Paracetamol Dari Pharma 1 g effervescent tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paracetamol Dari Pharma 1 g effervescent tablets EFG

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Paracetamol Dari Pharma is and what it is 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. How to store Paracetamol Dari Pharma.
6. Contents of the pack and other information.

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

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 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Do not exceed the recommended dose stated in section 3. How to take Paracetamol Dari Pharma.

To ensure this, check that you are not simultaneously taking other medicines containing paracetamol.

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

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

• if you have liver, kidney, heart or lung disease, or if you have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells),
• if you have Gilbert's syndrome (mild jaundice), if you are dehydrated or suffer from chronic malnutrition,
• if you are undergoing treatment with antiepileptic medicines, you should consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.
• in chronic alcoholics, caution should be taken not to exceed 2 g/24 hours of paracetamol.
• if pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you should consult your doctor and re-evaluate the clinical situation.

During treatment with Paracetamol Dari Pharma, inform your doctor immediately if:

You have serious underlying 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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

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

Interference with laboratory tests

If you are due to undergo any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Paracetamol may interfere with analytical determinations of uric acid and glucose.

Use of Paracetamol Dari Pharma 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 in the treatment of 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 abnormalities (called metabolic acidosis) requiring 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 any other medicine. In patients on oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Use of Paracetamol Dari Pharma with food, drinks and alcohol

Taking this medicine with food does not affect its effectiveness.

Pregnancy and lactation

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Paracetamol Dari Pharma may be used during pregnancy if necessary. Use the lowest 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.

IMPORTANT FOR WOMEN

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus, and should be monitored by your doctor.

Lactation

Consult your doctor or pharmacist before using any medicine.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is none or negligible.

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

• This medicine contains 205.5 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.
• This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine.
• This medicine contains 330 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 16.5% of the maximum daily recommended sodium intake for an adult.

3. How to take Paracetamol Dari Pharma

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Instructions for use:

Paracetamol Dari Pharma is available as effervescent tablets and must be taken orally. The tablet should not be divided using the score line. Dissolve the tablet completely in a glass of water. Do not ingest the medicine until effervescence has completely stopped.

Consult your doctor or pharmacist if you have any doubts.

Recommended dose:

Adults and adolescents over 15 years of age: The usual dose is 1 tablet (1 g of paracetamol) 3 times daily. Doses must 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 medicine, they must consult their doctor. They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses. They must not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

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

Take a maximum of 500 milligrams per dose.

Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this patient group.

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 feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When lower doses than 1 g of paracetamol per dose are required, other paracetamol formulations adapted to the required dosage should be used.

If you take more Paracetamol Dari Pharma than you should

Consult 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.

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.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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 toxic effects of a paracetamol overdose.

If you forget to take Paracetamol Dari Pharma

Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

If you stop taking Paracetamol Dari Pharma

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Paracetamol Dari Pharma may produce adverse effects, although not everyone will experience them.

Rare adverse effects (occurring in up to 1 in 1,000 people) include: malaise, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (occurring in up to 1 in 10,000 people) include: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Cases of serious skin reactions have been reported.

Adverse effects with unknown frequency (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 are using paracetamol (see section 2).

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

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

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 through 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 Paracetamol Dari Pharma

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Expiry date:

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Dari Pharma

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

Appearance of the medicinal product and contents of the pack

Paracetamol Dari Pharma 1 g effervescent tablets EFG is presented as white effervescent tablets with a slight lemon flavour and a breakline. The tablets are packed in polypropylene tubes with a polyethylene cap and a silica gel desiccant, and are available in pack sizes of 10, 20 and 40 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/ .