PARACETAMOL NEOGEN 1 g FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET:

Package Leaflet: Information for the User

Paracetamol Neogen 1 g film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

This medicine contains the active substance paracetamol, which belongs to a group of medicines called analgesics (pain-relieving medicines).

This medicine can be used in adults and children weighing more than 55 kg (i.e., around 15 years of age).

The use of this medicine is not suitable for children weighing less than 55 kg. Consult your doctor or pharmacist.

Paracetamol Neogen is used to relieve pain and reduce fever. The tablets can treat mild to moderate pain and/or fever.

2. What you need to know before you take Paracetamol Neogen

Do not take Paracetamol Neogen:

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

Warnings and precautions

Consult your doctor before taking Paracetamol Neogen:

• If you are taking other medicines that contain paracetamol, as they can seriously damage the liver.
• If you have any liver problems (including Gilbert's syndrome or acute hepatitis).
• If you have kidney failure.
• If you have a deficiency of a certain enzyme called glucose-6-phosphate dehydrogenase.
• If you have hemolytic anemia (anemia caused by abnormal breakdown of red blood cells).
• If you have a poor nutritional status, such as due to alcoholism, lack of appetite (anorexia), or malnutrition. You may need to take a lower dose or otherwise you could damage your liver.
• If you are asthmatic or hypersensitive to acetylsalicylic acid.
• If you have a high fever, signs of infection (e.g., sore throat), or if the pain lasts for more than three days.
• If you drink alcohol.

If you take paracetamol for headache over a prolonged period, the headaches could get worse or become more frequent. If you suffer from frequent or daily headaches, contact your doctor.

If you are going to have a blood or urine test, always inform your doctor that you are taking paracetamol, as this medicine may affect the test results.

Children and adolescents

Paracetamol Neogen is not recommended for children weighing less than 55 kg. Consult your doctor or pharmacist.

Other medicines and Paracetamol Neogen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines prescribed by your doctor, medicines bought at the pharmacy, herbal medicines, and vitamin and mineral supplements.

Do not use Paracetamol Neogen in combination with other medicines that contain paracetamol.

Consult your doctor if you are taking:

• Medicines used to treat nausea and vomiting (metoclopramide or domperidone).
• Medicines used to lower cholesterol (cholestyramine).
• Medicines used to treat epilepsy (such as phenytoin, carbamazepine, and lamotrigine).
• Medicines for gout (probenecid). The dose may need to be changed.
• Anticoagulants (e.g., warfarin and other coumarin derivatives). If you take paracetamol regularly over a prolonged period, you may be at risk of bleeding.
• Salicylamide (a pain reliever).
• Medicines used to treat tuberculosis (isoniazid or rifampicin).
• Medicines that cause relaxation and drowsiness (barbiturates or carbamazepines).
• A medicine used to treat depression (St. John's Wort).
• Chloramphenicol (an antibiotic).
• Zidovudine (a medicine used to treat AIDS).
• Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and that can occur particularly in case of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

If you are going to have a blood test (such as blood test, urine test, skin allergy tests, etc.), you must inform your doctor that you are taking this medicine, as it could affect the test results.

If you are taking medicines for high cholesterol (such as cholestyramine), take Paracetamol Neogen at least one hour before or 4 to 6 hours after this medicine and inform your doctor.

Using Paracetamol Neogen with food, drinks, and alcohol

You can take Paracetamol Neogen with food, although it is not necessary.

You should take the paracetamol tablets with a glass of water.

It is advised not to drink large amounts of alcohol during treatment with paracetamol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Paracetamol Neogen can be used during pregnancy if necessary. You should use the lowest possible dose that reduces your pain and/or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain and/or fever do not improve or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol is excreted in breast milk, but at therapeutic doses of Paracetamol, no effects are expected in newborns/infants during breastfeeding. Paracetamol can be used during breastfeeding, provided that the recommended dose is not exceeded. In case of prolonged use, caution is advised.

Fertility

No harmful effects on fertility are expected with the normal use of paracetamol.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Paracetamol does not affect the ability to drive or use machines safely.

3. How to take Paracetamol Neogen

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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Use in adults and children over 15 years of age

Take 0.5 to 1 gram of paracetamol in a single dose, up to a maximum of 3 grams (3 tablets) per day (24 hours). The interval between doses should be at least 4 hours.

