Oxynador

Package leaflet: information for the patient

Oxynador, 10 mg + 5 mg, prolonged-release tablets
Oxynador, 20 mg + 10 mg, prolonged-release tablets
Oxynador, 40 mg + 20 mg, prolonged-release tablets
oxycodoni hydrochloridum + naloxoni hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Oxynador is and what it is used for
2. Important information before taking Oxynador
3. How to take Oxynador
4. Possible side effects
5. How to store Oxynador
6. Contents of the pack and other information

1. What Oxynador is and what it is used for

Oxynador is available as prolonged-release tablets, meaning that the active substances are released from the tablet over an extended period. Their effect lasts for 12 hours.
These tablets may be used only in adults.
Pain relief
Oxynador is indicated for the treatment of severe pain that can be adequately managed only with opioid analgesics.
How the tablets work in relieving pain
Oxynador contains oxycodoni hydrochloridum and naloxoni hydrochloridum as active substances. Oxycodoni hydrochloridum is responsible for the analgesic effect of Oxynador and is a potent opioid analgesic. The second active substance in Oxynador – naloxoni hydrochloridum – is intended to reduce certain adverse effects associated with opioid analgesic therapy.

2. Important information before using Oxynador

When not to use Oxynador

• if the patient is allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has breathing problems resulting in insufficient oxygen delivery to the blood and inability to remove carbon dioxide produced in the body (respiratory depression),
• if the patient suffers from severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease, COPD),
• if the patient has been diagnosed with cor pulmonale. In this condition, the right side of the heart is enlarged due to increased pressure in the blood vessels of the lungs (e.g. as a result of COPD – see above),
• if the patient has been diagnosed with severe bronchial asthma,
• if the patient has paralytic ileus (a type of intestinal obstruction) not caused by opioids,
• if the patient has moderate to severe liver impairment.

Warnings and precautions
Before starting treatment with Oxynador, consult a doctor or pharmacist:

• in elderly patients and weakened patients,
• if the patient has opioid-induced paralytic ileus (a type of intestinal obstruction),
• if the patient has renal impairment,
• if the patient has mild liver impairment,
• if the patient has severe lung disease (i.e. reduced vital capacity),
• if the patient experiences frequent breathing pauses during sleep at night (sleep apnoea), which may cause excessive daytime sleepiness,
• if the patient suffers from a disorder characterized by frequent breathing pauses at night, which may cause daytime sleepiness (sleep apnoea);
• if the patient has myxoedema (a thyroid disorder presenting with dryness, reduced body temperature, and skin swelling ("puffy face") affecting the face and limbs),
• if the thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
• if the adrenal glands do not produce sufficient hormones (adrenal insufficiency or Addison's disease),
• if the patient has a mental disorder with accompanying (partial) loss of reality perception (psychosis) caused by alcohol or other substances (psychosis-inducing substances),
• if the patient has symptoms related to gallstones or other disorders of the biliary tract (biliary diseases, gallbladder disorders, etc.),
• if the patient has been diagnosed with abnormal enlargement of the prostate gland (prostate hyperplasia),
• if the patient suffers from alcoholism or alcoholic delirium,
• if the patient has pancreatitis,
• if the patient has low blood pressure (hypotension),
• if the patient has high blood pressure (hypertension),
• if the patient has previously diagnosed cardiovascular disease,
• if the patient has a head injury (due to risk of increased intracranial pressure),
• if the patient has epilepsy or predisposition to seizures,
• if the patient is currently taking monoamine oxidase inhibitors (MAOIs) (used in the treatment of depression or Parkinson's disease), or if the patient has taken any of the following within the last two weeks: tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid;
• if the patient feels sleepy or experiences unexpected episodes of falling asleep;

