5 mg / 2.5 mg, 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg, 40 mg / 20 mg prolonged-release tablet is
oxycodone hydrochloride / naloxone hydrochloride
What Oxycodone / Naloxone Sandoz is and what it is used for
Oxycodone / Naloxone Sandoz is a prolonged-release tablet, which means that its active substances are released for a longer period. Its effect lasts for 12 hours.
These tablets are for adults only.
Pain relief
You have been prescribed Oxycodone / Naloxone Sandoz for the treatment of severe pain that can only be relieved by strong painkillers ( opioids ). Naloxone hydrochloride is added to counteract constipation.
How these tablets work in pain relief
Oxycodone / Naloxone Sandoz contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the analgesic effect of Oxycodone / Naloxone Sandoz and is a potent analgesic (“analgesic”) in the opioid group.
The other active substance in Oxycodone / Naloxone Sandoz, naloxone hydrochloride, is intended to counteract constipation. Intestinal disorders (eg constipation) are a typical side effect of treatment with opioid analgesics.
Oxycodone hydrochloride and naloxone hydrochloride contained in Oxycodone / Naloxone Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionalsOxycodone / Naloxone Sandoz is a prolonged-release tablet , which means that its active substances are released for a longer period of time. Its effect lasts for 12 hours
if you have any further questions, and always follow their instructions.
What you need to know before taking Oxycodone / Naloxone Sandoz
Do not take Oxycodone / Naloxone Sandoz
- 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, e.g. that you breathe slower or weaker than expected ( respiratory depression )
- if you suffer from severe chronic lung disease associated with narrowing of the airways ( chronic obstructive pulmonary disease or COPD)
- if you suffer from a disease called cor pulmonale; in this disease, the right side of the heart becomes enlarged due to an 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 intestinal obstruction) that has not been caused by opioids
- if you have moderate to severe hepatic impairment.
Warnings and cautions
Talk to your doctor or pharmacist before taking Oxycodone / Naloxone Sandoz
- in the treatment of elderly patients or debilitated (powerless) patients
- if you have paralytic ileus (a type of intestinal obstruction) that has been caused by opioids
- if you have impaired kidney function
- if you have mild hepatic impairment
- if you have severe lung function (ie reduced respiratory capacity)
- if you suffer from a condition characterized by frequent pauses in breathing during the night that can make you feel very sleepy during the day ( sleep apnea )
- if you have myxedema (a thyroid disease with dry, cold, and swollen skin that affects the face, arms, and legs)
- if your thyroid gland does not produce enough hormones (underactive thyroid gland or hypothyroidism )
- if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison’s disease )
- if you have a mental illness that is 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 ( 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 ( 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 seizures
- if you are also taking MAOIs (used to treat depression, Parkinson’s disease, or bacterial infections ), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid
- if drowsiness or episodes of sudden drowsiness occur
You should tell your doctor if you have ever had any of the above. Also, tell your doctor if any of the above conditions occur while you are taking Oxycodone / Naloxone Sandoz.
The most serious risk of opioid overdose is respiratory depression (slow and shallow breathing). This can also lead to the oxygen levels in the blood falling, which in turn can lead to fainting etc.
Tell your doctor if you have cancer with peritoneal metastases or incipient bowel movements in advanced stages of gastrointestinal or pelvic cancer.
If you experience severe diarrhea at the beginning of treatment, this may be due to the effect of naloxone. This 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 worrying.
If you have used another opioid, withdrawal symptoms may appear initially when you switch to Oxycodone / Naloxone Sandoz treatment, e.g. restlessness, sweating, and muscle pain. If you experience such symptoms, you may need to be specially monitored by your doctor.
Like other opioids, oxycodone can affect your body’s normal production of hormones, such as cortisol or sex hormones, especially if you have been taking high doses for a long time. If you experience persistent symptoms, such as being or feeling sick or nauseous (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 like Examine your hormone levels.
Operation
If you have to have surgery, tell your doctor that you are taking Oxycodone / Naloxone Sandoz.
Long-term use
When used for a long time, you may develop tolerance to Oxycodone / Naloxone Sandoz. This means that you may need a higher dose to achieve the desired effect. Prolonged use of Oxycodone / Naloxone Sandoz can also lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too quickly (restlessness, sweating, muscle aches). If you no longer need treatment, reduce your daily dose gradually, in consultation with your doctor.
