DZUVEO

Package leaflet: Information for the user

Dzuveo 30 micrograms sublingual tablet

sufentanil
Please read all of this leaflet carefully before you start 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, pharmacist or nurse.
• 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 this leaflet

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

1. What Dzuveo is and what it is used for

The active substance of Dzuveo is sufentanil, which belongs to a group of potent pain-relieving medicines called opioids.
Sufentanil is used to treat sudden, moderate to severe pain in adults, in medically controlled settings such as a hospital.

2. What you should know before using Dzuveo

Do not use Dzuveo

• if you are allergic to sufentanil or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe lung or breathing problems.

Warnings and precautions
Talk to your doctor or nurse before using Dzuveo. Inform your doctor or nurse before treatment if:

• you suffer from a condition affecting your breathing (e.g. asthma, wheezing or shortness of breath). Since Dzuveo can affect breathing, your doctor or nurse will monitor your breathing during treatment;
• you have a head injury or brain tumour;
• you have heart or circulation problems, especially if you have a slow heart rate, irregular heartbeat, 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 medicine;
• you have unusually slow intestinal movements;
• you have a disease of the gallbladder or pancreas;
• you or a family member has ever had alcohol, prescription medicine or illegal substance abuse or dependence (“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 effectiveness of the drug (you become tolerant to it). It may also lead to dependence and abuse, which can result in potentially fatal overdose. If you are concerned about developing dependence on Dzuveo, it is important to consult your doctor.
Contact your doctor WHILE using Dzuveo if:

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

What you need to know before taking Dzuveo:
Sleep-related breathing disorders

• Dzuveo may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Children and adolescents
Dzuveo must not be used in children and adolescents under 18 years of age.
Other medicines and Dzuveo
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:

• ketoconazole, used to treat fungal infections; this medicine may affect how your body breaks down sufentanil;
• any medicine that may cause drowsiness (sedative effect), such as sleeping pills, medicines for anxiety (e.g. benzodiazepines), tranquillisers or other opioid medicines, as they may increase the risk of serious breathing problems and coma, and may be life-threatening;
• medicines for the treatment of depression known as monoamine oxidase inhibitors (MAOIs). These medicines must not be taken within 2 weeks before or during treatment with Dzuveo;
• medicines for the treatment of depression known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Concomitant use of these medicines with Dzuveo is not recommended;
• medicines used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin), as they may increase the risk of opioid overdose, respiratory depression and may be life-threatening;
• other medicines also administered sublingually (placed under the tongue, where they dissolve) or medicines that have an effect in the mouth (e.g. nystatin, liquid or lozenges, which are held in the mouth to treat fungal infections), as the effect on Dzuveo has not been studied;
• an opioid medicine prescribed regularly (e.g. morphine, codeine, fentanyl, hydromorphone, oxycodone);
• medicines used to treat high blood pressure or angina (chest pain), known as calcium channel blockers or beta-blockers, e.g. diltiazem and nifedipine.

Dzuveo and alcohol
Do not drink alcohol while taking Dzuveo, as it may increase the risk of serious breathing problems.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Dzuveo must not be used during pregnancy and in women of childbearing potential who are not using effective contraception.
Dzuveo passes into breast milk and may affect the breastfed infant. Breastfeeding should be avoided while taking Dzuveo.
Driving and using machines
Dzuveo impairs your ability to drive or operate machinery, as it may cause drowsiness, dizziness or visual disturbances. If you experience any of these symptoms during or after treatment with sufentanil, you must not drive or operate machinery. You may drive or use machinery only after a sufficient amount of time has passed since your last dose of Dzuveo.
Dzuveo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to use Dzuveo

This medicine will be administered to you by a doctor or nurse using the single-dose delivery device. You must not self-administer this medicine.
Dzuveo is used only in medically controlled settings, such as a hospital. It is prescribed only by doctors experienced in the use of strong painkillers such as sufentanil and who are familiar with its effects on you, particularly on breathing (see section “Warnings and precautions” above).
The maximum recommended dose is one 30 microgram sublingual tablet every hour. The sublingual tablet will be administered to you by a healthcare professional using the single-use, single-dose applicator. The applicator will assist the healthcare professional in placing the tablet under your tongue. The tablets dissolve under the tongue and must not be chewed or swallowed, as they are not effective for pain relief unless dissolved under the tongue. You must not eat or drink, and should speak as little as possible for 10 minutes after each dose.
After receiving a dose, you will not be given another dose for at least one hour. The maximum daily dose is 720 micrograms (24 tablets per day).
Dzuveo must not be used for more than 48 hours.
After treatment, the medical staff will dispose of the applicator.
If you use more Dzuveo than you should
Symptoms of overdose include severe breathing problems such as slow and shallow breathing, loss of consciousness, extremely low blood pressure, collapse, and muscle rigidity. If you start to experience these symptoms, inform a doctor or nurse immediately.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
The most serious side effects are severe breathing problems such as slow and shallow breathing, which may lead to respiratory arrest.
If you experience any of the side effects listed above, inform your doctor or nurse immediately.
Very common side effects (may affect more than 1 in 10 people):
Nausea or feeling unwell, vomiting or nausea and a general feeling of warmth.
Common side effects (may affect up to 1 in 10 people):

