Accordeon

Package leaflet: Information for the patient

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
Oxycodoni hydrochloridum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm another person, even if their symptoms are the same.

• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, you should inform your doctor or

Contents of the leaflet

1. What Accordeon is and what it is 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 pack and other information

1. What Accordeon is and what it is used for

The active substance in Accordeon is oxycodone, which belongs to a group of medicines called strong painkillers.
Accordeon is used to treat severe pain which can only be appropriately 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 disorders such as chronic obstructive pulmonary disease, severe
bronchial asthma or severe respiratory depression. The doctor will inform the patient whether they
have any of these conditions. Symptoms may include shortness of breath, cough, or slower or
weaker breathing.
If the patient has a condition in which the small intestine does not function properly (paralytic
ileus), the stomach empties more slowly than normal (delayed gastric emptying), or if the patient
has severe abdominal pain.
If the patient has heart disease due to long-term lung disease (cor pulmonale).
If the patient has moderate to severe liver impairment. If the patient has other long-term liver
disorders, taking this medicine requires special medical advice.
If the patient has constipation.
In children under 12 years of age.

Warnings and precautions
Before starting to take Accordeon, discuss this with your doctor or pharmacist if:
the patient is elderly or debilitated;
the patient has hypothyroidism, as a lower dose may be required;
the patient suffers from liver or kidney disease;
the patient suffers from myxoedema (a thyroid disorder in which the skin is dry, cold,
and swelling of the skin on the face and limbs occurs);
the patient has adrenal insufficiency (the adrenal glands do not function properly,
which may cause symptoms such as weakness, weight loss, dizziness, nausea or
vomiting (e.g. Addison's disease);
the patient has low blood pressure (hypotension);
the patient has low blood volume (hypovolemia). This may occur in cases of severe
external or internal bleeding, severe burns, excessive sweating,
severe diarrhoea or vomiting;
the patient has psychiatric disorders resulting from infection (toxic psychosis);
the patient has disorders related to the gallbladder or bile ducts;
the patient has intestinal inflammation;
the patient has an enlarged prostate gland, causing difficulty in passing urine in men;
the patient has inflammation of the pancreas (causing severe pain in the abdomen and
back);
the patient has severe headaches or nausea, as these may be symptoms of
increased intracranial pressure;
the patient has breathing disorders such as severe lung disease. The doctor will inform
the patient. Symptoms may include shortness of breath and cough;
agitation, anxiety, tremor or
sweating, after stopping alcohol consumption or taking medicines;
the patient has increased sensitivity to pain;
the patient requires increasingly higher doses of oxycodone to achieve the same level
of pain relief (tolerance).

Contact your doctor if the patient experiences severe pain in the upper abdomen, possibly radiating
to the back, nausea, vomiting or fever, as these may be symptoms associated with
pancreatitis and biliary tract inflammation.

Tolerance, dependence and addiction
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid
painkillers may lead to reduced effectiveness of the medicine (the patient's body becomes
accustomed to it, known as tolerance).
Repeated use of the medicinal product Accordeon may lead to dependence, misuse and addiction,
which may lead to life-threatening overdose. The risk of these adverse effects may be higher when
higher doses are used for a prolonged period.
Dependence or addiction may lead to the patient being unable to control how much
medicine to take or how often to take it. The patient may feel a need to take the medicine,
even if it does not relieve pain.
The risk of dependence or addiction varies between individuals. The risk of addiction or
dependence on Accordeon may be higher if:

• the patient (or someone in their family) has ever misused or been dependent on alcohol, prescription medicines 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, this may indicate that dependence or addiction is developing:

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

If the patient observes any of these symptoms, they should contact their doctor
to discuss the best treatment plan for them, including the appropriate timing and safe
way to discontinue treatment (see section 3 "Stopping treatment with Accordeon").

Sleep-related breathing disorders
Accordeon may cause sleep-related breathing disorders, such as
sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxaemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep or excessive daytime sleepiness. If
the patient or another person notices such symptoms, contact the doctor. The doctor may
consider reducing the dose.
If the patient is scheduled for surgery, inform the hospital doctor about taking this
medicine.
Taking crushed tablets or chewing them leads to rapid release and absorption
of a potentially fatal dose of oxycodone (see section 3).

