Instanyl

Основна информация

  • Търговско наименование:
  • Instanyl
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Instanyl
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • ANALGESICS
  • Терапевтична област:
  • Pain, Cancer
  • Терапевтични показания:
  • Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
  • Каталог на резюме:
  • Revision: 22

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000959
  • Дата Оторизация:
  • 19-07-2009
  • EMEA код:
  • EMEA/H/C/000959
  • Последна актуализация:
  • 25-12-2019

Доклад обществена оценка

Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands

An agency of

the European

Union

Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us

Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

Official address

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

An agency of the European

Union

Address for visits and deliveries

Refer to www.ema.europa.eu/how-to-find-us

Send us a question

Go to www.ema.europa.eu/contact

Telephone

+31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/163439/2019

EMEA/H/C/000959

Instanyl (fentanyl)

An overview of Instanyl and why it is authorised in the EU

What is Instanyl what is it used for?

Instanyl is a medicine used to treat breakthrough pain in adults with cancer. Breakthrough pain is

when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.

Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine

and fentanyl) to control long-term cancer pain.

Instanyl contains the active substance fentanyl.

How is Instanyl used?

Instanyl is available as a nasal spray (50, 100 and 200 micrograms per dose). It is available in single-

dose containers and in multidose containers.

The medicine can only be obtained by ‘special’ prescription. This means that because the medicine can

be misused or cause addiction, it is used under stricter conditions than normal.

Treatment with Instanyl should be started by and remain under the supervision of a doctor who has

experience in the management of opioid treatment in cancer patients. The doctor should keep in mind

the potential for Instanyl to be abused.

Before starting treatment with Instanyl, the patient’s long-term pain should be well controlled by

opioid pain killers and they should have no more than 4 episodes of breakthrough pain a day.

The first dose of Instanyl is 50 micrograms (one spray of the lowest strength) in one nostril; this is

increased as necessary until reaching the dose that gives the patient adequate pain relief. If there has

been insufficient pain relief, the same dose can be given again at the earliest after 10 minutes.

The patient should be given Instanyl for a maximum of 4 episodes of breakthrough pain a day.

Instanyl (fentanyl)

Page 2/3

For more information about using Instanyl, see the package leaflet or contact your doctor or

pharmacist.

How does Instanyl work?

The active substance in Instanyl, fentanyl, is an opioid. It is a well-known substance, which has been

used to control pain for many years. In Instanyl, fentanyl is contained inside a nasal spray. When the

patient sprays Instanyl into the nose, a dose of fentanyl is absorbed into the blood stream through the

blood vessels in the nose. Once in the bloodstream, fentanyl acts on receptors in the brain and spinal

cord to relieve pain.

What benefits of Instanyl have been showed in studies?

Because fentanyl has been in use for many years, the company presented data from the scientific

literature, as well as from studies that it had carried out, which showed that Instanyl was more

effective than placebo (a dummy treatment) at treating breakthrough pain in cancer patients.

In one main study, 178 adult cancer patients with breakthrough pain took one spray of either Instanyl

(50, 100 or 200 microgram) or placebo when they experienced breakthrough pain. The reduction in

pain intensity after 10 minutes was between 1.8 and 2.7 points on an 11-point pain scale for patients

who took Instanyl, compared with 1.4 for patients who took placebo. The number of patients who

responded to treatment was also higher in the Instanyl group than in the placebo group. A patient’s

breakthrough pain was considered to have responded to treatment if there was a reduction of at least

2 points.

In another main study, 128 patients were given increasing doses of Instanyl until the adequate dose

for pain relief was reached. The highest dose was 200 microgram given as one spray in one nostril and

the patients were allowed to take a second spray after 10 minutes if there had been insufficient pain

relief. Each patient then used the identified dose of Instanyl or placebo to treat breakthrough pain. The

change in pain intensity after 10 minutes was between 2.0 and 2.7 points after receiving doses of

Instanyl compared with 1.3 after receiving placebo. The number of breakthrough pain episodes that

responded to treatment was also higher among patients who received Instanyl than those who

received placebo.

