Targin

Package leaflet: Information for the patient

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
Oxycodoni hydrochloridum + Naloxoni hydrochloridum
Please read this leaflet carefully before taking 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 further 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 someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Targin is and what it is used for

Targin is available as prolonged-release tablets, which means that the active substances are released from the tablet over an extended period. The effect lasts for 12 hours.
The tablets may be used only in adults.

Pain treatment
Targin is indicated for the treatment of severe pain which can be adequately managed only with opioid analgesics. Naloxone hydrochloride counteracts constipation.

How do the tablets work for pain relief?
The tablet contains: oxycodone hydrochloride and naloxone hydrochloride as active substances.
Oxycodone hydrochloride is responsible for the analgesic effect of Targin and is a potent opioid analgesic. The second active substance in Targin, naloxone hydrochloride, helps prevent constipation. Gastrointestinal disturbances, such as constipation, are typical side effects of opioid medications.

Treatment of restless legs syndrome
Targin is indicated for second-line symptomatic treatment of moderate to severe to very severe restless legs syndrome in patients in whom dopaminergic treatment has been ineffective.
Patients with restless legs syndrome experience unpleasant sensations in the limbs. These sensations may occur when sitting or lying down and are relieved by an irresistible urge to move the legs, sometimes the arms or other parts of the body. This makes sitting still and sleeping very difficult. Naloxone hydrochloride counteracts constipation.

How do the tablets work in restless legs syndrome?
The tablets reduce unpleasant sensations and the urge to move the limbs.
The second active substance in Targin, naloxone hydrochloride, is intended to counteract constipation.
Gastrointestinal disturbances (e.g. constipation) are typical side effects of opioid treatment.

2. Important information before taking Targin

When not to use Targin

• if the patient is allergic (hypersensitive) to oxycodone hydrochloride and naloxone hydrochloride or to 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 has severe lung disease associated with airway narrowing (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 bowel obstruction) not caused by opioids,
• if the patient has moderate to severe liver impairment.

Additionally, in restless legs syndrome:

• if the patient has previously been or currently is addicted to opioid medicines.

Warnings and precautions
Before starting treatment with Targin, discuss the following with your doctor or pharmacist:

• in elderly patients and weakened patients,
• if the patient has opioid-induced paralytic ileus (a type of bowel obstruction),
• if the patient has renal impairment,
• if the patient has mild liver impairment,
• if the patient has severe lung insufficiency (i.e. reduced lung capacity),
• if the patient experiences frequent breathing interruptions during sleep at night (sleep apnoea), which may cause excessive daytime sleepiness,
• if the patient has myxoedema (a thyroid disorder characterised by dryness, lowered body temperature, and swelling of the skin affecting the face ["puffy 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 (substances causing psychotic symptoms),
• if the patient has gallstone problems or disorders of the biliary tract (biliary tract disease, gallbladder disease, etc.),
• if the patient has been diagnosed with benign prostatic hyperplasia (enlarged prostate),
• if the patient has alcoholism or alcohol withdrawal 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 a tendency to seizures,
• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) (used in the treatment of depression or Parkinson's disease) or has taken such medicines within the last two weeks, e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid,
• if the patient experiences somnolence or episodes of sudden sleep.

Sleep-related breathing disorders
Targin may cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and hypoxaemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes such symptoms, medical advice should be sought. The doctor may consider reducing the dose.
Consult your doctor if any of the above conditions have ever applied to the patient in the past. You should also consult your 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 preserve the prolonged-release properties of oxycodone hydrochloride from the tablet. Do not break, chew, or crush the tablets. Taking broken or crushed tablets may result in the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking more Targin than you should").
If severe diarrhoea occurs at the beginning of treatment, this may be due to the action 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 bothersome, the patient should contact their doctor.
When switching to Targin from previous opioid treatment, withdrawal symptoms such as restlessness, sweating, and muscle pain may initially occur. If the patient experiences such symptoms, special medical supervision may be required.

Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. It may cause dependence and (or) addiction.
This medicine contains oxycodone, an opioid medicine. Repeated use of opioid medicines may lead to reduced effectiveness of the medicine (the patient becomes accustomed, known as tolerance). Repeated use of Targin 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 a loss of 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 or severe restless legs syndrome.
The risk of dependence or addiction varies between patients. The risk of dependence on Targin 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, while taking Targin, the patient notices any of the following symptoms, this may indicate the development of tolerance to the medicine or dependence:

• The patient needs to take the medicine longer than prescribed by the doctor.
• The patient needs to 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 with falling asleep".
• 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 your doctor to discuss the best treatment approach for the patient, including when and how to safely discontinue treatment (see section 3 "Stopping Targin").
Contact your doctor if the patient experiences severe upper abdominal pain 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 doctor that the patient is taking Targin.
Like other opioids, oxycodone may affect normal hormone production, such as cortisol or sex hormones, particularly with prolonged use of high doses. If the patient notices persistent symptoms such as nausea (including vomiting), loss of appetite, fatigue and weakness, dizziness, menstrual irregularities, impotence, infertility, or reduced libido, consult a doctor to determine a monitoring plan for hormone levels.
This medicine may increase sensitivity to pain, especially when high doses are used. Inform your doctor if this occurs. Dose reduction or switching to another medicine may be necessary.
Undissolved tablet residue 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 during passage through the gastrointestinal tract.

Improper use of Targin
The tablets are not suitable for treating withdrawal symptoms.
Never misuse Targin, especially in cases of drug dependence. In individuals dependent on substances such as heroin, morphine, or methadone, misuse of Targin may cause severe withdrawal symptoms because the tablets contain 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 lung tissue changes (pulmonary granulomas). Such misuse may also lead to other serious consequences, including death.
Use of Targin may result in a positive doping test for stimulants.
Using Targin as a stimulant may pose a life-threatening risk.

Targin and other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
The risk of adverse effects increases when taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, leading to symptoms such as 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 such symptoms occur, contact your doctor.
Concomitant use of opioids (including oxycodone) and sedatives such as benzodiazepines or similar medicines increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not feasible.
If your doctor has prescribed Targin together with sedative medicines, the dose and duration of combination therapy should be limited.
Inform your doctor about all sedative medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members about the possibility of the above-mentioned symptoms. If any symptoms occur, contact your 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 phenothiazine neuroleptics),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

Inform your doctor if you are taking any of the following medicines, as their combined use with Targin may result in unexpected effects:

• medicines that affect blood clotting (coumarin derivatives), which may prolong or shorten blood clotting time,
• macrolide antibiotics (e.g. clarithromycin, erythromycin, or telithromycin),
• azole antifungals (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 to treat tuberculosis),
• carbamazepine (used to treat seizures, convulsions, or certain types of pain),
• phenytoin (used to treat seizures, convulsions, or seizures),
• St John's wort (also known as Hypericum perforatum),
• quinidine (a medicine for treating heart rhythm disorders).

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

Targin with food, drink, and alcohol
Drinking alcohol during treatment with Targin may cause drowsiness or increase the risk of serious adverse effects such as shallow breathing, apnoea, and loss of consciousness. Alcohol consumption during treatment with Targin is contraindicated.
Avoid drinking grapefruit juice during treatment with these tablets.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
The use of these tablets should be avoided in pregnant women whenever possible. Long-term use of Targin during pregnancy may cause withdrawal symptoms in the newborn. If Targin is used during childbirth, respiratory depression (slow and shallow breathing) may occur in the newborn.

Breastfeeding
Breastfeeding must be discontinued during treatment with these tablets. Oxycodone passes into breast milk. It is unknown whether naloxone also passes into breast milk. Therefore, the risk to a breastfed infant cannot be excluded if the mother is taking Targin long-term.

Driving and operating machinery
Targin may impair the ability to drive and operate machinery. This effect is particularly expected at the beginning of treatment with Targin, after each dose increase, or when switching to another medicine. However, when the patient has been taking a stable dose of Targin for a prolonged period, these impairments usually subside.
Targin may cause drowsiness or episodes of sudden sleep. If these occur, the patient should not drive or operate machinery. Inform your doctor about these effects.
The patient should consult their doctor regarding the ability to drive or operate machinery.

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

3. How to take Targin

This medicine should always be taken 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 what to expect from taking Targin, when and for how long you should take it, when to contact your doctor, and when to stop taking it (see also "Stopping Targin").

Targin is available as prolonged-release tablets, meaning that its active substances are released slowly over an extended period. The effect lasts for 12 hours. Prolonged-release tablets must be swallowed whole to avoid disrupting the slow release of hydrochloride oxycodone from the tablet. Tablets must not be broken, chewed, or crushed. Taking a broken, chewed, or crushed tablet may lead to a rapid release of the active substance, which could result in the absorption of a potentially fatal dose of hydrochloride oxycodone (see section 3: "Taking more Targin than you should").

