Oxycodone/naloxone Stada 30 mg/15 mg prolonged-release tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Oxycodone/Naloxone Stada 5 mg/2.5 mg prolonged-release tablets EFG

Oxycodone/Naloxone Stada 10 mg/5 mg prolonged-release tablets EFG

Oxycodone/Naloxone Stada 20 mg/10 mg prolonged-release tablets EFG

Oxycodone/Naloxone Stada 30 mg/15 mg prolonged-release tablets EFG

Oxycodone/Naloxone Stada 40 mg/20 mg prolonged-release tablets EFG

Oxycodone hydrochloride / naloxone hydrochloride

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

Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Oxycodone/Naloxone Stada is and what it is used for
What you need to know before taking Oxycodone/Naloxone Stada
How to take Oxycodone/Naloxone Stada
Possible side effects
How to store Oxycodone/Naloxone Stada
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, meaning that its active substances are released over an extended period. Its effect lasts for 12 hours.

These tablets are for use in adults only.

Pain relief

You have been prescribed oxicodone/naloxone for the treatment of 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 as active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the analgesic effect of oxicodone/naloxone and is a potent opioid analgesic.

The second active substance in oxicodone/naloxone, 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 for second-line symptomatic treatment in patients with severe 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 need to move the legs, sometimes the arms and other parts of the body. This makes it very difficult to remain seated and to sleep. Naloxone hydrochloride has been added to counteract constipation.

How these tablets work in restless legs syndrome

These tablets help relieve unpleasant sensations and thereby reduce the compelling need to move the limbs.

2. What you need to know before taking Oxicodone/Naloxone Stada

DO NOT take Oxicodone/Naloxone 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 deliver enough oxygen to the blood or remove 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 (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 Oxicodone/Naloxone Stada:

in elderly or debilitated (weak) patients,
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 breathing pauses during sleep, which may make you feel very sleepy during the day (sleep apnea),
if you have myxoedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin, affecting the face and limbs),
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 partial or complete loss of touch with reality (psychosis) due to alcoholism or intoxication with other substances (substance-induced psychosis),
if you have problems related to gallstones,
if you have abnormal enlargement of the prostate (prostate hypertrophy),
if you have alcoholism or delirium tremens,
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), for example, medicines containing tranylcypromine, phenelzine, isocarbazid, moclobemide, or linezolid,
if you experience drowsiness or sudden episodes of sleep.

Tell your doctor if you have ever had any of these conditions 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 may also lead to reduced oxygen concentration in the blood, which can cause fainting, etc.

Contact your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.

Diarrhea

If you experience severe diarrhea 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 diarrhea 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.

Switching to oxicodone/naloxone

If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment with oxicodone/naloxone, such as restlessness, sweating episodes, and muscle pain. If you experience any of these symptoms, you may require special monitoring by your doctor.

Long-term treatment

If you take oxicodone/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. Prolonged use may also lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped suddenly (restlessness, sweating episodes, muscle pain). If you no longer need treatment, your daily dose should be gradually reduced, in consultation with your doctor.

Psychological dependence

The active ingredient oxycodone hydrochloride, when not combined, has the same potential for abuse as other strong opioids (potent 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.

Cancer

Inform your doctor if you have cancer with peritoneal metastases or initial intestinal obstruction in advanced stages of gastrointestinal or pelvic cancers.

If you need to undergo surgery, inform the medical staff that you are taking oxicodone/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 high doses have been taken for long periods. If you experience persistent symptoms such as feeling unwell or actually being ill (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased sexual desire, speak with your doctor, as they may wish to monitor your hormone levels.

Incorrect use of oxicodone/naloxone

These tablets are not suitable for the treatment of withdrawal syndrome.

Oxicodone/Naloxone Stada 5 mg/2.5 mg prolonged-release tablets EFG

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

Ingesting divided, broken, chewed, or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you take more Oxicodone/Naloxone Stada than you should”).

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

The tablet may be divided, but must not be broken, chewed, or crushed.

Ingesting broken, chewed, or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you take more Oxicodone/Naloxone Stada than you should”).

Abuse

Oxicodone/naloxone must never be abused, especially if you have substance addiction. If you are addicted to substances such as heroin, morphine, or methadone, you are likely to experience severe withdrawal symptoms if you misuse these tablets, because they contain naloxone. Pre-existing withdrawal symptoms may worsen.

