Paracetamol Codramol 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Codramol 1 g tablets EFG

Read the entire 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 have any questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only, and you should not give it 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Paracetamol Codramol is and what it is used for

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

This medicine is used for the symptomatic treatment of moderate pain and fever in adults and adolescents aged 15 years and older, weighing over 50 kg.

2. What you need to know before taking Paracetamol Codramol

Do not take Paracetamol Codramol

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

Warnings and precautions

Do not take more than the recommended dose indicated in section 3 or as prescribed by your doctor. Do not take other medicines containing paracetamol at the same time.

Consult your doctor or pharmacist before starting to take this medicine:

• If you have liver, 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).

• If you suffer from chronic malnutrition or are dehydrated.

• If you are asthmatic and sensitive to acetylsalicylic acid.

• If you are taking antiepileptic medications, as the concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.

• In chronic alcoholics, caution is required not to exceed 2 g of paracetamol in 24 hours.

During treatment with Paracetamol Codramol, 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 have 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 in breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

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 re-evaluate your clinical condition.

Children and adolescents

For 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 Codramol

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 elimination (loop diuretics such as furosemide group)
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.

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

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking other medicines. In patients on oral anticoagulants, paracetamol may occasionally be used 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 these tests.

Paracetamol may alter the analytical values of uric acid and glucose.

Taking Paracetamol Codramol with food and drink:

The use of paracetamol in patients who regularly consume alcohol (three 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.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

If necessary, paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever 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.

Driving and using machines

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

3. How to take Paracetamol Codramol

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

This medicine is for oral use.

The tablets may be taken whole or split in half, according to your preference, with a glass of liquid, preferably water. The tablets are scored, which allows them to be split in half to facilitate swallowing.

Consult your doctor or pharmacist if you have any doubts.

Recommended dose:

Adults and adolescents over 15 years of age (and weighing more than 50 kg): The recommended dose is 1 tablet (1 g of paracetamol) 3 times a day. Do not exceed 1 gram per dose. If necessary, 1 tablet may be taken every 6–8 hours, up to 4 times a day. Do not exceed 4 tablets in 24 hours, administered in divided doses at intervals of at least 4 hours.

Patients with liver disease: Should take the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Should reduce the dose of paracetamol. Your doctor will advise you on the appropriate dose.

Due to the dosage (1 gram of paracetamol), this medicine should not be used in patients with moderate or severe kidney disease.

Elderly patients: Should consult their doctor.

Use in children

Do not use in children or adolescents under 15 years of age.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When lower doses than 1 g of paracetamol per dose are required, other paracetamol formulations should be used.

If you take more Paracetamol Codramol than you should

Contact your doctor or pharmacist immediately. 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 have taken an overdose, you should 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.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Codramol

Do not take a double dose to make up for a 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, this medicine can cause adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, drop in 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).

Paracetamol can cause liver damage when taken at high doses or during prolonged treatment. Very rare cases of serious skin reactions have been reported.

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).

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Codramol

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 refers to the last day of the month indicated.

“Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point* at your pharmacy. If you have any doubts, 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 Codramol

• The active substance is paracetamol. Each tablet contains 1 gram of paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the medicine and contents of the pack

Oblong, white tablets, scored on one side, packed in aluminum-PVC-PVDC blisters and available in pack sizes of 20 and 40 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER S.A.

C/ La Granja, 1, 28108 Alcobendas,

Madrid.

Manufacturer

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

“or”

Frosst Iberica, S.A.

Vía Complutense, 140

28805 Alcalá de Henares – Madrid

Spain

“or”

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

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

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