Paracetamol STADA 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol STADA 650 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

Paracetamol Stada is used for the symptomatic treatment of moderate pain and febrile conditions.

2. What you need to know before taking Paracetamol Stada

Do not take Paracetamol Stada:

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

• If you have any liver disease.

Warnings and precautions

Consult your doctor or pharmacist before taking Paracetamol Stada.

Do not take more than the recommended dose.

During treatment with Paracetamol Stada, inform your doctor immediately if:

You have serious illnesses 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 body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

If you have kidney, heart, or lung disease, or if you have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.

In chronic alcoholics, care should be taken not to exceed 2 grams/day of paracetamol.

If pain persists for more than 10 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor. For children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

Taking Paracetamol Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)

• Anticoagulants (used to treat thromboembolic disorders)

• Antiepileptics (used to treat epileptic seizures)

• Oral contraceptives

• Diuretics (used to increase urine elimination)

• Isoniazid (used to treat tuberculosis)

• Lamotrigine (used to treat epilepsy)

• Probenecid (used to treat gout)

• Propranolol (used to treat hypertension, cardiac arrhythmias)

• Rifampicin (used to treat tuberculosis)

• Anticholinergics (used to relieve spasms or contractions of the stomach, intestine, and bladder)

• Zidovudine (used to treat HIV infections)

• Cholestyramine (used to lower blood cholesterol levels)

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are undergoing treatment with another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Interactions with diagnostic tests

Consult your doctor if you need to undergo blood or urine tests.

Taking Paracetamol Stada with food, drinks, and alcohol

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

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

IMPORTANT FOR WOMEN

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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

Breast-feeding

Consult your doctor or pharmacist before taking any medicine.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

3. How to take Paracetamol Stada

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

Remember to take your medicine.

This medicine should be taken orally. Depending on your preference, the tablets can be swallowed whole or split in half with water, milk, or fruit juice. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults and adolescents over 15 years of age (and weighing more than 50 kg): 1 tablet every 4–6 hours, up to a maximum of 6 tablets per day.

Use in children and adolescents

It is necessary to follow the dosage guidelines based on body weight. The child's age according to weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Between 21 and 25 kg body weight (6 to 10 years of age): 1/2 tablet per dose, every 6 hours, up to a maximum of 2 tablets per day.
• Between 26 and 40 kg body weight (8 to 13 years of age): 1/2 tablet per dose, every 4 hours, up to a maximum of 3 tablets per day.
• Between 41 and 50 kg body weight (12 to 15 years of age): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Patients with liver or kidney disease: must consult their doctor.

Elderly patients: must consult their doctor.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When doses lower than 650 mg of paracetamol per dose are required, other paracetamol formulations better suited to the required dosage should be used.

The tablet can be divided into equal doses.

If you take more Paracetamol Stada than you should

If you have taken more paracetamol than you should, contact your doctor or the Toxicology Information Service immediately, telephone number 915 620 420. If an overdose has occurred, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until three days after the overdose, even in cases of severe poisoning. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients undergoing treatment with barbiturates or who suffer from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Paracetamol Stada

Do not take a double dose to make up for a missed dose. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Paracetamol Stada may cause the following adverse effects:

• Rare (may affect up to 1 in 1,000 people): malaise, low blood pressure (hypotension), and increased blood transaminase levels.
• Very rare (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). Cases of serious skin reactions have been reported.
• Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Paracetamol can cause liver damage 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 may 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 Stada

Keep out of sight and reach of children.

This medicine does not require any special storage conditions.

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Stada

• The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable-source magnesium stearate.

Appearance of the medicinal product and contents of the container

Paracetamol Stada 650 mg tablets are presented as white, oblong tablets, scored on one side. Each pack contains 20 or 40 tablets, packed in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

SAG MANUFACTURING S.L.U. Carretera Nacional I, Km. 36

28750 San Agustin de Guadalix,

Spain

Date of the most recent revision of this leaflet: February 2025

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