Oxicodone Polpharma

Package Leaflet: Information for the User

Oxycodone Polpharma

50 mg/ml, solution for injection/infusion

Oxycodone hydrochloride

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

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

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

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

This medicine has been prescribed by your doctor for the treatment of moderate to severe pain.
It contains the active substance oxycodone, which belongs to a group of medicines called strong analgesics
or painkillers.
The other ingredients are listed in section 6 of the package leaflet.

2. Important information before using Oxycodone Polpharma

Do not use Oxycodone Polpharma if:

you are allergic (hypersensitive) to oxycodone or any of the other ingredients of this medicine (listed in section 6);

• you have breathing difficulties, such as severe chronic obstructive pulmonary disease, severe asthma, or severe respiratory depression. Your doctor will inform you if you have such a condition. Symptoms may include shortness of breath, coughing, or slow or shallow breathing;
• you have intestinal obstruction or severe abdominal pain;
• you have heart failure caused by lung disease (cor pulmonale);
• you have moderate to severe liver disease. If you have any other chronic liver disease, you may only use this medicine if your doctor has prescribed it;
• you have chronic constipation;
• you are under 18 years old.

Warnings and precautions

Before starting treatment with Oxycodone Polpharma, discuss with your doctor, pharmacist, or nurse:
if you are elderly or frail;
if you have hypothyroidism, as your dose may need to be reduced;
if you have myxedema (a condition characterized by dry, cold, and swollen skin on the face and limbs);
if you have had a head injury, have severe headache, or nausea, as these symptoms may indicate increased intracranial pressure;
if you have low blood pressure (hypotension);
if you have low blood volume (hypovolemia); hypovolemia may occur due to severe internal or external bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting;
if you have toxic psychosis (a mental disorder caused by infection);
if you have pancreatitis (causing severe abdominal and back pain);
if you have gallbladder or bile duct disease;
if you have inflammatory bowel disease;
if you have an enlarged prostate gland, causing difficulty urinating (in men);
if you have adrenal insufficiency (adrenal gland dysfunction, which may cause weakness, weight loss, dizziness, nausea, or vomiting), such as Addison's disease;
if you have respiratory disorders due to severe lung disease. You will know from your doctor if you have such a condition. Symptoms may include shortness of breath and coughing;
if you have kidney or liver disease;
if you have previously experienced withdrawal symptoms after stopping alcohol or psychoactive substances, such as agitation, anxiety, tremors, or cold sweats;
if you are or have been addicted to alcohol or psychoactive substances, or if you are known to be opioid-dependent;
if you have increased sensitivity to pain;
if you need to take increasingly larger doses of oxycodone to achieve the same level of pain relief (tolerance).
If you are to undergo surgery, tell your doctor in the hospital that you are using this medicine.
During treatment with this medicine, hormonal changes may occur. Your doctor may decide to monitor these changes.

Oxycodone Polpharma with other medicines

Concomitant use of opioids and benzodiazepines increases the risk of sedation, respiratory depression, coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If, however, your doctor has prescribed benzodiazepines or opioid-like medicines, they should reduce the dosage and recommend the shortest possible treatment duration.
Follow your doctor's instructions carefully. It may be helpful to inform your friends or relatives to be aware of the above symptoms. If such symptoms occur, contact your doctor.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken. Using this medicine with certain other medicines may affect the action of this medicine or other medicines used.
Tell your doctor or pharmacist if you are taking:

• monoamine oxidase inhibitors or if you have taken this type of medicine in the last two weeks;
• sleeping pills or sedatives (including benzodiazepines);
• medicines used to treat depression (such as paroxetine);
• medicines used to treat mental disorders or diseases (such as phenothiazine derivatives or neuroleptics);
• other strong painkillers (analgesics);
• muscle relaxants;
• medicines used to treat high blood pressure;
• quinidine (a medicine used to treat rapid heart rate);
• cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
• antifungal medicines (such as ketoconazole, voriconazole, itraconazole, and posaconazole);
• antibiotics (such as clarithromycin, erythromycin, or telithromycin);
• protease inhibitors used to treat HIV infection (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• rifampicin (used to treat tuberculosis);
• carbamazepine (a medicine used to treat epilepsy or certain types of pain);
• phenytoin (a medicine used to treat epilepsy or seizures);
• the herbal medicine St. John's Wort (Hypericum perforatum);
• antihistamines;
• medicines used to treat Parkinson's disease;
• medicines used to treat depression (antidepressants). The risk of side effects increases if you are taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or 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. If you experience any of these symptoms, contact your doctor.

