Oxycodone hydrochloride hameln

Package leaflet: Information for the user

Oxycodone Hydrochloride Hameln, 10 mg/ml, solution for injection/infusion
Oxycodone hydrochloride
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Oxycodone Hydrochloride Hameln is and what it is 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 pack and other information

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

This medicine is prescribed by a doctor to relieve moderate to 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 bronchial asthma, or severe respiratory depression. The doctor will inform the patient if
any of these conditions apply. Symptoms may include shortness of breath, cough, or slower or weaker
breathing than expected;
if the patient has a condition in which the small intestine does not function properly (paralytic
intestinal obstruction) or has severe abdominal pain;
if the patient has heart disease secondary to long-term lung disease (cor pulmonale);
if the patient has chronic constipation;
if the patient is under 18 years of age.

Warnings and precautions
Before starting treatment with Oxycodone Hydrochloride Hameln, discuss with your doctor,
pharmacist, or nurse if the patient:
is elderly or frail;
has hypothyroidism, as a lower dose of Oxycodone Hydrochloride Hameln may be required;
has myxoedema (a thyroid disorder causing dryness, cold intolerance, and swelling [oedema] of
the skin of the face and limbs);
has a head injury, severe headache, or nausea, as these may indicate increased intracranial pressure;
has low blood pressure (hypotension);
has low blood volume (hypovolaemia), which may occur due to severe external or internal bleeding,
severe burns, excessive sweating, severe diarrhoea, or severe vomiting;
has psychiatric disorders caused by infection (toxic psychosis);
has pancreatitis (causing severe abdominal and back pain);
has gallbladder or biliary tract problems;
has intestinal inflammation;
has an enlarged prostate gland causing difficulty in urinating (in men);
has adrenal gland dysfunction (abnormal adrenal function that may cause symptoms such as
weakness, weight loss, dizziness, nausea, or vomiting), e.g. Addison’s disease;
has breathing problems such as severe lung disease. The doctor will inform the patient if this
condition applies. Symptoms may include shortness of breath and cough;
has kidney or liver problems;
has previously experienced withdrawal symptoms such as restlessness, anxiety, tremor, or sweating
after stopping alcohol or drugs;
has increased sensitivity to pain;
needs to take increasingly higher doses of Oxycodone Hydrochloride Hameln to achieve the same
level of pain relief (tolerance).

Contact the doctor if the patient experiences severe upper abdominal pain that may radiate to the
back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis or biliary tract
inflammation.

Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers
may lead to reduced effectiveness of the medicine (the patient’s body becomes accustomed to it, known
as tolerance). Repeated use of Oxycodone Hydrochloride Hameln may lead to dependence, abuse, and
addiction, which may result in life-threatening overdose. The risk of these adverse effects may be higher
when higher doses are used for longer periods.

Dependence or addiction may cause the patient to lose control over how much medicine to take or how
often to take it. The patient may feel a need to take the medicine even if it is not relieving pain.

The risk of dependence or addiction varies between individuals. The risk of developing addiction or
dependence on Oxycodone Hydrochloride Hameln may be higher if:

• the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or drugs (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 psychiatric disorders.

If the patient notices any of the following symptoms while taking Oxycodone Hydrochloride Hameln,
this may indicate that dependence or addiction is developing:

• need to take the medicine for 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 sleep”;
• repeated unsuccessful attempts to stop or reduce use of the medicine;
• feeling unwell after stopping the medicine and improvement after restarting (withdrawal effect).

If the patient observes any of these symptoms, they should contact their doctor to discuss the best
treatment plan, including the appropriate timing and safe way to discontinue treatment (see section 3
“Stopping treatment with Oxycodone Hydrochloride Hameln”).

Hormonal changes may occur during treatment with this medicine. These changes may require
monitoring by a doctor.

If surgery is required, inform the hospital doctor that the patient is taking this medicine.

