5 mg / 2.5, 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg and 40 mg / 20 mg prolonged-release tablets are
oxycodone hydrochloride / naloxone hydrochloride
What Oxycodone / Naloxone Teva is and what it is used for
Oxycodone / Naloxone Teva 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.
You have been prescribed Oxycodone / Naloxone Teva for the treatment of severe pain that can only be relieved by strong painkillers ( opioids ). Naloxone hydrochloride is added to counteract constipation.
How Oxycodone / Naloxone Teva works
Oxycodone / Naloxone Teva contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the analgesic effect of Oxycodone / Naloxone Teva and is a potent analgesic (“analgesic”) belonging to the group of opioids.
The other active substance in Oxycodone / Naloxone Teva, naloxone hydrochloride, is intended to counteract constipation. Intestinal disorders (eg constipation) are a typical side effect of treatment with opioid analgesics.
Oxycodone hydrochloride/naloxone hydrochloride contained in Oxycodone / Naloxone Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Oxycodone / Naloxone Teva
Do not take Oxycodone / Naloxone Teva:
- 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 can not 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 airway constriction (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 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 Teva:
- if you are elderly or debilitated (powerless),
- if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
- if you have impaired kidney function,
- if you have a mild hepatic impairment,
- if you have severe lung function (ie reduced breathing),
- if you suffer from a condition characterized by frequent shortness of breath 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 and legs),
- if your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism ),
- if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison’s disease ),
- if you have a mental 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 or Parkinson’s disease ), or if you have taken this type of medicine in the last two weeks, e.g. drugs containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
- if drowsiness or episodes of sudden drowsiness occur.
This medicine can cause breathing problems while you sleep. These problems may include pauses in breathing during sleep, awakenings due to shortness of breath, difficulty maintaining sleep, or excessive drowsiness during the day. If you or anyone else observes these symptoms, consult a doctor. Your doctor may reduce your dose one.
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 Teva.
The most serious risk of opioid overdose is respiratory depression (slow and shallow breathing). This can also lead to a drop in oxygen levels in the blood, which in turn can lead to fainting, etc.
Diarrhea
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.
Switch to Oxycodone / Naloxone Teva
If you have used another opioid, withdrawal symptoms may appear initially when you switch to Oxycodone / Naloxone Teva treatment, e.g. restlessness, sweating, and muscle pain. If you experience such symptoms, you may need to be specially monitored by your doctor.
Long-term use
When used for a long time, you may develop tolerance to Oxycodone / Naloxone Teva. This means that you may need a higher dose to achieve the desired effect. Prolonged use of Oxycodone / Naloxone Teva 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 your daily dose gradually, in consultation with your doctor.
Mentally addicted
The active substance oxycodone hydrochloride 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 abuse or have previously abused alcohol, drugs, or medicines.
Advanced cancer of the gastrointestinal tract or pelvis
Tell your doctor if you have cancer with peritoneal metastases or incipient bowel movements in advanced stages of gastrointestinal or pelvic cancer.
Operation
If you are going to have surgery, you must tell your doctor that you are taking Oxycodone / Naloxone Teva.
Effect on hormone production
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.
Pain sensitivity
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.
Tablet residues in the stool
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.
Improper use of Oxycodone / Naloxone Teva
Oxycodone / Naloxone Teva is not suitable for the treatment of abstinence.
Oxycodone / Naloxone Teva 5 mg / 2.5 mg:
The prolonged-release tablets must be swallowed whole and must not be split, broken, chewed, or crushed. If the prolonged-release 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 Teva”).
Oxycodone / Naloxone Teva 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg, 40 mg / 20 mg:
The prolonged-release tablets can be divided into two equal doses but must not be chewed or crushed.
Ingestion of chewed or crushed tablets may result in absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 “If you have taken too much Oxycodone / Naloxone Teva”).
Abuse
Oxycodone / Naloxone Teva 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 suffer from severe withdrawal symptoms if you abuse Oxycodone / Naloxone Teva as it contains the ingredient naloxone hydrochloride. Pre-existing withdrawal symptoms may worsen.
Misuse
You must never abuse Oxycodone / Naloxone Teva 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.
Other medicines and Oxycodone / Naloxone Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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.
Concomitant use of opioids, including oxycodone hydrochloride, and sedatives for sleep disorders, such as benzodiazepines or similar drugs, increases the risk of drowsiness, difficulty breathing ( breathing depression ), 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 prescribes Oxycodone / Naloxone Teva together with 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 recommendation. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms listed above. Contact a doctor when you experience such symptoms. Examples of these sedatives or similar drugs are:
- other potent analgesics ( opioids );
- medicines for epilepsy, pain, and anxiety e.g. gabapentin and pregabalin,
- hypnotics and sedatives ( sedatives including benzodiazepines, hypnotics , anxiolytics )
- medicines to treat depression,
- medicines used to treat allergies, motion sickness or nausea ( antihistamines or antiemetics),
- drugs for the treatment of mental or mental illness (antipsychotics that include phenothiazines and neuroleptics ).
