Oxycodone Depot Orion - Oxycodone hydrochloride uses, dose and side effects

Oxycodone hydrochloride contained in Oxycodone Depot Orion prolonged-release tablets may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before using Oxycodone Depot Orion

Do not use Oxycodone Depot Orion

if you are allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6),
if you suffer from severe respiratory distress ( respiratory depression ) with too little oxygen in the blood ( hypoxia ) and/or too much carbon dioxide ( hypercapnia ) in the blood,
if you suffer from severe chronic obstructive pulmonary disease, cor pulmonale (heart changes due to constant congestion of the circulation in the lungs) or acute, severe bronchial asthma,
if you suffer from intestinal obstruction (paralytic ileus ),
if you have severe abdominal pain or suffer from delayed emptying of the stomach.

Warnings and cautions

Talk to your doctor or pharmacist before taking Oxycodone Depot Orion prolonged-release tablets

if you are elderly or debilitated,
if your lung, liver, or kidney function is severely impaired,
if you suffer from myxedema (a certain disease of the thyroid gland), impaired function of the thyroid gland,
if you suffer from insufficient adrenal function ( Addison’s disease ),
if you suffer from prostate hypertrophy,
if you suffer from alcoholism or undergo alcohol withdrawal,
if you suffer from a known opioid addiction,
if you suffer from inflammatory bowel disease,
if you suffer from inflammation of the pancreas ( pancreatitis ),
in conditions with increased pressure in the brain,
if you suffer from disorders of the regulation of blood circulation,
if you suffer from colic in the bile ducts and ureters,
if you suffer from epilepsy or tend to have seizures,
if you are taking MAOIs (monoamine oxidase inhibitors) (to treat depression).

Talk to your doctor if any of these apply to you or if you have had any of these conditions before.

Dependence and tolerance

Oxycodone Depot Orion prolonged-release tablets have a primary addictive potential. When used for a long time, tolerance to the effect may arise, which means that an increased dose is required to maintain control over the pain.

Chronic use of Oxycodone Depot Orion prolonged-release tablets can lead to physical dependence and withdrawal symptoms may occur with abrupt discontinuation of treatment. When a patient no longer needs treatment with oxycodone hydrochloride, it is advisable to reduce the dose gradually to prevent withdrawal symptoms.

When used as prescribed, in patients with chronic pain, the risk of developing physical or mental dependence is small and this risk must be weighed against the potential benefits. Discuss this with your doctor.

Oxycodone Depot Orion prolonged-release tablets are for oral use only. In case of intravenous abuse ( injection via a blood vessel) of the tablets, excipients (especially talc) can lead to damage ( necrosis ) of local tissue, alteration of lung tissue, (granuloma of the lungs), or other serious potentially fatal events.

This medicine should not be given to patients with known alcohol and drug abuse.

Doping warning

Athletes should be aware that this drug may give a positive result in “anti-doping tests”.

Using Oxycodone Depot Orion prolonged-release tablets as a doping substance can be a health risk.

Children and young people

Oxycodone Depot Orion prolonged-release tablets have not been studied in children under 12 years of age. Safety and efficacy have not been established and therefore use in children under 12 years of age are not recommended.

Other medicines and Oxycodone Depot Orion

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take the tablets with other medicines, the effect of the tablets or the other medicine may be affected.

The tablets must not be taken with monoamine oxidase inhibitors or if you have taken this type of medicine in the last two weeks. (see section 2 Do not take Oxycodone Depot Orion)

Tell your doctor or pharmacist if you are taking:

Sedatives or hypnotic drugs (eg sedatives, hypnotics )
Antidepressants (eg paroxetine )
Drugs designed to treat mental or mental disorders (eg phenothiazines, or neuroleptics )
Other strong painkillers ( analgesics )
Muscle relaxants
Quinidine (a drug for calming fast heartbeats)
Cimetidine (a medicine for stomach ulcers, indigestion, heartburn)
Medicines intended to treat fungal infections (eg ketoconazole , voriconazole, itraconazole or posaconazole)
Drugs intended to treat infections (eg clarithromycin, erythromycin, or telithromycin)
A special type of medicine known as a protease inhibitor ( protease inhibitor ) for the treatment of HIV (eg boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir)
Rifampicin to treat tuberculosis
Carbamazepine (a medicine used to treat seizures, convulsions, or certain pain conditions)
Phenytoin (a medicine used to treat seizures, seizures, or convulsions)
An herbal remedy from the plant kingdom, St. John’s wort (Hypericum perforatum)

Also, tell your doctor if you have recently been given an anesthetic.

Oxycodone Depot Orion with food, drink, and alcohol

Drinking alcohol while taking Oxycodone Depot Orion prolonged-release tablets makes you feel more sleepy or increases the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and thereby losing consciousness. The recommendation is not to drink alcohol when using Oxycodone Depot Orion prolonged-release tablets. You should avoid drinking grapefruit juice when using Oxycodone Depot Orion prolonged-release tablets.

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

Oxycodone Depot Orion prolonged-release tablets should not be used during pregnancy unless necessary. There are very little data from the use of oxycodone in pregnant women.