Children and adolescents
Studies on the use of Accordeon in children under 12 years of age have not been conducted. Use of this medicine is not recommended in children under 12 years of age, as safety and efficacy have not been established in this patient group.

Elderly patients (over 65 years)
In elderly patients who have not previously used opioid medicines, treatment usually starts with the lowest dose.

Anti-doping warning
Use of Accordeon may result in a positive anti-doping test.
Using Accordeon as a doping agent may pose a health risk.

Accordeon and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines available without a prescription. If the patient takes Accordeon with other medicines, the effect of this medicine or other medicines may change.
Tell your doctor or pharmacist if the patient is taking:
a type of medicine called a monoamine oxidase inhibitor or if the patient has taken such
a medicine within the last two weeks;
medicines to help sleep or to calm down (e.g. sedatives or hypnotics);
medicines used to treat depression (e.g. paroxetine);
medicines used to treat psychiatric 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 epileptic seizures, convulsions and certain
pain conditions);
phenytoin (a medicine used to treat epileptic seizures or convulsions);
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 the doctor about any recent anaesthesia.
Concomitant use of Accordeon and sedative medicines such as benzodiazepines or similar
medicines increases the risk of drowsiness, breathing difficulties (respiratory depression),
coma and may be life-threatening. For this reason, concomitant use should only be considered
if no other treatment options are possible.
If the doctor has prescribed Accordeon together with sedative medicines, the dose and duration of
concomitant treatment should be limited.
Inform the doctor about all sedative medicines being taken and strictly
follow the doctor's dosing instructions. It may be helpful to inform friends or relatives so they are aware of the above-mentioned symptoms. If such symptoms occur, contact the doctor.
The risk of adverse effects increases if the patient takes antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine,
paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the patient to experience the following symptoms: involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, increased reflexes, increased muscle tension, elevated body temperature above 38°C. If the above symptoms occur, contact the doctor.

Accordeon with food, drink and alcohol
Consuming alcohol while taking Accordeon intensifies drowsiness and may also
increase the risk of serious adverse effects such as shallow breathing with risk of respiratory arrest and loss of consciousness.
It is recommended that patients taking Accordeon do not drink alcohol.
Avoid drinking grapefruit juice during treatment with this medicine.
Accordeon can be taken with or without food.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
Data are limited. Newborns of mothers who received oxycodone during the last 3-4 weeks before
delivery may have serious breathing difficulties. Withdrawal symptoms may be observed in
newborns of mothers receiving oxycodone treatment.

Breastfeeding
Oxycodone passes into breast milk.
Therefore, 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
limited ability or may not be able to drive or operate machinery at all.
With balanced therapy, a complete ban on driving may not be necessary. The doctor
should assess the patient's individual ability to drive.
Consult the doctor about whether and under what conditions the patient may drive a car.
For information on possible adverse effects affecting the ability to drive and concentrate, see section 4 "Adverse effects".

Accordeon contains sucrose
This medicine contains sucrose. If the patient has been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Accordeon

This medicine has been prescribed by your doctor to relieve severe pain over a 12-hour period.
This medicine should always be taken exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Accordeon, when and how long you should take it, when to contact your doctor, and when to stop taking it (see also "Stopping Accordeon").
For dosing regimens that cannot be achieved with this medicine, other strengths or formulations are available.

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.
Your doctor will determine the daily dose, how the daily dose is divided into individual doses, and whether dose adjustments are needed during treatment, based on prior opioid exposure.
Patients who have previously taken other strong opioid painkillers may be prescribed a higher starting dose, taking into account their previous response to opioids.
Patients who have been taking Accordeon 5 mg prolonged-release tablets according to a regular schedule may require a fast-acting painkiller to relieve breakthrough pain. Accordeon 5 mg prolonged-release tablets are not intended for the rapid relief of pain.
For the treatment of non-cancer-related pain, a daily dose of 40 mg of oxycodone hydrochloride is usually sufficient, although higher doses may be required. Patients with cancer-related pain typically require doses of 80 to 120 mg of oxycodone hydrochloride, which may be increased up to 400 mg in exceptional cases.
Treatment should be monitored, taking into account pain relief and other factors. Monitoring allows for optimal therapy selection, prompt management of adverse effects, and decisions regarding continuation of treatment.

