OSSICODONE 5 mg Extended-Release Tablet

Зміст інструкції

1. Ossicodone Aurobindo 5 mg prolonged-release tablets, 10 mg prolonged-release tablets, 20 mg prolonged-release tablets
   1. What is Ossicodone Aurobindo and what is it used for
   2. What you need to know before you take Ossicodone Aurobindo
   3. How to take Ossicodone Aurobindo
   4. Possible side effects
   5. How to store Ossicodone Aurobindo
   6. Package contents and other information

Ossicodone Aurobindo 5 mg prolonged-release tablets, 10 mg prolonged-release tablets, 20 mg prolonged-release tablets

oxycodone hydrochloride

Generic medicine

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ossicodone Aurobindo is and what it is used for
• 2. What you need to know before you take Ossicodone Aurobindo
• 3. How to take Ossicodone Aurobindo
• 4. Possible side effects
• 5. How to store Ossicodone Aurobindo
• 6. Contents of the pack and other information

1. What is Ossicodone Aurobindo and what is it used for

Ossicodone Aurobindo contains the active ingredient oxycodone, which belongs to a group of
medicines called opioids, which are strong painkillers.
Ossicodone Aurobindo is used to relieve severe pain that can only be controlled
with opioid analgesics in adults and adolescents aged 12 years and older.

2. What you need to know before you take Ossicodone Aurobindo

Do not take Ossicodone Aurobindo:

• if you are allergic to oxycodone hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe breathing problems, low levels of oxygen in the blood (hypoxia) or too much carbon dioxide in the blood;
• if you suffer from a severe chronic obstructive pulmonary disease, cor pulmonale (heart changes due to chronic overload of the pulmonary circulation) or acute severe bronchial asthma;
• if you suffer from intestinal paralysis;
• if you have suffered from acute abdomen or if you suffer from delayed gastric emptying.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ossicodone Aurobindo:

• if you are elderly or debilitated,
• if you have problems with your lungs, liver or kidneys,
• if you suffer from some diseases of the thyroid gland, impaired thyroid gland function,
• if you have poor adrenal gland function (the adrenal gland does not work properly), such as Addison's disease,
• if you suffer from enlargement of the prostate gland (prostatic hypertrophy),
• if you or a family member has ever abused or been dependent on alcohol, prescription medications or illegal drugs (“addiction”);
• if you are a smoker;
• if you have had mood disorders (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
• if you suffer from inflammation of the pancreas,
• if you suffer from conditions with increased brain pressure, such as head injury,
• if you suffer from circulatory regulation disorders,
• if you suffer from biliary and ureteral colic,
• if you suffer from low blood pressure or reduced blood volume,
• if you suffer from epilepsy or if you have a tendency to seizures,
• if you are taking MAO inhibitors (for the treatment of depression),
• if you suffer from inflammatory bowel disorders,
• if you have recently undergone abdominal surgery.

Repeated use of Ossicodone Aurobindo can cause dependence and abuse, which can lead to a
potentially fatal overdose. Ask your doctor for advice if you are afraid of developing a
dependence on Ossicodone Aurobindo.
This medicine can cause breathing problems during sleep. These problems can
include pauses in breathing during sleep, waking up short of breath, difficulty
falling asleep or excessive daytime sleepiness. If you or someone else observes these symptoms
contact your doctor. The doctor may decide to reduce the dose.
Talk to your doctor if any of these conditions apply to you or if any of these conditions
have affected you in the past.
The most dangerous consequence of an opioid overdose is weakening and slowing
of breathing (respiratory depression). This is more likely to occur in elderly
and debilitated patients and can also cause a drop in blood oxygen levels.
Ossicodone Aurobindo has a primary dependence potential. When used for a long
period of time, tolerance to the effects can develop and progressively higher doses may be necessary
to maintain pain control.
Opioids are not the first choice of treatment for non-cancer pain and are not
recommended as a single treatment. Other medicines should be used in the treatment of
chronic pain along with opioids. The doctor should monitor you carefully and make the necessary
dose adjustments while taking Ossicodone Aurobindo to prevent dependence and
abuse.
Chronic use of Ossicodone Aurobindo can lead to physical dependence and withdrawal symptoms may occur after abrupt discontinuation. When a patient no longer needs
oxycodone hydrochloride therapy, it is advisable to gradually reduce the dose to
prevent withdrawal symptoms.
Rarely, increased sensitivity to pain that does not respond to dose increases can develop. If
this happens, the doctor will reduce the dose or switch to an alternative opioid pain reliever.
The use of Ossicodone Aurobindo is not recommended before surgery or within 24 hours
after surgery.
Ossicodone Aurobindo must be used with particular caution in patients with a history of
or current abuse of alcohol and drugs. Do not drink alcohol while taking Ossicodone
Aurobindo. Drinking alcohol while taking Ossicodone Aurobindo may make you more sleepy or
increase the risk of serious side effects such as labored breathing with the risk of not
breathing anymore, and loss of consciousness.

