PARACETAMOL STADA 1 g EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

ParacetamolStada1 g Effervescent TabletsEFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Paracetamol Stada is and what it is used for.
2. What you need to know before you take Paracetamol Stada.
3. How to take Paracetamol Stada.
4. Possible side effects.
5. Storing Paracetamol Stada.

Contents of the pack and additional information

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

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

This medicine is indicated for the symptomatic treatment of moderate pain and fever in adults and adolescents over 15 years of age.

2. What you need to know before you take 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).

Warnings and precautions

Do not take more than the recommended dose in section 3. How to take Paracetamol Stada.

Check that you are not taking other medicines that contain paracetamol at the same time.

Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

Consult your doctor or pharmacist before starting to take Paracetamol Stada.

• if you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin level in the blood, due to or not due to a reduction in red blood cells),
• if you have Gilbert's syndrome (mild jaundice), if you are dehydrated or have chronic malnutrition
• when you are being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, because when used at the same time, the efficacy of paracetamol is decreased and its hepatotoxicity is increased, especially in treatments with high doses of paracetamol.
• in chronic alcoholics, caution should be exercised not to take more than 2 g/24 hours of paracetamol.
• 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 consult your doctor and reassess the clinical situation.

During treatment with Paracetamol Stada, 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 if you 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.

Children and adolescents

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other presentations with doses suitable for these patients may be available.

Interference with laboratory tests

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

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

Use of Paracetamol Stada with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use other medicines.

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

• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: (isoniazid, rifampicin)
• Medicines to treat depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
• Medicines used to treat 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).

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.

Use of Paracetamol Stada with food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

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 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.

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

Driving and using machines

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

Paracetamol Stada contains sorbitol(E-420), lactose, and sodium

This medicine contains 205.50 mg of sorbitol in each tablet.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 330.05 mg of sodium (main component of table/cooking salt) in each tablet. This is equivalent to 16.50% of the maximum recommended daily intake of sodium for an adult.

Consult your doctor or pharmacist if you need 1 or more tablets per day for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

3. How to take Paracetamol Stada

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

Method of administration:

Paracetamol Stada is presented in the form of effervescent tablets and should be taken orally.

The score line should not be used to break the tablet.

Dissolve the tablet completely in a glass of water. Before ingesting the medicine, the effervescence must cease.

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults and adolescents over 15 years of age:The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

Patients with liver disease

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

Patients with kidney disease: Before taking this medicine, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medicine is not indicated for this group of patients.

Elderly patients:

They should consult their doctor

Use in children and adolescents

Do not use in children or adolescents under 15 years of age.

If you think that 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 dosage should be used.

If you take more Paracetamol Stada than you should

You should consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, you should go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice symptoms, since they often do not appear until 3 days after ingestion of 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 overdose is more effective if started within 4 hours of ingestion of the medicine.

Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a 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 next doses with the indicated spacing between them (at least 4 hours).

If you stop taking Paracetamol Stada

If you have any further questions on 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.

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

Very rare side effects that may occur (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and low blood sugar (hypoglycemia). Serious skin reactions have been reported.

Frequency not known (cannot be estimated from the 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).

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

If you think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not mentioned in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Paracetamol Stada

Keep out of the sight and reach of children.

Do not store above 30°C.

Keep in the original package to protect from moisture.

Do not use this medicine after the expiry date stated on the package 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 packages and medicines you no longer need to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Paracetamol Stada

• The active ingredient is paracetamol.
• The other ingredients are: sodium hydrogen carbonate, anhydrous citric acid, sorbitol (E-420), lactose monohydrate, sodium saccharin, lemon flavor, L-leucine, and ascorbic acid.

Appearance of the product and contents of the pack

Paracetamol Stada 1 g Effervescent Tablets are presented in the form of white effervescent tablets with a slight lemon flavor and a score line, which are packaged in propylene tubes with a polyethylene cap and a silica gel desiccant, and are available in packs of 10, 20, and 40 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69 (Sant Joan Despí)

08970 (Barcelona)

Spain

Date of the last revision of this leaflet: January 2025

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