Label: information for the user

PecFent 100micrograms/spray, nasal spray solution

PecFent 400micrograms/spray, nasal spray solution

Fentanyl

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyou experienceadverse effects,consult your doctor or pharmacist,evenifthey do not appearin this label. See section 4.

What is PecFent

PecFent contains fentanil, which is a potent medication for pain relief, known as an opioid analgesic.

How is PecFent used

PecFent is used in adults with cancer for a type of pain called "breakthrough" pain.

• This type of pain appears suddenly.
• It occurs even though the usual opioid analgesic (for example, morphine, fentanyl, oxycodone, or hydromorphone) has been taken daily to control the underlying constant pain.

PecFent should only be used by adults who are already taking other opioids daily for the constant pain caused by cancer.

How PecFent works

PecFent is a nasal spray solution.

• When PecFent is sprayed into the nose, the tiny droplets of the spray form a fine gel.
• Fentanil is absorbed quickly through the nasal mucosa and passes directly into the bloodstream.

This means that the medication reaches the body quickly to relieve breakthrough pain.

Do not use PecFent:

• If you are allergic to fentanyl or any of the other components of this medication (listed in section 6).
• If you are not regularly using a prescribed opioid medication (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine) every day at the same time, for at least one week, to control persistent pain. If you have not been using those medications,do not usePecFent as its use may increase the risk of your breathing becoming slower and/or shallower, and even stopping.
• If you have short-term pain that is not episodic pain.
• If you have a severe respiratory or pulmonary problem.

Do not use PecFent if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before using PecFent.

Warnings and precautions

Keep PecFent out of the reach of children

• You must keep PecFent within the child-resistant storage container when not in use, even if you have used all eight sprays. This is because PecFent is potentially fatal if a child accidentally takes it.

Consult your doctor or pharmacist before using PecFent:

• If you have not been taking the same daily dose of your opioid for some time, for the persistent pain you are experiencing.
• If you have respiratory problems, such as asthma, wheezing, or difficulty breathing.
• If you have had a severe head injury.
• If you have heart problems, especially low heart rate.
• If you have low blood pressure or a low amount of fluid in circulation.
• If you have kidney or liver problems as they may affect how your body breaks down the medication.
• If you are taking antidepressants or antipsychotics, consult the section “Using PecFent with other medications”.

If any of the above conditions apply to you (or you are unsure), consult your doctor or pharmacist before using PecFent.

• If you are an athlete, PecFent may give positive results in antidoping tests.

Consult your doctor if during the use of PecFent:

• You experience recurrent nasal bleeding; your doctor may advise an alternative treatment.
• You consider that PecFent is becoming less effective in treating episodic pain.
• You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medication as prescribed by your doctor.
• You believe you are becoming addicted to PecFent.
• You experience a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms may be an indication of a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.
• You have ever experienced adrenal insufficiency or hormone deficiency (androgen deficiency) with the use of opioids.

Children and adolescents

PecFent has not been approved for use in children under 18 years old.

Using PecFent with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to useany other medication.

Specifically, inform your doctor or pharmacist before using PecFent if you are taking or have taken recently any of the following medications:

• Medications that may cause drowsiness, such as sleep aids, tranquilizers, muscle relaxants, anxiety medications, or allergy medications (antihistamines).
• Depression medications called “monoamine oxidase inhibitors” (MAOIs). Inform your doctor or pharmacist if you have been taking an MAOI in the two weeks prior to using PecFent.

The risk of adverse effects increases if you are taking medications such as certain antidepressants or antipsychotics. PecFent may interact with these medications and you may experience changes in mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, unstable heart rate, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will tell you if PecFent is suitable for you.

• Nasal sprays for treating nasal congestion (containing a decongestant such as oxymetazoline).
• Medications that may affect how your body breaks down PecFent, including:
• • Medications for HIV infection (e.g., ritonavir, nelfinavir, amprenavir, or fosamprenavir).
  • Medications for fungal infections (e.g., ketoconazole, itraconazole, or fluconazole).
  • Medications for bacterial infections (e.g., troleandomycin, clarithromycin, or erythromycin).
  • “Aprepitant”, used to alleviate nausea.
  • “Diltiazem” and “verapamil”, used for hypertension or heart problems.
  • Other pain medications called agonists/antagonists, such as buprenorphine, nalbuphine, and pentazocine. You may experience symptoms of withdrawal(nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medications.

