Summary of Product Characteristics: Information for the User

Oxicodona/Naloxona Cinfa10 mg/5 mg prolonged-release EFG tablets

Oxicodone hydrochloride / Naloxone hydrochloride

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• 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 only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Oxicodona/naloxona cinfa is a prolonged-release tablet, meaning that its active ingredients are released over a prolonged period of time. Its action lasts 12 hours.

This medication is intended for use only in adults.

Pain relief

You have been prescribed oxicodona/naloxona for the treatment of intense pain, which can only be adequately treated with opioid analgesics. Hydrochloride of naloxone is added to counteract constipation.

How these tablets work for pain relief

These tablets contain as active ingredients hydrochloride of oxicodona and hydrochloride of naloxona. Hydrochloride of oxicodona is responsible for the analgesic effect of the medication. It is a potent analgesic of the opioid group. The second active ingredient of this medication, hydrochloride of naloxona, has the function of counteracting constipation. Intestinal dysfunction (e.g. constipation) is a common adverse effect of treatment with opioid analgesics.

Do not take oxicodona/naloxona cinfa:

• if you are allergic to hydrochloride of oxicodona, hydrochloride of naloxona or to any of the other components of this medicine (listed in section 6),
• if you are unable to breathe in enough oxygen into your blood or remove the carbon dioxide produced in the body (respiratory depression),
• if you have a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
• if you have a condition called cor pulmonale. This condition consists of the right side of the heart increasing in size due to the increase in pressure inside the blood vessels of the lung, etc. (for example, as a result 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 oxicodona/naloxona cinfa:

• if you are an elderly or debilitated patient,
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney diseases,
• if you have mild liver diseases,
• if you have severe lung diseases (i.e., reduced ability to breathe),
• if you have a disease characterized by frequent pauses in breathing during sleep, which may make you feel very sleepy during the day (sleep apnea),
• if you have mixedema (a thyroid disorder characterized by dryness, coldness and swelling of the skin, affecting the face and extremities),
• if your thyroid gland does not produce enough hormones (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 loss (partial) of the notion of reality (psychosis), due to alcoholism or intoxication by other substances (substance-induced psychosis),
• if you have gallstones problems,
• if you have an abnormal enlargement of the prostate (prostatic hypertrophy),
• if you have pancreatitis (inflammation of the pancreas),
• 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 and brain trauma (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), for example, medications containing tranilcipromina, phenelzine, isocarboxazide, moclobemide and linezolid,
• if you experience drowsiness or sudden episodes of sleep.

Contact your doctor if you have severe upper abdominal pain that may extend to the back, nausea, vomiting or fever, as these may be symptoms associated with pancreatitis and biliary tract system inflammation.

Inform your doctor if you have had any of these diseases in the past. Inform your doctor also if you present any of them during treatment with oxicodona/naloxona.

Tolerance, dependence and addiction

This medicine contains oxicodona, which is an opioid medication. Repeated use of opioid analgesics may make the drug less effective (you become accustomed to it, known as tolerance). Repeated use of oxicodona/naloxona may cause dependence, abuse and addiction, which may lead to an overdose that puts your life at risk. The risk of these side effects may increase with a higher dose and a longer duration of use.

Dependence or addiction may make you feel that you no longer have control over the amount of medication you need to take or how often you need to take it. You may feel that you need to continue taking the medication, even when it no longer helps to relieve your pain.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to oxicodona/naloxona:

-if you or a family member has a history of abuse or dependence on alcohol, prescription medications or illicit substances (“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 health disorders.

If you notice any of the following signs while taking oxicodona/naloxona, it could be a sign that you have become dependent or addicted.

-You need to take the medication for a longer period than recommended by your doctor.

-You need to take more doses than recommended.

-You are using the medication for reasons other than those prescribed, for example, “to stay calm” or “to help you sleep”.

-You have made repeated and unsuccessful attempts to stop or control the use of the medication.

-You do not feel well when you stop taking the medication and feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, talk to your doctor to analyze the best treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you interrupt treatment with oxicodona/naloxona).

The most severe result of opioid overdose is respiratory depression (slow and shallow breathing). This may also cause a decrease in oxygen concentration in the blood, which may cause fainting, etc.

