Targin

Leaflet accompanying the packaging: patient information

Targin, 5 mg + 2.5 mg, prolonged-release tablets

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

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

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

Oxycodone hydrochloride + Naloxone hydrochloride
Before taking the medicine, you should carefully read the contents of the leaflet, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Targin and what is it used for

Targin is a prolonged-release tablet, which means that the active substances are released from the tablet over a prolonged period. Their effect lasts for 12 hours.
The tablets can only be used in adults.
Pain relief treatment
Targin is indicated for the treatment of severe pain that can only be adequately controlled with opioid analgesics. Naloxone hydrochloride counteracts constipation.
What is the pain-relieving effect of the tablets
The tablet contains: oxycodone hydrochloride and naloxone hydrochloride as active substances.
Oxycodone hydrochloride is responsible for the pain-relieving effect of Targin and is a strong opioid analgesic. The second active substance of Targin, naloxone hydrochloride, prevents constipation. Gastrointestinal disorders are a typical side effect of opioid medications.
Treatment of restless legs syndrome
Targin is indicated for the symptomatic treatment of moderate to severe restless legs syndrome in patients for whom dopaminergic treatment has been ineffective.
Patients with restless legs syndrome have unpleasant sensations in their limbs. They can occur when the patient is sitting or lying down and subside when an irresistible urge to move the legs, sometimes arms or other parts of the body, occurs. This makes it very difficult to sit still and sleep. Naloxone hydrochloride counteracts constipation.
What is the effect of the tablets in restless legs syndrome
The tablets reduce unpleasant sensations and reduce the urge to move the limbs.
The second active substance of Targin, naloxone hydrochloride, is intended to counteract constipation.
Gastrointestinal disorders (e.g., constipation) are a typical side effect of opioid treatment.

2. Important information before taking Targin

When not to take Targin

• if the patient has been found to be hypersensitive (allergic) to oxycodone hydrochloride and 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 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.

In addition, in restless legs syndrome

• if the patient has a history of opioid dependence.

Warnings and precautions

Before starting Targin, you should discuss it with your doctor or pharmacist:

• 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 disease (i.e., reduced lung capacity),
• if the patient experiences frequent pauses in breathing during sleep at night (sleep apnea), which can cause excessive daytime sleepiness,
• if the patient has myxedema (a condition affecting thyroid function, characterized by dryness, decreased temperature, and swelling of the skin, including the face ["moon 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 disorder with accompanying (partial) loss of reality (psychosis) caused by alcohol or other substance intoxication (substances that induce psychotic symptoms),
• if the patient has problems with gallstones or bile duct disorders (bile duct disease, gallbladder disease, etc.),
• if the patient has an enlarged prostate gland,
• if the patient has 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 tendency to seizures,
• if the patient is taking MAO inhibitors (used to treat depression or Parkinson's disease) or if the patient has taken them within the last two weeks, e.g., drugs containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
• if the patient experiences sleepiness or episodes of sudden sleepiness.

Breathing disorders related to sleep
Targin may cause breathing disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, they should consult a doctor. The doctor may consider reducing the dose.
You should consult a doctor if the above information applied to the patient in the past. You should 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). This can lead to a decrease in oxygen levels in the blood, resulting in fainting.
The prolonged-release tablet should be swallowed whole to avoid disrupting the prolonged release of oxycodone hydrochloride from the 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 Targin than recommended").
If severe diarrhea occurs at the beginning of treatment, it may be caused by the effect of naloxone. This may indicate that bowel function is returning to normal. Such diarrhea may occur within the first 3-5 days of treatment. If diarrhea persists after 3-5 days or bothers the patient, they should contact their doctor.
In the case of switching to Targin after previously taking other opioids, initial withdrawal symptoms may occur, such as restlessness, sweating, and muscle pain. If the patient experiences such symptoms, special medical supervision may be necessary.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. Repeated use of opioid medications can lead to decreased effectiveness (the patient becomes accustomed to it, which is called tolerance). Repeated use of Targin can lead to dependence and abuse, which can lead to life-threatening overdose. The risk of these adverse effects may increase with increasing dose and longer duration of treatment.
Dependence or abuse can cause the patient to feel that they have lost control over the dose they take or how often they take it. The patient may feel that they need to continue taking the medicine, even if it no longer helps to relieve pain or severe restless legs syndrome.
The risk of dependence on Targin varies from person to person. The risk of dependence on Targin may be higher if:

