PARACETAMOL STADA 650 mg TABLETS

2. What you need to know before taking Paracetamol Stada

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 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, inform your doctor immediately if:

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 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 of discomfort (nausea) and vomiting.

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

In chronic alcoholics, it is recommended 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 the pain or fever worsen or other symptoms appear, treatment should be discontinued and a doctor consulted. In children under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Taking Paracetamol Stada with other medications

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

Paracetamol may interact with the following medications:

• Antibiotics (chloramphenicol)

• Anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epileptic seizures)
• 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 stomach, intestine, and bladder spasms or contractions)
• Zidovudine (used to treat HIV infections)
• Colestyramine (used to decrease cholesterol levels in the blood)
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion imbalance) that should be treated urgently (see section 2).

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

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

Interactions with diagnostic tests

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

Taking Paracetamol Stada with food, drinks, and alcohol

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

Pregnancy

Consult your doctor or pharmacist before using any medication.

IMPORTANT FOR WOMEN

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

If necessary, paracetamol can 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 does 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 that you consult your doctor or pharmacist before taking this medication.

Driving and using machines

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

3. How to take Paracetamol Stada

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

Remember to take your medication.

This medication should be taken orally. According to your preferences, the tablets can be taken directly 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 (and weighing over 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 respect the defined posologies based on weight. The child's age based on weight is provided for informational purposes.

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

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

• Between 41 and 50 kg in weight (12 to 15 years): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Patient with liver or kidney disease: should consult their doctor

Elderly patients: should consult their doctor

If the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol (less than 650 mg) are required, other presentations of paracetamol that adapt 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, consult your doctor or the Toxicology Information Service (telephone 915 620 420) immediately. If an overdose has been taken, you should go to a medical center immediately, even if there are no symptoms, as they often do not appear until three days after taking the overdose, even in cases of severe poisoning. The symptoms of an overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of the overdose is more effective if started within 4 hours of taking the medication.

Patient treated with barbiturates or suffering 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 forgotten doses; simply take the forgotten dose when you remember, taking the next doses with the indicated time interval (at least 4 hours).

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Paracetamol Stada may cause the following side effects:

• Rare (may affect up to 1 in 1,000 people): discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.
• Very rare (may affect up to 1 in 10,000 people): 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). Serious skin reactions have been reported.
• Frequency not known (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Paracetamol Stada

Keep out of sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Stada

• The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other ingredients are: pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the product and package contents

Paracetamol Stada 650 mg tablets are presented in the form of oblong tablets, white in color, and scored on one side. Each package contains 20 or 40 tablets, packaged in blisters.

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)

[email protected]

Manufacturer

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

28750 San Agustin de Guadalix,

Spain

Date of the last revision of this leaflet:February 2025

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