COD-EFFERALGAN 500 mg / 30 mg effervescent tablets

Introduction

Package Leaflet: Information for the User

Cod-Efferalgan 500mg/ 30mg Effervescent Tablets

Paracetamol/codeine phosphate hemihydrate

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Cod-Efferalgan and what is it used for
2. What you need to know before you take Cod-Efferalgan
3. How to take Cod-Efferalgan
4. Possible side effects
5. Storing Cod-Efferalgan
6. Contents of the pack and other information

1. What is Cod-Efferalgan and what is it used for

Cod-Efferalgan is used in adults and adolescents who weigh 50 kg or more (approximately 15 years and older) for the relief of moderate acute pain for which ibuprofen or paracetamol alone is not considered suitable.

2. What you need to know before you take Cod-Efferalgan

Do not take Cod-Efferalgan:

• if you are allergic to the active substances or any of the other ingredients (listed in section 6)
• in cases of severe hepatic impairment or active liver disease
• if you have bronchial asthma
• if you have respiratory failure
• children and adolescents under 15 years
• to relieve pain in children and adolescents (0-18 years) after tonsillectomy and/or adenoidectomy due to obstructive sleep apnea syndrome
• if you know you metabolize codeine very quickly into morphine
• if you are breastfeeding

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Cod-Efferalgan.

• Medication will be administered with caution to patients with renal or hepatic function disorders, anemia, or chronic cardiopulmonary insufficiency.
• Tell your doctor or pharmacist if you suffer or have suffered from dependence on opioids, alcohol, prescription drugs, or illicit substances, or if you suffer from mental disorders (e.g., major depression).
• As with all analgesics, it should not be administered for prolonged periods, except under medical judgment.
• Paracetamol may cause severe skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Use of this medication should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
• Frequent use of analgesics for a long time can cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics for more than 3 months, at least on alternate days, do not increase the dose of analgesics, but consult your doctor.

During treatment with Cod-Efferalgan, inform your doctor immediately if:

• You have severe diseases, such as severe renal impairment 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. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Effects on the Central Nervous System

The depressant effects of opioids such as codeine on the central nervous system (CNS) can cause severe respiratory depression.

Prolonged use of this medication increases the risk of medication-overuse headache.

Treatment with opioids, particularly with chronic use, can induce an increase in pain in certain patients.

Alcohol consumption is not recommended during treatment with Cod-Efferalgan.

Effects on the Respiratory System

Opioids produce respiratory depression due to the depressant effects on the CNS. The risk of respiratory depression can be increased by concomitant medication and pharmacogenetic factors.

Cod-Efferalgan should be used with caution in patients with asthma.

Gastrointestinal Effects

Administration of opioids can mask symptoms of acute abdominal diseases.

Caution is recommended in case of biliary tract disease, such as pancreatitis and cholestasis.

Dermatological Effects

Itching.

Hormonal Effects

Decrease in hormone levels, so it should be used with caution in patients with hormonal disorders.

Musculoskeletal Effects

Muscle stiffness and myoclonus.

Urogenital Effects

Urinary retention. It should be used with caution in patients with urethral contractions or prostate hypertrophy.

Cardiovascular and Cerebrovascular Effects

Possible hemodynamic effects.

Tolerance

Prolonged use of opioids can produce a decrease in analgesic efficacy or tolerance.

• Prolonged and regular administration of codeine (one of the active substances of this medication) can produce physical and psychological dependence, addiction, or misuse. This can lead to overdose and/or death. Do not take this medication for longer than necessary. Do not give this medication to others.
• In order to avoid the risk of overdose, check that other medications you are taking (with or without a prescription) do not contain paracetamol.
• Administration of paracetamol doses higher than recommended carries the risk of producing severe liver damage. An antidote should be administered as soon as possible.
• Paracetamol should be used with caution in cases of mild or moderate hepatic impairment.

To avoid the risk of overdose or severe side effects, check that other medications you are taking (with or without a prescription) do not contain opioids or other CNS depressants.

CYP2D6 Metabolism

Codeine is metabolized by the liver enzyme CYP2D6 to morphine, its active metabolite. If you have a deficiency or lack this enzyme, you will not obtain an adequate analgesic effect. However, if you are an extensive or ultra-rapid metabolizer, you may have a higher risk of developing opioid toxicity side effects even at commonly prescribed doses.

Alternative analgesic treatment is recommended in ultra-rapid metabolizer patients.

Low codeine metabolizers:

Patients with a low CYP2D6 metabolizer phenotype have a reduced ability to form morphine from codeine and therefore do not experience an analgesic effect with codeine treatment, but may have side effects.

Children and Adolescents

In pediatric patients, signs of CNS depression associated with codeine, such as excessive sleepiness and reduced respiratory rate, should be carefully monitored.

Children with Compromised Respiratory Function

The use of codeine is not recommended in children in whom respiratory function may be compromised, including neuromuscular disorders, severe cardiac or respiratory disorders, upper respiratory tract disorders, or pulmonary infections, multiple trauma, or extensive surgical procedures.

