5 mg / 2.5, 10 mg / 5 mg, 20 mg / 10 mg, 30 mg / 15 mg, 40 mg / 20 mg prolonged-release tablets are
oxycodone hydrochloride / naloxone hydrochloride
What Oxycodone / Naloxone GL is and what it is used for
You have been prescribed Oxycodone / Naloxone GL for the treatment of severe pain that can only be managed with enough analgesic opioids.
How Oxycodone / Naloxone GL works as a pain reliever
Oxycodone / Naloxone GL contains the active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone gives the analgesic effect of Oxycodone / Naloxone GL It is a strong analgesic (“analgesic”) that belongs to a group of drugs called opioids.
Naloxone is intended to reduce constipation. Constipation is a common side effect of treatment with opioid painkillers.
Oxycodone hydrochloride and naloxone hydrochloride contained in Oxycodone / Naloxone GL 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 using Oxycodone / Naloxone GL
Do not use Oxycodone / Naloxone GL
- if you are allergic to oxycodone, naloxone, or any of the other ingredients of this medicine (listed in section 6).
- if you have difficulty breathing, such as slower or weaker breathing than expected ( respiratory depression ).
- if you suffer from a severe lung disease associated with narrowed airways (chronic obstructive pulmonary disease or COPD).
- if you suffer from a condition called cor pulmonale. In this condition, the right part of the heart becomes enlarged due to increased pressure inside the blood vessels in the lung and so on. (eg as a result of COPD – see above).
- if you suffer from severe bronchial asthma.
- if you have a type of intestinal obstruction (paralytic ileus ) that is not caused by opioids.
- if you have moderate to severe hepatic impairment.
Warnings and cautions
Talk to your doctor or pharmacist before taking Oxycodone / Naloxone GL
- if you are elderly or debilitated
- if you have a type of intestinal obstruction (paralytic ileus ) caused by opioids
- if you suffer from kidney problems
- if you suffer from mild liver problems
- if you suffer from severe lung problems (ie decreased breathing capacity)
- if you suffer from a condition characterized by frequent shortness of breath during the night that can make you feel very tired during the day ( sleep apnea )
- if you have myxedema (a condition of the thyroid gland that causes dry, cold and swollen skin [“bloating”] in the face, arms, and legs)
- if your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism )
- if you have a poor adrenal function (ie the adrenal glands do not work properly), for example, Addison’s disease.
- if you have a mental illness that is accompanied by a (partial) loss of reality ( psychosis ) caused by alcohol or intoxication with other substances (substance-induced psychosis )
- if you have gallstone problems
- if your prostate gland is abnormally enlarged ( prostate hypertrophy )
- if you are or have ever been addicted to alcohol or drugs, or if you have previously had symptoms of abstinence such as worry, anxiety, shaking, or sweating when you stopped drinking alcohol or taking drugs
- if you have inflammation of the pancreas ( pancreatitis )
- if you have low blood pressure ( hypotension )
- if you have high blood pressure ( hypertension )
- if you suffer from heart problems
- 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 a type of medicine called an MAOI (used to treat depression or Parkinson’s disease ), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid and moclobemide
- if fatigue or episodes of sudden drowsiness occur.
Talk to your doctor if any of the above have affected you in the past. Also, talk to a doctor if you experience any of the above while taking Oxycodone / Naloxone GL
Oxycodone / Naloxone GL is not recommended for the treatment of patients with advanced cancer of the gastrointestinal tract or pelvis where intestinal obstruction may be a problem.
If you experience severe diarrhea at the beginning of treatment (within the first 3 to 5 days), this may be due to the effect of naloxone. It may be a sign that your bowel movements are returning to normal. Contact a doctor if diarrhea persists after 3 to 5 days, or is worrying.
If you have used high doses of another opioid, you may initially experience withdrawal symptoms (such as restlessness, sweating, and muscle pain) when switching to Oxycodone / Naloxone GL. If you experience withdrawal symptoms, you may need special medical attention.
Tell your doctor that you are taking Oxycodone / Naloxone GL if you need surgery.
