PARACETAMOL STADA 1 g 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 ingredients of this medicine (listed in section 6).
• If you have 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:

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 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 medicine.

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 worsens 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 adapt to this group of patients.

Taking Paracetamol Stada with other medicines

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

Paracetamol may interact with the following medicines:

• 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 blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion imbalance) 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.

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 and Breastfeeding

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

Pregnancy

Consult your doctor or pharmacist before using any medicine.

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 medicine. The use of medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

In case of necessity, 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 medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and Using Machines

No effects have been described that alter the ability to drive and use machinery.

3. How to Take Paracetamol Stada

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Remember to take your medicine.

This medicine should be taken orally. According to your preferences, the tablets can be swallowed 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): the usual dose is 1 tablet (1 gram of paracetamol) 3-4 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 grams) in 24 hours.

Patient with liver or kidney disease: should consult their doctor

Elderly patients: should consult their doctor

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

When lower doses of paracetamol are required per dose, other presentations of paracetamol that adapt to the required dosing 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, phone 915 620 420, immediately. If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they may not appear until three days after taking the overdose, even in cases of severe poisoning. The symptoms of overdose may be: 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 medicine.

Patient taking 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 following doses with the indicated time interval (at least 4 hours).

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 the 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 may damage the liver when taken in high doses or for prolonged treatments.

Reporting of Side Effects

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

5. Storage of Paracetamol Stada

Keep 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 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. Return the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Stada

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

• The other ingredients are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

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 blister packs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

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 Package Leaflet:February 2025

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