Oxycodone stada

Patient Information Leaflet

Oxycodon Stada, 5 mg, hard capsules
Oxycodon Stada, 10 mg, hard capsules
Oxycodon Stada, 20 mg, hard capsules
For use in adults and adolescents over 12 years of age.
Oxycodoni hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Oxycodon Stada is and what it is used for

Oxycodon Stada is a centrally-acting, strong analgesic medicine belonging to the opioid group.
Oxycodon Stada is used to treat severe pain that can only be properly managed with opioid analgesics.
For use in adults and adolescents over 12 years of age.

2. Important information before using Oxycodon Stada

When not to take Oxycodon Stada

• 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 severe respiratory disorders (respiratory depression) with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide in the blood (hypercapnia);
• if the patient has chronic obstructive pulmonary disease, cor pulmonale (heart changes caused by long-term pulmonary circulatory overload), or acute, severe bronchial asthma;
• if the patient has intestinal paralysis (paralytic ileus);
• if the doctor advises against taking a strong painkiller (opioid).

Warnings and precautions
Before starting to take Oxycodon Stada, discuss this with your doctor or pharmacist.

• if the patient is elderly or debilitated;
• if the patient has severe impairment of lung, liver, or kidney function;
• if the patient has myxedema (certain thyroid disorders), or thyroid dysfunction;
• if the patient has adrenal insufficiency (Addison's disease);
• if the patient has an enlarged prostate gland (prostate hypertrophy);
• if the patient has pancreatitis;
• in conditions with increased intracranial pressure, such as head injury;
• if the patient has circulatory regulation disorders;
• if the patient has biliary or ureteric colic;
• if the patient has low blood pressure or reduced blood volume;
• if the patient has epilepsy or a tendency to seizures;
• if the patient is taking MAO inhibitors (used in the treatment of depression);
• if the patient has recently undergone intestinal surgery or abdominal surgery;
• if the patient has obstructive or inflammatory bowel disease.

Consult a doctor if any of these conditions affect or have previously affected the patient.
Tolerance, dependence, and abuse
Oxycodon Stada has inherent abuse potential. With prolonged use, tolerance to its effects may develop, requiring gradually increasing doses to maintain desired pain control.
Chronic use of Oxycodon Stada may lead to physical dependence, and withdrawal symptoms may occur if treatment is abruptly discontinued. When the patient no longer requires therapy with Oxycodon Stada, gradual dose reduction may be indicated to avoid withdrawal symptoms.
This medicine contains oxycodone, which is an opioid. Repeated use of opioid painkillers may lead to reduced effectiveness of the drug (the patient's body becomes accustomed to it, known as tolerance). Repeated use of Oxycodon Stada may lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may be higher when higher doses are used over a longer period.
Dependence or abuse 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 abuse varies among individuals. The risk of abuse or dependence on Oxycodon Stada may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines, or drugs (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 Oxycodon Stada, this may indicate that dependence or abuse is developing:

• need to take the medicine longer than prescribed by the doctor;
• need to take a higher dose than recommended;
• use of the medicine for reasons other than prescribed, e.g., "to calm down" or "to help fall asleep";
• repeated, unsuccessful attempts to stop or reduce 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 method of discontinuing treatment (see section 3 "Stopping Oxycodon Stada").

Rarely, increased sensitivity to pain may develop, which cannot be relieved by increasing the dose of the medicine. In such a case, the doctor may reduce the dose or switch to an alternative opioid medicine.
The use of Oxycodon Stada is not recommended before surgery or within 24 hours after surgery.
Under no circumstances should the capsule contents be injected, as this may lead to serious adverse reactions, which may be fatal.
Hormonal changes may occur during treatment with these capsules. The doctor may wish to monitor these changes.
Abuse for doping purposes
The use of Oxycodon Stada may cause positive results in anti-doping tests.
Using Oxycodon Stada as a doping agent may pose a health risk.
Sleep-related breathing disorders
Oxycodon Stada may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxaemia (low oxygen levels in the blood during sleep). Symptoms may include breathing pauses during sleep, nocturnal awakening 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.
Children
The safety and efficacy of Oxycodon Stada in children under 12 years of age have not been established. Therefore, Oxycodon Stada is not recommended for children under 12 years of age.
Oxycodon Stada and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

• Medicines that reduce central nervous system activity, e.g., medicines that help sleep or treat anxiety (sedatives, hypnotics); other medicines acting on the nervous system (phenothiazines, neuroleptics); medicines used to treat depression; muscle relaxants; medicines used to treat allergies or vomiting (antihistamines, antiemetics); other opioids or alcohol may enhance the adverse effects of oxycodone, particularly respiratory disorders (respiratory depression).

