OXYCODONE/NALOXONE STADA 30 mg/15 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Oxicodona/Naloxona Stada 5 mg/2.5 mg prolonged-release tablets EFG

Oxicodona/Naloxona Stada 10 mg/5 mg prolonged-release tablets EFG

Oxicodona/Naloxona Stada 20 mg/10 mg prolonged-release tablets EFG

Oxicodona/Naloxona Stada 30 mg/15 mg prolonged-release tablets EFG

Oxicodona/Naloxona Stada 40 mg/20 mg prolonged-release tablets EFG

Oxycodone hydrochloride / Naloxone hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What Oxicodona/Naloxona Stada is and what it is used for
2. What you need to know before you take Oxicodona/Naloxona Stada
3. How to take Oxicodona/Naloxona Stada
4. Possible side effects
5. Storage of Oxicodona/Naloxona Stada
6. Contents of the pack and other information

1. What Oxicodona/Naloxona Stada is and what it is used for

Oxicodona/Naloxona Stada is a prolonged-release tablet, which means that the active substances are released over a longer period. Its effect lasts 12 hours.

These tablets are for use in adults only.

Pain relief

You have been prescribed oxycodone/naloxone for the treatment of severe pain, which 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 oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the analgesic effect of oxycodone/naloxone and is a potent analgesic from the opioid group.

The second active substance of oxycodone/naloxone, naloxone hydrochloride, has the function of counteracting constipation. Bowel dysfunction (e.g., constipation) is a common side effect of treatment with opioid analgesics.

Restless Legs Syndrome

You have been prescribed oxycodone/naloxone for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome, when treatment with dopaminergic medications is not possible. People with Restless Legs Syndrome feel an unpleasant sensation in their limbs. This can start as soon as they sit or lie down and can only be relieved by an urgent and irresistible urge to move their legs, sometimes arms, and other parts of the body. This makes it very difficult to stay seated and to sleep. Naloxone hydrochloride has been added to counteract constipation.

How these tablets work in Restless Legs Syndrome

These tablets help to alleviate the unpleasant sensations and thus reduce the urgent need to move the limbs.

The second active substance of oxycodone/naloxone, naloxone hydrochloride, has the function of counteracting constipation. Bowel dysfunction (e.g., constipation) is a common side effect of treatment with opioid analgesics.

2. What you need to know before you take Oxicodona/Naloxona Stada

Do not take Oxicodona/Naloxona Stada

• 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 is not sufficient to provide enough oxygen to the blood or to remove the carbon dioxide produced by 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 condition called cor pulmonale. This condition consists of the right side of the heart becoming enlarged due to increased pressure inside the blood vessels of the lungs, etc. (e.g., 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.

Additionally for Restless Legs Syndrome

• if you have a history of opioid abuse.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Oxicodona/Naloxona Stada:

• in the case of elderly or debilitated patients (weak),
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney disorder,
• if you have mild liver disorder,
• if you have severe lung disorder (i.e., reduced breathing capacity),
• if you have a condition characterized by frequent stops in breathing during the night, which can make you feel very sleepy during the day (sleep apnea),
• if you have myxedema (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 (underactive thyroid, or hypothyroidism),
• if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
• if you have a mental illness accompanied by a loss (partial) of the sense of reality (psychosis), due to alcoholism or intoxication with other substances (substance-induced psychosis),
• if you have problems with gallstones,
• if you have an abnormal increase in the size of the prostate (prostate hypertrophy),
• if you have a history of alcoholism or delirium tremens,
• 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 history of 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), e.g., medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid.
• if you experience drowsiness or sudden sleep episodes.

Tell your doctor if you have had any of these diseases in the past. Also, inform your doctor if you develop any of them during treatment with these tablets.

The most serious consequence of opioid overdose is respiratory depression(slow and shallow breathing). This can also lead to a decrease in oxygen concentration in the blood, which can cause fainting, etc.

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

Diarrhea

If you experience severe diarrhea at the start of treatment, it may be due to the effect of naloxone. It may be a sign that bowel function is returning to normal. This diarrhea may occur in the first 3 to 5 days of treatment. If it persists beyond this period or if you are concerned, contact your doctor.

Switching to oxycodone/naloxone

If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment with oxycodone/naloxone, e.g., restlessness, sweating, and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor.