Oxycodone Polpharma with food, drink, and alcohol

Drinking alcohol during treatment with this medicine may cause drowsiness and increase the risk of serious side effects, such as shallow breathing, which can lead to loss of consciousness and even death. It is not recommended to drink alcohol while using Oxycodone Polpharma.
Avoid drinking grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

Do not use this medicine during pregnancy or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor, pharmacist, or nurse for advice before using this medicine.

Driving and using machines

You may feel drowsy when starting treatment with Oxycodone Polpharma or after increasing the dose. If you experience drowsiness, do not drive or operate machinery.
This medicine may affect your ability to drive or operate machinery.
Do not drive while using this medicine until you know how it affects you.
If you are unsure whether you can drive safely while using this medicine, ask your doctor or pharmacist.

Oxycodone Polpharma contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, which is considered "sodium-free".

3. How to use Oxycodone Polpharma

The solution is usually prepared and administered by a doctor or nurse. The medicine should be used immediately after opening. The dose and frequency of administration will be adjusted according to the severity of the pain.

Adults (18 years and older)

The recommended initial dose depends on how the injection is given. The recommended initial doses are listed below.

• Intravenous single dose: the recommended dose is 1 to 10 mg administered slowly over 1 to 2 minutes. This dose can be repeated every 4 hours.
• Intravenous infusion: the recommended initial dose is 2 mg per hour.
• Subcutaneous single dose: the recommended initial dose is 5 mg; this dose can be repeated every 4 hours if necessary.
• Subcutaneous infusion: the recommended initial dose is 7.5 mg per day.
• Patient-controlled analgesia (PCA): the dose is determined based on the patient's body weight (0.03 mg per kg of body weight). The doctor or nurse will determine the appropriate administration frequency.

Use in children and adolescents

Do not use in children and adolescents under 18 years old.

Patients with kidney or liver disease

Tell your doctor if you have kidney or liver disease, as your doctor may prescribe a lower dose, depending on your condition.
Do not exceed the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.
If you continue to experience pain while using this medicine, discuss it with your doctor.

Using a higher dose of Oxycodone Polpharma than recommended or if someone else uses the medicine prescribed for you

Contact your doctor or go to the hospital immediately. People who have taken more medicine than they should may experience severe drowsiness, nausea, or dizziness. They may also have breathing difficulties, leading to loss of consciousness and even death. These people may require emergency medical attention in the hospital.
When seeking medical help, show your doctor this package leaflet and any remaining medicine.

Stopping treatment with Oxycodone Polpharma

Do not stop using this medicine suddenly, unless your doctor advises you to do so.
If you want to stop using this medicine, discuss it with your doctor first.
Your doctor will advise you on the proper way to stop using the medicine, usually by gradually reducing the dose, to avoid unwanted symptoms.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxycodone Polpharma can cause side effects, although not everybody gets them.
Any medicine may cause an allergic reaction, although serious allergic reactions are rare. Tell your doctor immediatelyif you experience any of the following symptoms: sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially if it spreads over the whole body.
The most serious side effect is respiratory depression (breathing more slowly or shallowly than normal). Tell your doctor immediatelyif this occurs.
As with all strong painkillers, there is a risk that you may become addicted to this medicine.