Mentally addicted
The active substance oxycodone hydrochloride alone has the same abuse profile as other strong opioids (strong painkillers). There is a risk of developing mental dependence. Medicines containing oxycodone hydrochloride should be avoided in patients who have previously abused alcohol, drugs, or medicines.
Improper use of Oxycodone / Naloxone Sandoz
Oxycodone / Naloxone Sandoz is not suitable for the treatment of withdrawal symptoms.
Oxycodone / Naloxone Sandoz 5 mg / 2.5 mg
The tablets should be swallowed whole. You must not split, break, chew or crush the tablets.
If the tablets are split, broken, chewed, or crushed, this may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you have taken too much Oxycodone / Naloxone Sandoz”).
Oxycodone / Naloxone Sandoz 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg, 40 mg / 20 mg
You must not break, chew or crush the tablets. However, the tablet can be divided into two equal doses (see section 3 “Method of administration”).
If the tablets are broken, chewed, or crushed, this may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you have taken too much Oxycodone / Naloxone Sandoz”).
Oxycodone / Naloxone Sandoz 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 are likely to experience severe withdrawal symptoms if you abuse Oxycodone / Naloxone Sandoz because it contains the active substance naloxone. Pre-existing withdrawal symptoms may worsen.
You must never abuse these prolonged-release tablets by dissolving and injecting them (eg into a blood vessel). The tablets contain talc which can lead to local tissue destruction ( necrosis ) and changes in the lung tissue (lung granuloma). Such abuse can also have other serious consequences and can even be fatal.
You may notice remnants of the prolonged-release tablets in your stool. Do not worry about this. The active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and intestines and absorbed into the body.
Children and young people
Some studies of Oxycodone / Naloxone Sandoz in children and adolescents under 18 years of age have not yet been performed. Its safety and efficacy have not yet been proven in children and adolescents. For this reason, the use of Oxycodone / Naloxone Sandoz is not recommended for children and adolescents under 18 years of age.
Other medicines and Oxycodone / Naloxone Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Oxycodone / Naloxone Sandoz with sedatives or sleeping pills such as benzodiazepines or similar medicines (medicines that affect brain function, see below) increases the risk of drowsiness, difficulty breathing ( breathing depression ), and coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
If your doctor still prescribes Oxycodone / Naloxone Sandoz at the same time as sedatives, the dose and treatment time should be limited by your doctor. Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Drugs that affect brain function are, for example:
- other potent painkillers ( opioids )
- hypnotics and sedatives (sedatives such as benzodiazepines, hypnotics, anxiolytics )
- drugs to treat depression
- medicines used to treat allergies, motion sickness, or nausea ( antihistamines, antiemetics)
- medicines to treat mental or mental illness (phenothiazines, neuroleptics, antipsychotics)
The risk of side effects is increased if you take antidepressant drugs (for example, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine ). These drugs can affect or be affected by oxycodone, and you may experience symptoms such as involuntary, rhythmic muscle contractions, including in the muscles that control eye movements, sudden movements, heavy sweating, tremors, excessive reflexive movements, increased muscle tension, body temperature above 38 ° C. Contact your doctor if you experience these symptoms.
If you are taking Oxycodone / Naloxone Sandoz while taking other medicines, the effect of Oxycodone / Naloxone Sandoz or the other medicine may change. Tell your doctor if you are taking:
- drugs that reduce the blood’s ability to coagulate (coumarin derivatives); the coagulation time can be increased or decreased
- macrolide antibiotics (eg clarithromycin, erythromycin, or telithromycin)
- azole antifungals (eg ketoconazole , voriconazole, itraconazole or posaconazole)
- a specific type of medicine called a protease inhibitor (used to treat HIV ) (eg ritonavir, indinavir, nelfinavir, or saquinavir)
- cimetidine (a medicine for stomach ulcers, indigestion, or heartburn)
- rifampicin (used to treat tuberculosis )
- carbamazepine (used to treat convulsions or convulsions and certain pain conditions)
- phenytoin (used to treat seizures or convulsions)
- a (traditional) herbal medicine for the treatment of depression called St. John’s wort (also known as Hypericum perforatum)
- quinidine (a drug used to treat irregular heartbeat).
Oxycodone / Naloxone Sandoz with food, drink, and alcohol
If you drink alcohol while taking Oxycodone / Naloxone Sandoz, 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. It is recommended not to drink alcohol while taking Oxycodone / Naloxone Sandoz.
