Oxicodone Molteni

Package Leaflet: Information for the User

Oxycodone Molteni, 10 mg/ml, Solution for Injection / Infusion

Oxycodone Hydrochloride

Read All of This Leaflet Carefully Before You Start Using This Medicine.

• You Should Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicine Has Been Prescribed for You. Do Not Pass It On to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Get Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

• 1. What Oxycodone Is and What It Is Used For
• 2. Before You Use Oxycodone
• 3. How to Use Oxycodone
• 4. Possible Side Effects
• 5. How to Store Oxycodone
• 6. Contents of the Pack and Other Information

1. What Oxycodone Is and What It Is Used For

The Full Name of the Medicine Is Oxycodone Molteni. In This Leaflet, the Shorter Name "Oxycodone" Is Used. The Medicine Contains the Active Substance Oxycodone Hydrochloride. The Medicine Belongs to a Group of Medicines Called Painkillers (or "Analgesics"). Oxycodone Is Used to Treat Pain, from Moderate to Severe.

2. Before You Use Oxycodone

When You Should Not Use Oxycodone:

• If You Are Allergic to Oxycodone or Any of the Other Ingredients of This Medicine (Listed in Section 6)
• If You Have Breathing Problems, Such as Severe Chronic Obstructive Pulmonary Disease, Severe Asthma, or Severe Respiratory Depression, or If You Have a Condition That Affects Your Breathing, Such as Pneumonia, or If You Are Taking Other Medicines That Affect Breathing
• If You Have Severe Abdominal Pain or Intestinal Obstruction
• If You Have Heart Problems Caused by Long-Term Lung Disease (Cor Pulmonale)
• If You Have Moderate or Severe Liver Problems
• If You Have Frequent Constipation
• If You Are Under 18 Years Old. Do Not Use Oxycodone If Any of the Above Applies to You. If You Are in Doubt, Consult Your Doctor, Pharmacist, or Nurse Before Using Oxycodone.

Warnings and Precautions

Before Starting to Use the Medicine, Discuss with Your Doctor, Pharmacist, or Nurse If You:

• Are Elderly or Weak
• Have an Underactive Thyroid Gland (Hypothyroidism) - Your Doctor May Need to Reduce Your Dose
• Have Myxoedema (a Thyroid Disorder Characterized by Dry, Cold, and Swollen Skin on the Face and Extremities)
• Have Had a Head Injury, Have Severe Headaches, or Feel Unwell - This Could Be a Sign of Increased Pressure in the Skull
• Have Low Blood Volume (Hypovolemia); This Can Occur Due to Severe External or Internal Bleeding, Severe Burns, Excessive Sweating, Severe Diarrhea, or Vomiting
• Have Low Blood Pressure (Hypotension)
• Have Mental Disorders Caused by Poisoning (Toxic Psychosis)
• Have Problems with Your Gallbladder or Bile Ducts
• Have Pancreatitis (Which Causes Severe Abdominal and Back Pain)
• Have Inflammatory Bowel Disease
• Have Prostate Problems
• Feel Weak or Dizzy, Nauseous or Vomit, or Have Lost Weight - These Could Be Signs of Adrenal Gland Problems
• Have Breathing Problems, Such as Severe Lung Disease, Which Can Cause Shortness of Breath with Coughing
• Have a History of Withdrawal Symptoms, Such as Restlessness or Anxiety, Shaking or Sweating, When Stopping Alcohol or Drug Use
• Have Kidney Problems
• Have Liver Problems. If Any of the Above Applies to You (or If You Are Not Sure), Consult Your Doctor, Pharmacist, or Nurse Before Using Oxycodone.

Tolerance, Dependence, and AddictionThis Medicine Contains Oxycodone, Which Is an Opioid. It Can Cause Dependence and (or) Addiction. This Medicine Contains Oxycodone, Which Is an Opioid Medicine. Repeated Use of Opioid Painkillers Can Lead to Tolerance (Your Body Gets Used to the Medicine). Repeated Use of Oxycodone Can Lead to Dependence, Abuse, and Addiction, Which Can Be Life-Threatening. The Risk of These Side Effects Is Higher When Using Higher Doses for Longer Periods.

