PARACETAMOL COMBIX 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Combix 1 g Tablets EFG

Read this package leaflet carefully before starting to take this medicine because it contains important information for you.

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

This medicine can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used with caution.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• - You should consult your doctor if your symptoms worsen or do not improve after 3 days with fever or 5 days with pain.

Contents of the Package Leaflet

1. What is Paracetamol Combix and what is it used for
2. What you need to know before taking Paracetamol Combix
3. How to take Paracetamol Combix
4. Possible side effects
5. Storage of Paracetamol Combix
6. Contents of the pack and further information

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

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

This medicine is used for the symptomatic relief of mild or moderate pain and febrile states.

2. What you need to know before taking Paracetamol Combix

Do not take Paracetamol Combix

• If you are allergic to paracetamol or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Do not take more than the recommended dose of medicine indicated in section 3 of this package leaflet "How to take Paracetamol Combix". Check that you are not taking other medicines that contain paracetamol, such as pain, fever, cold, and flu medications. A higher dose than recommended does not increase pain relief and can cause severe liver damage. Symptoms of liver damage occur for the first time after a few days. If you have taken more paracetamol than recommended in this package leaflet, it is essential to consult your doctor as soon as possible.

In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

If you have liver, kidney, heart, or lung disease, or if you have anemia (decreased hemoglobin level in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medicine.

In chronic alcoholics, caution should be exercised not to take more than 2 g/day of paracetamol.

During treatment with Paracetamol Combix, inform your doctor immediately if:

If you have severe diseases, such as severe renal 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 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. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

This medicine should not be used in children or adolescents under 15 years of age or weighing less than 50 kg.

Use of Paracetamol Combix with other medicines:

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epileptic seizures)
• Diuretics (used to increase urine elimination)
• Isoniazid (used to treat tuberculosis)
• Lamotrigine (used to treat epilepsy)
• Probenecid (used to treat gout)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Colestyramine (used to decrease cholesterol levels in the blood)

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

Tell your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently.

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.

Interference with laboratory tests:

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

Paracetamol may increase uric acid and blood sugar levels.

Taking Paracetamol Combix with food, drinks, and alcohol:It is recommended not to consume alcohol during treatment with paracetamol due to the increased risk of liver damage.

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

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.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended to consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effects have been described that modify the ability to drive and use machines.

3. How to take Paracetamol Combix

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. Remember to take your medicine.

The recommended dose is:

• Adults and adolescents over 15 years: 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 3 tablets (3 g) in 24 hours.
• Patients with liver or kidney disease: should consult their doctor.
• Elderly patients: should consult their doctor.
• The tablets are scored, which allows the tablet to be divided into equal doses. The dose of half a tablet is equivalent to 500 mg of paracetamol.

This medicine should be taken orally.

According to your preferences, the tablets can be taken directly or broken in half with water, milk, or fruit juice. Consult your doctor or pharmacist if you have doubts.

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, you should discontinue treatment and consult your doctor.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Children and adolescents under 15 years should not take this medicine; consult your doctor or pharmacist, as there are other presentations with doses suitable for this group of patients.

If you take more Paracetamol Combix than you should

If you have taken more paracetamol than you should, consult your doctor, pharmacist, or the Toxicology Information Service, phone 915 620 420, immediately. If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after taking the overdose, even in cases of severe poisoning. Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patients being treated with barbiturates or who have chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Paracetamol Combix

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 time interval (at least 4 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Paracetamol Combix may cause the following side effects:

• Rare (up to 1 in 1000 people): discomfort, increased levels of liver transaminases, and low blood pressure.
• Very rare (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), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported. Paracetamol can damage the liver when taken in high doses or for prolonged treatment.
• Frequency not known (cannot be estimated from 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).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Website www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Combix

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Combix 1 g Tablets

The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

The other ingredients are: pregelatinized maize starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the product and packaging

Paracetamol Combix 1 g Tablets are oblong, white, and scored on both sides.

They are presented in packs of 10 tablets in aluminum-PVC-PVDC blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón

Madrid - Spain

Manufacturer

Toll Manufacturing Services S.L

C/ Aragoneses, 2. 28108 Alcobendas (Madrid)

Or

Rovi Pharma Industrial Services, S.A

Via Complutense, 140

Alcalá de Henares (Madrid)

28805 – Spain

Or

Pharmaloop, S.L.

C/ Bolivia, N° 15, Pol. Ind Azque,

Alcalá de Henares, 28806 Madrid

Spain

Date of the last revision of this package leaflet:February 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/