You should avoid drinking grapefruit juice while taking Oxycodone / Naloxone Sandoz.
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 taking this medicine.
Pregnancy
The use of Oxycodone / Naloxone Sandoz should be avoided as much as possible during pregnancy. When used for a long time during pregnancy, oxycodone hydrochloride may lead to withdrawal symptoms in the newborn. If oxycodone hydrochloride is given during delivery, the newborn baby may develop respiratory depression (slow and shallow breathing).
Breast-feeding
Stop breastfeeding during treatment with Oxycodone / Naloxone Sandoz. Oxycodone hydrochloride passes into breast milk. It is not known if naloxone hydrochloride also passes into breast milk. The risk to the breast-fed baby can not be ruled out, especially after taking repeated doses of Oxycodone / Naloxone Sandoz in the breast-feeding mother.
Driving and using machines
Oxycodone / Naloxone Sandoz may affect your ability to drive or use machines. This is especially true at the beginning of Oxycodone / Naloxone Sandoz treatment, after a dose increase, or after switching from another medicine. However, these side effects disappear as soon as you are on a stable dose of Oxycodone / Naloxone Sandoz.
Oxycodone / Naloxone Sandoz has been associated with drowsiness and episodes of sudden drowsiness. If you experience these side effects, do not drive or use machines. You should tell your doctor if these side effects occur.
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 sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oxycodone / Naloxone Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per prolonged-release tablet, ie it is essentially ‘sodium-free’.
How to take Oxycodone / Naloxone Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Oxycodone / Naloxone Sandoz is a prolonged-release tablet, which means that its active substances are released for a longer period. Its effect lasts for 12 hours.
The usual dose, unless your doctor prescribes 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 Oxycodone / Naloxone Sandoz to take each day and how to divide the total daily dose into morning and evening doses. The doctor also decides if any dose adjustment needs to be made during treatment. Your dose will be adjusted depending on the degree of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you are already being treated with opioids, treatment with Oxycodone / Naloxone Sandoz may start at a higher dose.
The highest 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. The maximum daily dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal activity may be affected if additional oxycodone hydrochloride is given without additional naloxone hydrochloride.
If you are allowed to switch Oxycodone / Naloxone Sandoz to another strong opioid, your bowel function will probably deteriorate.
If you experience pain between two doses of Oxycodone / Naloxone Sandoz, you may need to take a fast-acting painkiller. Oxycodone / Naloxone Sandoz is not suitable for this. Talk to your doctor in such a case.
If you have the impression that the effect of Oxycodone / Naloxone Sandoz is too strong or too weak, talk to your doctor or pharmacist.
For doses that are not achievable/practical with this strength, other strengths of this medicine are available.
Elderly patients
In general, no dose adjustment is required for elderly patients with normal renal and/or hepatic function.
Hepatic or renal impairment
If you suffer from renal impairment or mild hepatic impairment, your doctor will prescribe Oxycodone / Naloxone Sandoz with special caution. If you have a moderate or severe hepatic impairment, do not use Oxycodone / Naloxone Sandoz (see also section 2 “Do not take Oxycodone / Naloxone Sandoz” and “Warnings and precautions”).
Method of administration
Taken by mouth.
- Swallow Oxycodone / Naloxone Sandoz with a glass of water.
- Oxycodone / Naloxone Sandoz 5 mg / 2.5 mg: The tablets must be swallowed whole and must not be split, broken, chewed, or crushed.
- Oxycodone / Naloxone Sandoz 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg, 40 mg / 20 mg:The tablet can be divided into two equal doses . You must not break, chew or crush the tablets.
- The prolonged-release tablets can be taken with or without food. Take Oxycodone / Naloxone Sandoz every 12 hours according to a fixed schedule (eg 8 am and 8 pm).
There are two different types of blister packs:
Blister packs with pull-back
How to remove the tablets from the child-resistant blister pack
The tablets are packaged in a child-resistant perforated single-dose blister.
Do not push the tablets through the blister foil.
To remove the tablets, proceed as follows:
1. Bend the blister back and forth along the perforated line.
2. Separate a cell from the blister pack at the perforated lines.
3. Slowly pull off the foil to open the pocket. Start in the highlighted corner.
Take out the tablet.
Blister packs in which the tablet is pressed:
How to remove the tablets from the child-resistant blister pack
The tablets are packaged in a child-resistant perforated single-dose blister.
