PARACETAMOL DERMOGEN 650 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Paracetamol Dermogen 650 mg Tablets

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

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

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You should consult a doctor if your condition worsens or does not improve after 3 days with fever or 5 days with pain.

Contents of the Package Leaflet

1. What Paracetamol Dermogen is and what it is used for
2. What you need to know before taking Paracetamol Dermogen
3. How to take Paracetamol Dermogen
4. Possible side effects
5. Storage of Paracetamol Dermogen
6. Package Contents and Additional Information

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

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild to moderate pain and in febrile states in adults and adolescents over 15 years old (body weight over 50 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 starting to take paracetamol.

• Do not take more medication than recommended in section 3. How to take Paracetamol Dermogen.

• 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 effectiveness and increases the hepatotoxicity of paracetamol, especially in high-dose paracetamol treatments (see below in this section Other Medications and Paracetamol)
• 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 can 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 3 g per day.
• The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can 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 paracetamol than you should").
• Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.

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, the clinical situation should be evaluated by your doctor. 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 indicated by your doctor, as these situations may require medical evaluation and treatment.

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 illnesses, 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 severe 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.

Children and Adolescents

This medication should not be used in children under 15 years old or weighing less than 50 kg. Ask your pharmacist.

Other Medications and Paracetamol Dermogen

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 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 and cardiac arrhythmias: propranolol.
• Salicylamide, a medication to treat fever and pain, may prolong the elimination half-life of paracetamol
• Medications to treat HIV infections (Zidovudine).

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 per day: beer, wine, liquor, ...) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before taking this medication

Pregnancy and Breastfeeding

In case of need, 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 zero or insignificant.

3. How to Take Paracetamol Dermogen

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

The recommended dose is:

Adults and adolescents over 15 years old: 1 tablet 3-4 times a day, depending on the intensity of the symptoms. The doses should be spaced at least 4 hours apart.

Maximum dosage: do not exceed 3 g (4 tablets) in 24 hours.

This medication is not intended for children under 15 years old or weighing less than 50 kg. Ask your pharmacist.

Patient with liver disease: consult your doctor before taking this medication. They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.

Do not take more than 2 g of paracetamol (3 tablets) in 24 hours.

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

Patient with kidney disease: consult your doctor before taking this medication. In patients with moderate or severe renal insufficiency, the recommended dose is half a tablet (325 mg of paracetamol) every 6-8 hours, respectively.

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 divided in half. The tablet can be divided into equal doses.

Always use the lowest effective dose.

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

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

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, treatment should be discontinued and your doctor consulted.

If You Take More Paracetamol Than You Should

You should consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the package 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 have not noticed symptoms, as they often do not manifest 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 the overdose is more effective if started within 4 hours after ingestion of the medication.

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If You Forget to Take Paracetamol

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the following doses with the indicated separation between doses (at least 4 hours).

If You Stop Treatment with Paracetamol

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

4. Possible Side Effects

Like all medications, paracetamol can have side effects, although not everyone experiences 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
• cloudy urine
• allergic dermatitis (skin rash)
• jaundice (yellowing of the skin)
• blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia)
• hypoglycemia (low blood sugar).
• Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data)

• 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 in prolonged treatments.

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 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 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 package 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 packages and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Dermogen

• The active ingredient is paracetamol. Each tablet contains 650 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 Package Contents:

The tablets are oblong, biconvex, white, and scored

Paracetamol Dermogen is presented in oral tablets in packages of 20 and 40 tablets packaged in PVC-PVDC and aluminum blisters. It is also presented in packages of 20 tablets packaged in a white high-density polyethylene (HPDE) bottle with a white polypropylene (PP) cap.

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

O

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km.

Almodóvar del Río, 19

14720 Córdoba

Spain

O

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the 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/