In a third study, which involved 139 patients and compared Instanyl with ‘transmucosal’ fentanyl

(absorbed through the lining of the mouth), patients who received Instanyl had faster pain relief than

patients who received transmucosal fentanyl . Patients taking Instanyl were allowed to take a second

spray 10 minutes after the first dose if there had been insufficient pain relief.

What are the risks associated with Instanyl?

The most common side effects with Instanyl (which may affect up to 1 in 10 people) are somnolence

(sleepiness), dizziness, headache, vertigo (a spinning sensation), flushing (reddening of the skin), hot

flushes, throat irritation, nausea (feeling sick), vomiting and hyperhidrosis (excessive sweating). For

the full list of side effects with Instanyl, see the package leaflet.

Instanyl must not be used in patients who are not already taking opioids to maintain pain control, who

have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung

conditions (diseases that severely impede breathing). It must not be used to treat short-term pain

other than breakthrough pain. It must also not be used in patients who have had facial radiotherapy

(treatment with radiation to the face) or who have recurrent episodes of epistaxis (nosebleeds). It

Instanyl (fentanyl)

Page 3/3

must not be used in patients treated with medicines containing sodium oxybate (used to treat

narcolepsy, a sleep disorder). For the full list of restrictions, see the package leaflet.

Why is Instanyl authorised in the EU?

Instanyl has been shown to provide rapid relief of pain in patients with cancer. Side effects are similar

to those of other medicines containing fentanyl, and measures have been put in place to minimise the

risk of misuse and overdose. The European Medicines Agency decided that Instanyl’s benefits are

greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of

Instanyl?

The company that markets Instanyl will also provide educational materials to be supplied to patients,

doctors and pharmacists, explaining the correct and safe use of the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Instanyl have also been included in the summary of product characteristics and

the package leaflet.

As for all medicines, data on the use of Instanyl are continuously monitored. Side effects reported with

Instanyl are carefully evaluated and any necessary action taken to protect patients.

Other information about Instanyl

Instanyl received a marketing authorisation valid throughout the EU on 20 July 2009.

Further information on Instanyl can be found on the Agency’s

website: ema.europa.eu/medicines/Human/EPAR/Instanyl.

This overview was last updated in 03-2019

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Instanyl 50 micrograms/dose nasal spray, solution

Instanyl 100 micrograms/dose nasal spray, solution

Instanyl 200 micrograms/dose 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, nurse or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Instanyl is and what it is used for

What you need to know before you use Instanyl

How to use Instanyl

Possible side effects

How to store Instanyl

Contents of the pack and other information

1.

What Instanyl is and what it is used for

Instanyl contains the active substance fentanyl and belongs to a group of strong painkillers called

opioids. Opioids act by blocking the pain signals to the brain.

Instanyl acts rapidly and is used for relieving breakthrough pain in adult cancer patients already treated

with opioids for their usual pain. Breakthrough pain is an additional sudden pain that occurs despite

you having taken your usual opioid pain relieving medicines.

2.

What you need to know before you use Instanyl

Do not use Instanyl:

if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in

section 6).

if you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl,

hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least

a week, to control your persistent pain. If you have not been using these medicines you must not

use Instanyl, because it may increase the risk that breathing could become dangerously slow

and/or shallow, or even stop.

If you are taking a medicine which contains sodium oxybate.

if you suffer from short-term pain other than breakthrough pain.

if you have serious difficulties breathing or suffer from a serious obstructive lung disease.

if you have previously received facial radiotherapy.

if you suffer from recurrent episodes of nose bleeding.

Warnings and precautions

Talk to your doctor before using Instanyl, especially:

if you suffer from a long-term obstructive lung disease, your breathing may be impaired by

Instanyl.

if you have problems with your heart especially slow heart rate, low blood pressure or low

blood volume.

if you have problems with your liver or kidneys.

if you have problems with your brain function, e.g. due to a brain tumour, a head injury or

increased intracranial pressure.

if you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency)

with opioid use.

if you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and

Instanyl’.

if you take medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and

pentazocine (medicines for treatment of pain) as you may experience symptoms of withdrawal

syndrome. Please refer to the section

Other medicines and Instanyl

for more information.

if you use other nasal spray products, e.g. for common cold or allergy.

