Targiniq 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg prolonged-release tablet er
oxycodone hydrochloride/naloxone hydrochloride
What Targiniq is and what it is used for
Targiniq is a prolonged-release tablet, which means that its active substances are released over a longer period. Its effect lasts for 12 hours.
These tablets are intended for adults only.
Pain relief:
You have been prescribed Targiniq for the treatment of severe pain that can only be relieved by strong painkillers ( opioids ). Naloxone hydrochloride is added to prevent 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 Targiniq and is a potent analgesic (“pain reliever”) in the opioid group. The other active ingredient in Targiniq, naloxone hydrochloride, is intended to provide relief from and prevent constipation. Bowel disturbances (eg, constipation) are a typical side effect of treatment with opioid analgesics.
Restless legs syndrome:
You have been prescribed Targiniq as a second-line treatment for symptoms of severe to very severe restless legs syndrome in people who cannot be treated with dopamine medication. People with restless legs syndrome have an unpleasant feeling in their legs. This can occur as soon as they sit or lie down and can only be relieved by moving the legs, but sometimes also the arms and other parts of the body. It makes it very difficult to sit still and sleep. Naloxone hydrochloride is added to prevent constipation.
How these tablets work for restless legs syndrome:
These tablets help relieve unpleasant feelings and reduce the urge to move arms and legs.
The other active ingredient in Targiniq, naloxone hydrochloride, is intended to provide relief from and prevent constipation. Intestinal disturbances (e.g. constipation) are a typical side effect of treatment with strong painkillers ( opioids ).
The oxycodone hydrochloride/naloxone hydrochloride contained in Targiniq may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Targiniq
Do not take Targiniq:
• 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 cannot supply enough oxygen to the blood and remove the carbon dioxide produced in the body ( respiratory depression )
• if you suffer from severe lung disease associated with narrowing of the airways ( chronic obstructive pulmonary disease or COPD)
• if you suffer from a disease known as cor pulmonale; in this disease, the right side of the heart becomes enlarged due to increased pressure inside the blood vessels in the lungs, etc. (eg as a result of COPD – see above)
• if you suffer from severe bronchial asthma
• if you have paralytic ileus (a type of bowel obstruction) that has not been caused by opioids
• if you have moderately to severely impaired liver function.
Also for restless legs syndrome:
• if you have previously abused opioids
Warnings and precautions
Talk to your doctor or pharmacist before taking Targiniq:
• when treating elderly patients or weakened (powerless) patients
• if you have paralytic ileus (a type of bowel obstruction) that has been caused by opioids
• if you have reduced kidney function
• if you have mildly impaired liver function
• if you have severely reduced lung function (i.e. reduced ability to breathe)
• if you suffer from a condition characterized by frequent pauses in breathing during the night which can make you feel very sleepy during the day ( sleep apnea )
• if you have myxedema (a thyroid disorder with dry, cold, and swollen skin affecting the face and legs)
• if your thyroid does not produce enough hormones (underactive thyroid or hypothyroidism )
• if your adrenal glands do not produce enough hormones (adrenocortical insufficiency or Addison’s disease )
• if you have a mental illness accompanied by a ( partial ) loss of perception of reality ( psychosis ), due to alcohol or intoxication with other substances (substance-induced psychosis )
• if you suffer from gallstone problems
• if your prostate gland is abnormally enlarged ( prostatic hypertrophy )
• if you suffer from alcoholism or delirium tremens
• if your pancreas is inflamed ( pancreatitis )
• if you have low blood pressure ( hypotension )
• if you have high blood pressure ( hypertension )
• if you have a pre-existing cardiovascular disease ( cardiovascular disease)
• if you have a head injury (due to the risk of increased pressure in the brain)
• if you suffer from epilepsy or are prone to convulsions
• if you also take MAO inhibitors (used to treat depression or Parkinson’s disease ) or if you have taken this type of medicine in the last two weeks, e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid.
• if sleepiness or episodes of sudden falling asleep occur.
This medicine may cause breathing problems when you sleep. These problems may include breathing pauses during sleep, awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, see a doctor. The doctor may lower the dose.