• If You or Someone in Your Family Has Ever Abused or Been Dependent on Alcohol, Prescription Medicines, or Street Drugs (So-Called "Addiction")
• If You Smoke
• If You Have Ever Had Mood Disorders (Depression, Anxiety, or Personality Disorder) or Have Been Treated by a Psychiatrist for Other Mental Disorders. If You Notice Any of the Following Symptoms While Taking Oxycodone, It May Indicate That You Are Developing Dependence or Addiction:
• Needing to Take the Medicine for Longer Than Prescribed by Your Doctor
• Needing to Take a Higher Dose Than Prescribed
• Taking the Medicine for Reasons Other Than Those Prescribed, for Example, to Feel Calm or to Help You Sleep
• Making Repeated, Unsuccessful Attempts to Stop or Cut Down on the Medicine
• Feeling Unwell When You Stop Taking the Medicine and Feeling Better When You Start Taking It Again ("Withdrawal Symptoms"). If You Notice Any of These Symptoms, You Should Talk to Your Doctor to Discuss the Best Treatment Plan for You, Including the Right Time and Safe Way to Stop the Medicine (See Section 3 "Stopping Oxycodone").

Sleep-Related Breathing DisordersOxycodone Can 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, Waking Up at Night with Shortness of Breath, Difficulty Staying Asleep, or Excessive Daytime Sleepiness. If You or Someone Else Notices These Symptoms, You Should Talk to Your Doctor. Your Doctor May Consider Reducing Your Dose.

Children and Adolescents

Do Not Use This Medicine in Children Under 18 Years Old.

Oxycodone with Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking Now or Have Recently Taken, Including Herbal Medicines, as Oxycodone May Affect the Way They Work. Also, Some Other Medicines May Affect the Way Oxycodone Works.

Do Not Take Oxycodone and Tell Your Doctor or Pharmacist If You Are Taking:

• A Type of Medicine Known as a Monoamine Oxidase Inhibitor, Such as Tranylcypromine, Phenelzine, Isocarboxazid, Moclobemide, and Linezolid

Tell Your Doctor or Pharmacist If You Are Taking:

• Medicines Known as Monoamine Oxidase Inhibitors or If You Have Taken These Medicines in the Last Two Weeks
• Sedative Medicines, Such as Benzodiazepines or Medicines That Can Make You Feel Calm or Help You Sleep
• Antidepressant Medicines
• Medicines Used to Treat Mental Health Problems, Such as Phenothiazines or Neuroleptics
• Other Strong Painkillers or "Analgesics"
• Muscle Relaxants
• Medicines Used to Treat High Blood Pressure
• Medicines Used to Treat Infections, Such as Clarithromycin, Erythromycin, or Telithromycin
• Antifungal Medicines, Such as Ketoconazole, Voriconazole, Itraconazole, or Posaconazole
• A Type of Medicine Used to Treat HIV Called "Protease Inhibitors", Such as Boceprevir, Ritonavir, Indinavir, Nelfinavir, or Saquinavir
• Rifampicin (Used to Treat Tuberculosis)
• Carbamazepine (Used to Treat Seizures, Epilepsy, or Certain Pain Conditions)
• Phenytoin (Used to Treat Seizures, Epilepsy, or Certain Pain Conditions)
• Cimetidine (Used to Treat Stomach Ulcers, Indigestion, or Heartburn)
• Quinidine (Used to Treat Fast Heart Rate)
• Anesthetics Used Before Surgery or Medical Procedures
• A Herbal Substance Called St. John's Wort (Also Known as Hypericum Perforatum)
• Antihistamine Medicines
• Medicines Used to Treat Parkinson's Disease. If Any of the Above Applies to You (or If You Are Not Sure), Consult Your Doctor, Pharmacist, or Nurse Before Using Oxycodone.

Oxycodone with Food, Drink, and Alcohol

• Do Not Drink Grapefruit Juice While Taking Oxycodone.
• Do Not Drink Alcohol While Taking Oxycodone, as It Can Cause Drowsiness or Increase the Risk of Serious Side Effects, Such as Shallow Breathing with Risk of Respiratory Arrest and Loss of Consciousness.

