Oxycodone/naloxone CINFA 5 mg/2.5 mg prolonged-release tablets EFG
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What oxicodone/naloxone cinfa is and what it is used for
- 2. What you need to know before starting to take oxycodone/naloxone cinfa
- 3. How to take oxicodone/naloxone cinfa
- 4. Possible adverse effects
- 5. Storage of oxycodone/naloxone cinfa
- 6. Contents of the container and additional information
Patient Information Leaflet
Introduction
Patient Information Leaflet
oxicodone/naloxone cinfa 5 mg/2.5 mg prolonged-release tablets EFG
oxycodone hydrochloride / naloxone hydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What oxicodone/naloxone cinfa is and what it is used for
- What you need to know before taking oxicodone/naloxone cinfa
- How to take oxicodone/naloxone cinfa
- Possible side effects
- How to store oxicodone/naloxone cinfa
- Contents of the pack and other information
1. What oxicodone/naloxone cinfa is and what it is used for
Oxicodone/naloxone cinfa is a prolonged-release tablet, meaning that its active substances are released over an extended period of time. Its effect lasts for 12 hours.
This medicine is intended for use in adults only.
Pain relief
Your doctor has prescribed oxicodone/naloxone to treat severe pain that can only be adequately managed with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.
How these tablets work for pain relief
These tablets contain the active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the analgesic effect of the medicine. It is a potent analgesic belonging to the opioid group. The second active substance in this medicine, naloxone hydrochloride, acts to counteract constipation. Gastrointestinal dysfunction (e.g., constipation) is a common adverse effect of treatment with opioid analgesics.
Restless legs syndrome
You have been prescribed Oxicodone/naloxone cinfa for second-line symptomatic treatment in patients with moderate to very severe idiopathic restless legs syndrome who cannot be treated with dopaminergic medications. People with restless legs syndrome experience unpleasant sensations in their limbs. These sensations may begin as soon as they sit or lie down and are only relieved by an urgent and irresistible urge to move the legs, sometimes also the arms and other parts of the body. This makes it very difficult to remain seated or to sleep. Naloxone hydrochloride has been added to counteract constipation.
How these tablets work in restless legs syndrome
This medicine helps relieve unpleasant sensations and thereby reduces the compelling need to move the limbs.
The second active substance in this medicine, naloxone hydrochloride, acts to counteract constipation. Gastrointestinal dysfunction (e.g., constipation) is a common adverse effect of treatment with opioid analgesics.
2. What you need to know before starting to take oxycodone/naloxone cinfa
Do not take oxycodone/naloxone cinfa:
- if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
- if your breathing does not provide sufficient oxygen to the blood or remove the carbon dioxide produced in the body (respiratory depression),
- if you have severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
- if you have a disorder known as cor pulmonale. This condition involves enlargement of the right side of the heart due to increased pressure in the blood vessels of the lungs, etc. (for example, as a consequence of COPD, see above),
- if you have severe bronchial asthma,
- if you have paralytic ileus (a type of intestinal obstruction) not caused by opioids,
- if you have moderate to severe liver disease.
Warnings and precautions
Consult your doctor or pharmacist before starting to take oxycodone/naloxone cinfa:
- if you are an elderly or debilitated (weak) patient,
- if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
- if you have kidney diseases,
- if you have mild liver disease,
- if you have severe lung diseases (i.e., reduced breathing capacity),
- if you have a condition characterized by frequent breathing pauses during sleep, which may make you feel very sleepy during the day (sleep apnea),
- if you have myxedema (a thyroid disorder characterized by dry, cold, and swollen skin, affecting the face and extremities),
- if your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
- if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
- if you have a mental disorder accompanied by a partial or complete loss of touch with reality (psychosis) due to alcoholism or intoxication by other substances (substance-induced psychosis),
- if you have problems related to gallstones,
- if you have an abnormal enlargement of the prostate (prostate hypertrophy),
- if you have inflammation of the pancreas (pancreatitis),
- if you have low blood pressure (hypotension),
- if you have high blood pressure (hypertension),
- if you have a previous cardiovascular disease,
- if you have a head injury (due to the risk of increased pressure in the brain),
- if you have epilepsy or are prone to seizures,
- if you are also receiving treatment with MAO inhibitors (used to treat depression or Parkinson's disease) or have taken such medications within the past two weeks, for example, medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid,
- if you experience drowsiness or sudden episodes of falling asleep.