Other possible side effects

Very common(may affect more than 1 in 10 people)
Constipation (your doctor may prescribe a laxative to relieve this symptom)
Nausea or vomiting (these symptoms should subside after a few days; if they persist, your doctor may prescribe an anti-emetic)
Drowsiness (this symptom usually occurs at the start of treatment or after increasing the dose, but should subside after a few days)
Dizziness
Headache
Itching of the skin
Common(may affect up to 1 in 10 people)
Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea
Confusion, depression, feeling of unusual weakness, shivering, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, and sleep disorders
Breathing difficulties or wheezing, shortness of breath, weakened cough reflex
Rash
Cold sweats
Uncommon(may affect up to 1 in 100 people)
Difficulty swallowing, belching, hiccups, gas, abnormal bowel function (intestinal obstruction), stomach inflammation, and gastrointestinal disorders
Dizziness (of labyrinthine origin) or feeling of spinning, hallucinations, mood changes, unpleasant or disturbed mood, feeling of euphoric happiness, restlessness, agitation, general malaise, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness of hands or feet, seizures or convulsions, blurred vision, fainting, unusual stiffness or flaccidity of muscles, involuntary muscle contractions
Difficulty urinating, impotence, decreased libido, low hormone levels in the blood (hypogonadism) as shown in blood tests
Rapid, irregular heartbeat, flushing of the skin
Dehydration, thirst, shivering, swelling of hands, feet, and ankles
Dry skin, severely peeling skin
Flushing of the face, pinpoint pupils, muscle contractions, high fever
Need to take increasingly larger doses of oxycodone to achieve the same level of pain relief (tolerance)
Colic or discomfort in the abdomen
Abnormal liver function test results (as shown in blood tests)
Rare(may affect up to 1 in 1,000 people)
Low blood pressure
Feeling of weakness, especially when changing position to standing
Hives
Unknown(frequency cannot be estimated from the available data)
Increased sensitivity to pain
Aggression
Tooth decay
Absence of menstruation
Blockage of bile flow from the liver (cholestasis), which may cause itching of the skin, yellowing of the skin, very dark urine, and very light stools
Prolonged use of Oxycodone Polpharma during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to watch for in the baby include irritability, hyperactivity, and sleep disorders, failure to gain weight.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Oxycodone Polpharma

Keep this medicine out of the sight and reach of children. Accidental overdose in a child is dangerous and may be fatal.
Do not use this medicine after the expiry date stated on the ampoule label and carton after "EXP". The expiry date refers to the last day of the month.
The packaging is labeled with the expiry date and batch number. The doctor or nurse will check the expiry date.
Do not store above 25°C. Store the ampoules in the outer packaging to protect from light. The injection should be administered immediately after opening the ampoule. After opening, any unused portion of the medicine should be discarded. The chemical and physical stability of the solution has been demonstrated for 24 hours at room temperature.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Oxycodone Polpharma contains

• The active substance is oxycodone hydrochloride. Each 1 ml contains 50 mg of oxycodone hydrochloride (equivalent to 45 mg of oxycodone).
• The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid 3M, sodium hydroxide 3M, and water for injections.

What Oxycodone Polpharma looks like and contents of the pack

Oxycodone Polpharma is a clear, colorless solution, practically free from particles, supplied in colorless glass ampoules. Available in packs of 5 ampoules.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański

Manufacturer

CP Pharmaceuticals Ltd.
Ash Road North, Wrexham Industrial Estate
Wrexham, Clwyd, LL13 9UF
United Kingdom

For further information on this medicine, please contact the local representative of the marketing authorization holder:

Polpharma Biuro Handlowe Sp. z o.o.
Bobrowiecka 6, 00-728 Warsaw
Phone: 22 364 61 01

Date of last revision of the package leaflet:

Information for healthcare professionals

Oxycodone Polpharma

50 mg/ml, solution for injection/infusion

More information on this product can be found in the summary of product characteristics (SmPC).

Qualitative and quantitative composition

Each 1 ml contains 50 mg of oxycodone hydrochloride (Oxycodoni hydrochloridum) (equivalent to 45 mg of oxycodone).
This medicinal product contains less than 1 mmol (23 mg) of sodium per dose.
The full list of excipients is given below.

Pharmaceutical form

Solution for injection or infusion (injection or infusion). Clear, colorless solution, practically free from particles.

Therapeutic indications

For the treatment of moderate to severe pain in cancer patients and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.

