Sufentanil Hameln

Package leaflet: Information for the patient

Sufentanil hameln 50 micrograms/ml injection or infusion solution

Sufentanil
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Sufentanil hameln is and what it is used for
2. What you need to know before using Sufentanil hameln
3. How to use Sufentanil hameln
4. Possible side effects
5. How to store Sufentanil hameln
6. Contents of the pack and other information

1. What Sufentanil hameln is and what it is used for

Sufentanil hameln belongs to a group of medicines known as opioid anaesthetics, which relieve or prevent pain during or after general anaesthesia. Sufentanil hameln is administered intravenously during and after major surgical procedures requiring mechanical ventilation.

Sufentanil hameln administered intravenously is used in:

Adults

• to prevent pain during induction and maintenance of anaesthesia, in combination with other anaesthetic medicines
• as a medicinal agent to induce and maintain anaesthesia during major surgical procedures

Children
Intravenous sufentanil is indicated as an analgesic during induction and/or maintenance of balanced general anaesthesia in children older than 1 month.

Sufentanil hameln administered epidurally is used in:

Adults

• to prevent pain after surgery and caesarean section
• for the treatment of pain during labour and delivery

Children:
Epidural sufentanil is indicated in children older than 1 year for postoperative pain management following general surgery, thoracic surgery, or orthopaedic procedures.

2. What you need to know before using Sufentanil hameln

Do not use Sufentanil hameln

• intravenously if:
• you are allergic to sufentanil, to other morphine-like medicines, or to any of the other ingredients of this medicine (listed in section 6).
• you suffer from any condition causing breathing difficulties, such as asthma or chronic bronchitis.
• you are taking antidepressant medicines known as monoamine oxidase inhibitors (MAOIs). MAOI therapy must be discontinued at least 2 weeks before surgery.
• you have a liver disorder known as acute hepatic porphyria.
• you are currently taking or have recently taken other strong opioid painkillers such as nalbuphine, buprenorphine, or pentazocine.
• you are in labour or before clamping of the umbilical cord during caesarean section.
• epidurally if:
• you have severe bleeding or shock
• you have a severe infection
• you have impaired wound healing
• you have an infection at the injection site
• you have blood cell count abnormalities or are taking other medicines that prevent blood clotting (anticoagulants)

Warnings and precautions
Talk to your doctor or pharmacist before using Sufentanil hameln if:

• you have unusually slow intestinal movements
• you have a disease of the gallbladder or pancreas
• you or a family member has ever suffered from alcohol, prescription medicine, or illegal substance abuse ("addiction")
• you are a smoker
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. This medicine contains sufentanil, which is an opioid medicine. Repeated use of opioid analgesics may reduce the drug's effectiveness (tolerance may develop). It may also lead to dependence and abuse, which could result in potentially fatal overdose. If you are concerned about developing dependence on Sufentanil hameln, it is important to consult your doctor.
• Sufentanil hameln must be administered only by experienced anaesthetists and in a hospital or other facility equipped with mechanical ventilation and postoperative monitoring equipment.
• As with all strong opioid analgesics of this type, dose-dependent respiratory depression may occur. This may persist until the recovery phase or recur during this period. Therefore, careful postoperative monitoring of patients is essential.
• Sufentanil hameln may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. The doctor may consider reducing the dose.
• Sufentanil hameln must be used with extreme caution in patients with lung, liver, kidney, or thyroid disorders, and in alcoholic patients.
• Sufentanil hameln must be administered with caution in patients with increased intracranial pressure or head injury.
• In patients with reduced blood volume (hypotension), administration of Sufentanil hameln may cause a drop in blood pressure and slow heart rate.
• Involuntary muscle contractions may occur.

Consult your doctor while using Sufentanil hameln if:

• you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increase in dose as prescribed by your doctor.