Sleep-related breathing disorders
Oxycodone Hydrochloride Hameln may cause sleep-related breathing disorders such as sleep apnoea
(breathing pauses during sleep) and nocturnal hypoxaemia (low oxygen levels in the blood during
sleep). Symptoms may include breathing pauses during sleep, waking up at night due to shortness of
breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else
notices such symptoms, contact the 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 drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma,
and may be life-threatening. Therefore, concomitant use of other medicines should only be considered
when no other treatment options are possible.

If the doctor prescribes Oxycodone Hydrochloride Hameln to be taken together with sedative
medicines, the doctor should limit the dose and duration of concomitant treatment.

Inform the doctor about all sedative medicines being taken and strictly follow the doctor’s dosing
instructions. Inform friends or family members about the above-mentioned subjective and objective
symptoms. If such symptoms occur, contact the doctor.

The risk of adverse effects increases if the patient is taking antidepressants (such as citalopram,
duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines
may interact with oxycodone and cause the following symptoms in the patient: involuntary rhythmic
muscle contractions, including muscles controlling eye movements, restlessness, excessive sweating,
tremor, increased reflexes, increased muscle tension, and elevated body temperature above 38°C. If
these symptoms occur, contact the doctor.

Tell your doctor or pharmacist about all medicines currently or recently taken, including those
available without a prescription. When this medicine is administered by injection together with certain
other medicines, the effect of this medicine or the other medicines may be altered.

Inform your doctor or pharmacist if you are taking:
a type of medicine called monoamine oxidase inhibitor (MAOI), including if such medicine was taken
within the last two weeks;
medicines to help sleep or maintain calm (e.g. sleeping pills or sedatives, including benzodiazepines);
medicines used to treat depression (e.g. paroxetine);
medicines used to treat psychiatric disorders (e.g. phenothiazines or neuroleptics);
other strong analgesics (“painkillers”);
muscle relaxants;
medicines used to treat high blood pressure;
quinidine (a medicine used to treat fast 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 epileptic seizures or convulsions);
an herbal medicine called St John’s wort (also known as Hypericum perforatum);
antihistamines;
medicines used to treat Parkinson’s disease.

Additionally, inform the doctor if the patient has recently received an anaesthetic agent.

Using Oxycodone Hydrochloride Hameln with food, drink, and alcohol
Drinking alcohol while being treated with Oxycodone Hydrochloride Hameln may cause drowsiness or
increase the risk of serious adverse effects such as shallow breathing (including risk of respiratory
arrest) and loss of consciousness. Do not drink alcohol while taking Oxycodone Hydrochloride
Hameln.

Avoid drinking grapefruit juice during treatment with this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she
should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of this medicine during pregnancy and childbirth is not recommended unless specifically advised
by a doctor. Depending on the dose and duration of oxycodone treatment, newborns may show slow and
shallow breathing (respiratory depression) or withdrawal symptoms.

Breastfeeding
Breastfeeding mothers should not use this medicine, as oxycodone may pass into breast milk and cause
respiratory depression in the newborn.

Driving and using machines
Drowsiness may occur when starting treatment or increasing the dose of this medicine. If this symptom
occurs, the patient should not drive or operate machinery. This medicine may affect the ability to drive
as it may cause drowsiness or dizziness.

If in doubt about whether it is safe to drive while taking this medicine, consult a doctor or pharmacist.

Oxycodone Hydrochloride Hameln contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, meaning the medicine is considered
“sodium-free”.