If you have been taking Oxycodone / Naloxone GL for a long time, you may become tolerant. This means that you may need a higher dose to achieve the desired effect. Prolonged use of this drug can also lead to physical dependence. Medicines containing oxycodone should be avoided in patients with current or past alcohol, drug, or drug abuse. Withdrawal symptoms can occur if treatment is stopped too suddenly. If you no longer need treatment, gradually reduce your daily dose in consultation with your doctor.
There is a risk of developing psychological dependence on oxycodone.
Residues of prolonged-release tablets may be present in the feces. This is nothing to worry about, as the active substances have already been released in the stomach and intestines and absorbed into the body.
Improper use of Oxycodone / Naloxone GL
Oxycodone / Naloxone GL should never be abused, especially if you have a drug addiction. If you are addicted to drugs such as heroin, morphine, or methadone , you are likely to suffer from severe withdrawal symptoms if you abuse Oxycodone / Naloxone GL, as it contains the active substance naloxone. Pre-existing withdrawal symptoms may worsen.
Oxycodone / Naloxone GL prolonged-release tablets should never be abused by dissolving and injecting (eg into a blood vessel) or inhaling. The tablets contain talc that can destroy local tissue ( necrosis ) and cause changes in the lung tissue (lung granuloma). Improper use can also have other serious consequences that can be life-threatening.
The prolonged-release tablets must be swallowed whole so as not to affect the slow release of oxycodone from the tablets. The tablets must not be split, broken, chewed, or crushed. If the tablets are split, broken, chewed, or crushed, this may cause the body to take up a potentially life-threatening dose of oxycodone (see section 3 “If you take more Oxycodone / Naloxone GL”).
Children and young people
This medicine should not be given to children or adolescents under 18 years of age when safety and efficacy have not been established.
Other medicines and Oxycodone / Naloxone GL
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 Oxycodone / Naloxone GL at the same time as medicines that affect brain function. For example, you may feel very tired and breathing difficulties (slow and shallow breathing) may worsen.
Examples of drugs that affect brain function:
- other strong painkillers ( opioids )
- hypnotics and sedatives ( sedatives, hypnotics )
- antidepressant drugs (such as paroxetine or fluoxetine )
- medicines used to treat allergies, motion sickness, or nausea ( antihistamines or antiemetics)
- other drugs that affect the nervous system (phenothiazines, neuroleptics )
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 Oxycodone / Naloxone GL and sedatives or medicines for insomnia such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may 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 GL at the same time as sedatives, dose one and the 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.
Talk to a doctor if you are taking:
- drugs that reduce the coagulation capacity of the blood (coumarin derivatives), the coagulation time may be faster or slower
- Macrolide type antibiotics are (eg clarithromycin, erythromycin, telithromycin )
- antifungal drugs of the type azoles (eg ketoconazole , voriconazole, itraconazole, posaconazole)
- ritonavir or other protease inhibitors (used to treat HIV, eg indinavir, nelfinavir, saquinavir)
- cimetidine (used to treat stomach ulcers, stomach upset, or heartburn).
- rifampicin (used to treat tuberculosis )
- carbamazepine (used to treat seizures and certain pain conditions)
- phenytoin (used to treat seizures)
- St. John’s wort (also known as Hypericum perforatum).
- quinidine (used to treat irregular heartbeat).
Oxycodone / Naloxone GL with food, drink, and alcohol
Alcohol intake during treatment with Oxycodone / Naloxone GL may make you more tired or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and loss of consciousness. Alcohol intake should be avoided during treatment with Oxycodone / Naloxone GL
Intake of grapefruit juice should be avoided during treatment with Oxycodone / Naloxone GL
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.
The use of Oxycodone / Naloxone GL should be avoided during pregnancy as far as possible. Prolonged use of oxycodone during pregnancy can lead to withdrawal symptoms in newborns. Treatment with oxycodone during childbirth may cause respiratory depression (slow and shallow breathing) in the newborn.
