ACCORDEON 10 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Accordeon, 5 mg, prolonged-release tablets
3. Accordeon, 10 mg, prolonged-release tablets
4. Accordeon, 20 mg, prolonged-release tablets
5. Accordeon, 40 mg, prolonged-release tablets
6. Accordeon, 80 mg, prolonged-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
7. What is Accordeon and what is it used for
8. Important information before taking Accordeon
   1. When not to take Accordeon
   2. Warnings and precautions
   3. Accordeon with other medicines
   4. Accordeon with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Accordeon contains sucrose
9. How to take Accordeon
   1. Recommended dose
   2. Instructions for opening the blister:
   3. Taking a higher dose of Accordeon than recommended
   4. Missing a dose of Accordeon
   5. Stopping Accordeon treatment
10. Possible side effects
    1. Reporting side effects
11. How to store Accordeon
12. Contents of the packaging and other information
    1. What Accordeon contains
    2. What Accordeon looks like and contents of the packaging
    3. Marketing authorization holder
    4. Importer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. Date of last revision of the leaflet: May 2024

Leaflet accompanying the packaging: patient information

Accordeon, 5 mg, prolonged-release tablets

Accordeon, 10 mg, prolonged-release tablets

Accordeon, 20 mg, prolonged-release tablets

Accordeon, 40 mg, prolonged-release tablets

Accordeon, 80 mg, prolonged-release tablets

Oxycodone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.

• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Accordeon and what is it used for
• 2. Important information before taking Accordeon
• 3. How to take Accordeon
• 4. Possible side effects
• 5. How to store Accordeon
• 6. Contents of the packaging and other information

1. What is Accordeon and what is it used for

The active substance of the medicine is oxycodone, which belongs to a group of medicines called strong painkillers.
Accordeon is used to treat severe pain that can only be adequately managed with opioid painkillers.
Accordeon is indicated for adults and adolescents over 12 years of age.

2. Important information before taking Accordeon

When not to take Accordeon

If the patient is allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
If the patient has breathing difficulties, such as chronic obstructive pulmonary disease, severe asthma or severe respiratory depression. The doctor will inform the patient if they have any of these conditions. Symptoms may include shortness of breath, coughing, and slower or weaker breathing.
If the patient has a disease in which the small intestine does not work properly (paralytic ileus), the stomach empties more slowly than it should (delayed gastric emptying), or severe abdominal pain.
If the patient has heart problems after a long-standing lung disease (cor pulmonale)
If the patient has moderate to severe liver impairment. If the patient has other long-standing liver disorders, taking this medicine requires special recommendation by the doctor.
If the patient has constipation.
In children under 12 years of age.

Warnings and precautions

Before starting to take Accordeon, the patient should discuss it with their doctor or pharmacist.
if the patient is elderly or weakened;
has hypothyroidism, as they may require a lower dose;
if the patient has liver or kidney disease;
if the patient has myxedema (a thyroid disorder in which the skin is dry, cold, and swollen);
if the patient has adrenal insufficiency (the adrenal glands do not work properly, which can cause symptoms such as weakness, weight loss, dizziness, nausea, or vomiting (e.g., Addison's disease);
if the patient has low blood pressure (hypotension);
if the patient has low blood volume (hypovolemia). This can occur in case of severe external or internal bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting;
if the patient has psychotic disorders caused by infection (toxic psychosis);
if the patient has disorders related to the gallbladder or bile ducts;
if the patient has inflammation of the intestine;
if the patient has an enlarged prostate gland, which causes difficulty urinating in men;
if the patient has inflammation of the pancreas (which causes severe abdominal and back pain);
if the patient has severe headaches or nausea, as this may be a sign of increased intracranial pressure;
if the patient has breathing difficulties, such as severe lung disease. The doctor will inform the patient about this. Symptoms may include shortness of breath and coughing;
agitation, anxiety, tremors, or sweating after stopping alcohol or medication use;
if the patient has increased sensitivity to pain;
if the patient needs increasingly higher doses of oxycodone to achieve the same level of pain relief (tolerance).

If the patient experiences severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, they should consult their doctor, as these may be symptoms related to pancreatitis and bile duct disorders.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers can lead to reduced efficacy of the medicine (the patient's body gets used to it, which is called tolerance).
Repeated use of Accordeon may lead to dependence, abuse, and addiction, which can be life-threatening. The risk of these side effects may be higher when using higher doses for a longer period.
Dependence or addiction can lead to the patient being unable to control how much medicine they take or how often they take it. The patient may feel the need to take the medicine even if it does not relieve pain.
The risk of developing dependence or addiction varies from person to person. The risk of addiction or dependence on Accordeon may be higher if:

• the patient (or a family member) has ever abused or been dependent on alcohol, prescription drugs, or illegal substances ("addiction");
• the patient is a smoker;
• the patient has ever had mood disorders (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental disorders.

If the patient notices any of the following symptoms while taking Accordeon, it may indicate that they are developing dependence or addiction.

• need to take the medicine for longer than prescribed by the doctor;
• need to take a higher dose than recommended;
• using the medicine for reasons other than prescribed, such as "to calm down" or "to help fall asleep";
• making repeated, unsuccessful attempts to stop or reduce the use of the medicine;
• feeling unwell after stopping the medicine and improving after resuming it ("withdrawal effect").

If the patient has observed any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the right time and safe way to stop treatment (see also "Stopping Accordeon treatment").
Sleep-related breathing disorders
Accordeon may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and hypoxemia during sleep (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, they should consult their doctor. The doctor may consider reducing the dose.
If the patient is scheduled for surgery, they should inform their doctor in the hospital about taking this medicine.
Taking crushed or chewed tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone (see "Taking a higher dose of Accordeon than recommended").
Children and adolescents
Accordeon has not been studied in children under 12 years of age. It is not recommended to use the medicine in children under 12 years of age, as the safety and efficacy of the medicine in this patient group have not been established.
Elderly patients (over 65 years old)
In elderly patients who have not taken opioid medicines before, treatment usually starts with the lowest dose.
Anti-doping warning
Taking Accordeon may result in positive doping test results.
Taking Accordeon as a doping agent can be a health hazard.

Accordeon with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription. If the patient takes Accordeon with other medicines, the effect of this medicine or other medicines may change.
The patient should tell their doctor or pharmacist if they are taking:
a type of medicine called a monoamine oxidase inhibitor or if they have taken this type of medicine in the last two weeks;
medicines that help them sleep or relax (e.g., sedatives or sleeping pills);
medicines used to treat depression (e.g., paroxetine);
medicines used to treat mental disorders (e.g., phenothiazine derivatives or neuroleptics);
other strong painkillers;
muscle relaxants;
medicines used to treat high blood pressure;
quinidine (a medicine used to treat rapid heart rate);
cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
antifungal medicines (e.g., ketoconazole, voriconazole, itraconazole, and posaconazole);
antibiotics (e.g., clarithromycin, erythromycin, or telithromycin);
medicines called "protease inhibitors" used to treat HIV (e.g., boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
rifampicin (used to treat tuberculosis);
carbamazepine (a medicine used to treat epilepsy, seizures, or certain pain conditions);
phenytoin (a medicine used to treat epilepsy or seizures);
a herbal remedy called St. John's Wort (also known as Hypericum perforatum);
antihistamines;
medicines used to treat Parkinson's disease.
The patient should also inform their doctor about any recent anesthesia.
Taking Accordeon and sedatives, such as benzodiazepines or similar medicines, at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, taking them together should only be considered when other treatment options are not possible.
If the doctor has prescribed Accordeon and sedatives at the same time, the dose and duration of concurrent treatment should be limited.
The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's instructions for dosing. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.
The risk of side effects increases if the patient is taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, increased muscle tone, elevated body temperature above 38°C. If the patient experiences any of these symptoms, they should contact their doctor.

Accordeon with food, drink, and alcohol

Drinking alcohol while taking Accordeon increases the feeling of drowsiness and may also increase the risk of serious side effects, such as slowed breathing with the risk of respiratory arrest and loss of consciousness.
The patient is advised not to drink alcohol while taking Accordeon.
The patient should avoid drinking grapefruit juice during treatment with this medicine.
Accordeon can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
there is limited experience. Newborns of mothers who received oxycodone in the last 3-4 weeks before delivery may have serious breathing difficulties. Withdrawal symptoms can be observed in newborns of mothers receiving oxycodone treatment.
Breastfeeding
in this case, Accordeon should not be used during breastfeeding.

Driving and using machines

Oxycodone may impair alertness and reaction ability to such an extent that the patient may have reduced ability or be unable to drive vehicles and operate machines.
With balanced therapy, a complete ban on driving may not be necessary. The doctor should assess the patient's ability to drive individually.
The patient should consult their doctor about whether and under what conditions they can drive a car.
To learn about possible side effects that may affect the ability to drive and concentrate, see section 4 "Side effects".

Accordeon contains sucrose

The medicine contains sucrose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Accordeon

This medicine has been prescribed by the doctor to relieve severe pain for 12 hours.
This medicine should always be taken as directed by the doctor.
In case of doubts, the patient should consult their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Accordeon treatment, when and how long to take it, when to contact the doctor, and when to stop taking it (see also "Stopping Accordeon treatment").
In case of dosing schedules that cannot be established using this medicine, there are other medicines with different strengths or forms that can be used.

Recommended dose

Accordeon, 5 mg / 10 mg / 20 mg / 40 mg / 80 mg prolonged-release tablets
Adults and adolescents over 12 years of age
The usual starting dose is 10 mg of oxycodone hydrochloride every 12 hours.
The doctor, based on previous dosing, will decide on the daily dose, the division of the daily dose into individual doses, and any change in dosing during treatment.
Patients who have previously taken other strong opioid painkillers may be prescribed a higher starting dose by the doctor, taking into account their previous response to opioids.
Patients who have taken Accordeon, 5 mg prolonged-release tablets according to a fixed schedule, may need a fast-acting painkiller to quickly relieve breakthrough pain. Accordeon, 5 mg, prolonged-release tablets are not intended for quick relief of breakthrough pain.
For the treatment of pain other than cancer, the daily dose of 40 mg of oxycodone hydrochloride is usually sufficient, but higher doses may be necessary. Patients with cancer pain usually require doses of 80 to 120 mg of oxycodone hydrochloride, which may be increased to 400 mg in special cases.
Treatment should be monitored, taking into account pain relief and other factors. Monitoring treatment allows for the selection of the best therapy, quick treatment of side effects, and decisions about continuing treatment.
Elderly patients (over 65 years old)
In the case of frail elderly patients who have not taken opioid medicines before, the starting dose is usually one 5 mg tablet taken every 12 hours. The doctor will prescribe the dose required for effective pain relief. The patient should inform their doctor if the taken doses do not provide pain relief.
Patients at risk
If the patient has kidney or liver disorders or has a low body mass, the doctor may recommend reducing the starting dose.
Method of administration
Accordeon, 5 mg, prolonged-release tablets
Tablets should be swallowed whole with a sufficient amount of liquid (½ glass of water) in the morning and evening, according to the established schedule (e.g., at 8 am and 8 pm), regardless of meals or with meals.
Accordeon, 10/20/40/80 mg, prolonged-release tablets
Tablets should be swallowed whole or broken into two parts with a sufficient amount of liquid (½ glass of water) in the morning and evening, according to the established schedule (e.g., at 8 am and 8 pm), regardless of meals or with meals.
Prolonged-release tablets should not be crushed or chewed, as this leads to loss of their properties. Chewing and crushing Accordeon leads to rapid release of the active substance into the body and absorption of a potentially fatal dose of oxycodone (see "Taking a higher dose of Accordeon than recommended").
Accordeon should only be taken orally. In case of intravenous administration, the excipients of the medicine may cause destruction (necrosis) of local tissues, changes in lung tissue (pulmonary granuloma), or other severe, life-threatening events.
The doctor should adjust the dosing based on the severity of the pain and the patient's response to therapy. The medicine should be taken twice a day in the amount prescribed by the doctor.

Instructions for opening the blister:

The medicine is packaged in blisters, protected against opening by children. The tablet cannot be squeezed through the blister. The blister should be opened according to the following instructions:

• 1. Tear off a single dose along the perforated line of the blister.
• 2. This will expose a non-adhesive surface located where the perforated lines intersect.
• 3. Pull the non-adhesive strip and tear off the remaining protective layer.

Taking a higher dose of Accordeon than recommended

In case of taking a higher dose of Accordeon than recommended, the patient should immediately consult their doctor, who will notify the local toxicology center if necessary.
Overdose symptoms include: constricted pupils, breathing difficulties (respiratory depression), muscle weakness, and low blood pressure. Overdose can lead to brain damage called toxic leukoencephalopathy. In severe cases, it can cause circulatory collapse, physical and mental numbness, loss of consciousness (coma), slowed heart rate, and fluid accumulation in the lungs (pulmonary edema). Taking large doses of strong opioid painkillers can be fatal. The patient should absolutely avoid situations that require increased concentration, such as driving a car.

Missing a dose of Accordeon

In case of taking a lower dose of Accordeon than recommended or missing a dose, pain relief may be impaired or impossible.
The patient can take the missed tablet if the next scheduled dose is to be taken in at least 8 hours. Then, the patient can continue taking the medicine as directed by the doctor.
The patient can also take the prolonged-release tablet if the next scheduled dose is to be taken in less than 8 hours; in this case, the next dose should be delayed by 8 hours.
As a rule, the medicine should not be taken more often than every 8 hours.
The patient should not take a double dose to make up for a missed dose.

Stopping Accordeon treatment

The patient should not stop treatment without consulting their doctor.
If Accordeon treatment is no longer necessary, the doctor will gradually reduce the dose to avoid withdrawal symptoms.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Accordeon can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although severe allergic reactions are rare.
The patient should immediately inform their doctorif they suddenly experience wheezing, breathing difficulties, swelling of the eyelids, face, or lips, rash, or itching, especially if it affects the whole body.
The most serious side effect is a condition in which the patient breathes more slowly or weakly than they should (respiratory depression). In this case, the patient should immediately inform their doctor.
As with all strong painkillers, there is a risk of dependence on this medicine.
Other possible side effects
Very common (may affect more than 1 in 10 people):

• itching of the skin
• drowsiness (usually occurs when starting to take the medicine or increasing the dose; the symptom usually disappears after a few days)
• dizziness
• headaches
• nausea and vomiting (usually disappear after a few days; however, if the problem persists, the doctor may prescribe a medicine to prevent nausea)
• constipation (the doctor may prescribe a laxative to solve this problem)

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

• dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea
• disorientation, depression, feeling of unusual weakness, tremors, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, thinking disorders, or abnormal dreams
• breathing difficulties or wheezing, shortness of breath, weakened cough reflex
• rash
• sweating
• Uncommon (may affect up to 1 in 100 people):
• difficulty swallowing, belching, hiccups, gas, abnormal bowel movements (obstruction), stomach inflammation, changes in taste
• dizziness or feeling of "spinning", hallucinations, mood changes, unpleasant or embarrassing moods, feeling of great happiness, anxiety, agitation, general malaise, memory loss, speech difficulties, decreased sensitivity to pain or touch, feeling of tingling or numbness, seizures or convulsions, blurred vision, fainting, unusual stiffness or relaxation of muscles, and involuntary muscle contractions
• difficulty urinating, impotence, decreased sex drive, low hormone levels in the blood ("hypogonadism", observed in blood tests)
• rapid, irregular heartbeat, flushing of the skin
• dehydration, thirst, chills, swelling of hands, ankles, or feet
• dry skin, severe peeling or flaking of the skin, hives
• flushing of the face, decreased pupil size, muscle spasms, high fever
• need to take increasingly higher doses of the medicine to achieve the same level of pain relief (tolerance)
• colicky abdominal pain or discomfort
• worsening of liver function test results (observed in blood tests)
• Rare (may affect up to 1 in 1000 people):
• low blood pressure
• dizziness, especially when standing up
• hives
• Frequency not known (frequency cannot be estimated from the available data):
• increased sensitivity to pain
• aggression
• absence of menstruation
• blockage of bile flow from the liver (cholestasis). This can cause itching of the skin, yellowing of the skin, very dark urine, and very light stools.
• long-term use of oxycodone during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms in the child to watch out for include irritability, excessive activity, sleep disturbances, high-pitched crying, tremors, vomiting, diarrhea, and lack of weight gain.
• Sleep apnea (pauses in breathing during sleep).
• A disorder affecting the valve in the intestines, which can cause severe abdominal pain (Oddie's sphincter dysfunction)

The patient may notice remnants of tablets in their stool. This should not affect the medicine's action.
Measures to be taken
The doctor will take appropriate action if the patient experiences any of the above side effects. To prevent constipation, the patient should consume more fiber and drink more fluids. If the patient experiences nausea, the doctor should prescribe appropriate medicines.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Accordeon

The medicine should be stored out of sight and reach of children. This medicine should be stored in a closed and secure place, to which other people do not have access. It can be very harmful and may cause death if taken by someone it was not prescribed for.
The patient should not use this medicine after the expiry date stated on the blister or bottle after: "EXP". The expiry date refers to the last day of the month stated.
The term "Lot" on the packaging and blister means "Batch number".
The term "EXP" on the packaging and blister means "Expiry date".
The patient should not use the medicine if they notice that the tablets are damaged (broken or crushed).
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Accordeon contains

The active substance of the medicine is oxycodone hydrochloride.
Each prolonged-release tablet contains 5 mg/10 mg/20 mg/40 mg/80 mg of oxycodone hydrochloride, which corresponds to 4.5 mg/9.0 mg/17.9 mg/36 mg/72 mg of oxycodone.
Other ingredients are:
Tablet core: sucrose, pellets (containing sucrose, cornstarch, starch hydrolyzates, colorants), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, propylene glycol, sodium carmellose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica
Coating:
5 mg and 20 mg: titanium dioxide (E 171), macrogol 3350, talc.
10 mg and 40 mg: titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172)
80 mg: macrogol 3350, talc, iron oxide red (E 172)

What Accordeon looks like and contents of the packaging

Accordeon, 5 mg, are white or almost white, biconvex, round prolonged-release tablets
Accordeon, 10 mg, are pink, oblong, biconvex prolonged-release tablets with a score line on both sides, along which the tablet can be divided into two equal parts.
Accordeon, 20 mg, are white or almost white, oblong, biconvex prolonged-release tablets with a score line on both sides, along which the tablet can be divided into two equal parts.
Accordeon, 40 mg, are pale pink, oblong, biconvex prolonged-release tablets with a score line on both sides, along which the tablet can be divided into two equal parts.
Accordeon, 80 mg, are red, oblong, biconvex prolonged-release tablets with a score line on both sides, along which the tablet can be divided into two equal parts.
Pack sizes:
10, 14, 20, 28, 30, 50, 56, 60, 98, 100, and 120 prolonged-release tablets packaged in PVC/PE/PVDC/Aluminum blisters.
10, 20, 30, 50, 100 prolonged-release tablets packaged in HDPE bottles.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Importer

Phast Gesellschaft für Pharmazeutische Qualitätsstandards mbH
Kardinal-Wendel-Strasse 16
66424 Homburg
Germany
Develco Pharma GmbH
Grienmatt 27,
79650 Schopfheim,
Germany
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: May 2024