COXUMADOL 500 mg/30 mg EFFERVESCENT GRANULES

Introduction

Package Leaflet: Information for the User

Coxumadol 500 mg/30 mg Effervescent Granules

Paracetamol/Codeine Phosphate Hemihydrate

Contents of the Package Leaflet:

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

1. What is Coxumadol and what is it used for

Coxumadol belongs to a group of medicines called analgesics.

Coxumadol is indicated for the short-term treatment of moderate acute pain in patients over 15 years of age that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

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

2. What you need to know before you take Coxumadol

Do not take Coxumadol:

• If you are under 15 years of age.
• If you are allergic to paracetamol, codeine, or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease.
• If you have acute respiratory depression, acute asthma, or chronic obstructive pulmonary disease.
• 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 that you metabolize codeine very quickly into morphine.
• If you are breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medicine.

It is important to use the smallest dose that relieves your pain. Do not take more than the recommended dose by your doctor or as stated in section 3 of this leaflet "How to take Coxumadol". To do this, avoid taking other medicines that contain paracetamol or codeine at the same time (used, for example, to treat colds, pain, and fever).

During treatment with Coxumadol, inform your doctor immediately:

• If you have any heart or lung disease, and in patients with anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), consult your doctor before taking the medicine.

• If you have liver or kidney problems, or suffer from chronic malnutrition or are dehydrated, you may need a reduction in the dose of this medicine.
• 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, prostate, or urethral stricture (both of which cause difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder conditions.
• If you are an elderly person or feel weakened.
• If you have chronic constipation, the use of this medicine may worsen the symptoms.
• If you consume alcoholic beverages, it may cause paracetamol to produce liver damage. As a precaution, do not take more than 4 tablets (2g of paracetamol) in less than 24 hours.
• If the pain persists for more than 3 days, worsens, or other symptoms appear, treatment should be discontinued and a doctor consulted.
• Codeine is converted 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, no morphine is produced or it 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 side effects, you should stop taking this medicine and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.
• The prolonged or frequent use of analgesics to treat headaches can worsen the symptoms, which should not be treated with higher doses of the medicine.
• With repeated administration of this drug, physical dependence and tolerance may occur. Administration should be gradually discontinued after prolonged treatments as indicated by your doctor.
• If you need to take this medicine for a prolonged period, the treatment should be reevaluated periodically by your doctor. If you have serious diseases, such as severe renal insufficiency 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 serious 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.

Children and Adolescents:

This medicine is contraindicated in children and adolescents under 15 years of age.

Use in children and adolescents after surgery:

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

Use in children and adolescents with respiratory problems:

The use of codeine is not recommended in children and adolescents with respiratory problems, as the symptoms of morphine toxicity can be worse in these patients.

Interference with laboratory tests:

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

Using Coxumadol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Paracetamolmay interact with the following medicines:

• Anticoagulants (used to treat thromboembolic diseases), although paracetamol may be administered occasionally as an analgesic of choice.
• Antiepileptics (used to treat epileptic seizures).
• 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).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Zidovudine (used to treat HIV infections).
• Colestyramine (used to decrease cholesterol levels in the blood).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomalies (called metabolic acidosis) that requires urgent treatment (see section 2).

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

Codeinemay interact with the following medicines:

• Narcotic analgesics (used to treat pain) such as nalbuphine, buprenorphine, pentazocine.
• Alcohol: May enhance the depressant effect of codeine.
• Antidepressants (used to treat depression).
• Sedatives (used to treat depression, anxiety).
• Sedating antihistamines (used to treat allergies).
• Anxiolytics (used to treat anxiety).
• Neuroleptic hypnotics (used to treat insomnia).
• Clonidine and related medicines (used to treat hypertension and migraine).
• Thalidomide (used to treat certain types of cancer).
• Benzodiazepines.
• Medicines used to relieve stomach, intestine, or bladder spasms (anticholinergics).

Taking Coxumadol with food, drinks, and alcohol

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

Pregnancy, Breastfeeding, and Fertility

Pregnancy:

Consult your doctor or pharmacist before taking any medicine.

Taking medicines during pregnancy can be dangerous for the embryo or fetus.

If you are pregnant or think you may be pregnant, consult your doctor before taking Coxumadol.

Breastfeeding:

Consult your doctor or pharmacist before taking any medicine.

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

Driving and Using Machines

This medicine contains codeine, which may cause drowsiness, affecting your mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Use in Athletes:This medicine contains codeine. As a result of its metabolism, some compounds are produced that can result in a positive doping test.

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

Patients on low-sodium diets should be aware that this medicine contains 629 mg (27.35 mmol) of sodium per dose.

3. How to Take Coxumadol

Follow exactly the instructions for administration of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

Adults and adolescents over 15 years of age: 1 or 2 sachets, 1 to 3 times in 24 hours. The doses should be spaced at least 4 hours apart. Do not exceed 8 sachets per day.

Adolescents under 15 years of age:should not take this medicine (see section 2).

Children under 12 years of age:

Children under 12 years of age should not take this medicine due to the risk of serious respiratory problems.

Patient with liver or kidney disease: should consult their doctor (see section 2).

Elderly patients:should consult their doctor (see section 2).

This medicine should be taken orally.

Dissolve the contents of the sachet in a glass of water and wait for the effervescence to cease.

If you think that the action of Coxumadol is too strong or too weak, tell your doctor or pharmacist.

If you take more Coxumadol than you should

If you take more Coxumadol than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you have taken an overdose, you should go quickly to a medical center 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. Treatment of the overdose is more effective if started within 4 hours after taking the medicine.

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

Patients being treated with barbiturates or suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

Symptoms of codeine overdose may include: headache, ringing in the ears, blurred vision, and drowsiness leading to stupor, cold skin, muscle flaccidity, and occasionally bradycardia, hypotension, and respiratory depression.

If you forget to take Coxumadol

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the indicated interval between them (at least 4 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 have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Coxumadol, due to its paracetamol content, may cause the following side effects, listed by frequency:

• Rare (may affect up to 1 in 1,000 people): discomfort, increased liver transaminases (liver enzymes), and hypotension (low blood pressure).
• Very rare (may affect up to 1 in 10,000 people): (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), and jaundice (yellowing of the skin and mucous membranes), hypoglycemia (low blood sugar levels), thrombocytopenia (reduced platelet count), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count), sterile pyuria (cloudy urine), and adverse renal effects. Very rare cases of severe skin reactions have been reported.
• Frequency not known (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).

Due to its codeine content, it may cause:

• Rare (may affect up to 1 in 1,000 people): 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 (may affect up to 1 in 10,000 people): allergic reactions (hypersensitivity) ranging from a simple skin rash or urticaria to anaphylactic shock, fever, jaundice (yellowing of the skin and eyes), hypoglycemia (low blood sugar levels), thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Coxumadol

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the package, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. They will dispose of it in an environmentally friendly way. If you have any further questions on the disposal of unused medicines, ask your pharmacist.

6. Contents of the pack and further information

Composition of Coxumadol:

• The active ingredients are paracetamol and codeine phosphate. Each sachet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
• The other ingredients (excipients) are: sodium saccharin, sucrose, povidone, sodium carbonate, sodium bicarbonate, citric acid, sodium citrate, orange flavor, and lemon flavor.

Appearance of the product and pack contents:

Coxumadol is a white-yellowish effervescent granule with a citrus odor and flavor, presented in single-dose sachets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

ITALFARMACO S.A.

San Rafael, 3, 28108 – Alcobendas (Madrid). Spain

Manufacturer:

Kern Pharma S.L.

Polígono Industrial Colón II

Venus 72-08228-Tarrasa (Barcelona). Spain

Date of last revision of this leaflet: December 2024

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/