PECFENT 100 micrograms/SPRAY, NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

PecFent 100micrograms/spray, nasal spray solution

PecFent 400micrograms/spray, nasal spray solution

fentanyl

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is PecFent and what is it used for

What is PecFent

PecFent contains fentanyl, which is a potent pain-relieving medicine, known as an opioid analgesic.

What is PecFent used for

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

• This type of pain comes on suddenly.
• It happens even though you are already taking other opioid pain-relieving medicines (such as morphine, fentanyl, oxycodone or hydromorphone) for your underlying persistent pain.

PecFent should only be used by adults who are already taking other opioids every day for their persistent cancer pain.

How PecFent works

PecFent is a nasal spray solution.

• When you spray PecFent into your nose, the tiny droplets of the spray form a fine gel.
• The fentanyl is quickly absorbed through the lining of your nose and goes straight into your bloodstream.
• This means the medicine gets to work quickly to relieve your breakthrough pain.

2. What you need to know before you use PecFent

Do not use PecFent:

• If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• If you are not already using a prescribed opioid medicine every day (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), for your persistent pain. If you have not been using these medicines, do not usePecFent as it may increase the risk that your breathing becomes slow and/or shallow and/or stops.
• If you have short-lasting pain which is not breakthrough pain.
• If you have severe breathing or lung problems.
• If you are taking medicines that contain sodium oxybate.

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

Warnings and precautions

Keep this medicine in a safe place out of the sight and reach of other people (see section 5 Storing PecFent for more information).

Keep PecFent out of the reach of children

• You must keep PecFent in the child-resistant container when you are not using it, even if you have used the 8 sprays. This is because PecFent can be life-threatening if a child takes it by mistake.

Consult your doctor or pharmacist before starting to use PecFent:

• If you have not been taking the same daily dose of your opioid for some time for your persistent pain.
• If you have breathing problems, such as asthma, wheezing or difficulty breathing.
• If you have had a recent head injury.
• If you have heart problems, especially a slow heart rate.
• If you have low blood pressure or a low volume of fluid in your blood vessels.
• If you have kidney or liver problems as they may affect how your body breaks down the medicine.
• If you are taking antidepressants or antipsychotics, see the section “Other medicines and PecFent”.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before using PecFent.

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

Consult your doctor if, whilst using PecFent, you:

• Get repeated nosebleeds; your doctor may advise an alternative treatment.
• Think that PecFent is becoming less effective in treating your breakthrough pain episodes.
• Feel pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medicine as prescribed by your doctor.
• Think you are becoming addicted to PecFent.
• Get a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure. Together, these symptoms can be a sign of a potentially life-threatening condition called adrenal insufficiency, where the adrenal glands do not produce enough hormones.
• Have ever had adrenal insufficiency or a lack of sex hormones (androgen deficiency) when using opioids.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid pain-relievers can make the medicine less effective (your body gets used to it, known as tolerance). You may also become more sensitive to pain when using PecFent. This is known as hyperalgesia. Increasing the dose of PecFent may continue to relieve pain for a time, but it can also be harmful. If you find that the medicine is not working as well, consult your doctor. Your doctor will decide whether it is best for you to increase your dose or to gradually reduce your use of PecFent.

Dependence and addiction

Repeated use of PecFent can also lead to dependence, abuse and addiction, which could result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a loss of control over how much medicine you use or how often you use it. You may feel a need to keep using the medicine even when it no longer controls your pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to PecFent may be greater if:

• you or a member of your family have abused alcohol, prescription medicines or illegal drugs (‘addiction’).
• you smoke.
• you have ever had mood problems (depression, anxiety or a personality disorder) or have been treated for any other mental health condition by a psychiatrist.

If you notice any of the following while using PecFent, it could be a sign of dependence or addiction.

• you need to use the medicine for longer than your doctor has instructed.
• you need to use a higher dose than recommended.
• you are using the medicine for reasons other than those prescribed by your doctor, for example, ‘to feel calm’ or ‘to help you sleep’.
• you have tried to reduce or stop your use of the medicine but have been unsuccessful.
• you feel unwell when you stop using the medicine (for example, nausea, vomiting, diarrhoea, anxiety, shivering, shaking and sweating), and you feel better once you start using it again (‘withdrawal symptoms’).

If you notice any of these signs, consult your doctor to determine the best course of treatment for you, when it is appropriate to stop the medicine and how to do so safely.

Sleep-related breathing disorders

PecFent may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood). Symptoms may include pauses in breathing during sleep, waking up during the night due to lack of breath, difficulty staying asleep or excessive daytime sleepiness. If you or another person notice these symptoms, contact your doctor. Your doctor may consider reducing your dose.

Children and adolescents

PecFent should not be used in children under 18 years.