• the patient or someone in their family has previously 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 Targin, it may indicate that they are developing tolerance to the medicine or becoming dependent on it.
• 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 takes the medicine for reasons other than those recommended by the doctor, such as "to feel calm" or "to help with sleep".
• The patient has repeatedly tried to stop or control the use of the medicine but has failed.
• 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 consult a doctor to discuss the best treatment option, including when to stop taking the medicine and how to safely stop treatment (see section 3 "Stopping Targin treatment").
The patient should consult a doctor if they experience severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disorders.
In the case of patients with cancer-related metastases to the peritoneum or intestinal obstruction in advanced stages of cancer of the digestive system and pelvis, the doctor should be informed about this fact.
If surgery is necessary, the doctor should be informed about the use of Targin.
Like other opioids, oxycodone can affect the normal production of hormones, such as cortisol or sex hormones, especially if high doses are taken for a long time. If the patient notices persistent symptoms such as nausea (including vomiting), loss of appetite, fatigue, and weakness, dizziness, irregular menstrual cycle, impotence, infertility, or decreased libido, they should consult a doctor to determine the monitoring of hormone levels.
This medicine may increase sensitivity to pain, especially when taking high doses. The patient should inform their doctor if this happens. It may be necessary to reduce the dose or switch to another medicine.
The remains of the tablet may be visible in the stool. The patient should not be concerned, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released and absorbed during the passage of the tablet through the digestive system.

Incorrect use of Targin

The tablets are not suitable for the treatment of withdrawal symptoms.
Never abuse Targin, especially if the patient is dependent on substances such as heroin, morphine, or methadone. Abuse of Targin in dependent individuals can cause severe withdrawal symptoms, as the tablets contain naloxone. Existing withdrawal symptoms may worsen.
The patient should not misuse these tablets 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 Targin may result in a positive test for stimulants (doping).
Taking Targin as a stimulant can be life-threatening.

Targin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The risk of adverse effects increases if the patient is taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone and cause symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, the patient should consult their doctor.
Concomitant use of opioids (including oxycodone) and sedative medicines, such as benzodiazepines or similar medicines, increases the risk of sleepiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If the doctor prescribes Targin together with sedative medicines, they should limit the dose and duration of concomitant treatment.
The patient should inform their doctor about all sedative medicines they are taking and strictly follow the doctor's instructions for dosing. It may be helpful to inform friends or relatives to be aware of the possibility of the above symptoms.
If any symptoms occur, the patient should consult their doctor.
Examples of sedative medicines or medicines with a similar effect are:

1. other strong painkillers (opioids),
2. medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
3. sleeping pills and sedatives (including benzodiazepines and anxiolytics),
4. medicines used to treat depression,
5. medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics),
6. medicines used to treat mental or psychiatric disorders (antipsychotics containing phenothiazines, neuroleptics),
7. muscle relaxants,
8. medicines used to treat Parkinson's disease.

The patient should tell their doctor if they are taking any of the following medicines, as concomitant use of these medicines and Targin may cause an unexpected effect:

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

No interaction is expected between Targin and paracetamol, acetylsalicylic acid (aspirin), or naltrexone.

