Oxycodone vitabalans

Package leaflet: Information for the patient

Oxycodone Vitabalans, 5 mg, coated tablets
Oxycodone Vitabalans, 10 mg, coated 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.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Oxycodone Vitabalans is and what it is used for
2. Important information before taking Oxycodone Vitabalans
3. How to take Oxycodone Vitabalans
4. Possible side effects
5. How to store Oxycodone Vitabalans
6. Contents of the pack and other information

1. What Oxycodone Vitabalans is and what it is used for

Oxycodone Vitabalans contains oxycodone as the active substance, which belongs to a group of strong painkillers known as opioids. Oxycodone Vitabalans is used in adults and adolescents aged 12 years and older for the treatment of severe pain that requires opioid analgesic therapy.

2. Information before taking Oxycodone Vitabalans

When not to take Oxycodone Vitabalans:

• if the patient is allergic to oxycodone 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 (hypercapnia);
• if the patient has breathing problems such as severe chronic lung disease or severe bronchial asthma;
• if the patient has heart disorders resulting from long-term lung disease (cor pulmonale);
• if the patient has elevated levels of carbon dioxide in the blood;
• if the patient has conditions related to intestinal obstruction (paralytic ileus), severe abdominal pain, or delayed gastric emptying.

Warnings and precautions
Before using Oxycodone Vitabalans, consult a doctor or
pharmacist. Before starting to take Oxycodone Vitabalans, consult
your
doctor or pharmacist:

• if the patient is elderly or frail;
• if the patient has severe impairment of lung, liver, or kidney function;
• if the patient has thyroid disease (myxedema) or underactive thyroid (hypothyroidism);
• if the adrenal glands do not produce enough hormone (Addison's disease or adrenal insufficiency), which may cause weakness, weight loss, dizziness, nausea, vomiting;
• if the patient has psychiatric disorders due to intoxication, e.g. alcohol (toxic psychosis);
• in case of benign prostatic hyperplasia;
• in case of pancreatitis (causing severe abdominal and back pain) or disorders of the gallbladder;
• if the patient has inflammatory bowel diseases (inflammation of the colon and small intestine);
• if the patient has difficulty urinating or pain during urination;
• if the patient has hypovolemia (reduced blood volume in circulation);
• if the patient has severe headaches or nausea, which may indicate increased intracranial pressure;
• if the patient has low blood pressure or dizziness upon standing;
• if the patient has epilepsy or a tendency to seizures;
• when taking medicines known as MAO inhibitors (used in the treatment of depression or Parkinson's disease).

Contact a doctor if the patient develops severe upper abdominal pain, possibly radiating to the back,
nausea, vomiting, or fever, as these may be symptoms associated with
pancreatitis and biliary tract disorders.
Before undergoing surgery, inform the doctor about the use of Oxycodone
Vitabalans.
Oxycodone Vitabalans may lead to physical dependence and withdrawal symptoms if opioid therapy is stopped abruptly. If continued use of the medicine is no longer necessary, gradual reduction of the daily dose is recommended to avoid withdrawal symptoms.
Tolerance, dependence, and abuse
This medicine contains oxycodone, which is an opioid. It may cause dependence and (or)
abuse.
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may reduce the effectiveness of the medicine (the patient's body becomes accustomed to it, known as tolerance). Repeated use of Oxycodone Vitabalans may lead to dependence, misuse, and abuse, 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 Oxycodone Vitabalans may be higher if:

• the patient (or a family member) 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 Oxycodone
Vitabalans, it may indicate the development of dependence or abuse:

• 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 medicine use;
• feeling unwell after stopping the medicine and improvement after restarting (withdrawal effect).

If the patient observes any of these symptoms, they should contact a doctor to discuss the best treatment plan, including the appropriate timing and safe way to discontinue treatment (see section 3 "Stopping treatment with Oxycodone Vitabalans").
Very rarely, hyperalgesia (increased sensitivity to pain) may occur, which does not respond to further increases in oxycodone dose, especially with high-dose treatment. A reduction in oxycodone dose or a switch to another opioid may be required.
Sleep-related breathing disorders
Oxycodone Vitabalans may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and nocturnal hypoxemia (low oxygen levels in the blood during sleep). 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 a doctor. The doctor may consider reducing the dose.
Children
The safety and efficacy of Oxycodone Vitabalans have not been sufficiently studied in children under 12 years of age. Therefore, Oxycodone Vitabalans is not recommended for use in children under 12 years of age.
Oxycodone Vitabalans and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Inform your doctor or pharmacist if the patient is taking any of the following
medicines:

