PARACETAMOL STADAPHARM 650 mg TABLETS

1. What is Paracetamol Stadapharm and what is it used for

This medication is used in adults and adolescents from 14 years of age for the symptomatic relief of occasional mild or moderate pain, as well as in febrile conditions.

You should consult a doctor if your pain worsens or does not improve after 5 days, or if your fever worsens or persists after 3 days.

2. What you need to know before taking Paracetamol Stadapharm

Do not take Paracetamol Stadapharm:

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

Warnings and Precautions

• Consult your doctor, pharmacist, or nurse before starting to take Paracetamol Stadapharm.
• Do not take more medication than recommended in section 3. How to take Paracetamol Stadapharm.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

Patient with liver, kidney, heart, or lung disease, and patients with anemia should consult their doctor before taking this medication.

• The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

When being treated with medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.

Chronic alcoholics should be cautious not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.

• During treatment with paracetamol, immediately inform your doctor if:
• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from 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 unwell (nausea) and vomiting.

Interference with laboratory tests.

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Children and Adolescents

Due to the amount of paracetamol in this medication, children and adolescents under 14 years of age cannot take this medication.

Taking Other Medications and Paracetamol Stadapharm:

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications for reducing cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used for the treatment of gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used for the treatment of high blood pressure and heart rhythm disorders (arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Paracetamol Stadapharm 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, etc.) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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 if the pain or fever does not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and Using Machines:

The influence of this medication on the ability to drive and use machines is zero or insignificant.

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

3. How to Take Paracetamol Stadapharm

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

The recommended dose is:

Adults and adolescents from 14 to 18 years:

They can take 1 tablet every 4 or 6 hours as needed, up to a maximum of 4 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours.

Patient with liver disease:

Before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose. They should not take more than 2 grams (3 tablets) of paracetamol in 24 hours, divided into 3 doses.

Patient with kidney disease:

Before taking this medication, they must consult their doctor.

Patient with severe or moderate kidney disease can take a maximum of 500 milligrams of paracetamol per dose, so they should not use this medication.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens, or other symptoms appear, you should discontinue treatment and consult your doctor.

Always use the lowest effective dose. The intake of this medication is subject to the appearance of pain or fever. As they disappear, treatment should be suspended.

Use in Children and Adolescents:

This medication is for use exclusively in adults and adolescents from 14 years of age. Children and adolescents under 14 years of age cannot take this medication.

How to Take

This medication is administered orally.

The tablets should be swallowed whole or broken with the help of some liquid.

If you take more Paracetamol Stadapharm than you should:

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 symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

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

Patient taking 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, pharmacist, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount taken.

If you forget to take Paracetamol Stadapharm:

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

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

Possible side effects are:

Rare side effects, may affect up to 1 in 1,000 people: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

Very rare side effects 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, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Frequency unknown (cannot be estimated from available data): headache induced by analgesic abuse, 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 periods.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Stadapharm

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

No special storage conditions are required.

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 via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, 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 Stadapharm

The active ingredient is paracetamol. Each tablet contains 650 milligrams of paracetamol.

The other components (excipients) are potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the Product and Package Contents:

White, oblong, biconvex film-coated tablets with a score line on one side and marked with PB on the other side, packaged in PVC/PVdC/Aluminum blisters.

Packaging of 20 tablets.

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

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: January 2025

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