Oxicodone Polpharma

Leaflet included in the packaging: information for the user

Oxycodone Polpharma

10 mg/ml, solution for injection or infusion

Oxycodone hydrochloride
Read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of further questions, consult a 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 the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

This medicine has been prescribed by a doctor for the treatment of moderate or severe pain.
It contains the active substance oxycodone, which belongs to a group of medicines called strong analgesics or painkillers.

2. Important information before using Oxycodone Polpharma

When not to use Oxycodone Polpharma:

If the patient is allergic (hypersensitive) to oxycodone or any of the other ingredients of this medicine (listed in section 6);

• If the patient has breathing difficulties, e.g. severe chronic obstructive pulmonary disease, severe asthma, or severe respiratory depression. The patient will be informed by their doctor that they have such a disease. Symptoms may include shortness of breath, cough, or slow or shallow breathing;
• If the patient has intestinal obstruction or severe abdominal pain;
• If the patient has heart failure caused by lung disease (cor pulmonale);
• If the patient has moderate or severe liver disease. If the patient has any other chronic liver disease, this medicine may only be used on the advice of a doctor;
• If the patient has chronic constipation;
• If the patient has increased carbon dioxide levels in the blood.

Warnings and precautions

Before starting treatment with Oxycodone Polpharma, the patient should discuss with their doctor, pharmacist, or nurse:
if the patient is elderly or weakened;
if the patient has hypothyroidism, as the dose may need to be reduced;
if the patient has myxoedema (a condition characterized by dry, cold, and swollen skin on the face and extremities);
if the patient has had a head injury, has a severe headache, or feels nauseous, as these symptoms may indicate increased intracranial pressure;
if the patient has low blood pressure (hypotension);
if the patient has low blood volume (hypovolemia); hypovolemia may occur due to severe internal or external bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting;
if the patient has a history of toxic psychosis (a mental disorder caused by infection);
if the patient has pancreatitis (causing severe abdominal and back pain);
if the patient has a gallbladder or bile duct disease;
if the patient has inflammatory bowel disease;
if the patient has an enlarged prostate gland, causing difficulty urinating (in men);
if the patient has adrenal insufficiency (the adrenal gland does not function properly, which may cause weakness, weight loss, dizziness, nausea, or vomiting), e.g. Addison's disease;
if the patient has breathing difficulties due to severe lung disease. The patient will be informed by their doctor that they have such a disease. Symptoms may include shortness of breath and cough;
if the patient has kidney or liver disease;
if the patient has previously experienced withdrawal symptoms after stopping alcohol or psychoactive substances, such as agitation, anxiety, tremors, or cold sweats;
if the patient is or has been dependent on alcohol or psychoactive substances, or if it is known that the patient is dependent on opioids;
if the patient has increased sensitivity to pain;
if the patient needs to take increasingly larger doses of oxycodone to achieve the same level of pain relief (tolerance).
If the patient is to undergo surgery, they should inform their doctor in the hospital that they are taking this medicine.
During treatment with this medicine, hormonal changes may occur. The doctor may decide to monitor these changes.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as the potential benefits do not outweigh the risks.

Oxycodone Polpharma and other medicines

Concomitant use of opioids and benzodiazepines increases the risk of sedation, respiratory depression, somnolence, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If the doctor has prescribed benzodiazepines or similar medicines with opioids, the doctor should reduce the dosage and recommend the shortest possible treatment duration.
Patients should strictly follow the doctor's instructions. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.
Patients should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken.
Concomitant use of this medicine with certain other medicines may affect the efficacy of this medicine or other medicines used.
Patients should tell their doctor or pharmacist if they are taking:

• monoamine oxidase inhibitors or if they have taken this type of medicine in the last two weeks;
• sedatives or tranquilizers (including benzodiazepines);
• medicines used to treat mental disorders (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 (e.g. 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 the patient is taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). These medicines may interact with oxycodone, causing the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, anxiety, sweating, shivering, or increased reflexes, and elevated body temperature above 38°C. If these symptoms occur, the patient should contact their doctor.

The patient should also tell their doctor if they have recently been given an anesthetic.

Oxycodone Polpharma with food, drink, and alcohol

Consuming 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 respiratory failure and loss of consciousness. It is not recommended to consume alcohol while taking Oxycodone Polpharma.
The patient should avoid drinking grapefruit juice during treatment with this medicine.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy or breastfeeding.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

This medicine may cause side effects such as drowsiness, which can affect the ability to drive or operate machinery (see section 4 for a full list of side effects).
These effects are usually most noticeable at the start of treatment or after a dose increase. If the patient experiences such effects, they should not drive or operate machinery.
This medicine may affect the ability to drive or operate machinery.
The patient should not drive while taking this medicine until it is known how the medicine affects them.
If the patient is unsure whether they can drive safely while taking this medicine, they should consult their doctor or pharmacist.
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, which means it is essentially 'sodium-free'.

3. How to use Oxycodone Polpharma

The solution for injection 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 (over 18 years of age)

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

• Intravenous injection (bolus):The recommended dose is 1 to 10 mg, administered slowly over 1 to 2 minutes. The dose may be repeated every 4 hours.
• Intravenous infusion:The recommended initial dose is 2 mg per hour.
• Subcutaneous injection (bolus):The recommended initial dose is 5 mg; the dose may 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 frequency of administration.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Elderly patients

The lowest dose required to control symptoms should be used.