Concomitant use of Oxycodon Stada and sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered if other treatment options are not possible.
However, if the doctor prescribes Oxycodon Stada together with sedatives, they should limit the dose and duration of concurrent treatment.
Inform the doctor about all sedative medicines being taken and strictly follow dosing instructions. It may be helpful to inform friends or family members so they are aware of the above symptoms. If such symptoms occur, contact the doctor.

• Anticholinergic medicines, e.g., other medicines acting on parasympathetic and cholinergic nerve fibres in the central nervous system (psychotropic medicines); medicines used to treat allergies (antihistamines) or vomiting (antiemetics); medicines used to treat Parkinson's disease may enhance the adverse effects of oxycodone (e.g., constipation, dry mouth, or urinary disorders).
• Macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin), certain antifungal medicines (e.g., ketoconazole, voriconazole, itraconazole, posaconazole), and antiviral medicines (e.g., boceprevir, ritonavir, indinavir, nelfinavir, saquinavir) may enhance the effect of oxycodone, so dose adjustment may be necessary if the patient is taking these medicines.
• Cimetidine (a medicine used to treat heartburn), paroxetine (a medicine used to treat depression), and quinidine (a medicine used to treat heart conditions) may inhibit oxycodone metabolism, thereby enhancing its effect.
• Certain antiepileptic medicines (carbamazepine, phenytoin), rifampicin (a medicine used to treat tuberculosis), and herbal medicines containing St. John's wort (Hypericum perforatum) may reduce the effect of oxycodone.
• Certain medicines used to treat depression (monoamine oxidase inhibitors) may enhance the adverse effects of oxycodone (e.g., agitation, decreased or increased blood pressure).
• Clinically significant increases or decreases in blood coagulation have been observed in patients when anticoagulant medicines (coumarins) are taken simultaneously with oxycodone hydrochloride.

The risk of adverse effects increases if the patient is taking 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 stiffness, elevated body temperature above 38°C. If the above symptoms occur, contact the doctor.
Oxycodon Stada with food, drink, and alcohol
Consuming alcohol while taking Oxycodon Stada may cause drowsiness or increase the risk of serious adverse effects, such as shallow breathing with risk of respiratory arrest and loss of consciousness. Alcohol consumption is not recommended during treatment with Oxycodon Stada.
Grapefruit juice may inhibit oxycodone metabolism, enhancing its effect. Therefore, the patient should avoid drinking grapefruit juice while taking Oxycodon Stada.
Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
Oxycodon Stada should not be used during pregnancy unless absolutely necessary. There is limited data on the use of oxycodone in pregnant women. Oxycodone crosses the placenta into the fetal circulation.
Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Use of oxycodone during labour may cause breathing problems (respiratory depression) in the newborn.
Breastfeeding
Breastfeeding must be discontinued during treatment with Oxycodon Stada. Oxycodone passes into breast milk and may affect the breastfed infant, especially after repeated doses.
Driving and operating machinery
Oxycodone impairs alertness and reaction ability to such an extent that the ability to drive or operate machinery may be impaired or completely inhibited. In cases of established therapy, a complete ban on driving or operating machinery may not be necessary. The treating doctor must assess individual cases. Discuss with the doctor whether and under what conditions the patient may drive or operate machinery.
Oxycodon Stada contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e., it is considered "sodium-free".