Elderly patients (over 65 years of age)
In frail elderly patients who have not previously taken opioids, the usual starting dose is one 5 mg tablet every 12 hours. Your doctor will prescribe the dose required for effective pain relief. Inform your doctor if the prescribed doses do not provide adequate pain relief.

Patients at risk
If a patient has kidney or liver impairment or low body weight, the doctor may recommend a reduced starting dose.

Method of administration
Accordeon 5 mg prolonged-release tablets
Swallow the tablets whole with sufficient fluid (½ glass of water) in the morning and evening, according to the prescribed schedule (e.g., 8 a.m. and 8 p.m.), with or without food.

Accordeon 10/20/40/80 mg prolonged-release tablets
Swallow the tablets whole or split in half with sufficient fluid (½ glass of water) in the morning and evening, according to the prescribed schedule (e.g., 8 a.m. and 8 p.m.), with or without food.

Do not crush or chew prolonged-release tablets, as this destroys their properties. Chewing or crushing Accordeon tablets leads to rapid, uncontrolled release of the active substance into the body and may result in life-threatening absorption of oxycodone (see section "Taking more Accordeon than you should").

Accordeon must only be taken orally. Intravenous administration may cause destruction (necrosis) of local tissues, lung tissue changes (pulmonary granuloma), or other serious, life-threatening events due to the excipients in the formulation.

Your treating physician should adjust the dose according to the intensity of pain and your body's response to therapy. The medicine should be taken twice daily in the amount prescribed by your doctor.

Instructions for opening the blister pack:
The medicine is packaged in child-resistant blister packs. Do not push the tablet through the blister. Open the blister according to the following instructions:

1. Tear off a single dose along the perforated line of the blister.
2. This exposes a non-adhered tab located at the intersection of the perforated lines.
3. Pull the non-adhered tab to remove the remaining protective layer.

Taking more Accordeon than you should
If you take more Accordeon than prescribed, contact your doctor immediately. Your doctor may contact the local poison control center if necessary.
Symptoms of overdose include: pinpoint pupils, breathing difficulties (respiratory depression), muscle weakness, and low blood pressure. Overdose may lead to a brain disorder known as toxic leukoencephalopathy. In severe cases, circulatory collapse, physical and mental stupor, loss of consciousness (coma), slowed heart rate, and fluid accumulation in the lungs (pulmonary edema) may occur. Taking large doses of strong opioid painkillers may lead to death. Avoid situations requiring high concentration, such as driving a car.

If you forget to take Accordeon
If you take less than the prescribed dose or miss a dose, pain relief may be inadequate or impossible.
You may take the missed tablet if the next scheduled dose is due in at least 8 hours. Then continue taking the medicine as prescribed by your doctor.
If the next scheduled dose is due in less than 8 hours, take the missed tablet and delay the next dose by 8 hours.
In general, do not take the medicine more often than every 8 hours.
Do not take a double dose to make up for a missed dose.

Stopping Accordeon
Do not stop treatment without consulting your doctor.
If treatment with Accordeon is no longer needed, your doctor will gradually reduce the dose to avoid withdrawal symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
All medicines can cause allergic reactions, although severe allergic reactions are rare.
You should contact your doctor immediately if you suddenly develop wheezing, breathing difficulties,
eyelid swelling, facial or lip swelling, rash or itching, particularly if it spreads all over the body.
The most serious adverse effect is a condition in which the patient breathes more slowly or weakly
than normal (respiratory depression). In such a case, you should contact your doctor immediately.
As with all strong painkillers, there is a risk that you could become addicted to this medicine.

