Paracetamol/codeine Kern Pharma 500 mg/30 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Paracetamol/codeine phosphate hemihydrate

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

Paracetamol/Codeine Kern Pharma is a combination of paracetamol and codeine. Paracetamol is a well-established analgesic and antipyretic (relieves pain and reduces fever), whose effects are enhanced by the action of codeine, a centrally-acting analgesic.

This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. It may be used alone or in combination with other analgesics such as paracetamol.

This medicine is indicated for the treatment of moderate pain.

2. What you need to know before taking Paracetamol/Codeine Kern Pharma

Do not take Paracetamol/Codeine Kern Pharma

• If you are allergic (hypersensitive) to paracetamol or propacetamol (a precursor of paracetamol), codeine, or any of the other components of Paracetamol/Codeine Kern Pharma.
• If you have any respiratory disease.
• 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 are a known rapid metabolizer of codeine into morphine.
• If you are breastfeeding.

Take special care with Paracetamol/Codeine Kern Pharma

• Do not take more than the recommended dose.
• If you have liver, kidney, heart, or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a decrease in red blood cells), you should consult your doctor before taking this medicine.
• If you have thyroid disease, prostate disorders (prostatic hypertrophy), intracranial lesions, or acute asthma attacks, you should consult your doctor before taking this medicine.
• This medicine should be administered with caution, avoiding prolonged treatment in patients with anemia, chronic cardiorespiratory insufficiency, or pulmonary conditions.
• Consuming alcoholic beverages (three or more alcoholic drinks per day) may cause paracetamol to cause liver damage.
• In chronic alcoholics, caution should be taken not to exceed 2 g/day of paracetamol.
• Patients with asthma or a history of asthma, particularly those sensitive to acetylsalicylic acid, should consult their doctor before taking this medicine.
• If pain persists for more than 10 days, worsens, or new symptoms appear, treatment should be stopped and a doctor consulted.
• In children under 15 years of age, consult your doctor or pharmacist, as use of this medicine is not recommended in this patient group.
• In elderly patients, it is recommended to consult your doctor before taking this medicine.
• Prolonged and excessive administration of codeine may lead to dependence and/or tolerance, especially in individuals with a tendency to abuse and addiction. After prolonged treatment, discontinuation should be gradual, as directed by your doctor.

Warnings and precautions

Tolerance, dependence, and addiction

This medicine contains codeine, which is an opioid. It may cause dependence and/or addiction.

Repeated use of opioids may lead to reduced effectiveness of the medicine (becoming accustomed to it, known as tolerance). Repeated use of Paracetamol/Codeine Kern Pharma may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine used or how often it is taken.

The risk of dependence or addiction varies from person to person. You may have a higher risk of dependence or addiction to Paracetamol/Codeine Kern Pharma if:

• You or any family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while taking Paracetamol/Codeine Kern Pharma, it could be a sign of dependence or addiction:

• You need to take the medicine for longer than recommended by your doctor
• You need to take a higher dose than recommended
• You feel a need to continue taking the medicine, even when it does not help relieve pain
• You are using the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help you sleep"
• You have made repeated unsuccessful attempts to stop or control your use of the medicine
• You feel unwell when you stop taking the medicine, and feel better once you resume taking it ("withdrawal effects")

If you notice any of these signs, speak with your doctor to determine the best treatment approach, when to stop treatment, and how to do so (see section 3, "If you stop treatment with Dolomedil").

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some people have a variation in this enzyme that may affect them differently. In some individuals, morphine is not produced or is produced in very low amounts, resulting in insufficient pain relief. In others, a very high amount 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 and seek immediate medical help: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.

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

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

Contact your doctor if you have severe abdominal pain possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms of pancreatitis or biliary tract system inflammation.

Sleep-related breathing disorders

Paracetamol/Codeine Kern Pharma 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 breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Use of other medicines

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

In particular, if you are using medicines containing any of the following active substances, dose adjustment or discontinuation of treatment may be necessary:

Paracetamol may interact with the following medicines:

• Antibiotics: chloramphenicol

• Anticoagulants (used to treat thromboembolic disorders)

• Oral contraceptives and estrogen treatments

• Antiepileptics (used to treat epileptic seizures)

• Metoclopramide and domperidone (used to prevent nausea and vomiting)

• Activated charcoal (used for diarrhea or gas treatment)

• 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, 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)

• Cholestyramine (used to lower blood cholesterol levels)

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap), which must be treated urgently (see section).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor. As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In the case of treatment with oral anticoagulants, occasional use as an analgesic of choice may be permitted.

Codeine, in turn, may interact with the following medicines:

• Nalbuphine, buprenorphine, pentazocine (used to treat pain)
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• Sedating H1 antihistamines (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Neuroleptic hypnotics (used to treat insomnia)
• Clonidine and related drugs (used to treat hypertension and migraine)
• Other morphine-like analgesics, barbiturates, benzodiazepines (used to treat pain)
• Gabapentin or pregabalin (used to treat epilepsy or nerve injury-related pain (neuropathic pain)).

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

Concomitant use of this medicine with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes this medicine together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's recommendations regarding dosage carefully. It may be helpful to inform friends or family members so they are aware of the aforementioned signs and symptoms. Contact your doctor if you experience such symptoms.

Children and adolescents

Use in children and adolescents after surgery

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

Use in children with respiratory problems

The use of codeine is not recommended in children with respiratory problems, as symptoms of morphine toxicity may be worse in these children.