Targin with food, drink, and alcohol

Drinking alcohol while taking Targin may cause sleepiness or increase the risk of severe adverse effects, such as shallow breathing with a risk of apnea and loss of consciousness. Drinking alcohol while taking Targin is contraindicated.
The patient should avoid drinking grapefruit juice 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
The patient should avoid taking these tablets during pregnancy if possible. Long-term use of Targin during pregnancy may cause withdrawal symptoms in the newborn. If Targin is taken during delivery, the newborn may experience respiratory depression (slow and shallow breathing).
Breastfeeding
The patient should stop breastfeeding while taking these tablets. Oxycodone passes into breast milk. It is not known whether naloxone also passes into breast milk. Therefore, the risk to the breastfed infant cannot be excluded if the mother takes Targin for a long time.

Driving and using machines

Targin may impair the ability to drive and use machines. Such effects can be expected especially at the beginning of treatment with Targin, after each dose increase, or after switching to another medicine. However, when the patient has been taking a fixed dose of Targin for a long time, these disturbances disappear.
Targin may cause sleepiness or episodes of sudden sleepiness. If these occur, the patient should not drive or operate machinery. The patient should tell their doctor about these effects.
The patient should consult their doctor about the possibility of driving or operating machinery.

Targin contains lactose

The medicine contains lactose (a sugar found in milk).
One prolonged-release tablet of Targin 5 mg + 2.5 mg contains 68.17 mg of anhydrous lactose.
One prolonged-release tablet of Targin 10 mg + 5 mg contains 61.04 mg of anhydrous lactose.
One prolonged-release tablet of Targin 20 mg + 10 mg contains 51.78 mg of anhydrous lactose.
One prolonged-release tablet of Targin 40 mg + 20 mg contains 103.55 mg of anhydrous lactose.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking these tablets.

3. How to take Targin

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 what to expect from Targin treatment, when and how long to take the medicine, when to contact the doctor, and when to stop taking it (see also "Stopping Targin treatment").
Targin is available in the form of prolonged-release tablets, which means that the active substances are released over a prolonged period. Their effect lasts for 12 hours.
The prolonged-release tablets should be swallowed whole, without breaking, to avoid disrupting the slow release of oxycodone hydrochloride from the 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 Targin than recommended").
Unless the doctor has prescribed otherwise, the usual dose of Targin is:
Pain relief treatment
Adults
The initial dose is usually 10 mg of oxycodone hydrochloride + 5 mg of naloxone hydrochloride (which corresponds to a dose of Targin, 10 mg + 5 mg, prolonged-release tablets) every 12 hours.
The doctor will decide what dose the patient should take daily and how to divide the daily dose into morning and evening doses. The doctor will also 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. In the case of previous opioid use, Targin treatment 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 prescribe additional doses of oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose should not exceed 400 mg of oxycodone hydrochloride. When additional doses of oxycodone hydrochloride are administered, the beneficial effect of naloxone hydrochloride on bowel function may be reduced.
If the doctor prescribes a change in tablets to another opioid medicine, bowel function may worsen.
If the patient experiences pain between two doses of Targin, it may be necessary to use a fast-acting pain reliever. Targin is not intended for this purpose. In such cases, the patient should consult their doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.
Treatment of restless legs syndrome
Adults
The initial dose is 5 mg of oxycodone hydrochloride + 2.5 mg of naloxone hydrochloride (which corresponds to a dose of Targin, 10 mg + 5 mg, prolonged-release tablets) every 12 hours.
The doctor will decide what dose of Targin the patient should take daily and how to divide the daily dose into morning and evening doses. The doctor will also decide on any necessary dose adjustments during treatment. The doctor will adjust the dose according to the patient's individual sensitivity. The patient should receive the smallest effective dose to control the symptoms of restless legs syndrome.
If the patient feels that the effect of Targin is too strong or too weak, they should consult their doctor or pharmacist.
The maximum daily dose is 60 mg of oxycodone hydrochloride and 30 mg of naloxone hydrochloride.
Pain relief treatment or restless legs syndrome
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 the medicine with caution. If the patient has moderate to severe liver failure, they should not take these tablets (see also section 2 "When not to take Targin" and "Warnings and precautions").
Children and adolescents under 18 years of age
Targin 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, the use of Targin in children and adolescents under 18 years of age is not recommended.
Method of administration
Oral use.
The tablets should be swallowed whole (without chewing), with a sufficient amount of liquid (half a glass of water). The prolonged-release tablets can be taken with or without food. The tablets should be taken every 12 hours, according to the established treatment schedule (e.g., in the morning at 8:00, in the evening at 20:00). The prolonged-release tablets should not be divided, chewed, or crushed (see section 2: "Warnings and precautions").
Duration of treatment
Basically, the patient should not take these tablets 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 Targin than recommended
If the patient has taken a higher dose of the tablets than recommended, they should immediately consult their doctor.
Overdose of the medicine may be characterized by:

