Leaflet: information for the user

Paracetamol pensavital 500 mg tablets EFG

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

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

This medicine can be purchased without a prescription. Nevertheless, for 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 any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if your fever worsens or persists after 3 days of treatment or if your pain lasts for more than 5 days.

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

2. What you need to know before starting to take Paracetamol pensavital

3. How to take Paracetamol pensavital

4. Possible side effects

5. Storage of Paracetamol pensavital

6. Contents of the pack and additional information

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

Paracetamol is used for the treatment of pain of mild to moderate intensity and febrile states in adults and children aged 12 years and above (or with a body weight of 40 kg or more).

No take Paracetamol pensavital:

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

Warnings and precautions:

- Do not take more of the medication than recommended in section 3, Taking Paracetamol pensavital.

- Avoid using this medication with other medications that contain paracetamol, for example, medications for the flu and cold, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

- If you have asthma that is sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

- If you have any 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), consult your doctor before taking this medication.

- When you are being treated with any medication for epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is decreased and the hepatotoxicity of paracetamol is increased, especially in treatments with high doses of paracetamol.

- In chronic alcoholics, be careful not to take more than 4 tablets of 500 mg or 2 g per day of paracetamol.

- If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.

- In children under 10 years, consult your doctor or pharmacist as there are other presentations with doses that are adapted to this group of patients.

Inform your doctor immediately during treatment with Paracetamol pensavital 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 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 difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medications and Paracetamol pensavital:

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

Paracetamol may interact with the following medications:

- Blood clot prevention medication: oral anticoagulants (acenocoumarol, warfarin).

- Epilepsy medications: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Tuberculosis medications: isoniazid, rifampicin.

- Depression and convulsion medications: barbiturates (used as hypnotics, sedatives, and anticonvulsants).

- Cholesterol-lowering medications: cholestyramine.

- Diuretics (such as furosemide) used to increase urine elimination.

- Gout medications: probenecid and sulfinpyrazone.

- Nausea and vomiting prevention medications: metoclopramide and domperidone.

- High blood pressure and heart rhythm medications: 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 if you are being treated with another medication. In the case of oral anticoagulants, Paracetamol pensavital may be used occasionally as the preferred analgesic.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Paracetamol pensavital with food, drinks, and alcohol:

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage.

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

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication may be used during pregnancy if necessary. 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.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery:

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

Paracetamol pensavital contains sodium (Potato starch glycolate sodium (Type A)):

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow these instructions unless your doctor has given you different instructions. Remember to take your medication. Paracetamol must be taken orally.

The normal dose is:

Adults and children 12 years of age or older, or with a body weight of 40 kg or more:

Take 1 tablet every 4-6 hours as needed, up to a maximum of 6 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours.The doses should be spaced at least 4 hours apart.

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

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

Children: It is necessaryto respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 doses per day, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

Children weighing between 33 and 40 kg:1 tablet per dose, every 6 hours,up to a maximum of 4 tablets per day.

Between 41 and 50 kg of body weight:1 tablet per dose, every 4-6 hours,up to a maximum of 6 tablets per day.

Patients with liver disease:must consult their doctor before taking this medication.

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 (4 tablets of 500 mg) of paracetamol in 24 hours.

Patients with kidney disease:must consult their doctor before taking this medication. Take a maximum of 500 mg per dose.

Older adults:

must consult their doctor.

Use in children and adolescents:

Do not use in children under 12 years of age

If you estimate that the action of Paracetamol is too strong or too weak, inform your doctor or pharmacist.

When administering doses less than 500 mg of paracetamol per dose, other presentations of paracetamol should be used that adapt to the required dosage.

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

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Paracetamol pensavital:

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 spacing between doses (at least 4 hours).

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rare adverse effects that may occur (in 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 may occur (in 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). Rarely, severe skin reactions have been reported.

Unknown frequency (cannot be estimated from available data): a serious disease that can make the blood more acidic (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 treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Paracetamol pensavital:

The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.

The other components (excipients) are: sodium starch glycolate (Type A) from potato, purified water, pregelatinized cornstarch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and contents of the packaging:

Paracetamol pensavital is presented in tablets for oral administration.

The tablets are biconvex, white in color, and round in shape.

The packaging is 20 tablets, conditioned in a PVC/PVDC/Aluminum blister.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

SAG Manufacturing S.L.U

Crta.N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Last review date of this leaflet:February 2025

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