Newborns/Infants

• Newborns are susceptible to breathing difficulties after administration of sufentanil, as with other opioids. Limited data are available on the intravenous use of sufentanil in infants. Therefore, your doctor will carefully evaluate the risks and benefits before administering Sufentanil hameln to newborns and infants.
• Due to the risk of overdose or underdose, intravenous use of Sufentanil hameln is not recommended during the neonatal period.
• The use of Sufentanil hameln via epidural route is not recommended in children under 1 year of age.

Doping warning in sports
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping
and may lead to a positive anti-doping test and health risks.

Other medicines and Sufentanil hameln
Concomitant use of Sufentanil hameln and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Sufentanil hameln together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Concomitant use of opioids and medicines used to treat epilepsy, neuralgia, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression, and may be potentially fatal.
Inform your doctor if you are taking, have recently taken, or might take any other medicine. In particular, inform your doctor if you are taking any of the following medicines:

• Medicines for depression known as monoamine oxidase inhibitors (MAOIs). These medicines must not be taken within 2 weeks before or during treatment with Sufentanil hameln.
• Medicines for depression known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Concomitant use of these medicines with Sufentanil hameln is not recommended.

The mechanism of action of sufentanil, the duration of its effect, and the effects of sufentanil and other medicines may be increased when taken together.
Inform your doctor if you are taking any of the following medicines:

• strong painkillers such as other opioids
• sedatives and anxiolytics such as barbiturates or tranquilizers
• muscle relaxants (e.g., vecuronium, suxamethonium)
• general anaesthetics (e.g., thiopental, etomidate, nitrous oxide)
• neuroleptic (antipsychotic) medicines
• antibiotics used to treat bacterial infections (e.g., erythromycin)
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole)
• medicines used to treat viral infections (e.g., ritonavir for the treatment of HIV/AIDS)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Sufentanil hameln must not be administered intravenously during labour, as it crosses the placenta and may affect the baby's breathing.
Sufentanil passes into breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from sufentanil therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Breastfeeding may be resumed 24 hours after the last administration of sufentanil.
Sufentanil hameln may be administered epidurally during childbirth.

Driving and using machines
After receiving Sufentanil hameln, you must not drive or operate machinery for the next 24 hours.

Sufentanil hameln contains sodium
This medicine contains 3.54 mg of sodium (the main component of table salt) per millilitre of solution. This corresponds to 0.2% of the maximum daily recommended dietary intake for an adult.

3. How to use Sufentanil hameln

Sufentanil hameln will be injected by a physician experienced in anesthesia either into a vein (intravenously) or into the space surrounding the spinal cord (epidurally), prior to the start of surgery. It will help induce unconsciousness and prevent you from feeling pain during and after the operation.
During treatment with Sufentanil hameln, you will be closely monitored by specialized medical personnel, and emergency equipment will be available.

Use in children over one month of age and adolescents
Intravenous administration
Sufentanil is slowly injected into a vein by an anesthesiologist. The dosage depends on the dose of concomitant anesthetics, the type and duration of surgical procedure, and will be determined by the anesthesiologist.

Use in children over one year of age and adolescents
Epidural administration
Sufentanil hameln is slowly injected into the epidural space (part of the spine) by an anesthesiologist experienced in pediatric anesthetic techniques. The dosage depends on the concomitant use of local anesthetics and the required duration of analgesia.
Pediatric patients will be monitored for signs of respiratory depression for at least 2 hours after epidural administration of Sufentanil hameln.

Dosage
Your doctor will decide the appropriate dosage and duration of treatment with Sufentanil hameln.
The dosage depends on your age, body weight and physical condition, the type of surgical procedure, and the required level of anesthesia.

• The recommended dose should be carefully adjusted in patients with hypothyroidism (underactive thyroid gland), renal impairment, obesity, or alcoholism. After surgery, it is recommended that vital signs in these patients be monitored for a prolonged period.
• For induction and maintenance of anesthesia, the doctor will carefully determine the appropriate dose for your child.
• Patients with hepatic or renal impairment require lower doses.
• Elderly and debilitated patients require lower doses.