Posology and method of administration

Route of administration:
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Posology:
The dose will be adjusted according to the severity of the pain, the patient's overall condition, and any other medicines being taken.
Adults over 18 years:
Recommended initial doses are given below. The dose may need to be increased gradually if the analgesic effect is insufficient or if the pain worsens.
iv.(bolus): Dilute in sodium chloride 0.9% solution, glucose 5% solution, or water for injections. Administer 1 to 10 mg slowly over 1 to 2 minutes in patients not previously treated with opioids. Doses should not be administered more frequently than every 4 hours.
iv.(infusion): Dilute in sodium chloride 0.9% solution, glucose 5% solution, or water for injections. Recommended initial dose is 2 mg per hour in patients not previously treated with opioids.
iv.(patient-controlled analgesia, PCA): Dilute in sodium chloride 0.9% solution, glucose 5% solution, or water for injections. Administer 0.03 mg/kg body weight as a bolus. The doctor or nurse will determine the appropriate administration frequency.
sc.(bolus): Dilute in sodium chloride 0.9% solution, glucose 5% solution, or water for injections. Recommended initial dose is 5 mg, repeated every 4 hours as needed in patients not previously treated with opioids.
sc.(infusion): Dilute in sodium chloride 0.9% solution, glucose 5% solution, or water for injections if necessary. In patients not previously treated with opioids, recommended initial dose is 7.5 mg per day, gradually increasing as needed to control symptoms.
Patients with cancer who are being switched from oral oxycodone may require much higher doses (see below).
Switching from oral oxycodone to parenteral administration:
The dose should be adjusted according to the following rule: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is a guideline dose. Due to interindividual variability, each patient should be carefully titrated to the appropriate dose.
Elderly patients:
Treatment should be started with caution in elderly patients. The lowest dose should be administered, gradually increasing as needed to control pain.
Patients with renal or hepatic impairment:
Patients with mild or moderate renal impairment and/or mild hepatic impairment should be treated with caution. The lowest dose should be administered, gradually increasing as needed to control pain.
Children under 18 years:
There are no data on the use of oxycodone in patients under 18 years old.
Use in non-cancer pain:
Opioids are not the first-line treatment for chronic non-cancer pain, nor are they recommended as the sole treatment method. The types of chronic pain for which the efficacy of strong opioids has been demonstrated include chronic pain caused by degenerative joint disease and spinal disc disease. The need for continued treatment of non-cancer pain should be regularly assessed.
Discontinuation of therapy:
If the patient no longer requires oxycodone, it is recommended to gradually reduce the dose to avoid withdrawal symptoms.

Pharmaceutical particulars

Excipients:citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid 3M, sodium hydroxide 3M, and water for injections.

Incompatibilities

Do not mix this medicinal product with other medicinal products, except those mentioned below (Special precautions for disposal).
Cyclizine at concentrations of 3 mg/ml or less, when mixed with Oxycodone Polpharma, undiluted or diluted with water for injections, does not precipitate in a 24-hour period at room temperature. Precipitation has been observed in mixtures with Oxycodone Polpharma at cyclizine concentrations above 3 mg/ml or after dilution with sodium chloride 0.9% solution. Water for injections is recommended as a diluent when cyclizine and oxycodone hydrochloride are administered concurrently by intravenous or subcutaneous infusion.
Prochlorperazine is chemically incompatible with Oxycodone Polpharma.

Shelf life and special precautions for storage

Unopened packaging: 2 years
The injection should be administered immediately after opening the ampoule. After opening, any unused portion of the product should be discarded. The chemical and physical stability of the solution has been demonstrated for 24 hours at room temperature.
From a microbiological point of view, the diluted product should be used immediately. If the diluted product is not used immediately, the responsibility for the storage conditions and duration before use lies with the user. Normally, these would not exceed 24 hours at 2-8°C, unless reconstitution, dilution, etc. has been carried out in controlled and validated aseptic conditions.
Do not store above 25°C. Store the ampoules in the outer packaging to protect from light.

Package sizes

Colorless glass ampoules of 1 ml. Pack size: 5 ampoules

Special precautions for disposal

Oxycodone Polpharma has been shown to be compatible with the following medicines:
Hyoscine butylbromide
Hyoscine hydrobromide
Dexamethasone sodium phosphate
Haloperidol
Midazolam hydrochloride
Metoclopramide hydrochloride
Levomepromazine hydrochloride
Oxycodone Polpharma, undiluted or diluted to a concentration of 1 mg/ml using sodium chloride 0.9% solution, glucose 5% solution, or water for injections, is physically and chemically stable in contact with typical types of polypropylene or polyethylene syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags for 24 hours at room temperature.
Improper handling of the undiluted solution after opening the original ampoule or the diluted solutions may negatively affect the sterility of the product.
Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański

Marketing authorization number

Marketing authorization number

Date of last revision of the package leaflet: