DONELOXON 5 MG / 2.5 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

6. contents of the pack and other information

What Doneloxon is and what it is used for

Doneloxon is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours.

These tablets are only for use in adults.

Pain relief

You have been prescribed Doneloxon for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.

How these tablets work in pain relief

Doneloxon contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-killing effect of Doneloxon, and is a potent analgesic (“painkiller”) of the opioid group.

The second active substance of Doneloxon, naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioid painkillers.

Restless legs syndrome

You have been prescribed Doneloxon as a second line symptomatic treatment of severe to very severe restless legs syndrome in people who cannot be treated with dopamine medicines. People with restless legs syndrome have unpleasant sensations in their limbs. This can start as soon as they sit or lie down and is only relieved by an irresistible urge to move the legs, sometimes the arms and other parts of the body. It makes sitting still and sleeping very difficult. Naloxone hydrochloride is added to counteract constipation.

How these tablets work in restless legs syndrome

These tablets help to relieve the unpleasant sensations and so reduces the urge to move the limbs.

The second active substance of Doneloxon, naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioids.

What you need to know before you take Doneloxon

Do not take Doneloxon

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have breathing problems, such as breathing more slowly or weakly than expected (respiratory depression),
• if you suffer from a severe chronic lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
• if you suffer from a condition known as Cor pulmonale. In this condition the right side of the heart becomes enlarged, due to increased pressure inside blood vessels in the lung etc.

(e.g. as a result of COPD – see above),

• if you suffer from severe bronchial asthma,
• if you have paralytic ileus (a type of bowel obstruction) not caused by opioids,
• if you have moderate to severe liver problems.
• Additionally for restless legs syndrome if you have a history of opioid abuse.
• Talk to your doctor or pharmacist before taking Doneloxon if you are elderly or debilitated (weak),
• if you have paralytic ileus (a type of bowel obstruction) caused by opioids,
• if you have kidney problems,
• if you have mild liver problems,
• if you have severe lung problems (i.e. reduced breathing capacity),
• if you suffer from frequent breathing stops during the night which may make you feel very sleepy during the day (sleep apnoea),
• if you have myxoedema (a thyroid disorder, with dryness, coldness and swelling [‘puffiness’] of the skin, affecting the face and limbs),
• if your thyroid gland is not producing enough hormones (underactive thyroid, or hypothyroidism),
• if your adrenal glands are not producing enough hormones (adrenal insufficiency, or Addison’s disease),
• if you have a mental illness accompanied by a (partial) loss 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 (prostate 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 pre-existing cardiovascular disease, if you have a head injury (due to the risk of increased brain pressure),
• if you suffer from epilepsy or are prone to fits,
• if you are also taking MAO inhibitors (used to treat depression, Parkinson’s disease or bacterial infections), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid
• if you feel sleepy or if you suddenly fall asleep sometimes.

Tell your doctor if any of the above has ever applied to you in the past. Also, please tell your doctor if you develop any of the above disorders while you are taking Doneloxon.

The most serious result of opioid overdose is respiratory depression (slow and shallow breathing). This may also cause blood oxygen levels to fall, resulting in possible fainting, etc.

Tell your doctor in case you have cancer associated to peritoneal metastases or beginning bowel obstruction in advanced stages of digestive and pelvic cancers.

If you experience severe diarrhoea at the start of treatment, this may be due to the effect of naloxone. It may be a sign that bowel function is returning to normal. Such diarrhoea can occur within the first 3–5 days of treatment. If diarrhoea should persist after 3–5 days, or give you cause for concern, please contact your doctor.

If you have been using another opioid, withdrawal symptoms may occur when you initially switch to Doneloxon treatment, e.g. restlessness, bouts of sweating and muscle pain. If you experience such symptoms, you may need to be specially monitored by your doctor.

Similar to other opioids, oxycodone may affect the normal production of hormones in the body such as cortisol or sex hormones, particularly if you have taken high doses for long periods of time. If you experience symptoms which persist, such as feeling or being sick (including vomiting), loss of appetite, tiredness, weakness, dizziness, changes in menstrual cycle, impotence, infertility or decreased sex drive, talk to your doctor as he/she may want to monitor your hormone levels.

Surgery

If you need to undergo surgery, please tell your doctors that you are taking Doneloxon.

Long-term treatment

If used over the long term, you may become tolerant to Doneloxon. This means you may need a higher dose to achieve the desired pain relief. Also, long-term use of Doneloxon may lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too suddenly (restlessness, bouts of sweating, muscle pain). If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.