You should tell your doctor if you have previously suffered from any of the above. Also, tell your doctor if any of the above diseases occur while you are taking these tablets.
The most serious risk of opioid overdose is respiratory depression (slow and shallow breathing). This can also cause the oxygen levels in the blood to drop, which in turn can lead to fainting, etc.
You must swallow the prolonged-release tablets whole in order not to affect the slow release of oxycodone hydrochloride from the prolonged-release tablet. You must not split, chew or crush the tablets. If the tablets are split, chewed, or crushed, this can lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 “If you take too much Targiniq”).
If you suffer from severe diarrhea at the beginning of treatment, this may be due to the effect of naloxone hydrochloride. It may be a sign that bowel function is returning to normal. Such diarrhea may occur during the first 3–5 days of treatment. Contact your doctor if diarrhea continues after 3-5 days, or is of concern.
If you have been using another opioid, withdrawal symptoms may appear at first when you switch to treatment with Targiniq, e.g. restlessness, sweating, and muscle pain. If you experience such symptoms, you may need special monitoring by your doctor.
With long-term use, you may develop a tolerance to these tablets. This means that you may need a higher dose to achieve the desired effect. Long-term use of these tablets can also lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too quickly (restlessness, sweating, muscle pain). If you no longer need treatment, reduce the daily dose gradually, in consultation with your doctor.
The active substance oxycodone hydrochloride has the same abuse profile as other strong opioids (strong painkillers). There is a risk of developing psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients who have previously abused alcohol, drugs, or medicines.
Tell your doctor if you have cancer with peritoneal metastases or incipient colon cancer in advanced stages of cancer of the gastrointestinal tract or pelvis.
If you have to have surgery, tell your doctors that you are taking Targiniq.
Like other opioids, oxycodone can affect the body’s normal production of hormones, such as cortisol or sex hormones, especially if you have taken high doses for a long time. If you experience persistent symptoms, such as being or feeling sick or sick (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in the menstrual cycle, impotence, infertility, or decreased sex drive, talk to your doctor as he/she may want to examine your hormone levels.
This medicine may increase your pain sensitivity, especially at high doses. Tell your doctor if this happens. It may be necessary to lower your dose or switch to another medicine.
You may detect residues of prolonged-release tablets in your stool. Don’t worry about this. The active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released into the stomach and intestines and absorbed into the body.
Improper use of Targiniq
These tablets are not suitable for the treatment of withdrawal.
Targiniq should never be abused. This is especially true if you are addicted to drugs. If you are addicted to substances such as heroin, morphine, or methadone, you will likely suffer severe withdrawal symptoms if you abuse these tablets because they contain the ingredient naloxone hydrochloride. Pre-existing withdrawal symptoms may worsen.
You must never abuse these tablets by dissolving them and injecting them (eg into a blood vessel). The tablets contain talc which can lead to local tissue destruction ( necrosis ) and changes to the lung tissue (pulmonary granuloma). Such abuse can also have other serious consequences and can even be fatal.
Other medicines and Targiniq
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The risk of side effects increases if you take antidepressants (for example citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine ). These medicines can affect or be affected by oxycodone, and you may have symptoms such as involuntary, rhythmic muscle contractions, including in the muscles that control eye movements, sudden movements, profuse sweating, tremors, and exaggerated reflexes movements, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.
The simultaneous use of opioids, including oxycodone hydrochloride, and sedative drugs for sleep disorders, such as benzodiazepines or similar drugs, increases the risk of drowsiness, breathing difficulties ( respiratory depression ), coma, and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Targiniq together with sedative drugs, the dose and duration of treatment should be limited by the doctor.