Sleep-related breathing disorders
Oxynador may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up due to breathlessness, difficulty falling asleep, or excessive daytime sleepiness. If the patient or someone else observes such symptoms, medical advice should be sought. The doctor may recommend reducing the dose.
Consult a doctor if any of the above conditions have ever applied to the patient in the past. Also consult a doctor if any of the above disorders develop during treatment with these tablets. The most serious consequence of opioid overdose is respiratory depression (slow and shallow breathing), which may lead, among other things, to reduced blood oxygen levels and fainting.
The prolonged-release tablet must be swallowed whole to ensure the controlled, slow release of oxycodone hydrochloride from the prolonged-release tablets. Do not break, chew, or crush the tablets. Ingesting broken or crushed tablets may result in absorption of a potentially fatal dose of oxycodone hydrochloride (see "Taking more Oxynador than you should" in section 3).
If severe diarrhoea occurs at the beginning of treatment, this may be due to the effect of naloxone. This may indicate that bowel function is returning to normal. Such diarrhoea may occur within the first 3–5 days of treatment. If diarrhoea persists beyond 3–5 days or is distressing to the patient, the patient should contact a doctor.
When switching to Oxynador from previous opioid painkillers, withdrawal symptoms such as restlessness, sweating, and muscle pain may initially occur. If the patient experiences such symptoms, special medical monitoring may be necessary.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. Repeated use of opioid medicines may lead to reduced effectiveness of the medicine (the patient becomes accustomed, known as tolerance). Repeated use of Oxynador may lead to dependence and abuse, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence or abuse may cause the patient to feel they have lost control over the dose or frequency of medicine intake. The patient may feel compelled to continue taking the medicine, even if it no longer helps relieve pain.
The risk of dependence or addiction varies between patients. The risk of addiction to Oxynador may be higher if:

• the patient or a family member has ever abused or been dependent on alcohol,
• prescription medicines, or drugs;
• the patient smokes cigarettes;
• the patient has had mood problems (depression, anxiety, or personality disorders) or has been treated
• by a psychiatrist for other mental disorders.

If, during treatment with Oxynador, the patient notices any of the following symptoms, this may indicate the development of tolerance or addiction:

• The patient needs to take the medicine for longer than prescribed by the doctor.
• The patient must take a higher dose than recommended.
• The patient uses the medicine for reasons other than those prescribed by the doctor, e.g., "to stay calm" or "to help sleep".
• The patient has made repeated, unsuccessful attempts to stop or control medicine use.
• The patient feels unwell after stopping the medicine, and symptoms improve after resuming intake ("withdrawal effects").

If any of these symptoms are observed, contact a doctor to discuss the best treatment approach for the patient, including when and how to safely discontinue treatment (see section 3 "Stopping Oxynador").
Contact a doctor if the patient experiences severe pain in the upper abdomen, possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis or biliary tract disorders.
Patients with cancer involving peritoneal metastases or intestinal obstruction in advanced stages of gastrointestinal or pelvic cancer should inform their doctor.
If surgery is required, inform the medical team about taking Oxynador.
Like other opioids, oxycodone may affect normal hormone production in the body, such as cortisol or sex hormones, particularly if the patient has taken high doses for a prolonged period. If the patient experiences persistent symptoms such as nausea (including vomiting), loss of appetite, fatigue, weakness, dizziness, menstrual cycle changes, impotence, infertility, or reduced libido, discuss this with a doctor, as hormone level monitoring may be necessary.
This medicine may increase sensitivity to pain, especially at high doses. Inform the doctor if this occurs. Dose reduction or a change in medication may be necessary.
Remnants of the prolonged-release tablet may be visible in the stool. This is not a cause for concern, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released and absorbed as the tablet passes through the gastrointestinal tract.
Improper use of Oxynador tablets
The tablets are not suitable for treating withdrawal symptoms.
Never abuse Oxynador, especially if the patient is drug-dependent. In individuals dependent on substances such as heroin, morphine, or methadone, abuse of these tablets may cause severe withdrawal symptoms due to the presence of naloxone. Existing withdrawal symptoms may worsen.
Do not misuse these tablets by dissolving and injecting the contents (e.g. intravenously). The tablets contain, in particular, talc, which may cause local tissue necrosis and pulmonary granulomatosis. Such abuse may also lead to other serious consequences, including death.
Use of Oxynador may yield a positive result in doping tests for stimulants.
Using Oxynador as a stimulant may pose a life-threatening risk.
Oxynador and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
The risk of adverse effects increases if the patient takes antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the following symptoms in the patient: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C.
If these symptoms occur, contact a doctor.
Concomitant use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or similar drugs, increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered if no other treatment options are available.
If the doctor prescribes Oxynador together with sedative medicines, the doctor should limit the dose and duration of concomitant use.
Inform the doctor about all sedative medicines taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the above symptoms. If such symptoms occur, contact a doctor.
Examples of sedative or similarly acting medicines include:

• other strong painkillers (opioids);
• medicines used to treat epilepsy, pain, and anxiety disorders, such as gabapentin and pregabalin;
• sleeping pills and sedatives (including benzodiazepines and anti-anxiety medicines);
• medicines used to treat depression;
• medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics);
• medicines used to treat mental or psychiatric disorders (antipsychotics containing phenothiazines, neuroleptics);
• muscle relaxants;
• medicines used to treat Parkinson's disease.