• pupil constriction
• slow and shallow breathing (respiratory depression)
• sleepiness, 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.
The patient should avoid engaging in activities that require increased attention (e.g., driving vehicles).

Missing a dose of Targin

or taking a lower dose than prescribed may result in inadequate pain relief.
If the patient has missed a dose, they should follow the instructions below:

• If there are 8 hours or more until the next dose: the patient should take the missed dose immediately. Then, they should continue taking the medicine according to the usual schedule.
• If there are less than 8 hours until the next dose: the patient should take the missed dose. Then, they 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.

The patient should not take a double dose to make up for a missed dose.

Stopping Targin treatment

The patient should not stop taking Targin without consulting their doctor.
If treatment is no longer necessary, the patient should gradually reduce the daily dose after consulting their doctor. This can help avoid withdrawal symptoms, such as restlessness, sweating, and muscle pain.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

If any of the following side effects occur, the patient should immediately consult their doctor.
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 susceptible individuals.

Side effects that occur in patients treated for pain relief Common (may occur in less than 1 in 10 treated patients) :

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

Uncommon (may occur in less than 1 in 100 treated patients) :

• abdominal distension
• abnormal thinking
• anxiety
• palpitations
• biliary colic
• chest pain
• common cold
• cough
• confusion
• depression
• anxiety
• chest tightness
• general malaise
• pain
• swelling of hands, feet, and ankles
• concentration disorders
• speech disorders
• tremors
• breathing difficulties
• restlessness
• muscle spasms
• muscle twitching
• increased enzyme activity
• allergic reactions
• weight loss
• accidental injuries
• increased urination, especially if the patient has coronary artery disease
• decreased blood pressure
• withdrawal symptoms, such as urination disorders
• muscle cramps
• muscle twitching
• muscle pain
• visual disturbances
• seizures, agitation
• fainting
• lack of energy
• thirst
• liver function disorders
• increased blood pressure
• decreased sex drive (especially in patients with seizure disorders or a predisposition to seizures)

Rare (may occur in less than 1 in 1000 treated patients) :

• increased heart rate
• weight gain
• changes in teeth
• yawning
• dependence on the medicine

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

• euphoria
• excessive sleepiness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• urination disorders
• tingling sensation
• belching
• aggressive behavior
• sleep apnea (pauses in breathing during sleep)

Known side effects of the active substance oxycodone hydrochloride, when not in combination with naloxone hydrochloride

Oxycodone may cause breathing difficulties (respiratory depression), pupil constriction, bronchial spasms, and smooth muscle spasms, as well as inhibition of the cough reflex.
Common (may occur in less than 1 in 10 treated patients) :

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

Uncommon(may occur in less than 1 in 100 treated patients):

• concentration disorders
• migraines
• increased tension
• decreased sensitivity to
• toothache
• perception disorders, touch
• coordination disorders
• voice changes (hoarseness)
• fluid retention
• hearing disorders
• mouth ulcers
• dry skin
• tolerance to the medicine (e.g., hallucinations, depersonalization)
• skin redness
• swallowing difficulties
• dehydration
• agitation
• hormonal disorders, especially those affecting

sex hormones, which can affect sperm production in men or the menstrual cycle in women
Rare (may occur in less than 1 in 1000 treated patients) :