Unless otherwise prescribed by your doctor, the usual dosage of Targin is as follows:

Pain treatment
Adults
The usual starting dose is 10 mg hydrochloride oxycodone + 5 mg hydrochloride naloxone (corresponding to the dose of Targin, 10 mg + 5 mg, prolonged-release tablets) every 12 hours.

Your doctor will decide the daily dose you should take, how to divide the daily dose into morning and evening doses, and any necessary dose adjustments during treatment. The dose will be adjusted according to the intensity of pain and your individual sensitivity. You should receive the lowest effective dose needed to control your pain. If you have previously been treated with opioids, treatment with Targin may be initiated with higher doses.

The maximum daily dose is 160 mg hydrochloride oxycodone and 80 mg hydrochloride naloxone. If you require a higher dose, your 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 are administered, the beneficial effect of hydrochloride naloxone on bowel function may be reduced.

If your doctor switches you from Targin to another opioid medicine, bowel function may worsen.

If you experience pain between two doses of Targin, it may be necessary to use a fast-acting painkiller. Targin is not intended for this purpose. In such cases, consult your doctor.

If you feel the medicine is too strong or too weak, consult your doctor or pharmacist.

Treatment of restless legs syndrome
Adults
The starting dose is 5 mg hydrochloride oxycodone + 2.5 mg hydrochloride naloxone (corresponding to the dose of Targin, 10 mg + 5 mg, prolonged-release tablets) every 12 hours.

Your doctor will decide the daily dose of Targin you should take, how to divide the daily dose into morning and evening doses, and any necessary dose adjustments during treatment. The dose will be adjusted according to your individual sensitivity. You should receive the lowest effective dose needed to control symptoms of restless legs syndrome.

If you feel the effect of Targin is too strong or too weak, consult your doctor or pharmacist.

The maximum daily dose is 60 mg hydrochloride oxycodone and 30 mg hydrochloride naloxone.

Pain treatment or restless legs syndrome
Elderly patients
Dose adjustment is usually not necessary in elderly patients with normal liver and/or kidney function.

Liver or kidney impairment
If you have kidney problems or mild liver impairment, your doctor will prescribe Targin with special caution. If you have moderate to severe liver impairment, these tablets should not be used (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 Targin have not been established in this population. Therefore, Targin 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 (half a glass of water). Prolonged-release 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 split, chewed, or crushed (see section 2: "Warnings and precautions").

Duration of treatment
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 you still need them.

Taking more Targin than you should
If you take more tablets than prescribed, contact your doctor immediately.

Overdose symptoms may include:

• Constricted pupils
• Slow and shallow breathing (respiratory depression)
• Drowsiness progressing to loss of consciousness
• Reduced muscle tone (hypotonia)
• Slowed heart rate
• Low blood pressure
• Brain disorders (known as toxic leukoencephalopathy)

In severe cases, unconsciousness (coma), pulmonary edema, and circulatory collapse may occur, which can lead to death.

Avoid engaging in activities requiring increased attention (e.g., driving).

Missing a dose of Targin
Missing a dose 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, then continue taking the medicine according to your regular schedule.
• If less than 8 hours remain until the next dose: take the missed dose, then wait 8 hours before taking the next dose. Try to return to your original dosing schedule (e.g., 8:00 a.m. and 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 Targin
Do not stop taking Targin without consulting your doctor.

If treatment is no longer needed, the daily dose should be gradually reduced under medical supervision. This helps prevent withdrawal symptoms such as restlessness, sweating, and muscle pain.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Important information on adverse reactions or their symptoms and actions to take if they occur:
If any of the following adverse reactions occur, contact your nearest doctor immediately.
Slow and shallow breathing (respiratory depression) is the main risk associated with opioid overdose. It occurs most commonly in elderly and debilitated patients. Opioids may also cause severe drop in blood pressure in susceptible individuals.

