Paracetamol Combix 500 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Combix 500 mg hard capsules EFG

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

• 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 adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen, do not improve, or if fever persists beyond 3 days or pain beyond 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 is effective in reducing pain and fever.

This medicine is used in adults and adolescents from 12 years of age (body weight above 33 kg) for the symptomatic relief of mild to moderate occasional pain and febrile conditions.

You should consult your doctor if your condition worsens or does not improve, or if fever persists for more than 3 days or pain for more than 5 days.

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).

Do not take more than the recommended dose indicated in section 3. How to take Paracetamol Combix, as serious liver damage may occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take paracetamol if:

• you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• you have kidney problems;
• you have glucose-6-phosphate dehydrogenase deficiency;
• you have anorexia, bulimia, cachexia, or chronic malnutrition;
• you are dehydrated or have hypovolemia;
• you are taking medication for epilepsy; you must consult your doctor before taking this medicine, as concomitant use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section);
• you have Gilbert's disease (also known as Meulengracht's disease);
• you have heart failure, respiratory failure, or anemia; in these cases, treatment should be administered under medical supervision and only for short periods;
• you have asthma and are sensitive to acetylsalicylic acid.

Paracetamol may cause severe skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and the medicine must be discontinued at the first sign of a skin rash or any other sign of hypersensitivity.

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, malaise (nausea), and vomiting.

The total daily dose of paracetamol must not exceed 3 g.

Chronic alcoholics should be careful not to exceed 2 grams of paracetamol in 24 hours.

Concomitant use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor. If an overdose occurs, seek medical attention immediately.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, your condition should be evaluated by your doctor. This medicine should not be used for self-treatment of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless directed by your doctor, as these situations may require medical evaluation and treatment.

Taking paracetamol doses higher than recommended poses a serious risk of severe liver injury. Medicines containing paracetamol should not be taken for more than a few days or in high doses unless directed by your doctor.

Prolonged use of analgesics or inappropriate use of high doses may cause headaches, which should not be treated with higher doses of the medicine (see "If you take more than you should").

Children and adolescents

Due to the amount of paracetamol it contains, this medicine must not be used in children (under 12 years of age or weighing less than 33 kg).

Other medicines and Paracetamol Combix

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• 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: colestyramine
• Medicines used to increase urine output (loop diuretics such as furosemide)
• Medicines used in the treatment of 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
• Salicylamide, a medicine used to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Zidovudine (used in the treatment of HIV infections)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap), which requires urgent treatment.

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 affect test results. Paracetamol may alter analytical results for uric acid and glucose.

Taking Paracetamol Combix with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

Paracetamol may be used during pregnancy if necessary. Use the lowest effective 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.

Breastfeeding

Paracetamol passes into breast milk. Therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Fertility

No harmful effects on fertility are known with normal use of paracetamol.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or none.

Paracetamol Combix contains carmoisine

It may cause allergic-type reactions.

3. How to take Paracetamol Combix

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adolescents aged 12 to 18 years (weighing 33–50 kg)

• Between 33 kg and 40 kg body weight: Take 1 capsule every 4–6 hours as needed, up to a maximum of 4 capsules per day.
• Between 41 kg and 50 kg body weight: Take 1 capsule every 4–6 hours as needed, up to a maximum of 5 capsules per day.

Adults (body weight over 50 kg)

Take 1 capsule every 4–6 hours as needed, up to a maximum of 6 capsules per day. Do not exceed 3 grams in 24 hours.

Patients with liver disease

Consult your doctor before taking this medicine.

They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

They should not take more than 2 grams (4 capsules) of paracetamol in 24 hours.

Patients with kidney disease

Consult your doctor before taking this medicine.

Patients with moderate to severe renal disease should take a maximum of 500 mg of paracetamol per dose. Depending on the severity of the condition, your doctor will advise whether you should take the medicine with a minimum interval of 6 or 8 hours.

Method of administration

The capsules are for oral use.

They should be swallowed with a glass of liquid, preferably water.

Always use the lowest effective dose.

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

This medicine should only be administered when pain or fever is present. As symptoms subside, treatment should be discontinued.

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

If you take more Paracetamol Combix than 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 an overdose has been ingested, seek immediate medical attention even if no symptoms are present, 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 of taking the medicine.

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

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), stating the name of the medicine and the amount ingested.

If you forget to take Paracetamol Combix

Do not take a double dose to make up for missed doses.

If you forget to take a dose, take it as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The adverse effects that may occur in adults and adolescents are:

Rare adverse effects: may affect up to 1 in 1,000 people:

• Malaise,
• hypotension (low blood pressure),
• increased levels of transaminases in the blood.

Very rare adverse effects: may affect up to 1 in 10,000 people:

• Kidney disorders,
• cloudy urine,
• allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome),
• jaundice (yellowing of the skin),
• blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia) and hypoglycaemia (low blood sugar).
• Very rarely, serious skin reactions have been reported. Bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

Frequency not known: cannot be estimated from the available data:

• Headache caused by analgesic overuse
• 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).

Stop taking this medicine and speak to a doctor immediately if:

• You experience allergic reactions such as skin rash or itching, sometimes with breathing difficulties or swelling of the lips, tongue, throat, or face.

• You develop a skin rash or peeling, or mouth ulcers.

• You have previously experienced breathing problems with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), and have a similar reaction with this medicine.

• You experience unexplained bruising or bleeding.

These reactions are rare.

Paracetamol can cause liver damage when taken in high doses or with prolonged use.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish System of Pharmacovigilance 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 in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Combix

• The active substance is paracetamol. Each capsule contains 500 mg of paracetamol.
• The other components (excipients) are: magnesium stearate.

The gelatin capsule is composed of: gelatin, carmoisine (E-122), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

This medicine is presented as hard capsules, with a transparent red cap and an opaque white body. The length of the capsule is approximately 21.4 mm and the width is approximately 7.6 mm.

The capsules are supplied in blisters packed in boxes of 24 capsules.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the most recent review of this 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/