Long-term treatment

If you take oxycodone/naloxone for a long time, you may develop tolerance to these tablets. This means you may need a higher dose to achieve the desired effect. Long-term use can also lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped suddenly (restlessness, sweating, muscle pain). If you no longer need treatment, you should gradually reduce the daily dose, consulting your doctor.

Psychological dependence

Oxycodone hydrochloride, when used alone, has the same potential for abuse as other potent opioids (potent analgesics). It can lead to psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients with a history of alcohol, drug, or medicine abuse.

Cancer

Tell your doctor if you have cancer associated with peritoneal metastasis or initial intestinal obstruction in advanced stages of digestive and pelvic cancers.

If you need to undergo surgery, tell the doctors that you are taking oxycodone/naloxone.

Hormonal effects

As with other opioids, oxycodone may affect the normal production of hormones in the body, such as cortisol or sex hormones, especially if taken in high doses for long periods. If you experience persistent symptoms such as feeling or being sick (including vomiting), loss of appetite, tiredness, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased sexual desire, talk to your doctor, as they may want to check your hormone levels.

Misuse of oxycodone/naloxone

These tablets are not for the treatment of withdrawal symptoms.

Oxicodona/Naloxona Stada 5 mg/2.5 mg prolonged-release tablets EFG

The tablet should be swallowed whole and not divided, broken, chewed, or crushed.

Taking divided, broken, chewed, or crushed tablets can lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 "If you take more Oxicodona/Naloxona Stada than you should").

Oxicodona/Naloxona Stada 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, and 40 mg/20 mg prolonged-release tablets EFG

The tablet can be divided, but it should not be broken, chewed, or crushed.

Taking broken, chewed, or crushed tablets can lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 "If you take more Oxicodona/Naloxona Stada than you should").

Abuse

Never misuse oxycodone/naloxone, especially if you have a history of substance abuse. If you are addicted to substances like heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse these tablets, as they contain naloxone. This can worsen pre-existing withdrawal symptoms.

Misuse

Never dissolve these tablets to inject them (e.g., into a blood vessel). The reason is that they contain talc, which can cause local tissue destruction (necrosis) and changes in lung tissue (pulmonary granuloma). This misuse can also have other serious consequences and even lead to death.

Doping

The use of this medicine can result in positive doping tests. The use of oxycodone/naloxone as a doping agent can endanger health.

Other medicines and Oxicodona/Naloxona Stada

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

The risk of adverse reactions increases if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone and you may experience symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience such symptoms.

The concomitant use of oxycodone/naloxone and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes oxycodone/naloxone together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking and strictly follow your doctor's recommendation regarding the dose. It may be useful 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 medicines or related medicines are:

• other potent analgesics (opioids);
• medicines for treating epilepsy, pain, and anxiety, such as gabapentin and pregabalin;
• sleeping pills and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics);
• medicines for treating 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 at the same time as other medicines, the effects of the tablets or the other medicines described below may change. Tell your doctor if you are taking:

• medicines that reduce blood clotting (coumarin derivatives), the clotting speed may increase or decrease;
• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin);
• azole-type antifungal agents (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 for treating stomach ulcers, indigestion, or heartburn);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures or certain painful conditions);
• phenytoin (used to treat seizures);
• a herbal medicine called St. John's Wort (also known as Hypericum perforatum);
• quinidine (a medicine for treating arrhythmias).

No interactions are expected between oxycodone/naloxone and paracetamol, acetylsalicylic acid, or naltrexone.

Taking Oxicodona/Naloxona Stada with food, drink, and alcohol

Drinking alcohol while taking oxycodone/naloxone can make you feel more drowsy or increase the risk of serious adverse reactions such as shallow breathing with the risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while taking oxycodone/naloxone.

You should avoid drinking grapefruit juice while taking these tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

These tablets should be avoided during pregnancy whenever possible. If used during prolonged periods of pregnancy, oxycodone hydrochloride may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during labor, the newborn may experience respiratory depression (slow and shallow breathing).

Breastfeeding

Breastfeeding should be discontinued during treatment with these tablets. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to the breastfed child cannot be excluded, especially if the mother receives multiple doses of oxycodone/naloxone.

Driving and using machines

Oxycodone/naloxone may affect your ability to drive or use machines. This is especially true at the start of treatment, after a dose increase, or after switching to a different medication. However, these unwanted effects disappear once the dose of oxycodone/naloxone is established.