Patients with kidney or liver disease

The patient should inform their doctor if they have kidney or liver disease, as the doctor may prescribe a lower dose, depending on the patient's condition.
The patient should not exceed the dose recommended by their doctor. If in doubt, they should consult their doctor or pharmacist.
If the patient still experiences pain while taking this medicine, they should discuss it with their doctor.

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

The patient should contact their doctor or go to the hospital immediately. People who have taken more medicine than they should may feel very drowsy, nauseous, or dizzy. They may also experience breathing difficulties, leading to loss of consciousness and even death. These people may require emergency medical attention in the hospital.
When seeking medical help, the patient should show their doctor this leaflet and any remaining medicine.

Stopping treatment with Oxycodone Polpharma

The patient should not suddenly stop taking this medicine unless their doctor advises them to do so.
If the patient wants to stop taking this medicine, they should discuss it with their doctor first.
The doctor will advise on the appropriate way to stop taking the medicine, usually by gradually reducing the dose, to avoid withdrawal symptoms.
Sudden stopping of this medicine may cause withdrawal symptoms, such as agitation, anxiety, tremors, or cold sweats.
If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any medicine can cause an allergic reaction, although serious allergic reactions are rare.
The patient should immediately inform their doctor if they experience any of the following symptoms:sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially if these symptoms spread over the whole body.
The most serious side effect is respiratory depression (the patient breathes more slowly or shallowly than normal).
In such cases, the patient should immediately inform their doctor.
As with all strong painkillers, there is a risk that the patient may become dependent on this medicine.

Other possible side effects

Very common (may affect more than 1 in 10 people)
Constipation (the doctor may prescribe a laxative to resolve this issue).
Nausea or vomiting (these symptoms should subside after a few days; if they persist, the doctor may prescribe an anti-emetic).
Drowsiness (this side effect usually occurs at the start of treatment or after a dose increase, but should subside after a few days).
Dizziness.
Headache.
Itching.
Common (may affect up to 1 in 10 people)
Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea.
Confusion, depression, feeling of abnormal weakness, shivering, fatigue, anxiety, nervousness, difficulty sleeping, or sleep disturbances.
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, taste disturbance.
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, blurred vision, fainting, abnormal stiffness or flaccidity of muscles.
Difficulty urinating, impotence, decreased sexual desire, low hormone levels in the blood (hypogonadism) as shown in blood tests.
Rapid or irregular heartbeat, flushing.
Dehydration, thirst, shivering, swelling of hands, feet, and ankles.
Dry skin, severely peeling skin.
Flushing of the face, narrowed pupils, muscle spasms, 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).
Withdrawal syndrome.
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.
Amenorrhea (absence of menstruation).
Blockage of bile flow from the liver (cholestasis). This may cause yellowing of the skin, dark urine, and pale stools.
Prolonged use of Oxycodone Polpharma during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to watch for in the child include irritability, hyperactivity, and sleep disturbances, as well as failure to gain weight.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
email: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Oxycodone Polpharma

The medicine should be stored out of sight and reach of children.

There are no special storage instructions for this medicine.
The ampoules should be stored in the outer packaging to protect them from light.
The medicine should not be used after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the month stated.
The packaging is marked with the expiry date and batch number.
The medicine should be used immediately after opening.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
Such measures will help protect the environment.

6. Contents of the packaging and other information

What Oxycodone Polpharma contains

The active substance is oxycodone hydrochloride.
Each 1 ml contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone).
Each 1 ml ampoule contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone).
Each 2 ml ampoule contains 20 mg of oxycodone hydrochloride (equivalent to 18 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, supplied in packs of 5 ampoules of 1 ml or 2 ml, made of transparent glass type I.

Marketing authorization holder

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

Manufacturer

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

For more information about this medicine and its authorized names in the European Economic Area, 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 leaflet:June 2019

Information intended for healthcare professionals

Oxycodone Polpharma

10 mg/ml, solution for injection or infusion

More information about this medicine can be found in the summary of product characteristics (SPC).

Qualitative and quantitative composition

Each 1 ml contains 10 mg of oxycodone hydrochloride (Oxycodoni hydrochloridum) (equivalent to 9 mg of oxycodone).
Each 1 ml ampoule contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone).
Each 2 ml ampoule contains 20 mg of oxycodone hydrochloride (equivalent to 18 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 particulate matter.

Therapeutic indications

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

Posology and method of administration

Route of administration:
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Dosage:
The dose should be adjusted according to the severity of the pain, the patient's overall condition, and any medicines they are currently taking or have recently taken.
Adults over 18 years of age:
The recommended initial doses are given below.
The dose may need to be gradually increased if the analgesic effect is insufficient or if the pain worsens.

Special precautions for disposal and other handling

Incompatible with:
Prochlorperazine.
Shelf life:
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.
Chemical and physical stability has been demonstrated for 24 hours at room temperature.
From a microbiological point of view, the product should be used immediately.
If not used immediately, the in-use storage times and conditions are the responsibility of the user.
Normally, these would not exceed 24 hours at 2-8°C, unless reconstitution or dilution has been carried out in controlled and validated aseptic conditions.

Marketing authorization number

Authorization number: 22711

Date of last revision of the leaflet:June 2019