Oxinador

Leaflet accompanying the packaging: patient information

Oxynador, 10 mg + 5 mg, prolonged-release tablets

Oxynador, 20 mg + 10 mg, prolonged-release tablets

Oxynador, 40 mg + 20 mg, prolonged-release tablets

Oxycodone hydrochloride + naloxone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Oxynador and what is it used for
• 2. Important information before taking Oxynador
• 3. How to take Oxynador
• 4. Possible side effects
• 5. How to store Oxynador
• 6. Package contents and other information

1. What is Oxynador and what is it used for

Oxynador is a prolonged-release tablet, which means that the active substances are released from the tablet over a longer period. Their effect lasts for 12 hours. These tablets can only be used in adults.

Pain relief

Oxynador is indicated for the treatment of severe pain that can only be adequately controlled with opioid analgesics.

How the tablets work to relieve pain

Oxynador contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the analgesic effect of Oxynador and is a strong opioid analgesic. The second active substance of Oxynador, naloxone hydrochloride, is intended to alleviate some of the side effects that occur during treatment with opioid analgesics.

2. Important information before taking Oxynador

When not to take 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, which means that not enough oxygen can be delivered to the blood and carbon dioxide produced in the body cannot be removed (respiratory depression),
• if the patient has severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease, COPD),
• if the patient has been diagnosed with a condition called cor pulmonale. In this case, the right side of the heart is enlarged due to increased pressure in the blood vessels in the lungs (e.g., as a result of COPD - see above),
• if the patient has been diagnosed with severe asthma,
• if the patient has paralytic ileus (a type of intestinal obstruction) not caused by opioids,
• if the patient has moderate to severe liver failure.

Warnings and precautions

Before starting treatment with Oxynador, the doctor or pharmacist should be consulted:

• in the case of elderly and frail patients,
• if the patient has paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if the patient has kidney failure,
• if the patient has mild liver failure,
• if the patient has severe lung failure (i.e., reduced vital capacity),
• if the patient experiences frequent pauses in breathing during sleep at night (sleep apnea), which can cause excessive daytime sleepiness
• if the patient suffers from a condition characterized by frequent pauses in breathing at night, which can cause sleepiness during the day (sleep apnea);
• if the patient has angioedema (a disorder of thyroid function characterized by a feeling of dryness, decreased temperature, and swelling of the skin ("moon face"), including the face and limbs),
• if the thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
• if the adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
• if the patient has a mental illness with accompanying (partial) loss of touch with reality (psychosis) caused by alcohol or other substance intoxication (substances that induce psychosis),
• if the patient has gallstone or other bile duct disorders (bile duct diseases, gallbladder, etc.),
• if the patient has been diagnosed with benign prostatic hyperplasia (enlarged prostate),
• if the patient has a history of alcoholism or delirium tremens,
• 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 the risk of increased intracranial pressure),
• if the patient has epilepsy or a predisposition to seizures,
• if the patient is taking MAO inhibitors (used to treat depression or Parkinson's disease) or has taken them in the last two weeks, e.g., drugs containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid;
• if the patient feels drowsy or falls asleep unexpectedly;

Respiratory disorders during sleep

Oxynador may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up due to shortness of breath, difficulty falling asleep, or excessive daytime sleepiness. If the patient or another person observes such symptoms, they should contact a doctor. The doctor may recommend reducing the dose of the medicine.

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid. Repeated use of opioid medicines can lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, which is called tolerance). Repeated use of Oxynador may lead to dependence and abuse, which can lead to life-threatening overdose. The risk of these side effects may increase with increasing dose and longer treatment duration.

• The patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illicit drugs;
• The patient smokes;
• The patient has had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If the patient notices any of the following symptoms while taking Oxynador, it may indicate that they are developing tolerance to the medicine or are becoming dependent:

• The patient needs to take the medicine for a longer period than the doctor recommended.
• The patient needs to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those recommended by the doctor, e.g., "to calm down" or "to help fall asleep".
• The patient has repeatedly tried to stop or control the use of the medicine but has been unable to do so.
• The patient feels unwell after stopping the medicine and feels better after taking it again ("withdrawal symptoms").

If any of these symptoms are observed, the patient should contact their doctor to discuss the best course of treatment, including when to stop taking the medicine and how to safely stop treatment (see section 3 "Stopping Oxynador treatment").

Incorrect use of Oxynador tablets

The tablets are not suitable for treating withdrawal symptoms. Oxynador should never be abused, especially in the case of drug dependence. In people dependent on substances such as heroin, morphine, or methadone, abusing these tablets can cause severe withdrawal symptoms, as they contain naloxone. Existing withdrawal symptoms may worsen.

The tablets should not be misused by dissolving and injecting the contents of the tablets (e.g., into blood vessels). The tablets contain talc, which can cause local tissue breakdown (necrosis) and changes in lung tissue (pulmonary granulomas). Such abuse can also lead to other serious consequences and even death.

Taking these tablets may result in a positive test for stimulants (doping). Using Oxynador as a stimulant can be life-threatening.

Oxynador and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.

The risk of side effects increases if the patient is taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, which can cause the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, increased muscle tone, and elevated body temperature above 38°C.

If these symptoms occur, the doctor should be contacted.

The concurrent use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, the concurrent use of these medicines should only be considered when other treatment options are not possible.

If the doctor prescribes Oxynador together with sedative medicines, they should limit the dose and duration of concurrent use.

The doctor should be informed about all sedative medicines being taken, and the doctor's instructions regarding dosage should be followed carefully. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the doctor should be contacted.

Examples of sedative medicines or medicines with a similar effect are:

• other strong painkillers (opioids);
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin;
• sleeping pills and sedatives (including benzodiazepines and anxiolytics)
• 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.

In the event of concurrent use of these tablets and other medicines, the effect of both the tablets and the medicines may change.

The doctor should be informed about the use of medicines such as:

• medicines that reduce blood clotting (coumarin derivatives), as the blood clotting time may be prolonged or shortened;
• macrolide antibiotics (e.g., clarithromycin, erythromycin, or telithromycin);
• azole antifungal medicines (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
• protease inhibitors used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, and saquinavir);
• cimetidine (a medicine for stomach ulcers, indigestion, or heartburn);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures, shocks, or certain types of pain);
• phenytoin (used to treat seizures, shocks, or certain types of pain);
• St. John's Wort (also known as Hypericum perforatum);
• quinidine (a medicine for heart rhythm disorders).

No interaction is expected between Oxynador and paracetamol, acetylsalicylic acid, or naltrexone.

Oxynador with food, drink, and alcohol

Drinking alcohol while taking Oxynador may cause drowsiness or increase the risk of serious side effects, such as shallow breathing with a risk of apnea and loss of consciousness. It is not recommended to drink alcohol while taking Oxynador. Grapefruit juice should be avoided while taking these tablets.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Oxynador should be avoided in pregnant women whenever possible. Long-term use of prolonged-release tablets during pregnancy may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is used during delivery, it may cause respiratory depression in the newborn (slow and shallow breathing).

Breastfeeding

Breastfeeding should be stopped while taking these tablets. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to the breastfed infant cannot be excluded if the mother takes Oxynador for a long time.

Driving and using machines

Oxynador may impair the ability to drive and use machines. Such effects can be expected especially at the beginning of treatment with Oxynador, after each dose increase, or when switching to another medicine. However, when the patient has been taking a fixed dose of Oxynador for a longer period, these disturbances will subside.

Oxynador has been associated with drowsiness and sudden sleep episodes. If the patient experiences this side effect, they should not drive or operate machinery. The patient should discuss this with their doctor if they experience such side effects.

The patient should consult their doctor about the possibility of driving or operating machinery.

Oxynador contains lactose

The medicine contains lactose (milk sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking these tablets.

3. How to take Oxynador

This medicine should always be taken exactly as the doctor has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.

Before starting treatment and regularly during treatment, the doctor will discuss with the patient the expected symptoms of taking Oxynador, when and for how long the patient should take it, when the patient should contact the doctor, and when the patient should stop taking Oxynador (see "Stopping Oxynador treatment").

Oxynador is available as prolonged-release tablets, which means that the active substances are released over a longer period. Their effect lasts for 12 hours.

The prolonged-release tablets should be swallowed whole, without chewing, to avoid disrupting the slow release of oxycodone hydrochloride from the prolonged-release tablet. The tablets should not be broken, chewed, or crushed. Taking a broken, chewed, or crushed tablet can lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking a higher dose of Oxynador than recommended").

