PARACETAMOL DARI PHARMA 1 g EFFERVSCENT TABLETS

Introduction

Leaflet: Information for the user

Paracetamol Dari Pharma 1 g effervescent tablets EFG

Read the entire leaflet carefully before starting to take this medication 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Paracetamol Dari Pharma and what is it used for.
2. What you need to know before taking Paracetamol Dari Pharma.
3. How to take Paracetamol Dari Pharma.
4. Possible side effects.
5. Storage of Paracetamol Dari Pharma.
6. Package contents and additional information

1. What is Paracetamol Dari Pharma and what is it used for

Paracetamol belongs to the group of medications called analgesics and antipyretics.

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

2. What you need to know before taking Paracetamol Dari Pharma

Do not take Paracetamol Dari 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 in section 3. How to take Paracetamol Dari Pharma.

Therefore, check that you are not taking other medications that contain paracetamol at the same time.

Asthmatic patients 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 any liver, kidney, heart, or lung disease, or if you have anemia (decrease in hemoglobin levels in the blood, due to 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 any medication for epilepsy, you should consult your doctor before taking this medication, because when used at the same time, the efficacy of paracetamol is decreased and its hepatotoxicity is increased, especially in treatments with high doses of paracetamol.
• in chronic alcoholics, precautions should be taken 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 worsens or other symptoms appear, you should consult your doctor and re-evaluate the clinical situation.

During treatment with Paracetamol Dari Pharma, 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 have 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 of discomfort (nausea) and vomiting.

Children and adolescents

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other presentations with doses suitable for these patients may be available.

Interference with analytical tests

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

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

Use of Paracetamol Dari Pharma with other medications

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

In particular, if you are using any of the following medications, 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 convulsions: Barbiturics (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious 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 systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

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

Taking this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

If necessary, Paracetamol Dari Pharma 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 medication more frequently.

IMPORTANT FOR WOMEN

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is zero 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 told you that you (or your child) 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 medication.
• This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.
• This medication contains 330 mg of sodium (main component of table/cooking salt) in each tablet. This is equivalent to 16.5% of the maximum daily sodium intake recommended for an adult.

3. How to take Paracetamol Dari Pharma

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Mode of use:

Paracetamol Dari Pharma is presented in the form of effervescent tablets and should be taken orally. The notch should not be used to split the tablet. Completely dissolve the tablet in a glass of water. Before ingesting the medication, it is necessary for the effervescence to cease.

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults and adolescents over 15 years of age:The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) 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 between each dose of 8 hours. 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.

Elderly patients:They should consult their doctor.

Use in children and adolescents

Do not use in children or adolescents under 15 years of age.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol are required per dose, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol Dari Pharma than you should

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

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, since they often do not appear 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, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of the overdose is more effective if started within 4 hours of taking the medication.

Patient's undergoing treatment with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Dari Pharma

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the following doses with the indicated separation between doses (at least 4 hours).

If you stop treatment with Paracetamol Dari Pharma

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

4. Possible side effects

Like all medications, Paracetamol Dari Pharma can cause side effects, although not everyone will experience them.

Rare side effects that may occur (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 occur (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), and hypoglycemia (low blood sugar). Serious skin reactions have been reported.

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

Paracetamol can damage the liver when taken in high doses or for prolonged treatments.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is 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 contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Dari Pharma

Keep out of sight and reach of children.

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

Expiration date:

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Dari 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 flavor, L-Leucine, ascorbic acid (E-300), and povidone.

Appearance of the product and package contents

Paracetamol Dari Pharma 1 g effervescent tablets EFG are presented in the form of white effervescent tablets with a slight lemon flavor and a notch, which are packaged in propylene tubes with a polyethylene cap and a silica gel desiccant, and are available in packages of 10, 20, and 40 tablets.

Marketing authorization holder and manufacturer

Holder:

Dari Pharma, S.L.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

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

Spain.

Date of the last revision of this leaflet: February 2025

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