Package Insert: Information for the User

Dolocatil Codeine 650 mg/30 mg Tablets

Paracetamol/ Codeine Phosphate Hemihydrate

Dolocatil Codeína belongs to the group of analgesic medications.

Dolocatil Codeína is indicated for patients over 15 years old for the short-term treatment of moderate acute pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

This product contains codeína. Codeína belongs to a group of medications called opioid analgesics that act by relieving pain. It may be used alone or in combination with other analgesics such as paracetamol.

Do not take Dolocatil Codeína:

• If you are allergic to paracetamol, codeína, or any of the other components of this medication (listed in section 6).
• If you have a severe liver disease.
• If you have acute respiratory depression, acute asthma, or chronic obstructive pulmonary disease.
• If you are under 15 years old.
• To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you are breastfeeding.
• If you know that you metabolize codeína very quickly to morphine.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Dolocatil Codeína.

It is essential to use the smallest dose that relieves or controls pain. Do not take more doses than recommended by your doctor or the amount listed in section 3 of this leaflet “How to take Dolocatil Codeína.” To do this, avoid taking other medications that contain paracetamol or codeína (used, for example, to treat colds, pain, and fever) simultaneously.

Be especially careful with Dolocatil Codeína:

• If you have any heart or lung disease and in patients with anemia (decrease in hemoglobin levels in the blood, due or not to a decrease in red blood cells), consult your doctor before taking the medication.

• If you have liver or kidney problems or suffer from chronic malnutrition or dehydration, you may require a reduction in the dose of 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/or are sensitive to acetylsalicylic acid.

• If you have any thyroid disease, prostate disease, or urethral stricture (both accompanied by difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or biliary tract diseases.

• If you are an elderly person or feel weakened.

• If you have chronic constipation, the use of this medication may worsen symptoms.

• If you consume alcoholic beverages, it may cause paracetamol to damage the liver.

• As a precaution, do not take more than 4 tablets (2 g of paracetamol) in less than 24 hours.

• If the pain persists for more than 3 days, worsens, or other symptoms appear, discontinue treatment and consult your doctor.

• 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, stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea, or vomiting, constipation, loss of appetite.

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

• With repeated administration of this drug, physical dependence and tolerance may appear. Administration should be suspended gradually after prolonged treatments as indicated by your doctor.

• If you need to take this medication for a prolonged period, the treatment should be reevaluated periodically by your doctor.

• If you have a history of cholecystectomy. Consult a doctor before using this medication, as it may cause acute pancreatitis in some patients.

• During treatment with Dolocatil Codeína, 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 suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) 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 difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents:

Dolocatil Codeína is contraindicated in children and adolescents under 15 years old.

Use in children and adolescents after surgery:

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

Use in children and adolescents with respiratory problems:

Codeína should not be used in children and adolescents with respiratory problems, as the symptoms of morphine toxicity may be worse in these patients.

Interference with analytical tests:

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

Use of Dolocatil Codeína with other medications:

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

Theparacetamolmay interact with the following medications:

• Anticoagulants (used to treat thromboembolic diseases), although paracetamol can be administered occasionally as the preferred analgesic.
• Antiepileptics (used to treat epileptic seizures)
• 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)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Zidovudine (used to treat HIV infections)
• Colestiramine (used to reduce blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

It should not be used with other analgesics (pain-relieving medications) without consulting your doctor.

Thecodeínamay interact with the following medications:

• Narcotic analgesics (used to treat pain) such as nalbufina, buprenorphine, pentazocina
• Alcohol: May potentiate the depressant effect of codeína.
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Antihistamines H1 sedatives (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Hypnotic neuroléptics (used to treat insomnia)
• Clonidina and related (used to treat hypertension and migraine)
• Talidomida (used to treat some types of cancer)
• Benzodiacepinas
• Medications used to relieve spasms or cramps in the stomach, intestines, and bladder (anticolinérgics).

Taking Dolocatil codeína with food, drinks, and alcohol:

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day) may damage the liver. Additionally, alcohol may potentiate the depressant effect of codeína. Therefore, do not consume alcohol during treatment with this medication.

