Leaflet: information for the user

Paracetamol Satadapharm 650 mg tablets EFG

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

Follow exactly the administration instructions for this medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again
• If you need advice or more information, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if your fever worsens or persists after 3 days of treatment or if your pain lasts for 5 days.

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

2. What you need to know before starting to take Paracetamol Stadapharm

3. How to take Paracetamol Stadapharm

4. Possible side effects

5. Storage of Paracetamol Stadapharm

6. Contents of the pack and additional information

This medication is used in adults and adolescents aged 14 years and above for the symptomatic relief of occasional mild to moderate pain, as well as in febrile states.

Consult a doctor if the pain worsens or does not improve after 5 days, or if the fever persists after 3 days.

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 of the medication than recommended in section 3. How to take Paracetamol Stadapharm.
• Patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

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

• Concomitant use of this medication with other medications containing paracetamol, such as cold and flu medications, may lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

When taking medications for epilepsy, consult your doctor before taking this medication, as concomitant use may reduce efficacy and increase hepatotoxicity, 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, inform your doctor immediately if:
• You have severe diseases, such as severe renal insufficiency 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 (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.

Interference with analytical tests.

Inform your doctor if you are to undergo any analytical tests (including blood, urine, etc.) as this medication may alter the results.

Children and adolescents

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

Taking other medications and Paracetamol Stadapharm:

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of one of them or discontinue treatment:

• Medications 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 seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (colestiramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Paracetamol Stadapharm with food, drinks, and alcohol

Using paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor...) 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, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

This medication can be used during pregnancy if necessary. Use the lowest possible dose to reduce pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever do not decrease or if you need to take the medication more frequently.

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist or nurse. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 14 to 18 years:

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

Patients with liver disease:

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

Patients with kidney disease:

Before taking this medication, they must consult their doctor.

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

It is recommended to avoid high daily doses of paracetamol for prolonged periods of time, as this increases the risk of adverse 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 worsen or other symptoms appear, they must interrupt the treatment and consult their doctor.

Always use the smallest effective dose. The taking of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be discontinued.

Use in children and adolescents:

This medication is for exclusive use in adults and adolescents from 14 years old. Children and adolescents under 14 years old cannot take this medication.

How to take

This medication is administered orally.

The tablets must 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 must go immediately to a medical center, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Paracetamol Stadapharm:

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may cause adverse effects, although not all people will experience them.

The possible adverse effects are:

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

Very rare adverse effects may affect up to 1 in 10,000 people: 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).

Unknown frequency (cannot be estimated with available data): headache induced by analgesic abuse, a serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does 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 on the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash.Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Stadapharm

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

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

Appearance of the product and contents of the packaging:

Oblong, biconvex tablets, white in color, with a notch on one face and marked with PB on the other face, are presented in a PVC/PVdC/Aluminum blister.

Packaging of 20 tablets.

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Junt Desvern (Barcelona)

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: January 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/