Oxicodone Hidrohloride Hameln

Leaflet accompanying the packaging: information for the user

Oxycodone Hydrochloride Hameln, 10 mg/ml, solution for injection/infusion

Oxycodone hydrochloride

Read the leaflet carefully 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 any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects 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 Hydrochloride Hameln and what is it used for
• 2. Important information before using Oxycodone Hydrochloride Hameln
• 3. How to use Oxycodone Hydrochloride Hameln
• 4. Possible side effects
• 5. How to store Oxycodone Hydrochloride Hameln
• 6. Contents of the packaging and other information

1. What is Oxycodone Hydrochloride Hameln and what is it used for

This medicine is prescribed by a doctor to relieve moderate or severe pain. The medicine contains the active substance (oxycodone), which belongs to a group of medicines called strong analgesics or "painkillers".

2. Important information before using Oxycodone Hydrochloride Hameln

When not to use Oxycodone Hydrochloride Hameln:

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

if the patient has breathing problems, such as severe chronic obstructive pulmonary disease, severe asthma, or severe respiratory depression. The doctor will inform the patient if they have any of these conditions. Symptoms may include shortness of breath, coughing, and slower or weaker breathing than expected;

if the patient has a disease in which the small intestine does not function properly (paralytic ileus) or has severe abdominal pain;

if the patient has heart problems after long-term lung disease (pulmonary heart disease);

if the patient has chronic constipation;

if the patient is under 18 years old.

Warnings and precautions

Before starting treatment with Oxycodone Hydrochloride Hameln, the patient should discuss with their doctor, pharmacist, or nurse if they:

are elderly or weakened;

have hypothyroidism, as a smaller dose of Oxycodone Hydrochloride Hameln may be necessary;

have myxedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin of the face and limbs);

have a head injury, severe headache, or nausea, as this may indicate increased intracranial pressure;

have low blood pressure (hypotension);

have low blood volume (hypovolemia), which may occur due to severe external or internal bleeding, severe burns, excessive sweating, severe diarrhea, or severe vomiting;

have psychiatric disorders caused by infection (toxic psychosis);

have pancreatitis (causing severe abdominal and back pain);

have problems with the gallbladder or bile ducts;

have enteritis;

have an enlarged prostate gland that makes it difficult to urinate (in men);

have adrenal dysfunction (abnormal adrenal function that can cause symptoms such as weakness, weight loss, dizziness, nausea, or vomiting), such as Addison's disease;

have breathing problems, such as severe lung disease. The doctor will inform the patient if they have this condition. Symptoms may include shortness of breath and coughing;

have kidney or liver problems;

have previously experienced withdrawal symptoms, such as agitation, anxiety, tremors, or sweating after stopping alcohol or drugs;

have increased sensitivity to pain;

need to take increasingly larger doses of Oxycodone Hydrochloride Hameln to achieve the same level of pain relief (tolerance).

If the patient notices any of the following symptoms while taking Oxycodone Hydrochloride Hameln, it may indicate that they are developing tolerance or dependence.

• need to take the medicine for longer than prescribed by the doctor;
• need to take a larger dose than prescribed;
• use the medicine for reasons other than prescribed, such as "to calm down" or "to help fall asleep";
• make repeated, unsuccessful attempts to stop or reduce the use of the medicine;
• feel unwell after stopping the medicine and feel better after taking it again ("withdrawal effect").

If the patient has noticed any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the right time and safe way to stop taking the medicine (see section 3 "Stopping Oxycodone Hydrochloride Hameln").

During treatment with this medicine, hormonal changes may occur. These changes may need to be monitored by a doctor.

In case of surgery, the patient should inform the doctor in the hospital about taking this medicine.

Respiratory depression during sleep

Oxycodone Hydrochloride Hameln 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 a doctor. The doctor may consider reducing the dose.

Oxycodone Hydrochloride Hameln and other medicines

Concomitant use of Oxycodone Hydrochloride Hameln and sedative medicines, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use of other medicines should only be considered when other treatment options are not possible.

If the doctor prescribes Oxycodone Hydrochloride Hameln to be used concomitantly with sedative medicines, they should limit the dose and duration of concomitant use.

The patient should inform their doctor about all sedative medicines they are taking and follow their dosing instructions carefully. It is worth informing friends or relatives about the above symptoms and contacting a doctor if they occur.

The risk of side effects increases if the patient is taking antidepressant medicines (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, increased muscle tone, elevated body temperature above 38°C. If these symptoms occur, the patient should contact their doctor.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription. When using this medicine for injection with certain other medicines, the effect of the injection of this medicine or other medicines may change.

The patient should inform their doctor or pharmacist if they are taking:

a type of medicine called a monoamine oxidase inhibitor, even if they have taken this type of medicine in the last two weeks;

medicines that help with sleep or relaxation (e.g., sleeping pills or sedatives, including benzodiazepines);

medicines used to treat depression (e.g., paroxetine);

medicines used to treat mental disorders (e.g., phenothiazines or neuroleptic medicines);

other strong analgesics ("painkillers");

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);

medicines used to treat fungal infections (e.g., ketoconazole, voriconazole, itraconazole, and posaconazole);

medicines used to treat infections (e.g., clarithromycin, erythromycin, or telithromycin);

medicines known as "protease inhibitors" used to treat HIV (e.g., boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);

rifampicin (used to treat tuberculosis);

carbamazepine (a medicine used to treat seizures, convulsions, or certain pain conditions);

phenytoin (a medicine used to treat seizures or convulsions);

a herbal medicine called St. John's Wort (also known as Hypericum perforatum);

antihistamine medicines;

medicines used to treat Parkinson's disease.

Additionally, the patient should inform their doctor if they have recently received an anesthetic.

Using Oxycodone Hydrochloride Hameln with food, drink, and alcohol

Drinking alcohol during treatment with Oxycodone Hydrochloride Hameln may cause drowsiness or increase the risk of serious side effects, such as shallow breathing (including the risk of respiratory arrest) and loss of consciousness. The patient should not drink alcohol while taking Oxycodone Hydrochloride Hameln.

During treatment with this medicine, the patient should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

The use of this medicine is not recommended during pregnancy and childbirth, unless the doctor explicitly advises otherwise.

Depending on the dose and duration of treatment with oxycodone, newborns may experience slow and shallow breathing (respiratory depression) or withdrawal symptoms.

Breastfeeding

Mothers who are breastfeeding should not use this medicine, as oxycodone may pass into breast milk and cause respiratory depression in the newborn.

Driving and using machines

When starting treatment with this medicine or increasing the dose, the patient may experience drowsiness. If this occurs, they should not drive or operate machinery.

The medicine may affect the ability to drive, as it may cause drowsiness or dizziness.

In case of doubts about safe driving while taking this medicine, the patient should consult their doctor or pharmacist.

Oxycodone Hydrochloride Hameln contains sodium

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

3. How to use Oxycodone Hydrochloride Hameln

The doctor will decide on the correct dose, method, and duration of treatment with this medicine. The dose and frequency of administration of this medicine should be adjusted according to the severity of the pain. The medicine can be administered by injection or infusion under the skin (subcutaneous injection) or directly into a vein (intravenous injection). The medicine is administered to the patient by a doctor or nurse.

Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Oxycodone Hydrochloride Hameln, when and how long to take it, when to contact the doctor, and when to stop taking it (see also "Stopping Oxycodone Hydrochloride Hameln").

Use in children and adolescents

This medicine should not be given to children and adolescents under 18 years old.

Patients with kidney or liver problems

The patient should inform their doctor about any kidney or liver problems, as the doctor may recommend a smaller dose depending on the patient's condition.

The patient should not take a larger dose than prescribed by the doctor. In case of any doubts, they should consult their doctor or pharmacist.

If the administration of Oxycodone Hydrochloride Hameln does not relieve the pain, the patient should consult their doctor.

Taking a larger dose of Oxycodone Hydrochloride Hameln than prescribed or using it for a longer period than prescribed

The patient should contact their doctor or hospital immediately. People who overdose may feel drowsy, nauseous, or dizzy. They may also have breathing difficulties leading to loss of consciousness and even death, and may require immediate hospital treatment. Overdose can also lead to brain damage (toxic leukoencephalopathy). When seeking medical help, the patient should have this leaflet and any remaining medicine with them to show the doctor.

Stopping Oxycodone Hydrochloride Hameln

The patient should not stop taking this medicine abruptly, unless their doctor advises otherwise. If they want to stop taking the medicine, they should first consult their doctor. The doctor will advise them on how to do this - usually by gradually reducing the dose, so the patient does not experience unpleasant withdrawal effects. If the medicine is stopped abruptly, the patient may experience withdrawal symptoms, such as agitation, anxiety, tremors, or sweating.

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxycodone Hydrochloride Hameln can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although severe allergic reactions are rare. The patient should immediately inform their doctorif they suddenly experience: 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 a condition in which the patient breathes more slowly or weakly than they should (respiratory depression). The patient should immediately inform their doctorif they notice this condition in themselves.

As with all strong painkillers, there is a risk of dependence on Oxycodone Hydrochloride Hameln.

Very common side effects

(may affect more than 1 in 10 people)

Constipation (the doctor may prescribe a laxative to overcome this problem).

Nausea or vomiting (this condition should improve after a few days; if it does not, the doctor may prescribe an anti-emetic).

Drowsiness (this condition usually occurs after starting the medicine or after increasing the dose, but it should improve after a few days).

Dizziness.

Headache.

Itching of the skin.

Common side effects

(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, tremors, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, unusual thoughts or dreams.

Breathing difficulties or wheezing, shortness of breath, decreased cough reflex.

Rash.

Sweating.

Uncommon side effects

(may affect up to 1 in 100 people)

Difficulty swallowing, belching, hiccups, bloating, abnormal bowel function (intestinal obstruction), stomach inflammation, changes in taste.

Dizziness or feeling of "spinning", hallucinations, mood changes, bad mood, feeling of extreme happiness, anxiety, especially restlessness, agitation, general malaise, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness of hands and feet, seizures, convulsions, blurred vision, fainting, excessive muscle stiffness or relaxation, involuntary muscle contractions.

Difficulty urinating, impotence, decreased sexual desire, low hormone levels in the blood (hypogonadism, observed in blood tests).

Fast or irregular heartbeat, flushing of the skin.

Dehydration, thirst, chills, swelling of hands, ankles, or feet.

Dry skin, severe skin peeling.

Flushed face, constricted pupils, muscle spasms, high fever.

Need to take increasingly larger doses of the medicine to achieve the same level of pain relief (tolerance).

Colicky abdominal pain or discomfort.

Worsening of liver function (observed in blood tests).

Rare side effects

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

Low blood pressure.

Feeling of "fainting", especially when standing up.

Hives.

Unknown frequency of side effects

(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). This can lead to itching of the skin, yellow skin, very dark urine, and very pale stools.

A disorder affecting the valve in the intestines, which can cause severe abdominal pain (Oddi's sphincter dysfunction).

Prolonged use of Oxycodone Hydrochloride Hameln during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms in the child include: irritability, hyperactivity, and abnormal sleep pattern, loud crying, tremors, vomiting, diarrhea, and failure to gain weight.

Sleep apnea (pauses in breathing during sleep).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Oxycodone Hydrochloride Hameln

The medicine should be stored out of sight and reach of children. This medicine should be stored in a closed and secure place, to which other people do not have access. It can be very harmful and may cause death if taken by someone it was not prescribed for.

Accidental overdose of the medicine by a child is dangerous and may be fatal.

The medicine should not be used after the expiry date stated on the ampoule label and carton after: EXP. The expiry date refers to the last day of the month stated.

There are no special precautions for storage of the medicinal product.

The ampoules should be stored in the outer packaging to protect them from light.

The medicine should be used immediately after opening the ampoule. Any unused remainder of the medicine should be disposed of immediately.

The medicine should be inspected visually and not used if it has changed color or contains impurities.

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. This will help protect the environment.

6. Contents of the packaging and other information

What Oxycodone Hydrochloride Hameln contains

The active substance of the medicine is oxycodone hydrochloride.