Psychological dependence

The active substance oxycodone hydrochloride alone has an abuse profile similar to other strong opioids (strong analgesics). There is potential for development of psychological dependence. Oxycodone hydrochloride containing products should be avoided in patients with a present or past abuse of alcohol, drugs or medicines.

Incorrect use of Doneloxon

These tablets are not suitable for withdrawal treatment.

Doneloxon 5 mg/2.5 mg

The tablet must be swallowed whole and not be divided, broken, chewed or crushed.

Taking divided, broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see under section 3. “If you take more Doneloxon than you should”).

Doneloxon 10 mg/5 mg, 20 mg/10 mg or 40 mg/20 mg The tablet must not be broken, chewed or crushed. However, the tablets can be divided into equal halves (see section 3. “Method of administration”)

Taking broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see under section 3. “If you take more Doneloxon than you should”).

Doneloxon should never be abused, particularly if you have a drug addiction. If you are addicted to substances such as heroin, morphine or methadone, severe withdrawal symptoms are likely if you abuse Doneloxon because it contains the active substance naloxone. Pre-existing withdrawal symptoms may be made worse.

You should never misuse these tablets by dissolving and injecting them (e.g. into a blood vessel). In particular, they contain talc, which can cause destruction of local tissue (necrosis) and changes in lung tissue (lung granuloma). Such abuse can also have other serious consequences and may even be fatal.

You may see residue of the tablet in your stool. Do not worry, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have been released earlier while the tablet passed through the stomach and gut and have started to be effective in your body.

The use of Donelexon may produce positive results in doping controls.

The use of Doneloxon as a doping agent may become a health hazard.

Children and adolescents

Doneloxon has not yet been studied in children and adolescents under 18 years of age. Its safety and effectiveness have not been proven in children and adolescents. For this reason, Doneloxon use in children and adolescents under 18 years of age is not recommended.

Other medicines and Doneloxon

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

Concomitant use of Doneloxon and sedative medicines such as benzodiazepines or related medicines (medicines which affect the brain function see below) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Doneloxon together with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

These medicines which affect the brain function are for example:

• other strong painkillers (opioids),
• sleep medication and tranquillisers (sedative medicines including benzodiazepines, hypnotics, anxiolytics),
• medicines to treat depression,
• medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics),
• medicines to treat psychiatric or mental disorders (phenothiazines, neuroleptics, antipsychotics)

The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

If you take Doneloxon at the same time as you take other medicines, the effects of Doneloxon or the other medicines may be changed. Tell your doctor if you are taking:

• medicines that decrease the blood’s clotting ability (coumarin derivatives), this clotting time may be speeded up or slowed down,
• antibiotics of the macrolide type (such as clarithromycin, erythromycin or telithromycin),
• antifungal medicines of the azole type (such as ketoconazole, voriconazole, itraconazole or posaconazole),
• certain medicines used to treat HIV infections (protease inhibitors, such as ritonavir indinavir, nelfinavir or saquinavir),
• cimetidine (used to treat stomach ulcers, indigestion or heartburn),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizures, fits or convulsions and certain pain conditions),
• phenytoin (used to treat seizures, fits or convulsions).
• St John’s wort (a herbal remedy to treat depression also known as Hypericum perforatum),
• quinidine (a medicine to treat an irregular heartbeat).

Doneloxon with food, drink and alcohol

Drinking alcohol whilst taking Doneloxon may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you’re taking Doneloxon.

You should avoid drinking grapefruit juice while you are taking Doneloxon.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

Use of Doneloxon should be avoided to the extent possible during pregnancy. If used over prolonged periods during pregnancy, oxycodone hydrochloride may lead to withdrawal symptoms in the newborn baby. If oxycodone hydrochloride is given during childbirth, the baby may have breathing problems (respiratory depression).

• Breast-feeding

Breast-feeding should be stopped during treatment with Doneloxon. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, a risk for the suckling infant cannot be excluded in particular following intake of multiple doses of Doneloxon.

Driving and using machines

Doneloxon can affect your ability to drive or operate machines. This is most likely at the start of Doneloxon therapy, after a dose increase or after switching from a different medication. However, these side effects should disappear once you are on a stable Doneloxon dose.

Doneloxon has been associated with sleepiness and episodes of suddenly falling asleep. If you have this side effect, you must not drive or operate machinery. Talk to your doctor if these side effects occur.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However you would not be committing an offence if:

• – The medicine has been prescribed to treat a medical or dental problem and

• – You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

• – It was not affecting your ability to drive safely.

