PARACETAMOL/CODEINE KERN PHARMA 500 mg/30 mg TABLETS

Introduction

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 starting to take the medication.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What is Paracetamol/Codeine Kern Pharma and what is it 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. Storage of Paracetamol/Codeine Kern Pharma
6. Package contents and additional information

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

Paracetamol/Codeine Kern Pharma is an association of paracetamol and codeine. Paracetamol is a proven effective analgesic and antipyretic medication (pain relief and fever reduction) whose effects are enhanced by the action of codeine, a central analgesic.

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

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

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 (paracetamol precursor), 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 old) after tonsil or adenoid removal due to obstructive sleep apnea syndrome.
• If you know you metabolize codeine to morphine very quickly.
• If you are breastfeeding.

Be careful with Paracetamol/Codeine Kern Pharma

• Do not take more than the recommended dose.
• If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin level in the blood, due to or not due to a reduction in red blood cells), you should consult your doctor before taking this medication.
• If you have any thyroid disease, prostate disorders (prostatic hypertrophy), intracranial lesions, as well as acute asthma attacks, you should consult your doctor before taking this medication.
• This medication should be administered with caution, avoiding prolonged treatments in patients with anemia, chronic cardiopulmonary insufficiency, or pulmonary conditions.
• Consuming alcoholic beverages (three or more alcoholic drinks per day) can cause paracetamol to damage the liver.
• In chronic alcoholics, caution should be taken not to take more than 2 g/day of paracetamol.
• Asthmatic patients or those with 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, or worsens, or other symptoms appear, treatment should be interrupted and a doctor consulted.
• In children under 15 years old, consult your doctor or pharmacist, as the use of this medication is not recommended in this patient group.
• In elderly patients, it is recommended to consult a doctor before taking this medication.
• Prolonged and excessive administration of codeine can cause dependence and/or tolerance, especially in individuals with a tendency to abuse and addiction. After prolonged treatments, the administration should be gradually interrupted 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 in different ways. In some people, morphine is not produced or is produced in very low quantities, 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 adverse effects, you should 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/Codeine Kern Pharma, inform your doctor immediately if:

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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.

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.

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

Paracetamolmay interact with the following medications:

• Antibiotics: chloramphenicol
• Anticoagulants (used to treat thromboembolic diseases)
• 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 stomach, intestine, and bladder spasms or contractions)
• Zidovudine (used to treat HIV infections)
• Colestyramine (used to decrease blood cholesterol levels)

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (called metabolic acidosis with high anion 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 systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

On the other hand, codeinemay interact with the following medications:

• Nalbuphine, buprenorphine, pentazocine (used to treat pain)
• 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 medications (used to treat hypertension and migraine)
• Other morphine-like analgesics, barbiturates, benzodiazepines (used to treat pain).

Interference with analytical tests:

If you are going to undergo any analytical test (including blood tests, urine tests, 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 sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can 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 sedative medications, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedative medications you are taking and follow your doctor's recommendations regarding the dose carefully. It may be useful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Children and adolescents

Use in children and adolescents after surgery

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

Use in children with respiratory problems

Codeine is not recommended for use in children with respiratory problems, as the symptoms of morphine toxicity can be worse in these children.

Taking Paracetamol/Codeine Kern Pharma with food and drinks

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor...) can cause liver damage.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Paracetamol/Codeine Kern Pharma is not recommended during pregnancy and, in case of use, 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 medication can alter the ability to drive vehicles or operate machinery that requires special attention.

Therefore, do not drive or use machinery until you have checked how you tolerate this medication.

Alcohol can enhance this effect, so you should not consume alcoholic beverages during treatment.

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

Be careful with Paracetamol/Codeine Kern Pharma if you are an athlete, as this medication contains a component, codeine, which can result in a positive doping test.

Paracetamol/Codeine Kern Pharma contains sodium

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

3. How to take Paracetamol/Codeine Kern Pharma

Follow the administration instructions of Paracetamol/Codeine Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have 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 old: 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 old:Consult your doctor, as the administration of this medication is not recommended in this population group.

Children under 12 years old: Children under 12 years old should not take Paracetamol/Codeine Kern Pharma, due to the risk of serious respiratory problems.

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

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

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

Patient with liver disease: before taking this medication, they must consult their doctor. They should take the prescribed amount of medication by their doctor 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.

Patient with kidney disease: before taking this medication, they must consult their doctor.

According to their disease, their doctor will indicate whether 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, not exceeding 500 milligrams per intake in any case.

Elderly patients: They should consult their doctor.

If you think 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning. The treatment of the overdose is more effective if it is started within 4 hours after taking the medication.

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

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

The symptoms of codeine overdose may be: initial excitement, anxiety, insomnia, and later in certain cases drowsiness, headache, changes in blood pressure, arrhythmias, dry mouth, skin rashes, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

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

If you forgot to take Paracetamol/Codeine Kern Pharma

Do not take a double dose to make up for the missed doses. Take the missed dose as soon as you remember and if your next dose is near in time, skip the missed dose and continue taking the medication at the usual schedule. 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.

4. Possible side effects

Like all medications, Paracetamol/Codeine Kern Pharma can cause side effects, although not all people experience them.

The observed side effects are described below according to their frequency of presentation: Very common (affects more than 1 in 10 patients), Common (affects between 1 and 10 in 100 patients), Uncommon (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 side effects have been observed with paracetamol:

Rare: Discomfort, increased liver transaminase levels (liver enzymes), hypotension (low 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) and jaundice (yellowing of the skin and mucous membranes), hypoglycemia (low blood sugar levels), thrombocytopenia (reduced platelet count in the blood), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count in the blood), sterile pyuria (cloudy urine), adverse renal effects.

Very rare cases of severe skin reactions have been reported.

Side effects of 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 following side effects have also been described with codeine, whose frequency has not been established with precision:

Discomfort, drowsiness, skin rashes, constipation, nausea, and yellowing of the skin and eyes (jaundice), low blood sugar (hypoglycemia), blood alterations.

Reporting side effects

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

5. Storage of Paracetamol/Codeine Kern Pharma

Keep out of sight and reach of children.

Do not use Paracetamol/Codeine Kern Pharma after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the indicated month.

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging contents and additional information

Composition of Paracetamol/Codeine Kern Pharma

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

Appearance of the product and packaging contents

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

Each package 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 revised in February 2025

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