PARACETAMOL ALTER 1 g TABLETS

Introduction

Package Leaflet: Information for the Patient

Paracetamol Alter1 gEFG Tablets

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 doubts, 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 side effects not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Paracetamol Alter and what is it used for
2. What you need to know before taking Paracetamol Alter
3. How to take Paracetamol Alter
4. Possible side effects
5. Storage of Paracetamol Alter
6. Package Contents and Additional Information

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

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

This medication is used for the symptomatic treatment of mild or moderate pain and fever in adults and adolescents over 15 years old and weighing more than 50 kg.

2. What you need to know before taking Paracetamol Alter

Do not take Paracetamol Alter

• If you are allergic to paracetamol 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 Alter.

• Do not take more medication than recommended in section 3. How to take Paracetamol Alter 1 g tablets.
• Avoid taking this medication simultaneously with other medications that contain paracetamol, such as flu and cold medications, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol in 24 hours.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.
• When being treated with 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.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• 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 suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious 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. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children

In children under 15 years old, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Other Medications and Paracetamol Alter

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• 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 alteration of the blood and fluids (called metabolic acidosis) that must be treated urgently (see section 2).

Interference with Analytical Tests:

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

Taking Paracetamol Alter with Food, Drinks, and Alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

In case of necessity, paracetamol 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.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

3. How to Take Paracetamol Alter

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

According to your preferences, the tablets can be swallowed directly or broken in half, with the help of a glass of liquid, preferably water.

The recommended dose is:

Adults and adolescents over 15 years old

1 tablet (1 g of paracetamol) every 6-8 hours, 3 or 4 times a day.

Do not exceed 1 gram of paracetamol per dose. Do not take more than 4 grams of paracetamol in 24 hours, divided into 4 doses.

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. They should not take more than 2 paracetamol tablets in 24 hours, divided into 2 doses.

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, 1 gram of paracetamol, the medication is not indicated for this group of patients.

This medication is taken orally.

The tablets should be swallowed whole or broken in half, with the help of a glass of 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, not to administer 500 mg doses, as there are other presentations available with this amount of active ingredient.

Always use the lowest effective dose.

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

The administration of this medication is subject to the appearance of pain or fever. As they disappear, treatment should be discontinued.

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, treatment should be interrupted and your doctor consulted.

.

If you take more Paracetamol Alter than you should

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 medication and the amount ingested.

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

If you have ingested an overdose, you should go immediately to a medical center, 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 after ingestion of the medication.

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

If you forget to take Paracetamol Alter

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

4. Possible Side Effects

Like all medications, Paracetamol Alter can have side effects, although not everyone experiences them.

Rare side effects that may occur (between 1 and 10 out of 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 less than 1 out of 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).

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

Very rare cases of severe skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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 Alter

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 shown 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 medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Alter

• The active ingredient is paracetamol.
• The other ingredients are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

Paracetamol Alter is presented in the form of tablets for oral administration, in packages of 20 and 40 tablets. The tablets are scored, which allows them to be broken in half to facilitate swallowing.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter S.A

C/ Mateo Inurria 30

28036 Madrid

Manufacturer

Toll Manufacturing Services S.L

Aragoneses, 2

28108 Alcobendas (Madrid)

or

Farmalider, S.A.

Aragoneses, 2

28108 Alcobendas (Madrid)

Date of the Last Revision of this Package Leaflet:February 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/