Targin 10 mg/5 mg prolonged-release tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Targin 10 mg/5 mg prolonged-release tablets

Oxycodone hydrochloride / naloxone hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Targin is and what it is used for
What you need to know before taking Targin
How to take Targin
Possible side effects
How to store Targin
Contents of the pack and other information

1. What Targin is and what it is used for

Targin is a prolonged-release tablet, meaning that its active substances are released over an extended period of time. Its action lasts for 12 hours.

These tablets are for use in adults only.

Pain relief

You have been prescribed Targin for the treatment of severe pain that can only be adequately managed with opioid analgesics. Naloxone hydrochloride has been added to counteract constipation.

How these tablets work for pain relief

These tablets contain oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the analgesic effect of Targin; it is a potent opioid analgesic. The second active substance in Targin, naloxone hydrochloride, functions to counteract constipation. Gastrointestinal dysfunction (e.g., constipation) is a common adverse effect of treatment with opioid analgesics.

Restless legs syndrome

You have been prescribed Targin for second-line symptomatic treatment in patients with severe to very severe idiopathic restless legs syndrome who cannot be treated with dopaminergic medicinal products. People with restless legs syndrome experience unpleasant sensations in their limbs. These sensations may begin as soon as they sit or lie down and are only relieved by an urgent and irresistible need to move the legs, sometimes the arms and other parts of the body. This makes it very difficult to remain seated and to sleep. Naloxone hydrochloride has been added to counteract constipation.

How these tablets work in restless legs syndrome

These tablets help relieve unpleasant sensations and thereby reduce the compelling need to move the limbs.

The second active substance in Targin, naloxone hydrochloride, functions to counteract constipation. Gastrointestinal dysfunction (e.g., constipation) is a common adverse effect of treatment with opioid analgesics.

2. What you need to know before taking Targin

Do not take Targin

if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
if your breathing does not provide enough oxygen to the blood or remove carbon dioxide produced in the body (respiratory depression),
if you have severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
if you have a disorder called cor pulmonale. This condition involves enlargement of the right side of the heart due to increased pressure in the blood vessels of the lungs (e.g., as a result of COPD, see above),
if you have severe bronchial asthma,
if you have paralytic ileus (a type of intestinal obstruction) not caused by opioids,
if you have moderate to severe liver disease.

Additionally for restless legs syndrome

if you have a history of opioid abuse.

Warnings and precautions

Talk to your doctor or pharmacist before taking Targin:

if you are an elderly or debilitated (weak) patient,
if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
if you have kidney disorder,
if you have mild liver disorder,
if you have severe lung disorder (i.e., reduced ability to breathe),
if you have a condition characterized by frequent breathing pauses during sleep, which may make you feel very sleepy during the day (sleep apnea),
if you have myxedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin, affecting the face and limbs),
if your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
if you have a mental disorder accompanied by a partial or complete loss of touch with reality (psychosis), due to alcoholism or intoxication by other substances (substance-induced psychosis),
if you have problems related to gallstones,
if you have abnormal enlargement of the prostate (prostate hypertrophy),
if you have alcoholism or delirium tremens,
if you have inflammation of the pancreas (pancreatitis),
if you have low blood pressure (hypotension),
if you have high blood pressure (hypertension),
if you have a previous cardiovascular disease,
if you have a head injury (due to the risk of increased pressure in the brain),
if you have epilepsy or are prone to seizures,
if you are also receiving treatment with MAO inhibitors (used to treat depression or Parkinson's disease), or have taken such medicines within the last two weeks, for example, medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid,
if you experience drowsiness or sudden episodes of sleep.

Sleep-related breathing disorders

Targin 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, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell your doctor if you have ever had any of these conditions in the past. Also inform your doctor if you develop any of them while taking these tablets.

The most serious consequence of opioid overdose is respiratory depression (slow and shallow breathing). This may also lead to decreased oxygen concentration in the blood, which can cause fainting, etc.

Swallow the prolonged-release tablet whole, so as not to affect the slow release of oxycodone hydrochloride from the prolonged-release tablet. Do not split, chew, or crush the tablets. Taking them split, chewed, or crushed may lead to potentially fatal absorption of oxycodone hydrochloride (see section 3 “If you take more Targin than you should”).

