Oxynorm Caps 5 mg 30 pcs (2023)

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.

Oxynorm capsules

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?

pregnancy

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).

lactation

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.

Adult

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.

Storage Notice

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.

More information

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?

active ingredients

Oxycodonhydrochlorid.

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.

excipients

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.

registration number

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.