Oxicodone Vitabalans

Leaflet accompanying the packaging: patient information

Oxycodone Vitabalans, 5 mg, coated tablets

Oxycodone Vitabalans, 10 mg, coated tablets

Oxycodone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Oxycodone Vitabalans and what is it 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 packaging and other information

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

Oxycodone Vitabalans contains the active substance oxycodone, which belongs to a group of strong painkillers called opioids. Oxycodone Vitabalans is used in adults and adolescents over 12 years of age to treat severe pain that can only be adequately managed with opioid painkillers.

2. Important information before taking Oxycodone Vitabalans

When not to take Oxycodone Vitabalans:

• if you are allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6);
• if you have severe breathing difficulties (respiratory depression) with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide (hypercapnia);
• if you have breathing difficulties, such as severe chronic lung disease or severe asthma;
• if you have heart problems due to long-term lung disease (cor pulmonale);
• if you have increased levels of carbon dioxide in the blood;
• if you have conditions associated with obstruction of the small intestine (paralytic ileus), severe abdominal pain, or delayed gastric emptying.

Warnings and precautions

Before taking Oxycodone Vitabalans, consult your doctor or pharmacist. Before starting treatment with Oxycodone Vitabalans, tell your doctor or pharmacist:

• if you are elderly or weakened;
• if you have severe liver, kidney, or lung disease;
• if you have thyroid disease (myxoedema) or if your thyroid does not produce enough hormone (hypothyroidism);
• if your adrenal glands do not produce enough hormone (Addison's disease or adrenal insufficiency), which can cause weakness, weight loss, dizziness, nausea, vomiting;
• if you have mental disorders due to poisoning, e.g., with alcohol (toxic psychosis);
• in case of prostate enlargement;
• in case of pancreatitis (which causes severe abdominal and back pain) or biliary disorders;
• if you have inflammatory bowel disease (inflammatory conditions of the colon and small intestine);
• if you have difficulty urinating or pain while urinating;
• if you have hypovolemia (reduced blood volume in the circulatory system);
• if you have severe headaches or nausea, which may indicate increased intracranial pressure;
• if you have low blood pressure or dizziness when standing up;
• if you have epilepsy or are prone to seizures;
• when taking MAO inhibitors (used to treat depression or Parkinson's disease).

Tell your doctor if you experience severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and biliary disorders. Before surgery, inform your doctor that you are taking Oxycodone Vitabalans. Oxycodone Vitabalans may lead to physical dependence and withdrawal symptoms when therapy is stopped abruptly. If treatment is no longer necessary, it is recommended to gradually reduce the daily dose to avoid withdrawal symptoms. Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid. It can cause dependence and addiction.

This medicine contains oxycodone, which is an opioid medication. Repeated use of opioid painkillers can lead to decreased efficacy of the medicine (the patient's body gets used to it, which is called tolerance). Repeated use of Oxycodone Vitabalans may lead to dependence, abuse, and addiction, which can be life-threatening. The risk of these side effects may be higher when using higher doses for a longer period. Dependence or addiction can lead to the patient being unable to control how much medicine they take or how often they take it. The patient may feel the need to take the medicine even if it does not relieve pain. The risk of developing dependence or addiction varies from person to person. The risk of addiction or dependence on Oxycodone Vitabalans may be higher if:

• the patient (or a family member) has ever abused or been dependent on alcohol, prescription drugs, 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 that they are developing dependence or addiction.

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

If the patient has observed any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the right time and safe way to stop treatment (see also "Stopping Oxycodone Vitabalans"). Very rarely, hyperalgesia (excessive pain sensation) may occur, which does not respond to further dose increases of oxycodone, especially when using high doses. It may be necessary to reduce the dose of oxycodone or switch to treatment with other opioids. Sleep-related breathing disordersOxycodone Vitabalans may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and hypoxemia during sleep (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, they should contact their doctor. The doctor may consider reducing the dose.

