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The product code(s) for this leaflet is: PL 21597/0064.
Oxylan 5mg, 10mg, 20mg, 40mg, 80mg prolonged-release tablets
Oxylan 5 mg prolonged-release tablets
Oxylan 10 mg prolonged-release tablets
Oxylan 20 mg prolonged-release tablets
Oxylan 40 mg prolonged-release tablets
Oxylan 80 mg prolonged-release tablets
Oxycodone hydrochloride
What is in this leaflet:
1. What Oxylan is and what it is used for
2. What you need to know before you take Oxylan
3. How to take Oxylan
4. Possible side effects
5. How to store Oxylan
6. Contents of the pack and other information
Oxylan is a strong painkiller (analgesic) from the group of opioids.
Oxylan is indicated in adults and adolescents (from 12 years and older) for the treatment of severe pain, which can be adequately managed only with opioid analgesics.
Talk to your doctor or pharmacist before using Oxylan
Sleep-related breathing disorder
Oxylan can cause sleep-related breathing disorders such as sleep apnea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
The most significant threat of opioid overdose is a flattening and slowing of breathing (respiratory depression). This is most likely to occur in the elderly and debilitated patient and can also cause the oxygen level in the blood to decrease. This could lead to e.g. faint.
This medicine is specially formulated to deliver the active substance over a 12 hour period. The prolonged-release tablets must not be broken, divided, chewed or crushed. This would lead to the absorption of a potentially dangerous dose of the active substance oxycodone hydrochloride (see under “If you take more Oxylan than you should or someone else has accidentally swallowed Oxylan”).
Tolerance, dependence and addiction
This medicine contains oxycodone, which is an opioid. It can cause dependence and/or addiction.
When Oxylan is used for long-term treatment, tolerance to the medicine may occur. This means, that you may need a higher dose to achieve the desired pain relief. Do not change the dosage without consulting your doctor.
Opioids are not the first choice of treatment for pain not related to cancer and are not recommended as the only treatment. Other medicines should be used in the treatment of chronic pain along with opioids. Your doctor should monitor you closely and make necessary adjustments to your dose while you are taking Oxylan to prevent addiction and abuse.
This medicine contains oxycodone which is an opioid medicine. Repeated use of opioid painkillers can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Oxylan may lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Oxylan if:
If you notice any of the following signs whilst taking Oxylan, it could be a sign that you have become dependent or addicted.
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Oxylan).
Oxylan has a dependence potential. If the treatment is stopped too suddenly, withdrawal symptoms such as yawning, dilted pupils, tearing, runny nose, tremors, sweating, anxiety, restlessness, seizures, insomnia or musle pain may occur. If you no longer need treatment, your doctor will gradually reduce your daily dose.
Your doctor will weigh the possible risks against the expected benefit. Ask your doctor if you have any questions about this.
The active ingredient oxycodone hydrochloride, like other highly effective opioids (strong pain killers), has potential for abuse. The development of psychological addiction is possible. Oxylan should only be used with particular caution if there has been or has been a history of alcohol, drug or drug abuse.
Particularly in high doses, increased sensitivity to pain (hyperalgesia) can occur, which does not respond to a further increase in the dose of Oxylan. Your doctor will then decide whether to reduce the dose or switch to this strong pain reliever (opioid).
Oxylan is for ingestion only (swallowing as a whole prolonged release tablet). The prolonged-release tablets must not be dissolved and injected, as this can have serious, possibly fatal consequences.
If you need to have an operation, please tell your doctor that you are taking Oxylan.
Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.
Similar to other opioids, oxycodone can affect the body's normal production of hormones (such as cortisol and sex hormones). This happens especially after you have received large doses for long periods of time.
The safety and effectiveness of Oxylan have not been adequately studied in children under 12 years of age. Therefore, Oxylan is not recommended for children under 12 years of age.
Anti-Doping Warning
The use of Oxylan may produce positive results in doping controls.
Use of Oxylan as a doping agent may be a health hazard.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of Oxylan and sedative medicines such as benzodiazepines or related drugs 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 Oxylan 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.
The side effects of Oxylan may become more common or more severe if Oxylan is used at the same time as medicines that can affect brain function or are used to treat allergies, motion sickness or vomiting. Side effects can be, e.g. flattening and slowing of breathing (respiratory depression), constipation, dry mouth or urination problems occur.
The risk of side effects increases if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).
These medicines can interact with oxycodone. You may experience the following symptoms, among others: involuntary, rhythmic muscle contractions, including the muscles that control the movement of the eye, restlessness, excessive sweating, tremors, exaggerated reflexes, increased muscle tension and body temperature above 38 ° C. Contact your doctor if you experience these symptoms.
Please tell your doctor or pharmacist if you are taking any of the medicines from the following list:
Drinking alcohol whilst taking Oxylan 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 Oxylan.
The tablets should be avoided in patients with a history of or present alcohol and drug abuse.
Grapefruit juice may increase the levels of Oxylan in your blood. Check with your doctor if you drink grapefruit juice regularly.
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
You should not take Oxylan during pregnancy. There are no adequate data from the use of oxycodone in pregnant women. Oxycodone crosses the placenta into the blood circulation of the baby.
Prolonged use of oxycodone during pregnancy can cause withdrawal symptoms in newborns. Infants born to mothers who have received oxycodone during the last 3-4 weeks before labour may experience severe difficulty (respiratory depression).
