Fludeten 500 mg/30 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fludetén 500 mg/30 mg effervescent tablets

Paracetamol/Codeine phosphate hemihydrate

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

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

Leaflet contents

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

1. What Fludetén is and what it is used for

Fludetén is a combination of paracetamol and codeine. Paracetamol is an active ingredient with analgesic and antipyretic properties (relieves pain and reduces fever), and its analgesic effect is enhanced by codeine. Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain.

This medicine can be used in adolescents over 15 years of age for the short-term treatment of moderate pain not relieved by other analgesics such as paracetamol or ibuprofen alone.

2. What you need to know before starting Fludetén

Do not take Fludetén

• if you are allergic to paracetamol, codeine, or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from bronchial asthma
• if you suffer from respiratory depression
• if you have been diagnosed with increased intracranial pressure
• to relieve pain in children and adolescents (0–18 years of age) after tonsil or adenoid removal who have obstructive sleep apnoea syndrome
• if you know that you metabolize codeine into morphine very rapidly
• if you are breastfeeding.

Warnings and precautions

• It is important to use the smallest dose that relieves pain, and you must not exceed the recommended doses in section 3 – "How to take Fludetén". To avoid this, do not take other medicines containing paracetamol or codeine (used, for example, to treat colds, pain, and fever).
• Contact your doctor if you experience severe abdominal pain possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms of inflammation of the pancreas (pancreatitis) or of the biliary tract system.

Tolerance, dependence and addiction

Repeated use of opioids may reduce the drug's effectiveness (the body becomes accustomed to it; this is called tolerance). Repeated use of Fludetén 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. You may have a higher risk of dependence or addiction to Fludetén if:

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

If you notice any of the following signs while taking Fludetén, it could indicate that you have developed dependence or addiction:

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

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

Sleep-related breathing disorders

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

Consult your doctor or pharmacist before starting Fludetén:

• If you have any heart or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a decrease in red blood cells), or low levels of an enzyme in the blood called glucose-6-phosphate dehydrogenase, you should consult your doctor before taking the medication.
• If you have liver problems (including Gilbert's syndrome) or kidney problems, or suffer from chronic malnutrition or dehydration, you may require a reduced dose.
• If you have any disease affecting your ability to breathe, intracranial lesions (e.g., due to head contusion), asthma or a history of asthma, or are additionally sensitive to acetylsalicylic acid.
• If you have thyroid disease, prostate problems, or urethral narrowing (both associated with difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder conditions.
• If you are elderly or feel weak.
• If you suffer from chronic constipation, the use of this medication may worsen symptoms.
• Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some people have variations in this enzyme that may affect them differently. In some individuals, morphine is not produced or is produced in very low amounts, resulting in insufficient pain relief. In others, a very high amount of morphine may be produced, increasing the likelihood of serious adverse reactions. If you experience any of the following adverse effects, you must stop taking this medication and seek immediate medical help: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, or loss of appetite.
• Alcohol consumption may cause paracetamol to cause liver damage.
• 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 develop. Treatment should be gradually discontinued after prolonged use. If you need to take this medication for a prolonged period, your treatment should be periodically reevaluated by your doctor.
• If pain persists for more than 3 days (2 days for sore throat), worsens, or new symptoms appear, you should stop treatment and consult your doctor.
• If you have severe conditions such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from 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 in these situations when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
• Pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increased dose of the medication.

Interference with diagnostic tests

If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking Fludetén, as it may alter the results of these tests.

Taking Fludetén with other medicines

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

In particular, if you are taking medications containing any of the following active substances, a dose adjustment or discontinuation of treatment may be necessary.

Paracetamol may interact with the following medicines:

• Oral anticoagulants (acenocoumarol, warfarin)
• Medications used to relieve spasms or cramps in the stomach, intestines, or bladder (anticholinergics)
• Antiepileptics (lamotrigine, phenytoin and other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculosis drugs (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Colestyramine (used to lower blood cholesterol levels)
• Propranolol (adrenergic blocker) used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) that must be urgently treated (see section 2).

Codeine may interact with the following medicines:

• Narcotic analgesics (used to treat pain) such as nalbuphine, buprenorphine, pentazocine
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Sedating H1 antihistamines (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Hypnotic neuroleptics (used to treat insomnia)
• Clonidine and related drugs (used to treat hypertension and migraine)
• Thalidomide (used to treat certain types of cancer)
• Benzodiazepines
• Medications used to relieve spasms or cramps in the stomach, intestines, and bladder (anticholinergics)
• Gabapentin or pregabalin for the treatment of epilepsy or pain caused by nerve system injuries (neuropathic pain).