• stool changes
• infections, such as
• increased appetite
• herpes simplex
• bleeding gums
• herpes zoster (which can cause blisters around the mouth or genitals) (hives)

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

• acute generalized reactions
• amenorrhea
• withdrawal syndrome
• bile duct disorders
• allergic reactions (anaphylactic reactions)
• increased sensitivity in newborns
• bowel disorders affecting the ileocecal valve, which can cause severe abdominal pain (bowel disorders affecting the ileocecal valve)

Side effects that occur in patients treated for restless legs syndrome Very common (may occur in 1 in 10 treated patients) :

• headache
• sleepiness
• constipation
• nausea
• sweating
• fatigue or exhaustion

Common (may occur in less than 1 in 10 treated patients) :

• decreased appetite up to loss of appetite
• hot flashes
• decreased blood pressure
• increased blood pressure
• abdominal pain
• dry mouth
• vomiting
• increased enzyme activity
• itching
• skin reactions / rash
• chest pain
• chills
• pain
• thirst
• sleep disorders
• depression
• dizziness or "spinning" sensation
• concentration disorders
• tremors
• tingling sensation in hands or feet
• visual disturbances
• liver function disorders (elevated alanine aminotransferase, elevated gamma-glutamyltransferase)

Uncommon (may occur in less than 1 in 100 treated patients) :

• decreased sex drive
• flatulence
• erectile dysfunction
• withdrawal symptoms, such as
• swelling of hands, feet, and ankles
• episodes of sudden sleepiness
• taste disorders
• breathing difficulties
• restlessness
• muscle spasms

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

• hypersensitivity (allergic reactions)
• excessive sleepiness
• speech disorders
• fainting
• chest tightness,
• belching
• nausea
• changes in teeth
• biliary colic
• muscle spasms
• muscle twitching
• muscle pain
• weakness
• lack of energy

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to: Department of Drug Safety, 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Targin

The medicine should be stored out of sight and reach of children. This medicine should be stored in a closed and secure place, to which other people do not have access. It can be very harmful and may cause death if taken by someone it was not prescribed for.
The patient should not use this medicine after the expiry date stated on the carton after the words "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.
Storage conditions
The patient should not store the medicine at temperatures above 25°C.
Targin 5 mg + 2.5 mg
The patient should store the medicine in its original packaging and protect it from light.
Only for bottles
Shelf life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Targin contains

The active substances of Targin are oxycodone hydrochloride and naloxone hydrochloride.

Targin, 5 mg + 2.5 mg, prolonged-release tablets

Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride, which corresponds to 4.5 mg of oxycodone, and 2.5 mg of naloxone hydrochloride as 2.73 mg of naloxone hydrochloride dihydrate, which corresponds to 2.25 mg of naloxone.
Other ingredients of the medicine are:
Tablet core: Hydroxypropylcellulose, ethylcellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate.
Tablet coating: Opadry II Blue 85F30569: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, brilliant blue FCF (E133), lactose.

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

Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride, which corresponds to 9 mg of oxycodone, and 5 mg of naloxone hydrochloride as 5.45 mg of naloxone hydrochloride dihydrate, which corresponds to 4.5 mg of naloxone.
Other ingredients of the medicine are:
Tablet core: Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate.
Tablet coating: Opadry II White 85F18422: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc.

Targin, 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 dihydrate, equivalent to 10.9 mg of naloxone hydrochloride and 9 mg of naloxone.
Other ingredients of the medicinal product are:
Tablet core: Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate.
Tablet coating: Opadry II Pink 85F24151: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172).

Targin, 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 dihydrate, equivalent to 21.8 mg of naloxone hydrochloride and 18 mg of naloxone.
Other ingredients of the medicinal product are:
Tablet core: Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate.
Tablet coating: Opadry II Yellow 85F32109: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172).