Misuse

You must never dissolve these tablets for injection (e.g., into a blood vessel). The reason is that they contain talc, which may cause local tissue destruction (necrosis) and lung tissue abnormalities (pulmonary granuloma). This type of abuse may also have other serious consequences and may even cause death.

Doping

Use of this medicine may result in positive outcomes in anti-doping tests. The use of oxicodone/naloxone as a doping agent may endanger health.

Other medicines and Oxicodone/Naloxone Stada

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

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

Concomitant use of oxicodone/naloxone and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are available.

However, if your doctor prescribes oxicodone/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 strictly follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members about 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);
medicines used to treat epilepsy, pain, and anxiety such as gabapentin and pregabalin;
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), which may cause blood clotting speed to 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 medicine called St. John's wort (also known as Hypericum perforatum);
quinidine (a medicine used to treat arrhythmias).

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

Taking Oxicodone/Naloxone Stada with food, drink, and alcohol

Drinking alcohol while taking oxicodone/naloxone may make you feel more drowsy or increase the risk of serious adverse reactions such as shallow breathing with risk of respiratory arrest and loss of consciousness. It is recommended not to drink alcohol while taking oxicodone/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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of these tablets should be avoided as much as possible during pregnancy. 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 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 infant cannot be ruled out, especially if the mother receives multiple doses of oxicodone/naloxone.

Driving and use of machines

Oxicodone/Naloxone Stada may affect your ability to drive or operate machinery. This is particularly true at the beginning of treatment, after a dose increase, or after switching to a different medication. However, these undesirable effects usually disappear once the dose of oxicodone/naloxone is stabilized.

Oxicodone/Naloxone Stada has been associated with drowsiness and sudden episodes of sleep. If you experience this adverse effect, you must not drive or operate machinery. Consult your doctor if you experience this adverse effect.

Ask your doctor whether you can drive or operate machinery.

Oxicodone/Naloxone Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Oxycodeone/Naloxone Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Oxycodone/naloxone is a prolonged-release tablet, meaning that the active substances are released over an extended period of time. Its effect lasts 12 hours.

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

For the treatment of pain

Adults

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

Your doctor will decide the daily dose of oxycodone/naloxone you should take and how to divide it between the morning and evening doses. Your doctor will also decide whether the dose needs to be adjusted during treatment. Your dose will be adapted according to the intensity of your pain and your individual sensitivity. You should receive the lowest dose necessary to relieve pain. If you have previously been treated with opioids, the initial dose of oxycodone/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 compromised 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 oxycodone/naloxone, you may need a fast-acting analgesic. Oxycodone/naloxone is not suitable for this purpose. 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 starting dose is 5 mg of oxycodone hydrochloride/2.5 mg of naloxone hydrochloride in prolonged-release tablets every 12 hours.

Your doctor will decide how much oxycodone/naloxone you should take each day and how to divide the total daily dose between the 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 the symptoms of restless legs syndrome.

If you feel that the effect of oxycodone/naloxone 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 the treatment of pain or restless legs syndrome

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 impairment or mild liver impairment, your doctor will prescribe these tablets with special caution. If you have moderate or severe liver impairment, you must not take these tablets (see also section 2 “Do not take Oxycodone/Naloxone Stada” and “Warnings and precautions”).

Use in children and adolescents

Oxycodone/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 oxycodone/naloxone is not recommended in children and adolescents under 18 years of age.

Method of administration

Oral use.

Take oxycodone/naloxone every 12 hours, following a fixed schedule (e.g., 8 a.m. and 8 p.m.).

Oxycodone/Naloxone Stada 5 mg/2.5 mg prolonged-release tablets EFG

Take oxycodone/naloxone with sufficient liquid (½ glass of water). The tablet must be swallowed whole and must not be broken, chewed, or crushed. The tablet may be taken with or without food.

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

Take oxycodone/naloxone with sufficient liquid (½ glass of water). The tablet may be divided into equal doses. The tablet must not be broken, chewed, or crushed. The tablet may be taken with or without food.

Duration of use

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

If you take more Oxycodone/Naloxone 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 at 91 562 04 20, indicating the medication and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

An overdose may cause:

constricted pupils
slow and shallow breathing (respiratory depression)
drowsiness progressing to loss of consciousness
low muscle tone (hypotonia)
reduced heart rate, and
decreased 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 instances.