If any of the above conditions apply to you (or you are unsure), consult your doctor or pharmacist before using PecFent.

Do not use any other type of nasal spray for at least 15 minutes after using PecFent.

Using PecFent with food, drinks, and alcohol

• Do not drink alcohol while using PecFent, as it may increase the risk of severe adverse effects.
• Do not drink grapefruit juice while using PecFent, as it may affect how your body breaks down the medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Do not use PecFent if you are pregnant or may become pregnant, unless your doctor has told you to do so.
• Do not use PecFent during labor as it may cause respiratory problems in your baby.
• Do not use PecFent during breastfeeding, as the medication may pass into breast milk and cause adverse effects in the infant.
• Do not initiate breastfeeding within 5 days of the last PecFent dose.

Driving and operating machinery

• Consult your doctor if it is safe to drive or operate machinery while taking PecFent.
• You may feel drowsy, dizzy, or have vision problems after using PecFent. If this happens, do not drive or operate machinery.
• Do not drive or operate machinery until you know how this medication affects you.

PecFent contains propylparahydroxybenzoate (E216).

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (if you do not use the nasal spray correctly).

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

PecFent is available in two different concentrations:a bottle of 100 micrograms per spray and a bottle of 400 micrograms per spray. Make sure to use the concentration prescribed by your doctor.

How much PecFent to use

• A dose to treat an episode of breakthrough pain could consist of one or two sprays (one in each nostril). Your doctor will tell you how many sprays (one or two) to use to treat the episode of breakthrough pain.
• Do not use a dose greater than the one prescribed by your doctor for a single episode of breakthrough pain.
• Do not use PecFent more than four times a day.
• Wait at least four hours to take the next dose of PecFent.

Initial dose

• The initial dose is 100 micrograms.
• It consists of a single spray from the 100 micrograms per spray bottle.
• See the instructions on how to use a dose in “Using the PecFent bottle”.

Searching for the correct dose

• Your doctor will help you find the correct dose to relieve your breakthrough pain. It is very important to follow your doctor's instructions.
• Inform your doctor about your pain and the effect of PecFent. Your doctor will decide if it is necessary to change the dose of PecFent.
• Do not change the dose yourself.

Once you have found the correct dose

• Inform your doctor if the dose you receive from PecFent does not relieve your breakthrough pain. Your doctor will decide if it is necessary to change the dose.Do not change the dose of PecFent or other pain medications yourself.
• Inform your doctor immediately if you have more than four episodes of breakthrough pain per day. Your doctor may change your pain medication. Once your constant pain is controlled, your doctor may change your PecFent dose.

If you are unsure about the correct dose or how much PecFent to use, ask your doctor.

Using the PecFent bottle

Preparing the PecFent bottle for use

Before using a new PecFent bottle, you must prepare it for use. This is called “priming”.

To prime the bottle, follow these instructions:

1. A new PecFent bottle will show two red lines in the counting window on the white plastic top of the bottle (figures 1 and 3a).
2. Remove the plastic transparent protective cap from the nozzle (figure 1).
3. Point the nasal spray away from you (and others).
4. Hold the nasal spray PecFent in a vertical position, with your thumb at the bottom of the bottle, and your index and middle fingers on the finger grips on either side of the nozzle (figure 2).
5. Press firmly down on the finger grips until you hear a “click”; then, release the grips (figure 2). You will hear a second “click” and a large red bar will appear in the counting window (figure 3b).
6. Repeat step 5 three times. When you repeat step 5, the red bar will decrease in size each time, until you see a green bar in the counting window (figure 3b-e). The green bar means the nasal spray PecFent is ready to use.
7. Wipe the nozzle with a tissue and throw the tissue in the toilet.
8. If you are not going to use the medication immediately, put the protective cap back on. Then, place the PecFent bottle inside the child-resistant storage container. If five days pass without using PecFent, prime the bottle by spraying once.

Using PecFent

PecFent should only be used by spraying it into the nostrils.

