PARACETAMOL/CODEINE FARMALIDER 500 mg/30 mg TABLETS

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

Do not take Paracetamol/Codeine Farmalider:

• if you are allergic to paracetamol or propacetamol (paracetamol precursor), codeine, 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 paralytic ileus.
• To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you know you metabolize codeine to morphine very quickly
• 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/Codeine Farmalider" for this purpose, check that you are not using other medications that contain paracetamol or codeine at the same time.
• Taking more than one medication that contains paracetamol at the same time can lead to poisoning.
• If you have any liver, kidney, heart, or lung disease, or have anemia (decrease in hemoglobin levels in the blood due to or not due to a decrease in 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 (e.g., due to a head injury), are asthmatic, or have a history of asthma, and are also sensitive to acetylsalicylic acid, you should consult your doctor before taking this medication.
• If you have any thyroid disease, prostate or urethra disorders (which can cause difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder disorders, you should consult your doctor before taking this medication.
• Paracetamol should be administered with caution in patients with chronic malnutrition or dehydration.
• Consuming alcoholic beverages (three or more alcoholic beverages per day) can cause paracetamol to damage the liver.
• In chronic alcoholics, paracetamol should not be taken in doses exceeding 2 g/day.
• Children: Codeine is indicated only for the treatment of acute moderate pain in children over 12 years old who do not respond to other analgesics such as paracetamol or ibuprofen as the sole 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 elderly, you should consult your doctor before taking this medication.
• Codeine is converted to morphine in the liver by an enzyme. Morphine is the substance that provides pain relief. Some people have a variation of this enzyme that can affect people in different ways. In some people, morphine is not produced or is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to experience severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following side effects, you should stop taking this medication and seek immediate medical attention: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.
• Codeine can inhibit peristalsis, worsening constipation in patients with chronic constipation.
• It is essential to use the smallest dose that relieves/controls the pain and for the shortest possible period for pain relief. Prolonged or excessive administration of codeine can lead to dependence and/or tolerance, especially in people with a tendency to abuse and addiction. After prolonged treatments, the administration should be gradually discontinued as indicated by your doctor.
• Prolonged or frequent use of analgesics to treat headaches can worsen symptoms, which should not be treated with higher doses of the medication.
• The benefit/risk balance during continued use should be periodically reevaluated by the doctor.
• If the pain persists for more than 3 days, or worsens, or other symptoms appear, treatment should be discontinued, and a doctor should be consulted.

During treatment with Paracetamol/Codeine 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 organ damage), 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and Adolescents

Use in children and adolescents after surgery

Codeine should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

Codeine is not recommended for use in children with respiratory problems, as the symptoms of morphine toxicity can be worse in these children.

Other Medications and Paracetamol

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

In particular, if you are using medications that contain any of the following active ingredients, it may be necessary to modify the dose or discontinue treatment of either of them:

Paracetamolmay interact with the following medications:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic diseases)
• Oral contraceptives and estrogen treatments.
• Antiepileptics (used to treat epileptic seizures)
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Activated charcoal, used for diarrhea or gas treatment
• 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, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergics (used to relieve stomach, intestine, and bladder spasms or contractions).
• Zidovudine (used to treat HIV infections).
• Colestyramine (used to decrease blood cholesterol levels).

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

On the other hand, codeinemay interact with the following medications:

• Nalbuphine, buprenorphine, pentazocine (used to treat pain).
• Antidepressants (used to treat depression).
• Sedatives (used to treat depression, anxiety).
• Sedating antihistamines H1 (used to treat allergies).
• Anxiolytics (used to treat anxiety).
• Hypnotic neuroleptics (used to treat insomnia).
• Clonidine and related medications (used to treat hypertension and migraine)
• Other morphinic analgesics, barbiturates, benzodiazepines (used to treat pain).

Tell your doctor or pharmacist if you are taking:

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

Interference with Analytical Tests:

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

Taking Paracetamol/Codeine Farmalider with Food, Beverages, and Alcohol

Taking paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor...) can cause liver damage. Additionally, alcohol can enhance the depressive effect of codeine.

Pregnancy and Breastfeeding

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

Pregnancy

Paracetamol/Codeine Farmalider is not recommended during pregnancy and, if necessary, should only be used under the supervision of your doctor, who will assess the potential risks and benefits of treatment. Never exceed the recommended dose.

Breastfeeding

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

Driving and Using Machines

This medication contains codeine, which can cause drowsiness, affecting mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Alcohol can enhance this effect, so you should not consume alcoholic beverages during treatment.

3. How to Take Paracetamol/Codeine Farmalider

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in 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 can be adjusted to half a tablet per dose.

The recommended dose is:

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

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

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

Children under 12 years old:Should not take Paracetamol/Codeine Farmalider due to 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, consult your doctor.

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.

Administration of the preparation is subject to the appearance of painful or febrile 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 prescribed amount of medication 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.

According to their disease, their doctor will indicate whether 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, never exceeding 500 milligrams per dose.

Elderly patients:before taking this medication, they must consult their doctor.

If you think the effect of Paracetamol/Codeine Farmalider is too strong or too weak, inform your 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 Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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

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

Paracetamol overdose is considered to be a single dose of more than 6 g in adults (12 tablets of Paracetamol/Codeine Farmalider) and more than 100 mg/kg body weight in children (for a 20 kg child, 4 tablets in a single dose).

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

The symptoms of codeine overdose may be: initial excitement, anxiety, inability to fall asleep (insomnia), and later, in certain cases, drowsiness, headache, changes in blood pressure, arrhythmias, dry mouth, skin rashes, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

If you forget to take Paracetamol/Codeine Farmalider

Do not take a double dose to make up for forgotten doses. Take the missed dose as soon as you remember, and if your next dose is near in time, skip the missed dose and continue taking the medication at the usual schedule. 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.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The observed adverse 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 adverse effects have been observed with 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), and jaundice (yellowish color of skin and mucous membranes), hypoglycemia (reduced glucose levels in the blood), thrombocytopenia (reduced platelet count in the blood), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count in the blood), hemolytic anemia (reduced red blood cell count in the blood), sterile pyuria (cloudy urine), adverse renal effects.

The following adverse effects have also been described with codeine:

Rare:Discomfort, drowsiness (somnolence), 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, yellowish discoloration of the skin and eyes (jaundice), low blood sugar (hypoglycemia), blood disorders. Very rare cases of severe skin reactions have been reported.

Frequency not known(cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness 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 that does not appear in this prospectus. You can also report them directly through the national reporting system included in www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Paracetamol/Codeine Farmalider

No special storage conditions are required.

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

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol/Codeine Farmalider

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

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER S.A.

C/ Aragoneses 15

28108 – Alcobendas (Madrid)

Manufacturer

FARMALIDER S.A.

C/ Aragoneses 15

28108 – Alcobendas (Madrid)

or

TOLL MANUFACTURING SERVICES S.L.

C/ Aragoneses 2

28108 – Alcobendas (Madrid)

Date of the Last Revision of this Prospectus: March 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/