What Targin looks like and what the pack contains

Targin, 5 mg + 2.5 mg
Blue, prolonged-release tablets, nominal length 9.5 mm, marked "OXN" on one side and "5" on the other side.
Targin, 10 mg + 5 mg
White, prolonged-release tablets, nominal length 9.5 mm, marked "OXN" on one side and "10" on the other side.
Targin, 20 mg + 10 mg
Pink, prolonged-release tablets, nominal length 9.5 mm, marked "OXN" on one side and "20" on the other side.
Targin, 40 mg + 20 mg
Yellow, prolonged-release tablets, nominal length 14 mm, marked "OXN" on one side and "40" on the other side.
5mg + 2.5mg; 10mg + 5mg; 20mg + 10mg
Tablets are available in: blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 tablets or in a hospital pack containing 100 (10 x 10) tablets or in a bottle with a child-resistant closure containing 100 tablets.
40mg + 20mg
Tablets are available in: blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 tablets or in a hospital pack containing 100 (10 x 10) tablets or in a bottle with a child-resistant closure containing 100 tablets or in collective packs containing 2 cardboard boxes, each containing 50 tablets.
In Poland, the following pack sizes are authorized: 30 and 60 tablets in blisters, in a cardboard box, and 100 tablets in an HDPE bottle with a PP child-resistant closure, in a cardboard box.
Not all pack sizes or types may be available in the market.
The batch number on the blister is marked with the abbreviation Lot.
The expiry date on the blister is marked with the abbreviation EXP.

Marketing Authorisation Holder

Mundipharma A/S
Frydenlundsvej 30
2950 Vedbæk, Denmark

Manufacturer

Fidelio Healthcare Limburg GmbH
Mundipharma Str. 2
65549 Limburg, Germany
Synergy Health Utrecht B.V.
Reactorweg 47 A
3542AD Utrecht, Netherlands

Importer and Manufacturer

Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden, Netherlands
In order to obtain more detailed information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Mundipharma Polska Sp. z o.o.,
ul. Międzyborska 11B lok. 104, 04-041 Warsaw, tel. +48 22 3824850.

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

Economic Area under the following names:

Austria
Targin 5 mg/2.5 mg <40 mg 20> Retardtabletten
Belgium
Targinact 5 mg/2.5 mg <40 mg 20>
Croatia
Targinact 5 mg/ 2.5mg <10 mg 5> <20 mg 10> <40 mg 20> tablets with prolonged release
Cyprus
Targinact 5/2.5mg <10><20><40>Δισκίο παρατεταμένης
αποδέσμενσης
Czech Republic
Targin <10><20><40>Tablet with prolonged release
Germany
Targin 5 mg/2.5 mg <10 mg 5> <20 mg 10> <40 mg 20>
Retardtabletten
Denmark
Targin
Estonia
Targinact 5 mg/2.5 mg <10 mg 5> <20 mg 10> <40 mg 20>
Toimeainet prolongeeritult vabastav tablet
Spain
Targin 5/2.5mg <10><20><40>Comprimido de liberación
prolongada
Finland
Targiniq
France
Targinact 5 mg/2.5 mg <10 mg 5> <20 mg 10> <40 mg 20>
Comprimé à liberation prolongée
Ireland
Targin 5 mg/2.5 mg <40 mg 20> prolonged-release tablets
Iceland
Targin
Italy
Targin
Luxembourg
Targinact
Netherlands
Targinact 5 mg/ 2,5 mg <40 mg>, tabletten met verlengde afgifte
Norway
Targiniq
Poland
Targin
Portugal
Targin
Slovakia
Targin 5 mg/2.5 mg <10 mg 5> <20 mg 10> <40 mg 20> Tablet with prolonged release
Slovenia
Targinact
Sweden
Targiniq

Date of last revision of the leaflet: 02/2025