Oxycodone/naloxone has been associated with drowsiness and sudden sleep episodes. If you experience this side effect, you should not drive or use machines. Talk to your doctor if you experience this side effect.

Ask your doctor if you can drive or use machines.

Oxicodona/Naloxona Stada contains sodium

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

3. How to take Oxicodona/Naloxona Stada

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

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

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

For pain treatment

Adults

The recommended starting dose is 10 mg of oxicodone hydrochloride/5 mg of naloxone hydrochloride in prolonged-release tablets every 12 hours.

Your doctor will decide what dose of oxicodona/naloxona you should take per day and how to divide the total daily dose between the morning and evening doses. Your doctor will also decide if it is necessary to adjust the dose during treatment. Your dose will be adjusted according to your degree 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 of oxicodona/naloxona may be higher.

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

If you replace these tablets with another opioid analgesic, it is likely that your intestinal function will worsen.

If you experience pain between two doses of oxicodona/naloxona, you may need a fast-acting analgesic. Oxicodona/naloxona is not suitable for treatment in this case. Discuss this with your doctor.

If you feel that the effect of these tablets is too strong or too weak, consult your doctor or pharmacist.

For the treatment of restless legs syndrome

Adults

The usual initial dose is 5 mg of oxicodone hydrochloride/2.5 mg of naloxone hydrochloride in prolonged-release tablets every 12 hours.

Your doctor will decide what amount of oxicodona/naloxona you should take each day and how to divide the total daily dose between the morning and evening doses. Your doctor will also decide if it is necessary to adjust the dose during treatment. Your dose will be adjusted according to your individual response. The minimum dose will be chosen to mitigate the symptoms of restless legs syndrome.

If you feel that the effect of oxicodona/naloxona is too strong or too weak, consult your doctor or pharmacist.

The maximum daily dose is 60 mg of oxicodone hydrochloride and 30 mg of naloxone hydrochloride.

For the treatment of pain or restless legs syndrome

Elderly patients

In general, it is not necessary to adjust the dose in elderly patients with normal kidney and/or liver function.

Liver or kidney disorder

If you have a kidney disorder of any degree or a mild liver disorder, your doctor will prescribe these tablets with special caution. If you have a moderate or severe liver disorder, you should not take these tablets (see also section 2 "Do not take Oxicodona/Naloxona Stada" and "Warnings and precautions").

Use in children and adolescents

Oxicodona/naloxona has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been demonstrated in these patients. For this reason, the use of oxicodona/naloxona is not recommended in children and adolescents under 18 years of age.

Method of administration

Oral route.

Take oxicodona/naloxona every 12 hours, following a fixed schedule (e.g., at 8 am and 8 pm).

Oxicodona/Naloxona Stada 5 mg/2.5 mg prolonged-release tablets EFG

You should take oxicodona/naloxona with sufficient liquid (½ glass of water). The tablet should be swallowed whole and not broken, chewed, or crushed. The tablet can be taken with or without food.

Oxicodona/Naloxona Stada 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, and 40 mg/20 mg prolonged-release tablets EFG

You should take oxicodona/naloxona with sufficient liquid (½ glass of water). The tablet can be divided into equal doses. The tablet should not be broken, chewed, or crushed. The tablet can be taken with or without food.

Duration of use

In general, you should not take these tablets for longer than necessary. If you are undergoing long-term treatment, your doctor should periodically check if you still need these tablets.

If you take more Oxicodona/Naloxona Stada than you should

If you have taken more than the prescribed dose of these tablets, inform your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

An overdose can cause:

• contraction of the pupils
• slow and shallow breathing (respiratory depression)
• drowsiness leading to loss of consciousness
• low muscle tone (hypotonia)
• reduction in heart rate, and
• decrease in blood pressure.

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

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

If you forget to take Oxicodona/Naloxona Stada

Or if you take a lower dose than prescribed, you may stop noticing the effect.

If you forget to take a dose, follow these instructions:

• If there are 8 hours or more left until the next dose: take the missed tablet immediately, and continue with the normal schedule.
• If there are less than 8 hours left until the next dose: take the missed tablet. Wait another 8 hours before taking the next tablet. Try to recover the original schedule (e.g., 8 am and 8 pm). Do not take oxicodona/naloxona more than once in an 8-hour period.