Pregnancy and Breastfeeding

Pregnancy

Do Not Use This Medicine During Pregnancy Unless Your Doctor Has Told You to Do So. This Medicine Should Not Be Used During Childbirth, as It Can Cause Slow or Shallow Breathing (Respiratory Depression) or Withdrawal Symptoms in the Newborn. If You Are Pregnant, Think You May Be Pregnant, or Plan to Become Pregnant, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine.

Breastfeeding

Do Not Breastfeed While Taking Oxycodone, as It Can Pass into Breast Milk.

Driving and Using Machines

You May Feel Drowsy or Experience Other Side Effects, Such as Weakness, Dizziness, or Fainting, While Taking Oxycodone. These Effects Are More Likely at the Start of Treatment or When Increasing the Dose. In This Case, Do Not Drive or Operate Machinery.

Oxycodone Contains Sodium

Oxycodone Molteni, 10 mg/ml - a 1 ml Ampoule Contains Less Than 1 mmol (23 mg) of Sodium per Ampoule, Which Means the Medicine Is Essentially "Sodium-Free". Oxycodone Molteni, 10 mg/ml - a 2 ml Ampoule Contains Less Than 1 mmol (23 mg) of Sodium per Ampoule, Which Means the Medicine Is Essentially "Sodium-Free". Oxycodone Molteni, 10 mg/ml - a 20 ml Ampoule Contains 57.0 mg of Sodium (a Major Component of Common Salt) per Ampoule. This Is Equivalent to 2.85% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Use Oxycodone

Before Starting Treatment and Regularly During Treatment, Your Doctor Will Discuss with You What to Expect from Oxycodone, When and How Long to Take It, When to Contact Your Doctor, and When to Stop Taking It (See Also "Stopping Oxycodone"). Oxycodone Is Usually Given by a Doctor or Nurse. The Solution Should Be Used Immediately After Opening.

Using the Medicine

The Solution Can Be Given in 3 Ways:

• Intravenously Over a Period of 1 to 2 Minutes
• Subcutaneously Using a Needle
• As an Infusion (Drip).

Recommended Dose

Your Doctor Will Decide the Right Dose for You. The Dose and Frequency of Administration May Be Adjusted According to Your Level of Pain. The Usual Starting Dose Depends on the Method of Administration - Your Doctor Will Decide the Method of Administration. The Usual Starting Doses Are as Follows:

• Single Intravenous Injection - Usually 1 to 10 mg Given Slowly Over 1 to 2 Minutes. Further Single Doses Should Not Be Given More Often Than Every 4 Hours
• Single Subcutaneous Injection - the Recommended Starting Dose Is 5 mg. Further Single Doses Should Be Given at Intervals of Not Less Than 4 Hours
• Intravenous Infusion - the Usual Starting Dose Is 2 mg Given Over 1 Hour
• Subcutaneous Infusion - the Usual Starting Dose Is 7.5 mg per Day
• Patient-Controlled Analgesia (PCA) - the Dose Depends on the Patient's Body Weight (0.03 mg per kg Body Weight). Your Doctor or Nurse Will Decide the Frequency of Administration for You

If You Still Have Pain While Taking Oxycodone, You Should Talk to Your Doctor or Pharmacist.

Children and Adolescents

Do Not Use This Medicine in Children Under 18 Years Old.

Patients with Kidney or Liver Problems

If You Have Any Kidney or Liver Problems, You Should Talk to Your Doctor or Pharmacist, as You May Need a Different Medicine or a Lower Dose of Oxycodone.

Taking a Higher Dose of Oxycodone Than Recommended, or Using the Medicine for Longer Than Recommended

Do Not Take More Oxycodone Than Your Doctor Has Told You to Take. If You Are in Doubt, Talk to Your Doctor or Pharmacist. If You Think You Have Taken Too Much of the Medicine (Overdose), You Should Talk to Your Doctor or Go to the Hospital. Take the Medicine Packaging with You. Do Not Drive or Operate Machinery. If You Have Taken Too Much of the Medicine, You May Experience the Following Symptoms:

• Pupil Constriction
• Slower or Shallower Breathing Than Normal (Respiratory Depression)
• Feeling Drowsy or Fainting
• Low Muscle Tone (Hypotonia)
• Slow Heartbeat
• Low Blood Pressure
• Brain Disorders (Toxic Leukoencephalopathy). In Severe Cases, Overdose Can Cause Fainting (Loss of Consciousness) or Even Death.