When taking these tablets together with other medicines, the effects of both the tablets and the medicines listed below may be altered.
Inform the doctor about taking medicines such as:

• medicines that affect blood clotting (coumarin derivatives), which may prolong or shorten blood clotting time;
• macrolide antibiotics (e.g. clarithromycin, erythromycin, or telithromycin);
• azole antifungal medicines (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
• protease inhibitors used in HIV treatment (examples include ritonavir, indinavir, nelfinavir, and saquinavir);
• cimetidine (a medicine for stomach ulcers, indigestion, or heartburn);
• rifampicin (used in the treatment of tuberculosis);
• carbamazepine (used to treat seizures, fits, or certain types of pain);
• phenytoin (used to treat seizures, fits, or convulsions);
• St John's wort (also known as Hypericum perforatum);
• quinidine (a medicine for treating heart rhythm disorders).

No interaction between Oxynador and paracetamol, acetylsalicylic acid, or naltrexone is expected.
Oxynador with food, drink, and alcohol
Drinking alcohol while taking Oxynador may cause drowsiness or increase the risk of serious adverse effects such as shallow breathing with risk of apnoea and loss of consciousness. Alcohol consumption is not recommended during treatment with Oxynador. Avoid drinking grapefruit juice while taking these tablets.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Avoid using these tablets in pregnant women whenever possible. Prolonged use of prolonged-release tablets during pregnancy may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is used during labour, respiratory depression (slow and shallow breathing) may occur in the newborn.
Breastfeeding
Breastfeeding must be discontinued during treatment with these tablets. Oxycodone hydrochloride passes into breast milk. It is unknown whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to a breastfed infant cannot be excluded if the mother is taking Oxynador long-term.
Driving and operating machinery
Oxynador may impair the ability to drive and operate machinery. This effect is particularly expected at the beginning of treatment with Oxynador, after each dose increase, or when switching to another medicine. However, once the patient has been on a stable dose of Oxynador for a prolonged period, these disturbances usually resolve.
Use of Oxynador has been associated with drowsiness and sudden episodes of falling asleep. If the patient experiences this adverse effect, driving or operating machinery must not be undertaken. Discuss such adverse effects with a doctor.
The patient should consult a doctor regarding the ability to drive or operate machinery.
Oxynador contains lactose
The medicine contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking these tablets.

3. How to use Oxynador

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you the
expected effects of taking Oxynador, when and for how long you should take it, when you should
contact your doctor, and when you should stop taking Oxynador (see "Stopping treatment with
Oxynador").
Oxynador is available as prolonged-release tablets, meaning that its active substances are released
over an extended period. Its effect lasts for 12 hours.
Prolonged-release tablets must be swallowed whole to avoid disrupting the slow release of
hydrochloride oxycodone from the prolonged-release tablet. Tablets must not be broken, chewed,
or crushed. Taking a broken, chewed, or crushed tablet may lead to rapid release of the active
substance from the tablet. This may result in absorption of a potentially fatal dose of hydrochloride
oxycodone (see section 3 "Taking more Oxynador than prescribed").
Unless otherwise prescribed by your doctor, the usual dose of Oxynador is:
Pain treatment
Adults
The usual starting dose is 10 mg hydrochloride oxycodone + 5 mg hydrochloride naloxone in the
form of prolonged-release tablet(s) every 12 hours.
Your doctor will decide on any necessary dose adjustments during treatment. The doctor will adjust
the dose according to the intensity of pain and individual patient sensitivity. Patients should receive
the lowest effective dose needed to control pain. In patients previously treated with opioid pain
medications, treatment with Oxynador may be initiated with higher doses.
The maximum daily dose is 160 mg hydrochloride oxycodone and 80 mg hydrochloride naloxone.
If a patient requires a higher dose, the doctor may prescribe additional doses of hydrochloride
oxycodone without hydrochloride naloxone. However, the total daily dose of hydrochloride
oxycodone should not exceed 400 mg.
When additional doses of hydrochloride oxycodone without hydrochloride naloxone are given, the
beneficial effect of hydrochloride naloxone on intestinal function may be impaired.
If your doctor decides to switch you from Oxynador to another opioid medicine, intestinal function
may worsen.
If you experience pain before the next scheduled dose of Oxynador, it may be necessary to use a
fast-acting pain reliever. These tablets are not intended for this purpose.
In such a case, consult your doctor or pharmacist.
Your doctor will determine the daily dose you should take and how to divide the daily dose into
morning and evening doses.
If you feel the effect of the tablets is too strong or too weak, consult your doctor or pharmacist.
Elderly patients
Dose adjustment is usually not necessary in elderly patients with normal liver and/or kidney
function.
Liver or kidney function impairment
If you have kidney dysfunction or mild liver impairment, your doctor will prescribe these tablets
with particular caution. If you have moderate to severe liver impairment, these tablets should not
be used (see also section 2 "When not to use Oxynador" and "Warnings and precautions").
Children and adolescents under 18 years of age
Oxynador has not been studied in children and adolescents under 18 years of age. The safety and
efficacy of the medicine have not been established in children and adolescents. Therefore,
Oxynador is not recommended for use in children and adolescents under 18 years of age.
Method of administration
Oral use.
Tablets should be swallowed whole (without chewing), with an adequate amount of liquid (½ glass
of water).
Tablets may be taken with or without food. Tablets should be taken every 12 hours, according to
the prescribed treatment schedule (e.g., in the morning at 8:00 a.m., in the evening at 8:00 p.m.).
Prolonged-release tablets must not be broken, chewed, or crushed (see section 2 "Warnings and
precautions").
For single-dose blisters with child-resistant packaging only:
Oxynador is available in single-dose blisters with child-resistant packaging. The prolonged-release
tablet should be removed from the blister as follows:

