PATIENT INFORMATION LEAFLET

Paracetamol Pharma Combix1 gfilm-coated tablets

Read this leaflet carefully before you start to take 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

2.Before you take Paracetamol Pharma Combix 1 g film-coated tablets

3.How to take Paracetamol Pharma Combix 1 g film-coated tablets

4.Possible side effects

5.Storage of Paracetamol Pharma Combix 1 g film-coated tablets

6.Further information

Paracetamol Pharma Combix1 gtablets belong to a group of medicines called analgesics and antipyretics.

Paracetamol Pharma Combix1 gtablets are indicated for the symptomatic treatment of moderate intensity pain of any cause,such as: postoperative pain and postpartum pain, rheumatic pains (osteoarthritis and rheumatoid arthritis), lumbago, torticollis, sciatica, neuralgias, back pain, muscle pains, menstrual pains, headache, and toothache. Feverish states

Do not take Paracetamol Pharma Combix1 gtablets:

• If you are allergic (hypersensitive) to paracetamol or to any of the other components of Paracetamol Pharma Combix1 gtablets

Be especially careful with Paracetamol Pharma Combix1 gtablets:

Do not take more than the recommended dose.

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

If you have kidney, heart, or lung disease, or have anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medication.

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

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

You have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Use of other medications:

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

Paracetamol may interact with the following medications:

• Oral anticoagulants (used for the treatment of thromboembolic diseases)
• Antiepileptics (used for the treatment of epileptic seizures)
• Diuretics (used to increase urine elimination)
• Isoniazid (used for the treatment of tuberculosis)
• Lamotrigine (used for the treatment of epilepsy)
• Probenecid (used for the treatment of gout)
• Propanolol (used for the treatment of hypertension, cardiac arrhythmias)
• Rifampicin (used for the treatment of tuberculosis)
• Colestiramine (used to reduce blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (called metabolic acidosis with high anionic imbalance) that must be treated urgently.

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

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it may be occasionally administered as the preferred analgesic.

Interference with analytical tests:

If you are to undergo any analytical test (including blood and urine tests, etc...) inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Paracetamol Pharma Combix1 gtablets with food and drinks:

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

Pregnancy

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus, and should be monitored by your doctor.

In case of need, Paracetamol Pharma Combix may be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not decrease or if you need to take the medication more frequently.

Lactation

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

No effects have been described that modify the ability to drive and operate machinery.

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

Remember to take your medication. Paracetamol Pharma Combix1 gtablets should be taken orally. According to your preference, the tablets can be swallowed whole or broken 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 old: the usual dose is 1 tablet (1 gof 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

Older patients: should consult their doctor

If the pain persists for more than 5 days, or if the pain worsens or other symptoms appear, consult the doctor and reevaluate the clinical situation.

If it is estimated that the action ofParacetamol Pharma Combix1 gtabletsis too strong or too weak, inform your doctor or pharmacist.

For children under 15 years old, consult your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.

If you take moreParacetamol Pharma Combix1 gtabletsthan you should:

If you have taken Paracetamol Pharma Combix1 gtablets more than you should, consult your doctor, pharmacist, or the Toxicological Information Service immediately, telephone 91 562 04 20. If you have taken an overdose, go to a medical center immediately, even if you do not have symptoms, as symptoms may not appear until three days after taking the overdose, even in cases of severe poisoning. The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forgot to takeParacetamol Pharma Combix1 gtablets:

Do not take a double dose to make up for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours).

Like all medications, Paracetamol Pharma Combix1 gtabletscan produce adverse effects, although not everyone will experience them.

Paracetamol Pharma Combix1 gtablets can produce the following adverse effects:

- Rare (between 1 and 10 in every 10,000 patients): discomfort, elevated levels of liver enzymes, and decreased blood pressure.

- Very rare (in fewer than 1 in every 10,000 patients): allergic reactions (such as skin rashes), decreased glucose, blood disorders, jaundice (yellow discoloration of the skin), kidney alterations, cloudy urine.

- Unknown frequency (cannot be estimated from available data): A severe disease that can cause blood to become more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

There have been very rare cases of severe skin reactions reported.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

This medication does not require special storage conditions.

Do not use Paracetamol Pharma Combix 1 g tablets after the expiration date appearing on the packaging (after CAD.). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Composition ofParacetamol Pharma Combix1 gtablets

The active ingredient is paracetamol.

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

Appearance of the product and contents of the package

Paracetamol Pharma Combix1 gtabletsare presented in the form of oral tablets, in packages of 20 and 40 tablets.The tablets are scored, allowing the tablet to be divided into equal doses. The dose of half the tablet is equivalent to 500 mg

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Combix Laboratories, S.L.U.

C/ Badajoz 2. Building 2

28223 Pozuelo de Alarcón (Madrid), Spain

Responsible for manufacturing:

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 prospectus was approved in February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/