Oxylan should only be used during pregnancy if the benefit outweighs the possible risks to the baby.
Breast-feeding
Oxycodone passes into breast milk and causes sedation and shallow and slow breathing (respiratory depression) in the breast-fed child. Oxylan should therefore not be used during breast-feeding.
Oxylan may impair the ability to drive and use machines. This is to be expected especially at the beginning of therapy with Oxylan, after increasing the dose or after switching preparation, as well as when Oxylan interacts with alcohol or drugs that can impair brain function. In the case of stable therapy, a general driving ban is not necessary. Your attending physician must assess your individual situation.
If you are allergic to peanut or soya, do not use this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Oxylan, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also if you stop taking Oxylan).
For doses not realisable/practicable with this strength, other strengths of this medicinal product are available.
Your doctor will adjust your dosage according to pain intensity and to your individual susceptibility.
Do not change the dosage without consulting your doctor.
You should be given the lowest effective dose sufficient to relieve your pain.
If you have previously been treated with opioids, your doctor may start your therapy with a higher dose.
It may be necessary to increase the dose gradually if the pain relief is insufficient or if the pain becomes worse.
Please talk to your doctor, if you think that the effect of Oxylan is too weak or too strong.
The usual starting dose is one 10 mg tablet every 12 hours. In some cases, your doctor may prescribe a starting dose of 5 mg to reduce any side effects you may experience.
Your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor.
For the treatment of cancer pain, 40 mg oxycodone hydrochloride (20mg given twice daily) is generally a sufficient daily dose; however, higher dosages may also be necessary. Patients with tumor pain generally require doses of 80 to 120 mg oxycodone hydrochloride, which can be increased up to 400 mg in individual cases.
Some patients taking Oxylan on a set schedule require fast-acting painkiller as on-demand medication to manage breakthrough pain. Oxylan prolonged-release tablets are not intended for the treatment of these breakthrough pain.
Special populations
Safety and efficacy of Oxylan have not been tested sufficiently in children under 12 years of age. Therefore, treatment with Oxylan is not recommended in children under 12 years of age.
Elderly patients with normal liver and/or kidney function may take the same doses as given for adults above.
If you have liver or kidney problems and you have not yet received opioids, you should start with half the recommended adult dose.
If you are light or if your body metabolizes medicines more slowly, the starting dose should be half the recommended adult dose.
Your doctor will check your treatment on a regular basis.
Take the prolonged-release tablets as a whole with a sufficient amount of liquid (e.g. ½ glass of water) in the morning and in the evening, every 12 hours (for instance, one tablet at 8 o’clock in the morning, and the next one at 8 o’clock in the evening). You can take the tablets with or without food.
Swallow the prolonged-release tablets whole so that the specific release of the active ingredient is not impaired over a longer period of time. The prolonged-release tablets must be swallowed whole and must not be broken, divided, chewed, or crushed.
Your doctor will tell you how long to take Oxylan.
Do not stop your Oxylan treatment without talking to your doctor (see “If you stop taking Oxylan”). If you take Oxylan for a long time, you should monitor your therapy and discuss it with your doctor regularly. This is necessary in order to achieve the best possible pain therapy, i.e. to enable timely treatment of occurring side effects as well as a decision on dose adjustment and continuation of treatment.
Please talk to your doctor or pharmacist if you have the impression that the effect of Oxylan is too strong or too weak.
Contact a doctor immediately if you have taken more tablets than you have been prescribed.
Overdosing can cause:
In more severe cases, unconsciousness (coma), water retention in the lungs and circulatory failure - possibly with fatal outcome - can occur.
Never put yourself in situations that require heightened attention, such as: driving a car
If you take a smaller dose of Oxylan than prescribed, or if you miss a dose, adequate pain relief will probably not be achieved.
If you forget to take a dose, you can take it up if the next regular dose was scheduled in more than 8 hours. If the time to the next dose is shorter, take the missed dose and take the next dose 8 hours later.
You can then continue with your usual intake plan.
In general, you shouldn't take Oxylan more than every 8 hours.
Please ask your doctor or pharmacist if you are not sure
Do not take a double dose to make up for a forgotten tablet.
Do not stop treatment without first speaking with your doctor..
If you stop taking Oxylan, this may trigger withdrawal symptoms (e.g. yawning, dilated pupils, tearing, runny nose, tremors, sweating, anxiety, restlessness, seizures, insomnia or muscle pain). Therefore, it may be advisable for your doctor to reduce the dose gradually
If you do not require treatment with Oxylan anymore, your doctor will advise you on how to reduce the dose gradually to prevent the occurrence of withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system:
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children. Store this medicine in a locked safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away 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.
Oxylan 5 mg prolonged-release tablets are light grey, round and biconvex film-coated tablets.
Oxylan 10 mg prolonged-release tablets are white, round and biconvex film-coated tablets.
Oxylan 20 mg prolonged-release tablets are pale pink, round and biconvex film-coated tablets.
Oxylan 40 mg prolonged-release tablets are beige, round and biconvex film-coated tablets.
Oxylan 80 mg prolonged-release tablets are pale green, round and biconvex film-coated tablets.
Oxylan prolonged-release tablets are available in blisters containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 72, 98, and 100 prolonged-release tablets or in unit-dose blisters of 30x1, 50x1, 56x1, 60x1, 72x1, 98x1, and 100x1 prolonged-release tablets.
Not all pack sizes will be marketed.
Leaflet last revised in February 2025.