Breast-feeding must be discontinued during treatment with Oxycodone / Naloxone GL Oxycodone passes into breast milk. It is not known whether naloxone also passes into breast milk. Therefore, the risk to the breast-fed baby can not be ruled out, especially after taking several doses of Oxycodone / Naloxone GL
Driving and using machines
This medicine may affect your ability to drive or use machines as it may make you tired or dizzy. This is most likely at the start of treatment, after a dose increase, or after switching from another medicine. These side effects should go away when you are on a steady dose.
This drug has been associated with drowsiness and episodes of sudden drowsiness. If you experience these side effects, do not drive or use machines. Talk to your doctor if this happens.
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.
Talk to your doctor or pharmacist if you are not sure if it is safe to drive a vehicle during treatment with this medicine.
Oxycodone / Naloxone GL contains excipients
Oxycodone / Naloxone GL 5 mg / 2.5 mg and 10mg / 5mg contain lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Oxycodone / Naloxone GL
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
For doses that are not achievable/practical with this strength, there are other strengths of this medicine.
Unless your doctor prescribes otherwise, the recommended dose is:
For the treatment of pain
The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride every 12 hours.
Your doctor will decide how much to take each day and how to distribute your total daily dose morning and evening. Your doctor will also decide on any necessary dose adjustments during treatment, depending on your level of pain and individual sensitivity. You should receive the lowest dose required for pain relief. If you have already been treated with opioids, your treatment with Oxycodone / Naloxone GL can be started with 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 without naloxone. However, the maximum daily dose of oxycodone hydrochloride should not exceed 400 mg. The beneficial effect of naloxone on bowel movements may be affected if additional oxycodone is given without additional naloxone.
If you experience pain between doses, you may need to take additional fast-acting painkillers. Oxycodone / Naloxone GL is not suitable for this. Talk to your doctor.
Talk to your doctor or pharmacist if you find that Oxycodone / Naloxone GL is too strong or too weak.
Elderly patients r
In general, no dose adjustment is necessary for elderly patients with normal renal and/or hepatic function.
Hepatic or renal impairment
If you have kidney problems or mild liver problems, your doctor will prescribe Oxycodone / Naloxone GL with special caution. You should not take Oxycodone / Naloxone GL if you have moderate or severe liver problems (see also section 2. “Do not take Oxycodone / Naloxone GL” and “Warnings and precautions”).
Method of administration
To be swallowed.
Swallow the tablets whole with a glass of water. The tablets can be taken with or without food. Take them every 12 hours according to a fixed schedule. For example, if you take one tablet at 8 in the morning, take the next tablet at 20 in the evening. The prolonged-release tablets must not be split, broken, chewed, or crushed.
Instructions for opening the blister pack:
This medicine has child-resistant packaging. The prolonged-release tablets must be squeezed out of the blister pack with a firm hand.
Duration of treatment
You should not take Oxycodone / Naloxone GL for longer than you need. If you have been taking Oxycodone / Naloxone GL for a long time, your doctor should check regularly that you still need it.
Use for children and adolescents
Children and adolescents under 18 years of age: No studies have been performed to demonstrate that Oxycodone / Naloxone GL works properly in children and adolescents or that it is safe for them to take. It is therefore not recommended for patients under 18 years of age.
If you use more Oxycodone / Naloxone GL 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, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.
If you take more than the prescribed dose, you must tell your doctor immediately.
Overdose can lead to:
- reduced pupil in the eye
- slower or weaker breathing than expected ( respiratory depression )
- drowsiness or loss of consciousness
- low muscle tension ( hypotension )
- decreased heart rate
- drop in blood pressure.
In severe cases, loss of consciousness ( coma ), fluid in the lungs, and circulatory collapse can occur, which can be life-threatening.
Avoid situations that require attention, e.g. to drive vehicles.
If you forget to use Oxycodone / Naloxone GL
If you forget to take Oxycodone / Naloxone GL or if you take a lower dose than the prescribed dose, you may not experience any effect.
