Leaflet: information for the user

Paracetamol/codeine Level 24 mg/ml +2.40mg/ml oral solution

Paracetamol / Codeine phosphate hemihydrate

Read this leaflet carefullybefore 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, consult your doctor, pharmacist or nurse.
• 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, pharmacist or nurse,even if they are not listed in this leaflet. See section 4.

Paracetamol/codeína Level contains paracetamol and codeine phosphate as active substances. Paracetamol belongs to a group of medicines called analgesics and antipyretics, and codeine is an opioid analgesic.

Paracetamol/codeína Level is indicated in patients over 12 years old for the treatment of moderate acute pain that is not relieved with the use of ibuprofen or paracetamol as a single analgesic.

Do not take Paracetamol/codeína Level

• If you are allergic to paracetamol, codeína or any of the other components of this medication (listed in section 6),
• If you have acute respiratory depression, acute asthma or chronic obstructive pulmonary disease,
• If you have or are at risk of developing paralytic ileus,
• To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome,
• If you know that you metabolize codeína very quickly to morphine,
• If you are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Paracetamol/codeína Level:

• If you have any heart or lung disease and in patients with anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells), or with low levels of a blood enzyme called glucose-6-phosphate dehydrogenase, consult your doctor before taking the medication.
• If you have liver (including Gilbert's syndrome) or kidney problems or suffer from chronic malnutrition or dehydration, you may require a reduction in the dose of paracetamol.
• 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 disease, prostate problems or urethral stricture (difficulty urinating), adrenal insufficiency (Addison's disease) or intestinal or gallbladder diseases.
• If you are an elderly person or feel weakened.
• If you have chronic constipation, the use of this medication may worsen symptoms.
• Codeína is converted to morphine through an enzyme in the liver. Morphine is the active 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 amounts, 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, small pupils, nausea and vomiting, constipation, loss of appetite.
• It is essential to use the smallest dose that relieves/controls pain. Do not exceed the recommended dose in Section 3 - "How to take Paracetamol/codeína Level" to avoid this, avoid using other medications that contain paracetamol or codeína simultaneously.
• Consuming alcoholic beverages 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 medication, physical dependence and tolerance may develop. Administration should be gradually discontinued after prolonged treatment.
• The benefit-risk balance during continued use 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, treatment should be interrupted and your doctor consulted.

During treatment with Paracetamol/codeína Level, inform your doctor immediately 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 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. 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 Paracetamol/codeína Level, as it may alter the results of these tests.

Children and adolescents

Use in children and adolescents after surgery:

Codeína should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children over 12 years with respiratory problems:

Codeína should not be used in children over 12 years with respiratory problems, as the symptoms of morphine toxicity may be worse in these patients.

Other medications and Paracetamol/codeína Level

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Particularly, if you are using medications that contain any of the following active principles, as it may be necessary to modify the dose or interrupt treatment with any of them:

Paracetamol may interact with the following medications:

• Antibiotics (flucloxacillin), due to a severe risk of blood and fluid anomaly (denominated metabolic acidosis) that must receive urgent treatment (see section 2).Oral anticoagulants (acenocoumarol, warfarin)
• Medications used to relieve spasms or cramps of the stomach, intestines and bladder (anticholinergics)
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculosos (isoniazida, rifampicina)
• Barbiturates (used as sleep inducers, sedatives and anticonvulsants)
• Colestiramina (used to decrease blood cholesterol levels)
• Depressors of the central nervous system such as narcotic analgesics, anxiolytics, antipsychotics, neuromuscular blockers, sedatives, antihistamines H1, neuroleptics, adrenergic blockers
• Propranolol (adrenergic blocker) used in the treatment of high blood pressure (hypertension) and cardiac arrhythmias
• Inhibitors of MAO or tricyclic antidepressants
• Medications used to treat gout (probencid and sulfinpirazona)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, causing AIDS).

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

• Narcotic analgesics (used to treat pain) such as nalbufina, buprenorfina, pentazocina
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Antihistamines H1 sedatives (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Hypnotic neuroleptics (used to treat insomnia)
• Clonidina and related (used to treat hypertension and migraine)
• Talidomida (used to treat some types of cancer)
• Benzodiacepinas
• Medications used to relieve spasms or cramps of the stomach, intestines and bladder (anticholinergics).

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

Taking Paracetamol/codeína Level with food, drinks and alcohol

The use of paracetamol in patients who consume alcohol regularly (three or more alcoholic beverages per day) may damage the liver. In addition, alcohol may potentiate the depressive effect of codeína. Therefore, do not consume alcohol during treatment with this medication.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy, except if the potential benefit justifies the risk to the fetus.

Do not use codeína if you are breastfeeding. Codeína and morphine pass into breast milk.

Driving and operating machinery

Paracetamol/codeína Level contains codeína that may cause drowsiness, altering mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.