Tell your doctor if you are taking any sedative medication and follow your doctor’s dosage recommendation carefully. It may be helpful to inform friends or relatives to be aware of the signs and symptoms listed above. Contact a doctor when you experience such symptoms. Examples of these sedatives or similar drugs are:
- other potent pain relievers ( opioids )
- medicines for epilepsy, pain, and anxiety, e.g. gabapentin and pregabalin
- hypnotics and sedatives ( sedatives including benzodiazepines, hypnotics, and anxiolytics )
- drugs to treat depression
- medicines used to treat allergies, motion sickness, or nausea ( antihistamines or antiemetics)
- medicines to treat psychological or mental illnesses (antipsychotics which include phenothiazines and neuroleptics )
If you take this medicine at the same time as taking any of the medicines listed below, the effect may be affected. Tell your doctor if you are taking:
- medicines that reduce the blood’s ability to coagulate (coumarin derivatives); the clotting time can be increased or decreased
- macrolide antibiotics (eg clarithromycin, erythromycin, or telithromycin)
- azole-type medicines for fungal infections (eg ketoconazole , voriconazole, itraconazole or posaconazole)
- a specific type of medicine called a protease inhibitor (used to treat HIV ) (for example, ritonavir, indinavir, nelfinavir, or saquinavir)
- cimetidine (a medicine for stomach ulcers, indigestion, or heartburn)
- rifampicin (used to treat tuberculosis)
- carbamazepine (used to treat seizures or convulsions and certain pain conditions)
- phenytoin (used to treat fits or convulsions)
- a (traditional) herbal medicine called St. John’s wort (also known as Hypericum perforatum)
- quinidine (a medicine to treat irregular heart rhythms).
No interaction is expected between Targiniq and paracetamol, aspirin, or naltrexone.
Targiniq with food, drink, and alcohol
If you drink alcohol while taking Targiniq, it may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and unconsciousness. You should not drink alcohol while taking Targiniq.
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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of these tablets should be avoided as much as possible during pregnancy.
When used for a long time during pregnancy, oxycodone hydrochloride can lead to withdrawal symptoms in the newborn baby. If oxycodone hydrochloride is given during labor, the newborn baby may suffer from respiratory depression (slow and shallow breathing).
Breast-feeding
Stop breastfeeding during treatment with these tablets. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. A risk to the breastfed child cannot be ruled out, especially after repeated doses of Targiniq by the nursing mother.
Driving ability and use of machinery
Targiniq may affect your ability to drive or use machines. This is especially true at the beginning of treatment with Targiniq, after an increase in the dose, or after switching from another medicine. However, these side effects disappear as soon as you are on a stable dose of Targiniq.
Targiniq has been associated with drowsiness and episodes of suddenly falling asleep. If you experience these side effects, you must not drive or use machines. You should tell your doctor if this happens.
Ask your doctor if you can drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Targiniq contains lactose
The medicine contains lactose (milk sugar). If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to use Targiniq
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Targiniq is a prolonged-release tablet, which means that its active substances are released over a longer period. Its effect lasts for 12 hours.
The prolonged-release tablets must be swallowed whole so that the slow release of oxycodone hydrochloride from the prolonged-release tablet is not affected. You must not split, chew or crush the tablets. If the tablets are split, chewed, or crushed, this can lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 “If you take too much Targiniq”).
The usual dose, unless your doctor has prescribed otherwise :
For the treatment of pain:
Adults
The usual starting dose is 10 mg oxycodone hydrochloride/5 mg naloxone hydrochloride as a prolonged-release tablet (s) every 12 hours.
Your doctor will decide how much to take each day and how to divide the total daily dose into morning and evening doses. The doctor also decides if any dose adjustments need to be made during the treatment. Your dose will be adjusted depending on the level of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you are already being treated with an opioid, treatment with Targiniq can start at a higher dose.
The highest daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If you need a higher dose, your doctor may give additional oxycodone hydrochloride without naloxone hydrochloride. The maximum daily dose of oxycodone hydrochloride should not exceed 400 mg. The beneficial effect of naloxone hydrochloride on bowel activity may be affected if additional oxycodone hydrochloride is given without additional naloxone hydrochloride.
If you are allowed to switch these tablets to another opioid, your bowel function will probably deteriorate.
If you experience pain between two doses of Targiniq, you may need to take a fast-acting pain reliever. Targiniq is not suitable for this. Talk to your doctor in such a case.
Talk to your doctor or pharmacist if you feel that the effect of these tablets is too strong or too weak.
