PARACETAMOL STADAGEN 650 mg TABLETS

2. What you need to know before taking Paracetamol Stadagen

Do not take Paracetamol Stadagen

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

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before starting to take paracetamol.
• Do not take more than the recommended dose in section 3. How to take Paracetamol Stadagen.
• In patients with asthma who are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medicine.
• If you have kidney, liver, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), you should consult your doctor before taking this medicine.
• When being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity may be increased, especially with high doses of paracetamol.
• In chronic alcoholics, you should be cautious not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.
• If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should consult your doctor and reassess the clinical situation.
• During treatment with Paracetamol Stadagen, inform your doctor immediately if:
• 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 have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe 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. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

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

Other medicines and Paracetamol Stadagen

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Paracetamol may interact with the following medicines:

• 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 convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• medicines to lower cholesterol levels in the blood: colestyramine.
• medicines used to increase urine elimination: loop diuretics such as furosemide.
• medicines used to treat gout: probenecid and sulfinpyrazone.
• medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• medicines used to treat high blood pressure and heart rhythm disorders: propranolol.
• flucloxacillin (antibiotic), due to a serious risk of alteration of the blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

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

Interference with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Stadagen with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

If necessary, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces the 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 medicine more frequently.

Taking medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Small amounts of paracetamol may be present in breast milk, so you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or nonexistent.

Paracetamol Stadagen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially "sodium-free".

3. How to take Paracetamol Stadagen

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. Paracetamol should be taken orally.

The recommended dose is:

Adults and adolescents over 15 years: the usual dose is 1 tablet (650 mg of paracetamol) every 4-6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 6 tablets in 24 hours.

Patient with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

Do not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 milligrams per dose.

Due to the dose, 650 mg of paracetamol is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents: do not use in children under 15 years.

If the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of 650 milligrams of paracetamol per dose are required, other formulations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol Stadagen than you should

Consult your doctor or pharmacist immediately.

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

If you have taken an overdose, you should go to a medical center immediately, even if you do not notice the symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning. Treatment of overdose is more effective if started within 4 hours of taking the medicine.

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

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

If you forget to take Paracetamol Stadagen

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects that may occur (up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (up to 1 in 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). Very rare cases of severe skin reactions have been reported.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's online reporting system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Stadagen

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

This medicine does not require any special storage conditions.

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

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 further information

Composition of Paracetamol Stadagen

• The active substance is paracetamol.
• The other ingredients (excipients) are potato starch (Type A), maize starch pregelatinized, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and pack contents

Paracetamol Stadagen are oblong, biconvex, white film-coated tablets with a score line on one face and marked with PB on the other face.

They are available in blister packs containing 20 or 40 tablets and in a clinical pack of 500 tablets.

Not all 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)

Spain

[email protected]

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 last revision of this package leaflet:April 2025

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