• strong painkillers (e.g. other opioids);
• medicines that help sleep or treat anxiety (sedatives and hypnotics);
• medicines used to treat depression;
• medicines used for psychiatric disorders (such as antipsychotics);
• medicines used during surgical procedures (anesthetics);
• muscle relaxants;
• medicines used to treat allergic reactions (antihistamines);
• medicines used to treat nausea and vomiting (antiemetics);
• monoamine oxidase inhibitors (MAO inhibitors) or if the patient has taken MAO inhibitors within the last two weeks. MAO inhibitors are medicines used to treat depression or Parkinson's disease;
• medicines used in Parkinson's disease;
• macrolide antibiotics (e.g. clarithromycin, erythromycin, telithromycin);
• azole antifungal medicines (e.g. ketoconazole, voriconazole, itraconazole, posaconazole);
• protease inhibitors used in HIV treatment (e.g. boceprevir, ritonavir, indinavir, nelfinavir, saquinavir);
• cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
• rifampicin (an antibiotic used to treat tuberculosis);
• carbamazepine or phenytoin (medicines used for epilepsy);
• St. John's wort (in herbal products);
• paroxetine (an antidepressant);
• quinidine (a medicine used for heart arrhythmia);
• anticoagulants (medicines that prevent blood clots).

Concomitant use of Oxycodone Vitabalans and sedatives 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 when no other treatment options are available.
If a doctor prescribes Oxycodone Vitabalans together with sedative medicines, the doctor should also limit the dose and duration of concomitant treatment.
Inform the doctor about all sedative medicines the patient is taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the possible signs and symptoms mentioned above. If the above symptoms occur, contact a 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 tone, and elevated body temperature above 38°C. If these symptoms occur, contact a doctor.
Oxycodone Vitabalans with food, drink, and alcohol
Oxycodone Vitabalans may be taken with or without food, with an appropriate amount of liquid.
Drinking alcohol while taking Oxycodone Vitabalans may cause drowsiness or increase the risk of serious adverse effects such as shallow breathing with risk of respiratory arrest and loss of consciousness.
Avoid drinking alcohol while taking Oxycodone Vitabalans.
Grapefruit juice may inhibit the metabolism of oxycodone, which may intensify its effects. Avoid drinking grapefruit juice while taking Oxycodone Vitabalans.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Whenever possible, avoid using Oxycodone Vitabalans during pregnancy and breastfeeding.
Pregnancy
There is limited data on the use of oxycodone in pregnant women. Oxycodone crosses the placental barrier and enters the newborn's bloodstream.
Use of oxycodone during pregnancy may cause withdrawal symptoms in the newborn.
Use of oxycodone in pregnant women during the last 3-4 weeks before delivery may cause severe respiratory disorders in newborns. Oxycodone may be used during pregnancy only if the benefits to the mother outweigh the risks to the fetus.
Breastfeeding
Oxycodone may pass into breast milk and may cause breathing difficulties in the newborn. Do not use Oxycodone Vitabalans while breastfeeding.
Driving and operating machinery
Use of Oxycodone Vitabalans may impair alertness and reduce reaction ability to such an extent that the patient may not be able to drive vehicles or operate machinery at all. With balanced therapy, a complete ban on driving may not be necessary.
Consult your doctor.

3. How to take Oxycodone Vitabalans

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.

Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Oxycodone Vitabalans, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "Stopping Oxycodone Vitabalans").

Your doctor will adjust the dose according to the intensity of pain and your individual sensitivity. The usual dose is:

Adults and adolescents over 12 years of age
The usual starting dose is 5 mg taken every 6 hours. If necessary, your doctor may reduce the interval between doses to 4 hours. However, Oxycodone Vitabalans should not be taken more frequently than 6 times a day.

Elderly patients
Your doctor will determine the appropriate dose. Treatment should be started with the lowest initial dose and gradually increased until adequate pain control is achieved.

Patients with impaired kidney and/or liver function or low body weight
Your doctor may prescribe a lower starting dose.

Patients who have previously taken other strong painkillers (opioids) may be prescribed a higher starting dose.

Your doctor will decide on the daily dose and advise how to divide the total daily dose into morning and evening doses. Your doctor will also review the dosage if adjustment becomes necessary during treatment.

If you experience pain between doses of Oxycodone Vitabalans, it may be necessary to increase the dose. If this applies to you, consult your doctor.

If long-term treatment for severe pain is required, your doctor will recommend switching therapy to oxycodone hydrochloride in modified-release tablets.

The tablets should be taken with sufficient fluid (e.g. half a glass of water) every 4 to 6 hours, as directed by your doctor. The tablets may be taken with or without food.

Taking more Oxycodone Vitabalans than prescribed
If you take more Oxycodone Vitabalans than prescribed, or if a child accidentally takes the medicine, contact your doctor or hospital immediately for advice on possible risks and further management.

Overdose may cause profound drowsiness, breathing difficulties, pinpoint pupils, muscle weakness, low blood pressure, slowed heart rate, circulatory collapse, and pulmonary edema. This may lead to loss of consciousness, coma, and even death.

Overdose may lead to brain damage (known as toxic leukoencephalopathy).

When seeking medical help, bring this leaflet and any remaining tablets with you to show the doctor.