For the treatment of restless legs syndrome:
Adults
The usual starting dose is 5 mg oxycodone hydrochloride/2.5 mg naloxone hydrochloride as a prolonged-release tablet (s) every 12 hours.
Your doctor will decide how much Targiniq to take each day and how to divide the total daily dose into morning and evening doses. The doctor also decides if any dose adjustments need to be made during the treatment. Your dose will be adjusted depending on your sensitivity. You should be given the lowest dose needed to relieve your symptoms of restless legs syndrome. Talk to your doctor or pharmacist if you feel that the effect of Targiniq is too strong or too weak.
The maximum daily dose is 60 mg of oxycodone hydrochloride and 30 mg of naloxone hydrochloride.
For the treatment of pain or restless legs syndrome:
Elderly patients
In general, no dose adjustment is required for elderly patients with normal kidney and/or liver function.
Impaired liver or kidney function
If you suffer from impaired kidney function or mild impaired liver function, your attending physician will prescribe these tablets with special caution. If you suffer from a moderate or severe liver impairment, these tablets should not be used (see also section 2 “Do not take Targiniq” and “Warnings and precautions”).
Children and young people under the age of 18
Some studies of Targiniq in children and adolescents under the age of 18 have not yet been conducted. Its safety and efficacy have not yet been proven in children and adolescents. For this reason, the use of Targiniq is not recommended for children and adolescents under 18 years of age.
Mode of administration
Swallow these tablets whole (without chewing) with a sufficient amount of liquid (½ glass of water). The prolonged-release tablets can be taken with or without food. Take the tablets every 12 hours according to a fixed schedule (eg 8 in the morning and 8 in the evening). You must not split, chew or crush the extended-release tablets (see section 2 “Warnings and precautions”).
Treatment time
In general, you should not take these tablets for longer than you need. If you are on long-term treatment, your doctor should regularly check whether you still need these tablets.
If you have taken too much Targiniq
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have taken more than the prescribed dose of one of these tablets, you must inform your doctor immediately.
An overdose can lead to:
• pupil dilation
• slow and shallow breathing ( respiratory depression )
• sleepiness up to unconsciousness
• low muscle tone ( hypotonia )
• decreased heart rate
• drop in blood pressure
In severe cases, unconsciousness ( coma ), fluid in the lungs, and circulatory collapse can occur, which in some cases can be fatal.
You should avoid situations that require a high degree of alertness, e.g. driving a car.
If you forget to take Targiniq
If you forget to take Targiniq or if you take a lower dose than prescribed, you may not experience any effect.
Follow the instructions below if you forget to take your dose:
• If it is 8 hours or more until the next regular dose: Take the missed dose immediately and continue with your normal dosing schedule.
• If the next normal dose is to be taken in less than 8 hours: Take the missed dose one. Then wait another 8 hours before taking the next dose. Try to get back to your original dosing schedule (eg 8 am and 8 pm). Do not take more than one dose within 8 hours.
Do not take a double dose to make up for a missed tablet.
If you stop taking Targiniq
Do not stop treatment without consulting your doctor.
If you do not need any further treatment, you must reduce the daily dose by one gradually after talking to your doctor. In this way, you can avoid withdrawal symptoms, such as restlessness, sweating attacks, and muscle pain.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects or signs to watch out for and what to do if you are affected
If you are affected by any of the following important side effects, you should immediately contact your nearest doctor.
Slow and shallow breathing ( respiratory depression ) is the most dangerous of an opioid overdose. This mainly affects elderly and debilitated (powerless) patients. Opioids can also lead to a serious drop in blood pressure in susceptible patients.