If you take this medicine while you are taking any of the medicines listed below, the effect may be affected. 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-type medicines for fungal infections (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 called St. John’s wort (also known as Hypericum perforatum ),
- quinidine (a drug used to treat irregular heartbeat).
No interaction is expected between Oxycodone / Naloxone Teva and paracetamol, acetylsalicylic acid, or naltrexone.
Oxycodone / Naloxone Teva with food, drink, and alcohol
If you drink alcohol while taking Oxycodone / Naloxone Teva, 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 Oxycodone / Naloxone Teva.
You should avoid drinking grapefruit juice while taking Oxycodone / Naloxone Teva.
Pregnancy, breastfeeding, and fertility
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 Teva should be avoided as much as possible during pregnancy unless your doctor considers that treatment with this medicine is necessary.
When used for a long time during pregnancy, oxycodone hydrochloride can 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 Teva. Oxycodone hydrochloride passes into breast milk. It is not known if naloxone hydrochloride also passes into breast milk. The risk to the breastfed child can therefore not be ruled out, especially after taking repeated doses of Oxycodone / Naloxone Teva in the breast-feeding mother.
Driving and using machines
Oxycodone / Naloxone Teva may affect your ability to drive or use machines as it may make you drowsy or dizzy. This is especially true at the beginning of Oxycodone / Naloxone Teva treatment, after a dose increase, or after switching from another medicine. However, these side effects should go away as soon as you are on a stable dose of Oxycodone / Naloxone Teva.
Oxycodone / Naloxone Teva 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 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 sharpened vigilance. 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 Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Oxycodone / Naloxone Teva
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Oxycodone / Naloxone Teva is a prolonged-release tablet, which means that its active substances are released for a longer period. Its effect lasts for 12 hours.
Oxycodone / Naloxone Teva 5 mg / 2.5 mg:
The prolonged-release tablets must be swallowed whole and must not be split, broken, chewed, or crushed. If the prolonged-release 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 Teva”).
Oxycodone / Naloxone Teva 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg, 40 mg / 20 mg:
The prolonged-release tablets can be divided into two equal doses but must not be chewed or crushed.
Ingestion of chewed or crushed tablets may result in absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 “If you have taken too much Oxycodone / Naloxone Teva”).
The usual dose , unless your doctor prescribes otherwise:
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 Teva 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 Teva 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. However, 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 Teva to another opioid, your bowel function will probably be impaired.
If you experience pain between two doses of Oxycodone / Naloxone Teva, you may need to take a fast-acting painkiller. Oxycodone / Naloxone Teva is not suitable for this. Talk to your doctor in such a case.
If you have the impression that the effect of Oxycodone / Naloxone Teva is too strong or too weak, talk to your doctor or pharmacist.
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 these tablets with special caution. If you have a moderate or severe hepatic impairment, do not use these tablets (see also section 2 “Do not take Oxycodone / Naloxone Teva” and “Warnings and precautions”).
Use for children and adolescents under 18 years
Some studies of Oxycodone / Naloxone Teva 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 Teva is not recommended for children and adolescents under 18 years of age.
Method of administration
Oxycodone / Naloxone Teva 5mg / 2.5mg tablets
The tablets should be swallowed. Swallow Oxycodone / Naloxone Teva with a sufficient amount of liquid (½ glass of water). The tablet must be swallowed whole and must not be split, broken, chewed, or crushed. The tablet can be taken with or without food.
Oxycodone / Naloxone Teva 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg, 40 mg / 20 mg
The tablets should be swallowed. Swallow Oxycodone / Naloxone Teva with a sufficient amount of liquid (½ glass of water). The tablet can be divided into two equal doses but must not be chewed or crushed. The tablet can be taken with or without food.
Take Oxycodone / Naloxone Teva every 12 hours according to a fixed schedule (eg 8 am and 8 pm).
Treatment time
In general, do not take Oxycodone / Naloxone Teva for longer than you need. If you are on long-term treatment with Oxycodone / Naloxone Teva, your doctor should regularly check if you still need Oxycodone / Naloxone Teva.
If you take more Oxycodone / Naloxone Teva 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 Teva, 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 Teva
If you forget to take Oxycodone / Naloxone Teva 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 prolonged-release tablet. 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 Teva
Do not stop taking Oxycodone / Naloxone Teva 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 are what 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 danger of an overdose of opioids. This mainly affects elderly and debilitated (powerless) patients. Opioids can also lead to the severe drop in blood pressure in sensitive patients.
Common (may affect up to 1 in 10 people)
- abdominal pain
- constipation
- diarrhea
- dry mouth
- indigestion
- vomiting
- nausea
- gas formation
- decreased appetite to loss of appetite
- a feeling of dizziness or that it “spins”
- headache
- hot flashes
- unusual feeling of weakness
- fatigue or exhaustion
- skin itching
- skin reactions / rashes
- sweating
- dizziness
- difficulty sleeping
- drowsiness.