Stopping Oxycodone

Unless Your Doctor Has Told You to Do So, Do Not Suddenly Stop Taking the Medicine. If You Want to Stop Taking the Medicine, You Should Talk to Your Doctor First. Your Doctor Will Decide How to Stop the Medicine. The Dose Should Be Reduced Gradually to Avoid Withdrawal Symptoms. If You Suddenly Stop Taking the Medicine, You May Experience the Following Symptoms:

• Feeling Agitated or Anxious
• Rapid Heartbeat
• Shaking
• Sweating.

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Severe Side Effects

Stop Taking Oxycodone and Contact Your Doctor Immediately If You Experience Any of the Following Serious Side Effects:

• Allergic Reactions - Symptoms May Include Sudden Wheezing, Difficulty Breathing, Swelling of the Eyelids, Face, or Lips, Rash, or Itching - Symptoms May Affect the Whole Body
• Breathing Problems - Symptoms May Include Slow or Shallow Breathing.

Stop Taking Oxycodone and Contact Your Doctor Immediately If You Experience Any of the Above Serious Side Effects.

Other Side Effects

If You Experience Any of the Following Side Effects, You Should Contact Your Doctor or Nurse:

Very Common:May Affect More Than 1 in 10 People

• Constipation - Your Doctor May Prescribe a Laxative to Help
• Nausea, Vomiting - These Symptoms Should Normally Go Away After a Few Days. If They Do Not Go Away, Your Doctor May Prescribe Medicines to Help
• Feeling Drowsy - This Usually Occurs When You Start Taking the Medicine or When Your Dose Is Increased, but the Symptoms Should Go Away After a Few Days
• Headache
• Dizziness
• Itching

Common:May Affect Up to 1 in 10 People

• Dry Mouth, Loss of Appetite, Indigestion, Abdominal Pain or Discomfort, Diarrhea
• Confusion, Depression, Feeling Weak, Shaking, Lack of Energy, Tiredness, Anxiety or Nervousness, Sleep Disorders, Abnormal Thinking or Vivid Dreams
• Breathing Difficulties or Wheezing, Shortness of Breath, Difficulty Coughing
• Rash
• Sweating

Uncommon:May Affect Up to 1 in 100 People

• Allergic Reactions
• Breathing Difficulties
• Fast, Irregular Heartbeat, Flushing
• Feeling of Spinning, Seeing or Hearing Things That Are Not There (Hallucinations), Mood Changes, Unpleasant or Confused Mood, Feeling Euphoric, Feeling Anxious, Agitation or Restlessness, General Feeling of Being Unwell
• Difficulty Speaking, Decreased Sensitivity to Pain or Touch, Tingling or Numbness in the Hands and Feet, Seizures, Vision Disturbances, Fainting, Abnormal Muscle Stiffness or Floppiness, Involuntary Muscle Contractions
• Dry Skin, Severe Skin Peeling or Shedding
• Dehydration, Feeling Thirsty, Chills, Swelling of the Hands, Ankles, or Feet
• Flushing of the Face, Constriction of the Pupils, Muscle Spasm, High Body Temperature
• Difficulty Swallowing, Hiccup, Belching, Gas, a Condition Where the Intestine Does Not Work Properly (Intestinal Obstruction), Stomach Problems, Changes in Taste
• Difficulty Passing Urine, Problems Getting an Erection, Decreased Sex Drive, Low Levels of Sex Hormones in the Blood (So-Called "Hypogonadism", Found in Blood Tests)
• Need to Take a Higher Dose of the Medicine Than Normal to Get the Same Level of Pain Relief (Tolerance) - as with All Strong Painkillers, There Is a Risk of Dependence or Tolerance to the Medicine, Withdrawal Symptoms (See Section 2 "Warnings and Precautions")
• Changes in Liver Function Test Results, Gallstones.

