Leaflet: information for the user

Paracetamol pensavital 650 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, as 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 doctor, pharmacist or nurse.
• 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 the fever worsens or persists after 3 days of treatment or the 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

This medication is indicated for adults and adolescents over 14 years old.

It is indicated for the symptomatic relief of occasional mild to moderate pain, such as headache, toothache, muscle pain (contractures) or back pain (lumbago) and in febrile states.

Consult a doctor if the pain worsens or does not improve after 5 days, or the fever after 3 days.

Do not take Paracetamol pensavital

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

- Do not take more medication than recommended in section 3. “How to take Paracetamol pensavital”.

- Avoid simultaneous use of 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.

- Chronic alcoholics should be careful not to take more than 3 grams in 24 hours of paracetamol

- Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medication.

- When taking medication for epilepsy, 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 treatments with paracetamol.

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

During treatment with Paracetamol pensavital, immediately inform your doctor 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 suffer from 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 taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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:

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

- Medications for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Medications for treating tuberculosis: isoniazid, rifampicin.

- Medications for treating depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).

- Medications used to lower blood cholesterol levels: cholestyramine.

- Medications used to increase urine elimination (diuretics of the loop, such as those in the furosemide group).

- 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).

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, etc. …) inform your doctor that you are taking/using this medication, as it may alter the results.

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.

Use in children

Do not use in adolescents under 14 years old.

Pregnancy and Lactation

Pregnancy:

Consult your doctor or pharmacist before using any medication.

Important for women

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

In case of need, this medication can 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.

Lactation

Consult your doctor or pharmacist before using any medication. Paracetamol passes into breast milk, so women in 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

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; this is, essentially “sodium-free”.

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

Remember to take your medication. Paracetamol must be taken orally.

The recommended dose is:

Adults and adolescents over 14 years (weight 64-65 kg):

Take 1 tablet every 4 or 6 hours, as needed.Do not take more than 4 paracetamol tablets in 24 hours.

Patients with liver diseases:

Before taking this medication, you must consult your doctor. You must take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

You must not take more than 3 tablets of 650 mg of paracetamol in 24 hours, divided into 3 doses.

Patients with kidney diseases:

Before taking this medication, you must consult your doctor. Take a maximum of 500 mg per dose.

Due to the dose, 650 mg of paracetamol, it is not indicated for this group of patients.

It is recommended to avoid the use of high daily doses of paracetamol for prolonged periods of time, as this increases the risk of suffering adverse effects such as liver damage.

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, you must interrupt the treatment and consult your doctor.

Always use the smallest effective dose. The taking of this medication is subject to the disappearance of pain or fever. As these disappear, treatment should be suspended.

Usein children and adolescents:

This medication is for exclusive use in adults and adolescents from 14 years old. Children and adolescents under 14 years old cannot take this medication.

This medication is taken orally.

The tablets must be swallowed whole or broken in half with the help of a liquid, preferably water.

The tablets are scored, which allows them to be broken in half. The score serves only to break the tablet if it is difficult to swallow whole.

Always use the smallest effective dose.

It is recommended to avoid the use of high daily doses of paracetamol for prolonged periods of time, as this increases the risk of suffering adverse effects such as liver damage.

The administration of this medication is subject to the disappearance of pain or fever. As these disappear, treatment should be suspended.

If you take more Paracetamol pensavitalthan you should

You must consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, you must 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 intoxication.

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

Patients undergoing barbiturate treatment 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 interval (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 with available data): headache induced by analgesic abuse and 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 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 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 650 mg of paracetamol.

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

Appearance of the product and content of the packaging:

This medicationis presented in tablets for oral administration.

The tablets are oblong,biconvex, white in color, with a notch on one face and marked with PB on the other face.

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

Only some packaging sizes may be commercially marketed.

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/