PARACETAMOL CODRAMOL 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Codramol 1 g Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Paracetamol Codramol and what is it used for
2. What you need to know before taking Paracetamol Codramol
3. How to take Paracetamol Codramol
4. Possible side effects
5. Storage of Paracetamol Codramol
6. Package Contents and Additional Information

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

Paracetamol belongs to the group of medications called analgesics and antipyretics.

This medication is used for the symptomatic treatment of moderate pain and fever in adults and adolescents over 15 years of age and weighing more than 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 components of this medication (listed in section 6).

Warnings and Precautions

Do not take more than the recommended dose in section 3 or as indicated by your doctor. Do not take other medications that contain paracetamol at the same time.

Consult your doctor or pharmacist before starting to take this medication.

• If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells).
• If you suffer from chronic malnutrition or are dehydrated.
• If you are asthmatic and sensitive to acetylsalicylic acid.

• When you are being treated with any medication for epilepsy, as the efficacy of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.
• In chronic alcoholics, caution should be exercised not to take more than 2 g of paracetamol in 24 hours.

During treatment with Paracetamol Codramol, inform your doctor immediately 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 malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should consult your doctor and reassess the clinical situation.

Children and Adolescents

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Other Medications and Paracetamol Codramol

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Paracetamol may interact with the following medications:

• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.

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

Inform your doctor or pharmacist if you are taking:

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

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 can be administered occasionally as the analgesic of choice.

Interference with Analytical Tests:

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

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

Taking Paracetamol Codramol with Food and Drinks:

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

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

In case of necessity, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

3. How to Take Paracetamol Codramol

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

This medication should be taken orally.

According to your preferences, the tablets can be swallowed directly or broken in half, with the help of a glass of liquid, preferably water. The tablets are scored, which allows them to be broken in half to facilitate swallowing.

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

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, you can take 1 tablet every 6-8 hours, up to 4 times a day. Do not take more than 4 tablets in 24 hours, spaced out in several doses, at intervals of at least 4 hours.

Patients with liver disease: They should take the amount of medication prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 2 grams of paracetamol in 24 hours, spaced out in 2 doses.

Patients with kidney disease: They should reduce the dose of paracetamol, their doctor will indicate the appropriate dose.

Due to the dose, 1 gram of paracetamol, the medication should not be used in patients with severe or moderate 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 think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol are required, other presentations of paracetamol should be used.

If You Take More Paracetamol Codramol Than You Should

You should consult 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), indicating the medication and the amount ingested.

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

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

Treatment of overdose is more effective if started within 4 hours of ingestion of the medication.

Patients being treated with barbiturates or 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 forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the indicated interval in each case (at least 4 hours).

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Rare side effects that may occur (in up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Paracetamol may damage the liver when taken in high doses or for prolonged periods. Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Codramol

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging (after EXP.). The expiration date is the last day of the month indicated.

“Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.”

6. Package Contents and Additional Information

Composition of Paracetamol Codramol

• The active ingredient is paracetamol. Each tablet contains 1 gram of paracetamol.
• The other components are: pregelatinized cornstarch, stearic acid, povidone K-30, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

Oblong tablets, white in color, and scored on one side, packaged in aluminum-PVC-PVDC blisters and presented in packages of 20 and 40 tablets.

Only some package 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 Last Revision of this Package Leaflet: March 2025

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”