If you experience severe diarrhea at the beginning of treatment, it may be due to the effect of naloxone. It may be a sign that intestinal function is normalizing. This diarrhea may occur during the first 3 to 5 days of treatment. If it persists beyond this 3- to 5-day period, or if you are concerned, contact your doctor.

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

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid, and may cause dependence and/or addiction.

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of Targin may also lead to dependence, abuse, and addiction, which may result in a life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often you need to take it. You may feel that you need to continue taking the medicine, even when it no longer helps relieve your pain or severe restless legs syndrome.

The risk of becoming dependent or addicted to Targin varies from person to person. You may have a higher risk of becoming dependent or addicted to Targin:

if you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction").
if you smoke.
if you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Targin, it could be a sign that you have become dependent or addicted:

You need to take the medicine for longer than recommended by your doctor.
You need to take more than the recommended dose.
You are using the medicine for reasons other than prescribed, for example, "to stay calm" or "to help you sleep."
You have made repeated unsuccessful attempts to stop or control the use of the medicine.
You feel unwell when you stop taking the medicine and feel better once you take it again ("withdrawal symptoms").

If you notice any of these signs, speak with your doctor to discuss the best treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop treatment with Targin).

Contact your doctor if you experience severe pain in the upper abdomen that may extend to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.

Inform your doctor if you have cancer with peritoneal metastases or initial intestinal obstruction in advanced stages of gastrointestinal or pelvic cancers.

If you need to undergo surgery, tell the medical staff that you are taking Targin.

Like other opioids, oxycodone may affect the normal production of hormones in the body such as cortisol or sex hormones, especially if high doses are taken for long periods. If you experience persistent symptoms such as malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased sexual desire, consult your doctor so they can monitor your hormone levels.

This medicine may increase your sensitivity to pain, especially at high doses. Inform your doctor if this occurs. It may be necessary to reduce the dose or change the medicine.

You may notice remnants of the prolonged-release tablet in your stools. Do not be alarmed, as the active ingredients (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and intestine and absorbed by your body.

Incorrect use of Targin

These tablets are not suitable for the treatment of withdrawal syndrome.

You must never abuse Targin, especially if you have a history of substance addiction. If you are addicted to substances such as heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse these tablets, because they contain naloxone. Pre-existing withdrawal symptoms may worsen.

You must also never dissolve these tablets to inject them (e.g., into a blood vessel). This is because they contain talc, which may cause local tissue destruction (necrosis) and lung tissue damage (pulmonary granuloma). This type of abuse may also have other serious consequences and may even cause death.

The use of Targin may lead to positive results in anti-doping tests. Using Targin as a doping agent may endanger your health.

Taking Targin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

The risk of side effects increases if you take antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, and symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.

Concomitant use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Targin together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and carefully follow the doses recommended by your doctor. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience such symptoms. Some examples of sedative or related medicines include:

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

If you take these tablets together with other medicines, the effects of the tablets or the other medicines listed below may change. Inform your doctor if you are taking:

medicines that reduce blood clotting ability (coumarin derivatives), which may cause clotting speed to increase or decrease;
macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin);
antifungal agents of the -azole type (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
a specific type of medicine known as a protease inhibitor used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, or saquinavir);
cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
rifampicin (used to treat tuberculosis);
carbamazepine (used to treat seizures or convulsions and certain painful conditions);
phenytoin (used to treat seizures or convulsions);
a herbal medicine called St. John's Wort (also known as Hypericum perforatum);
quinidine (a medicine used to treat arrhythmias).

No interactions between Targin and paracetamol, acetylsalicylic acid, or naltrexone are expected.

Taking Targin with food, drinks, and alcohol

Drinking alcohol while taking Targin may make you feel more drowsy or increase the risk of serious adverse effects such as shallow breathing with risk of respiratory arrest and loss of consciousness. It is recommended not to drink alcohol while taking Targin.

You should avoid drinking grapefruit juice while taking these tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

These tablets should be avoided during pregnancy as much as possible. If used for prolonged periods during pregnancy, oxycodone hydrochloride may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during childbirth, the newborn may experience respiratory depression (slow and shallow breathing).

