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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Paracetamol/Codeine Level is and what it is used for

Paracetamol/Codeine 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/Codeine Level is indicated in patients over 12 years of age for the treatment of moderate acute pain that is not relieved by using ibuprofen or paracetamol alone as analgesic.

2. What you need to know before taking Paracetamol/codeine Level

Do not take Paracetamol/codeine Level

• If you are allergic to paracetamol, codeine, or any of the other ingredients of this medicine (listed in section 6).
• If you have acute respiratory depression, acute asthma, or chronic obstructive pulmonary disease (COPD).
• If you have or are at risk of developing paralytic ileus.
• To relieve pain in children and adolescents (0–18 years of age) after tonsil or adenoid removal due to obstructive sleep apnea syndrome.
• If you know that you metabolize codeine to morphine very rapidly.
• If you are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Paracetamol/codeine Level:

• If you have heart or lung disease, or if you have anemia (low hemoglobin levels in the blood, with or without a low red blood cell count), or if you have low levels of an enzyme in the blood called glucose-6-phosphate dehydrogenase, consult your doctor before taking this medicine.
• If you have liver disease (including Gilbert’s syndrome) or kidney disease, or if you suffer from chronic malnutrition or dehydration, you may require a reduced dose of paracetamol.
• If you have any condition affecting your ability to breathe, intracranial lesions (e.g., due to head trauma), asthma or a history of asthma, and/or if you are sensitive to acetylsalicylic acid.
• If you have thyroid disease, prostate disorders or urethral narrowing (causing difficulty in urination), adrenal insufficiency (Addison’s disease), or intestinal or gallbladder disorders.
• If you are elderly or feel physically weakened.
• If you suffer from chronic constipation, use of this medicine may worsen your symptoms.
• Codeine is converted into morphine by an enzyme in the liver. Morphine is the active substance that provides pain relief. Some people have a genetic variation of this enzyme that affects how they respond to codeine. In some individuals, little or no morphine is produced, resulting in inadequate pain relief. In others, very high levels of morphine may be produced, increasing the risk of serious adverse reactions. If you experience any of the following adverse effects, stop taking this medicine immediately and seek medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea and vomiting, constipation, or loss of appetite.
• It is important to use the lowest dose that effectively relieves/controls your pain. Do not exceed the recommended dose described in Section 3 – “How to take Paracetamol/codeine Level.” Avoid taking other medicines containing paracetamol or codeine at the same time.
• Drinking alcohol may increase the risk of liver damage caused by paracetamol.
• Prolonged or frequent use of painkillers to treat headaches may worsen the symptoms, and higher doses should not be used to treat this condition.
• The benefit-risk balance during long-term use should be periodically reassessed by your doctor.
• If pain persists for more than 3 days (2 days for sore throat), worsens, or new symptoms appear, stop treatment and consult your doctor.

During treatment with Paracetamol/codeine Level, inform your doctor immediately if:

• You have serious conditions such as severe kidney failure 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 under these circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty in breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
• You have 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 system.
• You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increased dose of the medicine.
• Sleep-related breathing disorders

Paracetamol/codeine Level 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 staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

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 Paracetamol/codeine Level 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 Paracetamol/codeine Level 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 Paracetamol/codeine Level, 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 no longer helps relieve your pain.
• You take the medication for reasons other than the one for which it was prescribed, 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 take it again ("withdrawal effects").

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

Interference with laboratory tests

If you are due to undergo any laboratory tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking Paracetamol/codeine Level, as it may alter the results of such tests.

Children and adolescents

Use in children and adolescents after surgery:

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

Use in children over 12 years with respiratory problems:

Codeine is not recommended in children over 12 years of age with respiratory problems, as morphine toxicity symptoms may be worse in these patients.

Other medicines and Paracetamol/codeine Level

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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:

• Antibiotics (flucloxacillin), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to relieve spasms or cramps in the stomach, intestine, and bladder (anticholinergics).
• Antiepileptic drugs (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculosis agents (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
• Cholestyramine (used to lower blood cholesterol levels).
• Central nervous system depressants such as narcotic analgesics, anxiolytics, antipsychotics, neuromuscular blockers, sedatives, H1 antihistamines, neuroleptics, adrenergic blockers.
• Propranolol (adrenergic blocker) used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• MAO inhibitors or tricyclic antidepressants.
• 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 human immunodeficiency virus, the cause of AIDS).

Codeine, in turn, 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 agents (used to treat hypertension and migraine).
• Thalidomide (used to treat certain types of cancer).
• Gabapentin or pregabalin used to treat epilepsy or pain caused by nerve system damage (neuropathic pain).
• Benzodiazepines.
• Medications used to relieve spasms or cramps in the stomach, intestine, and bladder (anticholinergics).

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

Taking Paracetamol/codeine Level with food, drinks, and alcohol

Using paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day) may damage the liver. In addition, alcohol may enhance the depressant effect of codeine. Therefore, alcohol must not be consumed during treatment with this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

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

Paracetamol/codeine Level contains ethanol, azorubine, sucrose, sodium benzoate, propylene glycol, benzyl alcohol (as raspberry flavoring), and sodium (as sodium saccharin and sodium benzoate):

This medicine 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, equivalent to 7.2% (v/v) ethanol. The amount per dose of this medicine 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.

The amount of alcohol in this medicine is unlikely to have any noticeable effect in adults or adolescents. It could have some effects in young children, such as drowsiness.

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

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

This medicine may cause allergic reactions as it contains azorubine (carmoisine) (E-122).

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 8.9 g of sucrose per 15 ml dose, 5.93 g of sucrose per 10 ml dose, and 2.97 g of sucrose per 5 ml dose.

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

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

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

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

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

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

If you have hepatic or renal impairment, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

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

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome"), in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor.

This product must not be used for more than one week in children under 3 years of age unless directed 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).

3. How to take Paracetamol/codeine Level

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

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using Paracetamol/codeine Level, 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 Paracetamol/codeine Level).

The recommended dose is:

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

This medicine must not be taken for more than 3 days. If pain does not subside within 3 days, you must consult your doctor.

Paracetamol/codeine Level should be used for the shortest period necessary to relieve symptoms. If adequate pain relief is not achieved during treatment with this medicine, you must consult a doctor.

Use in children and adolescents

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

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

Recommended maximum doses

In adults, the maximum dose corresponds to 100 ml of solution per day, and 60 ml per day for adolescents aged 12 to 18 years.

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

Instructions for correct administration of the preparation

Paracetamol/codeine Level is administered orally.

The solution may be taken directly or diluted with water, milk, or fruit juice.

Open the bottle following the instructions on the child-resistant safety cap (press down and turn counterclockwise). Upon first opening, the tamper-evident seal will break.

To ensure accurate dosing, it is recommended to use the dosing cup (with markings up to 15 ml) provided in the package.

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

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

The medicine may be taken with or without food. For faster pain relief, take the medicine without food.

If you take more Paracetamol/codeine Level than you should

If you have taken more Paracetamol/codeine Level than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken. 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 Paracetamol/codeine Level

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

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

If you stop taking Paracetamol/codeine Level

Your doctor will inform you of the duration of treatment with Paracetamol/codeine Level and when and how you should stop it. Do not stop treatment prematurely, as you will not achieve the intended effect.

There is a risk of possible withdrawal-related 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, pharmacist, or nurse.

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 frequency not known (cannot be estimated from available data).

The adverse effects of paracetamol are:

Rare: Malaise, increased hepatic transaminase levels (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 allergic reaction), hepatotoxicity (liver toxicity), jaundice (yellowing of the skin and mucous membranes), hypoglycemia (reduced blood glucose levels), thrombocytopenia (reduced platelet count), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count), haemolytic anaemia (reduced red blood cells), severe skin reactions, sterile pyuria (cloudy urine), and adverse renal effects.

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

The 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, haemolytic anaemia.

Frequency 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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Paracetamol/Codeine Level

Keep this medicine out of sight and reach of children.

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

Keep this medicine in a secure location inaccessible to other people. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

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 a SIGRE collection point at your pharmacy. If in doubt, 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 Paracetamol/Codeine Level

• The active substances are paracetamol and codeine phosphate hemihydrate. Each millilitre of solution contains 24 mg of paracetamol and 2.40 mg of codeine phosphate hemihydrate.
• The other components are: Propylene glycol (E-1520), Ethanol, Raspberry flavouring, Sodium benzoate (E-211), Sodium saccharin, Carmoisine (E-122), Sucrose and Water.

Appearance of the medicine and contents of the pack

Paracetamol/Codeine Level is presented as a red, raspberry-scented, transparent solution, packed in a 240 ml amber glass bottle closed with a child-resistant plastic cap and supplied with a dosing cup.

Marketing Authorization Holder

Laboratorios ERN, S.A.
C/Perú, 228
08020 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.
C/Gorchs Lladó, 188
Pol. Ind. Can Salvatella
08210 Barberá del Vallés (Barcelona), Spain

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

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/