10 mg/ml solution for injection or infusion
What Oxycodone Hameln is and what it is used for
This medicine has been prescribed for you by your doctor to relieve mild to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or painkillers.
Oxycodone hydrochloride contained in Oxycodone Hameln may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Oxycodone Hameln
Do not take Oxycodone Hameln:
- if you are allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6).
- if you have difficulty breathing such as severe chronic obstructive pulmonary disease (COPD), severe bronchial asthma, or severe impaired breathing. Your doctor will tell you if you have any of these conditions. Symptoms may include shortness of breath, coughing, or slower / weaker breathing than expected.
- if you have a condition where the small intestine does not work properly (paralytic bowel movement / stagnant bowel) or if you have severe abdominal pain.
- if you have heart problems after long-term lung disease (heart-lung disease/cor pulmonale).
- if you have recurrent/ongoing constipation.
- if you are under 18 years of age.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Oxycodone Hameln if you:
- is older or debilitated.
- have impaired thyroid function ( hypothyroidism ), as you may need a lower dose of Oxycodone Hameln.
- has myxedema (thyroid disease with dry, cold, and swollen skin on the face and limbs).
- have a head injury, severe headache, or feel nauseous, as this may indicate that the pressure in your head is elevated.
- have low blood pressure ( hypotension ).
- has decreased blood volume ( hypovolemia ). This can occur with severe external or internal bleeding, severe burns, heavy sweating, severe diarrhea, or vomiting.
- have a mental illness as a result of infection (toxic psychosis ).
- have inflammation of the pancreas (which causes severe pain in the abdomen and back).
- have problems with your gallbladder or bile duct.
- have an inflammatory bowel disease.
- have an enlarged prostate , with difficulty urinating (in men).
- has impaired adrenal function (your adrenal gland does not function properly, which can cause symptoms such as weakness, weight loss, dizziness, nausea, or vomiting), e.g. Addison’s disease.
- have difficulty breathing such as severe lung disease. Your doctor will have to tell you if you have this condition. Symptoms may include shortness of breath and coughing.
- have kidney or liver problems.
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking, or sweating when you stopped using alcohol or drugs.
- is or has been addicted to alcohol or other substances or has a known opioid dependence.
- has an increased sensitivity to pain.
- need successively higher doses of Oxycodone Hameln to achieve the same level of pain relief (tolerance).
You may experience hormonal changes while taking this medicine. Your doctor may want to monitor these changes.
If you are going to have an operation, tell your doctor at the hospital that you are taking this medicine.
Other medicines and Oxycodone Hameln
Concomitant use of Oxycodone Hameln and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
If your doctor still prescribes Oxycodone Hameln with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.
Inform your doctor about all sedatives you are taking and follow your doctor’s dose recommendation. It may be helpful to ask friends or relatives to pay attention to the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
The risk of side effects is increased if you take antidepressant drugs (for example, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine ). These drugs can affect or be affected by oxycodone, and you may experience symptoms such as involuntary, rhythmic muscle contractions, including in the muscles that control eye movements, sudden movements, heavy sweating, tremors, excessive reflexive movements, increased muscle tension, body temperature above 38 ° C. Contact your doctor if you experience these symptoms.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. If you use this injection with other medicines, the effect of the injection may be affected by one or the other medicines.
Tell your doctor or pharmacist if you are taking:
- any MAOI or if you have been taking this type of medicine in the last two weeks.
- medicines that help you sleep or relieve anxiety (such as sleeping pills or sedatives such as benzodiazepines ).
- medicines used to treat depression (such as paroxetine ).
- drugs for the treatment of psychiatric/mental illness (such as phenothiazines or neuroleptics ).
- other strong analgesics (painkillers).
- muscle relaxants.
- drugs for the treatment of high blood pressure.
- quinidine (to treat fast heartbeats).
- cimetidine (to treat stomach ulcers, digestive problems, or heartburn).