Contact your doctor if you have severe pain in the upper abdomen that may extend to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.
Inform your doctor if you have previously had any of these conditions. Also inform your doctor if you develop any of them during treatment with oxycodone/naloxone cinfa.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid, and may cause dependence and/or addiction. |
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of oxycodone/naloxone may lead to dependence, abuse, and addiction, which can result in a life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often you need to take it. You may feel that you need to continue taking the medicine, even when it no longer helps relieve your pain or restless legs syndrome.
The risk of becoming dependent or addicted to oxycodone/naloxone varies from person to person. You may have a higher risk of becoming dependent or addicted to oxycodone/naloxone:
- if you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction").
- if you smoke.
- if you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.
If you notice any of the following signs while taking oxycodone/naloxone, it could be a sign that you have become dependent or addicted:
- You need to take the medicine for longer than recommended by your doctor.
- You need to take higher doses than recommended.
- You are using the medicine for reasons other than prescribed, for example, "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 take it again ("withdrawal symptoms").
If you notice any of these signs, speak with your doctor to discuss the best treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking oxycodone/naloxone).
The most serious consequence of opioid overdose is respiratory depression (slow and shallow breathing). This may also cause a decrease in blood oxygen levels, which can lead to fainting, etc.
Sleep-related breathing disorders
Oxycodone/naloxone may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.
Swallow the prolonged-release tablet whole, so that the slow release of oxycodone hydrochloride from the tablet is not affected. Do not split, chew, or crush the tablets. If you do, your body may absorb a potentially fatal dose of oxycodone hydrochloride (see section 3, "If you take more oxycodone/naloxone cinfa than you should").
If you experience severe diarrhoea at the beginning of treatment, it may be due to the effect of naloxone. It may be a sign that intestinal function is normalizing. This diarrhoea may occur during the first 3 to 5 days of treatment. If it persists beyond this 3 to 5-day period, or if you are concerned, contact your doctor.
If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment with oxycodone/naloxone, for example, restlessness, sweating episodes, and muscle pain. If you experience any of these symptoms, you may require special monitoring by your doctor.
You may develop tolerance if you use oxycodone/naloxone for a long time. This means you will need a higher dose to achieve the desired effect. Long-term use of oxycodone/naloxone may also lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped abruptly (restlessness, sweating episodes, muscle pain). If you no longer need treatment, the daily dose should be gradually reduced, in consultation with your doctor.
The active substance oxycodone hydrochloride, when uncombined, has the same abuse characteristics as other potent opioids (strong analgesics). It may lead to psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients with current or past history of alcohol, drug, or medication abuse.
Inform your doctor if you have cancer associated with peritoneal metastases or the onset of intestinal obstruction in advanced stages of gastrointestinal or pelvic cancer.
If you need to undergo surgery, inform the medical team that you are receiving treatment with oxycodone/naloxone.
Like other opioids, oxycodone may affect the normal production of hormones in the body, such as cortisol or sex hormones, especially if high doses are taken for long periods. If you notice persistent symptoms such as malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased sexual desire, consult your doctor so that your hormone levels can be monitored.
You may notice remnants of the prolonged-release tablet in your stools. Do not be alarmed, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and intestine and absorbed by your body.
Incorrect use of oxycodone/naloxone cinfa
Oxycodone/naloxone is not suitable as a treatment for withdrawal syndrome.
