FLUDETEN 500 mg/30 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Fludetén 500 mg/30 mg Effervescent Tablets

Paracetamol/Codeine Phosphate Hemihydrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Fludetén and what is it used for
2. What you need to know before taking Fludetén
3. How to take Fludetén
4. Possible side effects
5. Storage of Fludetén
6. Package Contents and Additional Information

1. What is Fludetén and what is it used for

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 enhanced 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.

2. What you need to know before taking Fludetén

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 been diagnosed with increased intracranial pressure
• to relieve pain in children and adolescents (0-18 years of age) after tonsil or adenoid removal who suffer from obstructive sleep apnea syndrome
• if you know you metabolize codeine very quickly into morphine
• if you are breastfeeding.

Warnings and Precautions

• It is essential to use the smallest dose that relieves the pain and not exceed the recommended doses in Section 3 - "How to take Fludetén" for this, avoid taking other medications that contain 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 to or not due to a decrease in red blood cells), or with low levels of a blood enzyme called glucose-6-phosphate dehydrogenase, you should consult your doctor before taking the medication.
• If you have liver (including Gilbert's syndrome) or kidney problems or suffer from chronic malnutrition or are dehydrated, you may require a reduction in the dose of the 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, prostate, or urethral stricture (both of which cause difficulties in urination), adrenal insufficiency (Addison's disease), or intestinal or gallbladder conditions.
• If you are an elderly person or feel weak.
• If you have chronic constipation, the use of this medication can worsen the symptoms.
• 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, morphine is not produced or 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 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 can cause paracetamol to damage the liver.
• Prolonged or frequent use of analgesics to treat headaches can worsen symptoms, which should not be treated with higher doses of the medication.
• With repeated administration of this medication, physical dependence and tolerance may appear. Administration should be gradually suspended after prolonged treatments. If you need to take this medication for a prolonged period, the treatment should be periodically reevaluated by your doctor.
• If the pain persists for more than 3 days (2 days for throat pain), worsens, or other symptoms appear, you should interrupt treatment and consult your doctor.
• If you have severe diseases, such as severe renal failure 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 severe 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.

Interference with Analytical Tests

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

Taking Fludetén with Other Medications

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

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

Paracetamolmay interact with the following medications:

• Oral anticoagulants (acenocoumarol, warfarin)
• Medications used for the relief of stomach, intestine, and bladder spasms or cramps (anticholinergics)
• Antiepileptics (lamotrigine, phenytoin, and other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculars (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Colestyramine (used to decrease cholesterol levels in blood)
• Propranolol (adrenergic blocker) used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)
• Medications used for the treatment of 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, the cause of AIDS).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that should be treated urgently (see section 2).

On the other hand, codeinemay interact with the following medications:

• Narcotic analgesics (used for pain treatment) such as nalbuphine, buprenorphine, pentazocine
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Sedating antihistamines H1 (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Neuroleptic hypnotics (used to treat insomnia)
• Clonidine and related medications (used to treat hypertension and migraine)
• Thalidomide (used to treat some types of cancer)
• Benzodiazepines
• Medications used for the relief of stomach, intestine, and bladder spasms or cramps (anticholinergics).

Do not use other analgesics (medications that reduce pain) without consulting your doctor.

Taking Fludetén with Food, Drinks, and Alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day) can damage the liver. Additionally, alcohol can potentiate the depressive effect of codeine. Therefore, you should not consume alcohol 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 obstructive sleep apnea syndrome.

Use in children with respiratory problems

The use of codeine is not recommended in children with respiratory problems, as the symptoms of morphine toxicity can be worse 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 can cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Fludetén Contains Sodium

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

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

Use in Athletes:This medication contains codeine. As a consequence of its metabolism, some compounds are produced that can result in a positive test in doping controls.

3. How to Take Fludetén

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. 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 the pain disappears. It is essential to use the smallest dose that relieves the pain and not take the medication for longer than necessary.

Adults and Adolescents Over 15 Years:

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

Do not exceed 6 tablets per day.

Use in Children and Adolescents

The use of this medication is not recommended in adolescents under 15 years of age.

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

Patient with Kidney and/or Liver Disease

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

Elderly Patients

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

Method of Administration:

This medication is administered orally.

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

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, telephone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

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

In the case of patients being treated with barbiturates or suffering from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

The symptoms that characterize a codeine overdose consist of: drowsiness, leading 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 forgotten doses.

In case you have forgotten a dose, take another as soon as possible and continue with the new schedule, maintaining the minimum interval of 6 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 Stop Taking Fludetén

Your doctor will indicate the duration of treatment with Fludetén and when and how you should stop it.

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

There is a risk of possible effects derived from abstinence when stopping treatment. Therefore, in prolonged treatments, the 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The observed side effects are described below according to their 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 of paracetamolare:

• Rare: Discomfort, increased levels of liver transaminases (liver enzymes) and hypotension (decrease in blood pressure).
• Very rare: Allergic reactions (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 (yellow color of 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.

• Unknown frequency: A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

The side effects of codeineare:

• Rare: Discomfort, drowsiness (feeling of sleep), constipation, nausea, and vertigo, bronchospasm (spasms in the bronchi that make breathing difficult), and respiratory depression (slow breathing).
• Very rare: Allergic reactions (hypersensitivity) ranging from a simple skin rash or urticaria and anaphylactic shock, fever, jaundice (yellow color of skin and eyes), hypoglycemia (low blood sugar levels), 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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fludetén

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

No special storage conditions are required. Keep the package perfectly closed.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Fludetén

• The active ingredients 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 Package Contents

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

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Date of the Last Revision of this Package Leaflet: February 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/.