To remove a tablet, push the tablet out through the reinforced blister.
Treatment time
In general, do not take Oxycodone / Naloxone Sandoz for longer than you need. If you are on long-term treatment with Oxycodone / Naloxone Sandoz, your doctor should regularly check if you still need Oxycodone / Naloxone Sandoz.
If you take more Oxycodone / Naloxone Sandoz then you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. If you take more than the prescribed dose of Oxycodone / Naloxone Sandoz, you must tell your doctor immediately.
An overdose can lead to:
- pupil reduction
- slow and shallow breathing ( respiratory depression )
- drowsiness to unconsciousness
- low muscle tone ( hypotension )
- 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.
If you forget to take Oxycodone / Naloxone Sandoz
If you forget to take Oxycodone / Naloxone Sandoz or if you take a dose lower than the prescribed dose, you may not experience any effect.
If you forgot to take your dose, follow the instructions below:
- 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 once. Then wait another 8 hours before taking the next dose. Try to get back to your original dosing schedule (eg at 8 in the morning and at 20 in the evening). Do not take more than one dose within 8 hours.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Oxycodone / Naloxone Sandoz
Do not stop taking Oxycodone / Naloxone Sandoz without consulting your doctor.
If you do not need any further treatment, you must reduce the daily dose gradually after talking to your doctor. This way you can avoid withdrawal symptoms, such as restlessness, sweating attacks, and muscle pain.
If you have any further questions on the use of this product, ask 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 that you should watch out for and what to do if you are affected
If you have any of the following important side effects, talk to your healthcare provider immediately.
Slow and shallow breathing ( respiratory depression ) is the most dangerous with an overdose of opioids. This mainly affects elderly and debilitated (powerless) patients. Opioids can also lead to a severe drop in blood pressure in sensitive patients.
The following side effects have been seen in patients being treated for pain:
Common (may affect up to 1 in 10 people)
- decreased appetite to a loss of appetite
- difficulty sleeping, fatigue, or exhaustion
- a feeling of dizziness or that it “spins”, headache, drowsiness
- hot flashes
- abdominal pain, constipation, diarrhea, dry mouth, indigestion, vomiting, nausea, flatulence
- itchy skin, skin reactions, increased sweating
- unusual feeling of weakness.
Uncommon (may affect up to 1 in 100 people)
- hypersensitivity / allergic reactions
- restlessness, abnormal thoughts, anxiety, confusion, depression, nervousness
- decreased sexual drive
- epileptic seizures (especially in people with epilepsy or predisposition to seizures), difficulty concentrating, changes in taste, impaired speech, fainting, tremors, lack of energy
- visual impairment
- tight in the chest, especially if you already suffer from coronary heart disease, palpitations
- drop in blood pressure, increase in blood pressure
- difficulty breathing, runny nose, cough
- inflated stomach
- elevated liver values, biliary colic
- muscle cramps, muscle twitching, muscle pain
- increased need to urinate
- withdrawal symptoms, such as agitation
- chest pain
- chills, general malaise, pain, thirst
- swollen hands, ankles, or feet
- weight loss
- injuries due to accidents.
Rare (may affect up to 1 in 1,000 people)
- increased heart rate
- drug addiction
- yawning
- tooth changes
- weight gain.
Has been reported (occurs in an unknown number of users)
- euphoria, hallucinations, nightmares, aggression
- tingling in the skin, severe drowsiness
- shallow breathing
- burp
- difficulty urinating
- erectile dysfunction.
The active substance oxycodone hydrochloride is known to have the following adverse side effects when not combined with naloxone hydrochloride:
Oxycodone can cause respiratory problems ( respiratory depression ), pupillary reductions, bronchial muscle cramps, smooth muscle cramps, as well as inhibited cough reflex.
Common (may affect up to 1 in 10 people)
- mood and personality changes (eg depression, feeling of extreme joy), decreased activity, increased activity
- hiccup
- difficulty urinating.
Uncommon (may affect up to 1 in 100 people)
- dehydration
- upset, perception disorders (eg hallucinations, feeling unreal)
- concentration disorder, migraine, increased muscle tension, involuntary muscle contractions, decreased sensitivity to pain or touch, abnormal coordination
- hearing loss
- dilated blood vessels ( vasodilation )
- voice changes ( dysphonia )
- difficulty swallowing
- intestinal obstruction ( ileus )
- cold sores, sore gums
- dry skin
- a decrease in sex hormone levels that can 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)
- infection is such as cold sores or herpes (which can cause blisters around the mouth or genital areas)
- increased appetite
- black (tarry) stools, bleeding gums
- hives ( urticaria ).
