Paracetamol Pharma Combix 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Pharma Combix 650 mg tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

It is indicated for the treatment of symptoms of mild to moderate pain and fever. You should consult a doctor if your condition worsens or does not improve, pain after 5 days, or fever after 3 days.

2. What you need to know before taking Paracetamol Pharma Combix

Do not take Paracetamol Pharma Combix:

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

Warnings and precautions:

• Consult your doctor, pharmacist, or nurse before starting to take paracetamol.
• Do not take more than the recommended dose stated in section 3, How to take Paracetamol Pharma Combix.
• In asthmatic patients who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have kidney, liver, heart, or lung disease, or if you 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.
• If you are being treated with medications for epilepsy, 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, care should be taken not to exceed 3 tablets of 650 mg 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, you should consult your doctor and re-evaluate your clinical condition.

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

You have serious medical 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 circumstances 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 breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

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

Other medicines and Paracetamol Pharma 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 to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: (isoniazid, rifampicin)
• Medicines to treat 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 (medicines that relieve pain) 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 any other medicine. In patients taking oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Interference with laboratory tests:

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

Taking Paracetamol Pharma Combix with food, drinks, and alcohol:

The use of 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

Consult your doctor or pharmacist before using any medicine.

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

If necessary, Paracetamol Pharma Combix may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever does not subside or if you need to take the medicine more frequently.

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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.

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

3. How to take Paracetamol Pharma Combix

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Paracetamol should be taken orally.

The recommended dose is:

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

Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.

Do not take more than 3 tablets of 650 mg paracetamol in 24 hours.

Patients with kidney disease: Before taking this medicine, you must consult your doctor. Take a maximum of 500 milligrams per dose.

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

Elderly patients: You should consult your doctor.

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

If you think the effect of Paracetamol is too strong or too weak, inform your doctor or pharmacist. When doses lower than 650 milligrams of paracetamol per dose are required, other paracetamol formulations suitable for the required dosage should be used.

If you take more Paracetamol Pharma Combix than you should:

You should contact 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 center 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 for overdose is most effective if started within 4 hours after 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, consult your doctor or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Paracetamol Pharma Combix:

Do not take a double dose to make up for forgotten doses. Simply take the missed dose as soon as you remember, 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 will experience them.

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

Very rare adverse effects (occurring in up to 1 in 10,000 people) are: 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 cause liver damage when taken at high doses or during prolonged treatment.

Adverse effects with unknown frequency (cannot be estimated from available data) are: a serious illness 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 can 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 Pharma Combix

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

This medicine does not require any special storage conditions.

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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Pharma Combix:

Each tablet contains 650 mg of paracetamol as the active substance.

The other components (excipients) are sodium carboxymethyl starch from potato (Type A), pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and contents of the pack:

Paracetamol Pharma Combix is presented as tablets for oral administration.

The tablets are oblong, biconvex, white in colour, with a score on one side and marked "PB" on the other side.

Available in packs of 20 and 40 tablets, and hospital pack of 500 tablets, packaged in PVC/PVdC/Aluminum 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

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona

Spain

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

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