Never abuse oxycodone/naloxone, especially if you have a substance use disorder. If you are addicted to substances such as heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse oxycodone/naloxone, because it contains naloxone. Pre-existing withdrawal symptoms may worsen.
You should also never dissolve prolonged-release oxycodone/naloxone tablets for injection (e.g., into a blood vessel). This is because they contain talc, which can cause local tissue destruction (necrosis) and lung tissue damage (pulmonary granuloma). This incorrect use may also have other serious consequences and may even cause death.
The use of oxycodone/naloxone may result in positive anti-doping test results. The use of oxycodone/naloxone as a doping agent may endanger health.
Other medicines and oxycodone/naloxone cinfa
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
The concomitant use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Because of this, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes oxycodone/naloxone together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and carefully follow the doses recommended by your doctor. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms. Some examples of sedative or related medicines include:
- other strong analgesics (opioids);
- sleeping pills and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics);
- medicines used to treat depression;
- medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics);
- medicines used to treat psychiatric or mental disorders (antipsychotics including phenothiazines and neuroleptics);
- muscle relaxants;
- medicines used to treat Parkinson's disease.
If you take these tablets together with other medicines, the effects of the tablets or the other medicines listed below may change. Inform your doctor if you are taking:
- medicines that reduce blood clotting ability (coumarin derivatives), as clotting time may increase or decrease;
- macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin);
- antifungal agents of the -azole type (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
- a specific type of medicine known as a protease inhibitor used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, or saquinavir);
- cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
- rifampicin (used to treat tuberculosis);
- carbamazepine (used to treat seizures or convulsions and certain painful conditions);
- phenytoin (used to treat seizures or convulsions);
- a herbal remedy called St. John's wort (also known as Hypericum perforatum);
- quinidine (a medicine used to treat arrhythmias).
No interactions between oxycodone/naloxone and paracetamol, acetylsalicylic acid, or naltrexone are expected.
The risk of side effects increases if antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) are used. These medicines may interact with oxycodone, and symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.
Taking oxycodone/naloxone cinfa with food, drinks, and alcohol
Drinking alcohol while taking oxycodone/naloxone may make you feel more drowsy or increase the risk of serious adverse effects such as shallow breathing with the risk of respiratory arrest, and loss of consciousness. It is recommended not to drink alcohol while taking oxycodone/naloxone.
You should avoid drinking grapefruit juice while taking oxycodone/naloxone.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Oxycodone/naloxone should be avoided during pregnancy as much as possible. If used for prolonged periods during pregnancy, oxycodone hydrochloride may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during childbirth, the newborn may experience respiratory depression (slow and shallow breathing).
Breastfeeding
Breastfeeding must be discontinued during treatment with oxycodone/naloxone. Oxycodone hydrochloride passes into breast milk. It is unknown whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives multiple doses of oxycodone/naloxone.
Driving and using machines
Ask your doctor whether you can drive or operate machinery while being treated with oxycodone/naloxone. It is important that before driving or operating machinery, you observe how this medicine affects you. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.
oxycodone/naloxone cinfa contains sodium
This medicine contains less than 1 mmol of sodium (1 mmol = 23 mg) per tablet; essentially "sodium-free".
3. How to take oxicodone/naloxone cinfa
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using oxicodone/naloxone, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop taking oxicodone/naloxone cinfa”).
Oxicodone/naloxone cinfa is a prolonged-release tablet, meaning that the active substances are released over an extended period of time. Its effect lasts 12 hours.
You must swallow the prolonged-release tablet whole to avoid affecting the slow release of oxycodone hydrochloride from the tablet. Do not break, crush, or chew the tablets. If you do, your body may absorb a potentially fatal dose of oxycodone hydrochloride (see section 3 “If you take more oxicodone/naloxone cinfa than you should”).
Unless your doctor tells you otherwise, the recommended dose is:
For pain treatment
Adults
The recommended initial dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride in prolonged-release tablets every 12 hours.
