PARACETAMOL PENSAVITAL 1 g EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamolpensavital 1 g effervescent tabletsEFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

This medicine can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used with care.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, or if the fever persists after 3 days or the pain lasts more than 5 days.

Contents of the package leaflet

1. What is Paracetamol pensavital and what is it used for.
2. What you need to know before taking Paracetamol pensavital.
3. How to take Paracetamol pensavital.
4. Possible side effects.
5. Storage of Paracetamol pensavital.
6. Contents of the pack and further information.

1. What is Paracetamol pensavital and what is it used for

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

Paracetamol is indicated for the treatment of moderate-intensity pain and febrile states in adults and adolescents from 16 years old (or with a body weight over 50 kg).

2. What you need to know before taking Paracetamol pensavital

Do not take Paracetamol pensavital:

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

Warnings and precautions

• Do not take more medicine than recommended in section 3. How to take Paracetamol pensavital.
• You should avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

• If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), you should consult your doctor before taking this medicine.
• When you are being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol in 24 hours.
• 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 reassess the clinical situation.

During treatment with Paracetamol pensavital, inform your doctor immediately if:

If you have severe diseases, such as severe renal failure 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 adolescents under 16 years old, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Interference with laboratory tests

If you are going to undergo any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Other medicines and Paracetamol pensavital

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Paracetamol may interact with the following medicines:

• Medicines 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 convulsions: barbiturics (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in the blood: colestyramine
• Medicines used to increase urine elimination (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 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 medicines) without consulting your doctor.

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

Taking Paracetamol pensavital with food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If necessary, Paracetamol pensavital 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 medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible.

Paracetamol pensavital contains sorbitol (E420), lactose, and sodium

This medicine contains 205.50 mg of sorbitol per 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 medicine.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains 330 mg of sodium (the main component of table salt/cooking salt) per tablet. This is equivalent to 16.50% of the maximum recommended sodium intake for an adult.

3. How to take Paracetamol pensavital

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Mode of administration:

Paracetamol pensavital is presented in the form of effervescent tablets and should be taken orally. The notch should not be used to split the tablet.

Dissolve the tablet completely in a glass of water. Before ingesting the medicine, the effervescence must cease.

The recommended dose is:

Adults and adolescents over 16 years old: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 3 grams (3 tablets) in 24 hours.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

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 discontinue treatment and consult your doctor.

Patient with liver disease: Before taking this medicine, they must consult their doctor. They should take the amount of medicine 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.

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

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medicine 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 and adolescents under 16 years old.

If you think the action of this medicine 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 pensavital than you should

You should consult your doctor or pharmacist immediately.

The symptoms of overdose 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 to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

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

Patient being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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 forget to take Paracetamol pensavital

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

If you stop taking Paracetamol pensavital

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects that may occur (in up to 1 in 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in 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.

Frequency not known (cannot be estimated from the 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 in prolonged treatments.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol pensavital

Keep this medicine out of the sight and reach of children.

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

Store in the original packaging to protect it from moisture. Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol pensavital

• The active ingredient is paracetamol.
• The other ingredients (excipients) are: sodium bicarbonate, citric acid, sorbitol (E-420), lactose monohydrate, sodium saccharin, lemon flavor, L-leucine, ascorbic acid, and povidone.

Appearance of the product and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Neuraxpharm Pharmaceutical, S.L.

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

Spain.

Date of the last revision of this leaflet: February 2025

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