Adverse reactions occurring in patients treated for pain

Common (may affect up to 1 in 10 treated patients):

• abdominal pain • decreased appetite up to loss of appetite • unusual weakness
• constipation • dizziness or vertigo • itching of the skin
• dry mouth • nausea • skin reactions, rash
• indigestion • headache • sweating
• vomiting • hot flushes • drowsiness
• nausea • fatigue or exhaustion • sleep disturbances
• bloating (gas)

Uncommon (may affect up to 1 in 100 treated patients):

• abdominal distension • palpitations • catarrh
• impaired thinking • biliary colic • cough
• anxiety • chest pain • hypersensitivity/allergic reactions
• confusion • general malaise • pain
• depression • oedema of hands, ankles and feet • post-traumatic injuries
• chest tightness, • difficulty concentrating • increased bladder pressure especially if occurring • speech difficulties particularly in coronary heart disease • tremor • muscle cramps
• low blood pressure • breathing difficulties • muscle twitching
• withdrawal symptoms, e.g. • restlessness • muscle pain agitation • muscle tremors • visual disturbances
• fainting • increased liver enzyme activity • seizures
• feeling of lack of energy (especially in patients with epilepsy or predisposition to seizures)
• thirst • increased blood pressure
• taste disturbances • decreased libido

Rare (may affect up to 1 in 1000 treated patients):

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

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

• euphoria • shallow breathing • sleep apnoea (pauses in breathing during sleep)
• severe drowsiness • difficulty urinating
• erectile dysfunction • skin tingling
• nightmares • reflux
• hallucinations • aggressive behaviour

The following adverse reactions are known for the active substance oxycodone hydrochloride when not combined with naloxone hydrochloride:
Oxycodone may cause breathing problems (respiratory depression), pinpoint pupils, bronchial muscle spasms and smooth muscle spasms, as well as suppression of the cough reflex.

Common (may affect up to 1 in 10 treated patients):

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

Uncommon (may affect up to 1 in 100 treated patients):

• concentration difficulties • reduced sensitivity to pain and touch • gum pain
• migraine • perceptual disturbances (e.g. hallucinations, derealization)
• increased muscle tension • abnormal coordination • voice changes (hoarseness)
• involuntary muscle contractions • water retention • swallowing difficulties
• gastrointestinal dysfunction (intestinal obstruction) • hearing problems • dehydration
• oral ulceration • restlessness
• dry skin • decreased sex hormone levels, which may affect sperm production in men or the menstrual cycle in women

Rare (may affect up to 1 in 1000 treated patients):

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

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

• acute generalized allergic reactions (anaphylactic reactions) • absence of menstruation • biliary flow disorders
• neonatal abstinence syndrome • dental caries
• increased sensitivity to pain • disorders affecting the intestinal valve (Oddi's sphincter dysfunction), which may cause severe upper abdominal pain

Adverse reactions occurring in patients treated for restless legs syndrome

Very common (may affect up to 1 in 10 treated patients):

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

Common (may affect up to 1 in 10 treated patients):

• decreased appetite up to loss of appetite • hot flushes • skin itching
• low blood pressure • skin reactions/rash • high blood pressure
• chest pain • chills
• dizziness or vertigo • dry mouth • vomiting
• sleep disturbances • increased liver enzyme activity (increase in alanine aminotransferase, increase in gamma-glutamyltransferase)
• tremor • tingling in hands or feet
• visual disturbances • dizziness

Uncommon (may affect up to 1 in 100 treated patients):

• decreased sexual desire • flatulence • swelling of hands, ankles and feet
• erectile dysfunction • sudden sleep episodes • withdrawal symptoms such as restlessness
• taste disturbances • post-traumatic injury
• breathing difficulties

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

• hypersensitivity (allergic reactions) • severe drowsiness • reflux
• speech disorders • indigestion
• impaired thinking • fainting • dental changes
• anxiety • chest tightness, particularly if coronary heart disease is present
• confusion • muscle cramps
• nervousness • muscle twitching • muscle pain
• restlessness • tachycardia • difficulty urinating
• euphoria • increased heart rate • increased bladder pressure (especially in patients with epilepsy or predisposition to seizures)
• hallucinations • cough • general malaise
• nightmares • catarrh • shallow breathing
• seizures • yawning • weight loss
• bloating • weight gain
• diarrhoea • unusual weakness
• drug dependence • aggressive behaviour
• feeling of lack of energy

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to: Department of Monitoring of Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Targin

Keep this medicine out of sight and reach of children. This medicine must be stored in a closed and secure place inaccessible to others. It may be highly harmful and may cause death in a person for whom it has not been prescribed. Do not use this medicine after the expiry date stated on the cardboard box and blister pack after the words “Expiry date” or “EXP”. The expiry date refers to the last day of the stated month.

Storage conditions
Do not store above 25°C.
Targin 5 mg + 2.5 mg
Store in the original packaging and protect from light.
For bottles only
Shelf life after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Targin contains
The active substances in 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, equivalent to
4.5 mg of oxycodone, and 2.5 mg of naloxone hydrochloride as 2.73 mg of naloxone hydrochloride dihydrate, equivalent to 2.25 mg of naloxone.
Other ingredients are:
Tablet core: Hydroxypropylcellulose, ethylcellulose, stearyl alcohol, lactose monohydrate,
talc, magnesium stearate.
Tablet coating: Opadry II Blue 85F30569: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, brilliant blue FCF (E133), lacquer.

Targin 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.
Other ingredients are:
Tablet core: Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate,
talc, magnesium stearate.
Tablet coating: Opadry II White 85F18422: partially hydrolysed polyvinyl alcohol,
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 are:
Tablet core: Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate,
talc, magnesium stearate.
Tablet coating: Opadry II Pink 85F24151: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (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 are:
Tablet core: Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate,
talc, magnesium stearate.
Tablet coating: Opadry II Yellow 85F32109: partially hydrolysed polyvinyl alcohol,
titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Targin looks like and contents of the pack
Targin 5 mg + 2.5 mg
Blue, elongated coated tablets with a nominal length of 9.5 mm, marked “OXN” on one side and “5” on the other.

Targin 10 mg + 5 mg
White, elongated coated tablets with a nominal length of 9.5 mm, marked “OXN” on one side and “10” on the other.

Targin 20 mg + 10 mg
Pink, elongated coated tablets with a nominal length of 9.5 mm, marked “OXN” on one side and “20” on the other.

Targin 40 mg + 20 mg
Yellow, elongated coated tablets with a nominal length of 14 mm, marked “OXN” on one side and “40” on the other.

5 mg + 2.5 mg; 10 mg + 5 mg; 20 mg + 10 mg
Tablets are available in packs (blister packs) containing 10, 14, 20, 28, 30, 50, 56, 60, 98, and 100 tablets, or in hospital packs containing 100 (10 x 10) tablets, or in bottles with child-resistant closures containing 100 tablets.

40 mg + 20 mg
Tablets are available in packs (blister packs) containing 10, 14, 20, 28, 30, 50, 56, 60, 98, and 100 tablets, or in hospital packs containing 100 (10 x 10) tablets, or in bottles with child-resistant closures containing 100 tablets, or in multipacks containing 2 cardboard boxes, each containing 50 tablets.

In Poland, the following pack sizes are authorised: 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 on the market.
The batch number on the blister is indicated by the abbreviation "Lot".
The expiry date on the blister is indicated by the abbreviation "EXP".

Marketing Authorisation Holder
Mundipharma A/S
Frydenlundsvej 30
2950 Vedbæk, Denmark

Manufacturer
Synergy Health Utrecht B.V.
Reactorweg 47 A
3542AD Utrecht, The Netherlands

Importer and Manufacturer
Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden, The Netherlands

For further information about this medicinal product, 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 authorised for sale in the European Economic Area countries under the following names:
Austria Targin 5 mg/2.5 mg <40 mg/20 mg> Retardtabletten
Belgium Targinact 5 mg/2.5 mg <40 mg/20 mg>
Croatia Targinact 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> tablete s produljenim oslobadanjem
Cyprus Targinact 5/2.5mg <10/5mg> <20/10mg> <40/20mg> Δισκίο παρατεταμένης αποδέσμευσης
Czech Republic Targin <10/5mg> <20/10mg> <40/20mg> Tableta s prodlouženým uvolňováním
Germany Targin 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> Retardtabletten
Denmark Targin
Estonia Targinact 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> Toimeainet prolongeeritult vabastav tablet
Spain Targin 5/2.5mg <10/5mg> <20/10mg> <40/20mg> Comprimido de liberación prolongada
Finland Targiniq
France Targinact 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> Comprimé à libération prolongée
Ireland Targin 5 mg/2.5 mg <40 mg/20 mg> prolonged-release tablets
Iceland Targin
Italy Targin
Luxembourg Targinact
The Netherlands Targinact 5 mg/2.5 mg <40 mg/20 mg>, tabletten met verlengde afgifte
Norway Targiniq
Poland Targin
Portugal Targin
Slovakia Targin 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> Tableta s predĺženým uvoľňovaním
Slovenia Targinact
Sweden Targiniq