Has been reported (occurs in an unknown number of users)
- acute generalized allergic reactions (anaphylactic reactions)
- increased pain sensitivity
- caries
- problems with bile flow
- lack of menstrual periods
- withdrawal symptoms in newborns
How to store Oxycodone / Naloxone Sandoz
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, jar, or blister after EXP. or EXP. The expiration date is the last day of the specified month.
Blister:
Do not store above 25 ° C.
Can:
Do not store above 30 ° C.
Shelf life after first opening: 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone / Naloxone Sandoz 5 mg / 2.5 mg:
One prolonged-release tablet contains 5 mg oxycodone hydrochloride (equivalent to 4.5 mg
oxycodone) and 2.5 mg naloxone hydrochloride (as 2.74 mg naloxone hydrochloride dihydrate,
corresponding to 2.25 mg naloxone).
Oxycodone / Naloxone Sandoz 10 mg / 5 mg:
One prolonged-release tablet contains 10 mg oxycodone hydrochloride (equivalent to 9 mg
oxycodone) and 5 mg naloxone hydrochloride (as 5.45 mg naloxone hydrochloride dihydrate,
corresponding to 4.5 mg naloxone).
Oxycodone / Naloxone Sandoz 20 mg / 10 mg: One prolonged-release tablet contains 20 mg oxycodone hydrochloride (equivalent to 18 mg oxycodone) and 10 mg naloxone hydrochloride (as 10.9 mg naloxone hydrochloride dihydrate, equivalent to 9 mg naloxone).
Oxycodone / Naloxone Sandoz 30 mg / 15 mg:
One prolonged-release tablet contains 30 mg oxycodone hydrochloride (equivalent to 27 mg oxycodone) and 15 mg naloxone hydrochloride (as 16.35 mg naloxone hydrochloride dihydrate, equivalent to 13.5 mg naloxone).
Oxycodone / Naloxone Sandoz 40 mg / 20 mg: One prolonged-release tablet contains 40 mg oxycodone hydrochloride (equivalent to 36 mg oxycodone) and 20 mg naloxone hydrochloride (as 21.8 mg naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone).
Other ingredients are:
Tablet core: polyvinyl acetate, povidone, sodium lauryl sulfate, colloidal anhydrous silica, microcrystalline cellulose, and magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350 and talc.
10 mg / 5 mg and 40 mg / 20 mg prolonged-release tablets also contain: red iron oxide (E172).
30 mg / 15 mg prolonged-release tablets also contain: yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Oxycodone / Naloxone Sandoz 5 mg / 2.5 mg
White, round, biconvex prolonged-release tablet with a diameter of 4.7 mm and a height of 2.9-3.9 mm.
Oxycodone / Naloxone Sandoz 10 mg / 5 mg
Pink, oblong, biconvex prolonged-release tablet with incision grooves on both sides and 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.
Oxycodone / Naloxone Sandoz 20 mg / 10 mg
White, oblong, biconvex prolonged-release tablet with incisions on both sides and 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.
Oxycodone / Naloxone Sandoz 30 mg / 15 mg
Yellow, oblong, biconvex prolonged-release tablet with dividing grooves into both sides and with a length of 12.2 mm, a width of 5.7 mm, and a height of 3.3-4.3 mm. The tablet can be divided into equal doses.
Oxycodone / Naloxone Sandoz 40 mg / 20 mg
Pink, oblong, biconvex prolonged-release tablet with incisions on both sides and 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.
Oxycodone / Naloxone Sandoz is supplied in child-resistant perforated single-dose blisters with a removable back or pressure blisters of 10×1 (hospital packaging), 14×1, 20×1, 28×1, 30×1, 50×1, 56×1, 60×1, 98×1 and 100×1 prolonged-release tablets or in child-resistant blueprints 56 and 56 is or in a jar with a child-resistant screw cap of 50 or 100 prolonged-release tablets .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S Denmark
Manufacturer
Develco Pharma GmbH, Grienmatt 27, Baden-Wuerttemberg 79650 Schopfheim, Germany
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Saxony-Anhalt, 39179 Barleben, Germany