Other medicines and PecFent

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist before using PecFent if you are taking or have taken recently any of the following medicines:

• Medicines that may cause drowsiness, such as sleeping pills, sedatives, muscle relaxants, medicines for anxiety such as benzodiazepines (e.g. diazepam) or medicines for allergies (antihistamines). Using PecFent at the same time as these medicines increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma, and can be life-threatening. Contact your doctor if you experience any of these symptoms.For this reason, use of PecFent with sedatives should only be considered when other treatment options are not possible. However, if your doctor prescribes PecFent with sedative medicines, you should be monitored closely and the dose and duration of treatment should be limited. Tell your doctor about all sedative medicines you are taking and follow your doctor’s instructions carefully.It may be helpful to inform your friends or family members so they are aware of the signs and symptoms mentioned above.
• Medicines for depression called “monoamine oxidase inhibitors” (MAOIs). Tell your doctor or pharmacist if you have taken an MAOI in the 2 weeks before using PecFent.

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

• Nasal sprays for a blocked nose (which contain a decongestant such as oxymetazoline).
• Medicines that may affect how your body breaks down PecFent, including:
• • Medicines for HIV infection (e.g. ritonavir, nelfinavir, amprenavir or fosamprenavir).
  • Medicines for fungal infections (e.g. ketoconazole, itraconazole or fluconazole).
  • Medicines for bacterial infections (e.g. troleandomycin, clarithromycin or erythromycin).
  • “Aprepitant”, used to prevent nausea.
  • “Diltiazem” and “verapamil”, used for high blood pressure or heart problems.
  • Other pain-relieving medicines called partial agonist/antagonists, such as buprenorphine, nalbuphine and pentazocine. You may experience withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety, shivering, shaking and sweating) while using these medicines.
  • certain pain-relieving medicines for nerve pain (gabapentin and pregabalin).

If any of the above applies to you (or you are not sure), 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 serious side effects.
• Do not drink grapefruit juice while using PecFent, as it may affect how your body breaks down the medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• Do not use PecFent if you are pregnant or might become pregnant, unless your doctor has told you to do so.
• Do not use PecFent during labour, as it may cause breathing problems in your baby.
• Do not use PecFent during breast-feeding, as the medicine may pass into breast milk and cause side effects in the breast-fed child.
• You should not start breast-feeding until at least 5 days after your last dose of PecFent.

Driving and using machines

• Ask your doctor if it is safe to drive or use machines or tools while taking PecFent.
• You may feel drowsy, dizzy or have problems with your vision after using PecFent. If this happens, do not drive or use machines or tools.
• Do not drive or use machines or tools until you know how this medicine affects you.

PecFent contains propyl parahydroxybenzoate (E216)

It may cause allergic reactions (which may be delayed) and, exceptionally, bronchospasm (if the nasal spray is not used correctly).

3. How to use PecFent

Before starting treatment and on a regular basis during treatment, your doctor will also explain what you can expect from using PecFent, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

PecFent comes 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 that your doctor has prescribed.

How much PecFent to use

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

Initial dose

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

Finding the right dose

• Your doctor will help you find the right dose to relieve your breakthrough pain. It is very important that you follow the doctor's instructions.
• Tell your doctor about your pain and the effect that PecFent has. 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 right dose

• Tell your doctor if the dose of PecFent you receive 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.
• Tell your doctor immediately if you have more than four daily episodes of breakthrough pain. Your doctor may change your constant pain medication. Once the constant pain is controlled, your doctor may change the dose of PecFent.

If you are unsure about the right 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 count window on the top white plastic part of the bottle (figures 1 and 3a).
2. Remove the clear plastic protective cap from the nozzle (figure 1).
3. Point the nasal spray away from you (and others).
4. Hold the PecFent nasal spray in an upright position, with your thumb on 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 the finger grips firmly down until you hear a “click”; then release the grips (figure 2). You will hear a second “click” and a single large red bar will appear in the count window (figure 3b).
6. Repeat step 5 three times. When you repeat step 5, the red bar will get smaller each time, until you see a green bar in the count window (figure 3b-e). The green bar means that the PecFent nasal spray is ready to use.
7. Clean the nozzle with a paper 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 container. If it has been five days or more since you first primed or used the bottle, re-prime the spray 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 count 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 an upright position.
4. Remove the protective cap from the nozzle.
5. Hold the PecFent bottle with your thumb on the bottom of the bottle and your index and middle fingers on the finger grips.
6. Place the nozzle a short distance (about 1 cm) inside the nostril. Point towards the walls of the nose. This will slightly tilt the bottle (figure 5).
7. Close the other nostril with a finger from your other hand (figure 5).
8. Press the finger grips firmly 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 that this means the spray is not working; go by the click and the numeric counter.
9. Breathe in slowly through your nose and exhale through your mouth.
10. The numeric counter 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 what your doctor has prescribed to treat a single episode of pain.

1. After each use, put the bottle back in the child-resistant 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

Each PecFent bottle contains eight complete sprays.

• After the first spray, the number 1 will appear in the count window. The numbering will advance as you use the spray.
• When you see a red 8 in the count window, the bottle is empty and you will no longer be able to get complete sprays.

Disposal of unused PecFent

• If you can see a number, other than 8, in the count window, you have not used all 8 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 grips until the red number “8” appears in the count window.

