Targin 5 mg/2.5 mg prolonged-release tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Targin 5 mg/2.5 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. 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. Do not pass it on to others. It may harm them, even if they have the same symptoms as you.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Leaflet contents
- 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 its active substances are released over an extended period of time. Its effect 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 as active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the analgesic effect of Targin; it is a potent analgesic belonging to the opioid group. The second active substance in Targin, naloxone hydrochloride, serves 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 moderate 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 the unpleasant sensations and thereby reduce the compelling need to move the limbs.
The second active substance in Targin, naloxone hydrochloride, serves 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 is unable to supply sufficient 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 known as 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
Consult your doctor or pharmacist before starting Targin:
- if you are an elderly or debilitated (weak) patient,
- if you have opioid-induced paralytic ileus (a type of intestinal obstruction),
- if you have kidney disorder,
- if you have mild liver disorder,
- if you have severe lung disorder (i.e., reduced breathing capacity),
- if you have a disease characterized by frequent breathing pauses during sleep, which may make you feel very sleepy during the day (sleep apnoea),
- if you have myxoedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin, affecting the face and extremities),
- 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 partial or complete loss of contact with reality (psychosis), due to alcoholism or intoxication with other substances (substance-induced psychosis),
- if you have problems due to gallstones,
- if you have abnormal enlargement of the prostate (prostate hypertrophy),
- if you suffer from 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 any 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 medication within the last two weeks, for example, medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid,
- if you experience drowsiness or sudden episodes of falling asleep.
Sleep-related breathing disorders
Targin may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nocturnal 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 any of them occur during treatment with these tablets.
The most serious consequence of opioid overdose is respiratory depression (slow and shallow breathing). This may also lead to reduced oxygen concentration in the blood, which can cause fainting, etc.
Swallow the prolonged-release tablet whole, to ensure the slow release of oxycodone hydrochloride from the prolonged-release tablet is not affected. 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 develop severe diarrhoea 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 diarrhoea 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 analgesics 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”);
- you smoke;
- 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 your 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 Targin and how to do so safely (see section 3, If you stop taking 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 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 can cause local tissue destruction (necrosis) and lung tissue abnormalities (pulmonary granuloma). This type of abuse may also have other serious consequences and may even cause death.
The use of Targin may result in positive anti-doping tests. Using Targin as a performance enhancer 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 when antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) are used. These medicines may interact with oxycodone, and symptoms such as rhythmic, 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.
The 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. Therefore, 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), as clotting speed may 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 remedy called St. John’s Wort (also known as Hypericum perforatum);
- quinidine (a medicine used to treat arrhythmias).
Interactions between Targin and paracetamol, acetylsalicylic acid, or naltrexone are not 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 the 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 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 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 interfering with 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 initial 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 the severity of your pain and your individual sensitivity. You should receive the lowest dose necessary to relieve pain. If you have previously received opioid treatment, 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 total 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 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 initial 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 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 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.
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 taking 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, inform your doctor immediately. Contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating 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 progressing to loss of consciousness
- low muscle tone (hypotonia)
- reduced heart rate
- low blood pressure
- a brain disorder (known as toxic leukoencephalopathy).
In severe cases, loss of consciousness (coma), fluid accumulation in the lungs, and circulatory collapse may occur, which can be fatal in some instances.
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 lose 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 regular dosing schedule.
- If less than 8 hours remain 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 (e.g., 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 a missed dose.
If you stop taking Targin
Do not stop treatment without consulting your doctor. If you no longer need treatment, you should gradually reduce your daily dose after discussing it with your doctor. This will help you 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 already have any of the following important adverse effects, consult your nearest 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Uncommon (may affect up to 1 in 100 patients)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
|
| |
| ||
| ||
|
Rare (may affect up to 1 in 1,000 patients)
|
|
|
|
|
Frequency not known (cannot be estimated from the available data)
|
|
|
|
|
|
|
|
|
|
|
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.
Common (may affect up to 1 in 10 patients)
|
|
|
|
|
Uncommon (may affect up to 1 in 100 patients)
|
|
|
|
|
|
| ||
|
|
|
|
|
|
|
| |
|
|
|
| ||
|
Rare (may affect up to 1 in 1,000 patients)
|
|
|
|
|
Frequency not known (cannot be estimated from the available data)
|
|
|
|
|
|
|
The following adverse reactions have been observed in patients receiving treatment for restless legs syndrome
Very common (may affect more than 1 in 10 people) | ||
|
|
|
|
|
|
Common (may affect up to 1 in 10 people) | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
Uncommon (may affect up to 1 in 100 people) | ||
|
|
|
|
|
|
| ||
| ||
| ||
Frequency not known (cannot be estimated from available data) | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
|
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 safe, 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.
Keep in the original packaging to protect from light.
For bottles only
Once opened, use within 6 months.
Medicines must not be disposed of via wastewater or household waste. Return unused or expired medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and further information
Composition of Targin
The active substances are oxycodone hydrochloride and naloxone hydrochloride.
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.
The other components are:
- Tablet core: Hydroxypropylcellulose, ethylcellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate.
- Tablet coating: Partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, brilliant blue FCF aluminium lake (E133).
Appearance of Targin and contents of the pack
Targin 5 mg/2.5 mg are blue, oblong, film-coated tablets with a minimum length of 9.5 mm, marked "OXN" on one side and "5" on the other.
These tablets are marketed in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 tablets, in a clinical pack of 100 (10 x 10), or in a bottle with a child-resistant closure containing 100 tablets.
Only certain pack sizes and types may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Austria | Targin 5 mg/2.5 mg <10/5 mg> <20/10 mg> <40 mg/20 mg> prolonged-release tablets |
Belgium | Targinact 5 mg/2.5 mg <10/5 mg> <20/10 mg> <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 5/2.5 mg <10/5 mg> <20/10 mg> <40/20 mg> prolonged-release tablets |
Czech Republic | Targin 10/5 mg <20/10 mg> <40/20 mg> 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 5/2.5 mg <10/5 mg> <20/10 mg> <40/20 mg> prolonged-release tablets |
Finland | Targiniq |
Ireland | Targin 5 mg/2.5 mg <10/5 mg> <20/10 mg> <40 mg/20 mg> prolonged-release tablets |
Iceland | Targin |
Italy | Targin |
Luxembourg | Targinact-5/2.5 <10/5 mg> <20/10 mg> <40/20 mg> |
Netherlands | Targinact 5 mg/2.5 mg <10/5 mg> <20/10 mg> <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 leaflet: April 2025
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)