Paracetamol Stadapharm 650 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paracetamol Satadapharm 650 mg tablets EFG

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

• 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or if fever persists beyond 3 days of treatment, or if pain persists beyond 5 days.

Leaflet contents

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

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

This medicine is used in adults and adolescents from 14 years of age for the symptomatic relief of mild to moderate occasional pain, as well as in febrile conditions.

You should consult a doctor if your condition worsens or does not improve, pain after 5 days, or fever after 3 days.

2. What you need to know before taking Paracetamol Stadapharm

Do not take Paracetamol Stadapharm:

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

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to take Paracetamol Stadapharm.
• Do not take more medicine than recommended in section 3, How to take Paracetamol Stadapharm.
• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

Patients with liver, kidney, heart, or lung disease, and patients with anemia should consult their doctor before taking this medicine.

• Concomitant use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

If you are being treated with antiepileptic medicines, you should consult your doctor before taking this medicine, as the combination may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.

Chronic alcoholics should take care not to take more than 3 tablets of 650 mg paracetamol in 24 hours.

• During treatment with paracetamol, inform your doctor immediately if:
• You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Interference with laboratory tests.

If you are due to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Children and adolescents

Due to the paracetamol content of this medicine, children and adolescents under 14 years of age must not take this medicine.

Taking other medicines and Paracetamol Stadapharm:

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

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: (isoniazid, rifampicin)
• Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine output (loop diuretics such as furosemide group)
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Taking Paracetamol Stadapharm with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not subside or if you need to take the medicine more frequently.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and use of machines:

The influence of this medicine on the ability to drive and operate machinery is negligible or none.

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

3. How to take Paracetamol Stadapharm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 14 to 18 years:

May take 1 tablet every 4 or 6 hours as needed, up to a maximum of 4 tablets per day. Do not exceed 3 grams of paracetamol in 24 hours.

Patients with liver disease:

Must consult their doctor before taking this medicine. They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses. They must not take more than 2 grams (3 tablets) of paracetamol in 24 hours, divided into 3 doses.

Patients with kidney disease:

Must consult their doctor before taking this medicine.

Patients with moderate or severe kidney disease may take a maximum of 500 milligrams of paracetamol per dose, and therefore should not use this medicine.

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

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be discontinued and a doctor consulted.

Always use the lowest effective dose. This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be stopped.

Use in children and adolescents:

This medicine is intended for use only in adults and adolescents aged 14 years and older. Children and adolescents under 14 years must not take this medicine.

How to take

This medicine is administered orally.

The tablets should be swallowed whole or split with the help of a liquid.

If you take more Paracetamol Stadapharm than you should:

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

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Paracetamol Stadapharm:

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Possible adverse effects are:

Rare adverse effects (may affect up to 1 in 1,000 people): malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Frequency unknown (cannot be estimated from the available data): headache caused by analgesic abuse, a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Stadapharm

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Stadapharm

The active substance is paracetamol. Each tablet contains 650 milligrams of paracetamol.

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

Appearance of the product and contents of the pack:

Oblong, biconvex, white tablets, with a score line on one side and marked "PB" on the other side, presented in PVC/PVdC/Aluminum blisters.

Pack sizes of 20 tablets.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (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 most recent revision of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/