The following side effects have been seen in patients treated for pain.
| Common (may affect up to 1 in 10 users) | ||
| • abdominal pain• constipation• diarrhea• dry mouth• indigestion• vomiting• nausea• gas formation | • decreased appetite up to the loss of appetite• a feeling of dizziness or “spinning”• headache• hot flashes | • unusual feeling of weakness• tiredness or exhaustion• skin itching• skin reactions/rash• sweating• dizziness• difficulty sleeping• drowsiness |
| Uncommon (may affect up to 1 in 100 users) | ||
| inflated stomach abnormal thoughtsconcernconfusionDepressionnervousnesschest tightness, especially if you already suffer from coronary artery disease blood pressure drop withdrawal symptoms, such as agitationfaintinglack of energythirsttaste changes | palpitationbiliary colicchest pain general malaisepainswollen hands, ankles or feet concentration difficulties reduced ability to speaktremorsbreathing difficultiesrestlessnessoverindulgeelevated liver values blood pressure increase reduced sex driver funny nose | cough hypersensitivity/ allergic reactions weight loss injuries due to accidents increased need for urinatemuscle cramps muscle twitching muscle pain visual impairmentepileptic seizures (especially in people with epilepsy or a predisposition to seizures) |
| Rare (may affect up to 1 in 1,000 users) | ||
| • increased heart rate• drug dependence | • dental changes | • weight gain• yawning |
| Has been reported (occurring in an unknown number of users) | ||
| • euphoria• severe drowsiness• erectile dysfunction• nightmares | • hallucinations• shallow breathing• difficulty throwing water• aggressiveness | • tingling in the skin• belching• breathing problems during sleep ( sleep apnea ), see section 2 “Warnings and precautions” for more information. |
The active substance oxycodone hydrochloride is known to have the following, aberrant side effects when not combined with naloxone hydrochloride:
Oxycodone hydrochloride can cause breathing problems ( respiratory depression ), pupil dilation, spasms in the bronchial muscles, spasms in the smooth muscles, as well as inhibited cough reflex.
| Common (may affect up to 1 in 10 users) | ||
| • mood and personality changes (eg depression, feeling extremely happy) | • reduced activity• increased activity | • difficulty urinating• hiccups |
| Uncommon (may affect up to 1 in 100 users) | ||
| • concentration disorder• migraine• increased muscle tension• involuntary muscle contractions• intestinal obstruction ( ileus )• dry skin• drug tolerance | • reduced sensitivity to pain or touch• abnormal coordination• voice changes ( dysphonia )• water retention (more fluid stays in the body)• hearing loss• mouth ulcers• difficulty swallowing | • sore gums• perception disorders (e.g. hallucinations, sense of unreality)• redness• dehydration• upset• a decrease in sex hormone levels which may affect sperm production in men or the menstrual cycle in women |
| Rare (may affect up to 1 in 1,000 users) | ||
| • hives ( urticaria )• infection, such as cold sores or herpes (which can cause blisters around the mouth or genital areas) | • increased appetite• black (tarry) stools | • bleeding gums |
| Has been reported (occurring in an unknown number of users) | ||
| • acute generalized allergic reactions (anaphylactic reactions)• increased sensitivity to pain | • absence of menstrual periods• withdrawal symptoms in newborns | • problems with bile flow• caries |
The following side effects have been seen in patients treated for restless legs syndrome
| Very common (may affect more than 1 in 10 users) | ||
| • headache• sleepiness | • constipation• nausea | • sweating• tiredness or exhaustion |
| Common (may affect up to 1 in 10 users) | ||
| • decreased appetite up to the loss of appetite• difficulty sleeping• depression• a feeling of dizziness or “spinning”• concentration difficulties• tremors | • tingling in the hands and feet• visual impairment• dizziness• redness• drop in blood pressure• increase in blood pressure• abdominal pain• dry mouth | • vomiting• elevated liver values (increased alanine aminotransferase, increased gamma-glutamyltransferase)• skin itching• skin reactions/rash• chest pain• shiver• pain• thirst |
| Uncommon (may affect up to 1 in 100 users) | ||
| • reduced sex drive• episodes of sudden falling asleep• taste changes• breathing difficulties• weather tensions | • erectile dysfunction• withdrawal symptoms, such as agitation | • swollen hands, ankles, or feet• damaged due to accidents |
| hypersensitivity/allergic reactions• abnormal thoughts• anxiety• confusion• nervousness• restlessness• euphoria• hallucinations• nightmares• epileptic seizures (especially in people with epilepsy or a predisposition to seizures)• drug addiction | • severe drowsiness• impaired ability to speak• fainting• chest tightness, especially if you already suffer from coronary artery disease• palpitations• increased heart rate• shallow breathing• cough• rhinitis• yawning• inflated stomach• diarrhea• aggressiveness | • indigestion• belching• dental changes• biliary colic• muscle pain• muscle twitching• muscle cramps• difficulty urinating• increased need to urinate• general malaise• weight gain• weight loss• unusual feeling of weakness• lack of energy |
How to store Targiniq
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C. Targiniq 5 mg/2.5 mg prolonged-release tablets are light sensitive and should be stored in the original packaging.
