Leaflet: Information for the User

Paracetamol/Codeine Kern Pharma 500 mg/30 mg Tablets EFG

Paracetamol/codeine phosphate hemihydrate

Read this leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Paracetamol/Codeína Kern Pharma is a combination of paracetamol and codeine. Paracetamol is an analgesic and antipyretic (pain relief and fever reduction) medication of proven efficacy, whose effects are potentiated by the action of codeine, a central analgesic.

This product contains codeine. Codeine belongs to a group of medications called opioid analgesics that act to relieve pain. It may be used alone or in combination with other analgesics such as paracetamol.

This medication is indicated for the treatment of symptoms of moderate intensity pain.

Do not take Paracetamol/Codeína Kern Pharma

• If you are allergic (hypersensitive) to paracetamol or propacetamol (paracetamol precursor), codeine, or any of the other components of Paracetamol/Codeína Kern Pharma.
• If you have any respiratory disease.
• To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you know you metabolize codeine quickly to morphine.
• If you are breastfeeding.

Be especially careful with Paracetamol/Codeína Kern Pharma

• Do not take more than the recommended dose.
• If you have any liver, kidney, heart, or lung disease, or anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medication.
• If you have any thyroid disease, prostate alterations (prostatic hypertrophy), intracranial injuries, or acute asthma attacks, consult your doctor before taking this medication.
• Administer this medication with caution, avoiding prolonged treatments in patients with anemia, chronic cardiopulmonary insufficiency, or pulmonary diseases.
• Consuming three or more alcoholic beverages per day may cause paracetamol to damage the liver.
• In chronic alcoholics, do not take more than 2 g/day of paracetamol.
• Patients with asthma or a history of asthma, and sensitive to acetylsalicylic acid, should consult their doctor before taking this medication.
• If the pain persists for more than 10 days, worsens, or other symptoms appear, interrupt treatment and consult a doctor.
• Consult your doctor or pharmacist in children under 15 years old, as this medication is not recommended for this age group.
• In elderly patients, consult your doctor before taking this medication.
• Prolonged and excessive codeine administration may cause dependence and/or tolerance, especially in individuals with a tendency to abuse and addiction. After prolonged treatments, discontinue administration gradually as indicated by your doctor.

Warnings and precautions

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 differently. In some people, morphine is not produced or is produced in very small quantities, and it will not provide sufficient pain relief. In other people, it is more likely that they will experience severe adverse reactions because a very high amount of morphine is produced. If you experience any of the following adverse effects, stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea, or vomiting, constipation, loss of appetite.

During treatment with Paracetamol/Codeína Kern Pharma, 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 have malnutrition, chronic alcoholism, or if you 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 using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

Paracetamol may interact with the following medications:

• Antibiotics: chloramphenicol
• Anticoagulants (used to treat thromboembolic diseases)
• Oral contraceptives and estrogen treatments
• Antiepileptics (used to treat epilepsy)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Activated charcoal (used to treat diarrhea or gas)
• Diuretics (used to increase urine elimination)
• Isoniazid (used to treat tuberculosis)
• Lamotrigine (used to treat epilepsy)
• Probenecid (used to treat gout)
• Propranolol (used to treat hypertension and cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestines, and bladder)
• Zidovudine (used to treat HIV infections)
• Colestiramine (used to lower cholesterol levels in the blood)

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid alteration (denominated metabolic acidosis with high anionic imbalance) that must be treated urgently (see section).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor. As a general rule for any medication, it is recommended to inform your doctor or pharmacist systematically if you are taking another medication. In the case of oral anticoagulant treatment, this medication can be administered occasionally as the preferred analgesic.

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

• Nalbufina, buprenorphine, pentazocine (used to treat pain)
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Antihistamines H1 sedatives (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Hypnotic neuroléptics (used to treat insomnia)
• Clonidine and related (used to treat hypertension and migraine)
• Other morphine analgesics, barbiturates, benzodiazepines (used to treat pain).

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 this medication, as it may alter the results of these tests.

The concomitant use of this medication and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes this medication along with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members to be aware of the mentioned symptoms. Contact your doctor when you experience these symptoms.

Children and adolescents

Use in children and adolescents after surgery

Do not use codeine to relieve pain in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

Do not recommend the use of codeine in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.

Taking Paracetamol/Codeína Kern Pharma with food and drinks

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor, etc.) may cause liver damage.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not administer Paracetamol/Codeína Kern Pharma during pregnancy and, if used, it should always be under the supervision of your doctor, who will evaluate the possible risks and benefits of treatment. Do not exceed the recommended dose.

Small amounts of paracetamol may appear in breast milk.

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

Driving and operating machinery

This medication may alter your ability to drive vehicles or operate machinery that requires special attention.