3. How to use Oxycodone Hydrochloride Hameln

The correct dose, method, and timing of administration are determined by the physician. The dose and frequency of administration of this medicine should be adjusted according to the severity of pain. The medicine may be administered by subcutaneous injection (subcutaneous infusion) 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 ongoing treatment, the doctor will discuss with the patient what to expect from using Oxycodone Hydrochloride Hameln, when and for how long the patient should take it, when to contact the doctor, and when to discontinue its use (see also "Stopping Oxycodone Hydrochloride Hameln").
Use in children and adolescents
This medicine should not be given to children and adolescents under 18 years of age.
Patients with kidney or liver problems
Inform the doctor about any kidney or liver problems, as they may recommend a lower dose depending on the patient's condition.
Do not use a higher dose than recommended by the doctor. If in doubt, consult a doctor or pharmacist.
If administration of Oxycodone Hydrochloride Hameln does not relieve pain, this should be discussed with the doctor.
Use of a higher than recommended dose of Oxycodone Hydrochloride Hameln or use by another person
Seek immediate medical advice from a doctor or hospital. Individuals who overdose on this medicine may experience drowsiness, nausea, or dizziness. They may also have difficulty breathing, leading to loss of consciousness and even death, and may require immediate hospital treatment. Overdose may also lead to brain damage (known as toxic leukoencephalopathy). When seeking medical help, bring this leaflet and any remaining medicine to show the doctor.
Stopping Oxycodone Hydrochloride Hameln
Do not suddenly stop using this medicine unless otherwise instructed by a doctor. If you wish to discontinue treatment, discuss this first with your doctor. The doctor will advise you on how to do this—usually by gradually reducing the dose—so that you do not experience unpleasant withdrawal effects. If treatment is stopped abruptly, withdrawal symptoms such as agitation, anxiety, palpitations, tremor, or sweating may occur.
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.
All medicines can cause allergic reactions, although severe allergic reactions are rare. You should contact your doctor immediately if you suddenly experience: wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially if it affects the whole body.

The most serious adverse effect is a condition in which the patient breathes more slowly or weakly than normal (respiratory depression). You should contact your doctor immediately if you notice this condition in yourself.

As with all strong opioid painkillers, there is a risk of becoming addicted to Oxycodone Hydrochloride Hameln.

Very common adverse effects
(may affect more than 1 in 10 people)
Constipation (to help manage this, your doctor may prescribe a laxative).
Nausea or vomiting (this usually settles after a few days; if not, your doctor may prescribe an anti-sickness medicine).
Drowsiness (this usually occurs when starting the medicine or after an increase in dose, but should improve after a few days).
Dizziness.
Headache.
Itching of the skin.

Common adverse effects
(may affect up to 1 in 10 people)
Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.
Confusion, depression, feeling unusually weak, tremor, lack of energy, tiredness, restlessness, nervousness, difficulty sleeping, strange thoughts or dreams.

Breathing difficulties or wheezing, shortness of breath, reduced cough reflex.
Rash.
Sweating.

Uncommon adverse effects
(may affect up to 1 in 100 people)
Difficulty swallowing, burping, hiccups, bloating, bowel problems (intestinal obstruction), inflammation of the stomach, changes in taste sensation.
Dizziness or a spinning sensation, hallucinations, mood changes, irritability, feeling of extreme happiness, restlessness, especially physical, agitation, general malaise, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness in hands and feet, seizures, convulsions, blurred vision, fainting, unusual muscle stiffness or weakness, involuntary muscle contractions.

Difficulty passing urine, impotence, reduced sex drive, low levels of sex hormones in the blood ("hypogonadism", observed in blood tests).
Fast or irregular heartbeat, redness of the skin.
Dehydration, thirst, chills, swelling of the hands, ankles or feet.
Dry skin, severe peeling of the skin.
Flushing of the face, constricted pupils, muscle spasms, high temperature.
Need for increasingly higher doses of the medicine to achieve the same level of pain relief (tolerance).
Colicky abdominal pain or discomfort.
Worsening of liver function (seen in blood tests).

Rare adverse effects
(may affect up to 1 in 1,000 people)
Low blood pressure.
Feeling of "fainting" or "giving way", especially when standing up.
Urticaria (hives).

Adverse effects of unknown frequency
(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 may lead to itching of the skin, yellowing of the skin, very dark urine and very pale stools.
A disorder affecting the valve in the intestines, which may cause severe upper abdominal pain (Oddi sphincter dysfunction).
Prolonged use of Oxycodone Hydrochloride Hameln during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms in the baby include: irritability, hyperactivity and abnormal sleep patterns, loud crying, tremors, vomiting, diarrhoea and failure to gain weight.
Sleep apnoea (pauses in breathing during sleep).

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of 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. By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Oxycodone Hydrochloride Hameln

The medicine should be stored out of sight and reach of children. This medicine must be stored in a closed and secure place to which others do not have access. It can be highly harmful and may cause death in individuals for whom it has not been prescribed. Accidental overdose of this medicine by a child is dangerous and may be fatal.
Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicinal product.
Store the vials in the outer packaging to protect from light.
The medicine should be used immediately after opening the vial. Any unused medicine residue should be promptly disposed of.
The medicine should be visually inspected before use and must not be used if there is a change in colour or if particles are present.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Oxycodone Hydrochloride Hameln contains
The active substance is oxycodone hydrochloride.
The other components are:
Citric acid monohydrate
Disodium 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, colourless solution, practically free from visible particles, supplied in colourless glass ampoules.
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.
Pack sizes: 5 or 10 ampoules in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany

Manufacturers:
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 medicinal product is authorised 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

Information intended exclusively for medical professionals:

PREPARATION GUIDELINES FOR THE PRODUCT:
Oxycodone Hydrochloride Hameln, 10 mg/mL, solution for injection / for infusion
Refer to the Summary of Product Characteristics for complete recommendations
and other information.
Indications
Oxycodone is indicated for the treatment of moderate to severe pain in adult patients with cancer
and in patients experiencing postoperative pain. For the management of severe pain requiring
the use of a strong opioid.
Administration
Intravenous or subcutaneous administration.
Dilution
Each ampoule is intended for single use in one patient only. The medicinal product should be used
immediately after opening the ampoule, and any unused residue must be discarded.
The solution should be inspected visually; do not use if there is a change in colour or if particulate
matter is present.
Oxycodone Hydrochloride Hameln, undiluted or diluted to 1 mg/mL with 0.9% sodium chloride
solution, 5% dextrose solution, or water for injections, is physically and chemically stable when in
contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA
infusion bags from representative brands, over 24 hours at 25°C.
The 10 mg/mL injection solution, whether undiluted or diluted to 1 mg/mL in the infusion fluids
and containers mentioned above, does not require protection from light over 24 hours.
Improper handling of the undiluted solution after opening the original ampoule or of diluted
solutions may result in loss of sterility of the product.

Information intended exclusively for medical professionals:

( Continued )
Oxycodone Hydrochloride Hameln, 10 mg/ml, solution for injection / for infusion
Compatibility
Oxycodone Hydrochloride Hameln is compatible with the following medicinal products:
Hyoscine butylbromide
Hyoscine hydrobromide
Sodium phosphate of dexamethasone
Haloperidol
Hydrochloride of midazolam
Hydrochloride of metoclopramide
Hydrochloride of levomepromazine
Pharmaceutical incompatibilities
Cyclizine at a concentration of 3 mg/ml or less, when mixed with Oxycodone Hydrochloride Hameln, either in undiluted form or diluted with water for injections, shows no signs of precipitation over 24 hours of storage at 25°C. Precipitation has been observed in mixtures with Oxycodone Hydrochloride Hameln when cyclizine concentrations exceed 3 mg/ml or when diluted with 0.9% sodium chloride solution.
Water for injections is recommended as the diluent when cyclizine and oxycodone hydrochloride are administered intravenously or subcutaneously as an 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 prior to administration are provided in the Dilution section on the reverse.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for the storage duration and conditions of the ready-to-use solution lies with the user. Generally, this period should not exceed 24 hours at a temperature of 2°C to 8°C, unless the solution was prepared under controlled and validated aseptic conditions.