If you are given more Sufentanil hameln than you should, or if you miss a dose
Since Sufentanil hameln is normally administered by a physician under closely controlled conditions, it is unlikely that you will receive too much or that a dose will be missed.
In the very rare event that you accidentally receive an overdose of Sufentanil hameln, you may experience breathing difficulties. In such a case, you must inform the doctor or medical staff immediately so that the specialist team can act promptly.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are sedation, itching, nausea and vomiting. If you have difficulty breathing, inform your doctor immediately or seek medical assistance.

Very common (may affect more than 1 in 10 people)

• sedation
• itching

Common (may affect up to 1 in 10 people)

• high blood pressure
• low blood pressure
• nausea
• vomiting
• fast heartbeat
• pallor
• bluish skin colouration in the newborn due to low oxygen levels in the blood
• skin discoloration
• muscle contractions
• difficulty in holding or passing urine
• fever
• headache
• dizziness
• involuntary muscle contractions in the newborn

Uncommon (may affect up to 1 in 100 people)

• irregular heartbeat
• decreased muscle tone in the newborn
• lower back pain
• hypersensitivity
• rhinitis
• apathy
• nervousness
• lack of coordination of voluntary muscle movements
• sustained muscle contractions causing twisting and repetitive movements
• hyperactive reflexes
• abnormally increased muscle tension
• decreased voluntary movements in the newborn
• dizziness
• visual disturbances
• skin allergic reaction
• abnormal sweating
• dry skin
• skin rash
• muscle contractions (intraoperative muscle movements)
• chills
• breathing difficulty
• bronchospasm
• slow heartbeat
• cough
• hiccups
• voice alteration
• bluish skin colouration due to low oxygen levels in the blood
• abnormal electrocardiogram
• muscle rigidity, including rigidity of the chest wall, possibly resulting in breathing impairment
• reaction at injection site or pain at injection site
• increase or decrease in body temperature
• skin rash in the newborn

Not known (frequency cannot be estimated from the available data)

• constricted pupils
• difficulty in breathing
• severe allergic reactions including rash, breathing difficulty and shock
• uncontrollable sense of well-being (euphoria)
• involuntary movements
• cardiac arrest (the doctor has medications available to reverse this effect)
• spasms of throat muscles
• difficulty maintaining upright posture (vertigo)
• coma
• convulsions
• respiratory arrest
• fluid in the lungs
• skin flushing
• muscle spasms

Side effects in children and adolescents
The frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sufentanil hameln

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP:". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vials in the outer packaging to protect the medicine from light.
The product should be used immediately after opening. For the shelf life of the diluted solution, see "Information for healthcare personnel" below.
Do not use this medicine if you notice that the solution is not clear and free from particles, or if the container is damaged.
Your doctor and pharmacist are responsible for the correct storage, use, and disposal of Sufentanil hameln.

6. Package contents and other information

What Sufentanil hameln contains

• The active substance is sufentanil.

1 ml of solution contains 50 micrograms of sufentanil (equivalent to 75 micrograms of
sufentanil citrate).
Each vial containing 1 ml of solution contains 50 micrograms of sufentanil (equivalent to
75 micrograms of sufentanil citrate).
Each vial containing 5 ml of solution contains 250 micrograms of sufentanil (equivalent to
375 micrograms of sufentanil citrate).
Each vial containing 20 ml of solution contains 1000 micrograms of sufentanil (equivalent to
1500 micrograms of sufentanil citrate).

• The other components are water for injections, sodium chloride, citric acid monohydrate.