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

Taking Fludetén with food, drinks, and alcohol

Using paracetamol in patients who habitually 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 medication.

Children and adolescents

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after tonsil or adenoid removal due to the risk of obstructive sleep apnea syndrome.

Use in children with respiratory problems

Codeine is not recommended in children with respiratory problems, as symptoms of morphine toxicity may be more severe in these children.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

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

Fludetén contains sodium

This medicine contains 491.4 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 25% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need to take one or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

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.

3. How to take Fludetén

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

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using Fludetén, when and for how long you should use it, when you should contact your doctor, and when you should stop treatment (see also "If you stop taking Fludetén").

This medicine must not be taken for longer than 3 days. If pain does not improve after 3 days, seek advice from your doctor.

Fludetén should be used for the shortest period necessary to relieve symptoms. If effective pain relief is not achieved during treatment with this medicine, you should consult a doctor.

Dosage:

The administration of Fludetén depends on the presence of pain, and the dose may be reduced as the pain subsides. It is important to use the smallest dose that relieves the pain, and you should not take the medicine longer than necessary.

Adults and adolescents over 15 years of age:

Follow your doctor's instructions. The recommended dose for adults and adolescents over 15 years of age is 1 to 2 effervescent tablets, 1 to 4 times every 24 hours. Doses should be spaced at least 4 hours apart.

Do not exceed 6 tablets per day.

Use in children and adolescents

Use of this medicine is not recommended in adolescents under 15 years of age.

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

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose. If so, take exactly the dose prescribed by your doctor.

Elderly patients

Elderly people are generally more susceptible to adverse effects, so dose reduction may be necessary. Consult your doctor.

Method of administration:

This medicine is administered orally.

Dissolve 1 (or 2) tablets in a glass of water and ingest the solution after effervescence has ceased.

If you take more Fludetén than you should

If you have taken more Fludetén than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

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

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

Symptoms characteristic of codeine overdose include: drowsiness, progressing to stupor or coma, cold skin, miosis, muscle flaccidity, and occasionally bradycardia, hypotension, and respiratory depression.

If you forget to take Fludetén

Do not take a double dose to make up for missed doses.

If you have missed a dose, take it as soon as possible and continue with the new schedule, maintaining a minimum interval of 6 hours. However, if the time for the next dose is approaching, skip the missed dose and take the next dose at the usual time.

If you stop taking Fludetén

Your doctor will advise you on the duration of treatment with Fludetén and when and how to stop it.

Do not stop treatment prematurely, as you will not achieve the expected effect.

There is a risk of possible withdrawal effects when stopping treatment. Therefore, in prolonged treatments, doses should be gradually reduced (see section 2).

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 can cause adverse effects, although not everyone experiences them.

The observed adverse effects are described below according to their frequency of occurrence:

Rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), and not known (cannot be estimated from available data).

Adverse effects of paracetamol are:

• Rare: Malaise, increased levels of hepatic transaminases (liver enzymes), and 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 (yellowing of the skin and mucous membranes), hypoglycemia (reduced blood glucose levels), thrombocytopenia (reduced platelet count in blood), agranulocytosis, leucopenia, neutropenia (decreased white blood cells in blood), hemolytic anemia (decreased red blood cells in blood), sterile pyuria (cloudy urine), and adverse renal effects.

Very rare cases of serious skin reactions have been reported.

• Frequency not known: A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who are using paracetamol (see section 2).

Adverse effects of codeine are:

• Rare: Malaise, somnolence (drowsiness), constipation, nausea and dizziness, bronchospasm (spasms in the bronchi causing breathing difficulty), and respiratory depression (slow breathing).
• Very rare: 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, hemolytic anemia.
• Not known: 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 through 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 Fludetén

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

Store this medicine in a safe place where others cannot access it. It may cause serious harm or even death in individuals for whom it has not been prescribed.

No special storage conditions are required. Keep the container tightly closed.

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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fludetén

• The active substances are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
• The other components are: citric acid, sodium saccharin, sodium bicarbonate, anhydrous sodium carbonate, povidone 30 and sodium docusate.

Appearance of the medicine and contents of the pack

Each pack contains 20 effervescent tablets, cylindrical in shape, flat and smooth on both sides, white in colour, in aluminium tubes internally coated with epoxy resin and with a polyethylene cap fitted with a desiccant containing an indicator.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/ .