Patient Information Leaflet

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

Hydrochloride of oxicodone / hydrochloride of naloxone

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as 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.

1. What isOxicodona/Naloxona Stadaand what is it used for

2. What you need to know before you start takingOxicodona/Naloxona Stada

3. How to takeOxicodona/Naloxona Stada

4. Possible side effects

5. Storage ofOxicodona/Naloxona Stada

6. Contents of the pack and additional information

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

These tablets are only for use 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 naloxona is added to counteract constipation.

How these tablets work for pain relief

These tabletscontain as active ingredients hydrochloride of oxicodona and hydrochloride of naloxona. Hydrochloride of oxicodona is responsible for the analgesic effect ofoxicodona/naloxona, and it is a potent analgesic of the opioid group.

The second active ingredient ofoxicodona/naloxona, hydrochloride of naloxona, has the function of counteracting constipation. Intestinal dysfunction (e.g., constipation) is a common side effect of opioid analgesic treatment.

Do not take Oxicodona/Naloxona Stada

-if you are allergic to hydrochloride of oxicodona, to hydrochloride of naloxona or to any of the other components of this medication (included in section 6),

-if with your breathing you cannot provide enough oxygen to the blood or eliminate the carbon dioxide produced in the body (respiratory depression),

-if you have a severe lung disease associated with narrowing of the respiratory pathways (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 takeOxicodona/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 disease,

-if you have mild liver disease,

-if you have severe lung disease (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 drowsy 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 (hypothyroidism),

-if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),

-if you have any mental illness accompanied by a loss (partial) of the sense 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 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 any previous cardiovascular disease,

-if you have a head trauma (due to the risk of increased intracranial pressure),

-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 if you sometimes fall asleep.

-if you experience drowsiness or sudden episodes of sleep.

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

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

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 (inflammation of the pancreas) or biliary tract system inflammation.

Diarrea

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.

Switch tooxicodona/naloxona

If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment withoxicodona/naloxona, for example, restlessness, episodes of sweating and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor.

Long-term treatment

You may experience tolerance to these tablets if you takeoxicodona/naloxonafor a long time. This means that you will need a higher dose to achieve the desired effect. Prolonged use may also cause physical dependence. You may experience withdrawal symptoms if treatment is stopped suddenly (restlessness, episodes of sweating, muscle pain). If you no longer need treatment, you should gradually reduce your daily dose, consulting with your doctor.

Psychological dependence

The active principle hydrochloride of oxicodona without combination has the same characteristics of abuse as other potent opioids (potent analgesics). It can create psychological dependence. Avoid medications containing hydrochloride of oxicodona in patients who present or have presented a history of alcohol, drug or medication abuse.

Cancer

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

If you need to undergo surgery, tell the doctors that you are taking oxicodona/naloxona.

Hormonal effects

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

Incorrect use ofoxicodona/naloxona

These tablets are not suitable for treating withdrawal syndrome.

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.

Consuming divided, broken, chewed or crushed tablets may cause the absorption of a potentially lethal dose of hydrochloride of oxicodona (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 not broken, chewed or crushed.

Consuming broken, chewed or crushed tablets may cause the absorption of a potentially lethal dose of hydrochloride of oxicodona (see section 3 “If you take moreOxicodona/NaloxonaStadathan you should”).

Abuse

You must never abuseoxicodona/naloxona, especially if you have any substance abuse. If you are addicted to substances such as heroin, morphine or methadone, you may experience severe withdrawal symptoms if you misusethese tablets, because it contains naloxona. You may worsen pre-existing withdrawal symptoms.

Mal use

You must 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 alterations in lung tissue (pulmonary granuloma). This abuse may also have other serious consequences and even cause death.

Doping

The use ofthis medicationmay give positive results in antidoping controls. The use ofoxicodona/naloxonaas a doping agent may put your health at risk.

Other medications and Oxicodona/Naloxona Stada

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

The risk of adverse reactions 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 and rhythmic muscle contractions, including those that control eye movement, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when you experience such symptoms.

