Leaflet: Information for the user

Fludetén 500 mg/30 mg effervescent tablets

Paracetamol/Codeine phosphate hemihydrate

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

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

Fludetén is an association of paracetamol and codeine. Paracetamol is an active analgesic and antipyretic principle (relieves pain and reduces fever) whose analgesic activity is potentiated by codeine. Codeine belongs to a group of medications called opioid analgesics that act by relieving pain.

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

Do not take Fludetén

• if you are allergic to paracetamol, codeine, or any of the other components of this medication (listed in section 6)
• if you have bronchial asthma
• if you have respiratory depression
• if you have increased intracranial pressure
• to relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy with obstructive sleep apnea syndrome
• if you know you metabolize codeine quickly to morphine
• if you are breastfeeding

Warnings and precautions

• It is essential to use the smallest dose that relieves pain and not to exceed the recommended doses in Section 3 – “How to take Fludetén” for this, avoid taking other medications containing paracetamol or codeine (used, for example, to treat colds, pain, and fever).

Consult your doctor or pharmacist before starting to take Fludetén:

• If you have any heart or lung disease and in patients with anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), or with low levels of an enzyme in the blood called glucose-6-phosphate dehydrogenase, you must consult with your doctor before taking the medication.
• If you have liver (including Gilbert syndrome) or kidney problems or suffer from chronic malnutrition or dehydration, you may require a reduction in the dose of the medication.
• If you have any disease that affects the ability to breathe, present 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, prostate, or urethral stricture disease (both with difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or biliary tract diseases.
• If you are an elderly person or feel weak.
• If you have chronic constipation, the use of this medication may worsen symptoms.
• The 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 differently. In some people, morphine is not produced or is produced in very small 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 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.
• If you consume alcoholic beverages, it may cause paracetamol to damage the liver.
• 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. If you need to take this medication for a prolonged period, the treatment should be reevaluated periodically by your doctor.
• If the pain persists for more than 3 days (2 days for throat pain), worsens, or other symptoms appear, stop treatment and consult your doctor.
• 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 distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with analytical tests

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

Fludetén with other medications

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

In particular, if you are taking medications that contain any of the following active principles, it may be necessary to modify the dose or interrupt treatment with any of them.

Paracetamol may interact with the following medications:

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

On the other hand, codeine may interact with the following medications:

• Narcotic analgesics (used to treat pain) such as nalbuphine, buprenorphine, pentazocine
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• H1 antihistamines (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Hypnotic neuroleptics (used to treat insomnia)
• Clonidine and related (used to treat hypertension and migraine)
• Talidomide (used to treat certain types of cancer)
• Benzodiazepines
• Medications used to relieve spasms or cramps of the stomach, intestines, and bladder (anticholinergics).

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

Fludetén 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 depressive effect of codeine. Therefore, do not consume alcohol during treatment with this medication.

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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 operating machinery

Fludetén contains codeine, which may cause drowsiness, affecting mental and/or physical ability. If you note these effects, avoid driving vehicles or operating machinery.

Fludetén contains sodium

This medication contains 491.4 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 25% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need 1 or more tablets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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.

Dosage:

The administration of Fludetén is subject to the appearance of pain, and the dose can be reduced as it disappears. It is essential to use the smallest dose that relieves pain and should not take the medication for longer than necessary.

Adults and adolescents over 15 years:

Follow the doctor's instructions. The recommended dose for adults and adolescents over 15 years 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

This medication is not recommended for use in adolescents under 15 years old.

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

Patients with kidney and/or liver diseases

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

Older patients

Older patients are more prone to adverse effects, so it may be necessary to reduce the dose. Consult your doctor.

Administration form:

This medication is administered orally.

Dissolve 1 (or 2) tablets in a glass of water and ingest the contents after the effervescence stops.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

In cases where the patient is being treated with barbiturates or has chronic alcoholism, they may be more susceptible to a paracetamol overdose.

The symptoms that characterize a codeine overdose are: drowsiness, even to the point of stupor or coma, cold skin, miosis, muscle flaccidity, and, in some cases, bradycardia, hypotension, and respiratory depression.

If you forget to take Fludetén

Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Fludetén

Your doctor will indicate the duration of treatment with Fludetén and when and how to interrupt it.

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

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

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

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

The side effects observed are described below according to the frequency of presentation:

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

The side effects ofparacetamolare:

• Rare: Discomfort, increased levels of liver 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 (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: A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The side effects ofcodeineare:

• Rare: Discomfort, drowsiness (feeling of sleep), constipation, nausea, and dizziness, bronchospasm (bronchial spasms that make breathing difficult) and respiratory depression (slow breathing).
• Very rare: 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.

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 Pharmacovigilance 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. Keep the container tightly closed.

Do not use this medication after the expiration date that appears on the container 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 containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fludetén

• The active principles 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 product and contents of the packaging

Each package contains 20 effervescent tablets, cylindrical, flat, smooth on both sides, and white in color in aluminum tubes coated on the inside with epoxy resin and with a polyethylene cap provided with a desiccant and indicator.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet: February 2025

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/.