Postoperative Use in Children

There are data on the postoperative administration of codeine to children after tonsillectomy and/or adenoidectomy for the treatment of obstructive sleep apnea that led to rare but life-threatening adverse events, including death.

Use in Elderly Patients

Elderly patients may have an increased risk of opioid-associated side effects, such as respiratory depression and constipation. A lower initial dose is recommended in elderly patients.

These patients also have a high probability of using concomitant medication, which can increase the risk of drug interactions.

Other Medicines and Cod-Efferalgan

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

In particular, if you are using the following medication, it may be necessary to modify the dose or discontinue treatment:

• Flucloxacillin (antibiotic): due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Effect of Other Medicines on Cod-Efferalgan

• Associated with paracetamol:
  1. May increase the toxicity of chloramphenicol.
  2. If you take phenytoin concomitantly, it may produce a decrease in the effectiveness of paracetamol and an increase in the risk of hepatotoxicity.
  3. A reduction in the dose of paracetamol should be considered when administered concomitantly with probenecid.
  4. Salicylamide may prolong the elimination half-life (t1/2) of paracetamol.
  5. Caution should be exercised when paracetamol is administered concomitantly with enzyme-inducing substances, such as barbiturates, isoniazid, carbamazepine, rifampicin, and ethanol.

• Associated with codeine:

The concomitant use of codeine with other opioid medications, such as alfentanil, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol, methadone, and cough suppressants, such as dextromethorphan, noscapine, pholcodine, codeine, and ethylmorphine, can intensify the depressant effects on the CNS, including sedation and respiratory depression, increasing the risk of fatal overdose.

The use of agonist/antagonist opioids and partial opioid agonists (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine) can produce a reduction in the analgesic effect and opioid withdrawal symptoms.

Other CNS depressants, such as barbiturates; anxiolytics and antidepressants, including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), benzodiazepines, and hypnotics, can potentiate the depressant effects of codeine on the CNS.

Other medications that may cause drowsiness, such as analgesics, cough suppressants, and substitution treatments, neuroleptics, barbiturates, benzodiazepines, anxiolytics, and other benzodiazepines (meprobamate), hypnotics, sedative antidepressants, antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative antihistamines H1, antihypertensive medications with central action, baclofen, and thalidomide, can have an additional sedative effect with codeine.

Other medications that are metabolized by or inhibit CYP2D6, such as SSRIs (paroxetine, fluoxetine, bupropion, and sertraline), neuroleptics (chlorpromazine, haloperidol, levomepromazine, thioridazine), and tricyclic antidepressants (imipramine, clomipramine, amitriptyline, nortriptyline), celecoxib, quinidine, dexamethasone, and rifampicin, can reduce the analgesic effect of codeine.

Anticholinergics administered concomitantly with opioids, including codeine, can potentiate the inhibition of intestinal function and increase the risk of intestinal paralysis.

Naltrexone, as an opioid antagonist, blocks the analgesic effect of codeine.

Effect of Cod-Efferalgan on Other Medicines

Caution should be exercised with the concomitant use of paracetamol and anticoagulants, such as warfarin.

Taking Cod-Efferalgan with Food and Drinks

Alcohol consumption can potentiate the toxic effect of paracetamol, so you should not drink alcoholic beverages during treatment. Concomitant use of alcohol and codeine can potentiate CNS depression.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to use during pregnancy and breastfeeding, as paracetamol is excreted in breast milk in small amounts. Cases of itching have been reported in newborns. In case of use, it should always be under medical prescription, weighing the possible risks and benefits of treatment. Never exceed the recommended dose.

At therapeutic doses, codeine and its active metabolite may be present in breast milk at very low doses and are unlikely to affect the breastfed baby. However, if the patient is an ultra-rapid CYP2D6 metabolizer, higher levels of the active metabolite, morphine, may be found in breast milk, and in very rare cases, this can produce symptoms of opioid toxicity in the baby, which can be fatal.

Driving and Using Machines

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

If you feel drowsy, dizzy, or have visual disturbances while taking this medication, do not drive or use machines until you have checked that your ability to perform these activities is not affected.

Alcohol can potentiate this effect, so you should not drink alcoholic beverages during treatment.

Cod-Efferalgan Contains Aspartame (E-951), Sodium, Sorbitol (E-420), Sodium Benzoate, Glucose, Fructose, Sucrose, Ethanol, and Sulfites

This medicine contains 30 mg of aspartame in each effervescent tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains 300 mg of sorbitol in each effervescent tablet.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

This medicine contains 385 mg of sodium (the main component of table salt) in each effervescent tablet. This is equivalent to approximately 19.25% of the maximum recommended daily intake of sodium for an adult.

This medicine contains 59 mg of sodium benzoate in each effervescent tablet.

This medicine contains glucose and sucrose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains 5 mg of fructose in each effervescent tablet.

This medicine contains 0.5 mg of alcohol (ethanol) in each effervescent tablet. The amount per effervescent tablet of this medicine is equivalent to a small amount of beer or wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains sorbitol, which can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Cod-Efferalgan

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 is administered orally.

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

The score line must not be used to break the tablet.

This medication must not be taken for more than 3 days. If the pain does not improve after 3 days, ask your doctor for advice.