Description of the appearance of Sufentanil hameln and contents of the pack
Injectable or infusion solution.
Sufentanil hameln is a clear, colourless solution.
Sufentanil hameln 50 micrograms/ml is supplied in colourless glass vials.
Original pack containing 5 vials of 1, 5 or 20 ml solution.
Original pack containing 10 vials of 1 or 5 ml solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
hameln rds s.r.o.
Horná 36, 900 01 Modra
Slovakia

This medicinal product is authorized in the European Economic Area member states under the following names:
AT Sufentanil-hameln 50 Mikrogramm/ml Injektions-/Infusionslösung
Sufentanil-hameln 5 Mikrogramm/ml Injektions-/Infusionslösung
BE Sufentanil hameln 5 microgram/ml, solution for injection/infusion
Sufentanil hameln 50 microgram/ml, solution for injection/infusion
CZ Sufentanil hameln (5 mikrogramů/ml injekční/infuzní roztok)
Sufentanil hameln (50 mikrogramů/ml injekční/infuzní roztok)
DK Sufentanil Hameln 5 mikrog/ml injektions-/infusionsvæske, opløsning
Sufentanil hameln 50 mikrog/ml injektions-/infusionsvæske, opløsning
DE Sufentanil-hameln 50 Mikrogramm/ml Injektions-/Infusionslösung
Sufentanil-hameln 5 Mikrogramm/ml Injektions-/Infusionslösung
FI Sufentanil hameln 50 mikrog/ml injektio-/infuusioneste, liuos
Sufentanil hameln 5 mikrog/ml injektio-/infuusioneste, liuos
HR Sufentanil hameln 5 mikrograma/ml otopina za injekciju/infuziju
Sufentanil hameln 50 mikrograma/ml otopina za injekciju/infuziju
HU Sufentanil hameln 5 mikrogramm/ml oldatos injekció/infúzió
Sufentanil hameln 50 mikrogramm/ml oldatos injekció/infúzió
IS Sufentanil hameln 5 míkrógrömm/ml stungulyf/innrennslislyf, lausn
Sufentanil hameln 50 míkrógrömm/ml stungulyf/innrennslislyf, lausn
IT Sufentanil hameln
NL Sufentanil-hameln 50 microgram/ml, solution for injection / infusion
Sufentanil-hameln 5 microgram/ml, solution for injection / infusion
NO Sufentanil hameln (5 mikrog/ml injeksjons-/infusjonsvæske, oppløsning)
Sufentanil hameln (50 mikrog/ml injeksjons-/infusjonsvæske, oppløsning)
PL Sufentanil hameln (5 mikrogramów/ml roztwór do wstrzykiwań/do infuzji)
Sufentanil hameln (50 mikrogramów/ml roztwór do wstrzykiwań/do infuzji)
PT Sufentanil-hameln 0,05 mg/ml solution for injection or infusion
Sufentanil-hameln 0,005 mg/ml solution for injection or infusion
SE Sufentanil hameln 5 mikrogram/ml injektions-/infusionsvätska, lösning
Sufentanil hameln 50 mikrogram/ml injektions-/infusionsvätska, lösning
SI Sufentanil hameln 5 mikrogramov/ml raztopina za injiciranje/infundiranje
Sufentanil hameln 50 mikrogramov/ml raztopina za injiciranje/infundiranje
SK Sufentanil hameln 5 mikrogramov/ml injekčný/infúzny roztok
Sufentanil hameln 50 mikrogramov/ml injekčný/infúzny roztok

The following information is intended exclusively for physicians or healthcare professionals:

Sufentanil hameln 50 micrograms/ml solution for injection or infusion

Special precautions for use, handling and disposal
Sufentanil must be administered only by anaesthetists or other physicians experienced in its use and effects, or under their supervision. Administration via the epidural route must be performed by a physician experienced in the epidural technique. Before administration, the correct position of the needle or catheter must be confirmed.

Sufentanil citrate is physically incompatible with diazepam, lorazepam, sodium phenobarbital, sodium phenytoin and sodium thiopental.

The product may be mixed with Ringer's lactate solution, 0.9% sodium chloride infusion solution or 5% glucose solution. For epidural administration, the product may be mixed with 0.9% NaCl solution and/or bupivacaine.

Chemical and physical stability of diluted solutions is guaranteed for 72 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions are under the direct responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the dilution was prepared under controlled and validated aseptic conditions.

Before administration, inspect the solution for particulate matter and any signs of deterioration, and ensure the container is intact. The solution should be discarded if any such defects are observed.