Dolostop than you should
Contact 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.
Symptoms of overdose may include: 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 have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Treatment of overdose is most effective if started within 4 hours of taking the medicine.
Patients undergoing treatment with 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 missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare adverse effects, which may affect up to 1 in 1,000 people, are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects, which may affect up to 1 in 10,000 people, are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), and severe skin reactions.
Adverse effects with frequency not known (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).
Paracetamol may damage the liver when taken at high doses or during prolonged treatment.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dolostop
- The active substance 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 corn maltodextrin), masking SC274292 (containing sucralose (E955), maltodextrin (from potato) and monoammonium glycyrrhizinate), neohesperidin dihydrochalcone (E959), orange flavour (containing ethanol), citric acid monohydrate (for pH adjustment) and purified water.
Appearance of the medicine and contents of the pack
Brown coloured oral solution, supplied in single-dose sachets.
Each pack contains 10 or 20 sachets, packed in thermoformed blisters made of an aluminium complex (polyester/aluminium/polyethylene, polyester and polyethylene).
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Date of the most recent revision of this leaflet: February 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.