If you forget to take your dose, follow the instructions below:
- If there are 8 hours or more left until the next regular dose: Take the missed dose immediately and then continue with your usual dosing schedule.
- If it is less than 8 hours until the next regular dose: Take the missed dose one and then wait for 8 hours before taking the next dose. Try to return to your usual dosing schedule (eg at 8 in the morning and at 20 in the evening).
Do not take more than one dose within each eight hours.
Do not take a double dose to make up for a forgotten dose.
If you stop using Oxycodone / Naloxone GL
Do not stop taking Oxycodone / Naloxone GL without talking to your doctor first.
If you do not need further treatment, your doctor will tell you how to gradually reduce your daily dose. In this way, withdrawal symptoms such as restlessness, sweating, and muscle pain can be avoided.
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.
Important side effects or signs to be aware of and what to do if you are affected:
Stop taking Oxycodone / Naloxone GL, consult a doctor, or see your nearest emergency department immediately if you experience any of the following symptoms:
- Slower or shallower breathing ( respiratory depression ). This is the most serious side effect of Oxycodone / Naloxone GL and is most common in elderly and debilitated patients.
- Opioids can also cause a sharp drop in blood pressure in sensitive patients.
- Swelling of the face, tongue, or throat, difficulty swallowing, hives, difficulty breathing, and drop in blood pressure (anaphylactic reaction).
The following side effects have been reported in patients treated for pain
Common (may affect up to 1 in 10 people.)
- abdominal pain, indigestion, constipation, diarrhea, gas
- dry mouth
- vomiting, nausea
- decreased appetite, loss of appetite
- feeling dizzy or “spinning”
- hot flashes, sweating
- general weakness, fatigue, or exhaustion
- itching of the skin, skin reactions/rash
- difficulty sleeping, drowsiness
Uncommon (may affect up to 1 in 100 people)
- inflated stomach
- abnormal thoughts
- anxiety, confusion, depression, nervousness, difficulty concentrating
- a feeling of tightness in the chest, especially if you already have coronary artery disease, chest pain
- drop in blood pressure, high blood pressure
- withdrawal symptoms such as upset
- general malaise
- swollen hands, ankles, or feet
- impaired speech
- breathing difficulties
- elevated liver enzymes
- Runny nose
- hypersensitivity / allergic reactions
- weight loss
- injuries from accidents
- increased need to urinate
- muscle cramps, muscle twitching, muscle pain
- impaired vision
- epileptic seizures (especially in people with epilepsy or prone to seizures)
Rare (may affect up to 1 in 1,000 people)
- increased heart rate
- changes in teeth
- weight gain
Has been reported (occurs in an unknown number of users)
- severe drowsiness
- erectile dysfunction
- shallow breathing
- difficulties with urination
- tingling in hands or feet
The active substance oxycodone, when not combined with naloxone, is known for the following differentiating side effects:
Breathing problems such as slower or weaker breathing than expected ( respiratory depression ), decreased pupils in the eye, muscle cramps, and decreased cough reflex.
Common (may affect up to 1 in 10 people.)
- mood swings and personality changes (eg depression, extreme happiness)
- decreased activity, increased activity
- difficulty urinating
Uncommon (may affect up to 1 in 100 people)
- impaired concentration, agitation
- abnormal taste
- increased muscle tension, involuntary muscle contractions
- drug dependence, drug tolerance
- intestinal obstruction ( ileus )
- dry skin, reddening of the skin
- decreased sensitivity to pain or touch
- abnormal coordination
- voice changes ( dysphonia )
- fluid retention
- hearing problems
- cold sores, sore gums
- difficulty swallowing
- perceptual disorders (eg hallucinations, feelings of unreality)
- decreased sexual drive
- dehydration, thirst
Rare (may affect up to 1 in 1,000 people)
- rash with itching ( hives )
- herpes simplex (which can cause blisters around the mouth or genital areas)
- increased appetite
- black (tarry) feces
- bleeding gums
No known frequency (can not be calculated from the available data)
- acute general allergic reaction (anaphylactic reactions)
- missed menstruation
- problems with bile flow
- Prolonged use of Oxycodone / Naloxone GL during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms to pay attention to are irritability, hyperactivity, abnormal sleep patterns, crying, shaking, nausea, diarrhea, and no weight gain.
