This product is listed on the list of specialties (SL) and is reimbursed by the health insurance company - subject to deductible and franchise - if a doctor's prescription is available.
Swissmedic-approved patient information
Mundipharma Medical Company
Subject to the federal law on narcotics and psychotropic substances
What is Oxynorm and when is it used?
Oxynorm is a pain reliever used to treat moderate to severe pain. It contains the active ingredient oxycodone.
Oxynorm may only be used on prescription and under regular medical supervision.
When should Oxynorm not be used?
- If you are hypersensitive (allergic) to the active ingredient oxycodone or any of the excipients
- in the case of pronounced impairment of respiratory function, such as severe bronchial asthma or severe chronic narrowing of the airways,
- if there is an increase in pressure in the right heart as a result of pulmonary hypertension (cor pulmonale),
- in case of intestinal paralysis,
- if you are breastfeeding.
When is taking OxynormBe careful?
- If you have severe lung or kidney function or moderate to severe liver function
- with hypofunction of the thyroid gland,
- in functional weakness of the adrenal cortex (Addison's disease),
- mental disorders caused by alcohol or intoxication, alcohol dependence or serious reactions to alcohol withdrawal,
- if you suffer from gallstones or other diseases of the bile ducts,
- in inflammation of the pancreas,
- in case of intestinal obstruction or inflammatory bowel diseases,
- with enlarged prostate,
- if you have low or high blood pressure or pre-existing cardiovascular diseases,
- if you have a head injury, impaired consciousness, epilepsy or a tendency to seizures,
- in case of constipation,
- when taking medicines from the group of monoamine oxidase inhibitors (MAOIs). Oxynorm is not intended for concomitant therapy with MAOIs or within 14 days of discontinuing such therapy.
If you are elderly or physically weak, you may be more likely to experience side effects. So be extra careful.
Long-term use of Oxynorm can lead to habituation. This means you may need a higher dose to get the pain relief you want.
Long-term use of Oxynorm can also lead to physical dependence. If the therapy is stopped abruptly, withdrawal symptoms such as restlessness, sweating and muscle pain may occur. If you no longer need the therapy, you should gradually reduce the daily dose after consulting your doctor.
Oxynorm should not be used as the drug of first choice for the treatment of long-term pain due to benign diseases. Oxynorm should be used as part of a broader program of therapy that includes other medicines and treatments.
Talk to your doctor or pharmacist before taking Oxynorm if:
- you or a member of your family have ever abused or been dependent on alcohol, prescription drugs or illegal drugs (“addiction”),
- you are a smoker,
- you have ever had a mental health problem (depression, anxiety disorder or personality disorder) or have been treated by a psychiatrist for any other mental illness.
Repeated use of Oxynorm can lead to dependence and abuse, which can lead to a life-threatening overdose. If you are concerned that you may become dependent on Oxynorm, be sure to contact your doctor.
Oxynorm can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxaemia (low blood oxygen levels). Symptoms may include stopping breathing during sleep, waking up at night for shortness of breath, difficulty staying asleep, or being excessively sleepy during the day. If you or someone else notices these symptoms, contact your doctor. Your doctor will consider reducing the dose.
If you need an operation, please tell your doctors that you are taking Oxynorm.
Long-term use of morphine-like painkillers such as Oxynorm can result in reversible hormonal changes such as hypofunction of the adrenal cortex with symptoms such as nausea, vomiting, loss of appetite, tiredness, weakness, dizziness or low blood pressure or hypofunction of the genitals with symptoms such as reduced libido, erectile dysfunction or lack of menstrual bleeding occur.
Certain medicines may increase the likelihood of side effects (particularly impaired breathing (respiratory depression), low blood pressure, drowsiness and/or impaired alertness), which in severe cases can lead to severe drowsiness, coma and death:
- other morphine-like painkillers (opioids),
- sleeping pills and tranquilizers (such as benzodiazepines),
- certain medicines for allergies, motion sickness or nausea,
- certain medicines for depression (including St. John's wort) or psychosis,
- certain medicines used to treat seizures and certain pain conditions (carbamazepine, phenytoin, gabapentin, pregabalin),
- certain antibiotics (e.g. clarithromycin, rifampicin),
- certain medicines used to treat fungal infections (e.g. ketoconazole) or to treat HIV (e.g. ritonavir),
- certain medicines for heartburn and stomach ulcers (e.g. cimetidine),
- muscle relaxants,
- Medicines for Parkinson's disease.