1. Hold the edge of the blister and gently separate one square from the rest of the blister along the perforation line.
2. Pull the edge of the foil and completely remove the foil.
3. Push the prolonged-release tablet out onto your hand.
4. Swallow the prolonged-release tablet whole with an adequate amount of liquid, with or without food.

Duration of treatment
In general, these tablets should not be taken longer than necessary. If you are undergoing long-term
treatment with these tablets, your doctor should regularly assess whether continued treatment is
still needed.
Taking more Oxynador than prescribed
If you have taken more tablets than prescribed, contact your doctor immediately.
Overdose may cause:

• constricted pupils,
• slow and shallow breathing (respiratory depression),
• narcotic-like drowsiness (drowsiness up to loss of consciousness),
• reduced muscle tone (hypotonia),
• slowed heart rate,
• drop in blood pressure,
• brain disorders (toxic leukoencephalopathy).

In severe cases, unconsciousness (coma), pulmonary edema, and circulatory collapse may occur,
which in some cases may lead to death.
You should avoid activities requiring increased attention, such as driving.
Missing a dose of Oxynador
or taking a lower dose than prescribed may result in inadequate pain relief.
If you forget to take a dose, follow these instructions:

• If 8 hours or more remain until the next dose: take the missed dose immediately and continue taking the medicine according to the prescribed schedule.
• If less than 8 hours remain until the next dose: do not take the missed dose. Wait 8 hours before taking the next dose. Try to return to the original dosing schedule (e.g., morning at 8:00 a.m., evening at 8:00 p.m.). Do not take more than one dose within 8 hours.

Do not take a double dose to make up for a missed dose.
Stopping treatment with Oxynador
Do not stop treatment without consulting your doctor.
If treatment is no longer needed, the daily dose should be gradually reduced after consultation with
your doctor. This helps prevent withdrawal symptoms such as restlessness, especially motor
agitation, sweating, and muscle pain.
If you have any further questions about using these tablets, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Important information about adverse effects and what to do
if they occur:
If any of the following adverse effects occur, contact your doctor immediately.
Slow and shallow breathing (respiratory depression) is the main risk associated with opioid overdose. It occurs mainly in elderly and weakened patients. Opioids may also cause severe drop in blood pressure in sensitive patients.

The following adverse effects have been observed in patients treated for pain:
Common (may occur in up to 1 in 10 patients):

• abdominal pain
• constipation
• diarrhoea
• dry mouth
• indigestion
• vomiting
• nausea
• bloating (gas)
• decreased appetite up to complete loss of appetite
• dizziness or spinning sensation
• headache
• hot flushes
• fatigue or exhaustion
• feeling of unusual weakness
• itching of the skin
• skin reactions, rash
• sweating
• dizziness
• difficulty falling asleep
• drowsiness

Uncommon (may occur in up to 1 in 100 patients):