Do not take a double dose to make up for missed doses.

If you stop treatment with Oxicodona/Naloxona Stada

Do not stop treatment without consulting your doctor.

If you no longer need to continue treatment, the daily dose should be gradually reduced, after discussing it with your doctor. This will help you avoid withdrawal symptoms, such as restlessness, sweating episodes, and muscle pain.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Important side effects to look for, and what to do if you experience them:

If you already have any of the following important side effects, consult your doctor immediately.

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 significant decrease in blood pressure in susceptible patients.

Side effects are divided into two sections: pain treatment, treatment with only the active ingredient oxicodone hydrochloride, and treatment of restless legs syndrome.

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

Frequent (may affect up to 1 in 10 patients)

• abdominal pain
• constipation
• diarrhea
• dry mouth
• indigestion
• nausea (feeling sick)
• discomfort
• flatulence (gas)
• reduced or lost appetite
• feeling of dizziness or spinning
• headache
• flushing
• unusual feeling of weakness
• fatigue or exhaustion
• itching of the skin
• skin reactions/rashes
• sweating
• vertigo
• insomnia
• drowsiness

Uncommon (may affect up to 1 in 100 patients)

• meteorism
• abnormal thoughts
• anxiety
• confusion
• depression
• nervousness
• feeling of chest tightness, especially if you already have coronary heart disease
• decrease in blood pressure
• withdrawal symptoms such as agitation
• fainting
• loss of energy
• thirst
• altered taste
• palpitations
• biliary colic
• chest pain
• feeling of general discomfort
• pain
• swelling of hands, ankles, or feet
• difficulty concentrating
• speech disorders
• tremors
• breathing difficulties
• restlessness
• chills
• increased liver enzymes
• increased blood pressure
• decreased sexual desire
• rhinorrhea
• cough
• allergic/hypersensitivity reactions
• weight loss
• accidental injuries
• increased need to urinate
• muscle cramps
• muscle contractions
• muscle pain
• vision disorders
• seizures (especially in people with epilepsy or a predisposition to seizures)

Rare (may affect up to 1 in 1,000 patients)

• increased heart rate
• drug dependence
• dental disorders
• weight gain
• yawning

Frequency not known (cannot be estimated from available data)

• euphoria
• severe sedation
• erectile dysfunction
• nightmares
• hallucinations
• respiratory depression
• difficulty urinating
• aggression
• tingling of the skin
• belching

It is known that the active ingredient oxicodone hydrochloride, if not combined with naloxone hydrochloride, has the following side effects, different from those mentioned

Oxicodone may cause respiratory problems (respiratory depression), decreased pupil size, bronchial and smooth muscle spasms, and depression of the cough reflex.

Frequent (may affect up to 1 in 10 patients)

• mood changes and personality changes (e.g., depression, feeling extremely happy)
• decreased activity
• increased activity
• difficulty urinating
• hiccups

Uncommon (may affect up to 1 in 100 patients)

• difficulty concentrating
• migraines
• increased muscle tension
• involuntary muscle contractions
• condition in which the intestine stops functioning properly (ileus)
• dry skin
• tolerance to the medication
• reduced sensitivity to pain or touch
• coordination disorders
• voice disorders (dysphonia)
• water retention
• hearing disorders
• mouth ulcers
• difficulty swallowing
• gingivitis
• perception disorders (e.g., hallucinations, derealization)
• skin redness
• dehydration
• agitation
• decreased sex hormone levels, which can affect sperm production in men or the menstrual cycle in women

Rare (may affect up to 1 in 1,000 patients)

• urticaria (hives)
• infections such as herpes labialis or herpes (which can cause blisters around the mouth or genital area)
• increased appetite
• black stools (with a tar-like appearance)
• gum bleeding

Frequency not known (cannot be estimated from available data)

• acute generalized allergic reactions (anaphylactic reactions)
• increased sensitivity to pain
• absence of menstrual periods
• withdrawal syndrome in newborns
• bile flow problems
• a condition that affects a valve in the intestine, which can cause severe abdominal pain (disorders of the sphincter of Oddi)
• dental caries

The following side effects have been observed in patients receiving treatment for restless legs syndrome

Very common (may affect more than 1 in 10 patients)

• headache
• drowsiness
• constipation
• discomfort
• sweating
• fatigue or exhaustion