Therefore, do not drive or operate machinery until you check how you tolerate this medication.

Alcohol may potentiate this effect, so do not consume alcoholic beverages during treatment.

Important information about some components of Paracetamol/Codeína Kern Pharma

Be especially careful with Paracetamol/Codeína Kern Pharma if you are an athlete, as this medication contains a component, codeine, which may establish a positive analytical result for doping control.

Paracetamol/Codeína Kern Pharma contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of Paracetamol/Codeína Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the amount of medication to take and the duration of treatment based on the intensity and characteristics of the pain.

The normal dose is:

Adults and children over 15 years: 1 tablet every 6 hours, as needed. The maximum dose per intake will be 2 tablets and the maximum daily dose will be 8 tablets.

Never exceed the recommended dose.

Children under 15 years:Consult your doctor, as this medication is not recommended for this age group.

Children under 12 years: Children under 12 years should not take Paracetamol/Codeína Kern Pharma due to the risk of severe respiratory problems.

The administration of the preparation is subject to the appearance of painful or feverish symptoms. As these symptoms disappear, this medication should be discontinued.

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

Paracetamol/Codeína Kern Pharma should be taken orally. The ingestion of the tablets can be helped with a sip of water or another non-alcoholic liquid.

Patients with liver disease: Before taking this medication, they must consult their doctor. They should take the prescribed amount of medication with a minimum interval of 8 hours between each intake. They should not take more than 2 grams of paracetamol in 24 hours, divided into several intakes.

Patients with kidney disease: Before taking this medication, they must consult their doctor.

According to their disease, their doctor will indicate if they should take their medication with a minimum interval of 6 or 8 hours. They should not take more than 2 grams in 24 hours, divided into several intakes, without exceeding 500 milligrams per intake in any case.

Patients of advanced age:They should consult their doctor.

If they estimate that Paracetamol/Codeína Kern Pharma is too strong or too weak, they should inform their doctor or pharmacist.

If you take more Paracetamol/Codeína Kern Pharma than you should

If you have taken more Paracetamol/Codeína Kern Pharma than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you have taken an overdose, go to a medical center immediately, even if you do not have symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe intoxication.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

A paracetamol overdose is considered to be the ingestion of a single dose of more than 6 grams in adults (12 tablets of Paracetamol/Codeína Kern Pharma) and more than 100 mg per kg of body weight in children. (For a child of 20 kg, 4 tablets in a single dose).

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

The symptoms of a codeine overdose can be: initial excitement, anxiety, inability to fall asleep (insomnia), and later in some cases a feeling of sleepiness (somnolence), headache (cephalalgia), blood pressure alterations, arrhythmias, dry mouth, skin eruptions, tachycardia, convulsions, gastrointestinal disturbances, nausea, vomiting, and respiratory depression.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol/Codeína Kern Pharma

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as you remember and if your next dose is due soon, omit the missed dose and continue taking the medication at the usual time. In case of doubt, consult your doctor or pharmacist.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Paracetamol/Codeína Kern Pharma may produce adverse effects, although not all people will experience them.

The observed adverse effects are described below according to the frequency of presentation: Very frequent (affects more than 1 in 10 patients), Frequent (affects between 1 and 10 in 100 patients), Infrequent (affects between 1 and 10 in 1,000 patients), Rare (affects between 1 and 10 in 10,000 patients), Very rare (affects less than 1 in 10,000 patients).

The following adverse effects have been observed produced by paracetamol:

Rare: Discomfort, increased levels of liver transaminases (liver enzymes), 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 type of severe allergic reaction), hepatotoxicity (liver toxicity), jaundice (yellow discoloration of skin and mucous membranes), hypoglycemia (reduced blood glucose levels), thrombocytopenia (reduced platelet count), agranulocytosis, leucopenia, neutropenia (decreased white blood cell count), sterile pyuria (cloudy urine), adverse renal effects.

Very rarely reported cases of severe skin reactions have been notified.

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

The following adverse effects have been described produced by codeine, whose frequency has not been established with precision:

Discomfort, drowsiness, skin rashes, constipation, nausea, and yellow discoloration of skin and eyes (jaundice), hypoglycemia, blood alterations.

Reporting Adverse Effects

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

Keep out of sight and reach of children.

Do not use Paracetamol/Codeine Kern Pharma after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Composition of Paracetamol/Codeína Kern Pharma

• The active principles are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine (phosphate hemihydrate).
• The other components are maize starch, sodium croscarmellose, povidone, magnesium stearate, and stearic acid.

Appearance of the product and content of the packaging

Paracetamol/Codeína Kern Pharma 500 mg/30 mg tablets are presented as round, white, and scored tablets on one side. The tablet can be divided into two equal halves.

Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

This prospectus has been reviewed in February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/