3. How to take Oxycodon Stada

This medicine should always be taken exactly as instructed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the
patient what to expect from taking Oxycodon Stada, when and for how long the patient should take it,
when to contact the doctor, and when treatment should be discontinued (see also "Stopping Oxycodon Stada").
Adults and adolescents over 12 years of age
The usual starting dose is 5 mg of oxycodone hydrochloride every 6 hours. However, the doctor
will prescribe the appropriate dose and determine the required frequency of administration to treat pain.
If the patient continues to experience pain while taking this medicine, this should be discussed with the doctor.
Adults with impaired kidney or liver function
The usual starting dose is half the recommended dose for adults. The doctor will prescribe
the appropriate dose depending on the patient's clinical condition.
Use in children
Oxycodon Stada is not recommended for children under 12 years of age.
Method of administration
Oral administration
Oxycodon Stada should be swallowed whole with an adequate amount of liquid.
Oxycodon Stada may be taken with or without food.
Oxycodon Stada should not be taken with alcoholic beverages.
Instructions for use of child-resistant perforated single-dose blisters:

1. Do not push the capsule directly out of the blister.
2. Separate one blister cell along the perforation line.

3. Carefully remove the protective layer to open the cell and take out the capsule.

Taking more Oxycodon Stada than prescribed
If more Oxycodon Stada has been taken than prescribed, or if someone else accidentally swallows
the patient's capsules, contact the doctor or the local poison control center immediately.
Overdose may lead to:
constricted pupils
respiratory depression
muscle weakness
drowsiness and low blood pressure
brain disorder (known as toxic leukoencephalopathy).
In severe cases, circulatory collapse, lack of mental and physical activity, loss of consciousness,
slowed heart function, and accumulation of fluid in the lungs may occur.
Abuse of large doses of strong opioids such as oxycodone may result in death. Under no circumstances
should one expose oneself to situations requiring high concentration, e.g. driving a vehicle.
Missing a dose of Oxycodon Stada
If a dose is missed, take the next dose as soon as possible and then continue taking the medicine
as directed. Do not take two doses within 4 hours. Do not take a double dose to make up for a missed dose.
Stopping Oxycodon Stada
Do not stop taking this medicine without informing your doctor.
When the patient no longer requires treatment with Oxycodon Stada, gradual dose reduction may be
necessary 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 any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Important adverse effects or symptoms you should be aware of, and actions to take if they occur:
If any of the following adverse effects occur, stop taking Oxycodon Stada immediately and contact your doctor without delay.
Respiratory depression represents the most significant risk associated with opioids, and is most likely to occur in elderly or debilitated patients.
As a consequence, in predisposed patients, opioids may cause significant drops in blood pressure.
In addition, oxycodone may cause pupillary constriction, bronchospasm and smooth muscle spasm, and may suppress the cough reflex.

Other possible adverse effects
Very common (may occur in more than 1 in 10 people):

• sedation (from fatigue to drowsiness);
• dizziness;
• headache;
• constipation;
• nausea;
• vomiting;
• itching.

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

• decreased appetite, loss of appetite;
• severe psychiatric adverse effects such as:
• mood changes (e.g. generalized anxiety, depression);
• changes in activity (mainly sedation, sometimes accompanied by fatigue, occasionally with increased nervousness and sleep disturbances);
• behavioural changes (disturbances in thought process, confusion);
• tremor;
• wheezing, shortness of breath, hiccups;
• dry mouth, abdominal pain, diarrhoea, indigestion;
• rash, excessive sweating;
• increased urge to urinate;
• feeling of weakness (asthenia).

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

• allergic reactions;
• inappropriate secretion of antidiuretic hormone;
• dehydration;
• perceptual disturbances such as depersonalization, and seeing, hearing or feeling things that do not exist (hallucinations), decreased libido, restlessness, extreme emotional behaviour, feeling of intense happiness, drug or medication dependence (see section 2);
• increased or decreased muscle tone, coordination disorders, involuntary muscle contractions, seizures; particularly in patients with epilepsy or seizure tendency, increased muscle tension and difficulty in muscle stretching, speech disorders, fainting, tingling or prickling sensations (paraesthesia), impaired sense of touch (hypoesthesia), migraine, altered taste, memory loss;
• lacrimation disorders, pupillary constriction, visual disturbances;
• abnormal auditory hypersensitivity (hyperacusis), sensation of dizziness or spinning;
• rapid heartbeat, awareness of heartbeat;
• vasodilation;
• breathing difficulties, cough, sore throat, runny nose, voice changes;
• difficulty swallowing, mouth ulcers, gingivitis, stomatitis, bloating, belching, intestinal obstruction;
• increased liver enzyme activity;
• dry skin;
• difficulty urinating;
• impotence;
• low levels of sex hormones in blood ("hypogonadism", observed in blood tests);
• pain (e.g. chest pain), chills, excessive fluid in tissues (oedema), malaise, physical dependence including withdrawal symptoms, drug tolerance requiring increased dosing to maintain effect, craving;
• injuries resulting from accidents.