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

• You will need to press and release the grips four more times while pointing the nasal spray away from you (and anyone else).
• You will find greater resistance when you press, and the grips will only move a little.
• You will not hear a click when you press.
• The counter will remain on the number “8”.
• Put the protective cap on the spray bottle.
• Put the bottle back in the child-resistant container.
• Ask your local pharmacy about disposing of empty bottles (see “Storage of PecFent”).

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

• If the spray is blocked, point it away from you (and anyone else) and push the pump firmly down. This will clear any blockage.
• If the nasal spray continues to not work properly, discard the defective bottle and start a new one. Inform your doctor of what happened. Never try to fix the nasal spray yourself or try to disassemble it, as you could administer an incorrect dose.

Discard the PecFent bottle and start a new one:

• If it has been 60 days or more since you first primed or used the bottle.

If you use more PecFent than you should

• you may feel drowsy, nauseous, dizzy, or have slow or shallow breathing. In severe cases, using too much PecFent can lead to a coma. If you feel very dizzy, very drowsy, or have slow or shallow breathing, call an ambulance or ask someone to do it immediately.
• Overdose can also cause a brain disorder known as toxic leukoencephalopathy.

If you stop treatment with PecFent

If you no longer suffer from breakthrough pain, consult your doctor before stopping treatment with PecFent and follow their instructions. However, you should continue taking another opioid to treat 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 assess whether you need any medication to reduce or eliminate the withdrawal symptoms.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 moist skin, are pale, have a weak pulse, or other signs of shock.

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

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

• Not knowing where you are (disorientation)
• Change in taste
• Dizziness
• Nausea or vomiting
• Drowsiness, headache
• Nosebleed, nasal discomfort, (such as nasal burning), runny nose
• Constipation
• Itching of the skin

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

• Respiratory infection
• Pain, discomfort, or inflammation of the throat or nose
• Cough, sneezing, runny nose, or cold, changes in nasal fluid
• Allergic reaction, skin rash
• Loss or increase of appetite, weight gain
• Dehydration, thirst
• Medication misuse
• Seeing or hearing things that do not really exist (hallucinations or delirium), feeling confused
• Depression, worry, slowness, or restlessness
• Lack of concentration or increased activity
• Loss of memory
• Feeling “high”
• Being less aware or unresponsive, loss of consciousness
• Seizure (epileptic fit)
• Muscle convulsions or tremors
• Loss of taste, loss, or change of smell
• Difficulty speaking
• Bluish discoloration of the skin
• Dizziness, falls, general malaise
• Impaired heat and circulation function, feeling hot flashes or fever, chills, excessive sweating
• Swelling of soft tissues
• Low blood pressure
• Tracheal blockage
• Difficulty breathing
• Vaginal bleeding
• Intestinal perforation or stomach mucosa inflammation
• Numbness or tingling in the mouth, tongue, or nose, or other tongue problems, mouth ulcers, dry mouth
• Diarrhea
• Retching, stomach pain, indigestion.
• Pain or discomfort in the joints
• Difficulty or inability to drink water
• Chest pain
• Feeling tired or weak, problems moving
• Changes in blood cell counts (detected by laboratory tests)
• Increased blood sugar
• Protein in the urine

Other side effects (frequency not known [cannot be estimated from the available data]):

• Severe respiratory problems
• Flushing
• Insomnia
• Withdrawal syndrome (may manifest with the appearance of the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating)
• Pharmacological tolerance, drug dependence (addiction), drug abuse (see section 2)

Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which can be potentially fatal (see section 2).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of PecFent

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

Keep this medication in a safe and protected place, where others cannot access it. This medication can cause serious harm and even be fatal for people who use it accidentally or intentionally when it has not been prescribed for them.

• Do not use this medication after the expiration date that appears on the box and on the bottle after “EXP”. The expiration date is the last day of the month indicated.
• Do not store PecFent at a temperature above 25°C.
• Do not freeze.
• Keep the bottle in its child-resistant container to protect it from light.
• Always keep the PecFent bottle inside the child-resistant container, even when it is empty.
• Do not use for more than 60 days after first use (whether it is priming or use to treat a breakthrough pain episode).
• PecFent that has expired or is no longer needed may still contain enough medication to be harmful to others, especially children. PecFent should not be thrown away in drains or trash. Any leftover PecFent should be disposed of as soon as possible by following the instructions provided in Disposal of unused PecFent. Any empty bottle should be put back in its child-resistant container and disposed of; it should be taken to a pharmacy or disposed of according to local regulations.

6. Package contents and additional information

Composition of PecFent

The active ingredient is fentanyl.

• PecFent 100 micrograms/spray, nasal spray solution

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

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

• PecFent 400 micrograms/spray, nasal spray solution

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

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

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

Appearance of the product and package contents

The medication is a clear to almost clear 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 (preparing it for use), it administers eight complete sprays. Each PecFent bottle is supplied in a child-resistant container.

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

Only some pack sizes may be marketed.

Marketing authorization holder

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Manufacturer

• 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 last revision of this leaflet:

Other sources of information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/.