Adults

The recommended dose is 1 or 2 effervescent tablets dissolved in a glass of water, up to 4 times a day, as needed, at intervals of at least 6 hours. The maximum daily dose of codeine must not exceed 240 mg.

The administration of the medication is subject to the appearance of painful and febrile symptoms, and the dosage can be reduced as the symptoms disappear.

Use in children and adolescents

The use of this medication is not recommended in children and adolescents under 15 years of age. Children under 12 years of age must not take Cod-Efferalgan, due to the risk of serious respiratory problems.

Adolescents who weigh 50 kg or more (and are over 15 years old): The recommended dose is 1 to 2 effervescent tablets every 6 hours, as needed, up to a maximum dose of codeine of 240 mg per day (8 tablets). This dose is calculated based on weight (0.5 to 1 mg/kg).

Elderly patients

Elderly people must reduce the dose since they are more sensitive to the effects and adverse reactions of this medication.

Renal impairment

In case of moderate or severe kidney disease, the maximum dose per intake is one tablet. Depending on the severity of your disease, your doctor will indicate if you should take the medication with a minimum interval of 6 or 8 hours.

Liver disease

They must take the amount of medication prescribed by their doctor with a minimum interval between each intake of 8 hours.

Do not take more than 4 tablets (2 grams of paracetamol) in 24 hours, divided into several intakes.

If you take more Cod-Efferalgan than you should

The symptoms of overdose that usually appear in the first 24 hours include nausea, vomiting, anorexia, pallor, discomfort, and diaphoresis.

It is considered a paracetamol overdose if a single dose of more than 6 g is taken in adults and more than 100 mg per kg of body weight in children.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone (91) 562 04 20.

Those patients who are undergoing barbiturate therapy or are chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

Treatment consists of aspiration and gastric lavage, activated charcoal administered orally, and alkalization of the urine, preferably with sodium bicarbonate, and normalization of kalemia. To control respiration, it is necessary to administer naxolone and N-acetylcysteine intravenously and in adequate doses. In extreme cases, hemodialysis may be necessary.

The period during which treatment offers the greatest guarantee of efficacy is within 12 hours after ingestion of the overdose.

If you forget to take Cod-Efferalgan

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

Take the missed dose as soon as you remember and if your next dose is near in time, omit the missed dose and continue taking the medication at the usual schedule. In case of doubt, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Associated with paracetamol with unknown frequency:

• Blood and lymphatic system disorders: Thrombocytopenia, leucopenia, neutropenia
• Gastrointestinal disorders: Diarrhea, abdominal pain
• Hepatobiliary disorders: Increased liver enzymes
• Immune system disorders: Anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, angioedema
• Skin and subcutaneous tissue disorders: Urticaria, erythema, rash, purpura, pustular psoriasis

Exanthematous generalized acute, toxic epidermal necrolysis, Stevens-Johnson syndrome

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

Associated with codeine with unknown frequency:

• Blood and lymphatic system disorders: Thrombocytopenia
• Ear and labyrinth disorders: Vertigo
• Gastrointestinal disorders: Abdominal pain, constipation, diarrhea, nausea, pancreatitis, vomiting
• General disorders and administration site conditions: Asthenia, discomfort, edema
• Hepatobiliary disorders: Biliary colic, hepatitis
• Immune system disorders: Anaphylactic reaction, hypersensitivity
• Investigations: Increased alanine aminotransferase, increased aspartate aminotransferase, increased alkaline phosphatase in blood, increased amylase in blood, increased gamma-glutamyltransferase, increased INR
• Musculoskeletal and connective tissue disorders: Rhabdomyolysis
• Nervous system disorders: Dizziness, myoclonus, paresthesia, somnolence, syncope, tremor
• Psychiatric disorders: Confusional state, addiction, abuse, dependence in cases of prolonged administration, withdrawal syndrome after sudden discontinuation of treatment, and in newborns of mothers intoxicated with codeine during pregnancy, hallucinations
• Renal and urinary disorders: Renal failure, urinary retention
• Respiratory, thoracic, and mediastinal disorders: Dyspnea, respiratory depression
• Skin and subcutaneous tissue disorders: Angioedema, erythema, pruritus, rash, urticaria
• Vascular disorders: Hypotension

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Cod-Efferalgan

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications must not be thrown away through the sewers or in the trash. Deposit the packaging and medications that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Cod-Efferalgan

• The active ingredients are paracetamol and codeine phosphate hemihydrate.

Each effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.

• The other components are aspartame, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous citric acid, sorbitol, sodium docusate, sodium benzoate, povidone, and grapefruit flavor.

Appearance of Cod-Efferalgan and package contents

White, round, and scored tablets on one side, packaged in aluminum strips, which are presented in packages containing 20 effervescent tablets.

Marketing authorization holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer

UPSA

979, Avenue des Pyrénées

47520 - Le Passage

France

O

UPSA

304, avenue du Dr Jean Bru

47000 - Agen

France

Local representative

NEWLINE PHARMA, S.L.U.

Calle Tarragona 151-157, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Date of the last revision of this prospectus: January 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