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

If you forget to take Oxycodone/Naloxone Stada

If you miss a dose or take a lower dose than prescribed, you may stop feeling the effect.

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

If 8 hours or more remain until the next dose: take the missed tablet immediately and continue with your normal schedule.
If less than 8 hours remain until the next dose: take the missed tablet. Wait another 8 hours before taking the next tablet. Try to return to your original schedule (e.g., 8 a.m. and 8 p.m.). Do not take oxycodone/naloxone more than once within an 8-hour period.

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

If you stop taking Oxycodone/Naloxone Stada

Do not stop treatment without consulting your doctor.

If you no longer need treatment, the daily dose should be gradually reduced after discussion with your doctor. This will help prevent 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 can cause adverse effects, although not everyone will experience them.

Important adverse effects to watch for, and what to do if they occur:

If you are already experiencing any of the following important adverse effects, consult a doctor immediately.

Slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. This occurs particularly in elderly and debilitated patients. Opioids may also cause a marked drop in blood pressure in susceptible patients.

The adverse effects are divided below into two sections: pain treatment, treatment with the active substance oxycodone hydrochloride alone, and treatment of restless legs syndrome.

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

Common (may affect up to 1 in 10 patients)

abdominal pain
constipation
diarrhea
dry mouth
indigestion
vomiting (feeling sick)
malaise
flatulence (gas)
reduced or loss of appetite
dizziness or sensation that “everything is spinning”
headache
hot flushes
unusual feeling of weakness
fatigue or exhaustion
itching of the skin
skin reactions/rashes
sweating
vertigo
insomnia
somnolence

Uncommon (may affect up to 1 in 100 patients)

bloating
abnormal thoughts
anxiety
confusion
depression
nervousness
feeling of chest tightness, especially if you already have coronary disease
low blood pressure
withdrawal symptoms such as restlessness
fainting
loss of energy
thirst
altered taste
palpitations
biliary colic
chest pain
general feeling of discomfort
pain
swelling of hands, ankles, or feet
difficulty concentrating
speech disturbance
tremor
difficulty breathing
restlessness
chills
increase in liver enzymes
increase in blood pressure
decreased sexual desire
rhinorrhea
cough
hypersensitivity/allergic reactions
weight loss
accidental injuries
increased urgency to urinate
muscle cramps
muscle contractions
muscle pain
vision disorder
epileptic seizures (especially in people with epilepsy or 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
burping

It is known that the active substance oxycodone hydrochloride, when not combined with naloxone hydrochloride, has the following adverse effects, different from those listed above

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

Common (may affect up to 1 in 10 patients)

mood disturbances and personality changes (e.g., depression, feeling of extreme happiness)
decreased activity
increased activity
difficulty urinating
hiccups

Uncommon (may affect up to 1 in 100 patients)

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

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

itchy rash (urticaria)
infections such as cold sores or herpes (which may cause blisters around the mouth or genital area)
increased appetite
black, tarry stools
bleeding gums

Frequency not known (cannot be estimated from available data)

generalized acute allergic reactions (anaphylactic reactions)
increased sensitivity to pain
absence of menstrual periods
withdrawal syndrome in newborns
problems with bile flow
a condition affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction)
dental caries

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

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

headache
somnolence
constipation
malaise
sweating
fatigue or exhaustion

Common (may affect up to 1 in 10 patients)

reduced or loss of appetite
difficulty sleeping
depression
dizziness or sensation that “everything is spinning”
difficulty concentrating
tremor
tingling in hands or feet
vision disorders
vertigo
hot flushes
low blood pressure
high blood pressure
abdominal pain
dry mouth
vomiting
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)

reduced sexual desire
sudden sleep episodes
altered taste
difficulty breathing
flatulence
erectile dysfunction
withdrawal symptoms such as restlessness
swelling of hands, ankles, or feet
accidental injuries

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxycode/Naloxone Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxycode/Naloxone Stada

The active substances are oxycodone hydrochloride and naloxone hydrochloride.

Oxycode/Naloxone Stada 5 mg/2.5 mg prolonged-release tablets EFG

One 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).

Oxycode/Naloxone Stada 10 mg/5 mg prolonged-release tablets EFG

One 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).

Oxycode/Naloxone Stada 20 mg/10 mg prolonged-release tablets EFG

One 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).