Frequent (may affect up to 1 in 10 patients)

• reduced or lost appetite
• difficulty sleeping
• depression
• feeling of dizziness or spinning
• difficulty concentrating
• tremors
• tingling in hands or feet
• vision disorders
• vertigo
• flushing
• decrease in blood pressure
• increase in blood pressure
• abdominal pain
• dry mouth
• nausea
• increased liver enzymes (increased alanine aminotransferase, increased gamma-glutamyl transferase)
• itching of the skin
• skin reactions/rashes
• chest pain
• chills
• pain
• thirst

Uncommon (may affect up to 1 in 100 patients)

• decreased sexual desire
• sudden sleep episodes
• altered taste
• breathing difficulties
• flatulence
• erectile dysfunction
• withdrawal symptoms such as agitation
• swelling of hands, ankles, or feet
• accidental injuries

Frequency not known (cannot be estimated from available data)

• allergic/hypersensitivity reactions
• abnormal thoughts
• anxiety
• confusion
• nervousness
• restlessness
• euphoria
• hallucinations
• nightmares
• seizures (especially in people with epilepsy or a predisposition to seizures)
• drug dependence
• severe sedation
• speech disorders
• fainting
• feeling of chest tightness, especially if you already have coronary heart disease
• palpitations
• increased heart rate
• shallow breathing
• cough
• rhinorrhea
• yawning
• meteorism
• diarrhea
• aggression
• indigestion
• belching
• dental disorders
• biliary colic
• muscle cramps
• muscle fasciculations
• muscle pain
• difficulty urinating
• increased need to urinate
• feeling of general discomfort
• weight loss
• weight gain
• unusual feeling of weakness
• lack of energy

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Oxicodona/Naloxona Stada

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

Do not use this medication after the expiration date shown on the box and blister pack, after "EXP". The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Oxicodona/Naloxona Stada

The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Oxicodona/Naloxona Stada 5 mg/2.5 mg prolonged-release tablets EFG

A prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg of oxycodone) and 2.5 mg of naloxone hydrochloride (as 2.74 mg of naloxone hydrochloride dihydrate equivalent to 2.25 mg of naloxone).

Oxicodona/Naloxona Stada 10 mg/5 mg prolonged-release tablets EFG

A prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg of naloxone hydrochloride dihydrate equivalent to 4.5 mg of naloxone).

Oxicodona/Naloxona Stada 20 mg/10 mg prolonged-release tablets EFG

A prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg of oxycodone) and 10 mg of naloxone hydrochloride (as 10.9 mg of naloxone hydrochloride dihydrate equivalent to 9 mg of naloxone).

Oxicodona/Naloxona Stada 30 mg/15 mg prolonged-release tablets EFG

A prolonged-release tablet contains 30 mg of oxycodone hydrochloride (equivalent to 27 mg of oxycodone) and 15 mg of naloxone hydrochloride (as 16.35 mg of naloxone hydrochloride dihydrate equivalent to 13.5 mg of naloxone).

Oxicodona/Naloxona Stada 40 mg/20 mg prolonged-release tablets EFG

A prolonged-release tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36 mg of oxycodone) and 20 mg of naloxone hydrochloride (as 21.8 mg of naloxone hydrochloride dihydrate equivalent to 18 mg of naloxone).

The other components are:

• Core of the tablet:

Polyvinyl acetate, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate.

• Coating of the tablet:

Oxicodona/Naloxona Stada 5 mg/2.5 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, and talc.

Oxicodona/Naloxona Stada 10 mg/5 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and red iron oxide (E172).

Oxicodona/Naloxona Stada 20 mg/10 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, and talc.

Oxicodona/Naloxona Stada 30 mg/15 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and yellow iron oxide (E172).

Oxicodona/Naloxona Stada 40 mg/20 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and red iron oxide (E172).

Appearance of the Product and Container Content

Oxicodona/Naloxona Stada 5 mg/2.5 mg are prolonged-release tablets, round, biconvex, white, 4.7 mm in diameter, and 2.9-3.9 mm high.

Oxicodona/Naloxona Stada 10 mg/5 mg are prolonged-release tablets, oblong, biconvex, pink, with a score line on both sides, 10.2 mm long, 4.7 mm wide, and 3.0-4.0 mm high. The tablet can be divided into equal doses.