Be sure to tell your doctor or pharmacist if you are using any of these medicines and follow your doctor's dosage recommendations exactly. It might be helpful to inform friends or relatives to watch out for the above signs and symptoms. Contact your doctor or health care professional if you experience such symptoms.
If you take Oxynorm together with certain medicines that reduce the ability of the blood to clot (coumarin derivatives), blood clotting may be accelerated or slowed down.
Do not drink alcohol during treatment with Oxynorm. Drinking alcohol while being treated with Oxynorm can make you feel more sleepy and increase the risk of serious side effects such as shallow breathing with the risk of stopping breathing and loss of consciousness, which in severe cases can lead to coma and death.
It is recommended to avoid grapefruit and grapefruit juice while taking Oxynorm.
The risk of side effects increases if you use certain medicines for depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can affect the way oxycodone works, and symptoms such as involuntary, rhythmic muscle twitching, including eye twitching (twitching of the muscles that control eye movement), restlessness, excessive sweating, involuntary tremors, increased reflexes, increased muscle tension or body temperature above 38°C appear. Tell your doctor if you notice any of these signs.
Oxynorm capsules and orodispersible tablets must never be dissolved and injected (e.g. injected into a blood vessel) with improper intent. Oxynorm oral solution must also never be injected (e.g. injected into a blood vessel). Such misuse can have serious adverse health consequences, including the possibility of death.
Taking Oxynorm can lead to positive results in doping controls.
Contains less than 1mmol sodium (23mg) per capsule, i.e. they are virtually "sodium-free".
Oxynorm 5 mg capsules contain yellow orange S (E110), which can cause allergic reactions.
Oxynorm orodispersible tablets
Contains aspartame, a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare inherited disorder in which phenylalanine builds up because the body can't break it down enough.
Contains sucrose. Please only take Oxynorm melting tablets after consulting your doctor if you know that you suffer from a sugar intolerance.
Can be harmful to teeth.
Oxynorm oral solution
Contains less than 1mmol sodium (23mg) per ml of solution, i.e. it is virtually «sodium-free».
Contains the dye Sunset Yellow (E110), which may cause allergic reactions.
Contains 1.00 mg sodium benzoate per ml solution.
Oxynorm can impair your ability to react, the ability to drive and the ability to use tools and machines. You should therefore discuss with your doctor whether you are allowed to drive a car, operate machinery or carry out hazardous work.
Tell your doctor or pharmacist if you
- suffer from other diseases
- have allergies or
- take other medicines (including those you bought yourself!) or use them externally!
Can Oxynorm be taken during pregnancy or while breastfeeding?
If you are pregnant or planning to become pregnant, tell your doctor. He/she will decide on the use of Oxynorm. Long-term use of Oxynorm during pregnancy can lead to withdrawal symptoms in the newborn. If Oxynorm is used during childbirth, the newborn child may experience slower breathing (respiratory depression).
Oxynorm should not be taken if you are breastfeeding.
How do you use Oxynorm?
Always take Oxynorm exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not entirely sure.
The Oxynorm capsule should be swallowed whole with some water.
The Oxynorm orodispersible tablet can be removed from the blister as follows:
Do not push the orodispersible tablet through the foil as this may damage the orodispersible tablet (Fig.1).
Detach a single blister unit from the blister strip by carefully separating along the perforation (Fig.2).
Pull back the corner of the foil marked with an arrow and carefully remove the orodispersible tablet (Fig.3).
The Oxynorm orodispersible tablet is placed on the tongue and sucked until it has completely broken down before swallowing.
To open the bottle of Oxynorm oral solution, first press the cap down firmly, then turn it counterclockwise. The solution is to be measured with the enclosed measuring pipette (1ml = 10mg oxycodone hydrochloride) and taken in some liquid, preferably in fruit juice.
The usual starting dose is one Oxynorm capsule or 5mg orodispersible tablet or 0.5ml Oxynorm solution to be taken every 4-6 hours, with or between meals. Your doctor will adjust the dosage to the intensity of the pain and your individual sensitivity.
If you have taken more Oxynorm than prescribed, you should inform your doctor immediately.
Do not stop taking Oxynorm without talking to your doctor. If therapy is no longer indicated, it may be advisable to gradually reduce the daily dose to avoid the onset of withdrawal symptoms.
Children and young people under the age of 18
The use and safety of Oxynorm in children and adolescents has not yet been tested. Children and adolescents under the age of 18 should therefore not take Oxynorm.
Do not change the prescribed dosage on your own. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.