Rare:May Affect Up to 1 in 1,000 People

• Low Blood Pressure
• Feeling of "Fainting", Especially When Standing Up
• Hives (Urticaria)

Unknown Frequency:Frequency Cannot Be Estimated from the Available Data

• Increased Sensitivity to Pain
• Aggression
• Tooth Decay
• Loss of Menstruation
• Blockage of the Flow of Bile from the Liver (Cholestasis). This Can Cause Itching, Yellowing of the Skin, Very Dark Urine, and Very Pale Stool
• A Disorder Affecting the Valve in the Intestine, Which Can Cause Severe Abdominal Pain (Dysfunction of the Oddi Sphincter)
• Prolonged Use of Oxycodone Molteni During Pregnancy May Cause Life-Threatening Withdrawal Symptoms in the Newborn. Symptoms to Watch for in the Baby Include:

Irritability, Restlessness, and Sleep Disturbances, High-Pitched Cry, Shaking, Diarrhea, and Failure to Gain Weight

• Sleep Apnea (Pauses in Breathing During Sleep). If You Experience Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet.

Reporting Side Effects

If You Experience Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring of the 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. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Oxycodone

Keep This Medicine Out of the Sight and Reach of Children. This Medicine Should Be Stored in a Locked and Secure Place, Out of the Reach of Others. It Can Be Very Harmful and May Cause Death If Taken by Someone It Was Not Prescribed for. Do Not Use This Medicine After the Expiry Date Stated on the Carton and Ampoule Label, After "EXP.". The Medicine Does Not Require Any Special Storage Conditions. Store in the Original Packaging to Protect from Light. After Opening the Ampoule, the Solution Should Be Used Immediately. Any Unused Solution Should Be Discarded Immediately. 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 Contains

• The Active Substance Is Oxycodone Hydrochloride.
• The Other Ingredients Are Citric Acid Monohydrate, Sodium Citrate, Sodium Chloride, Hydrochloric Acid, Sodium Hydroxide, Water for Injections.

Oxycodone Molteni Contains a Known Ingredient (Sodium). See Section 2.

What Oxycodone Looks Like and Contents of the Pack

The Medicine Is a Clear, Colorless Solution in Transparent Glass Ampoules. Oxycodone Molteni 10 mg/ml Is Available as a Solution in Ampoules of 1 ml, 2 ml, or 20 ml (Containing 10 mg, 20 mg, and 200 mg of Oxycodone Hydrochloride, Respectively).

Marketing Authorization Holder and Manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. Strada Statale 67, Fraz. Granatieri 50018 Scandicci (Firenze), Italy Tel: +3905573611 Fax: +39055720057 e-mail: info@moltenifarma.it

This Medicine Is Authorized in the Member States of the European Economic Area Under the Following Names:

Poland: Oxycodone Molteni United Kingdom: Oxycodone Molteni France: Oxycodone Molteni Italy: Ossicodone Molteni Date of Last Revision of the Leaflet:02/2025

Information for Healthcare Professionals

Oxycodone Molteni, 10 mg/ml, Solution for Injection / Infusion

Oxycodone HydrochlorideThis Leaflet Provides Information for Healthcare Professionals on Oxycodone Molteni, 10 mg/ml, Solution for Injection / Infusion.

Dosage and Administration

Dosage:The Dosage Should Be Adjusted According to the Severity of the Pain and the Individual Sensitivity of the Patient and Medicines Currently Being Taken or Taken in the Past. Adults Over 18 Years:The Following Starting Doses Are Recommended for Patients Not Previously Treated with Opioids. The Starting Dose Should Be Adjusted According to Previous or Concomitant Treatment (Especially If the Patient Has Been Treated with Other Opioids), the Patient's General Condition, and the Severity of the Pain. If the Analgesic Effect Is Insufficient, or If the Pain Intensity Increases, It May Be Necessary to Gradually Increase the Dose.

