PARACETAMOL STADAPHARM 500 mg TABLETS

2. What you need to know before taking Paracetamol Stadapharm

Do not take Paracetamol Stadapharm

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Paracetamol Stadapharm:

• if you have liver problems, including those caused by excessive alcohol consumption (3 or more alcoholic beverages per day);
• if you have kidney problems;
• if you have glucose-6-phosphate dehydrogenase deficiency;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you have dehydration or hypovolemia;
• if you are taking a medication to treat epilepsy, you should consult your doctor before taking this medication, as when used at the same time, it decreases the efficacy and increases the hepatotoxicity of paracetamol, especially in high-dose paracetamol treatments (see below in this section "Other medications and Paracetamol Stadapharm");
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart problems, respiratory failure, or anemia; in these situations, administration should be done under surveillance and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid.

During treatment with Paracetamol Stadapharm, inform your doctor immediately if:

• you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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.

Paracetamol may cause severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the symptoms of severe skin reactions and the use of the medication should be discontinued at the first symptom of skin rash or any other symptom of hypersensitivity.

Do not take more paracetamol than recommended in section 3 "How to take Paracetamol Stadapharm".

The simultaneous use of this medication with other medications that contain paracetamol, such as medications for flu and colds, should be avoided, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor. If you suffer an overdose, seek medical attention immediately (see "If you take more Paracetamol Stadapharm than you should").

This medication should not be used for self-medication of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless your doctor prescribes it, as these situations may require medical evaluation and treatment.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medications containing paracetamol should not be taken for more than a few days or in high doses, unless your doctor indicates it.

Prolonged use of pain relievers or inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medication.

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. Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Children and Adolescents

This medication should not be used in children under 12 years of age or weighing less than 40 kg.

Other Medications and Paracetamol Stadapharm

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

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

Medications to treat seizures (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine): the combination of paracetamol and antiepileptic medications can cause or worsen liver damage.

Lamotrigine: The effect of lamotrigine may be reduced.

Medications to treat high blood pressure and heart rhythm disorders (arrhythmias) (propranolol): the combination of paracetamol and propranolol can increase the action and/or toxicity.

Medications to treat gout (probenecid): causes a reduction of almost 2 times in the excretion of paracetamol. The dose of paracetamol should be considered when concomitant treatment with probenecid is administered.

Medications to treat tuberculosis (rifampicin, isoniazid): the combination of paracetamol and rifampicin or isoniazid can cause or worsen liver damage.

Salicylamide, a medication to treat fever and pain: can prolong the elimination half-life (t1/2) of paracetamol.

Medications to reduce cholesterol levels in the blood (cholestyramine): reduces the absorption of paracetamol. To avoid this, paracetamol should be administered one hour before or 4 hours after the resin.

Medications to prevent nausea and vomiting (metoclopramide and domperidone): the simultaneous ingestion of medications that cause gastric emptying acceleration, e.g., metoclopramide and domperidone, increase the absorption and anticipate the onset of paracetamol action. However, it is not necessary to avoid concomitant use.

Medications to prevent blood clots (oral anticoagulants such as acenocoumarol, warfarin): paracetamol can increase the effects of oral anticoagulants. Prolonged use of this medication in patients treated with oral anticoagulants should only be done under medical supervision. The potentiation of warfarin effects has been observed with continued high doses of paracetamol.

Medications to increase urine production (loop diuretics such as furosemide): the effects of diuretics may be reduced.

Chloramphenicol, a medication to treat infections: the simultaneous administration of paracetamol and chloramphenicol can significantly delay the elimination of chloramphenicol, increasing its plasma concentrations and causing a greater risk of toxicity.

Zidovudine (AZT), a medication used in viral diseases: the concomitant administration of paracetamol and AZT can increase the incidence of neutropenia or worsen it (reduction of white blood cell count). Paracetamol should only be taken simultaneously with AZT if your doctor recommends it.

The concomitant use of substances that induce liver enzymes, such as barbiturics, carbamazepine, isoniazid, rifampicin, or ethanol, should be taken into account, as they can potentiate the toxic effect of paracetamol.

