Leaflet: Information for the User

Paracetamol Dari Pharma 1 g Effervescent TabletsEFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated for the symptomatic treatment of moderate pain and fever in adults and adolescents over 15 years old.

Do not take ParacetamolDari Pharma

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

Warnings and precautions

Do not take more than the recommended dose as stated in section 3, Paracetamol Dari Pharma.

Check that you are not taking other medications that contain paracetamol at the same time.

Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

Consult your doctor or pharmacist or nurse before starting to take Paracetamol Dari Pharma.

• if you have liver, kidney, heart, or lung disease, or have anemia (a decrease in the hemoglobin level in the blood, due or not due to a decrease in red blood cells),
• if you have Gilbert's syndrome (mild jaundice),if you are dehydrated,or have chronic malnutrition,
• when you are being treated with an antiepileptic medication, consult your doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose paracetamol treatments.
• in chronic alcoholics, be careful not to take more than 2 g/24 hours of paracetamol.
• 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, consult your doctor and reevaluate the clinical situation.

Inform your doctor immediately if during treatment with Paracetamol Dari Pharma:

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 have malnutrition, chronic alcoholism, or if you 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, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

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

Interference with analytical tests

Inform your doctor if you are to undergo any analytical test (including blood, urine, etc...), as this medication may alter the results.

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

Use of Paracetamol Dari Pharma with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications.

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

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (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: (colestiramine)
• 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 severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (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 systematically if you are being treated with another medication. In the case of oral anticoagulants, it may be possible to administer this medication occasionally as the preferred analgesic.

Use of Paracetamol Dari Pharma with food, drinks, and alcohol

The taking of this medication with food does not affect the efficacy of the same.

Pregnancy and lactation

Pregnancy

Consult your doctor or pharmacist before using any medication.

In case necessary,Paracetamol Dari Pharma 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 the pain or fever do not decrease or if you need to take the medication more frequently.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The consumption of medications during pregnancy may be hazardous to the embryo or fetus, and should be monitored by your doctor.

Lactation

Consult your doctor or pharmacist before using any medication.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor or pharmacist before taking this medication.

Driving and operating machines

The influence of paracetamol on the ability to drive and operate machines is negligible or insignificant.

Paracetamol Dari Pharma contains sorbitol(E-420), lactose, and sodium

• This medication contains 205.5 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a condition of intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor before taking this medication.
• This medication contains lactose. If your doctor has indicated that you have a condition of intolerance to certain sugars, consult your doctor before taking this medication.
• This medication contains 330 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 16.5% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Mode of use:

Paracetamol Dari Pharma is presented in the form of effervescent tablets and must be taken orally.
Thescoreshouldnotbeusedtobreakthetablet.
Disolve the tablet completely in a glass of water. Before ingesting the medication, it is necessary to stop the effervescence.

Consult your doctor or pharmacist if you have doubts.

The recommended dose is:

Adults and adolescents over 15 years:The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. No more than 4 tablets (4 g) should be taken in 24 hours.

Patients with liver disease: Before taking this medication, they must consult their doctor. 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 in 24 hours, divided into 2 doses.

Patients with kidney disease: Before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medication is not indicated for this group of patients.

Older patients:They should consult their doctor

Use in children and adolescents

Do not use in children orinadolescents under 15 years.

If it is estimated that the action ofthismedicationis too strong or weak, inform your doctor or pharmacist.

When requiring the administration of doses lower than 1 g of paracetamol per dose, other presentations of paracetamol should be used that adapt to the required dosage.

If you take more ParacetamolDari Pharmathan you should

You should 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.

If you have ingested an overdose, you should go immediately to a medical center even if you do not notice the symptoms, as they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice) and abdominal pain.

The treatment of overdose is more effective if it is initiated within 4 hours of ingestion of the medication.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to take ParacetamolDari Pharma

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated interval between doses (at least 4 hours).

If you interrupt treatment with ParacetamolDari Pharma

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Paracetamol Dari Pharmacan produce adverse effects, although not all people will experience them.

Rare adverse effects that mayproduce (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 mayproduce (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).Therehavebeenreportedcasesofseriousreactionsintheskin.

Adverse effects of unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated 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.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Expiration Date:

Do not use this medication after 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 medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of ParacetamolDari Pharma

• The active ingredient is paracetamol.
• The other components are: Sodium bicarbonate, anhydrous citric acid (E-330), sorbitol (E-420), lactose monohydrate, sodium saccharin (E-954ii), lemon aroma, L-Leucine, ascorbic acid (E-300), and povidone.

Appearance of the product and contents of the packaging

Paracetamol Dari Pharma 1 g effervescent tablets EFG are presented in the form of effervescent tablets, white in color, with a light lemon flavor and scored, which are packaged in polypropylene tubes with a polyethylene cap with a silica gel desiccant and are presented in containers of 10, 20, and 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Dari Pharma, S.L.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda, Barcelona, 69 (Sant Joan Despí)-08970- Barcelona

Spain.

Last review date of this leaflet: February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.