Reporting of side effects if you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products AgencyBox 26751 03 Uppsalawww.lakemedelsverket.se
How to store Oxycodone / Naloxone GL
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 blister and the carton after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° 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
The active substances are oxycodone hydrochloride and naloxone hydrochloride.
- Oxycodone / Naloxone GL 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 equivalent to 2.75 mg naloxone hydrochloride dihydrate equivalent to 2.25 mg naloxone.
- Oxycodone / Naloxone GL 10 mg / 5 mg: One prolonged-release tablet contains 10 mg oxycodone hydrochloride equivalent to 9 mg oxycodone and 5 mg naloxone hydrochloride as 5.5 mg naloxone hydrochloride dihydrate equivalent to 4.5 mg naloxone.
- Oxycodone / Naloxone GL 20 mg / 10 mg : One prolonged-release tablet contains 20 mg oxycodone hydrochloride equivalent to 18 mg oxycodone and 10 mg naloxone hydrochloride as 10.99 mg naloxone hydrochloride dihydrate equivalent to 9 mg naloxone.
- Oxycodone / Naloxone GL 30 mg / 15 mg : One prolonged-release tablet contains 30 mg oxycodone hydrochloride equivalent to 26.9 mg oxycodone and 15 mg naloxone hydrochloride as 16.448 mg naloxone hydrochloride dihydrate equivalent to 13.5 mg naloxone.
- Oxycodone / Naloxone GL 40 mg / 20 mg : One prolonged-release tablet contains 40 mg oxycodone hydrochloride equivalent to 36 mg oxycodone and 20 mg naloxone hydrochloride as 21.98 mg naloxone hydrochloride dihydrate equivalent to 18 mg naloxone.
The other ingredients are
Tablet core : Poly (vinyl acetate), Povidone K 30, sodium lauryl sulfate, silica, microcrystalline cellulose, lactose monohydrate (Oxycodone / Naloxone GL 5 mg / 2.5 mg and 10 mg / 5 mg) , colloidal , anhydrous silica, magnesium stearate.
Film coating : polyvinyl alcohol partially hydrolysed, macrogol 3350, titanium dioxide (E 171), talc, brilliant blue FCF aluminum lacquer (E 133) ( Oxycodone / Naloxone GL 5 mg / 2.5 mg), red iron oxide (E 172) (Oxycodone / Naloxone GL 20 mg / 10 mg, Oxycodone / Naloxone GL 30 mg / 15 mg), yellow iron oxide (E 172) (Oxycodone / Naloxone GL 30 mg / 15 mg, Drug name> 40 mg / 20 mg), black iron oxide (E 172) ( Oxycodone / Naloxone GL 30 mg / 15 mg) .
What the medicine looks like and the contents of the pack
Oxycodone / Naloxone GL is a prolonged-release tablet, which means that the active substances are released for a longer period. Their effect lasts for 12 hours.
Oxycodone / Naloxone GL 5 mg / 2.5 mg prolonged-release tablets are light blue, round, and biconvex prolonged-release tablets with a film coating with “5” embossed on one side.
Oxycodone / Naloxone GL 10 mg / 5 mg prolonged-release tablets are white to off-white, round, and biconvex prolonged-release tablets with a film coating with “10” debossed on one side.
Oxycodone / Naloxone GL 20 mg / 10 mg prolonged-release tablets are light pink, round, and biconvex prolonged-release tablets with a film coating with “20” embossed on one side.
Oxycodone / Naloxone GL 30 mg / 15 mg prolonged-release tablets are brown, round, and biconvex prolonged-release tablets with a film coating with “30” debossed on one side.
Oxycodone / Naloxone GL 40 mg / 20 mg prolonged-release tablets are yellow, round, and biconvex prolonged-release tablets with a film coating with “40” debossed on one side.
Blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
GL Pharma GmbH,