• Intravenous(Bolus): The Medicine Should Be Diluted to 1 mg/ml Using Sodium Chloride 0.9% Injection, Glucose 5% Injection, or Water for Injections. A Single Dose of 1 to 10 mg Should Be Given Slowly Over 1 to 2 Minutes. Doses Should Not Be Given More Often Than Every 4 Hours.
• Intravenous(Infusion): The Medicine Should Be Diluted to 1 mg/ml Using Sodium Chloride 0.9% Injection, Glucose 5% Injection, or Water for Injections. The Initial Dose Is Usually 2 mg per Hour.
• Intravenous(PCA): The Medicine Should Be Diluted to 1 mg/ml Using Sodium Chloride 0.9% Injection, Glucose 5% Injection, or Water for Injections. A Dose of 0.03 mg per kg Body Weight Should Be Given as a Bolus, with a Minimum Lockout Interval of 5 Minutes.
• Subcutaneous(Bolus): Use the Undiluted Solution (10 mg/ml). The Recommended Starting Dose Is 5 mg. Further Single Doses Should Be Given at Intervals of Not Less Than 4 Hours.
• Subcutaneous(Infusion): If Necessary, the Medicine Should Be Diluted Using Sodium Chloride 0.9% Injection, Glucose 5% Injection, or Water for Injections. The Initial Dose Is Usually 7.5 mg per Day.

Conversion from Oral Oxycodone to Parenteral Oxycodone:The Dose Should Be Based on the Following Ratio: 2 mg Oral Oxycodone Is Equivalent to 1 mg Parenteral Oxycodone. It Should Be Emphasized That This Is a Recommended Dose. Differences Between Patients Require That the Dose Be Adjusted for Each Patient. Elderly:The Lowest Dose Should Be Used with Careful Dose Titration to Control Pain. Patients with Renal or Hepatic Impairment:The Starting Dose Should Be Used with Caution in These Patients. The Recommended Starting Dose for Adults Should Be Reduced by 50% (for Example, Total Daily Dose 10 mg Orally in Patients Not Previously Exposed to Opioids), and Each Patient Should Have Their Dose Adjusted Individually to Achieve Adequate Pain Control, Depending on Their Clinical Condition.

Special Warnings

Opioids Are Not the First Choice for the Treatment of Chronic Non-Malignant Pain; They Are Not Recommended as the Only Treatment for Chronic Pain. Chronic Pain for Which Opioids Are Effective Include Chronic Degenerative Back Pain and Degenerative Disc Disease.

Method of Administration

Subcutaneous Injection or Infusion. Intravenous Injection or Infusion.

Goals of Treatment and Discontinuation

Before Starting Treatment with Oxycodone, the Treatment Strategy Should Be Agreed with the Patient, Including the Duration of Treatment and the Goals, and a Plan for Discontinuation Should Be Established, in Accordance with Treatment Guidelines for Pain. During Treatment, the Doctor Should Have Regular Contact with the Patient to Assess the Need for Continued Treatment, Consider Discontinuation, and Adjust the Dose as Necessary. If the Patient No Longer Requires Treatment with Oxycodone, It Is Recommended to Gradually Reduce the Dose to Prevent Withdrawal Symptoms. If Pain Control Is Not Adequate, Consider the Possibility of Hyperalgesia, Tolerance, and Progression of the Underlying Disease (See Section 4.4 of the Summary of Product Characteristics).

Duration of Treatment

Oxycodone Should Not Be Used for Longer Than Necessary.

Instructions for Use / Handling

Each Ampoule Is for Single Use in One Patient Only. The Medicine Should Be Administered Immediately After Opening the Ampoule, and Any Unused Solution Should Be Discarded. Chemical and Physical Stability in Use Has Been Demonstrated for 24 Hours at Room Temperature (15-25°C). From a Microbiological Point of View, the Product Should Be Used Immediately. If Not Used Immediately, the In-Use Storage Time and Conditions Are the Responsibility of the User and Should Not Be Longer Than 24 Hours at 2-8°C, Unless Reconstitution, Dilution, Etc. Has Been Carried Out in Controlled and Validated Aseptic Conditions.

Data of Last Revision of the Leaflet: 02/2025