Breastfeeding

Breastfeeding must be discontinued during treatment with 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 ruled out, especially if the mother receives multiple doses of Targin.

Driving and using machines

Targin may affect your ability to drive and use machines. This is especially true at the beginning of Targin treatment, after a dose increase, or after switching from another medication. However, these adverse effects usually disappear once the Targin dose is stabilized.

Targin has been associated with drowsiness and sudden episodes of falling asleep. If you experience these adverse effects, you must not drive or use machinery. If this happens, inform your doctor.

Ask your doctor whether you can drive or use machines during treatment with Targin.

Targin contains lactose

This medicine contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Targin

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using Targin, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop taking Targin”).

Targin is a prolonged-release tablet, which means that the active substances are released over an extended period of time. Its effect lasts for 12 hours.

You must swallow the prolonged-release tablet whole to avoid affecting the slow release of oxycodone hydrochloride from the tablet. Do not break, crush, or chew the tablets. Doing so may cause your body to absorb a potentially fatal dose of oxycodone hydrochloride (see section 3 “If you take more Targin than you should”).

Unless otherwise instructed by your doctor, the usual dose is:

For the treatment of pain

Adults

The usual starting dose is 10 mg oxycodone hydrochloride/5 mg naloxone hydrochloride in prolonged-release tablets every 12 hours.

Your doctor will decide the daily dose you should take and how to divide the total daily dose between the morning and evening doses. Your doctor will also decide whether the dose needs to be adjusted during treatment. Your dose will be adapted to your level of pain and individual sensitivity. You should receive the lowest dose necessary to relieve pain. If you have previously been treated with opioids, the initial dose of Targin may be higher.

The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. If you require a higher dose, your doctor may prescribe additional oxycodone hydrochloride without naloxone hydrochloride. However, the daily dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal activity may be reduced if the dose of oxycodone hydrochloride is increased without increasing the dose of naloxone hydrochloride.

If you switch from these tablets to another opioid analgesic, your bowel function may worsen. If you experience pain between doses of Targin, you may need a fast-acting analgesic. Targin is not suitable for treatment in this case. Discuss this with your doctor.

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

For the treatment of restless legs syndrome

Adults

The usual starting dose is 5 mg oxycodone hydrochloride/2.5 mg naloxone hydrochloride in prolonged-release tablets every 12 hours.

Your doctor will decide how much Targin you should take each day and how to divide the total daily dose between the morning and evening doses. Your doctor will also decide whether the dose needs to be adjusted during treatment. Your dose will be adjusted according to your individual response. The lowest effective dose will be chosen to relieve the symptoms of restless legs syndrome.

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

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

For the treatment of pain or restless legs syndrome

Elderly patients

In general, dose adjustment is not necessary in elderly patients with normal kidney and/or liver function.

Liver or kidney impairment

If you have any degree of kidney impairment or mild liver impairment, your doctor will prescribe these tablets with special caution. If you have moderate or severe liver impairment, you must not take these tablets (see also section 2 “Do not take Targin” and “Warnings and precautions”).

Children and adolescents under 18 years

Targin has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been established in these patients. Therefore, the use of Targin is not recommended in children and adolescents under 18 years of age.

Method of administration

Oral use.

Swallow these tablets whole (without chewing) with sufficient liquid (half a glass of water). You may take the prolonged-release tablets with or without food. Take these tablets every 12 hours, following a fixed schedule (for example, at 8 a.m. and 8 p.m.). Do not break, chew, or crush the prolonged-release tablets (see section 2 “Warnings and precautions”).

Duration of use

In general, you should not take these tablets longer than necessary. If you are receiving these tablets for a prolonged period, your doctor should regularly check whether you still need them.

If you take more Targin than you should

If you have taken more tablets than prescribed, you must inform your doctor immediately. Contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

An overdose may cause:

constricted pupils
slow and shallow breathing (respiratory depression)
drowsiness up to loss of consciousness
low muscle tone (hypotonia)
reduced heart rate
drop in blood pressure
a brain disorder (known as toxic leukoencephalopathy).