1. Check that there is a green bar or a number in the counting window (figure 4): this confirms that the PecFent bottle has been primed (see “Preparing the PecFent bottle for use”, above).
2. Blow your nose if you think you need to.
3. Sit with your head in a vertical position.
4. Remove the protective cap from the nozzle.
5. Hold the PecFent bottle with your thumb at the bottom of the bottle, and your index and middle fingers on the finger grips (figure 4).
6. Place the nozzle close to the inside of the nostril (about 1 cm). Point towards the nasal walls. Lean the bottle slightly (figure 5).
7. Close the other nostril with your finger from the other hand (figure 5).
8. Press firmly on the finger grips to spray PecFent into the nostril. When you hear a click, release the grips. Note: You may not feel anything in your nose; do not think this means the nasal spray is not working; follow the click and the counting window.
9. Breathe slowly through your nose and exhale through your mouth.
10. The counting window will advance after each use and show how many sprays have been used.
11. If your doctor has prescribed a second spray, repeat steps 5 to 9, using the other nostril.

Do not use a dose greater than the one prescribed by your doctor for a single episode of pain.

1. After each use, put the bottle back in the child-resistant storage container. Keep the medication out of sight and reach of children (figure 6).
2. Stay seated for at least one minute after using the nasal spray.

Number of sprays in a PecFent bottle

There are eight complete sprays in each PecFent bottle.

• After the first spray, the number 1 will appear in the counting window. The counting will advance as you use the nasal spray.
• When you see an 8 in the counting window, the bottle is empty and you will not be able to get any more complete sprays.

Disposing of unused PecFent

• If you can see a number, other than the 8 in the counting window,YOUhave not used the 8complete sprays in the bottle. There are still doses of PecFent left in the bottle.
• You must expel the remaining doses of PecFent from the bottleby pointing the nasal spray away from you (and anyone else) and pressing and releasing the finger grips until the number “8” red appears in the counting window.

When you see the number “8” in the counting window, there is still medication left in the bottle that must be expelled.

• You will have to press and release the finger grips4more times while pointing the nasal sprayaway from you (and anyone else).
• You will find a greater resistance when pressing, and the finger grips will only move a little.
• You will not hear a click when pressing.
• The counting window will remain on the number “8”.
• Put the protective capon the bottle of the nasal spray.
• Put the bottle back in the child-resistant storage container.
• Ask your local pharmacy about disposing of empty bottles (see “Storing PecFent”).

If the nasal spray PecFent is blocked or does not spray correctly

• If the nasal spray is blocked, point it away from you (and anyone else) and push the plunger firmly down. This will clear any blockage.
• If the nasal spray still does not work correctly, discard the defective bottle and start a new one. Inform your doctor of what happened.Do not try to fix the nasal spray yourself or try to disassemble it,as you may administer an incorrect dose.

Discard the PecFent bottle and start a new one:

• If 60days or more have passed since you primed or used the bottle for the first time.

If you use more PecFent than you should

• If you use more PecFent than you should, you may feel drowsy, nauseous, dizzy, or have slow or shallow breathing. If you feel very dizzy, very drowsy, or have slow or shallow breathing, call an ambulance or have someone do it immediately.

If you interrupt treatment with PecFent

If you no longer have breakthrough pain, consult your doctor before stopping treatment with PecFent and follow their instructions. However, you should continue taking another opioid for constant pain. Your doctor may need to check the dose.

You may experience withdrawal symptoms similar to the possible side effects of PecFent when you stop using PecFent. If you experience withdrawal symptoms, you should contact your doctor. Your doctor will evaluate if you need any medication to reduce or eliminate withdrawal symptoms.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Call an ambulance or ask someone to do it immediately in any of the following cases:

• If you feel very dizzy or faint.
• If you feel very sleepy.
• If you have slow or shallow breathing.
• If you have cold and clammy skin, are pale, have a weak pulse, or other signs of shock.

If you or the person caring for you notice any of the above effects, call an ambulance immediately.