Other ingredients are:

Citric acid monohydrate

Sodium citrate dihydrate

Sodium chloride

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Water for injections

What Oxycodone Hydrochloride Hameln looks like and contents of the pack

Oxycodone Hydrochloride Hameln is a clear, colorless solution, practically free from visible particles, supplied in colorless glass ampoules.

Each 1 ml ampoule contains 10 mg of oxycodone hydrochloride, which corresponds to 9 mg of oxycodone.

Each 2 ml ampoule contains 20 mg of oxycodone hydrochloride, which corresponds to 18 mg of oxycodone.

Package sizes: 5 or 10 ampoules in a carton.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

hameln pharma gmbh

Inselstraße 1

31787 Hameln

Germany

Manufacturer:

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovakia

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

hameln rds s.r.o.

Horná 36

900 01 Modra

Slovakia

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria

Oxycodon-hameln 10 mg/ml Injektions-/Infusionslösung

Denmark

Oxycodone Hameln

Ireland

Oxycodone Hydrochloride 10 mg/ml solution for injection or infusion

Germany

Oxycodon-hameln 10 mg/ml Injektions-/Infusionslösung

Norway

Oxycodone Hameln

Poland

Oxycodone Hydrochloride Hameln

Sweden

Oxycodone Hameln 10 mg/ml injektions-/infusionsvätska, lösning

United Kingdom

(Northern Ireland)

Oxycodone Hydrochloride 10 mg/ml solution for injection or infusion

Date of last revision of the leaflet: 29.01.2024.

Information intended for healthcare professionals only:

PREPARATION INSTRUCTIONS FOR Oxycodone Hydrochloride Hameln, 10 mg/ml, solution for injection/infusion Refer to the Summary of Product Characteristics for full instructions and other information.

Indications

Oxycodone is indicated for the treatment of moderate to severe pain in adult patients with cancer and patients with post-operative pain. For the treatment of severe pain that requires the use of a strong opioid.

Administration

Intravenous or subcutaneous administration.

Dilution

Each ampoule is for single use in one patient. The medicine should be administered immediately after opening the ampoule, and all unused remainder should be discarded.

The medicinal product should be inspected visually and not used if it has changed color or contains impurities.

Oxycodone Hydrochloride Hameln, undiluted or diluted to 1 mg/ml using sodium chloride 0.9% solution, dextrose 5% solution, or water for injections, is physically and chemically stable in contact with polypropylene or polyethylene syringes, polyethylene tubing, and infusion bags made of PVC or EVA from representative manufacturers, for 24 hours at 25°C.

The 10 mg/ml solution for injection, both undiluted and diluted to 1 mg/ml in infusion solutions and containers listed above, does not need to be protected from light for 24 hours.

Inappropriate handling of the undiluted solution after opening the original ampoule or of the diluted solutions may cause loss of sterility of the product.

Information intended for healthcare professionals only: (Continued)

Oxycodone Hydrochloride Hameln, 10 mg/ml, solution for injection/infusion

Compatibility

Oxycodone Hydrochloride Hameln is compatible with the following medicines:

Butylscopolamine bromide

Scopolamine bromide

Dexamethasone sodium phosphate

Haloperidol

Midazolam hydrochloride

Metoclopramide hydrochloride

Levomepromazine hydrochloride

Incompatibilities

Cyclizine at a concentration of 3 mg/ml or less, when mixed with Oxycodone Hydrochloride Hameln, both undiluted and diluted with water for injections, shows no signs of precipitation within 24 hours at 25°C. Precipitation has been shown to occur in mixtures with Oxycodone Hydrochloride Hameln at cyclizine concentrations greater than 3 mg/ml or after dilution with sodium chloride 0.9% solution. It is recommended to use water for injections as a diluent when cyclizine and oxycodone hydrochloride are administered concomitantly by intravenous or subcutaneous infusion.

Prochlorperazine is chemically incompatible with Oxycodone Hydrochloride Hameln.

Shelf life

Prepared infusion solutions:

Chemical and physical stability has been demonstrated for 24 hours at 25°C.

Instructions for dilution of the medicinal product before administration are given in the section Dilutionon the reverse.

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, the duration would not be longer than 24 hours at 2°C to 8°C, unless the solution has been prepared in controlled and validated aseptic conditions.