Dolostop is effective in reducing pain and fever.

It is indicated for the relief of occasional mild or moderate pain, such as headache, dental, muscular (contractures) or back (lumbago) and in febrile states in adults and children over 9 years of age.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

Do not take Dolostop

• If you are allergic to paracetamol or any of the other ingredients of it   medicine   (including   in   the   section   6).

Warnings and cautions

Talk to your doctor or pharmacist or nurse before taking this   medicine.

• Do not take more amount of medicine than recommended in section 3. How to take Dolostop .
• Simultaneous use of this medicine with other medicines containing paracetamol, for example medicines for flu and colds, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 g / in 24 hours of paracetamol.
• Patients with kidney, liver, heart or lung diseases and patients with anemia (decreased level of hemoglobin in the blood, caused or not by a decrease in red blood cells), or those patients suffering from chronic malnutrition or dehydration , they should consult their doctor before taking this medicine.
• When you are being treated with any medication to treat epilepsy, you should consult your doctor before taking this medication, because when used at the same time, the effectiveness is decreased and the hepatotoxicity of paracetamol is enhanced, especially in high dose treatments. of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

Children and adolescents

In children and adolescents under 15 years of age, consult your doctor or pharmacist as there may be other presentations available with doses that are adapted to these patients.

Interference with analytical tests

If you are going to do any analytical tests (including blood, urine, etc ...) tell your doctor that you are taking / using this medicine, as it may alter the results.

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

Using Dolostop with other medicines

Please inform your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription.

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

• Medicine 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 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 those of the furosemide group)
• 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 disturbances (cardiac arrhythmias): propranolol.

Do not use with other analgesics (pain relievers) without consulting your doctor.

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

Using Dolostop with food, drink and alcohol

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

IMPORTANT FOR WOMEN

If you are pregnant or think you might be, consult your doctor before taking this medicine. The use of medications during pregnancy can be dangerous for 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 subside or if you need to take the medicine more often.

Lactation

Consult your doctor or pharmacist before taking any medicine.

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

Driving and using machines

Paracetamol has no or negligible influence on the ability to drive and use machines.

Follow these instructions unless your doctor has given you different directions. Ask your doctor or pharmacist if you have doubts.

The recommended dose is :

Adults:

Take from half to 1 tablet (325 mg to 650 mg of paracetamol) every 4 to 6 hours, 3 times a day. Do not take more than 3 g (4 tablets) in 24 hours.

A daily dose of 2 g of paracetamol (3 tablets) is recommended for underweight adults and adolescents (less than 50 kg).

Always take the lowest dose that is effective.

The taking of this medicine is subject to the appearance of pain or fever. As these disappear, treatment should be stopped.

The use of high daily doses of paracetamol for prolonged periods of time should be avoided as the risk of suffering adverse effects such as liver damage is increased.

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

Patients with liver disease:

Before taking this medicine you have to consult your doctor.

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

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

Patients with kidney disease :

Before taking this medicine you have to consult your doctor.

Take a maximum of 500 milligrams per dose.

Depending on your illness, your doctor will tell you if you should take your medicine with a minimum interval of 6 or 8 hours.

Children:

It is necessary to respect the dosages defined according to weight. The age of the child based on weight is given for information purposes.The recommended daily dose of paracetamol is approximately 60 mg / kg / day, which is divided into 4 or 6 daily doses, that is, 15 mg / kg every 6 hours or 10 mg / kg every 4 hours.

• Between 27 and 43 kg of weight (from 9 to 12 years old): One taking of half a tablet , every 4 hours, up to a maximum of 6 doses a day (3 tablets).
• Between 43 and 50 kg of weight (from 12 to 15 years): One taking of one tablet, every 6 hours, up to a maximum of 4 doses per day (4 tablets).

This medicine should not be used in children weighing less than 27 kg (approximately 9 years) because the dose of this presentation is not adapted to this group of patients.

Do not use in children weighing more than 27 kg for more than 3 days without evaluating the clinical situation.

Whole, split or crushed tablets should be taken with the help of a glass of liquid, preferably water.

If you take more Dolostop than you should

You should immediately consult your doctor or pharmacist. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone number 91 562 04 20), indicating the medicine and the amount ingested.

Overdose symptoms 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 the symptoms, since these often do not appear until 3 days after the ingestion of the overdose, even in cases of severe poisoning.

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

Patients taking barbiturates or chronic alcoholics may be more susceptible to toxicity from a paracetamol overdose.

Like all medicines,   Dolostop can cause side effects, although not everyone gets it.

Rare side effects that may affect up to 1 in 1,000 people are: malaise, drop in 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, leukopenia, neutropenia, hemolytic anemia) , hypoglycemia (low blood sugar) and severe skin reactions.

Paracetamol can damage the liver when taken in high doses or in long-term treatments.

Communication of adverse effects

If you experience any kind of side effect, check with your doctor or pharmacist, even for side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: www.notificaRAM.es . By reporting side effects you can help provide more information on the safety of this medicine.

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Depos i like containers and medicines no longer required in Point SIGRE   from the pharmacy.   If in doubt, ask your pharmacist how to dispose of medicines no longer required. This will help protect the   environment.    

Composition of Dolostop :

• The active substance is paracetamol. Each tablet has 650 mg of paracetamol.
• The other ingredients are: pregelatinized corn starch, stearic acid and povidone.

What the product looks like and contents of the pack

Dolostop   I know   presents   in tablets for oral administration. The tablets are white, oblong and scored on one side. The boxes are 4, 12 or 20 tablets packed in PVC / aluminum blister.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, SL

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet: July 2019.

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