Pregnancy, lactation, and fertility:

Pregnancy:

Consult your doctor or pharmacist before using any medication.

The consumption of medications during pregnancy may be hazardous to the embryo or fetus.

If you are pregnant or believe you may be, consult your doctor before taking Dolocatil Codeína.

Lactation:

Consult your doctor or pharmacist before using any medication.

Do not take this medication if you are breastfeeding. Codeína and morphine pass into breast milk.

Driving and operating machines:

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

Use in athletes:This medication contains codeína. As a result of its metabolism, some compounds are produced that may produce a positive result in doping control tests.

Dolocatil Codeína contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free.”

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

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.

The recommended dose is:

Adults and adolescents over 15 years old:1 tablet per dose, up to a maximum of 6 tablets in 24 hours. Doses should be spaced at least 4 hours apart.

Children under 12 years old should not take Dolocatil Codeína due to the risk of severe respiratory problems.

Patients with liver or kidney disease:should consult their doctor (see section 2).

Patients of advanced age:should consult their doctor (see section 2).

If it is estimated that the action of Dolocatil Codeína is too strong or too weak, inform your doctor or pharmacist.

This medication should be taken orally. According to your preference, the tablet can be taken whole or broken, with water, milk, or fruit juice.

If you take more Dolocatil Codeína than you should:

If you take more Dolocatil Codeína than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If a overdose has been taken, you should go quickly to a medical center 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 the overdose is more effective if it is initiated within 4 hours of the medication ingestion.

The symptoms of overdose due to paracetamol may be:dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), abdominal pain and pancreatitis inflammation.

Patients undergoing barbiturate treatment or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

The symptoms of overdose due to codeine may be:headache, tinnitus, blurred vision, and somnolence, even to the point of stupor, cold skin, muscle flaccidity, and in some cases, bradycardia, hypotension, and respiratory depression.

If you forgot to take Dolocatil Codeína:

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours). However, if the next dose is very close, skip the missed dose and take the next dose at its usual time.

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

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

Dolocatil Codeine, due to its paracetamol content, can cause the following side effects, listed in order of frequency:

• Rare (may affect up to 1 in 1,000 people): Discomfort, elevated levels of liver enzymes (transaminases) and hypotension (decreased blood pressure).
• Very rare (may affect up to 1 in 10,000 people): (Hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a severe type of allergic reaction), hepatotoxicity (liver toxicity), jaundice (yellow discoloration of the skin and mucous membranes), hypoglycemia (low blood glucose levels), thrombocytopenia (reduced platelet count), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count), sterile pyuria (cloudy urine) and adverse renal effects. Very rarely, severe skin reactions have been reported.
• Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Due to its codeine content, it can cause:

• Rare (may affect up to 1 in 1,000 people): Discomfort, drowsiness (feeling sleepy), constipation, nausea, and dizziness, bronchospasm (bronchial spasms that make breathing difficult) and respiratory depression (slow breathing).
• Very rare (may affect up to 1 in 10,000 people): Allergic reactions (hypersensitivity) ranging from a simple skin rash or urticaria to anaphylactic shock, fever, jaundice (yellow discoloration of the skin and eyes), hypoglycemia, thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia, acute pancreatitis, with patients with a history of cholecystectomy being more susceptible.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

It is recommended not to remove the tablet from its packaging until the time of administration.

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 your local SIGRE drop-off point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dolocatil Codeína:

The active principles are paracetamol and codeine phosphate. Each tablet contains 650 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.

The other components (excipients) are: sodium starch glycolate (Type A), silica microcrystalline cellulose, povidone, and magnesium stearate.

Appearance of the product and content of the packaging:

Dolocatil Codeína 650 mg/30 mg tablets are presented in oral tablets. The tablets have a groove that allows them to be split in half. The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

Each box contains 20 tablets.

Holder of the marketing authorization:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94 – 08028 Barcelona

Responsible for manufacturing:

Ferrer Internacional, S.A.

Joan XXIII, 10

08950 – Esplugues de Llobregat (Barcelona)

or

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 – Sant Cugat del Vallés (Barcelona)

Last review date of this leaflet: April2025

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