Oxycode/Naloxone Stada 30 mg/15 mg prolonged-release tablets EFG

One 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).

Oxycode/Naloxone Stada 40 mg/20 mg prolonged-release tablets EFG

One 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).

Other components are:

Tablet core:

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

Tablet coating:

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

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

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

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

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

Appearance of the product and contents of the pack

Oxycode/Naloxone Stada 5 mg/2.5 mg are prolonged-release, round, biconvex tablets, white in colour, 4.7 mm in diameter and 2.9 – 3.9 mm in height.

Oxycode/Naloxone Stada 10 mg/5 mg are prolonged-release, oblong, biconvex tablets, pink in colour, 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.

Oxycode/Naloxone Stada 20 mg/10 mg are prolonged-release, oblong, biconvex tablets, white in colour, 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.

Oxycode/Naloxone Stada 30 mg/15 mg are prolonged-release, oblong, biconvex tablets, yellow in colour, 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.

Oxycode/Naloxone Stada 40 mg/20 mg are prolonged-release, oblong, biconvex tablets, pink in colour, 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.

Oxycode/Naloxone Stada prolonged-release tablets are available in child-resistant single-dose blister packs of 28x1, 56x1, 60x1 and 98x1 prolonged-release tablets.

Only certain 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
[email protected]

Manufacturer

Develco Pharma GmbH
Grienmatt 27
79650 Schopfheim
Germany

STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany

Saneca Pharmaceuticals A.S.
Nitrianska 100
920 27 Hlohovec
Slovakia

Laboratori Fundació Dau
Calle Lletra C De La Zona Franca 12-14
Poligono Industrial De La Zona Franca De Barcelona
Barcelona, 08040
Spain

This medicinal product is authorised 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" 20 mg/10 mg
Oxycodone/Naloxone "Stada" 10 mg/5 mg
Oxycodone/Naloxone "Stada" 40 mg/20 mg

Slovakia: OxyNal 30 mg/15 mg, tablety s predlženým uvolnovaním
OxyNal 5 mg/2.5 mg, tablety s predlženým uvolnovaním
OxyNal 10 mg/5 mg, tablety s predlženým uvolnovaním
OxyNal 20 mg/10 mg, tablety s predlženým uvolnovaním
OxyNal 40 mg/20 mg, tablety s predlženým uvolnovaním

Spain: Oxycode/Naloxone STADA 10 mg/5 mg prolonged-release tablets EFG
Oxycode/Naloxone STADA 40 mg/20 mg prolonged-release tablets EFG
Oxycode/Naloxone STADA 5 mg/2.5 mg prolonged-release tablets EFG
Oxycode/Naloxone STADA 20 mg/10 mg prolonged-release tablets EFG
Oxycode/Naloxone STADA 30 mg/15 mg prolonged-release tablets EFG

Finland: Oxycodone/Naloxone STADA 10 mg/5 mg depottabletti
Oxycodone/Naloxone STADA 40 mg/20 mg depottabletti
Oxycodone/Naloxone STADA 5 mg/2.5 mg depottabletti
Oxycodone/Naloxone STADA 20 mg/10 mg depottabletti

Italy: Ossicodone e Naloxone EG 5 mg/2.5 mg compresse a rilascio prolungato
Ossicodone e Naloxone EG 10 mg/5 mg compresse a rilascio prolungato
Ossicodone e Naloxone EG 20 mg/10 mg compresse a rilascio prolungato
Ossicodone e Naloxone EG 30 mg/15 mg compresse a rilascio prolungato
Ossicodone e Naloxone EG 40 mg/20 mg compresse a rilascio prolungato

Czech Republic: Oxynalon 40 mg/20 mg tablety s prodlouženým uvolnováním
Oxynalon 10 mg/5 mg tablety s prodlouženým uvolnováním
Oxynalon 5 mg/2.5 mg tablety s prodlouženým uvolnováním
Oxynalon 20 mg/10 mg tablety s prodlouženým uvolnováním

Sweden: Oxycodone/Naloxone STADA 10 mg/5 mg depottabletter
Oxycodone/Naloxone STADA 5 mg/2.5 mg depottabletter
Oxycodone/Naloxone STADA 20 mg/10 mg depottabletter
Oxycodone/Naloxone STADA 40 mg/20 mg depottabletter

Date of the most recent revision of this leaflet: August 2024

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