Label: information for the user

Dzuveo 30sublingual tablet, 30 micrograms

sufentanilo

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• Consult your doctor, pharmacist, or nurse if you experience any adverse effects, even if they are not listed in this label. See section 4.

The active ingredient of Dzuveo is sufentanil, which belongs to a group of powerful pain-relieving medications called opioids.

Sufentanil is used to treat moderate to severe acute pain in adults in a medically controlled setting, such as a hospital.

No use Dzuveo

-If you are allergic to sufentanil or any of the other components of this medication (listed in section 6).

-If you have severe respiratory or breathing problems.

Warnings and Precautions

Consult your doctor or nurse before starting to use Dzuveo. Inform your doctor or nurse before treatment if:

• You have any condition that affects your breathing (such as asthma, a hissing sound when breathing [stridor] or difficulty breathing). As Dzuveo may affect your breathing, your doctor or nurse will check your breathing during treatment.
• You have a head or brain injury or a brain tumor.
• You have heart and circulation problems, especially slow heart rate, irregular heartbeats, low blood volume or low blood pressure.
• You have moderate to severe liver problems or severe kidney problems, as these organs affect how your body breaks down and eliminates the medication; you have abnormally slow bowel movements.
• You have a gallbladder or pancreas disease.
• You or any member of your family has ever abused or had dependence on alcohol, prescription medications or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood-related problems (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

This medication contains sufentanil, which is an opioid. Repeated use of opioid analgesics may make the medication less effective (your body gets used to them). It may also produce dependence and abuse, which can lead to a potentially fatal overdose. It is essential to consult your doctor if you are concerned about developing dependence on Dzuveo.

Consult your doctor DURING use of Dzuveo if:

• You feel pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medication as prescribed by your doctor.

What you need to know before starting to use Dzuveo

Respiratory problems related to sleep

• Dzuveo may cause respiratory problems during sleep such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pauses in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Children and Adolescents

Dzuveo should not be used in children and adolescents under 18 years old.

Other Medications and Dzuveo

Inform your doctor if you are taking, have taken recently or may need to take any other medication. In particular, inform your doctor if you are taking any of the following:

• Ketoconazole, used to treat fungal infections, this medication may affect how your body breaks down sufentanil.
• Any medication that may sedate you (have a sedative effect), such as sleeping pills, anxiety medications (e.g., benzodiazepines), tranquilizers or other opioid medications, as they may increase the risk of severe respiratory problems, coma and death.
• Depression medications known as monoamine oxidase inhibitors (MAOIs). These medications should not be taken in the 2 weeks prior to or concurrently with Dzuveo administration.
• Medications for epilepsy, neurological pain or anxiety (gabapentin and pregabalin), as they increase the risk of opioid overdose and respiratory depression and may put the patient's life in danger.
• Depression medications known as selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). It is not recommended to use these medications concurrently with Dzuveo.
• Other medications taken sublingually (medications placed under the tongue, where they dissolve) or medications that have an effect on your mouth (such as nystatin, a liquid or tablets that are kept in the mouth to treat fungal infections), as the effect on Dzuveo has not been studied.
• Prescription opioids (e.g., morphine, codeine, fentanyl, hydromorphone, oxycodone).
• Medications used to treat hypertension or angina (chest pain), known as calcium channel blockers or beta blockers, such as diltiazem and nifedipine.

Use of Dzuveo with Alcohol

Do not drink alcohol while using Dzuveo. It may increase the risk of severe respiratory problems.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor before taking this medication.

Dzuveo should not be used during pregnancy or in women of childbearing age who are not using effective contraceptive methods.

Dzuveo passes into breast milk and may cause adverse effects in the infant. It is not recommended to breastfeed while taking Dzuveo.

Driving and Operating Machines

Dzuveo affects your ability to drive or operate machines, as it may cause drowsiness, dizziness or visual disturbances. Do not drive or operate machines if you experience any of these symptoms during or after treatment with sufentanil. You should only drive and operate machines if a sufficient amount of time has passed since the last administration of Dzuveo.

Dzuveo contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

This medication must be administered by a doctor or nurse using a single-dose administration device. Do not administer this medication yourself.

Dzuveo should only be used in a medically controlled setting, such as a hospital. Only experienced doctors who are familiar with the use of potent analgesics like sufentanil and who are aware of its effects, particularly on your breathing (see "Warnings and precautions" above), can prescribe it.

The recommended dose is a sublingual tablet of up to 30 micrograms administered every hour. A healthcare professional will administer the sublingual tablet using a disposable single-dose applicator. The applicator will help the healthcare professional place the tablet under your tongue. The tablets dissolve under the tongue and should not be chewed or swallowed because they will not be effective in relieving pain unless they can dissolve under the tongue. Do not eat or drink anything and speak as little as possible for the 10 minutes following each dose administration.

After receiving a dose, another dose will not be administered for at least one hour. The maximum daily dose is 720 micrograms per day (24 tablets per day).

Dzuveo should not be used for more than 48 hours.