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

• herpes simplex (skin and mucous membrane disease);
• lymph node disease (lymphadenopathy);
• increased appetite;
• low blood pressure, dizziness upon standing from sitting or lying positions;
• bleeding gums, black stools, tooth discolouration and damage;
• itchy skin rash (urticaria), increased sensitivity to light (photophobia);
• muscle spasms;
• blood in urine (haematuria);
• changes in body weight (decrease or increase), inflammation of subcutaneous connective tissue.

Very rare (may occur in up to 1 in 10,000 people):

• exfoliative rash (exfoliative dermatitis).

Not known (frequency cannot be estimated from available data):

• severe hypersensitivity reactions (anaphylactic reactions);
• aggressive behaviour;
• increased sensitivity to pain that cannot be relieved by increasing the dose;
• dental caries;
• pain in the right side of the abdomen, itching and jaundice caused by gallbladder inflammation;
• absence of menstruation;
• prolonged use of Oxycodon Stada during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to watch for in infants include irritability, hyperexcitability and sleep disturbances, high-pitched crying, tremors, vomiting, diarrhoea, and failure to gain weight;
• sleep apnoea (interruptions in breathing during sleep).

Remedial measures:
If the patient experiences any of the adverse effects listed above, the doctor will take appropriate action. Constipation, as an adverse effect, may be prevented by a diet enriched with fibre and increased fluid intake. If the patient experiences nausea or vomiting, the doctor will prescribe an appropriate medicine.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects may also be reported to the marketing authorisation holder. Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Oxycodon Stada

Keep this medicine out of the sight and reach of children. This medicine should be stored in a closed and secure place inaccessible to others. It may be highly harmful and could 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/label or carton after EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Oxycodon Stada contains

• The active substance is oxycodone hydrochloride.
  Oxycodon Stada 5 mg, hard capsules: Each hard capsule contains 5 mg of oxycodone hydrochloride, equivalent to 4.5 mg of oxycodone.
  Oxycodon Stada 10 mg, hard capsules: Each hard capsule contains 10 mg of oxycodone hydrochloride, equivalent to 9 mg of oxycodone.
  Oxycodon Stada 20 mg, hard capsules: Each hard capsule contains 20 mg of oxycodone hydrochloride, equivalent to 18 mg of oxycodone.
• Other ingredients are:
  Excipients: microcrystalline cellulose, magnesium stearate.
  Capsule shell: gelatin, water, sodium lauryl sulfate, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132).
  Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.

What Oxycodon Stada looks like and contents of the pack
Oxycodon Stada 5 mg:
Hard capsules, 14.4 mm in length, with a dark pink body marked with the number "5" and a brown cap marked with "OXY".
Oxycodon Stada 10 mg:
Hard capsules, 14.4 mm in length, with a white body marked with the number "10" and a brown cap marked with "OXY".
Oxycodon Stada 20 mg:
Hard capsules, 14.4 mm in length, with a light pink body marked with the number "20" and a brown cap marked with "OXY".

Pack sizes:
10, 14, 28, 30 or 56 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Balkanpharma-Dupnitsa AD
3, Samokovsko Shosse Street
2600 Dupnitsa
Bulgaria

This medicinal product is authorised for sale in the European Economic Area under the following names:
Czech Republic:
OXYKODON STADA
Germany:
Oxycodon AL 5 mg Hartkapseln
Oxycodon AL 10 mg Hartkapseln
Oxycodon AL 20 mg Hartkapseln
Finland:
Oxycodone STADA 5 mg kapseli, kova
Oxycodone STADA 10 mg kapseli, kova
Oxycodone STADA 20 mg kapseli, kova
Poland:
Oxycodon Stada