PARACETAMOL 650 mg Tablets

Contents of the leaflet

1. Introduction
3. ContentsofthePackageLeaflet
4. What is Paracetamol Pensa Pharma and what is it used for
5. What you need to know before taking Paracetamol Pensa Pharma
6. How to take Paracetamol Pensa Pharma
7. Possible side effects
8. Storage of Paracetamol Pensa Pharma
9. Contents of the pack and further information

Introduction

Package Leaflet: Information for the User

Paracetamol Pensa Pharma 650 mg Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package 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 package leaflet. See section 4.

ContentsofthePackageLeaflet

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

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

This medication belongs to the group of medications called analgesics and antipyretics.

This medication is indicated for the treatment of symptoms of mild to moderate pain and fever.

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

Do not take Paracetamol Pensa Pharma

• - if you are allergic (hypersensitive) to paracetamol, propacetamol hydrochloride, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take paracetamol.

• Do not take more than the recommended dose in section 3. "How to take Paracetamol Pensa Pharma".
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
• If you have any liver, kidney, heart, or lung disease, or if you have anemia (decreased hemoglobin levels in the blood, with or without a decrease in red blood cells), you should consult your doctor before taking this medication.
• When being treated with any medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• In chronic alcoholics, caution should be exercised not to take more than 3 tablets of 650 mg 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 reevaluate the clinical situation.

During treatment with Paracetamol Pensa Pharma, 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 the 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 there are other presentations with doses that are suitable for this group of patients.

Other medications and Paracetamol Pensa Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription.

Paracetamol may interact with the following medications:

• Medications to prevent blood clots: 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 convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to lower cholesterol levels in the blood: Cholestyramine.
• Medications used to increase urine elimination (diuretics such as those in the furosemide group)
• 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.

Interference with laboratory tests:

If you are going to have any laboratory tests (including blood tests, urine tests, 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 Pensa Pharma with food, drinks, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

If necessary, this medication 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.

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

Driving and using machines

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

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

3. How to take Paracetamol Pensa Pharma

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

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

The tablet can be divided into two equal halves.

The recommended dose is:

Adults and adolescents over 15 years:

The usual dose is 1 tablet (650 mg of paracetamol) every 4 or 6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 6 tablets in 24 hours.

Patient 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 of 8 hours between each dose.

Do not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patient with kidney disease:

Before taking this medication, they must consult their doctor. Take a maximum of 500 milligrams per dose. Due to the dose, 650 milligrams of paracetamol, the medication is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents: do not use in children under 15 years of age.

The score line is used to divide the tablet into equal doses, and if you find it difficult to swallow it whole.

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 Pensa Pharma than 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, even in cases of severe poisoning.

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

Patient being treated with 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Paracetamol Pensa Pharma

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Rare side 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 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, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Pensa Pharma

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated 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 any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Pensa Pharma

• The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other ingredients are: potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and packaging contents

This medication is presented in the form of oblong, biconvex tablets, white in color, with a score line on one face and marked with PB on the other face.

The packaging is available in 20 and 40 tablets, packaged in PVC/PVdC/Aluminum blisters.

Only certain pack sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

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

Date of the last revision of this package leaflet:January 2025

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