Patient Information Leaflet

Paracetamol/Codeine Farmalider 500 mg/30 mg Tablets EFG

Paracetamol/Codeine phosphate hemihydrate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Paracetamol/Codeine Farmalider and what is it used for

2.What you need to know before starting to take Paracetamol/Codeine Farmalider

3.How to take Paracetamol/Codeine Farmalider

4.Possible side effects

5.Storage of Paracetamol/Codeine Farmalider

6.Contents of the pack and additional information

Paracetamol/Codeína Farmalider is an association of paracetamol and codeine. Paracetamol is an analgesic and antipyretic (pain relief and fever reduction) medication of proven efficacy, whose effects are potentiated by the action of codeine, a central analgesic.

This medication can be used in adults and adolescents over 12 years old for the short-term treatment of moderate pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

Do not take Paracetamol/Codeína Farmalider:

-if you are allergic to paracetamol or propacetamol (paracetamol precursor), codeína, or any of the other components of this medication (listed in section 6).

-if you have respiratory depression, acute asthma, or chronic obstructive pulmonary disease.

-If you have or are at risk of developing paralytic ileus.

-To relieve pain in children and adolescents (0 – 18 years of age) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

-If you know you metabolize codeína very quickly to morphine.

-If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

-Do not take more than the recommended dose in Section 3 – “How to take Paracetamol/codeína Farmalider” to check if you are not taking other medications that contain paracetamol or codeína simultaneously.

-The simultaneous use of more than one medication that contains paracetamol may lead to intoxication.

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

-If you have any disease that affects your ability to breathe, have intracranial injuries, for example, due to a head injury, are asthmatic or have a history of asthma, and are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medication.

-If you have thyroid disease, prostate or urethral alterations (occurring with difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder diseases, you should consult your doctor before taking this medication.

-Paracetamol should be administered with caution in patients with chronic malnutrition or dehydration.

-The consumption of alcoholic beverages (three or more alcoholic beverages per day) may cause paracetamol to cause liver damage.

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

-Children:The codeína is indicated only for the treatment of moderate acute pain in children over 12 years old who do not relieve pain with other analgesics such as paracetamol or ibuprofen as a single analgesic. It should be used with caution in children over 12 years old who have compromised respiratory function or have undergone extensive surgery.

-If you are weak or are an elderly person, you should consult your doctor before taking this medication.

-Codeína is transformed into morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme that can affect people differently. In some people, morphine is not produced or is produced in very small quantities, and it will not provide sufficient pain relief. In other people, it is more likely that they will experience severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following adverse effects, you should stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.

-Codeína may inhibit peristalsis, worsening constipation in patients with chronic constipation.

-It is essential to use the smallest dose that relieves or controls pain and for the shortest possible period to relieve pain. Prolonged or excessive administration of codeína may cause dependence and/or tolerance, especially in people with a tendency to abuse and addiction. After prolonged treatment, you should interrupt administration gradually as indicated by your doctor.

-The prolonged or frequent use of analgesics to treat headaches may exacerbate symptoms, which should not be treated with higher doses of the medication.

-The benefit-risk balance during continued use should be reevaluated periodically by your doctor.

-If the pain persists for more than 3 days, worsens, or new symptoms appear, you should interrupt treatment and consult your doctor.

During treatment with Paracetamol/Codeína Farmalider, inform your doctor immediately if:

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 body 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. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

.Use in children and adolescents after surgery

Do not use codeína to relieve pain in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome

Use in children with respiratory problems

Do not recommend the use of codeína in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.

Other medications and paracetamol

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

Particularly, if you are using medications that contain any of the following active principles, as it may be necessary to modify the dose or interrupt treatment with any of them:

Paracetamol may interact with the following medications:

-Antibiotics (cloranfenicol)

-Anticoagulants (used to treat thromboembolic diseases)

-Oral contraceptives and estrogen treatments.

-Antiepileptics (used to treat epilepsy)

-Metoclopramide and domperidone (used to prevent nausea and vomiting)

-Activated charcoal, used to treat diarrhea or gas

-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, arrhythmias)

-Rifampicin (used to treat tuberculosis)

-Anticholinergics (used to relieve spasms or contractions of the stomach, intestines, and bladder).

-Zidovudine (used to treat HIV infections).

-Colestiramine (used to reduce blood cholesterol levels).

Do not use with other analgesics (medications that reduce pain) without consulting your doctor.

On the other hand, codeína may interact with the following medications:

-Nalbufina, buprenorfina, pentazocina (used to treat pain)

-Antidepressants (used to treat depression)

-Sedatives (used to treat depression, anxiety)

-Antihistamines H1 sedatives (used to treat allergies)

-Anxiolytics (used to treat anxiety)

-Hypnotics neuroléptics (used to treat insomnia)

-Clonidina and related (used to treat hypertension and migraine)

-Other morphine analgesics, barbiturates, benzodiazepines (used to treat pain)

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that must receive urgent treatment (see Section 2).

Interference with analytical tests:

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

Taking Paracetamol/Codeína Farmalider with food, drinks, and alcohol

The use of paracetamol in patients who consume alcohol regularly (three or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage. In addition, alcohol may potentiate the depressive effect of codeína.

Pregnancy and breastfeeding

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

Pregnancy

Do not administer Paracetamol/Codeína Farmalider during pregnancy and, if necessary, it should always be done under the supervision of your doctor, who will evaluate the possible risks and benefits of treatment. Do not exceed the recommended dose.