Respiratory disorders related to sleep

Oxicodona/naloxonamay cause respiratory disorders related to sleep such as sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal 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 it does not affect the slow release of hydrochloride of oxicodona from the tablet. Do not break, chew or crush the tablets. If you do, your body may absorb a potentially fatal dose of hydrochloride of oxicodona (see section 3 “If you take more oxicodona/naloxona cinfa than you should”).

If you experience intense diarrhea at the beginning of treatment, it may be due to the effect of naloxona. It may be a sign that intestinal function is normalizing. This diarrhea may occur in the first 3 to 5 days of treatment. If it persists after that period of 3 to 5 days, 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 oxicodona/naloxona, for example, restlessness, sweating and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor.

You may develop tolerance if you use oxicodona/naloxona for a long time.This means that you will need a higher dose to achieve the desired effect. Long-term use of oxicodona/naloxona may also produce physical dependence. Withdrawal symptoms may appear if treatment is stopped suddenly (restlessness, sweating, muscle pain). If you stop needing treatment, you should reduce the daily dose gradually, consulting with your doctor.

The active principle hydrochloride of oxicodona alone has the same abuse characteristics as other potent opioids (potent analgesics). It may create psychological dependence. Medicines containing hydrochloride of oxicodona should be avoided in patients who have a history of abuse of alcohol, drugs or medications.

Inform your doctor if you have cancer associated with peritoneal metastases or onset of obstruction in the intestine in advanced stages of digestive or pelvic cancer.

If you need to undergo surgery, inform the doctors that you are receiving treatment with oxicodona/naloxona.

Like other opioids, oxicodona may affect the normal production of hormones in the body such as cortisol or sex hormones, especially if you take high doses for a long period of time. If you notice persistent symptoms such as discomfort (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility or decreased libido, consult your doctor to monitor your hormone levels.

You may observe remnants of the prolonged-release tablet in the stool. Do not be alarmed, as the active principles (hydrochloride of oxicodona and hydrochloride of naloxona) have already been released in the stomach and intestine, and have been absorbed by your body.

Incorrect use of oxicodona/naloxona cinfa

Oxicodona/naloxonais not a treatment for withdrawal syndrome.

Do not abuse oxicodona/naloxona, especially if you have a substance abuse problem. If you are addicted to substances such as heroin, morphine or methadone, you may experience severe withdrawal symptoms if you misuse oxicodona/naloxona, because it contains naloxona. These symptoms may worsen existing withdrawal symptoms.

Do not dissolve the prolonged-release tablets of oxicodona/naloxonato inject them (for example, into a blood vessel). The reason is that they contain talc, which may cause local tissue destruction (necrosis) and alterations in lung tissue (pulmonary granuloma). This incorrect use may also have other serious consequences and even cause death.

The use of oxicodona/naloxonamay give positive results in drug tests. The use of oxicodona/naloxonaas a doping agent may put your health at risk.

Other medicines and oxicodona/naloxona cinfa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

The concomitant use of opioids, including hydrochloride of oxicodona and sedative medications such as benzodiazepines or related medications, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may put your life at risk. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes oxicodona/naloxona together with sedative medications, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedative medications you are taking and follow the recommended doses closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms. Some examples of sedative medications or related medications are:

• other potent analgesics (opioids);
• somnifacients and tranquilizers (sedatives, including benzodiazepines, hypnotics,anxiolytics);
• medications used to treat depression;
• medications used to treat allergies, dizziness or nausea (antihistamines or antiemetics);
• medications used to treat psychiatric or mental disorders (antipsychotics that include phenothiazines and neuroleptics);
• muscle relaxants;
• medications used to treat Parkinson's disease.

If you take these tablets at the same time as other medications, the effects of the tablets or the other medications described below may change. Inform your doctor if you are taking:

• blood thinners (derivative coumarins), the speed of coagulation 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 ofmedication known as protease inhibitor used to treat HIV (for example ritonavir, indinavir, nelfinavir or saquinavir);
• cimetidine (a medication used to treat stomach ulcers, indigestion or acid reflux);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures or convulsions and certain painful diseases);
• phenytoin (used to treat seizures or convulsions);
• a medicinal plant called St. John's Wort (also known asHypericum perforatum);
• quinidine (a medication used to treatarrhythmias).

No interactions are expected betweenoxicodona/naloxonaand paracetamol, acetylsalicylic acid or naltrexona.

The risk of side effects increases if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medications may interact with oxicodona and you may experience symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension and high body temperature above 38 °C. Contact your doctor if you experience these symptoms.