Missing a dose of Oxycodone Vitabalans
If you miss a dose, take it as soon as you remember and continue treatment according to the prescribed schedule. Do not take two doses within 4 hours. Do not take a double dose to make up for a missed dose.

Stopping Oxycodone Vitabalans
Do not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking Oxycodone Vitabalans, you should first consult your doctor. Your doctor will recommend an appropriate approach, usually by gradually reducing the dose to prevent unpleasant symptoms. Sudden discontinuation may cause withdrawal symptoms such as yawning, dilated pupils, runny nose, tearing, tremor, sweating, anxiety, restlessness, seizures, and insomnia.

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.

Very common (occur in more than 1 in 10 patients)

• drowsiness, dizziness, headache
• constipation, nausea, vomiting
• itching

Common (occur in 1 to 10 in 100 patients)

• loss of appetite, decreased appetite
• anxiety, confusion, depression, unusually good mood (euphoria), sleep disturbances (insomnia), restlessness, abnormal thoughts, fatigue
• seizures
• shortness of breath, severe breathing difficulties (respiratory depression), difficulty breathing or wheezing
• dry mouth, abdominal pain, diarrhoea, belching, indigestion
• rash, excessive sweating
• urinary problems
• weakness (asthenia)

Uncommon (occur in 1 to 10 in 1,000 patients)

• hypersensitivity, anaphylactic reactions, allergic reactions
• fluid retention
• dehydration
• agitation, emotional lability, decreased libido, personality changes, hallucinations, visual disturbances, hearing disturbances (hyperacusis), drug dependence
• memory loss, tremors, changes in muscle tone, reduced sensitivity to pain or touch, twitching, speech disorders, fainting, tingling or numbness (paraesthesiae), taste disturbances, lack of coordination of muscular movements
• disturbances in tear secretion, pinpoint pupils (miosis), visual disturbances
• sensation of dizziness or spinning
• fast, irregular heartbeat, abnormal heart rhythm (palpitations)
• blood vessel dilation
• increased cough, sore throat, runny nose, voice changes
• difficulty swallowing, mouth ulcers, gingivitis, stomatitis, bloating
• increased liver enzyme activity
• difficulty passing urine
• erectile dysfunction
• chills, accidental injury, pain (e.g. chest pain), malaise, swelling of hands, ankles or feet, migraine, withdrawal symptoms, drug tolerance, excessive thirst

Rare (occur in 1 to 10 in 10,000 patients)

• enlarged lymph nodes
• epileptic seizures, particularly in patients with epilepsy or a tendency to seizures, muscle spasms
• low blood pressure (hypotension), drop in blood pressure upon standing causing dizziness, lightheadedness or fainting (orthostatic hypotension)
• bleeding gums, increased appetite, black stools, tooth discolouration and damage, intestinal obstruction
• dry skin, viral infections caused by herpes simplex virus, increased sensitivity to light (photosensitivity)
• presence of blood in urine
• absence of menstruation
• changes in body weight, skin infections caused by bacteria (cellulitis)

Very rare (occur in less than 1 in 10,000 patients)

• urticaria or scaly skin

Unknown (cannot be estimated from available data)

• aggression
• increased sensitivity to pain
• sleep apnoea (pauses in breathing during sleep)
• dental caries
• inflammatory condition causing abdominal pain or diarrhoea (cholestasis), acute abdominal pain caused by gallstones (biliary colic)
• disorder affecting the valve in the intestine, potentially causing severe upper abdominal pain (Oddi sphincter dysfunction)
• Prolonged use of Oxycodone Vitabalans during pregnancy may result in life-threatening withdrawal symptoms in newborns. Symptoms to watch for include irritability, hyperactivity and abnormal sleep patterns, high-pitched crying, tremors, malaise, diarrhoea, and failure to gain weight.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 this medicine.

5. How to store Oxycodone Vitabalans

Keep this medicine out of 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 may cause death in a person to whom it has not been prescribed.
No special precautions for storage of the medicinal product are required.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice damaged tablets or if the tablets are of inferior quality.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Oxycodone Vitabalans contains

• The active substance is oxycodone hydrochloride. Each tablet contains 5 mg or 10 mg of oxycodone hydrochloride.
• Other components are: Tablet core: microcrystalline cellulose, pregelatinized maize starch, magnesium stearate. Tablet coating: polydextrose, hypromellose, titanium dioxide (E 171), and macrogol.

What Oxycodone Vitabalans looks like and contents of the pack
What Oxycodone Vitabalans looks like:
5 mg: white, round, convex tablets with a diameter of 6 mm.
10 mg: white, round, convex tablets with a division line on one side, with a diameter of 8 mm. The tablets may be divided into two equal parts.
Pack sizes:
30 or 100 tablets in a blister pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
FINLAND
Tel.: +358 3 615 600
Manufacturer
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
FINLAND
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Oxycodone Vitabalans (Denmark, Estonia, Finland, Lithuania, Latvia, Poland, Hungary)
Oksikodon Vitabalans (Slovenia)