Breastfeeding

Do not take this medication during breastfeeding. Codeína and morphine pass into breast milk.

Driving and operating machinery

This medication contains codeína, which may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or operating machinery.

Alcohol may potentiate this effect, so do not consume alcoholic beverages during treatment.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the amount of medication to take and the duration of treatment based on the intensity and characteristics of the pain. If necessary, the dosage may be adjusted to half a tablet per dose.

The recommended dose is:

Adults and adolescents over 15 years:1 tablet every 6 hours. The maximum dose per dose will be 2 tablets and the maximum daily dose will be 8 tablets.

Adolescents (over 12 years) and weight over 50 kg:1 tablet every 6 hours. The maximum dose per dose will be 1 tablet,lthe maximum daily dose will be 4 tablets.

Adolescents (over 12 years) and weight over 40 kg:half (1/2) tablet every 4-6 hours. The maximum dose per dose will be 1 tablet,lthe maximum daily dose will be 3 tablets.

Children under 12 years:They should not take Paracetamol/ codeine Farmalider, dueto the risk of severe respiratory problems.

This medication should not be taken for more than 3 days. If the pain does not improve after 3 days, ask your doctor for advice.

Never exceed the maximum recommended dose.

Paracetamol/Codeine Farmalider should be taken orally. The ingestion of the tablets can be helped with a sip of water or another non-alcoholic liquid.

The administration of the preparation is subject to the appearance of painful or feverish symptoms. As these symptoms disappear, this medication should be discontinued.

Patients with liver disease:Before taking this medication, they must consult their doctor.

They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose. They should not take more than 2 grams of paracetamol in 24 hours (4 tablets), divided into several doses.

Patients with kidney disease:Before taking this medication, they must consult their doctor.

Depending on their disease, their doctor will indicate if they should take the medication with a minimum interval of 6 or 8 hours. They should not take more than 2 grams in 24 hours (4 tablets), divided into several doses, without exceeding 500 milligrams per dose.

Patients of advanced age:Before taking this medication, they must consult their doctor.

If they estimate that the action of Paracetamol/Codeine Farmalider is too strong or too weak, they should inform their doctor or pharmacist.

If you take more Paracetamol/Codeine Farmalider than you should

If you have taken more Paracetamol/Codeine Farmalider than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, telephone 915 620 420, indicating the medication and the amount ingested.

If a overdose has been taken, you should go to a medical center immediately, even if there are no symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe intoxication.

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

A paracetamol overdose is considered to be the ingestion of a single dose of more than 6 grams in adults (12 tablets of Paracetamol/Codeine Farmalider) and more than 100 milligrams per kilogram of weight in children (for a child of 20 kilograms, 4 tablets in a single dose).

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

The symptoms of a codeine overdose may be: initial excitement, anxiety, inability to fall asleep (insomnia) and subsequently in certain cases a feeling of sleepiness (somnolence), headache (cephalalgia), alterations in blood pressure, arrhythmias, dry mouth, skin eruptions, tachycardia, convulsions, gastrointestinal disturbances, nausea, vomiting and respiratory depression.

If you forgot to take Paracetamol/Codeine Farmalider

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as you remember and if your next dose is due soon, omit the missed dose and continue taking the medication at the usual time. If in doubt, consult your doctor or pharmacist.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The observed side effects are described below according to their frequency of presentation:

Very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (may affect up to 1 in 100 people), rare (may affect up to 1 in 1000 people), and very rare (may affect up to 1 in 10,000 people).

The following side effects have been observed caused by paracetamol:

Rare:Discomfort, increased levels of liver transaminases (liver enzymes), hypotension (decreased blood pressure),

Very rare:Allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), hepatotoxicity (liver toxicity), jaundice (yellow discoloration of the skin and mucous membranes), hypoglycemia (low blood glucose levels), thrombocytopenia (reduced platelet count in the blood), agranulocytosis, leukopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count), sterile pyuria (cloudy urine), adverse renal effects.

The following side effects have also been described caused by codeine:

Rare: Discomfort, drowsiness, constipation, and nausea.

Very rare:Allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), fever, yellow discoloration of the skin and eyes (jaundice), low blood glucose levels (hypoglycemia), blood abnormalities. Rarely, severe skin reactions have been reported.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included inwww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Paracetamol/Codeína Farmalider

• The active principles are paracetamol and hemihydrate phosphate of codeine. Each tablet contains 500 mg of paracetamol and 30 mg of codeine (hemihydrate phosphate).

• The other components (excipients) are: pregelatinized cornstarch, stearic acid, povidone, crospovidone, microcrystalline cellulose, vegetable origin magnesium stearate.

Appearance of the product and contents of the packaging

Each package contains 20 tablets. The medication is presented conditioned in PVC/PVDC-white opaque/Al blisters.

Holder of the marketing authorization and responsible for the manufacturing

Holder of the marketing authorization

FARMALIDER S.A.

C/ Aragoneses 15

28108 – Alcobendas (Madrid)

Responsible for the manufacturing

FARMALIDER S.A.

C/ Aragoneses 15

28108 – Alcobendas (Madrid)

or

TOLL MANUFACTURING SERVICES S.L..

C/ Aragoneses 2

28108 – Alcobendas (Madrid)

Revision date of this prospectus: March 2025

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