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

Not knowing where you are (disorientation)

• Dizziness
• Nausea or vomiting
• Somnolence, headache
• Nosebleeds, nasal congestion, runny nose
• Constipation
• Itching skin

Less frequent side effects (may affect up to 1 in 100 people):

• Infection of the respiratory tract
• Pain, discomfort, or inflammation of the throat or nose
• Cough, sneezing, runny nose, or cold, changes in nasal discharge
• Allergic reaction, skin rash
• Loss or increase of appetite, weight gain
• Dehydration, thirst
• Abuse of the medication
• Seeing or hearing things that do not exist (hallucinations or delirium), feeling confused
• Depression, worry, slowness, or restlessness
• Loss of concentration or increased activity
• Memory loss
• Feeling "high"
• Being less conscious or unresponsive, loss of consciousness
• Seizure (epileptic crisis)
• Convulsions or muscle tremors
• Loss of taste, loss or change of smell
• Difficulty speaking
• Blue discoloration of the skin
• Dizziness, falls, general discomfort
• Inadequate functioning of heat and circulation, feeling of heat or fever, chills, excessive sweating
• Swelling of soft tissues
• Low blood pressure
• Blockage of the trachea
• Difficulty breathingVaginal bleeding
• Intestinal perforation or inflammation of the stomach lining
• Numbness or tingling in the mouth, tongue, or nose, or other problems in the tongue, ulcers in the mouth, dry mouth
• Diarrhea
• Belching, stomach pain, indigestion.
• Pain or discomfort in the joints
• Difficulty or inability to drink water
• Pain in the chest
• Feeling tired or weak, difficulty moving
• Changes in blood cells (detected by laboratory analysis)
• Increased blood sugar
• Protein in the urine

Other side effects (frequency unknown [cannot be estimated from available data]):

Severe respiratory problems

• Flush
• Insomnia
• Syndrome of abstinence (may manifest with the appearance of the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating)
• Drug dependence (addiction)
• Drug abuse

Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which may be potentially fatal (see section2).

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. PecFent could be potentially fatal if a child takes it by accident.

• Do not use this medication after the expiration date that appears on the box and the bottle after “CAD”. The expiration date is the last day of the month indicated.
• Do not store PecFent at a temperature above 25°C.
• Do not freeze.
• Store the bottle in its child-resistant packaging to protect it from light.
• Always store the PecFent bottle within the child-resistant packaging, even when it is empty.
• Do not use for more than 60 days after the first use (either priming or treating an episode of breakthrough pain).

Expired or no longer needed PecFent may still contain a sufficient amount of medication to be harmful to others, especially children. PecFent should not be disposed of through drains or in the trash. Any remainingPecFent that is no longer wanted should be disposed of as soon as possible following the instructions provided inDisposal of PecFent without a Prescription.Any empty bottle should be returned to its child-resistant packaging and disposed of; it should be taken to the pharmacy or disposed of according to local regulations.

Composition of PecFent

The active ingredient is fentanyl.

• PecFent 100micrograms/spray, nasal spray solution

Each ml of solution contains 1000micrograms of fentanyl (as citrate).

One spray (100microliters) contains 100micrograms of fentanyl (as citrate).

• PecFent 400micrograms/spray, nasal spray solution

Each ml of solution contains 4000micrograms of fentanyl (as citrate).

One spray (100microliters) contains 400micrograms of fentanyl (as citrate).

The other components(excipients)are pectin (E440), mannitol (E421), phenylethyl alcohol, propylparahydrobenzoate (E216), sucrose, purified water, and hydrochloric acid or sodium hydroxide for pH adjustment.

Appearance of theproduct and contents of the packaging

The medicine is a transparent to almost transparent and colorless nasal spray solution. It is contained in a transparent glass bottle, provided with a dosing pump. The pump has a spray counter that makes a "click" sound, so you can hear and see that the spray has been administered and a protective cap. After priming the PecFent bottle (prepared for use), administer eight full sprays. Each PecFent bottle is supplied in a child-resistant container.

The PecFent bottles in their child-resistant containers are supplied in boxes containing 1, 4, or 12 bottles.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Responsible for manufacturing

L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A

Strada Statale 67 Tosco Romagnola,

Fraz. Granatieri – 50018 Scandicci (FI)

Italy

Date of the last review of thisleaflet:

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu/.