Breathing-related sleep disorders
Ossicodone Aurobindo can cause sleep-related breathing disorders, such as sleep apnea
(pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty falling asleep or excessive daytime sleepiness. If you or another person observe these symptoms, see your doctor. The doctor may consider reducing the dose.

Children and adolescents
Ossicodone has not been studied in children under 12 years of age. Because its safety and
efficacy have not been established, use in children under 12 years of age is not recommended.

Elderly patients
If renal or hepatic function is not impaired, dose adjustment is usually not necessary in elderly patients.

Anti-doping warning
Athletes should be aware that this medicine may cause a positive result in “doping tests”. The use of Ossicodone Aurobindo as a doping agent may become dangerous for
health.

Other medicines and Ossicodone Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• sleeping pills or tranquilizers (sedatives, hypnotics);
• antidepressants;
• anesthetics;
• muscle relaxants;
• other opioids or alcohol can enhance the undesirable effects of oxycodone, in particular depressed breathing (respiratory depression);
• other medicines that act against the parasympathetic and cholinergic nerve fibers in the central nervous system;
• medicines used to treat allergies (antihistamines);
• medicines used to treat vomiting (antiemetics);
• medicines used to treat Parkinson's disease may enhance the undesirable effects of oxycodone (e.g. constipation, dry mouth or urinary disorders);
• coumarin anticoagulants (medicines used to reduce blood clotting);
• monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, isoniazid, tranylcypromine or selegiline as they may enhance some undesirable effects of oxycodone (e.g. excitement, reduction or increase in blood pressure);
• St. John's wort (herbal remedy);
• medicines used to treat epilepsy (carbamazepine, phenytoin);
• medicines used to treat tuberculosis such as rifampicin.

The concomitant use of Ossicodone Aurobindo and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma
and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Ossicodone Aurobindo together with sedatives, the dose and
duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow your
doctor's recommendations on dosage. It may be helpful to inform friends or relatives to pay
attention to the signs and symptoms listed above. See your doctor if you experience these symptoms.
The risk of side effects increases with the intake of antidepressants (such as citalopram,
duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines
can interact with oxycodone and you may experience symptoms such as involuntary and
rhythmic muscle contractions, including the muscles that control eye movements, agitation, excessive sweating,
tremor, exaggerated reflexes, increased muscle tension and body temperature above
38°C. See your doctor if you experience these symptoms.
The following medicines can increase the levels of oxycodone in the blood and the doctor may
need to review the dose of Ossicodone Aurobindo:

• medicines used to treat infections (e.g. clarithromycin, erythromycin and telithromycin) or to treat fungal infections (e.g. ketoconazole, voriconazole, itraconazole or posaconazole), medicines used to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir)
• cimetidine (for treating heartburn)
• medicines such as paroxetine and fluoxetine (antidepressants)
• quinidine (used in the treatment of heart diseases)

Grapefruit juice can also increase the levels of oxycodone in the blood.

Ossicodone Aurobindo with food, drinks and alcohol
Do not drink alcohol while taking Ossicodone Aurobindo. Drinking alcohol while taking
Ossicodone Aurobindo may make you more sleepy or increase the risk of serious side effects
such as labored breathing with the risk of not breathing anymore, and loss of consciousness.
Grapefruit juice can inhibit the metabolism of oxycodone which will increase its effect. Therefore
you should avoid drinking grapefruit juice while taking Ossicodone Aurobindo.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are limited data on the use of oxycodone in pregnant women. Oxycodone crosses the placenta
and enters the baby's bloodstream.
Prolonged use of oxycodone during pregnancy can cause withdrawal symptoms in
newborns. Newborns born to mothers treated with oxycodone during the last 3-4 weeks before
labor should be monitored for respiratory depression. The use of oxycodone during
labor can cause serious breathing difficulties in the newborn.
Ossicodone Aurobindo should be used during pregnancy only if the benefit outweighs the possible
risks to the baby.
Breastfeeding
Oxycodone passes into breast milk and can cause breathing difficulties in the newborn. Ossicodone
Aurobindo should not be taken during breastfeeding.
Fertility
There are no data on the effect of oxycodone on fertility in men. Studies in rats have not
shown any effect on fertility.

Driving and using machines
Oxycodone can affect your ability to drive and use machines.
With stable therapy, a general prohibition of driving is not necessary. The treating doctor must
assess the individual situation. Discuss with your doctor whether or under what conditions you can drive a
vehicle.

Ossicodone Aurobindo contains lactose
This product contains lactose. If your doctor has told you that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

3. How to take Ossicodone Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Adults and adolescents (aged 12 years and over)
The usual starting dose is 5 or 10 mg of oxycodone hydrochloride at intervals of 12 hours. However, the
doctor will prescribe you the dose needed to treat the pain.
Further determinations of the daily dose, the division into single doses and any adjustment
of the dose during the further course of therapy are made by the treating physician and depend on the
previous dosage.
Patients who are already receiving opioids may start treatment with higher doses, taking
into account their experience with previous opioid therapies.
Some patients receiving Ossicodone Aurobindo according to a fixed dosing schedule need
fast-acting painkillers as a rescue medication to control intense episodic pain. Ossicodone Aurobindo is not indicated for the treatment of intense episodic
pain.
For the treatment of non-cancer pain, a dose of 40 mg of oxycodone hydrochloride (20 mg
administered twice daily) is generally sufficient; however, higher doses may be required. Patients with cancer pain generally need doses between 80 to 120
mg of oxycodone hydrochloride, which, in individual cases, may be increased up to 400 mg.
Treatment should be monitored regularly to assess pain relief and other effects in order to achieve the best possible pain therapy, as well as being able to treat
any potential adverse effects promptly and to decide on the continuation of the
treatment.

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

Method and duration of administration
Swallow the extended-release tablet whole with a sufficient amount of liquid (½
glass of water), with or without food, in the morning and evening according to a fixed dosing schedule
(e.g. at 8:00 a.m. and 8:00 p.m.).
The tablets must not be broken, crushed or chewed as this leads to a rapid release
of oxycodone due to damage to the extended-release properties. The administration
of broken, chewed or crushed Ossicodone Aurobindo leads to the rapid release and absorption of
a potentially lethal dose of oxycodone (see section “If you take more Ossicodone Aurobindo
than you should”). Ossicodone Aurobindo is for oral use only. In case of inappropriate injection
(injection into a vein), the excipients of the tablet can lead to destruction (necrosis) of the
local tissue, changes in lung tissue (pulmonary granulomas) or other serious and
potentially fatal events.

[Only for child-resistant blister packs]

Instructions for using child-resistant blister packs:

• 1. Do not try to press the tablet directly out of the cavity. The tablet cannot be pressed out of the blister. It must be peeled off.
• 2. First separate one unit of the blister from the rest of the strip along the perforations.

• 3. Then carefully pull the backing sheet to open the cavity.

• 4. You can then remove the tablet from the blister. [Only for child-resistant bottle packs:]

Instructions for using the child-resistant bottle
Press the cap and turn to open.

The doctor will adjust the dosage according to the intensity of the pain and how you respond to treatment.
Take the number of extended-release tablets prescribed by your doctor twice a day.

If you take more Ossicodone Aurobindo than you should
If you have taken more Ossicodone Aurobindo than you have been prescribed, you must inform
your doctor or local poison control center immediately. The following symptoms may occur: constricted
pupils, depressed breathing, flaccidity of skeletal muscles, drowsiness and low blood pressure.
In severe cases, circulatory collapse, mental and motor inactivity, loss of
consciousness, slowing of the heart rate, fluid accumulation in the lungs, low blood pressure and death may occur; abuse of high doses of strong opioids such as oxycodone can be fatal. Do not
under any circumstances expose yourself to situations that require a high level of concentration, such as driving
a vehicle.

If you forget to take Ossicodone Aurobindo
If you take a lower dose of Ossicodone Aurobindo than prescribed by your doctor, or if
you skip a dose, the pain relief will consequently be insufficient or will cease altogether.
You can make up a missed dose if the next regular dose is not due for at least
another 8 hours. You can then continue taking the tablets as prescribed.
You should take the extended-release tablets even if the time for the next regular dose
is shorter, but you should delay the next dose by 8 hours. In principle, you should not
take Ossicodone Aurobindo more than once every 8 hours.
Do not take a double dose to make up for a missed dose.

If you stop taking Ossicodone Aurobindo
Do not stop treatment without informing your doctor.
When a patient no longer needs Ossicodone Aurobindo-based therapy, it is advisable
to reduce the dose gradually to prevent withdrawal symptoms.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Signs or significant side effects to be considered and measures to be taken when these signs or effects
occur:
Stop taking Ossicodone Aurobindo and inform your doctor immediately if you experience any of the
following side effects.
Respiratory depression is the most significant risk induced by opioids and is more likely to occur in elderly
or debilitated patients. Consequently, in predisposed patients, opioids can cause severe drops in blood
pressure.
In addition to this, oxycodone can cause constriction of the pupils, bronchospasm, spasms in the smooth
muscles and suppress the cough reflex.

Other possible side effects
Very common (may affect more than 1 in 10 people):

• sedation (tiredness up to drowsiness) - this is more likely when you start taking the tablets or when the dose is increased, but should subside after a few days
• dizziness
• headache
• constipation
• nausea
• vomiting
• itching.

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

• feeling of weakness (asthenia)
• numerous psychological side effects such as:
• alterations in mood (e.g., anxiety, depression)
• changes in activity (nervousness and insomnia)
• alterations in performance (abnormal thinking, confusion, amnesia, isolated cases of speech disorders)
• involuntary tremor
• depressed breathing
• difficulty breathing or wheezing
• dry mouth, rarely accompanied by thirst; gastrointestinal disorders such as stomach pain, diarrhea, stomach upset, loss of appetite
• skin disorders such as rash, rarely increased sensitivity to light (photosensitivity), in isolated cases rash with itching or scaling, excessive sweating
• urinary disorders (frequent urination)
• abnormal dreams.

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

• allergic reactions
• dehydration
• agitation
• alteration of perception such as emotional instability, depersonalization, feeling of extreme happiness, hallucinations, altered taste, visual disturbances, unusually acute sense of hearing, feeling of dizziness or spinning, reduced sexual drive, low levels of sex hormones in the blood ("hypogonadism", detected with a blood test), drug dependence (see section 2)
• abnormal production of the antidiuretic hormone
• memory loss, seizures, increased rigidity and difficulty stretching muscles, increase and decrease in muscle tone, tics, reduced sense of touch, coordination disorders, speech disorder, fainting, tingling
• feeling unwell, fast pulse, feeling your heartbeat
• dilation of blood vessels
• increased cough, pharyngitis, runny nose, nosebleeds, changes in voice, difficulty breathing
• oral ulcers, gum inflammation, inflamed mouth, difficulty swallowing, flatulence, intestinal obstruction
• increased liver enzymes
• dry skin
• difficulty passing urine
• sexual dysfunction, impotence
• injuries due to accidents
• pain (e.g. chest pain), excessive fluid in the tissues (edema), chills, hiccups, thirst, migraine, physical dependence with withdrawal symptoms
• disturbance of tear secretion, constriction of the pupils, impaired vision.

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

• lymph node disease
• lowering of blood pressure, dizziness when getting up from sitting or lying down
• muscle spasms (involuntary muscle contraction)
• gum bleeding, increased appetite, dark stools, spots on teeth
• herpes simplex (skin and mucous membrane disorder)
• urticaria
• blood in urine
• changes in body weight (increase or loss), cellulite

Frequency not known (frequency cannot be estimated from the available data):

• severe hypersensitivity reactions (anaphylactic reactions)
• aggression
• increased sensitivity to pain that cannot be improved by increasing the dose
• damage to teeth
• pain on the right side of the abdomen, itching and jaundice caused by inflammation of the gallbladder
• absence of menstrual bleeding
• sleep breathing problems (sleep apnea syndrome)
• spasm of the urethra
• long-term use of Ossicodone Aurobindo during pregnancy can cause potentially life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the newborn include irritability, hyperactivity and altered sleep patterns, high-pitched crying, tremor, malaise, diarrhea and failure to gain weight
• sleep apnea (pauses in breathing during sleep).

Counteracting measures
If you experience any of the side effects listed above, your doctor will take appropriate
measures.
The side effect of constipation can be prevented with a diet rich in fiber and drinking a
greater amount of fluids.
If you suffer from nausea or vomiting, your doctor may prescribe you an appropriate medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Ossicodone Aurobindo

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, on the carton and on the
bottle after EXP. The expiry date refers to the last day of that month.

Blister packs:Do not store at a temperature above 25°C.

HDPE container:
5mg, 10 mg: Do not store at a temperature above 30 °C.
20 mg: This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ossicodone Aurobindo contains

• The active ingredient is oxycodone hydrochloride. Each prolonged-release tablet contains 5, 10 or 20 mg of oxycodone hydrochloride.
• Other ingredients are: Tablet core:Lactose monohydrate, hypromellose, povidone, stearic acid, magnesium stearate, anhydrous colloidal silica. Coating:5 mg: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, Aluminium Indigo Carmine (E132), yellow iron oxide (E172). 10 mg: Titanium dioxide (E171), hypromellose, macrogol, polysorbate 80. 20 mg: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172).

Description of the appearance of Ossicodone Aurobindo and package contents

Ossicodone Aurobindo5 mg prolonged-release tablets are blue, round,
biconvex tablets, with a diameter of 7 mm, with “OX 5” imprinted on one side.

Ossicodone Aurobindo10 mg prolonged-release tablets are white, round,
biconvex tablets, with a diameter of 9 mm, with “OX 10” imprinted on one side.

Ossicodone Aurobindo20 mg prolonged-release tablets are pink, round,
biconvex tablets, with a diameter of 7 mm, with “OX 20” imprinted on one side.
Ossicodone Aurobindo is available in blister packs (PVC/Aluminum) of:
5 mg: 1, 20, 28, 30, 50, 56, 60 and 100 prolonged-release tablets.
10 mg, 20 mg: 1, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets.
Ossicodone Aurobindo is available in child-resistant blister packs
(PVC/PVdC/Al/PET/paper) of:
5 mg: 1, 20, 28, 30, 50, 56, 60 and 100 prolonged-release tablets
10 mg, 20 mg: 1, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets.
Ossicodone Aurobindo is also available in white, round HDPE tablet containers
with LDPE caps containing 98 and 100 prolonged-release tablets.
And in child-resistant, white, round HDPE tablet containers with PP caps
containing 98 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l. – Via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer:
Generis Farmacêutica, S.A. - Rua João de Deus, nº 19, Venda Nova - 2700-487 Amadora - Portugal
Puren Pharma GmbH & Co. KG - Willy-Brandt-Allee 2 - 81829 München - Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: Oxycodon Retard AB 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80
mg prolonged-release tablets
Germany: Oxycodonhydrochlorid Puren 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60
mg, 80 mg Retardtabletten
Italy: Ossicodone Aurobindo
Netherlands: Oxycodon HCl Aurobindo Retard 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40
mg, 60mg, 80 mg tablets with prolonged release