Package Insert: Information for the User

Paracetamol Combix 500 mg Hard Capsules EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

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

Paracetamol is effective in reducing pain and fever.

This medication is used in adults and adolescents 12 years and older (body weight over 33 kg) for symptomatic relief of occasional mild or moderate pain andfebrile states.

You should consult your doctor if it worsens or does not improve or if the fever persists after 3 days or the pain for 5 days.

Do not take Paracetamol Combix

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

Do not take more of the medication than recommended in the section3. How to take Paracetamol Combix, as it may cause severe liver damage.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 deficiency of glucose-6-phosphate dehydrogenase;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you are dehydrated or hypovolemic;
• if you are taking an antiepileptic medication, consult your doctor before taking this medication, as it may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially in high-dose treatments (see below in this section);
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart, respiratory, or anemia insufficiency; in these situations, administration should be carried out under close supervision 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. Inform patients about the signs of severe skin reactions and discontinue the use of the medication at the first sign of skin rash or any other sign of hypersensitivity.

During treatment with Paracetamol Combix, immediately inform your doctor 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 (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 respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

The total dose of paracetamol should not exceed 3 g per day.

Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.

Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.If an overdose occurs, seek medical attention immediately.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or new symptoms appear, the clinical situation should be evaluated by your doctor. This medication should not be used for self-medication of high fever (above 39°C), prolonged fever, or recurrent fever, unless your doctor indicates it, as these situations may require medical evaluation and treatment.

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

Prolonged use of analgesics or the use of high doses may cause headaches, which should not be treated with higher doses of the medication, consult "If you take more than you should").

Children and adolescents

Due to the amount of paracetamol it contains, children (under 12 years old or weighing less than 33 kg) cannot take this medication.

Other medications and Paracetamol Combix

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

In particular, 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 to treat epilepsy: antiepileptics (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 lower cholesterol levels in the blood: cholestyramine
• Medications used to increase urine elimination (diuretics of the loop, such as the furosemide group)
• Medications used to treat gout: probenecid and sulfinpyrazone
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): propranolol
• Salicylamide, a medication to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Zidovudine (used to treat HIV infections).
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that must be treated urgently.

Interference with analytical tests

If you are to undergo any analytical test (including blood and urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.Paracetamol may alter the values of uric acid and glucose determinations.

Paracetamol Combix with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

The taking of this medication with food does not affect its efficacy.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Paracetamol can be used during pregnancy if necessary. 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 do not decrease or if you need to take the medication more frequently.

Lactation

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

Fertility

No adverse effects on fertility have been reported with the normal use of paracetamol.

Driving and operating machinery

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

Paracetamol Combix contains carmoisine

It may cause allergic reactions.

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

The recommended dose is:

Adolescents 12 years to 18 years (33 – 50 kg)

• Between 33kg and 40kg of weight: Take 1 capsule every 4-6 hours, as needed, up to amaximum of 4 capsules per day.
• Between 41kg and 50 kg of weight: Take 1 capsule every 4-6 hours, as needed, up to amaximum of 5 capsules per day.

Adults (body weight over 50 kg)

Take 1 capsule, if necessary, every 4-6 hours, as needed, up to amaximum of 6 capsules per day.Do not take more than 3 grams in 24 hours.

Patients with liver diseases

Consult your doctor before taking this medication.

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

They should not take more than 2 grams (4 capsules) of paracetamol in 24 hours.

Patients with kidney diseases

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.Your doctor will indicate if you should take your medication with a minimum interval of 6 or 8 hours, depending on your disease.

Administration form

The capsules are administered orally.

They should be swallowed with a glass of liquid, preferably water.

Always use the lowest effective dose.

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

The administration of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, treatment should be interrupted and your doctor consulted.

If you take more Paracetamol Combix than you should

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

If an overdose has been ingested, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe intoxication.

The treatment of an overdose is more effective if initiated within 4 hours of medication ingestion.

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, go to a medical center 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 Combix

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

If you forgot to take a dose, take the missed dose as soon as you remember, taking the next doses with the indicated interval (at least 4 hours).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects that can occur in adults and adolescents are:

Rare side effects: can affect up to 1 in 1,000 people:

• Discomfort,
• hypotension (low blood pressure),
• increased levels of transaminases in the blood.

Very rare side effects: can affect up to 1 in 10,000 people:

• Kidney diseases,
• cloudy urine,
• allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome),
• jaundice (yellow discoloration of the skin),
• blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).
• Severe skin reactions have been reported very rarely. Bronchospasm in patients allergic to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs).

Unknown frequency: cannot be estimated with the available data:

• Headache induced by analgesic abuse
• A severe disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Stop taking this medicine and talk to a doctor immediately if:

-You experience allergic reactions such as skin rash or itching, sometimes with breathing problems or swelling of the lips, tongue, throat, or face.

-You suffer from a skin rash or peeling, or ulcers in the mouth.

-You have previously experienced breathing problems with aspirin or NSAIDs, and experience a similar reaction with this medicine.

-You experience bruising or bleeding without explanation.

These reactions are rare.

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

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects that do not appear in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Combix

• The active ingredient is paracetamol. Each capsule contains 500 mg of paracetamol.
• The other components (excipients) are: magnesium stearate.

The gelatin capsule is composed of: gelatin, carmoisina (E-122) and dióxido de titanio (E-171).

Appearance of the product and contents of the packaging

This medicine is presented in the form of hard capsules, with a red transparent cap and a white opaque body. The length of the capsule is approximately 21.4 mm and the width is approximately 7.6 mm.

The capsules are presented in blisters packaged in boxes of 24 capsules.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Last review date of this leaflet: February 2025

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