Unless the doctor has prescribed otherwise, the usual dose of Oxynador is:

Pain relief

Adults

The initial dose is usually 10 mg of oxycodone hydrochloride + 5 mg of naloxone hydrochloride in the form of a prolonged-release tablet every 12 hours.

The doctor will decide on any necessary dose adjustments during treatment. The doctor will adjust the dose according to the severity of the pain and the patient's individual sensitivity. The patient should receive the smallest effective dose to control the pain. If the patient has previously taken opioid analgesics, treatment with Oxynador can be started with higher doses.

The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If the patient requires a higher dose, the doctor may recommend additional doses of oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose should not exceed 400 mg of oxycodone hydrochloride.

If additional doses of oxycodone hydrochloride are given without naloxone hydrochloride, the beneficial effect of naloxone hydrochloride on bowel function may be disrupted.

If the doctor recommends switching from Oxynador to another opioid medicine, bowel function may worsen.

If the patient experiences pain before the next dose of Oxynador is due, it may be necessary to use a fast-acting painkiller. These tablets are not intended for this purpose.

In such cases, the patient should consult their doctor or pharmacist.

The doctor will decide what dose the patient should take daily and how to divide the daily dose into morning and evening doses.

If the patient feels that the effect of the tablets is too strong or too weak, they should consult their doctor or pharmacist.

Elderly patients

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

Impaired liver or kidney function

If the patient has impaired kidney function or mild liver failure, the doctor will prescribe these tablets with caution. If the patient has moderate to severe liver failure, these tablets should not be used (see also section 2 "When not to take 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 in children and adolescents have not been established. Therefore, Oxynador should not be used in children and adolescents under 18 years of age.

Method of administration

Oral use.

The tablets should be swallowed whole (without chewing), with a sufficient amount of liquid (½ glass of water). The tablets can be taken with or without food. The tablets should be taken every 12 hours, according to the established treatment plan (e.g., in the morning at 8:00, in the evening at 20:00). Prolonged-release tablets should not be broken, chewed, or crushed (see section 2 "Warnings and precautions").

This only applies to single-dose blisters with child-resistant closure:

Oxynador is available in single-dose blisters with child-resistant closure. The prolonged-release tablet should be removed from the blister as follows:

• 1. Hold the edge of the blister and separate one unit from the rest of the blister by gently tearing it along the perforation.
• 2. Pull the edge of the foil and completely remove the foil.
• 3. Push the prolonged-release tablet out onto the hand.
• 4. Swallow the prolonged-release tablet whole, with a sufficient amount of liquid, with or without food.

Duration of treatment

As a rule, the tablets should not be taken for longer than necessary. If the patient is undergoing long-term treatment with these tablets, the treating doctor should regularly check whether the patient still needs them.

Taking a higher dose of Oxynador than recommended

If the patient has taken a higher dose of the tablets than recommended, they should contact their doctor immediately.

Overdose of the medicine may cause:

• pupil constriction,
• slow and shallow breathing (respiratory depression),
• a state similar to drug intoxication (drowsiness up to loss of consciousness),
• decreased muscle tone (hypotonia),
• slow heart rate,
• decreased blood pressure,
• brain disorders (toxic leukoencephalopathy).

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

Activities that require increased attention, such as driving, should be avoided.

Missing a dose of Oxynador

or taking a lower dose than prescribed will result in inadequate pain relief.

If the patient has missed a dose, they should follow the instructions:

• If there are 8 hours or more until the next dose is due: the missed dose should be taken immediately, and the patient should continue taking the medicine according to the established schedule.
• If there are less than 8 hours until the next dose is due: the missed dose should be taken. Then, the patient should wait 8 hours before taking the next dose. The patient should try to return to the original dosing schedule (e.g., in the morning at 8:00, in the evening at 20:00). The patient should not take more than one dose in 8 hours.

A double dose should not be taken to make up for a missed dose.

Stopping Oxynador treatment

Treatment should not be stopped without consulting a doctor.

If treatment is no longer necessary, the daily dose should be gradually reduced after consulting a doctor. This can help avoid withdrawal symptoms, such as restlessness, especially agitation, sweating, and muscle pain.

If the patient has any further doubts about taking these tablets, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxynador can cause side effects, although not everybody gets them.

Important information about side effects and what to do if they occur:

If any of the following side effects occur, the patient should contact their doctor immediately.