Taking Paracetamol/Codeine Kern Pharma with food and drinks

Using paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Paracetamol/Codeine Kern Pharma is not recommended during pregnancy, and if used, it should always be under the supervision of your doctor, who will assess the potential risks and benefits of treatment. Never 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 using machines

This medicine may affect your ability to drive or operate machinery requiring special attention.

Therefore, do not drive or operate machinery until you know how you tolerate this medicine.

Alcohol may enhance this effect, so alcoholic drinks should not be consumed during treatment.

Important information about some of the components of Paracetamol/Codeine Kern Pharma

Take special care with Paracetamol/Codeine Kern Pharma if you are an athlete, as this medicine contains a component, codeine, which may result in a positive doping test.

Paracetamol/Codeine Kern Pharma contains sodium

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

3. How to take Paracetamol/Codeine Kern Pharma

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

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from using Paracetamol/Codeine Kern Pharma, when and for how long you should use it, when you should contact your doctor, and when you should interrupt treatment (see also “If you stop taking Paracetamol/Codeine Kern Pharma”).

Your doctor will determine the amount of medication you should take and the duration of treatment based on the intensity and characteristics of your pain. Paracetamol/Codeine Kern Pharma should be used for the shortest time necessary to relieve symptoms. If effective pain relief is not achieved during treatment with this medicine, you should consult a doctor.

The normal dose is:

Adults and adolescents over 15 years of age: 1 tablet every 6 hours as needed. The maximum dose per administration is 2 tablets, and the maximum daily dose is 8 tablets.

Never exceed the recommended dose.

Children under 15 years of age: Consult your doctor, as administration of this medicine is not recommended in this population group.

Children under 12 years of age: Children under 12 years of age must not take Paracetamol/Codeine Kern Pharma due to the risk of serious breathing problems.

Administration of this medicine should only occur when pain or fever symptoms are present. As these symptoms subside, the medication should be discontinued.

This medicine must not be taken for more than 3 days. If pain does not improve after 3 days, seek advice from your doctor.

Paracetamol/Codeine Kern Pharma should be taken orally. The tablets may be taken with a glass of water or another non-alcoholic liquid.

Patients with liver disease: You must consult your doctor before taking this medicine. You should take the amount of medication prescribed by your doctor, with a minimum interval of 8 hours between doses. You must not take more than 2 grams of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease: You must consult your doctor before taking this medicine.

Depending on your condition, your doctor will advise whether you should take the medicine with a minimum interval of 6 or 8 hours. You must not take more than 2 grams in 24 hours, divided into several doses, and must not exceed 500 milligrams per dose under any circumstances.

Elderly patients: You should consult your doctor.

If you feel that Paracetamol/Codeine Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

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

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

If you have taken an overdose, you must go immediately to a medical center even if you have no symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

An overdose of paracetamol is considered to occur when a single dose exceeding 6 g is taken in adults (12 tablets of Paracetamol/Codeine Kern Pharma) or more than 100 mg per kg of body weight in children (4 tablets in a single dose for a 20 kg child).

Symptoms of overdose due to paracetamol may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Symptoms of overdose due to codeine may include initial excitement, anxiety, inability to fall asleep (insomnia), and later in some cases drowsiness (somnolence), headache (cephalalgia), changes in blood pressure, arrhythmias, dry mouth, skin rashes, tachycardia, seizures, gastrointestinal disturbances, nausea, vomiting, and respiratory depression.

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

If you forget to take Paracetamol/Codeine Kern Pharma

Do not take a double dose to make up for a missed dose. Take the missed dose as soon as you remember. If your next dose is due soon, skip the missed dose and continue taking the medicine at your usual time. In case of doubt, consult your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, Paracetamol/Codeine Kern Pharma can cause adverse effects, although not everyone experiences them.

The adverse effects observed are described below according to their frequency of occurrence: Very common (affects more than 1 in every 10 patients), Common (affects between 1 and 10 in every 100 patients), Uncommon (affects between 1 and 10 in every 1,000 patients), Rare (affects between 1 and 10 in every 10,000 patients), Very rare (affects fewer than 1 in every 10,000 patients).

The following adverse effects have been observed with paracetamol:

Rare: Malaise, increased levels of hepatic transaminases (liver enzymes), hypotension (decrease in blood pressure).

Very rare: Allergic reactions (hypersensitivity) ranging from simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a severe type of allergic reaction), hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes), hypoglycemia (reduced glucose levels in blood), thrombocytopenia (reduction in platelets in blood), agranulocytosis, leucopenia, neutropenia (decrease in white blood cells in blood), sterile pyuria (cloudy urine), adverse renal effects.

Very rare cases of serious skin reactions have been reported.

Adverse effects of unknown frequency (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are taking paracetamol (see section 2).

The following adverse effects associated with codeine have also been reported, although their frequency has not been accurately established:

Malaise, drowsiness (somnolence), skin rashes, constipation, nausea, and yellowing of the skin and eyes (jaundice), low blood glucose (hypoglycemia), blood disorders.

Frequency not known (cannot be estimated from the available data): Symptoms associated with inflammation of the pancreas (pancreatitis) and of the biliary system (a condition affecting a valve in the digestive tract, known as Oddi sphincter dysfunction), for example, severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

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 not listed in this leaflet. You may also report them directly via 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 Kern Pharma

Keep out of sight and reach of children.

Store this medicine in a safe place inaccessible to others. It may cause serious harm and be fatal to individuals for whom it has not been prescribed.

Do not use Paracetamol/Codeine Kern Pharma after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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 you are unsure, 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 Kern Pharma

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

Appearance of the product and contents of the pack

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

Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was last reviewed in January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/