Oxycodone passes through the placenta and into the baby’s bloodstream.

Long-term use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. The use of oxycodone during childbirth may cause respiratory depression in the newborn.

Breast-feeding

Do not use Oxycodone Depot Orion prolonged-release tablets while breastfeeding as oxycodone passes into breast milk.

Driving and using machines

Oxycodone hydrochloride impairs alertness and responsiveness to such an extent that the ability to drive and use machines is affected or ceases altogether. To see the side effects that affect motor skills and concentration (see section 4).

In the case of stable treatment, a general ban on driving does not have to be necessary. The attending physician must assess the individual situation. Discuss with your doctor if and under what circumstances you can drive a vehicle.

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.

Oxycodone Depot Orion prolonged-release tablets 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.

3. How to use Oxycodone Depot Orion

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults and adolescents (over 12 years of age)

The usual starting dose is 10 mg oxycodone hydrochloride at 12-hour intervals. Your doctor will prescribe the dose needed to treat the pain.

Patients who have already received opioids can start with a higher dose because they have experience with opioid treatment.

For the treatment of non-cancer patients, a daily dose of 40 mg is generally sufficient, but a higher dose may be needed.

Patients with cancer pain usually require a dose of 80 mg to 120 mg of oxycodone hydrochloride, which can be increased to 400 mg in individual cases.

For doses that are not possible/practical to obtain, additional strengths of this drug are available.

At-risk patients

If you have impaired kidney and/or liver function or if you have low body weight, your doctor may prescribe a lower starting dose.

Method of administration

The prolonged-release tablets should be swallowed whole with a sufficient amount of liquid (½ glass of water) with or without food in the morning and the evening according to a fixed schedule (eg 8.00 in the morning and 20.00 in the evening).

The prolonged-release tablets should be swallowed whole, not crushed or chewed as this will lead to too rapid release of oxycodone due to damage to the sustained release properties. Ingestion of chewed or crushed Oxycodone Depot Orion prolonged-release tablets leads to rapid release and rapid uptake of a potentially lethal dose of oxycodone (see section “If you have taken too much Oxycodone Depot Orion prolonged-release tablets”).

The prolonged-release tablets should be taken with or without food with a sufficient amount of liquid.

Oxycodone Depot Orion prolonged-release tablets must not be taken with alcoholic beverages.

Instructions for opening the blister:

This medicine is supplied in a child-resistant package. The prolonged-release tablets cannot be squeezed through the blister. Follow these instructions when opening the blister.

Tear off a dose along the perforated line on the blister card.

2. An unsealed area becomes visible where the perforated lines intersect.

3. Remove the cover foil from the bottom foil at the unsealed tab.

Additional information on the daily dosage one, the division into single doses, and dose adjustment during the current treatment is made by the attending physician and depends on the previous dosage.

Some patients who receive Oxycodone Depot Orion prolonged-release tablets according to a fixed schedule need fast-acting pain relievers to treat breakthrough pain. Oxycodone Depot Orion prolonged-release tablets are not suitable for the treatment of breakthrough pain.

The treatment needs to be followed regularly about pain relief and other effects to achieve the best pain treatment possible as well as to be able to treat any side effect in good time and to decide whether the treatment should continue.

Use for children and adolescents

Oxycodone Depot Orion prolonged-release tablets are not recommended for children under 12 years of age.

If you use more Oxycodone Depot Orion then you should

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor or hospital immediately for assessment of the risk and advice.

The following symptoms may occur constricted pupils ( miosis ), impaired breathing (respiratory depression), drowsiness, skeletal muscle weakness, and a drop in blood pressure. In severe cases, circulatory collapse, mental and physical inactivity (dormancy), unconsciousness ( coma ), decrease in heart rate, and accumulation of water in the lungs (non-cardiogenic pulmonary edema ) may occur; abuse of high doses of strong opioids such as oxycodone can be fatal. Under no circumstances should you be exposed to situations that require increased concentration, such as driving a car.

If you forget to use Oxycodone Depot Orion

If you have taken a smaller dose of Oxycodone Depot Orion prolonged-release tablets than you were prescribed or if you missed a dose, the pain relief will be insufficient or stop completely.

You can make up for a missed dose if the next regular intake is not to take place until at least 8 hours. You can then continue to take the medicine as instructed.

You can also take the medicine if the time to the next regular intake is shorter, but postpone the next intake by 8 hours. In principle, you should not take Oxycodone Depot Orion prolonged-release tablets more than once every 8 hours.

Do not take a double dose to make up for a forgotten dose.

If you stop using Oxycodone Depot Orion

Do not stop treatment without informing your doctor.

When a patient no longer needs to be treated with Oxycodone Depot Orion prolonged-release tablets, it is advisable to reduce the daily dose gradually to avoid withdrawal symptoms.

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 serious side effects or symptoms that you should be aware of and actions to take when these side effects or symptoms occur:

If you get any of the following side effects, stop taking Oxycodone Depot Orion prolonged-release tablets and contact your doctor immediately.

Respiratory depression is the most significant risk posed by opioids and is most likely to occur in elderly or debilitated patients. As a result, opioids can cause a sharp drop in blood pressure in patients prone to low blood pressure.