Your doctor will decide the daily dose of oxicodone/naloxone you should take and how to divide the total daily dose between morning and evening doses. Your doctor will also decide whether dose adjustments are needed during treatment. Your dose will be adapted according to your level of pain and individual sensitivity. You should receive the lowest dose necessary to relieve pain. If you have previously been treated with opioids, the initial dose of oxicodone/naloxone may be higher.
The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If you require a higher dose, your doctor may prescribe additional oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal activity may be reduced if the dose of oxycodone hydrochloride is increased without increasing the dose of naloxone hydrochloride.
If you switch from these tablets to another opioid analgesic, your intestinal function may worsen.
If you experience pain between doses of oxicodone/naloxone, you may need a fast-acting analgesic. Oxicodone/naloxone is not suitable for this purpose. Consult your doctor.
If you feel that the effect of these tablets is too strong or too weak, consult your doctor or pharmacist.
For restless legs syndrome treatment
Adults
The usual initial dose is 5 mg oxycodone hydrochloride / 2.5 mg naloxone hydrochloride in prolonged-release tablets every 12 hours.
Your doctor will decide how much oxicodone/naloxone cinfa you should take each day and how to divide the total daily dose between morning and evening doses. Your doctor will also decide whether dose adjustments are needed during treatment. Your dose will be adjusted according to your individual response. The lowest effective dose will be chosen to relieve symptoms of restless legs syndrome.
If you feel that the effect of oxicodone/naloxone cinfa is too strong or too weak, consult your doctor or pharmacist.
The maximum daily dose is 60 mg of oxycodone hydrochloride and 30 mg of naloxone hydrochloride.
For pain or restless legs syndrome treatment
Elderly patients
In general, dose adjustment is not necessary in elderly patients with normal kidney and/or liver function.
Liver or kidney disorders
If you have any degree of kidney disorder or mild liver disorder, your doctor will prescribe these tablets with special caution. If you have moderate or severe liver disorder, you must not take these tablets (see also section 2 “Do not take oxicodone/naloxone cinfa” and “Warnings and precautions”).
Children and adolescents under 18 years of age
Oxicodone/naloxone has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been established in these patients. Therefore, the use of oxicodone/naloxone is not recommended in children and adolescents under 18 years of age.
Method of administration
Oral use.
Swallow the tablets whole (without chewing) with sufficient liquid (half a glass of water). You may take the prolonged-release tablets with or without food. Take the tablets every 12 hours, following a fixed schedule (for example, at 8 a.m. and 8 p.m.). Do not break, chew, or crush the prolonged-release tablets (see section 2 “Warnings and precautions”).
Opening instructions:
This medicine is available in a single-dose, peelable, perforated, child-resistant blister pack.
- Do not crush the prolonged-release tablet
To avoid crushing the prolonged-release tablet, do not press on the blister cavity (Figure 1).
- Separate one blister
Each blister pack contains seven blisters separated by perforations. Separate one blister along the perforated lines, where indicated “fold” (Figure 2).
- Remove the foil
Carefully remove the foil, starting from the corner marked with an arrow and where indicated “pull here” (Figure 3).
- Remove the prolonged-release tablet
Remove the prolonged-release tablet and swallow it whole (without chewing) with sufficient liquid (half a glass of water) (Figure 4).
Duration of treatment
In general, you should not take these tablets longer than necessary. If you are taking oxicodone/naloxone for a prolonged period, your doctor should regularly check whether you still need oxicodone/naloxone.
If you take more oxicodone/naloxone cinfa than you should
If you have taken more tablets than prescribed, you must inform your doctor immediately.
An overdose may cause:
- constricted pupils
- slow and shallow breathing (respiratory depression)
- drowsiness that may progress to loss of consciousness
- low muscle tone (hypotonia)
- reduced heart rate
- drop in blood pressure
- a brain disorder (known as toxic leukoencephalopathy).