Applies only to tablet containers:
To be used within 6 months after opening.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substances are oxycodone hydrochloride and naloxone hydrochloride.
Targiniq 5mg/2.5mg
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride corresponding to 4.5 mg of oxycodone and 2.5 mg of naloxone hydrochloride as 2.73 mg of naloxone hydrochloride dihydrate corresponding to 2.25 mg of naloxone.
Targiniq 10 mg/5 mg
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride corresponding to 9 mg of oxycodone and 5 mg of naloxone hydrochloride as 5.45 mg of naloxone hydrochloride dihydrate corresponding to 4.5 mg of naloxone.
Targiniq 20 mg/10 mg
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride corresponding to 18 mg of oxycodone and 10 mg of naloxone hydrochloride as 10.9 mg of naloxone hydrochloride dihydrate corresponding to 9 mg of naloxone.
Targiniq 40 mg/20 mg
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride corresponding to 36 mg of oxycodone and 20 mg of naloxone hydrochloride as 21.8 mg of naloxone hydrochloride dihydrate corresponding to 18 mg of naloxone.
Other ingredients are:
Targiniq 5mg/2.5mg
Tablet core:
Ethylcellulose, stearyl alcohol, lactose monohydrate, (see section 2 “Targiniq contains lactose”), talc, magnesium stearate, hydroxypropyl cellulose.
Tablet coating:
Polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, and brilliant blue FCF aluminum lake (E133).
Targiniq 10 mg/5 mg
Tablet core:
Povidone K30, ethyl cellulose, stearyl alcohol, lactose monohydrate, (see section 2 “Targiniq contains lactose”), talc, magnesium stearate.
Tablet coating:
Polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc
Targiniq 20 mg/10 mg
Tablet core:
Povidone K30, ethyl cellulose, stearyl alcohol, lactose monohydrate, (see section 2 “Targiniq contains lactose”), talc and magnesium stearate.
Tablet coating:
Polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172)
Targiniq 40 mg/20 mg
Tablet core:
Povidone K30, ethyl cellulose, stearyl alcohol, lactose monohydrate, (see section 2 “Targiniq contains lactose”), talc, magnesium stearate.
Tablet coating:
Polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172)
Appearance and package sizes of the medicine
Targiniq 5mg/2.5mg
Blue, oblong tablets with a length of 9.5 mm and film-coated, marked with “OXN” on one side and “5” on the other.
Targiniq 10 mg/5 mg
White oblong tablets with a length of 9.5 mm and film-coated, marked with “OXN” on one side and “10” on the other.
Targiniq 20 mg/10 mg
Pink oblong tablets with a length of 9.5 mm and film-coated, marked with “OXN” on one side and “20” on the other.
Targiniq 40 mg/20 mg
Yellow, oblong tablets with a length of 14 mm and film-coated, marked with “OXN” on one side and “40” on the other.
These tablets are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98, and 100 tablets and a jar with a child-resistant closure containing 100 tablets.
Not all pack sizes or pack types may be marketed.
Marketing Authorization Holder :
Mundipharma AB
Mölndalsvägen 30B
412 63 Gothenburg
Manufacturer:
Bard Pharmaceuticals Ltd.
Cambridge Science Park
Milton Road
Cambridge CB4 0GW
UK
or
Fidelio Healthcare Limburg GmbH
Mundipharma Strasse 2
65549 Limburg
Germany
or
Mundipharma DC BV
Leusderend 16
3832 RC Leusden
Netherlands