What side effects can Oxynorm have?
Taking Oxynorm can very often lead to constipation. This can be counteracted with a high-fiber diet and drinking enough water. In many cases, however, it is necessary for the doctor to prescribe an additional laxative.
Nausea and vomiting can occur very frequently, especially at the beginning of therapy. If you feel sick or vomit, tell your doctor, who can prescribe a medicine.
The following additional side effects can occur when taking Oxynorm:
Very common (affects more than 1 in 10 people)
Dizziness, headache, drowsiness, itching.
Common (affects 1 to 10 users in 100)
Loss of appetite, anxiety, confusion, insomnia, nervousness, thought disorders, depression, (muscle) tremors, sluggishness, impaired breathing, shortness of breath, abdominal pain, diarrhoea, dry mouth, indigestion, sweating, rash, weakness, tiredness.
Uncommon (affects 1 to 10 users in 1000)
Hypersensitivity reactions, dehydration, mood changes, excitement, euphoric mood, hallucinations, drug dependence, memory problems, seizures (especially in people with epilepsy or a tendency to seizures), increased muscle tension, muscle twitching, numbness or similar skin discomfort, speech problems, constriction of the pupils, vision problems , dizziness, palpitations, vasodilatation, fainting, slow breathing (respiratory depression), swallowing disorders, hiccups, belching, flatulence, intestinal obstruction, taste disorders, increased liver values, dry skin, urinary retention, reduced sex drive, erectile dysfunction, hypofunction of the genitals, chills, withdrawal symptoms, Water retention (oedema), malaise, thirst, habituation.
Rare (affects 1 to 10 users in 10,000)
Lowering of blood pressure, itchy rash (hives).
In addition, acute allergic general reactions, excessive sensitivity to pain (hyperalgesia), periodic cessation of breathing during sleep (sleep apnea syndrome), aggression, accelerated pulse, dental caries, bile stasis and absence of menstrual bleeding have been reported.
In the event of a suspected overdose, the doctor must be informed immediately, who will initiate the appropriate countermeasures. Signs of an overdose are constricted pupils, extreme slowing of breathing, low blood pressure, narcosis-like conditions. Respiratory paralysis is the most significant hazard of overdose.
Oxynorm 5mg capsules and Oxynorm oral solution can trigger hypersensitivity reactions in the skin and respiratory organs, particularly in patients with asthma, nettle fever (chronic urticaria) or hypersensitivity to acetylsalicylic acid and other rheumatism and painkillers.
If you notice side effects, contact your doctor or pharmacist. This also applies in particular to side effects that are not listed in this leaflet.
What should also be noted?
The medicinal product may only be used up to the date marked “EXP” on the container.
Capsules/orodispersible tablets:Do not store above 30°C. Keep out of reach of CHILDREN.
Oral solution:Store at 15-30°C. Keep out of reach of CHILDREN.
After completing the treatment, please return the medicine with the remaining contents to your place of delivery (doctor's practice, pharmacy) for professional disposal.
Your doctor or pharmacist can provide you with further information. These people have the detailed information for specialists.
What does Oxynorm contain?
1 Oxynorm capsule or orodispersible tablet contains 5.00 mg, 10.00 mg or 20.00 mg oxycodone hydrochloride, corresponding to 4.48 mg, 8.97 mg or 17.93 mg oxycodone.
1 ml Oxynorm oral solution contains 10.00 mg oxycodone hydrochloride, equivalent to 8.97 mg oxycodone.
Capsules:microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, gelatin, shellac, propylene glycol, titanium dioxide (E171), iron oxide red (E172), indigotine (E132), iron oxide yellow (E172) and iron oxide black (E172). The 5mg capsules also contain sunset yellow (E110).
orodispersible tablets:Sugar-starch pellets (consisting of sucrose and corn starch), polyacrylate dispersion 30%, hypromellose, mannitol, colloidal silica, microcrystalline cellulose, crospovidone, aspartame (E951), spearmint flavor (contains maltodextrin and spearmint oil) and magnesium stearate. 1 orodispersible tablet of 5 mg contains a maximum of 14.14 mg sucrose. 1 orodispersible tablet of 10 mg contains a maximum of 28.27 mg sucrose. 1 orodispersible tablet of 20 mg contains a maximum of 56.53 mg sucrose.
Oral solution:Sodium benzoate (E211), sodium saccharin, sodium citrate, citric acid monohydrate, sunset yellow FCF (E110), hydrochloric acid, sodium hydroxide, purified water.
59302, 63204, 55352 (Swissmedic)
Where can you get Oxynorm? What packs are available?
In pharmacies against a doctor’s prescription, which only entitles you to purchase it once.
Oxynorm, capsules:Packs of 10, 28, 30 and 60 capsules.
Oxynorm, orodispersible tablets 5 mg and 10 mg:Packs of 28 and 56 orodispersible tablets.
Oxynorm, orodispersible tablets 20 mg:Packs of 56 orodispersible tablets.
Oxynorm, oral solution:Bottles with measuring pipette of 30ml and 120ml.
Marketing Authorization Holder
Mundipharma Medical Company, Hamilton/Bermuda, Basel branch.
This leaflet was published in the November 2022last checked by the drug authority (Swissmedic).
Acute pain: Initial recommended doses of oxycodone are in the 5 to 15 mg range, every 4 to 6 hours as needed for adequate analgesia of acute pain. Further dosing should titrate upwards for pain control, with attention and monitoring for potential side effects.How long does 5mg OxyNorm last? ›
Take OxyNorm capsules every 4 to 6 hours or as directed by your doctor. If you begin to experience pain and you are taking your OxyNorm capsules as prescribed, contact your doctor as your dosage may have to be reviewed. Continue taking your medicine for as long as your doctor tells you.What is OxyNorm 5mg capsules used for? ›
OxyNorm capsules are used to relieve moderate to severe pain when other forms of treatment have not been effective. OxyNorm capsules belong to a class of drugs known as opioid analgesics. Opioid analgesics such as OxyNorm capsules have been used to treat pain for many years. In most cases addiction does not occur.How much OxyNorm should I take? ›
The usual starting dose is 5 mg every 4 to 6 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking this medicine discuss this with your doctor. Children and adolescents under 18 years of age should not take the medicine.Can you drive on 5mg of oxycodone? ›
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.What are normal doses of OxyContin? ›
OXYCONTIN is administered orally every 12 hours. The starting dosage for patients who are not opioid tolerant is OXYCONTIN 10 mg orally every 12 hours. Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.3)].When does OxyNorm peak? ›
Peak plasma concentrations of oxycodone are reached approximately one hour after administration of OxyNorm capsules, and less than one hour (approximately 45 minutes) after administration of OxyNorm liquid.How much morphine is in OxyNorm? ›
Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of OxyNorm capsules required.Does 5mg of OxyContin make you sleepy? ›
Yes, oxycodone can make you sleepy as it is a powerful opioid pain medication that can cause drowsiness as a side effect.What is the strongest pain killer? ›
The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.
Both drugs can provide effective pain relief, but generally, oxycodone is thought to be more potent than hydrocodone.How many 5mg oxycodone is it safe to take? ›
Dosage and strength
capsules containing 5mg, 10mg or 20mg of oxycodone – usually taken 4 to 6 times a day.
How long does it take oxycodone to work, and how long does it last? The immediate-release (IR) forms of oxycodone (Oxaydo, Roxicodone, generic oxycodone) generally start to work within 10 to 30 minutes. But the pain-relieving effects might wear off after about 3 to 6 hours.Is it safe to take 40 mg of OxyContin? ›
OxyContin Tablets are NOT intended for use as a prn analgesic. than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.How many pills is too much? ›
Taking more than five medications is called polypharmacy. The risk of harmful effects, drug interactions and hospitalizations increase when you take more medications.Is OxyContin the same as oxycodone? ›
OxyContin, a trade name for the narcotic oxycodone hydrochloride, is a painkiller available in the United States only by prescription. OxyContin is legitimately prescribed for relief of moderate to severe pain resulting from injuries, bursitis, neuralgia, arthritis, and cancer.How long does 5mg of oxycodone last for pain? ›
How long does it take oxycodone to work, and how long does it last? The immediate-release (IR) forms of oxycodone (Oxaydo, Roxicodone, generic oxycodone) generally start to work within 10 to 30 minutes. But the pain-relieving effects might wear off after about 3 to 6 hours.Is OxyContin the same as oxycodone 5 mg? ›
OxyContin and oxycodone are the same drug; the main difference is that OxyContin is a long-acting version of oxycodone. As such, they have a lot in common: Both drugs are opioids that people take to relieve and manage severe pain.How many mg is 5ml of oxycodone? ›
Each 5ml contains oxycodone hydrochloride 5 mg (equivalent to 4.5 mg of oxycodone base). For the full list of excipients, see section 6.1.