Slow and shallow breathing (respiratory depression) is the main risk associated with opioid overdose. It usually occurs in elderly and frail patients. Opioids can also cause a severe drop in blood pressure in sensitive patients.

The following side effects have been observed in patients treated for pain:

Common(may affect up to 1 in 10 people):

• abdominal pain
• constipation
• diarrhea
• dry mouth
• indigestion
• vomiting
• nausea
• bloating (gas)
• decreased appetite up to loss of appetite
• dizziness or "spinning" sensation
• headache
• hot flashes
• fatigue or exhaustion
• feeling of unusual weakness
• itching
• skin reactions, rash
• sweating
• dizziness
• sleep disorders
• sleepiness

Uncommon(may affect up to 1 in 100 people):

• abdominal bloating
• abnormal thinking
• anxiety
• disorientation
• depression
• irritability
• chest tightness, especially if there is coronary artery disease
• decreased blood pressure
• withdrawal symptoms, e.g., agitation
• fainting
• feeling of lack of energy
• thirst
• taste disorders
• palpitations
• biliary colic
• chest pain
• general malaise
• pain
• swelling of hands, feet, and ankles
• concentration disorders
• speech disorders
• tremors
• breathing difficulties
• anxiety, especially restlessness
• chills
• increased liver enzyme activity
• increased blood pressure
• decreased libido
• rhinitis
• cough
• hypersensitivity/allergic reactions
• weight loss
• accidents
• increased urination
• muscle cramps
• muscle twitching
• muscle pain
• vision disorders
• seizures (especially in people with a history of seizure disorders or predisposition to seizures)

Rare(may affect up to 1 in 1000 people):

• increased heart rate
• drug dependence
• changes in teeth
• weight gain
• yawning

Unknown(frequency cannot be estimated from the available data):

• aggression
• euphoric mood
• excessive sleepiness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• urination disorders
• tingling sensation (numbness and tingling)
• belching
• sleep apnea (pauses in breathing during sleep).

Known side effects of the active substance oxycodone hydrochloride when not combined with naloxone hydrochloride:

Oxycodone may cause breathing problems (respiratory depression), pupil constriction, bronchial muscle contractions, and smooth muscle contractions, as well as inhibition of the cough reflex.

Common(may affect up to 1 in 10 people):

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

Uncommon(may affect up to 1 in 100 people):

• concentration disorders
• migraines
• increased muscle tone
• involuntary muscle contractions
• abnormal bowel function (intestinal obstruction)
• dry skin
• tolerance to the medicine
• decreased sensitivity to pain and touch
• coordination disorders
• voice changes (hoarseness)
• fluid retention
• hearing disorders
• mouth ulcers
• swallowing disorders
• toothache
• perception disorders (e.g., hallucinations, derealization)
• skin redness
• dehydration
• agitation
• decreased sex hormone levels, which can affect sperm production in men or the menstrual cycle in women

Rare(may affect up to 1 in 1000 people):

• itchy rash (hives)
• infections, such as herpes (which can cause blisters around the mouth or genitals)
• increased appetite
• black (tarry) stools
• bleeding gums

Unknown(frequency cannot be estimated from the available data):

• severe generalized allergic reactions (anaphylactic reactions)
• increased sensitivity to pain
• amenorrhea
• neonatal abstinence syndrome
• bile duct disorders: disorders affecting the bile duct valve, which can cause severe abdominal pain (bile duct disorders)
• tooth decay

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Oxynador

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.

The batch number is stated on the packaging after "Lot".

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Oxynador contains

• The active substances of Oxynador 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, glycerol 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 convex on both sides, prolonged-release tablets with "10" embossed 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 convex on both sides, prolonged-release tablets with "20" embossed on one side of the tablet (dimensions: 9.5 mm x 4.5 mm)

40 mg + 20 mg, prolonged-release tablets (tablets): brown-yellow, capsule-shaped, slightly convex on both sides, prolonged-release tablets with "40" embossed on one side of the tablet (dimensions: 14.0 mm x 6.0 mm)

10 mg + 5 mg:

Packaging: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:

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

This only applies to single-dose blisters with child-resistant closure:

10 mg + 5 mg:

Packaging: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:

Packaging: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 authorization 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 authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of last revision of the leaflet:08.08.2024