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

You should avoid situations requiring a high level of alertness, such as driving.

If you forget to take Targin

If you miss a dose or take a lower dose than prescribed, you may stop experiencing the analgesic effect.

If you forget to take a dose, follow the instructions below:

If there are 8 hours or more until your next scheduled dose: Take the missed prolonged-release Targin tablet immediately and continue with your normal schedule.
If there are less than 8 hours until your next scheduled dose: Take the missed prolonged-release Targin tablet. Wait another 8 hours before taking the next prolonged-release tablet. Try to return to your original schedule (for example, 8 a.m. and 8 p.m.). Do not take Targin more than once within an 8-hour period.

Do not take a double dose to make up for missed doses.

If you stop taking Targin

Do not stop treatment without consulting your doctor. If you no longer need treatment, your daily dose should be gradually reduced after discussion with your doctor. This way you can avoid withdrawal symptoms such as restlessness, episodes of sweating, and muscle pain.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

Important adverse effects to watch for, and what to do if they occur:

If you are already experiencing any of the following important adverse effects, consult a doctor immediately.

Slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. This occurs mainly in elderly and debilitated patients. Opioids may also cause a marked decrease in blood pressure in susceptible patients.

The following adverse effects have been observed in patients receiving treatment for pain

Frequent (may affect up to 1 in 10 patients)

abdominal pain	malaise	fatigue or exhaustion
constipation	flatulence (gas)	itching of the skin
diarrhea	decreased or loss of appetite	skin reactions/rashes
dry mouth	dizziness or sensation of spinning	sweating
indigestion	headache	vertigo
vomiting	hot flushes	insomnia
	unusual weakness	drowsiness

Uncommon (may affect up to 1 in 100 patients)

flatulence	palpitations	rhinorrhea
abnormal thoughts	biliary colic	cough
anxiety	chest pain	hypersensitivity/allergic reactions
confusion	general malaise	injury from accidents
depression	pain	increased urgency to urinate
nervousness	swelling of hands, ankles, or feet	muscle cramps
feeling of tightness in the chest, especially if you already have coronary heart disease	weight loss	muscle contractions
decrease in blood pressure	difficulty concentrating	muscle pain
withdrawal symptoms such as agitation	speech disorder	vision disorder
fainting	tremor	epileptic seizures (especially in people with epilepsy or a predisposition to seizures)
loss of energy	increase in blood pressure
thirst	difficulty breathing
disturbance of taste	restlessness
	chills
	increase in liver enzymes
	decreased sexual desire

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

increased heart rate	dental disorders	weight gain
drug dependence		yawning

Frequency not known (cannot be estimated from the available data)

euphoria	hallucinations	skin tingling
severe sedation	respiratory depression	belching
erectile dysfunction	difficulty urinating	sleep apnea (pauses in breathing during sleep)
nightmares	aggression

It is known that the active substance oxycodone hydrochloride, when not combined with naloxone hydrochloride, has the following adverse effects, different from those mentioned above:

Oxycodone may cause respiratory problems (respiratory depression), decreased pupil size, bronchial muscle and smooth muscle cramps, and suppression of the cough reflex.

Frequent (may affect up to 1 in 10 patients)

changes in mood and personality (for example, depression, feeling extremely happy)	decreased activity	difficulty urinating
	increased activity	hiccups

Uncommon (may affect up to 1 in 100 people)

difficulty concentrating	reduced sensitivity to pain or touch	gingivitis
migraine	coordination abnormalities	perception disorders (e.g., hallucinations, derealization)
	voice alterations (dysphonia)
increased muscle tension	water retention	skin redness
involuntary muscle contractions	hearing difficulties	dehydration
	mouth ulcers	agitation
condition in which the intestine stops functioning properly (ileus)	difficulty swallowing	decreased levels of sex hormones which may affect sperm production in men or menstrual cycle in women
dry skin
drug tolerance

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

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

Frequency not known (cannot be estimated from the available data)

generalized acute allergic reactions (anaphylactic reactions)	absence of menstrual periods	problems with bile flow
increased sensitivity to pain	neonatal withdrawal syndrome	dental caries
a condition affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi's sphincter dysfunction)