The 1-gram presentation is not suitable for children weighing less than 55 kg (i.e., under 15 years of age).

• Do not use in combination with other medicines that contain paracetamol.
• Do not exceed the recommended dose.
• If the symptoms of pain or fever return, you may need to repeat the treatment with Paracetamol Neogen.

Kidney failure

The dose should be reduced in case of kidney failure (renal failure). Talk to your doctor or pharmacist.

Liver failure

In patients with liver failure or Gilbert's syndrome, the dose should be reduced or the administration interval prolonged. Talk to your doctor or pharmacist.

The effective daily dose should not exceed 60 mg/kg/day (up to a maximum of 2000 mg/day (2 g/day)) in the following situations:

• Adults weighing less than 50 kg
• Mild to moderate liver failure, Gilbert's syndrome (non-hemolytic familial jaundice)
• Dehydration
• Chronic malnutrition
• Chronic alcoholism

Follow these instructions unless your doctor tells you otherwise.

If you think the effect of Paracetamol Neogen is too strong or too weak, talk to your doctor or pharmacist.

Method of administration

Swallow the tablet with a glass of water.

The tablet can be divided into equal doses.

If you take more Paracetamol Neogen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

Seek immediate help in case of overdose, even if you feel well, as you may be at risk of severe delayed liver damage. The symptoms of paracetamol overdose are nausea, vomiting, and decreased appetite. Unconsciousness is not usually produced.

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Do not take a double dose to make up for forgotten doses. Just continue with the recommended dose.

If you have any further questions on 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. The possible side effects are listed below and are classified as:

Rare side effects (affect 1 to 10 users in 10,000)

• Various blood disorders, including agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hemolytic anemia, leukopenia, platelet disorders (blood clotting disorders), and disorders of the bone marrow cells (disorders of the cells that form the blood)
• Allergic reactions
• Depression, confusion, hallucinations
• Tremors, headache
• Visual disturbances
• Edema (abnormal accumulation of fluid under the skin)
• Abdominal pain, stomach or intestinal bleeding, diarrhea, nausea, vomiting
• Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver cell death (necrosis)
• Rash, itching, sweating, hives, red patches on the skin, angioedema, accompanied by symptoms such as swelling of the face, lips, throat, and tongue.
• Dizziness, general malaise, fever, sedation, interactions with other medicines
• Overdose and poisoning

Very rare side effects (occurring in less than 1 user in 10,000):

• Pancytopenia (reduction in the number of blood cells)
• Allergic reactions that require treatment to be discontinued, including angioedema, difficulty breathing, sweating, nausea, hypotension, shock, and anaphylaxis
• Low blood glucose levels
• Hepatotoxicity (liver damage caused by chemicals)
• Cloudy urine and kidney disorders
• Bronchospasm (difficulty breathing) in patients with hypersensitivity to acetylsalicylic acid and other anti-inflammatory medicines
• Hematuria (blood in the urine)
• Anuria (inability to urinate)

Frequency not known (cannot be estimated from the available data):

• Acute generalized exanthematous pustulosis (a drug rash characterized by the appearance of numerous small sterile pustules, mainly non-follicular)
• Severe skin rash or peeling
• Stevens-Johnson syndrome (a severe skin disorder that can be life-threatening)
• Redness of the skin, blisters, or rash due to taking paracetamol
• A serious condition that can make the blood more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

These symptoms should disappear after stopping the medicine. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Neogen

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions. Keep the medicine in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Neogen

• The active substance is paracetamol.
• The other ingredients are pregelatinized maize starch, maize starch, povidone, stearic acid, and talc. Coating: Opadry white (Y-1-7000): hypromellose, macrogol, titanium dioxide (E-171).

Appearance and packaging of the product

Paracetamol Neogen 1 g film-coated tablets EFG are white, oval, film-coated tablets with a score line on one side and a smooth surface on the other.

The film-coated tablets are packaged in PVC/aluminum blisters and HDPE bottles with a screw cap.

Package sizes

Blister packs of 8, 20, and 30 film-coated tablets.

Bottles of 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neogen N.V.

Square Marie Curie 50,

1070 Anderlecht, Brussels

Belgium

Manufacturer

SANTA S.A.

Str. Panselelor nr. 25, nr. 27, nr. 29,

Brasov, jud. Brasov, 500419,

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark Paradol

Netherlands Paracetamol Neogen

Date of last revision of this leaflet:January 2025

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