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 or have recently taken, as well as any medicines you plan to take. Inform your doctor or pharmacist if you are taking any of the following medicines:

• strong painkillers (e.g., other opioids);
• medicines that help you sleep or are used to treat anxiety (sedatives and hypnotics);
• medicines used to treat depression;
• medicines used to treat mental 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 (MAOIs) or if you have taken MAOIs in the last two weeks. MAOIs are medicines used to treat depression or Parkinson's disease;
• medicines used to treat Parkinson's disease;
• macrolide antibiotics (e.g., clarithromycin, erythromycin, and telithromycin);
• azole antifungal medicines (e.g., ketoconazole, voriconazole, itraconazole, and posaconazole);
• protease inhibitors used to treat HIV (e.g., boceprevir, ritonavir, indinavir, nelfinavir, and saquinavir);
• cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
• rifampicin (an antibiotic used to treat tuberculosis);
• carbamazepine or phenytoin (a medicine used to treat epilepsy);
• St. John's Wort (in herbal products);
• paroxetine (an antidepressant);
• quinidine (a medicine used to treat irregular heartbeat);
• anticoagulant medicines (medicines that prevent blood clotting).

Concomitant use of Oxycodone Vitabalans and sedatives, such as benzodiazepines or similar medicines, increases the risk of sedation, respiratory depression, coma, and may be life-threatening. Therefore, their concomitant use can only be considered when other treatment options are not available. If the doctor prescribes Oxycodone Vitabalans concomitantly with sedatives, the doctor should also limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and strictly follow the doctor's instructions regarding the dose. It may be helpful to inform friends or relatives so that they are aware of the possibility of these signs and symptoms. In case of these symptoms, contact your doctor. The risk of side effects may increase if you are taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine). These medicines may interact with oxycodone, causing symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, muscle tension, and elevated body temperature above 38°C. In case of these symptoms, contact your doctor.

Oxycodone Vitabalans with food, drink, and alcohol

Oxycodone Vitabalans can be taken with or without food, with a sufficient amount of liquid. Drinking alcohol while taking Oxycodone Vitabalans may cause sedation or increase the risk of serious side effects, such as shallow breathing with a 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 enhance its effect. Avoid drinking grapefruit juice while taking Oxycodone Vitabalans.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Whenever possible, avoid taking Oxycodone Vitabalans during pregnancy and breastfeeding. PregnancyThere are limited data on the use of oxycodone in pregnant women. Oxycodone crosses the placental barrier and enters the newborn's bloodstream. Using oxycodone during pregnancy may cause withdrawal symptoms in the newborn. Using oxycodone in pregnant women during the last 3-4 weeks before delivery may cause severe respiratory depression in newborns. Oxycodone should only be used during pregnancy if the benefits to the mother outweigh the risks to the child. BreastfeedingOxycodone may pass into breast milk and may cause breathing difficulties in the newborn. Do not take Oxycodone Vitabalans while breastfeeding.

Driving and using machines

Taking Oxycodone Vitabalans may impair your alertness and reduce your ability to react to such an extent that you may not be able to drive vehicles or operate machinery. With balanced therapy, a complete ban on driving vehicles may not be necessary. Consult your doctor.

3. How to take Oxycodone Vitabalans

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Oxycodone Vitabalans, when and how long to take it, when to contact your doctor, and when to stop taking it (see also "Stopping Oxycodone Vitabalans"). Your doctor will adjust the dosage based on the severity of your pain and your individual sensitivity. The usual dose is: Adults and adolescents over 12 years of ageThe usual starting dose for patients is 5 mg every 6 hours. If necessary, your doctor may reduce the intervals between doses to 4 hours. However, do not take Oxycodone Vitabalans more than 6 times a day. Elderly patientsYour doctor will determine the dose suitable for you. Start with the smallest starting dose and gradually increase it to achieve adequate pain control. Patients with kidney or liver disorders or low body weightYour doctor may prescribe a lower starting dose. Patients who have previously taken other strong painkillers (opioids) may be prescribed a higher starting dose by their doctor. Your doctor will decide on the daily dose and recommend how to divide the total daily dose into morning and evening doses. Your doctor will also verify the dosage if it needs to be adjusted during treatment. If you experience pain between doses of Oxycodone Vitabalans, it may be necessary to increase the dose. If this is a problem for you, consult your doctor. If long-term treatment of severe pain is necessary, your doctor will recommend switching to oxycodone hydrochloride in a modified-release tablet form. Take the tablets with a sufficient amount of liquid (e.g., half a glass of water) every 4 to 6 hours, as directed by your doctor. The tablets can be taken with or without food.

