PARACETAMOL DERMOGEN 500 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Paracetamol Dermogen 500 mg Tablets EFG

Readthe entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contentsof the package leaflet

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

5 Conservation of Paracetamol Dermogen

1. Contents of the pack and additional information

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

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild to moderate pain and febrile states in adults and children over 10 years old (body weight over 33 kg).

2. What you need to know before taking Paracetamol Dermogen

Do not take Paracetamol Dermogen

• 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 or pharmacist before taking paracetamol:

• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic beverages per day);
• if you have kidney problems;
• if you have a glucose-6-phosphate dehydrogenase deficiency;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you suffer from dehydration or hypovolemia;
• if you are taking a medication to treat epilepsy, you should consult your doctor before taking this medication, as it may decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially in high-dose treatments (see below in this section Other medications and Paracetamol Dermogen);
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart, respiratory, or anemia failure; in these situations, administration should be carried out under surveillance and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid;
• 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 signs of severe skin reactions and the use of the medication should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
• The total dose of paracetamol should not exceed 4 g per day.
• Concomitant use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor. If an overdose occurs, seek medical attention immediately (see "If you take more than you should").
• Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.

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 indicated by your doctor.

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

During treatment with paracetamol, inform your doctor immediately if:

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 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 of discomfort (nausea) and vomiting.

Other medications and Paracetamol Dermogen

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

This is especially important if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Medications to prevent blood clot formation: oral anticoagulants (acenocoumarol, warfarin).
• Medications to treat epilepsy: antiepileptic medications (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to reduce cholesterol levels in blood: (cholestyramine)
• Medications to increase urine elimination (loop diuretics such as furosemide).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications for the treatment of high blood pressure (hypertension) and cardiac arrhythmias (cardiac arrhythmias): Propranolol.
• Salicylamide, a medication to treat fever and pain, may prolong the elimination half-life of paracetamol
• Zidovudine (used in the treatment of HIV infections).

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2)

Interference with analytical tests:

If you are going to have any analytical test (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.

Taking Paracetamol Dermogen with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Children and adolescents

This medication should not be used in children under 10 years old or weighing less than 33 kg.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking this medication

IMPORTANT FOR WOMEN

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Taking medications during pregnancy can be hazardous to the embryo or fetus and should be controlled by your doctor.

Pregnancy and breastfeeding

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.

Breastfeeding

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

Fertility

No harmful effects on fertility are known with the normal use of paracetamol

Driving and using machines:

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

3. How to take Paracetamol Dermogen

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

The recommended dose is:

Adults andadolescents over 15 years old (body weight over 50 kg):

1 or 2 tablets 3 or 4 times a day. The doses should be spaced at least 4 hours apart.

Maximum dosage: Do not exceed 4 g of paracetamol (8 tablets) in 24 hours.

Children and adolescents over 10 years old (body weight over 33 kg)

It is necessary to respect the dosages defined according to weight. The child's age is given for informational purposes.

-Children between 33 kg and 40 kg of weight: 1 tablet 3 or 4 times a day. The doses should be spaced at least 4 hours apart.

Maximum dosage: 4 tablets per day.

-Between 41 and 50 kg of weight: 1 tablet 3 or 4 times a day. The doses should be spaced at least 4 hours apart.

Maximum dosage: 5 tablets per day.

This medication is not intended for children under 10 years old or weighing less than 33 kg. Ask your pharmacist.

Patients with liver disease: consult your doctor before taking this medication.

They should take the prescribed amount of medication by their doctor with a minimum interval of 8 hours between each dose.

They should not take more than 2 g (4 tablets) in 24 hours.

In chronic alcoholics, the dose should not exceed 2 g per day.

Patients with kidney disease:

consult your doctor before taking this medication.

Patients with moderate to severe kidney disease should take a maximum of 500 mg of paracetamol per dose, every 6-8 hours.

This medication is taken orally.

The tablets should be swallowed with the help of a glass of liquid, preferably water.

The tablets are scored, which allows them to be broken in half. The tablet can be divided into equal doses.

Always use the lowest effective dose.

Administration of this medication is subject to the appearance of pain or fever. As they disappear, treatment should be discontinued.

If you take more Paracetamol Dermogen than you should

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the packaging and the package leaflet of the medication to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center even if you do not have symptoms, as 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 after ingestion of the medication.

Patients treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Dermogen

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take the forgotten dose as soon as you remember, taking the following doses with the indicated spacing between doses (at least 4 hours).

If you interrupt treatment with Paracetamol Dermogen

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

4. Possible side effects

Like all medications, this medication can have side effects, although not all people experience them.

The following side effects have been reported:

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

• Very rare: may affect up to 1 in 10,000 people
• kidney disease,
• turbid urine,
• allergic dermatitis (skin rash),
• jaundice (yellowing of the skin),
• blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia)
• hypoglycemia (low blood sugar level).
• Very rarely, cases of severe skin reactions have been reported.

• Frequency not known (cannot be estimated from available data)
• A serious disease called metabolic acidosis (an anomaly in blood and fluids) in patients with severe disease using paracetamol (see section 2).

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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. Conservation of Paracetamol Dermogen

Keep this medication out of 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 collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Paracetamol Dermogen

• The active ingredient is paracetamol. Each tablet contains 500 milligrams of paracetamol.
• The other components (excipients) are pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the product and contents of the pack:

The tablets are oblong, biconvex, white, and scored.

Paracetamol Dermogen is presented in oral tablets in packs of 20 and 500 tablets, packaged in PVC-PVDC and aluminum blisters.

Marketing authorization holder:

Dermogen Farma, S.A.

C/ La Granja 1

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km.

Almodóvar del Río, 19

14720 Córdoba

Spain

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of last revision of this package leaflet: February 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/