Uncommon (may affect up to 1 in 100 people)
- inflated stomach
- abnormal thoughts
- concern
- confusion
- Depression
- nervousness
- tight in the chest, especially if you already suffer from coronary heart disease
- drop in blood pressure
- withdrawal symptoms, such as agitation
- fainting
- lack of energy
- thirst
- taste changes
- palpitation
- gallkolik
- chest pain
- general malaise
- pain
- swollen hands, ankles, or feet
- concentration difficulties
- impaired speech
- shaking
- breathing difficulties
- restlessness
- overindulge
- elevated liver values
- increase in blood pressure
- decreased sexual drive
- rinnsnuva
- cough
- hypersensitivity / allergic reactions
- weight loss
- injuries due to accidents
- increased need to urinate
- muscle cramps
- muscle twitching
- muscle pain
- visual impairment
- epileptic seizures (especially in people with epilepsy or predisposition to seizures).
Rare (may affect up to 1 in 1,000 people)
- increased heart rate
- drug addiction
- tooth changes
- weight gain
- yawning.
Has been reported (occurs in an unknown number of users)
- euphoria
- noticeable drowsiness
- erectile dysfunction
- nightmares
- hallucinations
- shallow breathing
- difficulty urinating
- aggressiveness
- tingling in the skin
- burp
- 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 adverse side effects when not combined with naloxone hydrochloride:
Oxycodone hydrochloride can cause breathing problems ( respiratory depression ), pupil 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
- difficulty urinating
- hiccup.
Uncommon (may affect up to 1 in 100 people)
- concentration disorder
- migraine
- increased muscle tension
- involuntary muscle contractions
- a condition in which the intestine stops functioning normally ( ileus )
- dry skin
- drug tolerance
- decreased sensitivity to pain or touch
- abnormal coordination
- voice changes ( dysphonia )
- swelling due to water retention
- hearing loss
- cold sores
- difficulty swallowing
- pain in the gums
- perceptual disorders (eg hallucinations, feelings of unreality)
- redness
- dehydration
- indignation
- a decrease in sex hormone levels that can affect sperm production in men or the menstrual cycle in women.
Rare (may affect up to 1 in 1,000 people)
- hives ( urticaria )
- infection, such as cold sores or herpes (which can cause blisters around the mouth or genital areas)
- increased appetite
- black (tarry) feces
- bleeding gums.
Has been reported (occurs in an unknown number of users)
- acute generalized allergic reactions (anaphylactic reactions)
- increased pain sensitivity
- missed menstruation
- withdrawal symptoms in newborns
- problems with bile flow
- caries.
How to store Oxycodone / Naloxone Teva
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, label, or blister after “EXP”. The expiration date is the last day of the specified month.
Blister: Do not store above 25 ° C.
Jars: Do not store above 30 ° C.
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 Teva 5 mg / 2.5 mg
Each 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 equivalent to 2.25 mg naloxone).
Oxycodone / Naloxone Teva 10 mg / 5 mg
Each 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 equivalent to 4.5 mg naloxone).
Oxycodone / Naloxone Teva 20 mg / 10 mg
Each 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 Teva 30 mg / 15 mg
Each 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 Teva 40 mg / 20 mg
Each 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
Oxycodone / Naloxone Teva 5 mg / 2.5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.
Oxycodone / Naloxone Teva 10 mg / 5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and red iron oxide (E172).
Oxycodone / Naloxone Teva 20 mg / 10 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.
Oxycodone / Naloxone Teva 30 mg / 15 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and yellow iron oxide (E172).
Oxycodone / Naloxone Teva 40 mg / 20 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and red iron oxide (E172).
What the medicine looks like and the contents of the pack
Oxycodone / Naloxone Teva 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 Teva 10 mg / 5 mg
Pink, oblong, biconvex prolonged-release tablet with break marks 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 two equal doses.
Oxycodone / Naloxone Teva 20 mg / 10 mg
White, oblong, biconvex prolonged-release tablet with break marks 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 two equal doses.
Oxycodone / Naloxone Teva 30 mg / 15 mg
Yellow, oblong, biconvex prolonged-release tablet with break marks on both sides, 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 two equal doses.
Oxycodone / Naloxone Teva 40 mg / 20 mg
Pink, oblong, biconvex prolonged-release tablet with notched grooves 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 two equal doses.
Oxycodone / Naloxone Teva is provided in:
Child protection blister packs: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 prolonged-release tablets .
Child-protective perforated single-dose blisters of 10×1, 14×1, 20×1, 28×1, 30×1, 50×1, 56×1, 60×1, 90×1, 98×1 and 100×1 prolonged-release tablets .
Jars with child-resistant closure containing 50, 100, 200, or 250 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Develco Pharma GmbH
Grienmatt 27
796 50 Schopfheim
Germany
Teva Operations Poland Sp. z oo,
ul. Mogilska 80,
Kraków, 31-546,
Poland
PLIVA Hrvatska doo,
Prilaz baruna Filipovića 25,
Zagreb, 10000,
Croatia