PARACETAMOL/CODEINE 24mg/ml + 2.40mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Paracetamol/Codeine Level 24 mg/ml +2.40mg/ml Oral Solution

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Paracetamol/Codeine Level and what is it 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 the use of ibuprofen or paracetamol as the only analgesic.

2. What you need to know before you take 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,
• If you have or are at risk of paralytic ileus,
• To relieve pain in children and adolescents (0-18 years of age) after tonsillectomy 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, pharmacist, or nurse before starting to take Paracetamol/Codeine Level:

• 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, consult your doctor before taking the medicine.
• If you have liver problems (including Gilbert's syndrome) or kidney problems, or suffer from chronic malnutrition or are dehydrated, you may need a reduction in the paracetamol dose.
• 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 disorders, or urethral stricture (which can cause difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder disorders.
• If you are an elderly person or feel weakened.
• If you have chronic constipation, the use of this medicine may worsen the symptoms.
• Codeine is converted into 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 in different ways. In some people, no morphine is produced or it is produced in very small amounts, and it will not provide sufficient pain relief. Other people are more likely to suffer from serious 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 medicine 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/control the pain. Do not exceed the recommended dose in Section 3 - "How to take Paracetamol/Codeine Level" to avoid the simultaneous use of other medicines that contain paracetamol or codeine.
• If you consume alcoholic beverages, it may cause paracetamol to produce liver damage.
• Prolonged or frequent use of analgesics to treat headaches may worsen the symptoms, which should not be treated with higher doses of the medicine.
• With repeated administration of this medicine, physical dependence and tolerance may appear. Administration should be gradually suspended after prolonged treatments.
• The benefit/risk balance during continued use must be reevaluated periodically by the doctor.
• If the pain persists for more than 3 days (2 days for throat pain), worsens, or other symptoms appear, treatment should be discontinued, and a doctor should be consulted.

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

• 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 the 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 laboratory tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking Paracetamol/Codeine Level, as it may alter the results of these tests.

Children and Adolescents

Use in children and adolescents after surgery:

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

Use in children over 12 years of age with respiratory problems:

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

Other Medicines and Paracetamol/Codeine Level

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

In particular, if you are using medicines that contain any of the following active ingredients, as it may be necessary to modify the dose or interrupt treatment of any of them:

Paracetamol may interact with the following medicines:

• Antibiotics (flucloxacillin), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2). Oral anticoagulants (acenocoumarol, warfarin)
• Medicines used for the relief of stomach, intestine, and bladder spasms or cramps (anticholinergics)
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculars (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Cholestyramine (used to decrease blood cholesterol levels)
• CNS depressants 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 heart rhythm disorders (cardiac arrhythmias)
• MAO inhibitors or tricyclic antidepressants
• Medicines 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).

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

• 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 (used to treat hypertension and migraine)
• Thalidomide (used to treat some types of cancer)
• Benzodiazepines
• Medicines used for the relief of stomach, intestine, and bladder spasms or cramps (anticholinergics).

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

Taking Paracetamol/Codeine Level with Food, Drinks, and Alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day) may damage the liver. Additionally, alcohol may potentiate the depressant effect of codeine. Therefore, you should not drink alcohol during treatment with this medicine.

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.

This medicine should not be used during pregnancy, unless the possible 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, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Paracetamol/Codeine Level contains ethanol, azorubine, sucrose, sodium benzoate, propylene glycol, benzyl alcohol (as raspberry essence), 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, which is equivalent to 7.2% (v/v) of 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.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect on adults or adolescents. However, it may have some effects on young children, such as drowsiness.

The amount of alcohol 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 because it contains azorubine (carmoisine) (E-122).

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

Patients with diabetes mellitus should note 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, which is 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, which is equivalent to 151 mg/ml.

If the child is under 5 years of age, consult your doctor or pharmacist, especially if they have been given other medicines that contain propylene glycol or alcohol.

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

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

This medicine 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 the risk of serious side effects, including respiratory problems ("gasping syndrome") in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor recommends it.

This product should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist recommends it.

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

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

3. How to Take Paracetamol/Codeine Level

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in 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 medicine should not be taken for more than 3 days. If the pain does not subside within 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 of age due to the risk of serious respiratory problems.

Maximum Recommended Doses

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

Patients with Kidney and/or Liver Disease

If you have kidney 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 likely to experience side effects, so the dose may need to be reduced. Consult your doctor.

Instructions for the 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 on the child-resistant cap (pressing and turning it counterclockwise). On the first opening, the guarantee seal will break.

In order to ensure correct dosing, it is recommended to use the measuring cup (with different markings up to 15 ml) included in the packaging.

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

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

It can be taken with or without food. For rapid 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the packaging and the package leaflet of the medicine 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 case 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 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 Paracetamol/Codeine Level

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 Paracetamol/Codeine Level

Your doctor will indicate the duration of treatment with Paracetamol/Codeine Level and when and how you should stop it. Do not stop treatment before, 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 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 all people suffer from them.

The observed adverse 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 the available data).

The adverse effects of paracetamol are:

Rare: Discomfort, increased levels of hepatic 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 (yellowish color of skin and mucous membranes), hypoglycemia (reduced glucose levels in blood), thrombocytopenia (reduction of platelets in blood), agranulocytosis, leucopenia, neutropenia (decrease in white blood cells in blood), hemolytic anemia (decrease in red blood cells in blood), severe skin reactions, sterile pyuria (cloudy urine), and adverse renal effects.

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

The adverse effects of codeine are:

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 (yellowish color of skin and eyes), hypoglycemia (reduced glucose levels in blood), thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia.

Reporting of Adverse Effects:

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

5. Conservation of Paracetamol/Codeine Level

Keep this medicine out of sight and reach of children.

Store the bottle in its outer packaging. It does not require special storage conditions.

Do not use this medicine after 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 thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Paracetamol/Codeine Level

• The active ingredients are paracetamol and codeine phosphate hemihydrate. Each milliliter 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 essence, Sodium benzoate (E-211), Sodium saccharin, Azorubine (E-122), Sucrose, and Water.

Appearance of the Product and Packaging Content

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

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228 08020 Barcelona, Spain

Manufacturers

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain.

Date of the Last Revision of this Prospectus: February 2025.

Other Sources of Information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/