Paracetamol stada 650 mg comprimidos efg

Leaflet: information for the patient

Paracetamol STADA 650 mg tablets 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

• Ifyou 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 for what it is used

2.What you need to know before starting to take 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

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

Paracetamol Stada is 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 chronic 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.

If 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. In children under 15 years, consult your doctor or pharmacist 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, cardiac 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 alteration (metabolic acidosis with high anionic imbalance) 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 your doctor or pharmacist systematically if you are being treated with another medication. In the case of oral anticoagulant treatment, Paracetamol can be administered occasionally as the preferred analgesic.

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, etc.) may cause liver damage.

Pregnancy

Consult your doctor or pharmacist before using any medication.

In case of need, 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 do not decrease or if you need to take the medication more frequently.

Lactation

Consult your doctor or pharmacist before using any medication.

Small amounts of paracetamol may appear in breast milk, so 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 administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Remember to take your medication.

This medication must be taken orally. According to your preferences, the tablets can be taken directly or divided in half with water, milk, or fruit juice. Consult your doctor or pharmacist if you have doubts.

The recommended dose is:

Adults and adolescents over 15 years (and weight over 50 kg):1 tablet every 4-6 hours,up to a maximum of 6tablets per day.

Use in childrenand adolescents

It is necessaryto respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/Kg/day, which is divided into 4 or 6 daily doses, that is15 mg /kg every 6 hours or 10 mg/kg every 4 hours.

• Between 21 and 25 kg of 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 of 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 of weight (12 to 15 years): 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

Patients of advanced age: must consult their doctor

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

When requiring the administration of doses lower than 650 mg 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, you must go to a medical center immediately, even if you do not have 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 can be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

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

If you forgot to take Paracetamol Stada

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

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

Like all medications, this medication may produce adverse effects, although not all people may 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). Se have reported cases of severe skin reactions.
• 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 may damage the liver when taken in high doses or prolonged treatments.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do 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 about the safety of this medication.

Keep out of sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Paracetamol Stada

• The active ingredient is paracetamol. Each tablet contains 650 mg 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 650 mg tablets are presented in the form of oblong tablets, white in color and scored on one of their faces. 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

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

info@stada.es

Responsible for manufacturing

SAG MANUFACTURING S.L.U. National Highway 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/