Taking oxicodona/naloxona cinfa with food, drinks and alcohol

Drinking alcohol while taking oxicodona/naloxona may make you feel more drowsy or increase the risk of severe side effects such as shallow breathing with the risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while taking oxicodona/naloxona.

You should avoid drinking grapefruit juice while taking oxicodona/naloxona.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy

During pregnancy, oxicodona/naloxona should be avoided as much as possible. If used during prolonged periods of pregnancy, hydrochloride of oxicodona may cause withdrawal symptoms in the newborn. If hydrochloride of oxicodona is administered during delivery, the newborn may experience respiratory depression (slow and shallow breathing).

Lactation

Breastfeeding will be suspended during treatment with oxicodona/naloxona. Hydrochloride of oxicodona passes into breast milk. It is unknown whether hydrochloride of naloxona also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives several doses of oxicodona/naloxona.

Driving and operating machines

Ask your doctor if you can drive or use machines during treatment with oxicodona/naloxona. It is essential to observe how this medicine affects you before driving or using machines. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Be especially careful at the beginning of treatment, after increasing the dose, after changing the formulation and/or when taking it together with other medications.

Oxicodona/naloxona cinfa contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist..

Before starting treatment and periodically during treatment, your doctor will talk to you about what you can expect from the use of oxicodona/naloxona, when and for how long you should take it, when to contact your doctor and when to stop taking it (see also “If you interrupt treatment with oxicodona/naloxona”).

Oxicodona/naloxona cinfa is a prolonged-release tablet, meaning that the active principles are released over a prolonged period of time. Its action lasts 12 hours.

You must swallow the prolonged-release tablet whole, without affecting the slow release of hydrochloride oxicodona from the tablet.Do not break, crush, or chew the tablets.If you do, your body may absorb a potentially fatal dose of hydrochloride oxicodona (see section 3 “If you take more oxicodona/naloxona cinfa than you should”).

Unless your doctor tells you otherwise, the recommended dose is:

For pain treatment

Adults

The initial recommended dose is 10 mg of hydrochloride oxicodona / 5 mg of hydrochloride naloxona in prolonged-release tablets every 12 hours.

Your doctor will decide the dose ofoxicodona/naloxonayou should take per day and how to divide the total daily dose between the morning dose and the evening dose. Your doctor will also decide if you need to adjust the dose during treatment. Your dose will be adjusted to your level of pain and individual sensitivity. You should receive the minimum dose necessary to relieve pain. If you have already received treatment with opioids, the initial dose ofoxicodona/naloxonamay be higher.

The maximum daily dose is 160 mg of hydrochloride oxicodona and 80 mg of hydrochloride naloxona. If you need a higher dose, your doctor may prescribe more hydrochloride oxicodona without hydrochloride naloxona. However, the maximum daily dose of hydrochloride oxicodona should not exceed 400 mg. The beneficial effect of hydrochloride naloxona on intestinal activity may be affected if the dose of hydrochloride oxicodona is increased without increasing the dose of hydrochloride naloxona.

If you substitutethese tabletswith another opioid analgesic, it is likely that your intestinal function will worsen.

If you experience pain between two doses ofoxicodona/naloxona,you may need a rapid-acting analgesic. Oxicodona/naloxona is not a treatment for this case. Consult your doctor.

If you think the effect ofthese tabletsis too strong or too weak, consult your doctor or pharmacist.

Older patients

Generally, no dose adjustment is necessary in older patients with normal kidney and/or liver function.

Renal or liver disorder

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 should not take these tablets (see also section 2 “Do not take oxicodona/naloxona cinfa” and “Warnings and precautions”).

Children and adolescents under 18 years of age

Oxicodona/naloxona has not been studied in children and adolescents under 18 years.Oxicodona/naloxona has not been demonstrated to be safe and effective inthese patients.Therefore, the use ofoxicodona/naloxonais not recommended in children and adolescents under 18 years.

Administration form

Oral route.

Swallow the tablets whole (without chewing them), with sufficient liquid (half a glass of water). You can take the prolonged-release tablets with or without food. Take the tablets every 12 hours, following a fixed schedule (for example, at 8 am and at 8 pm). Do not break, chew, or crush the prolonged-release tablets (see section 2 “Warnings and precautions”).

Instructions for opening:

This medication is available in a single-dose blister pack, peelable, perforated, and child-resistant.

1. Do not crush the prolonged-release tablet

To avoid crushing the prolonged-release tablet, do not press the alveolus (Figure 1).

1. Separate an alveolus

Each blister pack contains seven alveoli, separated by perforations. Separate an alveolus following the perforated lines, where it is indicated “fold” (Figure 2).

1. Remove the foil

Remove the foil carefully, starting from the corner marked with an arrow and where it is indicated “pull here” (Figure 3).

1. Remove the prolonged-release tablet

Remove the prolonged-release tablet, and swallow it whole (without chewing it) and with sufficient liquid (half a glass of water) (Figure 4).

Treatment duration

Generally, you should not take these tablets for longer than necessary. If you are administered oxicodona/naloxona for a long time, your doctor should regularly check that you still need oxicodona/naloxona.

If you take more oxicodona/naloxona cinfa than you should

If you have taken more tablets than prescribed, you should inform your doctorimmediately.

A overdose may cause:

• constricted pupils
• slow and shallow breathing (respiratory depression)
• drowsiness that can lead to loss of consciousness
• low muscle tone (hypotonia)
• reduced heart rate
• low blood pressure
• a brain disorder (known as toxic leukoencephalopathy).

In severe cases, it may cause loss of consciousness (coma), fluid accumulation in the lungs, and circulatory collapse, which can be fatal in some cases.

You should avoid situations that require a high level of alertness, such as driving.

In case of overdose or accidental ingestion, 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 forget to take oxicodona/naloxona cinfa

Or if you take a dose lower than prescribed, you may not notice the analgesic effect.

If you forget to take a dose, follow the instructions below:

• If there are8 hours or more until the next scheduled dose:Take the missed dose immediately and continue with the regular schedule.

• If there areless than 8 hours until the next scheduled dose:Take the missed dose. Wait 8 hours before taking the next dose.Try to recover the original schedule (for example, 8 am and 8 pm). Do not take more than one dose in an 8-hour period.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with oxicodona/naloxona cinfa

Do not interrupt treatment withoxicodona/naloxonawithout consulting your doctor.

If you no longer need to continue treatment, you should gradually reduce the daily dose, after consulting your doctor. This will help you avoid withdrawal symptoms, such as restlessness, sweating, and muscle pain.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Important side effects to be aware of and what to do if you experience them:

If you experience any of the following serious side effects, consult your doctor immediately.

The slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. It occurs mainly in elderly and debilitated patients. Opioids can also cause a severe drop in blood pressure in susceptible patients.

The following side effects have been observed in patients receiving pain treatment

We know that the active ingredient hydrochloride of oxycodone, if not combined with hydrochloride of naloxone, has the following side effects:

Oxycodone can cause respiratory problems (respiratory depression), pupil constriction, bronchial and smooth muscle spasms, and suppression of the cough reflex.

Reporting of side effects

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

Keep this medication out of the sight and reach of children. Store this medication in a safe and closed location, where other people cannot access it. It can cause serious harm and be fatal to people who have not been prescribed it.

Do not use this medication after the expiration date that appears on the packaging, and the blister pack, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Oxycodone/Naloxone Cinfa Composition

• The active principles are hydrochloride of oxycodone and hydrochloride naloxone.

Each prolonged-release tablet contains 10 mg of hydrochloride of oxycodone, equivalent to 9 mg of oxycodone and 5 mg of hydrochloride of naloxone in the form of 5.5 mg of hydrochloride of naloxone dihydrate equivalent to 4.5 mg of naloxone.

• The other components are:tablet core:hypromellose 603, polyvinyl acetate dispersion at 30 %, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose PH 102, silicon dioxide, magnesium stearate.tablet coating:polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc.

Appearance of oxycodone/Naloxone Cinfa and packaging content

Prolonged-release tablet.

White to cream-colored, elliptical, biconvex tablets, engraved with “10” on one face.

Oxycodone/Naloxone Cinfa prolonged-release tablets are available in single-dose blisters, peelable, perforated, child-resistant, with a polyamide-aluminium-PVC/aluminium-PET film.

Packaging sizes:20, 28, 30, 50, 56 and 100 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for Manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Or

Ethypharm

Poudrière Road

76121 Le Grand Quevilly

France

Last review date of this leaflet:January 2025

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

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/81210/P_81210.html

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