Oxicodona/Naloxona Stada 20 mg/10 mg are prolonged-release tablets, oblong, biconvex, white, with a score line on both sides, 11.2 mm long, 5.2 mm wide, and 3.3-4.3 mm high. The tablet can be divided into equal doses.

Oxicodona/Naloxona Stada 30 mg/15 mg are prolonged-release tablets, oblong, biconvex, yellow, with a score line on both sides, 12.2 mm long, 5.7 mm wide, and 3.3-4.3 mm high. The tablet can be divided into equal doses.

Oxicodona/Naloxona Stada 40 mg/20 mg are prolonged-release tablets, oblong, biconvex, pink, with a score line on both sides, 14.2 mm long, 6.7 mm wide, and 3.6-4.6 mm high. The tablet can be divided into equal doses.

The Oxicodona/Naloxona Stada tablets are presented in child-resistant single-dose blister packs of 28x1, 56x1, 60x1, and 98x1 prolonged-release tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Oxycodonhydrochlorid/Naloxonhydrochlorid STADA Arzneimittel 40 mg/20 mg Retardtabletten

Oxycodonhydrochlorid/Naloxonhydrochlorid STADA Arzneimittel 10 mg/5 mg Retardtabletten

Oxycodonhydrochlorid/Naloxonhydrochlorid STADA Arzneimittel 30 mg/15 mg Retardtabletten

Oxycodonhydrochlorid/Naloxonhydrochlorid STADA Arzneimittel 5 mg /2.5 mg Retardtabletten

Oxycodonhydrochlorid/Naloxonhydrochlorid STADA Arzneimittel 20 mg/10 mg Retardtabletten

Denmark: Oxycodone/Naloxone "Stada" 5 mg/2.5 mg

Oxycodone/Naloxone "Stada" 20mg/10mg

Oxycodone/Naloxone "Stada" 10 mg/5 mg

Oxycodone/Naloxone "Stada" 40 mg/20 mg

Slovakia: OxyNal 30 mg/15 mg, prolonged-release tablets

OxyNal 5 mg/2.5 mg, prolonged-release tablets

OxyNal 10 mg/5 mg, prolonged-release tablets

OxyNal 20 mg/10 mg, prolonged-release tablets

OxyNal 40 mg/20 mg, prolonged-release tablets

Spain: Oxicodona/Naloxona STADA 10 mg/5 mg prolonged-release tablets EFG

Oxicodona/Naloxona STADA 40 mg/20 mg prolonged-release tablets EFG

Oxicodona/Naloxona STADA 5 mg/2.5 mg prolonged-release tablets EFG

Oxicodona/Naloxona STADA 20 mg/10 mg prolonged-release tablets EFG

Oxicodona/Naloxona STADA 30 mg/15 mg prolonged-release tablets EFG

Finland: Oxycodone/Naloxone STADA 10 mg/5 mg prolonged-release tablets

Oxycodone/Naloxone STADA 40 mg/20 mg prolonged-release tablets

Oxycodone/Naloxone STADA 5 mg/2.5 mg prolonged-release tablets

Oxycodone/Naloxone STADA 20 mg/10 mg prolonged-release tablets

Italy: Ossicodone e Naloxone EG 5 mg/2.5 mg prolonged-release tablets

Ossicodone e Naloxone EG 10 mg/5 mg prolonged-release tablets

Ossicodone e Naloxone EG 20 mg/10 mg prolonged-release tablets

Ossicodone e Naloxone EG 30 mg/15 mg prolonged-release tablets

Ossicodone e Naloxone EG 40 mg/20 mg prolonged-release tablets

Czech Republic: Oxynalon 40 mg/20 mg prolonged-release tablets

Oxynalon 10 mg/ 5 mg prolonged-release tablets

Oxynalon 5 mg/ 2.5 mg prolonged-release tablets

Oxynalon 20 mg/10 mg prolonged-release tablets

Sweden: Oxycodone/Naloxone STADA 10mg/5mg prolonged-release tablets

Oxycodone/Naloxone STADA 5mg/2.5mg prolonged-release tablets

Oxycodone/Naloxone STADA 20mg/10mg prolonged-release tablets

Oxycodone/Naloxone STADA 40mg/20mg prolonged-release tablets

Date of the Last Revision of this Leaflet: August 2024

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

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