Ask your doctor whether you may drive or operate machines.

Doneloxon contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablets, that is to say essentially ‘sodium-free’.

3

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Doneloxon is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours.

Unless otherwise prescribed by your doctor, the usual dose is: To treat pain

Adults

The usual starting dose is 10 mg oxycodone hydrochloride/5 mg naloxone hydrochloride as prolonged-release tablet(s) every 12 hours.

Your doctor will decide how much Doneloxon you should take every day and how to divide your total daily dose into morning and evening doses. Your doctor will also decide on any necessary dose adjustments during treatment. Your dose will be adjusted according to your level of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you have already been treated with opioids, Doneloxon treatment can be started at a higher dose.

The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone hydrochloride without naloxone hydrochloride. However, 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 switched from Doneloxon to another strong opioid pain medication you have to anticipate, that your bowel function will probably worsen.

If you experience pain between two doses of Doneloxon, you probably may need a rapid-acting painkiller. Doneloxon is not suitable for this. In this case, please talk to your doctor.

If you have the impression that the effect of Doneloxon is too strong or too weak, please talk to your doctor or pharmacist.

To treat restless legs syndrome Adults

The usual starting dose is 5 mg oxycodone hydrochloride/2­.5 mg naloxone hydrochloride as prolonged- release tablet(s) every 12 hours.

Your doctor will decide how much Doneloxon you should take every day and how to divide your total daily dose into morning and evening doses. He/she will also decide on any necessary

dose adjustments during treatment. Your dose will be adjusted according to you individual sensitivity. You should be given the lowest dose needed to relieve your restless legs syndrome symptoms. Continued on the next page >> If you feel that these tablets are too strong or too weak, please talk to your doctor or pharmacist.

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

To treat pain or restless legs syndrome

For doses not realizable/prac­ticable with this strength, other strengths of this medicine are available.

Elderly patients

In general, no dose adjustment is necessary for older patients with normal kidney and/or liver function.

Liver or kidney problems

If you have an impairment of your kidney function or a mild impairment of your liver function, your attending doctor will prescribe Doneloxon with special caution. If you have a moderate or severe impairment of liver function, Doneloxon must not be used (see also section 2 “Do not take Doneloxon” and “Warnings and precautions”).

Method of administration

Oral use.

• You should take Doneloxon with a glass of water.
• Doneloxon 5 mg/2.5 mg:

The tablet must be swallowed whole and not divided, broken, chewed or crushed.

• Doneloxon 10 mg/5 mg, 20 mg/10 mg or 40 mg/20 mg: The tablet can be divided into equal doses. The tablet must not be broken, chewed or crushed.
• You can take the prolonged-release tablets with or without food.

Take Doneloxon every 12 hours, according to a fixed time schedule (e.g. at 8 o’clock in the morning and 8 o’clock in the evening).

Peel-off blisters:

How to remove the tablets from the child-resistant blister

The tablets are packaged in a child-resistant perforated unit doseblister.

Do not push the tablets through the blister foil.

Remove the tablets as follows:

• 1. Buckle the blister along the perforation line back and forth.

• 2. Separate one cell from the blister at the perforation lines.

• 3. Peel off the foil slowly starting at the marked corner to open the pocket.

Remove the tablet.

Push through blister packs:

How to remove the tablets from the child-resistant blister

The tablets are packed in a child-resistant perforated unit dose blister.

To remove a tablet, press the tablet through the reinforced blister foil.

Duration of use

In general, you should not take Doneloxon for any longer than you need to. If you are on long-term treatment with Doneloxon, your doctor should regularly check whether you still need Doneloxon.

If taken over the long term, you may become tolerant to these tablets. This means you may need a higher dose to achieve the desired effect. Also, long-term use may lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too suddenly (restlessness, bouts of sweating, muscle pain). If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.

If you take more Doneloxon than you should

If you have taken more than the prescribed dose of Doneloxon you must inform your doctor immediately.

An overdose may result in:

• narrowed pupils,
• slow and shallow breathing (respiratory depression),
• drowsiness up to loss of consciousness),
• low muscle tone (hypotonia),
• reduced pulse rate, and
• a drop in blood pressure.

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

You should avoid situations which require a high level of alertness, e.g. driving.