- medicines to treat fungal infections (such as ketoconazole , voriconazole, itraconazole and posaconazole).
- medicines to treat your infection (such as clarithromycin, erythromycin, or telithromycin).
- drugs in the group of protease inhibitors for the treatment of HIV (eg boceprevir, ritonavir, nelfinavir, or saquinavir).
- rifampicin (for the treatment of tuberculosis ).
- carbamazepine (for the treatment of seizures, epileptic seizures or convulsions, and certain pain conditions).
- phenytoin (for the treatment of seizures, epileptic seizures, or convulsions).
- traditional herbal medicines containing St. John’s wort ( Hypericum perforatum ).
- medicines for allergies ( antihistamines ).
- drugs to treat Parkinson’s disease.
Also, tell your doctor if you have recently been given anesthesia.
Oxycodone Hameln with food, drink, and alcohol
Drinking alcohol during your treatment with Oxycodone Hameln may make you drowsy or increase the risk of serious side effects such as shallow breathing with respiratory arrest and unconsciousness. It is recommended that you do not drink alcohol while taking Oxycodone Hameln.
You should avoid drinking grapefruit juice during your treatment with the medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended during pregnancy and childbirth unless your doctor has specifically asked you to take it. Depending on the dose and duration of your treatment with oxycodone, slow and shallow breathing ( respiratory depression ) or withdrawal symptoms may occur in the newborn.
It should not be used by breastfeeding mothers as oxycodone may be excreted in human milk and may lead to respiratory depression in the newborn.
Driving and using machines
You may feel drowsy when you first start taking this medicine or when taking a dose.
If this happens, do not drive or use machines. The drug can affect your ability to drive and make you sleepy or dizzy.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oxycodone Hameln contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 1 ml, ie essentially ‘sodium-free’.
How to use Oxycodone Hameln
The doctor will assess which dose is right for you and how and when the medicine should be given. Dose one and how often the drug is given can be adjusted depending on the pain level. The drug can be given as an injection or infusion under the skin ( subcutaneous injection ) or directly into a vein ( intravenous injection ). Your nurse or doctor will give you the medicine.
Use for children and adolescents
Children and adolescents under 18 years of age should not be given this medicine.
Patients with kidney or liver problems
Tell your doctor if you suffer from kidney or liver problems as these conditions may require a lower dose.
You should not exceed your doctor’s dose recommendation. If you are not sure, ask your doctor or pharmacist.
If you still have pain while taking Oxycodone Hameln, discuss this with your doctor.
If you take more Oxycodone Hameln than you should or if someone else is using your medicine
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
People who have had an overdose may feel sleepy, sick, or dizzy. They may also have difficulty breathing which may lead to unconsciousness or even death and may require emergency hospital treatment.
If you stop using Oxycodone Hameln
You should not abruptly stop your medication unless your doctor has told you to. If you want to stop using the medicine, discuss this with your doctor first. Your doctor will tell you how to gradually reduce the dose so that you do not experience any unpleasant side effects. Withdrawal symptoms such as agitation, anxiety, palpitations, tremors, or sweating may occur if you suddenly stop using the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, but severe allergic reactions are rare. Tell your doctor immediately if you experience sudden wheezing, difficulty breathing, swollen eyelids, face or lips, rash, or itching (especially all over the body).
The most serious side effect is a condition in which you breathe slower or weaker than expected ( respiratory depression ). Tell your doctor immediately if this happens to you.
As with all strong painkillers, there is a risk that you will become addicted to Oxycodone Hameln.
Very common side effects are
(May affect more than 1 user in 10)
- Constipation (your doctor may prescribe a laxative to get rid of the problem).
- Nausea or vomiting (this should subside after a few days; your doctor may prescribe an anti-nausea remedy if it continues to be a problem).
- Drowsiness (this usually occurs when you start taking the medicine or when the dose is increased but should decrease after a few days).
Common side effects are
(May affect up to 1 in 10 users)
- Dry mouth, loss of appetite, digestive problems, abdominal pain or discomfort, diarrhea.
- Confusion, depression, feelings of weakness, tremors, lack of energy, fatigue, anxiety, worry, difficulty sleeping, abnormal thoughts or dreams.
- Difficulty breathing or wheezing, shortness of breath, impaired cough reflex.
Uncommon side effects are
(May affect up to 1 in 100 users)
- Problems swallowing, belching, hiccups, gas in the stomach, stagnant bowel (intestinal upset), gastritis, taste changes.
- Dizziness, hallucinations, mood swings, discomfort, extreme feelings of happiness, restlessness, agitation, malaise, memory loss, difficulty speaking, increased sensitivity to pain or touch, tingling or numbness in hands or feet, cramps, seizures or convulsions, blurred vision, dizziness, fainting, fainting. , involuntary muscle contractions.
- Difficulty urinating, impotence, decreased sex drive, low levels of sex hormones in the blood ( hypogonadism, manifested in blood tests).
- Fast, irregular heartbeat, reddening of the skin.
- Dehydration, thirst, chills, swollen hands, ankles, or feet.
- Dry skin, flaky or scaly skin.
- Facial redness, decreased pupils, muscle spasms, elevated temperature.
- Need a gradually higher dose of the drug to achieve the same level of pain relief (tolerance).
- Colic pain or abdominal discomfort.
- Impaired liver function tests (shown in blood tests).
Rare side effects
(May affect up to 1 in 1,000 users)
- Low blood pressure.
- A feeling of dizziness/fainting, especially when you get up.
- Hives ( hives ).
Has been reported
(occurs in an unknown number of users)
- Increased pain sensitivity.
- Absence of menstruation.
- Gallstones (cholestasis). This can cause itching, yellow skin, very dark urine, and pale stools.
- Long-term use of Oxycodone Hameln during pregnancy can lead to life-threatening withdrawal symptoms in the newborn. Symptoms of the child may include irritability, hyperactivity and irregular sleep, crying, tremors, vomiting, diarrhea, and lack of weight gain.
How to store Oxycodone Hameln
Keep this medicine out of the sight and reach of children. Accidental overdose in children can be dangerous and directly life-threatening.
Do not use this medicine after the expiry date which is stated on the label, carton after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Store ampoule one in the outer carton. Sensitive to light.
Once the ampoule has been opened, the medicine should be used immediately. Any residue should be discarded immediately.
The drug should be inspected visually and should not be used if it contains particles or has been discolored.
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 to protect the environment.
Contents of the pack and other information
The active substance is oxycodone hydrochloride.
Other ingredients are:
- Citric acid monohydrate
- Sodium citrate (dihydrate)
- Sodium chloride
- Hydrochloric acid
- Sodium hydroxide
- Water for injections
What the medicine looks like and the contents of the pack
Oxycodone Hameln is a clear, colorless solution that is largely free of visible particles and is delivered in colorless glass ampoules.
Each 1 ml ampoule contains 10 mg oxycodone hydrochloride (equivalent to 9 mg oxycodone).
Each 2 ml ampoule contains 20 mg oxycodone hydrochloride (equivalent to 18 mg oxycodone).
Pack size: 5, 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Hameln pharma gmbh
HBM Pharma sro
036 80 Martin
Hameln rds as
900 01 Modra
This medicinal product is authorized under the European Economic Area under the names:
Austria: Oxycodone Hameln 10 mg/ml Solution for injection
Germany: Oxycodone Hameln 10 mg/ml Solution for injection
Denmark: Oxycodone Hameln
Ireland: Oxycodone Hydrochloride 10 mg/ml solution for injection or infusion
Norway: Oxycodone Hameln
Poland: Oxycodone Hydrochloride Hameln
Sweden: Oxycodone Hameln 10 mg/ml solution for injection or infusion
United Kingdom: Oxycodone Hydrochloride 10 mg/ml solution for injection or infusion