In addition to this, oxycodone can cause constricted pupils, tracheal spasms, and spasms in the smooth muscles and dampen the cough reflex.

Other possible side effects are

Very common (may affect more than 1 user in 10):

Sedation (fatigue to drowsiness); dizziness; headache; constipation; nausea; vomiting; itching.

Common (may affect up to 1 in 10 people):

Several psychological side effects are such as changes in mood (eg anxiety, depression), changes in activity (usually sedation, sometimes accompanied by drowsiness, temporary increase in activity with nervousness and sleep disorders), and changes in behavior (difficulty with the thought process, confusion, individual cases of speech disorders ).
Feeling weak ( asthenia ); tremors, fainting.
Heavy breathing, difficulty breathing, or wheezing ( dyspnoea, bronchospasm ).
Dry mouth, rarely accompanied by thirst and difficulty swallowing, stomach upset, such as stomach pain, diarrhea, upset stomach ( dyspepsia ), no appetite.
Skin problems such as rash, in rare cases, increased photosensitivity ( photosensitivity ), in some cases itching ( urticaria ) or flaking skin (exfoliative dermatitis ).
Constipation (increased frequency of urination), heavy sweating ( hyperhidrosis ), weakness ( asthenia ).

Uncommon (may affect up to 1 in 100 people):

A condition that causes abnormal production of a hormone that reduces the amount of urine (syndrome of insufficient secretion of antidiuretic hormone ).
Changes in perception such as loss of personality, hallucinations (the experience of things that do not exist), emotional instability, changes in the sense of taste, visual disturbances, abnormal acute increased sensitivity to sound (hyperacusis), euphoria, restlessness.
Increased and decreased muscle tension, involuntary muscle twitching, memory disorders ( amnesia ), seizures, speech disorders, decreased sensitivity to touch ( hypesthesia ), coordination disorders, malaise, and crawling ( paresthesia ), fainting ( vertigo ).
Increased heart rate, rapid or irregular heartbeat (supraventricular tachycardia ), palpitations (associated with withdrawal symptoms), dilated blood vessels ( vasodilation ).
Increased cough, inflammation of the throat ( pharyngitis ), runny nose, voice changes.
Cold sores, gingivitis, inflammation of the mouth ( stomatitis ), decreased ability to swallow ( dysphagia ), flatulence.
Belching, intestinal obstruction ( ileus ), taste disturbances, increased liver enzymes,
Dry skin.
Urinary retention.
Disorder of sexual function (decreased sexual desire and impotence ).
Accidental damage; pain (eg chest pain); accumulation of fluid in the tissues ( edema ); migraine; physically dependent with withdrawal symptoms; allergic reactions.
Lack of water in the body ( dehydration ).
Hypersensitivity ( allergic reaction ).
Thirst, changes in tear secretion.
Overindulge.
A ringing tone in the ear ( tinnitus ).
Drug tolerance (an increasing dose is required to achieve the same effect).

Rare (may affect up to 1 in 1,000 people):

Lymph node disease ( lymphadenopathy ).
Seizures, especially in patients with epilepsy, muscle spasms (involuntary
contraction is of the muscles).
Lowering of blood pressure, rarely accompanied by symptoms such as throbbing or
a very fast heartbeat.
Bleeding in the gums, increased appetite, dark-colored stools, tooth discoloration and
tooth damage.
Herpes simplex (disease of the skin and mucous membranes), hives ( urticaria ).
Change in body weight (increase or decrease), cellulite.

Unknown frequency (frequency can not be calculated from known data)

Anaphylactic reaction.
Aggression.
Increased sensitivity to pain (hyperalgesia).
Dental caries.
Bile duct stasis, gallstone attack.
No menstruation ( amenorrhea ).

Withdrawal syndrome with opioids

As oxycodone hydrochloride may lead to drug addiction, there is a risk of developing opioid withdrawal or withdrawal symptoms characterized by one or all of the following; restlessness, watery eyes ( lacrimation ), runny nose, yawning, sweating, chills, muscle pain, pupil dilation, and irregular heartbeat ( palpitation ). Other symptoms may include irritability, anxiety, back pain, joint pain, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea or increased blood pressure, respiratory rate, or heart rate.

Countermeasures

If you notice any of the side effects described above, your doctor will usually take appropriate action.

Constipation can be prevented by a high-fiber diet and increased water intake.

How to store Oxycodone Depot Orion

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister / can and on the carton after “EXP”. The expiration date is the last day of the specified month.

Oxycodone Depot Orion 5 mg prolonged-release tablets:

Do not store above 25 ° C.

Oxycodone Depot Orion 10 mg prolonged-release tablets:

Do not store above 30 ° C.

Oxycodone Depot Orion 15 mg / 20 mg / 30 mg / 40 mg / 60 mg / 80 mg:

This medicine does not require any special storage instructions.

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

Oxycodone Orion Depot prolonged-release tablet contains

The active substance is oxycodone hydrochloride.

5 mg:

Each prolonged-release tablet contains 5 mg oxycodone hydrochloride equivalent to 4.5 mg oxycodone.

Other ingredients are: