ACCORDEON 5 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 food, drink, and alcohol
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Accordeon contains sucrose
9. How to take Accordeon
   1. Recommended dose
   2. Instructions for opening the blister pack:
   3. Taking a higher dose of Accordeon than recommended
   4. Missing a dose of Accordeon
   5. Stopping Accordeon
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 pack
    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 you by a doctor and should not be given 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 inform 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 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 disease after long-term lung disease (cor pulmonale)
If the patient has moderate to severe liver impairment. If the patient has other long-term liver impairment, 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;
has liver or kidney disease;
has myxedema (a thyroid disorder in which the skin is dry, cold, and swollen);
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);
has low blood pressure (hypotension);
has low blood volume (hypovolemia). This can occur in the case of severe external or internal bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting;
has toxic psychosis (a mental disorder caused by infection);
has disorders related to the gallbladder or bile ducts;
has inflammation of the intestine;
has an enlarged prostate, which causes difficulty urinating in men;
has pancreatitis (which causes severe abdominal and back pain);
has severe headaches or nausea, as this may be a sign of increased intracranial pressure;
has breathing difficulties, such as severe lung disease. The doctor will inform the patient about this. Symptoms may include shortness of breath and coughing;
has a history of substance abuse or dependence;
has a history of seizures or convulsions;
has a history of head injury or increased intracranial pressure;
has a history of alcohol abuse or dependence;
has a history of drug abuse or dependence;
has a history of mental health disorders, such as depression, anxiety, or personality disorders.

Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid painkiller.
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.
Risk of these side effects may be higher when using higher doses for longer periods.
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.
Risk of developing dependence or addiction is different for different people.
There may be a higher risk of developing addiction or dependence on Accordeon if:

• the patient (or a family member) has previously abused or been dependent on alcohol, prescription drugs, or illegal substances ("addiction");
• the patient is a smoker;
• the patient has previously had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental health 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 prescribed;
• taking the medicine for reasons other than prescribed, such as "to calm down" or "to help fall asleep";
• repeatedly trying to stop or reduce the use of the medicine, but being unable to do so;
• feeling unwell after stopping the use of the medicine and improving after restarting it ("withdrawal effect").

If the patient has noticed any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the right time and safe way to stop taking the medicine (see section 3 "Stopping Accordeon").
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 contact their doctor.
The doctor may consider reducing the dose.
If the patient is scheduled for surgery, they should inform their doctor about taking this medicine.
Taking crushed or chewed tablets can lead to rapid release and absorption of a potentially fatal dose of oxycodone (see section 3).
Children and adolescents
Accordeon has not been studied in children under 12 years of age.
It is not recommended to use Accordeon 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)
In elderly patients who have not previously taken opioid painkillers, 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 hazardous to health.

Accordeon with food, drink, and alcohol

Consuming 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.
It is recommended that patients taking Accordeon do not drink alcohol.
Patients should avoid drinking grapefruit juice while taking 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 are limited data on the use of oxycodone in pregnant women.
Newborns of mothers who received oxycodone in the last 3-4 weeks before delivery may have severe breathing difficulties.
Withdrawal symptoms can be observed in newborns of mothers receiving oxycodone treatment.
Breastfeeding
In view of this, 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 machinery.
With balanced therapy, a complete ban on driving may not be necessary.
The doctor should assess the patient's ability to drive individually.
Patients should consult their doctor to determine if 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 exactly as prescribed 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, when and how long to take it, when to contact the doctor, and when to stop taking it (see also "Stopping Accordeon").
In case of dosing schedules that cannot be established with 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
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 been taking 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 non-cancer pain, 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 80-120 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 of treatment allows for the selection of the best therapy, quick treatment of side effects, and decision-making regarding continuation of treatment.
Elderly patients (over 65 years)
In the case of frail elderly patients who have not previously taken opioid painkillers, the starting dose is usually one 5 mg tablet every 12 hours.
The doctor will prescribe the dose required for effective pain relief.
Patients should inform their doctor if the taken doses do not provide pain relief.
Patients at risk
If the patient has kidney or liver impairment or is underweight, 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 cup of water) in the morning and evening, according to the established schedule (e.g., at 8 am and 8 pm), with or without food.
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 cup of water) in the morning and evening, according to the established schedule (e.g., at 8 am and 8 pm), with or without food.
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 the 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 treating doctor should adjust the dosage 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 pack:

The medicine is packaged in child-resistant blister packs.
The tablet cannot be pushed through the blister pack.
The blister pack should be opened according to the following instructions:

• 1. Separate a single dose along the perforated line of the blister pack.
• 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 part of the 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 contact the local toxicology center if necessary.
Symptoms of overdose are: constricted pupils, breathing difficulties (respiratory depression), feeling of 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), slowing of heart rate, and fluid accumulation in the lungs (pulmonary edema).
Taking large doses of strong opioid painkillers can be fatal.
Patients 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 missed tablet can be taken if the next scheduled dose is to be taken in at least 8 hours.
Then the patient can continue taking the medicine as prescribed 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.
A double dose should not be taken to make up for a missed dose.

Stopping Accordeon

The patient should not stop treatment without consulting their doctor.
If treatment with Accordeon is no longer necessary, the doctor will gradually reduce the dose to avoid withdrawal symptoms.
In case of any further doubts about the use of 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, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially if these symptoms spread throughout the body.
The most serious side effect is a condition in which the patient breathes more slowly or weakly than they should (respiratory depression).
In such a 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

• 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)

Frequently (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

Less frequently (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 muscle stiffness or relaxation, 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 the 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

Rarely (may affect up to 1 in 1,000 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 for include irritability, excessive activity, sleep disorders, 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 (dysfunction of the Oddi sphincter)

Residues of tablets may be found in the stool. This should not affect the action of the medicine.
Measures
The doctor will take appropriate action in case of any of the above side effects in the patient.
To prevent constipation, patients should consume more fiber and drink more fluids.
If the patient suffers from 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 inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 will help 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 in a person it was not prescribed for.
Do not use this medicine after the expiry date stated on the blister pack or bottle after: "EXP".
The expiry date refers to the last day of the month stated.
The "Lot" statement on the packaging and blister pack means "Batch number".
The "EXP" statement on the packaging and blister pack means "Expiry date".
Do not use the medicine if 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.
Patients 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:
Core of the tablet: sucrose, pellets (containing sucrose, cornstarch, 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 pack

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 blister packs.
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