Dolocatil Codeina 500/15 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dolocatil Codeine 500 mg/15 mg tablets

Paracetamol / Codeine phosphate hemihydrate

Contents of the leaflet:

1. What Dolocatil Codeine is and what it is used for
2. What you need to know before taking Dolocatil Codeine
3. How to take Dolocatil Codeine
4. Possible side effects
5. Storage of Dolocatil Codeine
6. Contents of the pack and other information

1. What Dolocatil Codeine is and what it is used for

Dolocatil Codeine belongs to the group of analgesic medicines.

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

This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. It may be used alone or in combination with other analgesics such as paracetamol.

2. What you need to know before taking 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 (COPD).
• If you are under 15 years of age.
• To relieve pain in children and adolescents (0–18 years of age) following tonsil or adenoid removal due to obstructive sleep apnea syndrome.
• If you are breastfeeding.
• If you are known to be a rapid metabolizer of codeine into morphine.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Dolocatil Codeine.

It is important to use the lowest effective dose that relieves/controls your pain. Do not take more than the recommended dose prescribed by your doctor or stated in section 3 of this leaflet, “How to take Dolocatil Codeine”. To avoid overdose, do not take other medicines containing paracetamol or codeine at the same time (e.g., medicines used to treat colds, pain, or fever).

Take special care with Dolocatil Codeine:

• If you have heart or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.

• If you have liver or kidney problems, chronic malnutrition, or dehydration, you may require a reduced dose of this medicine.

• If you have any condition affecting your ability to breathe, intracranial lesions (e.g., due to head trauma), asthma or a history of asthma, and/or are sensitive to acetylsalicylic acid.

• If you have thyroid disease, prostate problems, or urethral narrowing (all of which may cause difficulty in urination), adrenal insufficiency (Addison’s disease), or intestinal or gallbladder disorders.

• If you are elderly or feel generally weakened.

• If you suffer from chronic constipation, this medicine may worsen your symptoms.

• Alcohol consumption may increase the risk of liver damage caused by paracetamol.

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

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

• Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some people have genetic variations in this enzyme that affect how they respond to codeine. In some individuals, little or no morphine is produced, resulting in inadequate pain relief. In others, very high levels of morphine may be produced, increasing the risk of serious adverse reactions. If you experience any of the following side effects, stop taking this medicine immediately and seek medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.

• Prolonged or frequent use of painkillers to treat headaches may worsen symptoms, which should not be treated by increasing the dose of the medicine.

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

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

• Contact your doctor immediately if you experience severe abdominal pain possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms of pancreatitis or biliary tract inflammation.

• During treatment with Dolocatil Codeine, inform your doctor immediately if:

You have serious conditions such as severe renal failure 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 serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Pain or increased sensitivity to pain (hyperalgesia) that does not respond to increased doses of the medicine.

Tolerance, dependence, and addiction

Repeated use of opioids may reduce the effectiveness of the drug (the body becomes accustomed to it; this is known as tolerance). Repeated use of Dolocatil Codeine may also lead to dependence, abuse, and addiction, which in turn may result in potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you have lost control over how much medication you need to take or how often you need to take it.

The risk of developing dependence or addiction varies from person to person. Your risk of dependence or addiction to Dolocatil Codeine may be higher if:

• You or a family member have abused or been dependent on alcohol, prescription medicines, or drugs ("addiction").
• You smoke.
• You have had mood-related problems (depression, anxiety, or personality disorders), or a psychiatrist has treated you for other psychiatric disorders.

If you notice any of the following signs while taking Dolocatil Codeine, they may indicate that you have developed dependence or addiction:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take a higher dose than recommended.
• You feel that you need to continue taking the medicine, even though it does not help relieve .
• You take the medicine for reasons other than those for which it was prescribed, for example, to "feel calm" or "help you sleep".
• You have tried several times to stop taking the medicine or control its use, but without success.
• You feel unwell when you stop taking the medicine and feel better when you resume taking it ("withdrawal effects").

If you notice any of these signs, speak with your doctor to determine the best treatment approach for you, when to stop treatment, and how to do so (see section 3, If you stop taking Dolocatil Codeine).

Sleep-related breathing disorders

Dolocatil Codeine may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime drowsiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Children and adolescents:

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

Use in children and adolescents after surgery:

Codeine must not be used for pain relief in adolescents or children after tonsillectomy or adenoidectomy due to the risk of 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 symptoms of morphine toxicity may be worse in these patients.

Interference with diagnostic tests:

If you are undergoing any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking Dolocatil Codeine, as it may alter the results of these tests.

Use of Dolocatil Codeine with other medicines:

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

Paracetamol may interact with the following medicines:

• Anticoagulants (used to treat thromboembolic disorders), although paracetamol may occasionally be used 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)
• Cholestyramine (used to lower blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

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

Codeine may interact with the following medicines:

• Opioid analgesics (used to treat pain) such as nalbuphine, buprenorphine, pentazocine
• Alcohol: May enhance the depressant effect of codeine.
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Sedating H1 antihistamines (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Neuroleptic hypnotics (used to treat insomnia)
• Clonidine and related agents (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)
• Gabapentin or pregabalin used to treat epilepsy or nerve injury-related pain (neuropathic pain)

Taking Dolocatil Codeine with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day) may cause liver damage. In addition, alcohol may enhance the depressant effect of codeine. Therefore, alcohol should not be consumed during treatment with this medicine.

Pregnancy, breastfeeding, and fertility:

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

Taking medicines during pregnancy may 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 use of machines:

This medicine contains codeine, which may cause drowsiness and impair mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

Use in athletes: This medicine contains codeine. As a result of its metabolism, certain compounds are produced that may lead to a positive result in doping control tests.

Dolocatil Codeine contains sodium

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

3. How to take Dolocatil Codeine

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from the use of Dolocatil Codeine, when and for how long you should use it, when you should contact your doctor, and when you should interrupt treatment (see also If you stop taking Dolocatil Codeine).

This medicine should not be taken for longer than 3 days. If pain does not improve after 3 days, seek advice from your doctor. Dolocatil Codeine should be used for the shortest time necessary to relieve symptoms. If effective pain relief is not achieved during treatment with the medicine, you should consult a doctor.

The recommended dose is:

Adults and adolescents over 15 years of age: The recommended initial dose is 1–2 tablets. If necessary, continue with 1 tablet every 4–6 hours, up to a maximum of 8 tablets in 24 hours. Doses should be spaced at least 4 hours apart.

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

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

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

If you feel that the effect of Dolocatil Codeine is too strong or too weak, inform your doctor or pharmacist.

This medicine is taken orally. Depending on your preference, the tablet may be taken whole or split, with water, milk, or fruit juice.

If you take more Dolocatil Codeine than you should:

If you take more Dolocatil Codeine than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If an overdose has occurred, you must go quickly to a medical center even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning. Treatment for overdose is most effective if started within 4 hours of taking the medicine.

Symptoms of overdose due to paracetamol may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and inflammation of the pancreas (pancreatitis).

Patients undergoing treatment with barbiturates or who suffer from chronic alcoholism may be more susceptible to paracetamol overdose.

Symptoms of overdose due to codeine may include: headache, ringing in the ears, blurred vision, drowsiness progressing 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 missed dose when you remember, and take the following doses at the recommended intervals (at least 4 hours apart). However, if the time for the next dose is approaching soon, skip the missed dose and take the next dose at its scheduled time.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Rare (may affect up to 1 in 1,000 people): malaise, increased levels of hepatic transaminases (liver enzymes), and hypotension (decrease in blood pressure).
• Very rare (may affect up to 1 in 10,000 people): hypersensitivity reactions 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 (yellowing of the skin and mucous membranes), hypoglycemia (reduced blood glucose levels), thrombocytopenia (reduced platelets in the blood), agranulocytosis, leucopenia, neutropenia (decrease in white blood cells in the blood), haemolytic anaemia (reduction in red blood cells in the blood), sterile pyuria (cloudy urine), and adverse renal effects. Very rare cases of serious skin reactions have been reported.
• Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Due to its codeine content, it may cause:

• Rare (may affect up to 1 in 1,000 people): malaise, somnolence (drowsiness), constipation, nausea and dizziness, bronchospasm (spasms in the bronchi making 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 (yellowing of the skin and eyes), hypoglycemia (reduced blood glucose levels), thrombocytopenia, agranulocytosis, leucopenia, neutropenia, haemolytic anaemia, acute pancreatitis, with patients having a history of cholecystectomy being more susceptible.
• Frequency not known (cannot be estimated from available data): a problem affecting a valve in the intestine (Oddi sphincter dysfunction).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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.

Store this medicine in a secure place inaccessible to other people. It may cause serious harm and can be fatal to individuals for whom it has not been prescribed.

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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your usual pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolocatil Codeine

The active substances 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 from potato (Type A), silicified microcrystalline cellulose, povidone, and magnesium stearate.

Appearance of the product and contents of the pack:

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

The tablets have a score line which allows them to be divided into two equal parts. The score line is intended only to facilitate splitting the tablet and ease of swallowing, and not for dividing into equal doses.

Each pack 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 Vallès (Barcelona)

Date of the most recent revision of this leaflet: January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/