Paracetamol/codeína Level contains ethanol, azorrubina, sacarose, benzoate sodium, propylene glycol, benzyl alcohol (as raspberry essence) and sodium (as saccharin sodium and benzoate sodium):

This medication contains 856 mg of alcohol (ethanol) in each 15 ml dose, 571 mg in each 10 ml dose and 285 mg in each 5 ml dose, which is equivalent to 7.2% (v/v) of ethanol. The amount per dose of this medication is equivalent to 21.4 ml, 14.24 ml and 7.1 ml of beer or 8.5 ml, 5.7 ml and 2.8 ml of wine, respectively.

It is unlikely that the amount of alcohol contained in this medication will have any perceptible effect on adults or adolescents. It may have some effect on young children, such as drowsiness.

The amount of alcohol contained in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

This medication may cause allergic reactions because it contains azorrubina (carmoisina) (E-122).

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should note that this medication contains 8.9 g of saccharose per 15 ml dose, 5.93 g of saccharose per 10 ml dose and 2.97 g of saccharose per 5 ml dose.

This medication contains 22.5 mg of benzoate sodium (E-211) in each 15 ml dose, which is equivalent to 1.5 mg/ml.

Benzoate sodium may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains less than 23 mg of sodium (1 mmol) per 15 ml dose, which is essentially "sodium-free".

This medication contains 2.2 g of propylene glycol (E-1520) in each 15 ml dose, which is equivalent to 151 mg/ml.

If the child is under 5 years old, consult your doctor or pharmacist, particularly if other medications containing propylene glycol or alcohol have been administered.

If you are pregnant or breastfeeding, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

This medication contains 21.3 mg of benzyl alcohol in each 15 ml dose, which is equivalent to 1.42 mg/ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with severe adverse effects that include respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4 weeks old) unless recommended by your doctor.

This product should not be used for more than one week in children under 3 years old unless recommended by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults: 15 ml - 20 ml every 6 hours; up to a maximum of 25 ml every 6 hours.

This medication should not be taken for more than 3 days. If the pain does not subside in 3 days, you should consult your doctor.

Use in children and adolescents

Adolescents from 12 to 18 years: 10 to 15 ml, every 6 hours.

Do not use in patients under 12 years due to the risk of suffering severe respiratory problems.

Maximum recommended doses

In adults, the maximum doses correspond to 100 ml daily of solution, and 60 ml for adolescents from 12 to 18 years.

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 that they have prescribed.

Older patients

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

Instructions for correct administration of the preparation

Paracetamol/codeine Level is administered orally.

The solution can be administered directly or diluted with water, milk, or fruit juice.

Open the bottle by following the instructions indicated on the child-resistant safety cap (pressing and turning the same in the opposite direction to the clock hands). In the first opening, the guarantee seal will break.

To ensure a correct dosage, it is recommended to perform the dosage using the dosing cup (with different markings up to 15 ml) included in the package.

Place the dosing cup on a flat surface and at eye level. Fill it with the solution up to the line indicating your dose.

After use, wash the dosing cup with water and tightly close the bottle.

You can take it with or without food. To get quick relief from pain, take the medication without food.

If you take more Paracetamol/codeine Level than you should

If you have taken more Paracetamol/codeine Level 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 used. It is recommended to bring the package and the medication leaflet to the healthcare professional.

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

In case the patient is being treated with barbiturates or suffers from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

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

If you forgot to take Paracetamol/codeine Level

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 its usual time.

If you interrupt treatment with Paracetamol/codeine Level

Your doctor will indicate the duration of treatment with Paracetamol/codeine Level and when and how you should interrupt it. Do not suspend treatment before, as you will not get the expected effect.

There is a risk of possible effects derived from abstinence 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, pharmacist, or nurse.

Like all medicines, this medicine may 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), very rare (may affect up to 1 in 10,000 patients), and unknown frequency (cannot be estimated from available data).

The side effects of paracetamol are:

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 severe type of allergic reaction), hepatotoxicity (liver toxicity), jaundice (yellow discoloration of the skin and mucous membranes), hypoglycemia (reduced blood glucose levels), thrombocytopenia (reduced platelet count), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count), severe skin reactions, sterile pyuria (cloudy urine), and adverse renal effects.

Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The side effects of codeine are:

Rare: Discomfort, drowsiness (feeling of sleep), constipation, nausea, and vertigo, 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, and 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 of 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.

Store the bottle in its outer packaging. No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications.This will help protect the environment.

Composition of Paracetamol/codeína Level

• The active principles are paracetamol and codeine phosphate hemihydrate. Each milliliter of solution contains 24 mg of paracetamol and2.40mg of codeine phosphate hemihydrate.
• The other components are: Propylene glycol (E-1520), Ethanol, Raspberry flavor, Sodium benzoate (E-211), Sodium saccharin, Azorubine (E-122), Sucrose and Water.

Appearance of the product and contents of the packaging

Paracetamol/codeína Level is presented in the form of a transparent, red-colored solution with a characteristic raspberry aroma, packaged in a topaz glass bottle containing 240 ml, closed with a child-resistant plastic cap, along with a dosing cup.

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 22808020 Barcelona. Spain

Manufacturers responsible

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain.

Date of the last review of this leaflet: February 2025.

Other sources of information

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/