Patient Information Leaflet

Paracetamol STADA1 gTablets EFG

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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.Storage of Paracetamol Stada

6.Contents of the pack and additional information

Paracetamolbelongs to a group of medicines called analgesics and antipyretics.

Paracetamol Stadais used for the symptomatic treatment of moderate intensity pain. Feverish states.

Do not take Paracetamol Stada

• If you are allergic to paracetamol or any of the other components of this medication (listed in section 6).
• If you have any liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol Stada.

Do not take more than the recommended dose.

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

You have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

You have kidney, heart, or lung disease, or have anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells), you should consult your doctor before taking this medication.

In chronic alcoholics, be careful not to take more than 2 grams/day of paracetamol.

If the pain persists for more than 10 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, discontinue treatment and consult a doctor.

Consult your doctor or pharmacist in children under 15 years as there are other presentations with doses adapted to this group of patients.

Paracetamol Stada with other medications

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

Paracetamol may interact with the following medications:

• Antibiotics (cloranfenicol)
• Anticoagulants (used for the treatment of thromboembolic diseases)
• Antiepileptics (used for the treatment of epileptic seizures)
• Contraceptives
• Diuretics (used to increase urine elimination)
• Isoniazid (used for the treatment of tuberculosis)

• Lamotrigine (used for the treatment of epilepsy)
• Probenecid (used for the treatment of gout)

• Propanolol (used for the treatment of hypertension, arrhythmias)
• Rifampicin (used for the treatment of tuberculosis)
• Anticholinergics (used for the relief of spasms or contractions of the stomach, intestines, and bladder)
• Zidovudine (used for the treatment of HIV infections)
• Colestiramida (used to reduce blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting a doctor.

As a general rule for any medication, it is recommended to inform the doctor or pharmacist systematically if you are being treated with another medication. In the case of oral anticoagulants, Paracetamol may be administered occasionally as a pain-relieving medication of choice.

Interactions with diagnostic tests

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

Paracetamol Stada with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor or pharmacist before using any medication.

IMPORTANT FOR WOMEN

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

In case of need, Paracetamol may 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 or midwife if the pain or fever do not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

No effects have been described that modify the ability to drive and operate machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Remember to take your medication.

This medication must be taken orally. According to your preference, the tablets can be swallowed whole or broken 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 old (and weight over 50 kg): the usual dose is 1 tablet (1 gram of paracetamol) 3-4 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 grams) in 24 hours.

Patients with liver or kidney disease: should consult their doctor

Older patients: should consult their doctor

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

When requiring doses lower than 1 gram of paracetamol per dose, other paracetamol presentations should be used that adapt to the required dosage.

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, consult your doctor or the Toxicological Information Service immediately, phone 915 620 420. If you have taken an overdose, go to a medical center immediately, even if you have no symptoms, as they may not appear until three days after taking 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.

The treatment of an overdose is more effective if initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or those with chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forgot to take Paracetamol Stada

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Paracetamol Stada may produce the following adverse effects:

• Rare (may affect up to 1 in 1,000 people), these are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

-Very rare (may affect up to 1 in 10,000 people), these are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Severe skin reactions have been reported.

-Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Paracetamol Stada

• The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

• The other components are: pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and plant-derived magnesium stearate.

Appearance of the product and content of the packaging

Paracetamol Stada 1 g tablets are presented in the form of oblong tablets, white in color, and scored on both sides. Each package contains 20 or 40 tablets, packaged in blisters.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km. 36

28750 San Agustin de Guadalix,

Spain

Last review date of this leaflet:February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/