Other possible adverse effects

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

• itching of the skin
• drowsiness (usually occurs when starting treatment or increasing the dose; symptoms usually resolve within a few days)
• dizziness
• headache
• nausea and vomiting (usually resolve within a few days; if the problem persists, your doctor may prescribe an anti-nausea medicine)
• constipation (your doctor may recommend a laxative to help relieve this problem)

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

• dry mouth, loss of appetite, indigestion, stomach pain or discomfort, diarrhoea
• disorientation, depression, unusual tiredness, tremor, lack of energy, fatigue, restlessness, nervousness, difficulty sleeping, thinking disturbances 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, burping, hiccups, flatulence, intestinal dysfunction (obstruction), stomach inflammation, taste changes
• dizziness or a spinning sensation, hallucinations, mood changes, unpleasant or embarrassing moods, feelings of intense happiness, anxiety, agitation, general malaise, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness, seizures or convulsions, blurred vision, fainting, unusual muscle stiffness or relaxation, and involuntary muscle contractions
• difficulty passing urine, impotence, reduced sex drive, low levels of sex hormones in the blood ("hypogonadism", observed in blood tests)
• fast or irregular heartbeat, skin redness
• dehydration, thirst, chills, swelling of the hands, ankles or feet
• dry skin, severe flaking or peeling of the skin, urticaria
• facial flushing, pupil constriction, muscle spasms, high body temperature
• 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
• urticaria

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

• increased sensitivity to pain
• aggression
• absence of menstruation
• blockage of bile flow from the liver (cholestasis). This may cause itchy skin, yellowing of the skin, very dark urine, and very pale stools.
• prolonged use of oxycodone during pregnancy may cause life-threatening withdrawal symptoms in newborn babies. Symptoms to watch for in the baby include irritability, excessive activity, sleep disturbances, high-pitched crying, tremors, vomiting, diarrhoea, and failure to gain weight.
• sleep apnoea (pauses in breathing during sleep)
• a disorder affecting the valve in the intestine, which may cause severe pain in the upper abdomen (Oddi sphincter dysfunction)

Undissolved tablet residues may be seen in the stool. This should not affect the medicine's effectiveness.

Management of adverse effects
Your doctor will take appropriate action if you experience any of the adverse effects listed above.
To prevent constipation, you should consume more dietary fibre and drink more fluids. If you experience nausea, your doctor should prescribe appropriate medication.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store the medicine Accordeon

The medicine should be stored in a place inaccessible and not visible to children. This medicine must be kept in a closed and secure place to which others cannot gain access. It may be highly harmful and may cause death in a person for whom it has not been prescribed.
Do 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 stated month.
The term "Lot" on the packaging and blister means "Batch number".
The term "EXP" on the packaging and blister means "Expiry date".
Do not use the medicine if you notice that the tablets are damaged (broken or crushed).
No special storage instructions apply.
Medicines must not be disposed of via the sewage system or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Accordeon contains
The active substance is oxycodone hydrochloride.
Each prolonged-release tablet contains 5 mg/10 mg/20 mg/40 mg/80 mg of oxycodone hydrochloride, corresponding to 4.5 mg/9.0 mg/17.9 mg/36 mg/72 mg of oxycodone.
The other ingredients are:
Tablet core: sucrose, granules (containing sucrose, corn starch, starch hydrolysates, colouring agents), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, propylene glycol, sodium carmellose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silicon dioxide.
Coating:
5 mg and 20 mg: titanium dioxide (E 171), macrogol 3350, talc.
10 mg and 40 mg: titanium dioxide (E171), 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, round, biconvex prolonged-release tablets.
Accordeon 10 mg are pink, elongated, biconvex prolonged-release tablets, with a division line on both sides along which the tablet can be divided into two equal parts.
Accordeon 20 mg are white or almost white, elongated, biconvex prolonged-release tablets, with a division line on both sides along which the tablet can be divided into two equal parts.
Accordeon 40 mg are pale pink, elongated, biconvex prolonged-release tablets, with a division line on both sides along which the tablet can be divided into two equal parts.
Accordeon 80 mg are red, elongated, biconvex prolonged-release tablets, with a division 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 in PVC/PE/PVDC/Aluminium blisters.
10, 20, 30, 50, 100 prolonged-release tablets in HDPE bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: +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.
Lutomierska 50 Street
95-200 Pabianice
Poland

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