If you forget to take Doneloxon

If you forget to take Doneloxon or if you take a dose lower than the one prescribed, you may not feel any painkilling effect.

If you should forget to take your dose, please follow the instructions below:

• If your next usual dose is due in 8 hours or more: take the forgotten dose immediately and continue with your normal dosing schedule.
• If your next usual dose is due within less than 8 hours: take the forgotten dose. Then, wait another 8 hours before taking your next dose. Try to get back on track with your original dosing schedule (e.g. 8 o’clock in the morning and 8 o’clock in the evening). Do not take more than one dose within any 8-hour period.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Doneloxon

Do not stop your treatment with Doneloxon without consulting your doctor.

If you do not require any further treatment, you must reduce the daily dose gradually after talking to your doctor. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating and muscle pain.

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

4

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

Important side effects to look out for, and what to do if you are affected

If you are affected by any of the following important side effects, consult your nearest doctor immediately.

Slow and shallow breathing (respiratory depression) is the main danger of an opioid overdose. It mostly occurs in elderly and debilitated (weak) patients. Opioids can also cause a severe drop in blood pressure in susceptible patients.

The following side effects were observed in patients being treated for pain:

Common (may affect up to 1 in 10 people)

• decreased appetite up to loss of appetite
• difficulty in sleeping, tiredness or debility
• a feeling of dizziness or ‘spinning’, headache, drowsiness
• hot flushes
• abdominal pain, constipation, diarrhoea, dry mouth, indigestion, being sick, feeling sick, wind
• itchy skin, skin reactions, increased sweating
• feeling of unusual weakness

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity/ allergic reactions
• restlessness, abnormal thoughts, anxiety, confusion, depression, nervousness
• reduced sexual drive
• epileptic seizures (especially in persons with epileptic disorder or predisposition to seizures), difficulties to concentrate, altered taste, speech disorder, fainting, shaking, lack of energy
• vision impairment
• chest tightness especially if you already have coronary heart disease, palpitations
• drop in blood pressure, rise in blood pressure
• difficulties of breathing, runny nose, cough
• abdominal bloating
• hepatic enzymes increased, biliary colic
• muscle cramps, muscle twitches, muscle pain
• increased urge to urinate
• withdrawal symptoms such as agitation
• chest pain
• chills, generally feeling unwell, pain, thirst
• swelling of hands, ankles or feet
• weight loss
• injuries from accidents

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

• increase in pulse rate
• drug dependence
• yawning
• dental changes
• weight gain

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

• euphoric mood, hallucinations, nightmares, aggression
• pins and needles, severe drowsiness
• shallow breathing
• belching
• difficulties in passing urine
• erectile dysfunction

The active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, is known to have the following differing side effects:

Oxycodone can cause breathing problems (respiratory depression), reduction in size of the pupil in the eye, cramping of the bronchial muscles and cramping of the smooth muscles, as well as depression of the cough reflex.

Common (may affect up to 1 in 10 people)

• altered mood and personality changes (e.g. depression, feeling of extreme happiness), decreased activity, increased activity
• hiccups
• difficulty in passing urine

Uncommon (may affect up to 1 in 100 people)

• dehydration
• agitation, perception disturbances (e.g. hallucination, derealisation)
• impaired concentration, migraines, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, abnormal coordination
• difficulties in hearing
• widening of the blood vessels
• vocal changes (dysphonia)
• difficulties in swallowing
• a condition where the bowel stops working properly (ileus)
• mouth ulcers, sore gums
• dry skin
• a decrease in the concentration of sex hormones, which may affect sperm production in men or the menstrual cycle in women
• swelling due to water retention, drug tolerance

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

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

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

• acute generalised allergic reactions (anaphylactic reactions)
• increased pain sensitivity
• tooth decay
• problems with bile flow
• absence of menstrual periods
• withdrawal symptoms in the newborn

The following side effects have been observed in patients being treated for restless legs syndrome:

Very common (may affect more than 1 in 10 people)

• headache, drowsiness
• constipation, feeling sick
• sweating
• tiredness or exhaustion

Common (may affect up to 1 in 10 people)

• decreased appetite up to loss of appetite
• insomnia, depression
• dizziness, attention deficit disorder, (muscle-) tremor, pins and needles
• visual disturbances
• a feeling of dizziness or ‘spinning’
• hot flushes
• drop in blood pressure
• rise in blood pressure
• abdominal pain, dry mouth, vomiting
• increase in hepatic enzymes (alanine aminotransferase or gamma-glutamyltransfe­rase)
• itchy skin, skin reactions/rash
• pain in the chest, chills, thirst, pain