In severe cases, loss of consciousness (coma), fluid accumulation in the lungs, and circulatory collapse may occur, which can be fatal in some instances.
You should avoid situations requiring high alertness, such as driving.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take oxicodone/naloxone cinfa
If you miss a dose or take a lower dose than prescribed, you may lose the analgesic effect.
If you forget to take a dose, follow the instructions below:
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If 8 hours or more remain before your next scheduled dose: Take the missed dose immediately and continue with your regular dosing schedule.
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If less than 8 hours remain before your next scheduled dose: Take the missed dose. Wait another 8 hours before taking the next dose. Try to return to your original schedule (for example, 8 a.m. and 8 p.m.). Do not take more than one dose within an 8-hour period.
Do not take a double dose to make up for a missed dose.
If you stop taking oxicodone/naloxone cinfa
Do not stop treatment with oxicodone/naloxone without consulting your doctor.
If you no longer need treatment, you should gradually reduce the daily dose after consulting your doctor. This will help you avoid withdrawal symptoms such as restlessness, episodes of sweating, and muscle pain.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
Important adverse effects to be aware of and what you should do if you experience them:
If you experience any of the following important adverse effects, consult your nearest doctor immediately.
Slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. This occurs mainly in elderly and debilitated patients. Opioids may also cause a marked decrease in blood pressure in susceptible patients.
The following adverse effects have been observed in patients receiving pain treatment
Common (may affect up to 1 in 10 patients) | ||
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Uncommon (may affect up to 1 in 100 patients) | ||
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Rare (may affect up to 1 in 1,000 patients) | ||
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Frequency not known (cannot be estimated from the available data) | ||
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It is known that the active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, has the following adverse effects, in addition to those mentioned above:
Oxycodone may cause respiratory problems (respiratory depression), constriction of the pupils, cramps of the bronchial muscles and smooth muscles, and depression of the cough reflex.
Common (may affect up to 1 in 10 patients) | ||
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Uncommon (may affect up to 1 in 100 patients) | ||
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Rare (may affect up to 1 in 1,000 patients) | ||
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Frequency not known (cannot be estimated from the available data) | ||
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The following adverse reactions have been observed in patients receiving treatment for restless legs syndrome
Very common (may affect more than 1 in 10 patients)
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Frequent (may affect up to 1 in 10 patients)
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Uncommon (may affect up to 1 in 100 patients)
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Frequency not known (cannot be estimated from the available data)
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Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of oxycodone/naloxone cinfa
Keep this medicine out of the sight and reach of children. Store this medicine in a safe, closed place where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging and blister, 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 the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the container and additional information
Composition of oxycodone/naloxone cinfa
- The active substances are oxycodone hydrochloride and naloxone hydrochloride.
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride, equivalent to 4.5 mg of oxycodone, and 2.5 mg of naloxone hydrochloride in the form of 2.75 mg of naloxone hydrochloride dihydrate, equivalent to 2.25 mg of naloxone.
- The other components are: tablet core: hypromellose 603, polyvinyl acetate dispersion 30%, povidone K30, sodium lauryl sulfate, colloidal anhydrous silica, microcrystalline cellulose PH 102, silicon dioxide, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, brilliant blue FCF aluminum lake (E-133).
Appearance of oxycodone/naloxone cinfa and contents of the container
Prolonged-release tablet.
Blue, elliptical, biconvex coated tablets, engraved with "5" on one side.
Oxycodone/naloxone cinfa prolonged-release tablets are available in unit-dose, peelable, perforated, child-resistant blisters with polyamide-aluminum-PVC/aluminum-PET film.
Pack sizes: 20, 28, 30, 50, 56 and 100 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Or
Ethypharm
Chemin de la Poudrière
76121 Le Grand Quevilly
France
Date of the most recent review of this leaflet: November 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address https://cima.aemps.es/cima/dochtml/p/81209/P_81209.html
QR code: https://cima.aemps.es/cima/dochtml/p/81209/P_81209.html