The concomitant use of oxicodona/naloxona and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all sedatives you are taking and strictly follow your doctor's recommendation regarding the dose. 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 sedatives or related medications are:

•other potent analgesics (opioids);

•medications to treat epilepsy, pain and anxiety such as gabapentin and pregabalin;

•somnifacients and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics);

•medications to treat depression;

• medications used to treat allergies, dizziness or nausea (antihistamines or antiemetics);

•medications to treat psychiatric or mental disorders (antipsychotics that include phenothiazines and neuroleptics);

•muscle relaxants;

•medications 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 (coumarin derivatives), the speed of coagulation may increase or decrease;

•macrolide antibiotics (such as clarithromycin, erythromycin or telithromycin);

•specific type of antifungal agent known as azoles (such as ketoconazole, voriconazole, itraconazole or posaconazole)

•specific type of protease inhibitor used to treat HIV (for example ritonavir, indinavir, nelfinavir or saquinavir);

•cimetidine (a medication to treat stomach ulcers, indigestion or acidity);

•rifampicin (used to treat tuberculosis);

•carbamazepine (used to treat seizures or convulsions and certain painful diseases);

•phenytoin (used to treat seizures or convulsions);

•St. John's Wort (also known as Hypericum perforatum);

•quinidine (a medication to treat arrhythmias).

No interactions are expected between oxicodona/naloxona and paracetamol, acetylsalicylic acid or naltrexone.

TakingOxicodona/Naloxona Stada with food, drink and alcohol

Drinking alcohol while taking oxicodona/naloxona may make you feel more drowsy or increase the risk of severe 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 oxicodona/naloxona.

You should avoid drinking grapefruit juice while taking these tablets.

Pregnancy and breastfeeding

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

Pregnancy

During pregnancy, these tablets will be avoided as much as possible. If they are 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).

Breastfeeding

Lactation will be suspended during treatment with these tablets. Hydrochloride of oxicodona passes into breast milk. It is not known if 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 machinery

Oxicodona/naloxona may affect your ability to drive or operate machinery. This occurs especially at the beginning of treatment, after increasing the dose or after changing to a different medication. However, these undesirable effects disappear once the dose of oxicodona/naloxona is established.

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

Ask your doctor if you can drive or operate machinery.

Oxicodona/Naloxona Stada contains sodium

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

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

Oxicodona/naloxona is a prolonged-release tablet, meaning that the active principles 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 hydrochloride oxicodona/5 mg of hydrochloride naloxona in prolonged-release tablets every 12 hours.

Your doctor will decide on the dose of oxicodona/naloxona you should take per day and how to divide it into morning and evening doses. They will also decide if you need to adjust the dose during treatment. Your dose will be adjusted according 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 of oxicodona/naloxona may 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 substitute 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 rapid-acting analgesic. Oxicodona/naloxona is not a treatment for this case. Discuss it with your doctor.

If you think the effect of these tablets is 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.

Liver or kidney 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 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. Therefore, the use of oxicodona/naloxona in children and adolescents under 18 years of age is not recommended.

Administration form

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

Generally, you should not take these tablets for longer than necessary. If you are on long-term treatment, your doctor should check periodically 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

A overdose may cause:

• Constriction of the pupils
• Slow and shallow breathing (respiratory depression)
• Drowsiness to loss of consciousness
• Low muscle tone (hypotonia)
• Reduced heart rate, and
• Decreased blood pressure.

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.

If you forget to take Oxicodona/Naloxona Stada

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

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

• If 8 hours or more have passed since the next dose: take the missed tablet immediately and continue with the regular schedule.
• If less than 8 hours have passed since the next dose: take the missed tablet. Wait 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 compensate for the missed doses.

If you interrupt treatment with Oxicodona/Naloxona Stada

Do not interrupt treatment without consulting your doctor.

If you no longer need to continue treatment, your 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.

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

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

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

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

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

The following side effectshave been observed in patients receiving pain treatment

Frequent (may affect up to 1 in 10 patients)

•Abdominal pain

•Constipation

•Dyspepsia

•Diarrhea

•Dry mouth

•Indigestion

•Nausea (feeling sick)

•Malaise

•Flatulence (gas)

•Loss of appetite

•Sensation of dizziness or feeling like everything is spinning

•Headache

•Headaches

•Unusual feeling of weakness

•Fatigue or exhaustion

•Itching skin

•Reactions/eruptions on the skin

•Sweating

•Dizziness

•Insomnia

•Somnolence

Rare (may affect up to 1 in 100 patients)

