DOLOCATIL CODEINE 500/15 mg TABLETS

2. What you need to know before you take Dolocatil Codeine

Do not take Dolocatil Codeine:

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

Warnings and precautions:

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

It is important to use the smallest dose that relieves/control the pain. Do not take more doses than recommended by your doctor or as stated in section 3 of this leaflet "How to take Dolocatil Codeine". To do this, avoid taking other medicines that contain paracetamol or codeine (used, for example, to treat colds, pain, and fever) at the same time.

Be especially careful with Dolocatil Codeine:

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

• If you have liver or kidney problems or suffer from chronic malnutrition or are dehydrated, you may need a reduction in the dose of this medicine.

• If you have any disease that affects your ability to breathe, have intracranial lesions (e.g., 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, prostate, or urethral stricture (both of which cause difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder conditions.

• If you are an elderly person or feel weakened.

• If you have chronic constipation, the use of this medicine 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 (2g of paracetamol) in less than 24 hours.

• If the pain persists for more than 3 days, worsens, or other symptoms appear, treatment should be discontinued and a doctor consulted.

• Codeine 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 in different ways. In some people, no morphine is produced or it is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from 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 medicine 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 pain-relievers to treat headaches can worsen symptoms, which should not be treated with higher doses of the medicine.

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

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

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

• During treatment with Dolocatil Codeine, 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 are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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:

Dolocatil Codeine is contraindicated in children and adolescents under 15 years of age.

Use in children and adolescents after surgery:

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

Use in children and adolescents with respiratory problems:

The use of codeine is not recommended in children and adolescents with respiratory problems, as the symptoms of morphine toxicity can be worse in these patients.

Interference with laboratory tests:

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking Dolocatil codeine, as it may alter the results of these tests.

Using Dolocatil Codeine with other medicines:

Inform your doctor or pharmacist if you are taking, have taken, or might take any other medicines.

Paracetamolmay interact with the following medicines:

• Anticoagulants (used to treat thromboembolic diseases), although paracetamol may be administered occasionally as an analgesic of choice.
• 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)
• Colestyramine (used to decrease blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

It should not be used with other pain-relievers (medicines that reduce pain) without consulting your doctor.

Codeinemay interact with the following medicines:

• Narcotic analgesics (used to treat pain) such as nalbuphine, buprenorphine, pentazocine
• Alcohol: May potentiate the depressant effect of codeine.
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Sedating antihistamines (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Neuroleptic hypnotics (used to treat insomnia)
• Clonidine and related medicines (used to treat hypertension and migraine)
• Thalidomide (used to treat certain types of cancer)
• Benzodiazepines
• Medicines used to relieve spasms or cramps of the stomach, intestine, and bladder (anticholinergics).

Taking Dolocatil Codeine with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day) may damage the liver. Additionally, alcohol may potentiate the depressant effect of codeine. Therefore, you should not drink alcohol during treatment with this medicine.

Pregnancy, breastfeeding, and fertility:

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

Taking medicines during pregnancy can be dangerous for the embryo or fetus.

If you are pregnant or think you may be pregnant, consult your doctor before taking Dolocatil Codeine.

Breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Do not take this medicine if you are breastfeeding. Codeine and morphine pass into breast milk.

Driving and using machines:

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

Use in athletes:This medicine contains codeine. As a result of its metabolism, some compounds are produced that can result in a positive test result in doping tests.

Dolocatil Codeine contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially "sodium-free".

3. How to take Dolocatil Codeine

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

This medicine 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 of age: The initial recommended dose is 1-2 tablets, if necessary, it can be continued with the intake of 1 tablet every 4-6 hours, up to a maximum of 8 tablets in 24 hours. The intakes should be spaced at least 4 hours apart

Children under 12 years of age should not take Dolocatil Codeine due to the risk of serious respiratory problems.

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

Elderly patients: should consult their doctor (see section 2).

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

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

If you take more Dolocatil Codeine than you should:

If you take more Dolocatil Codeine than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 915 620 420, indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you have taken an overdose, you should go quickly to a medical center even if there are no symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning. The treatment of the overdose is more effective if it is started within 4 hours after taking the medicine.

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

Patient treated with barbiturates or suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

The symptoms of codeine overdose may be: headache, ringing in the ears, blurred vision, and drowsiness leading to stupor, cold skin, muscle flaccidity, and occasionally bradycardia, hypotension, and respiratory depression.

If you forget to take Dolocatil Codeine:

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 interval between doses indicated in each case (at least 4 hours). However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Dolocatil Codeine, due to its paracetamol content, may cause the following side effects, listed according to their frequency:

• Rare (may affect up to 1 in 1,000 people): malaise, increased liver transaminase levels, and hypotension (low 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) and anaphylactic shock (a type of severe allergic reaction), hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes), hypoglycemia (low blood sugar 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 rare cases of severe skin reactions have been reported.
• Frequency not known (cannot be estimated from the available data): A serious disease called metabolic acidosis (an anomaly in blood and fluids) in patients with severe disease who use paracetamol (see section 2).

Due to its codeine content, it may cause:

• Rare (may affect up to 1 in 1,000 people): malaise, drowsiness (feeling of sleep), constipation, nausea, and vertigo, bronchospasm (spasms in the bronchi 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 and anaphylactic shock, fever, jaundice (yellowing of the skin and eyes), hypoglycemia (low blood sugar levels), thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia, acute pancreatitis, being more susceptible patients with a history of cholecystectomy.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dolocatil Codeine

Keep this medicine 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 medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Dolocatil Codeine

The active ingredients are paracetamol and codeine phosphate. Each tablet contains 500 mg of paracetamol and 15 mg of codeine phosphate hemihydrate.

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

Appearance of the Product and Packaging Content:

Dolocatil Codeine 500 mg/15 mg tablets are presented in tablets for oral administration.

The tablets have a score line that allows them to be broken in half. The score line is only for the purpose of fractioning and facilitating swallowing, but not for dividing into equal doses.

Each box contains 30 tablets.

Marketing Authorization Holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94 – 08028 Barcelona

Manufacturer

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)

Date of the Last Revision of this Leaflet:April 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/