Inform your doctor if this medication is taken with medications that delay gastric emptying (e.g., propanteline) or accelerate gastric emptying (e.g., metoclopramide and domperidone).

Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Taking Paracetamol Stadapharm with Alcohol

Do not drink alcohol during treatment with paracetamol.

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 medication.

Pregnancy

Paracetamol can be used during pregnancy if necessary. 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

Paracetamol passes into breast milk. Therapeutic doses of paracetamol can be administered during breastfeeding.

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is zero or insignificant. However, during treatment with paracetamol, you may observe side effects such as mild drowsiness and dizziness.

Paracetamol Stadapharm Contains Sodium

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

3. How to Take Paracetamol Stadapharm

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults is 1 to 2 tablets, 1 to 3 times a day (a maximum of 6 tablets per day) with a large glass of water. Maximum daily dose: 3 g/day.

The use of high doses of paracetamol per day for prolonged periods of time should be avoided, as it increases the risk of suffering side effects, such as liver damage.

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 discontinue treatment and consult your doctor.

Liver Disease

Consult your doctor before taking this medication. You should take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose. Do not take more than 2 grams of paracetamol (4 tablets) in 24 hours. In chronic alcoholics, the dose should not exceed 2 grams per day.

Kidney Disease

Consult your doctor before taking this medication. Take a maximum of 1 tablet. Depending on the severity of your kidney disease, your doctor will tell you if you should take your medication with a minimum interval of 6 or 8 hours.

Elderly Patients

No dose adjustment is necessary.

Use in Children and Adolescents

• Between 12 and 15 years (or weighing more than 40 kg): 1 tablet 1 to 3 times a day with a large glass of water.
• Over 15 years (and weighing more than 55 kg), follow the recommendations for adults.
• This medication is not recommended for children and adolescents under 12 years of age or weighing less than 40 kg. This medication is not intended for children and adolescents under 12 years of age or weighing less than 40 kg. Ask your pharmacist.

If You Take More Paracetamol Stadapharm Than You Should

Contact your doctor or pharmacist immediately, even if you feel well. The appearance of symptoms of severe liver damage may be delayed by 1 to 2 days. Adequate control of paracetamol overdose requires immediate treatment. Despite the absence of early symptoms, patients should be taken to the hospital for immediate treatment.

The symptoms of overdose include nausea, vomiting, anorexia, pallor, general malaise, sweating, and abdominal pain, and usually appear within the first 24 hours.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If You Forget to Take Paracetamol Stadapharm

If you forget to take a dose, take another as soon as you remember, unless it is almost time for your next dose. Remember to leave at least four hours between doses. Do not take a double dose to make up for forgotten doses.

If You Stop Taking Paracetamol Stadapharm

If you have any other doubts 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.

The following side effects have been reported in patients treated with paracetamol:

Rare(may affect up to 1 in 1,000 people):

• Malaise.
• Low blood pressure (hypotension).
• Increased liver enzymes.

Very Rare(may affect up to 1 in 10,000 people):

• Changes in blood, including changes in blood cell counts (such as abnormally low levels of certain blood elements that can cause, for example, bleeding through the nose or gums) and bleeding.
• Allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure).
• Disruption of blood sugar.
• Jaundice (yellowing of the skin), liver failure.
• Skin reactions such as allergic dermatitis, urticaria, itching, skin rash.
• Changes in urination (difficult or painful urination, decreased urine output, and blood in the urine).

Frequency Not Known(cannot be estimated from available data):

• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown 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 medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Stadapharm

• The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components (excipients) are sodium starch glycolate (type A), povidone, pregelatinized corn starch, and stearic acid.

Appearance of the Product and Package Contents

White tablets, capsule-shaped, marked with "500" on one side and smooth on the other.

Paracetamol Stadapharm is available in blisters containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

Qualimetrix S.A.

579 Mesogeion Avenue, Agia Paraskevi,

Athens, 15343

Greece

Date of the Last Revision of this Package Leaflet:January 2025

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