Uncommon (may affect up to 1 in 100 people)

• decrease in sexual drive, suddenly occurring sleep attacks
• taste disturbances
• respiratory distress
• wind
• erectile dysfunction
• withdrawal symptoms such as agitation
• swelling due to water retention (e.g. hands, ankles or feet)
• injuries due to accidents

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

• hypersensitivi­ty/allergic reactions
• abnormal thoughts, anxiety, aggression, drug dependence, confusion, nervousness, restlessness, feeling of extreme happiness, hallucinations, nightmares
• fits/seizures (especially in persons with epileptic fits or predisposition to seizures)
• severe drowsiness
• impaired speaking
• fainting
• lack of energy
• painful chest tightness (angina pectoris) especially if you already have coronary heart disease, palpitations, increase in pulse rate
• cough, running nose, shallow and slowed breathing (respiratory depression), yawning
• bloated stomach, diarrhoea, indigestion, belching, dental changes
• biliary colic
• muscle cramps, muscle tics, muscle pain
• urge to urinate, difficulties in passing urine
• generally feeling unwell
• a feeling of unusual weakness
• weight gain, weight decrease

5

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, bottle or blister after EXP. The expiry date refers to the last day of that month.

Blister:

Do not store above 25°C.

Bottles:

Do not store above 30 °C.

Shelf life after first opening: 3 months.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Doneloxon contains

The active substances are oxycodone hydrochloride and naloxone hydrochloride.

Doneloxon 5 mg/2.5 mg:

Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg oxycodone) and 2.5 mg of naloxone hydrochloride (as 2.74 mg naloxone hydrochloride dihydrate, equivalent to 2.25 mg naloxone).

The other ingredients are:

Tablet core

Polyvinyl acetate, Povidone, Sodium laurilsulfate, Silica, colloidal anhydrous Cellulose, microcrystalline, Magnesium stearate

Tablet coating

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc

Doneloxon 10 mg/5 mg:

Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9mg oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg naloxone hydrochloride dihydrate, equivalent to 4.5 mg naloxone).

The other ingredients are:

Tablet core

Polyvinyl acetate, Povidone, Sodium laurilsulfate, Silica, colloidal anhydrous, Cellulose, microcrystalline, Magnesium stearate

Tablet coating

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide red (E172)

Doneloxon 20 mg/10 mg:

Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18mg oxycodone) and 10 mg of naloxone hydrochloride (as 10.9 mg naloxone hydrochloride dihydrate, equivalent to 9 mg naloxone).

The other ingredients are:

Tablet core

Polyvinyl acetate, Povidone, Sodium laurilsulfate, Silica, colloidal anhydrous, Cellulose, microcrystalline, Magnesium stearate

Tablet coating

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc

Doneloxon 40 mg/20 mg:

Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36mg oxycodone) and 20 mg of naloxone hydrochloride (as 21.8 mg naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone).

The other ingredients are:

Tablet core

Polyvinyl acetate, Povidone, Sodium laurilsulfate,

Silica, colloidal anhydrous, Cellulose, microcrystalline, Magnesium stearate

Tablet coating

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide red (E172)

What Doneloxon looks like and contents of the pack

White, round, biconvex prolonged-release tablet with a diameter of 4.7 mm and a height of 2.9 – 3.9 mm.

Doneloxon 10 mg/5 mg

Pink, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of

10.2 mm, a width of 4.7 mm and a height of 3.0 – 4.0 mm. The tablet can be divided into equal doses.

Doneloxon 20 mg/10 mg

White, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of 11.2 mm, a width of 5.2 mm and a height of 3.3 – 4.3 mm. The tablet can be divided into equal doses.

Doneloxon 40 mg/20 mg

Pink, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of

14.2 mm, a width of 6.7 mm and a height of 3.6 – 4.6 mm. The tablet can be divided into equal doses.

Doneloxon is available in child resistant perforated unit dose peel-off blister or push through blister of 10×1 (hospital pack), 14×1, 20×1, 28×1, 30×1, 50×1, 56×1, 60×1, 98×1 and 100×1 prolonged-released tablets or child resistant blister of 28, 56 and 84 prolonged-released tablets or bottles with child-resistant screw cap containing 50 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer(s)

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or

Develco Pharma GmbH, Grienmatt 27, D-79650 Schopfheim, Germany

This leaflet was last revised in 04/2021

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