•Flatulence

•Abnormal thoughts

•Anxiety

•Confusion

•Depression

•Nervousness

•Sensation of chest tightness, especially if you already have coronary disease

•Decrease in blood pressure

•Withdrawal symptoms such as agitation

•Loss of consciousness

•Loss of energy

•Thirst

•Alteration of taste

•Palpitations

•Biliary colic

•Chest pain

•General feeling of discomfort

•Pain

•Swelling of hands, ankles, or feet

•Difficulty concentrating

•Alteration of speech

•Tremor

•Difficulty breathing

•Restlessness

•Chills

•Increased liver enzymes

•Increased blood pressure

•Decrease in sexual desire

•Runny nose

•Cough

•Reactions of hypersensitivity/allergic

•Weight loss

•Accidents

•Urgent need to urinate

•Muscle cramps

•Muscle contractions

•Muscle pain

•Vision disorder

•Seizures (especially in people with epilepsy or predisposition to seizures)

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

•Increased heart rate

•Dependence on the medication

•Dental alterations

•Weight gain

•Yawns

Unknown frequency (cannot be estimated from available data)

•Euphoria

•Severe sedation

•Impotence

•Nightmares

•Alucinations

•Respiratory depression

•Difficulty urinating

•Aggression

•Itching skin

•Belching

The active ingredient hydrochloride of oxicodone, if not combined with hydrochloride of naloxone, has the following side effects, different from those mentioned:

Oxicodone can cause respiratory problems (respiratory depression), decrease in pupil size, muscle cramps of the bronchial muscles and smooth muscles, and depression of the cough reflex.

Frequent (may affect up to 1 in 10 patients)

•Mood alteration and changes in personality (e.g. depression, feeling extremely happy)

•Decrease in activity

•Increased activity

•Difficulty urinating

•Hypo

Rare (may affect up to 1 in 100 patients)

•Difficulty concentrating

•Migraines

•Increased muscle tension

•Involuntary muscle contractions

•Intestinal obstruction (ileus)

•Dry skin

•Tolerance to the medication

•Decrease in pain or touch sensitivity

•Coordination disorder

•Voice alteration (dysphonia)

•Water retention

•Auditory difficulties

•Oral ulcers

•Difficulty swallowing

•Gingivitis

•Perception disorder (e.g. hallucinations, derealization)

•Redness of the skin

•Dehydration

•Restlessness

•Decrease in sex hormones that can affect sperm production in men or menstrual cycle in women

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

•Urticaria (hives)

•Infections such as herpes labial or herpes (which can cause blisters around the mouth or genital area)

•Increased appetite

•Black stools (with tar-like appearance)

•Encrustation of the gums

Unknown frequency (cannot be estimated from available data)

•Generalized anaphylactic reactions

•Increased sensitivity to pain

•Absence of menstrual periods

•Withdrawal syndrome in newborns

•Problems with bile flow

•A problem affecting a valve in the intestine, which can cause severe pain in the upper abdomen (Oddi sphincter dysfunction)

•Dental caries

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 the Spanish System for the 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.

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

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Oxicodona/Naloxona Stada

The active principles are hydrochloride of oxicodona and hydrochloride of naloxona.

Oxicodona/Naloxona Stada 5 mg/2,5 mg prolonged-release tablets EFG

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

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

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

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

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

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

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

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

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

The other components are:

-Tablet core:

Acetate of polyvinylpyrrolidone, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate.

-Tablet coating:

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 contents of the package

Oxicodona/Naloxona Stada 5 mg/2,5 mg are prolonged-release tablets that are 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 that are oblong, biconvex, pink, with a groove on both sides, and 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 that are oblong, biconvex, white, with a groove on both sides, and 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 that are oblong, biconvex, yellow, with a groove on both sides, and 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 that are oblong, biconvex, pink, with a groove on both sides, and 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 safety blister packs of 28x1, 56x1, 60x1, and 98x1 prolonged-release tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Stada Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicine is authorized in the member states of the European Economic Area with 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, 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: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 depot tablets

Oxycodone/Naloxone STADA 40 mg/20 mg depot tablets

Oxycodone/Naloxone STADA 5 mg/2,5 mg depot tablets

Oxycodone/Naloxone STADA 20 mg/10 mg depot 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 depot tablets

Oxycodone/Naloxone STADA 5mg/2,5mg; depot tablets

Oxycodone/Naloxone STADA 20mg/10mg depot tablets

Oxycodone/Naloxone STADA 40mg/20mg depot tablets

Last review date of this leaflet: August 2024

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

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