Accordeon

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 specifically for you. 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 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 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 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 illness or depression.

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;
• using 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 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 the treatment (see section 3 "Stopping Accordeon").
Sleep-related breathing difficulties
Accordeon may cause sleep-related breathing difficulties, 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 for use 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 medicines, treatment usually starts with the lowest dose.

Accordeon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those 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 (MAOI) 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 hypnotics);
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 heartbeat);
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);
the herbal remedy 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 with sedatives, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, their concurrent use should only be considered when other treatment options are not possible.
If the doctor has prescribed Accordeon with sedatives, 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 regarding dosage. It may be helpful to inform friends or relatives to be aware of the above symptoms. In case of such symptoms, 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, muscle tension, and elevated body temperature above 38°C. In case of the above symptoms, the patient should contact their doctor.

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.
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 child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There are limited data on the use of oxycodone during pregnancy. Newborns of mothers who received oxycodone during 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
Due to the risk of side effects, Accordeon should not be used during breastfeeding.

Driving and using machines

Oxycodone may impair alertness and reaction time 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 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 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
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 possible dose change during treatment.
Patients who have previously taken other strong painkillers (opioids) may be prescribed a higher starting dose by the doctor, taking into account their previous reaction 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 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 decision-making regarding the continuation of treatment.
Elderly patients (over 65 years)
In frail elderly patients who have not previously taken opioid medicines, 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 impairment or has a low body mass, the doctor may recommend reducing the starting dose.

Method of administration

Accordeon, 5 mg prolonged-release tablets
The 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), with or without food.
Accordeon, 10/20/40/80 mg prolonged-release tablets
The 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), with or without food.
The prolonged-release tablets should not be crushed or chewed, as this leads to the loss of their properties. Chewing and crushing Accordeon can lead to the rapid release 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 serious, life-threatening events.
The treating doctor should adjust the dosage according to the severity of the pain and the patient's reaction to the 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. Tear off a single dose along the perforated line of the blister pack.
• 2. This will reveal 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 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 known as 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 painkillers (opioids) 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 difficult 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 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.
The patient should not take a double dose to make up for the 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
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 subsides after a few days)
• dizziness
• headaches
• nausea and vomiting (usually subside 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 resolve this issue)

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

• dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea
• confusion, 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), gastritis, 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
• 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 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.
• prolonged 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 disturbances, high-pitched crying, tremors, vomiting, diarrhea, and failure to gain weight.
• 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 action of the medicine.
Measures
The doctor will take appropriate action in case of 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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 will help 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, inaccessible to others. It can be very harmful and may cause death in a person for whom it has not been prescribed.
Do not use this medicine after the expiration date stated on the blister pack or bottle after:
“EXP”. The expiration date refers to the last day of the specified month.
The term "Lot" on the packaging and blister pack means "Batch number".
The term "EXP" on the packaging and blister pack means "Expiration 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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, equivalent to 4.5 mg/9.0 mg/17.9 mg/36 mg/72 mg of oxycodone.
The 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 pack

Accordeon, 5 mg, are white or almost white, biconvex, round prolonged-release tablets
Accordeon, 10 mg, are pink, oval, biconvex prolonged-release tablets with a score line on both sides, which allows the tablet to be divided into two equal parts.
Accordeon, 20 mg, are white or almost white, oval, biconvex prolonged-release tablets with a score line on both sides, which allows the tablet to be divided into two equal parts.
Accordeon, 40 mg, are pale pink, oval, biconvex prolonged-release tablets with a score line on both sides, which allows the tablet to be divided into two equal parts.
Accordeon, 80 mg, are red, oval, biconvex prolonged-release tablets with a score line on both sides, which allows the tablet to 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