The following adverse effects have been observed in patients receiving treatment for restless legs syndrome

Very common (may affect more than 1 in 10 people)
headache	constipation	sweating
drowsiness	malaise	fatigue or exhaustion
Common (may affect up to 1 in 10 people)
reduced or loss of appetite	tingling in hands or feet	vomiting
difficulty sleeping	vision disorders	increase in liver enzymes (increased alanine aminotransferase, increased gamma glutamyl transferase)
depression	dizziness	itchy skin
sensation of dizziness or spinning ("everything is spinning")	hot flushes	skin reactions/rashes
difficulty concentrating	decrease in blood pressure	chest pain
tremor	increase in blood pressure	chills
	abdominal pain	pain
	dry mouth	thirst
Uncommon (may affect up to 1 in 100 people)
reduced sexual desire	erectile dysfunction	swelling of hands, ankles or feet
sudden episodes of sleep	withdrawal symptoms such as agitation	accidental injuries
altered taste
difficulty breathing
flatulence
Frequency not known (cannot be estimated from available data)
hypersensitivity/allergic reactions	severe sedation	dyspepsia
abnormal thoughts	speech disorder	belching
anxiety	fainting	dental disorders
confusion	sensation of chest tightness, especially if you already have coronary heart disease	biliary colic
nervousness	palpitations	muscle cramps
restlessness	increased heart rate	fasciculations
euphoria	shallow breathing	muscle pain
hallucinations	cough	difficulty urinating
nightmares	rhinorrhea	increased urgency to urinate
seizures (especially in people with epileptic disorders or predisposition to seizures)	yawning	feeling of general malaise
drug dependence	flatulence	weight loss
	diarrhea	weight gain
	aggression	unusual weakness
		lack of energy

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Targin

Keep this medicine out of the sight and reach of children. Store this medicine in a secure, closed place where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the carton, label, and blister pack, following “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

For bottles only

Once opened, use within 6 months.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Targin

The active substances are oxycodone hydrochloride and naloxone hydrochloride.

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.

The other components are:

Tablet core: Povidone K30, ethylcellulose, stearyl alcohol, monohydrate lactose, talc, magnesium stearate.
Tablet coating: Partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of Targin and contents of the pack

Targin 10 mg/5 mg are white, oblong, film-coated tablets with a minimum length of 9.5 mm, marked "OXN" on one side and "10" on the other.

These tablets are marketed in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 tablets, or in a clinical pack of 100 (10 x 10) or in a child-resistant container containing 100 tablets.

Only certain pack sizes and types may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Tel: 91 3821870

Manufacturer

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria	Targin 5 mg/2.5 mg <10/5mg> <20/10mg> <40 mg/20 mg> prolonged-release tablets
Belgium	Targinact 5 mg/2.5 mg <10/5mg> <20/10mg> <40 mg/20 mg> prolonged-release tablets
Croatia	Targinact 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> prolonged-release tablets
Cyprus	Targinact 5/2.5mg <10/5mg> <20/10mg> <40/20mg> prolonged-release tablets
Czech Republic	Targin 10/5mg <20/10mg> <40/20mg> prolonged-release tablets
Germany	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
Denmark	Targin
Estonia	Targinact 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> prolonged-release tablets
Spain	Targin 5/2.5mg <10/5mg> <20/10mg> <40/20mg> prolonged-release tablets
Finland	Targiniq
Ireland	Targin 5 mg/2.5 mg <10/5mg> <20/10mg> <40 mg/20 mg> prolonged-release tablets
Iceland	Targin
Italy	Targin
Luxembourg	Targinact-5/2.5 <10/5mg> <20/10mg> <40/20>
Netherlands	Targinact 5 mg/2.5 mg <10/5mg> <20/10mg> <40 mg/20 mg> prolonged-release tablets
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> prolonged-release tablets
Slovenia	Targinact 5 mg/2.5 mg <10 mg/5 mg> <20 mg/10 mg> <40 mg/20 mg> prolonged-release tablets
Sweden	Targiniq

Date of the most recent review of this package leaflet: April 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)