• abdominal distension
• abnormal thinking
• restlessness
• disorientation
• depression
• nervousness
• chest tightness, especially if coronary heart disease is present
• drop in blood pressure
• withdrawal symptoms, e.g. agitation
• fainting
• feeling of lack of energy
• thirst
• taste disturbances
• palpitations
• biliary colic
• chest pain
• general malaise
• pain
• swelling of hands, ankles and feet
• difficulty concentrating
• difficulty speaking
• tremor
• breathing difficulties
• restlessness, especially motor restlessness
• chills
• increased liver enzyme activity
• increased blood pressure
• reduced libido
• catarrh
• cough
• hypersensitivity/allergic reactions
• weight loss
• accidental injuries
• increased urge to urinate
• muscle cramps
• muscle twitching
• muscle pain
• visual disturbances
• seizures (especially in patients with epilepsy or predisposition to seizures)

Rare (may occur in up to 1 in 1000 patients):

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

Not known (frequency cannot be estimated from available data):

• aggression
• euphoric state
• severe drowsiness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• difficulty passing urine
• tingling of the skin (numbness and tingling)
• belching
• sleep apnoea (pauses in breathing during sleep)

The following adverse effects of the active substance hydrochloride oxycodone are known
when it is not combined with hydrochloride naloxone:
Oxycodone may cause breathing problems (respiratory depression), pinpoint pupils, bronchospasm, and smooth muscle spasms, as well as suppression of the cough reflex.
Common (may occur in up to 1 in 10 patients):

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

Uncommon (may occur in up to 1 in 100 patients):

• concentration difficulties
• migraines
• increased muscle tension
• involuntary muscle contractions
• intestinal dysfunction (intestinal obstruction)
• dry skin
• drug tolerance
• reduced sensitivity to pain and touch
• impaired coordination
• voice changes (hoarseness)
• fluid retention
• hearing problems
• oral ulceration
• difficulty swallowing
• gum pain
• perceptual disturbances (e.g. hallucinations, derealization)
• skin redness
• dehydration
• agitation
• decreased levels of sex hormones, which may affect sperm production in men or menstrual cycle in women

Rare (may occur in up to 1 in 1000 patients):

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

Not known (frequency cannot be estimated from available data):

• acute generalized allergic reactions (anaphylactic reactions)
• increased sensitivity to pain
• absence of menstruation
• neonatal withdrawal syndrome
• bile flow problems: disorders affecting the valve in the intestine, which may cause severe upper abdominal pain (dysfunction of the sphincter of Oddi)
• dental caries

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Oxynador

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Oxynador contains

• The active substances are oxycodone hydrochloride and naloxone hydrochloride.
  10 mg + 5 mg, prolonged-release tablets
  Each 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.
  20 mg + 10 mg, prolonged-release tablets
  Each 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.
  40 mg + 20 mg, prolonged-release tablets
  Each 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 ingredients are hydroxypropylcellulose, ethylcellulose, glyceryl distearate, lactose monohydrate, talc and magnesium stearate; and in the tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172) – only in 20 mg + 10 mg tablets, and iron oxide yellow (E 172) – only in 40 mg + 20 mg tablets. See section 2, "Oxynador contains lactose".

What Oxynador looks like and contents of the pack
10 mg + 5 mg, prolonged-release tablets (tablets): white, oval, slightly biconvex coated prolonged-release tablets with "10" engraved on one side of the tablet (dimensions: 9.5 mm x 4.5 mm).
20 mg + 10 mg, prolonged-release tablets (tablets): light pink, oval, slightly biconvex coated prolonged-release tablets with "20" engraved on one side of the tablet (dimensions: 9.5 mm x 4.5 mm).
40 mg + 20 mg, prolonged-release tablets (tablets): brownish-yellow, capsule-shaped, slightly biconvex coated prolonged-release tablets with "40" engraved on one side of the tablet (dimensions: 14.0 mm x 6.0 mm).

10 mg + 5 mg:
Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 112 prolonged-release tablets in child-resistant blisters, in a cardboard box.

20 mg + 10 mg, 40 mg + 20 mg:
Pack sizes: 10, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 112 prolonged-release tablets in child-resistant blisters, in a cardboard box.

For single-dose blisters with child-resistant closure only:
10 mg + 5 mg:
Pack sizes: 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 112x1 prolonged-release tablet in single-dose child-resistant blisters, in a cardboard box.

20 mg + 10 mg, 40 mg + 20 mg:
Pack sizes: 10x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 112x1 prolonged-release tablet in single-dose child-resistant blisters, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised for supply in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: +48 22 57 37 500