Taking a higher dose of Oxycodone Vitabalans than recommended

If you have taken more Oxycodone Vitabalans than recommended or if a child has taken the medicine by accident, contact your doctor or hospital to get information about possible risks and advice on what to do. Overdose may cause severe sedation, breathing difficulties, pinpoint pupils, muscle weakness, low blood pressure, slow heart rate, circulatory collapse, and fluid accumulation in the lungs. This can lead to loss of consciousness, coma, and even death. Overdose may cause brain damage (toxic leukoencephalopathy). When seeking medical help, take the 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 adopted 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 Oxycodone Vitabalans abruptly unless your doctor tells you to. If you want to stop taking the medicine, consult your doctor first. Your doctor will recommend the appropriate course of action, usually by gradually reducing the dose, so you do not experience unpleasant withdrawal symptoms. If you stop taking the medicine abruptly, you may experience withdrawal symptoms such as yawning, dilated pupils, runny nose, tearing, tremors, sweating, anxiety, restlessness, seizures, and insomnia. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxycodone Vitabalans can cause side effects, although not everybody gets them. Very common(occurring in more than 1 in 10 patients)

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

Common(occurring in 1 to 10 in 100 patients)

• loss of appetite, decreased appetite
• restlessness, confusion, depression, euphoria, sleep disorders (insomnia), nervousness, abnormal thoughts, fatigue
• seizures
• breathing difficulties, severe respiratory depression, breathing difficulties
• dry mouth, abdominal pain, diarrhea, belching, indigestion
• rash, excessive sweating
• urination disorders
• weakness (asthenia)

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

• hypersensitivity, anaphylactic reactions, allergic reactions
• fluid retention
• dehydration
• agitation, emotional instability, decreased libido, personality changes, hallucinations, vision disorders, hearing disorders (hyperacusis), dependence on the medicine
• memory loss, tremors, changes in muscle tone, decreased sensitivity to pain or touch, tremors, speech disorders, fainting, tingling or numbness (paresthesia), taste disorders, lack of coordination
• disorders of tear secretion, pinpoint pupils, vision disorders
• feeling of dizziness or spinning
• rapid, irregular heartbeat, abnormal heartbeat (palpitations)
• vasodilation
• increased cough, sore throat, rhinitis, voice changes
• swallowing difficulties, mouth ulcers, gum inflammation, oral inflammation, bloating
• increased liver enzyme activity
• urination difficulties
• erectile dysfunction
• chills, accidental injuries, pain (e.g., chest pain), malaise, swelling of hands, feet, or ankles, migraine, withdrawal symptoms, tolerance to the medicine, excessive thirst

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

• lymphadenopathy
• seizures, especially in patients with epilepsy or a tendency to seizures, muscle spasms
• low blood pressure (hypotension), decreased blood pressure when standing up, causing dizziness, dizziness, or fainting (orthostatic hypotension)
• gum bleeding, increased appetite, black stools, tooth discoloration, intestinal obstruction
• dry skin, viral infections caused by the herpes simplex virus, increased sensitivity to light (photosensitivity)
• blood in urine
• amenorrhea
• weight changes, bacterial skin infections (cellulitis)

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

• hives or scaly skin

Unknown(cannot be estimated from available data)

• aggression
• increased sensitivity to pain
• sleep apnea (pauses in breathing during sleep)
• tooth decay
• inflammatory bowel disease (inflammatory conditions of the colon and small intestine), severe abdominal pain caused by gallstones (biliary colic).
• A disorder affecting the valve in the intestines, which can cause severe abdominal pain (dyssfunction of the Oddi sphincter).
• Prolonged use of Oxycodone Vitabalans during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to watch for include irritability, hyperactivity, and abnormal sleep duration, excessive crying, tremors, malaise, diarrhea, and failure to gain weight.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxycodone Vitabalans

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 can be very harmful and may cause death in a person it was not prescribed for. There are no special precautions for storing the medicinal product. 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 month stated. Do not use this medicine if you notice damage to the tablets or if the tablets are of poor quality. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Oxycodone Vitabalans contains

• The active substance of the medicine is oxycodone hydrochloride. Each tablet contains 5 mg or 10 mg of oxycodone hydrochloride.
• The other ingredients of the medicine are: Tablet core: microcrystalline cellulose, 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 score line on one side, with a diameter of 8 mm. The tablets can be divided into two equal parts.
Pack sizes:
30 or 100 tablets in a blister pack. Not all pack sizes may be marketed.

Marketing authorization 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 authorized 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)

Date of last revision of the leaflet: 02.05.2025