Paracetamol Combix 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Combix 650 mg tablets EFG

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.

This medicine is available without 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 need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if fever persists for more than 3 days of treatment, or if pain lasts for more than 5 days.

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 adverse 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.

Paracetamol is used for the treatment of mild to moderate pain and febrile conditions in adults and adolescents aged 15 years and older (or with a body weight over 50 kg).

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 ingredients of this medicine (listed in section 6).

Take special care with Paracetamol Combix:

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol Combix.

• Avoid taking this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

  • If you are an asthmatic patient sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
  • If you have liver, kidney, heart, or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
  • If you are being treated with antiepileptic medicines, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
  • In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol in 24 hours.
  • If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and reassess the clinical situation.

• For children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for this patient group are available.

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 under these conditions 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, malaise (nausea), and vomiting.

Other medicines and Paracetamol Combix:

Inform 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:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: (isoniazid, rifampicin)
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine output (loop diuretics such as furosemide)
• Medicines used to treat gout: (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

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

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

Interference with laboratory tests

If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Combix with food, drinks, and alcohol

Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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

If necessary, this medicine 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 if pain or fever does 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

The effect of paracetamol on the ability to drive and operate machinery is negligible or none.

Excipients

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially “sodium-free.”

3. How to take Paracetamol Combix

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. Paracetamol is to be taken orally.

The usual dose is:

Adults and adolescents over 15 years of age: the usual dose is 1 tablet (650 mg paracetamol) every 4–6 hours. Doses should be spaced at least 4 hours apart. Do not take more than 3 grams (4 tablets) in 24 hours.

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

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be discontinued and a doctor consulted.

Patients with liver disease: must consult their doctor before taking this medicine. They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses. They must not take more than 3 tablets of 650 mg paracetamol in 24 hours.

Patients with kidney disease: must consult their doctor before taking this medicine. Take a maximum of 500 mg per dose.

Due to the dosage (650 mg paracetamol), this medicine is not indicated for this patient group.

Elderly patients: should consult their doctor.

Use in children and adolescents: Do not use in children and adolescents under 15 years of age.

If you consider the effect of this paracetamol to be too strong or too weak, inform your doctor or pharmacist.

When lower doses than 650 mg paracetamol per dose are required, other paracetamol formulations appropriate for the required dosage should be used.

If you take more Paracetamol Combix than you should:

You should consult your doctor or pharmacist immediately. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have ingested an overdose, you must go immediately to a medical centre even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Paracetamol Combix

Do not take a double dose to make up for forgotten doses. Simply take the missed dose as soon as you remember, and take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

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

Rare adverse effects (may affect up to 1 in 1,000 people): malaise, hypotension (low blood pressure), and increased blood transaminase levels.

Very rare adverse effects (may affect 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 severe skin reactions have been reported.

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

Adverse effects of unknown frequency (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 Medicines: https://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 this medicine out of the sight and reach of children.

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Combix

The active substance is paracetamol. Each tablet contains 650 milligrams of paracetamol.

The other components (excipients) are sodium starch glycolate from potato (Type A), purified water, pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and contents of the pack

Paracetamol Combix is presented as tablets for oral administration.

The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PB" on the other side. The tablet can be divided into two equal parts.

The packs contain 20 tablets, packed in PVC/PVDC/Aluminium blisters.

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950,

Barcelona –
Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid –
Spain

Date of the most recent review of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/