After your treatment, the medical staff will dispose of the applicator as necessary.

If you use more Dzuveo than you should

The symptoms of overdose include severe respiratory problems, such as slow and shallow breathing, loss of consciousness, extremely low blood pressure, collapse, and muscle rigidity. If these symptoms begin to appear, inform a doctor or nurse immediately.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

The most severe side effects are serious respiratory problems, such as slow and shallow breathing, which can even cause you to stop breathing.

If you experience any of the side effects mentioned earlier, inform your doctor or nurse immediately.

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

Nausea, vomiting, or feeling like vomiting and a general feeling of heat.

Common side effects (may affect up to 1 in 10 people)

• Difficulty or inability to sleep, anxiety, or confusion, dizziness.
• Headache, drowsiness, feeling of sleepiness.
• Increased heart rate, high blood pressure, low blood pressure.
• Low oxygen levels in the blood, feeling of pain in the lower part of the throat, slow and shallow breathing.
• Dry mouth, flatulence (gas), constipation, indigestion, or reflux.
• Allergic reactions, skin itching.
• Muscle contractions and spasms.
• Inability to urinate.
• This medicine may also cause changes in red blood cell, white blood cell, calcium, albumin, potassium, and sodium levels in the blood, which can only be detected by a blood test. If you are going to have a blood test, make sure your doctor knows that you are taking this medicine.

Uncommon side effects (may affect up to 1 in 100 people)

• Pneumonia, eye redness and inflammation, throat inflammation.
• Fat accumulation under the skin.
• Inability to control blood sugar levels (diabetes), increased cholesterol.
• Agitation, lack of interest or emotion, lack of energy, disorientation, euphoria, hallucinations, or seeing things that do not exist, nervousness.
• Muscle movement coordination problems, muscle contractions, tremors, or excessive agitation, exaggerated reflexes, burning sensation, feeling of fainting, abnormal skin sensation (tingling), general numbness, fatigue, forgetfulness, migraine, tension headache.
• Vision problems, eye pain.
• Decreased heart rate, irregular heartbeats, angina, or other chest discomfort.
• High or low blood pressure when standing up, skin redness.
• Slow or difficult breathing (even while sleeping), nasal bleeding, hiccups.

• Chest pain and difficulty breathing caused by a blood clot in the lung, fluid in the lungs, wheezing.
• Diarrhea, belching, stomach lining inflammation or gastritis, gas, acid reflux, hiccups, stomach pain or stomach discomfort.
• Appearance of blisters, excessive sweating, skin rash, dry skin, numbness of the mouth or face.
• Back, chest, or other body part pain, limb pain.
• Difficulty urinating, strong urine odor, painful urination, kidney insufficiency.

• Swelling, uncomfortable sensations in the chest, chills, and weakness (lack of energy).

This medicine may also cause changes in platelet (which helps blood clotting), magnesium, protein, sugar, fat, phosphate, and plasma levels in the blood, which can only be identified by a blood test. If you are going to have a blood test, make sure your doctor knows that you are taking this medicine.

Unknown frequency (cannot be estimated from available data):

• Severe allergic reactions (anaphylactic shock), seizures, coma, small pupil size, skin redness.
• Withdrawal syndrome, which may include symptoms such as agitation, anxiety, muscle pain, insomnia, sweating, and yawning.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children. Your doctor or nurse will ensure that:

• this medication is not used after the expiration date that appears on the label and packaging after CAD. The expiration date is the last day of the month indicated.
• Store in the original packaging to protect it from light and oxygen.
• Do not use this medication if you observe signs of deterioration.

Medications should not be disposed of through drains or in the trash. Your healthcare professional will dispose of the packaging and medications that you no longer need in accordance with hospital regulations. In this way, you will help protect the environment.

Composition of Dzuveo

• The active ingredient is sufentanil. Each sublingual tablet contains 30micrograms of sufentanil (as citrate).
• The other components are mannitol (E421), calcium phosphate, hypromellose, croscarmellose sodium, indigo carmine (E132), stearic acid, and magnesium stearate.

Appearance of the product and contents of the package

Dzuveo is a blue, flat sublingual tablet with rounded edges. It measures 3mm in diameter and is supplied in a single-dose applicator (labeled with[sublingual tablet]). The applicator, with the tablet inside, is packaged in a pouch.

Each pouch contains an applicator and a sufentanil 30microgram tablet. Each package contains 5 or 10 pouches.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Laboratoire Aguettant

1, rue Alexander Fleming

69007 Lyon

France.

Last review date of this leaflet:

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This information is intended solely for healthcare professionals:

Instructions for use of the single-dose applicator (AUD)

Single-use product / Do not reuse

Do not use if the pouch seal is broken

Do not use if the single-dose applicator (AUD) is damaged

The patient should be instructed not to chew or swallow the tablet.

The patient should be instructed not to eat or drink anything and to speak as little as possible for 10minutes after administration of the tablet.

The contents of the pouch are shown below:

Trigger

Blocking system

The single-dose applicator (AUD) should be discarded in accordance with the center's policies and local requirements.