Oxycodone stada

Package leaflet: Information for the patient

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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 belonging to the opioid group.
Oxycodon Stada is used for the treatment of severe pain which can only be adequately managed
by opioid analgesics.
For use in adults and adolescents above 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 overload of the pulmonary circulation), or acute, severe bronchial asthma;
• if the patient has intestinal paralysis (paralytic ileus);
• if the doctor has advised 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 weakened;
• if the patient has severe impairment of lung, liver, or kidney function;
• if the patient has myxedema (certain thyroid disorders), thyroid dysfunction;
• if the patient has adrenal insufficiency (Addison's disease);
• if the patient has benign prostatic hyperplasia (enlarged prostate);
• 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 apply or have previously applied to the patient.
Tolerance, dependence, and addiction
Oxycodon Stada has inherent abuse potential. With prolonged use, tolerance to its effects may develop, and gradually increasing doses may be required to maintain the desired pain control.
Chronic use of Oxycodon Stada may lead to physical dependence, and withdrawal symptoms may occur after abrupt discontinuation of treatment. 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 for longer periods.
Dependence or addiction may lead to the patient being unable to control how much of the drug to take or how often to take it. The patient may feel a need to take the drug even if it does not relieve pain.
The risk of dependence or addiction varies among individuals. The risk of addiction or dependence on Oxycodon Stada may be higher if:

• the patient or a family member 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 addiction 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 (withdrawal effect). If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the appropriate timing and safe way to discontinue treatment (see section 3 "Discontinuing Oxycodon Stada").

Rarely, increased sensitivity to pain may develop, which cannot be relieved by increasing the dose of the medicine. In such cases, the doctor may reduce the dose or switch to an alternative opioid treatment.
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 effects, 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
Use of Oxycodon Stada may result in positive anti-doping test results.
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 hypoxemia (low oxygen levels in the blood during sleep). Symptoms may include pauses in breathing during sleep, nocturnal awakening due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices such symptoms, contact the doctor. The doctor may consider reducing the dose.
Children
The safety and efficacy of Oxycodon Stada have not been established in children under 12 years of age. 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, such as 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 nausea (antihistamines, antiemetics); other opioids or alcohol may enhance the adverse effects of oxycodone, particularly respiratory depression (breathing difficulties).

Concomitant use of Oxycodon Stada and sedative medicines such as benzodiazepines or similar drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered if no other treatment options are possible.
If the doctor prescribes Oxycodon Stada together with sedative medicines, they should limit the dose and duration of concomitant treatment.
Inform the doctor about all sedative medicines being taken and strictly follow dosing instructions. It may be helpful to inform friends or relatives so they are aware of the above symptoms. If such symptoms occur, contact the doctor immediately.

• Anticholinergic medicines, e.g., other medicines acting on parasympathetic and cholinergic nerve fibers in the central nervous system (psychotropic medicines); medicines used to treat allergies (antihistamines) or nausea (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, and dose adjustment may therefore 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 the metabolism of oxycodone, thereby enhancing its effects.
• Certain antiepileptic medicines (carbamazepine, phenytoin), rifampicin (a medicine used to treat tuberculosis), and herbal medicines containing St. John's wort 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 clotting 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 symptoms such as involuntary, rhythmic muscle contractions (including eye muscles), agitation, excessive sweating, tremor, increased reflexes, increased muscle tone, and elevated body temperature above 38°C. If any of these symptoms occur, contact the doctor immediately.
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 the metabolism of oxycodone, thereby enhancing its effect. Therefore, the patient should avoid drinking grapefruit juice during treatment with Oxycodon Stada.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Oxycodon Stada should not be used during pregnancy unless absolutely necessary. There are 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 childbirth 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 each individual case. 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, meaning it is considered "sodium-free."

3. How to take Oxycodon Stada

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to
expect from taking Oxycodon Stada, when and how long you should take it, when to contact your
doctor, and when you should stop taking it (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, your doctor
will prescribe the appropriate dose and determine the required frequency of administration to treat
your pain.
If you continue to experience pain while taking this medicine, discuss it with your doctor.
Adults with impaired kidney or liver function
The usual starting dose is half the recommended dose for adults. Your doctor will prescribe the
appropriate dose depending on your clinical condition.
Use in children
Oxycodon Stada is not recommended for children under 12 years of age.
Method of administration
Oral use
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.

3. Carefully remove the protective seal to open the cell and remove the capsule from the cell.

Taking more Oxycodon Stada than prescribed
If you take more Oxycodon Stada than prescribed, or if someone else accidentally swallows the
capsules, contact your doctor or local poison control centre 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 fluid accumulation in the lungs may occur.
Abuse of large doses of strong opioids such as oxycodone may result in death. Under no
circumstances should you expose yourself to situations requiring high concentration, e.g. driving a
vehicle.
Missing a dose of Oxycodon Stada
If you miss a dose, take the next dose as soon as possible and then continue taking the medicine
as prescribed. 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 you no longer require treatment with Oxycodon Stada, it may be advisable to 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.
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, you should stop taking Oxycodon Stada and contact your doctor immediately.
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 contraction, and may suppress the cough reflex.

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

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

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

• decreased appetite, loss of appetite;
• severe psychiatric adverse effects such as:
• mood changes (e.g. generalised fear, 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 affect up to 1 in 100 people):

• allergic reactions;
• inappropriate antidiuretic hormone secretion;
• fluid loss from the body (dehydration);
• perceptual disturbances such as depersonalisation, and seeing, hearing or feeling things that do not exist (hallucinations), reduced libido, restlessness, extreme emotional behaviour, sensation of extreme 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 a predisposition to seizures, increased muscle tension and difficulty in stretching muscles, speech disorders, fainting, tingling or prickling sensations (paraesthesia), impaired sense of touch (hypoesthesia), migraine, taste alteration, memory loss;
• disturbances in lacrimation, pupillary constriction, visual disturbances;
• abnormal hearing acuity (auditory hyperacusis), sensation of dizziness or spinning;
• rapid heartbeat, awareness of heart beat (palpitations);
• dilation of blood vessels;
• breathing difficulties, cough, sore throat, runny nose, voice changes;
• difficulty swallowing, oral ulcers, gingivitis, stomatitis, bloating, belching, intestinal obstruction;
• increased liver enzyme activity;
• dry skin;
• difficulty in passing urine;
• impotence;
• low levels of sex hormones in the blood ("hypogonadism", observed in blood tests);
• pain (e.g. chest pain), chills, excess fluid in tissues (oedema), malaise, physical dependence including withdrawal symptoms, drug tolerance requiring increased dosage to maintain effect, craving;
• injuries due to accidents.

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

• herpes simplex (a 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 the urine (haematuria);
• changes in body weight (decrease or increase), inflammation of subcutaneous connective tissue.

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

• exfoliative rash (exfoliative dermatitis).

Unknown (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, hyperactivity and sleep disturbances, high-pitched crying, tremors, vomiting, diarrhoea, and failure to gain weight;
• sleep apnoea (pauses 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, can 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 medication.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 Oxycodon Stada

This medicine should be stored in a place out of sight and reach of children. This medicine must be kept in a closed and secure location inaccessible to others. It may be highly harmful and can cause death in individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the blister pack/label or carton after EXP. The expiry date refers to the last day of the stated 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 in use. This will help 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.
• The 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), indigotine (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 in the Member States of 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 capsules, hard
Oxycodone STADA 10 mg capsules, hard
Oxycodone STADA 20 mg capsules, hard
Poland:
Oxycodon Stada