Paracetamol Pharma Combix 1 g tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Pharma Combix 1 g tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Paracetamol Pharma Combix 1 g tablets are and what they are used for
2. Before taking Paracetamol Pharma Combix 1 g tablets
3. How to take Paracetamol Pharma Combix 1 g tablets
4. Possible side effects
5. How to store Paracetamol Pharma Combix 1 g tablets
6. Further information

1. What Paracetamol Pharma Combix 1 g tablets are and what they are used for

Paracetamol Pharma Combix 1 g tablets belong to the group of medicines known as analgesics and antipyretics.

Paracetamol Pharma Combix 1 g tablets are indicated for the symptomatic treatment of moderate-intensity pain of any cause, such as: postoperative and postpartum pain, rheumatic pain (osteoarthritis and rheumatoid arthritis), lumbago, torticollis, sciatica, neuralgias, back pain, muscle pain, menstrual pain, headache, and dental pain. Also indicated for febrile conditions.

2. Before taking Paracetamol Pharma Combix 1 g tablets

Do not take Paracetamol Pharma Combix 1 g tablets:

• If you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of Paracetamol Pharma Combix 1 g tablets

Take special care with Paracetamol Pharma Combix 1 g tablets:

Do not exceed the recommended dose.

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

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

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

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

You have serious conditions such as severe renal impairment 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, feeling unwell (nausea), and vomiting.

Use with other medicines:

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to treat thromboembolic disorders)
• 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 lower blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (known as metabolic acidosis with high anion gap), which must be urgently treated.

Do not use with other analgesics (medicines that reduce 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 being treated with another medicine. In patients treated with oral anticoagulants, paracetamol may occasionally be used 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 such tests.

Taking Paracetamol Pharma Combix 1 g tablets with food and drinks:

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day—beer, wine, spirits, etc.) may cause liver damage.

Pregnancy

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 can be harmful to the embryo or fetus and should be monitored by your doctor.

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 time. Contact your doctor or midwife if pain or fever does not improve or if you need to take the medicine more frequently.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

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 use of machines

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

3. How to take Paracetamol Pharma Combix 1 g tablets

Follow these instructions unless your doctor has given you different advice.

Remember to take your medicine. Paracetamol Pharma Combix 1 g tablets are for oral use. Depending on your preference, the tablets can be taken whole or split in half with water, milk, or fruit juice. Consult your doctor or pharmacist if you have any doubts. The usual dose is:

Adults and children over 15 years of age: The usual dose is 1 tablet (1 g of paracetamol) 3 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.

If pain persists for more than 5 days, or if pain worsens or new symptoms appear, consult your doctor and the clinical situation should be re-evaluated.

If you feel that the effect of Paracetamol Pharma Combix 1 g tablets is too strong or too weak, inform your doctor or pharmacist.

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

If you take more Paracetamol Pharma Combix 1 g tablets than you should:

If you have taken more Paracetamol Pharma Combix 1 g tablets than you should, contact your doctor, pharmacist, or the Toxicology Information Service immediately, telephone 91 562 04 20. If you have taken an overdose, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until after three days following 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 undergoing treatment with barbiturates or who suffer from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Paracetamol Pharma Combix 1 g tablets:

Do not take a double dose to make up for the missed dose. 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, Paracetamol Pharma Combix 1 g tablets may produce adverse effects, although not everyone experiences them.

Paracetamol Pharma Combix 1 g tablets may cause the following adverse effects:

• Rare (between 1 and 10 in every 10,000 patients): malaise, increased levels of liver transaminase enzymes, and low blood pressure.
• Very rare (in less than 1 in every 10,000 patients): allergic reactions (such as skin rashes), low glucose levels, blood disorders, jaundice (yellowing of the skin), kidney disturbances, cloudy urine.
• 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 are using paracetamol (see section 2).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Very rare cases of serious skin reactions have been reported.

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 through 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 1 g tablets

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use Paracetamol Pharma Combix 1 g tablets after the expiry date stated on the container (after EXP.). The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Information for the user

Composition of Paracetamol Pharma Combix 1 g tablets

The active substance is paracetamol.

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

Appearance of the medicinal product and contents of the pack

Paracetamol Pharma Combix 1 g tablets are presented as oral tablets, available in packs of 20 and 40 tablets. The tablets are scored, allowing them to be divided into equal doses. The dose of half a tablet corresponds to 500 mg.

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), Spain

or

Ferrer Internacional, S.A.
Joan Buscallá, 1-9
08173 Sant Cugat del Valles, Spain

or

Farmalíder, S.A.
C/ Aragoneses, 2
28108 Alcobendas (Madrid), Spain

This leaflet was approved in February 2025

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