• Difficulty or inability to sleep, feeling anxious or confused, dizziness.
• Headache, drowsiness, feeling sleepy.
• Increased heart rate, high blood pressure, low blood pressure.
• Low levels of oxygen in the blood, soreness in the lower part of the throat, slow and shallow breathing.
• Dry mouth, flatulence, constipation, indigestion or reflux.
• Allergic reactions, skin itching.
• Muscle contractions and spasms. Inability to urinate. This medicine may also alter levels of red blood cells, white blood cells, calcium, albumin, potassium, and sodium in the blood, which can only be detected by a blood test. If you need to have a blood test, tell your doctor that you are taking this medicine.

Uncommon side effects (may affect up to 1 in 100 people):
Lung inflammation, redness and inflammation of the eyes, throat inflammation.
Fat accumulation under the skin.
Difficulty controlling blood sugar (diabetes), increased cholesterol.
Feeling restless, lack of interest or emotions, lack of energy, disorientation, euphoria, hallucinations or seeing things that are not there, nervousness.
Problems with coordination of muscle movements, muscle contractions, excessive tremor or shaking, increased reflexes, burning sensation, feeling faint, abnormal skin sensations (tingling, sensation of insects crawling on the skin), general numbness, fatigue, forgetfulness, migraine, tension-type headache.
Vision disturbances, eye pain.
Decreased heart rate, irregular heartbeat, angina or other chest discomfort.
High or low blood pressure when standing, skin flushing.

• Slow or laboured breathing (also during sleep), nosebleeds, hiccups. Chest pain and breathing difficulties caused by a blood clot in the lungs, fluid in the lungs, wheezing. Diarrhoea, belching, inflammation of the stomach lining or gastritis, bloated stomach, acid reflux, vomiting urges, stomach pain or stomach discomfort.
• Blister formation, excessive sweating, rash, dry skin, numbness of the mouth or face.
• Back pain, chest pain or pain in other parts of the body, limb pain.
• Difficulty urinating, strong odour of urine, pain during urination, impaired kidney function. Swelling, chest discomfort, chills and weakness (lack of energy). This medicine may also alter blood levels of platelets (which help blood to clot), magnesium, proteins, sugar, fats, phosphates, and plasma, which can only be detected by a blood test. If you need to have a blood test, tell your doctor that you are taking this medicine.

Frequency not known (cannot be estimated from the available data):
Severe allergic reactions (anaphylactic shock), seizures (fits), coma, pupil constriction, flushed skin.
Withdrawal syndrome which may include symptoms such as restlessness, anxiety, muscle aches, insomnia, sweating, and yawning.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dzuveo

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

• is not used after the expiry date which is stated on the carton and the box after “Exp.”. The expiry date refers to the last day of that month;
• is stored in the original packaging to protect it from light and oxygen;
• is not used if there are any signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Healthcare professionals
will dispose of waste in accordance with hospital policies. This will help protect the
environment.

6. Package Contents and Other Information

What Dzuveo Contains

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

Description of the Appearance of Dzuveo and Package Contents
Dzuveo is a blue sublingual tablet with a flat surface and rounded edges. It has a diameter of 3 mm and is contained in a single-dose applicator (labelled [sublingual tablet]).
The applicator, containing the tablet, is enclosed in a carton.
Each carton contains one applicator and one 30 microgram sufentanil tablet. Each package contains 5 or 10 cartons.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Laboratoire Aguettant
1, rue Alexander Fleming
69007 Lyon
France

Manufacturer
Laboratoire Aguettant
1, rue Alexander Fleming
69007 Lyon
France
Laboratoire Aguettant
Lieu Dit Chantecaille
07340 Champagne
France
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The following information is intended exclusively for healthcare professionals:

Instructions for use of the single-dose applicator

Single-use product / Do not reuse.
Do not use if the carton seal is damaged. Do not use if the single-dose applicator is
damaged.
Inform the patient not to chew or swallow the tablet.
Inform the patient not to eat or drink, and to avoid speaking for 10 minutes after taking the tablet.

1. At the time of administration, open the perforated carton by tearing along the top edge. The carton contains a transparent plastic single-dose applicator, inside which is a single blue tablet at one end and an oxygen-absorbing sachet. The oxygen-absorbing sachet must be discarded.

The contents of the carton are illustrated below:

Stantuf fo

Closure
Tablet

2. Remove the white closure from the green plunger by pressing simultaneously on both sides together and detaching it from the plunger. Discard the closure.

3. Ask the patient, if possible, to touch the palate with the tongue.
4. Gently rest the single-dose applicator on the patient's teeth or lips.
5. Place the tip of the single-dose applicator under the tongue and direct it toward the floor of the oral cavity. NOTE: Avoid direct contact between the mucosa and the tip of the single-use applicator.

6. Press the green plunger to release the tablet into the patient's sublingual space and confirm the tablet's position.

The single-dose applicator must be disposed of in accordance with institutional policies and local regulations.