Paracetamol Combix 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Combix 1 g tablets EFG

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as given by your doctor or pharmacist.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used carefully.

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

Contents of the leaflet

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

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

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

This medicine is used for the symptomatic relief of mild to moderate pain and feverish conditions.

2. What you need to know before taking Paracetamol Combix

Do not take Paracetamol Combix

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

Warnings and precautions

Do not take more medicine than recommended in section 3 of this leaflet, “How to take Paracetamol Combix”. Check that you are not simultaneously taking other medicines containing paracetamol, such as medicines used to treat pain, fever, cold symptoms, or flu-like conditions. Taking more than the recommended dose will not increase pain relief and may cause severe liver damage. Symptoms of liver damage may not appear until several days later. If you have taken more paracetamol than indicated in this leaflet, it is important to consult your doctor as soon as possible.

In asthmatic patients who are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medicine.

If you have liver, kidney, heart or lung disease, or have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.

In chronic alcoholics, care should be taken not to exceed 2 g/day of paracetamol.

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

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

This medicine must 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, have recently used, or might need to use any other medicines.

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to treat thromboembolic disorders)
• Antiepileptic drugs (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)
• Cholestyramine (used to lower blood cholesterol levels)

Do not use with other analgesics (medicines that reduce pain) without consulting your doctor.

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (known as metabolic acidosis with high anion gap), which must be treated urgently.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are receiving treatment with another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Interference with laboratory tests:

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

Paracetamol may increase blood levels of uric acid and glucose.

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 drinks per day—beer, wine, spirits) may cause liver damage.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

If necessary, paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not improve or if you need to take the medicine more frequently.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

3. How to take Paracetamol Combix

Follow exactly the dosing instructions for the medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Remember to take your medicine as prescribed.

The recommended dose is:

• Adults and adolescents over 15 years of age: the usual dose is 1 tablet (1 g of paracetamol) three times a day. 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, allowing them to be divided into equal doses. Half a tablet corresponds to 500 mg of paracetamol.

This medicine is for oral use.

The tablets may be taken whole or split in half with water, milk, or fruit juice, according to your preference. Consult your doctor or pharmacist if you have any doubts.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you should stop treatment and consult your doctor.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Children and adolescents under 15 years of age should not take this medicine. Consult your doctor or pharmacist, as other formulations with appropriate doses for this patient group are available.

If you take more Paracetamol Combix than you should

If you have taken more paracetamol than recommended, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 915 620 420. If you have taken an overdose, you must go immediately to a medical center even if you have no symptoms, as symptoms often do not appear until after three days, 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 for overdose is most effective when started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or those suffering from 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 missed doses. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Paracetamol Combix may cause the following adverse effects:

• Rare (up to 1 in 1,000 people): malaise, increased levels of liver transaminase enzymes, and hypotension.
• Very rare (up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of serious skin reactions have been reported. Paracetamol may damage the liver when taken in high doses or during prolonged treatment.
• Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Combix

Keep out of the 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Combix 1 g tablets

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

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

Appearance of the medicine and contents of the pack

Paracetamol Combix 1 g tablets are oblong, white tablets, 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, No. 15, Pol. Ind Azque,
Alcalá de Henares, 28806 Madrid
Spain

Date of the most recent revision of the leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/