If you experience difficulties breathing while being treated with Instanyl, it is very important

that you contact your doctor or hospital immediately.

Consult your doctor while using Instanyl, if:

you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a

higher dosage of your medicine as prescribed by your doctor.

you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue,

weakness, dizziness and low blood pressure. Together these symptoms may be a sign of a

potentially life-threatening condition called adrenal insufficiency, a condition in which the

adrenal glands do not produce enough hormones.

If you experience recurrent nose bleeding or nasal discomfort whilst being treated with Instanyl, you

must contact your doctor, who will consider alternative treatment for your breakthrough pain.

If you think you are becoming dependent on Instanyl, it is important that you inform you doctor.

Children and adolescents

Instanyl should not be used in children and adolescents under 18 years of age.

Other medicines and Instanyl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

Instanyl may affect or be affected by other medicines.

Special care should be taken if you are treated with any of the following medicines:

any medicines which might normally make you sleepy (have a sedative effect) such as sleeping

pills, medicines to treat anxiety, antihistamines, or tranquillisers. The use of such other drugs at

the same time as Instanyl, may cause deep sedation and affect your ability to breath, which may

lead to coma and be life-threatening.

any medicines that might have an effect on the way in which your body breaks down Instanyl,

such as:

ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV

infection);

CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment

of fungal infections);

troleandomycin, clarithromycin, or erythromycin (medicines for treatment of bacterial

infections);

aprepitant (used to treat severe nausea);

diltiazem and verapamil (medicines for treatment of high blood pressure or heart

diseases).

medicines called Monoamine Oxidase Inhibitors (MAOI) used for severe depression, even if

you have been treated with one in the past 2 weeks.

The risk of side effects increases if you are taking medicines such as certain antidepressants or

antipsychotics. Instanyl may interact with these medicines and you may experience mental

status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature

above 38 °C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes,

muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting,

diarrhoea). Your doctor will tell you whether Instanyl is suitable for you.

medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine

(medicines for treatment of pain). You could experience symptoms of withdrawal syndrome

(nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating).

other medicines taken via the nose, especially oxymetazoline, xylometazoline and similar

medicines, which are used for relief of nose congestions.

Instanyl with food, drink and alcohol

Do not drink alcohol whilst being treated with Instanyl, as it can increase the risk of experiencing

dangerous side effects.

Pregnancy and breast-feeding

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 taking any medicine.

Instanyl should not be used during pregnancy unless you have discussed this with your doctor.

Instanyl should not be used during childbirth because fentanyl may cause serious breathing problems

in the new-born child.

Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. Do not use

Instanyl if you are breast-feeding. You should not start breast-feeding until at least 5 days after the

last dose of Instanyl.

Driving and using machines

You should not drive or use machinery whilst being treated with Instanyl. Instanyl can cause

dizziness, drowsiness and visual disturbances, which may affect your ability to drive or use machines.

3.

How to use Instanyl

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

The dose of Instanyl is independent of your usual cancer pain treatment.

When you first start using Instanyl, your doctor will work with you to find the dose that will relieve

your breakthrough pain.

The initial dose is one puff of 50 micrograms in one nostril each time you have an episode of

breakthrough pain. During the determination of your right dose, your doctor may instruct you to

change to a higher dose.

If your breakthrough pain is not relieved after 10 minutes, you may use only one puff more for this

episode.

Generally you should wait 4 hours before treating another episode of breakthrough pain. On

exceptional occasions where a new episode occurs earlier, you can use Instanyl to treat it but you must

wait at least 2 hours before doing so. If you regularly have breakthrough pain episodes that are less

than 4 hours apart, contact your doctor as your usual cancer pain treatment may have to be changed.

You can use Instanyl to treat up to four episodes of breakthrough pain per day.

If you experience more than four episodes of breakthrough pain per day, contact your doctor, as your

usual cancer pain treatment may have to be changed.

In order to keep track of the number of doses of Instanyl used, you should use the tick-boxes in the

booklet placed on top of the child-resistant outer box.

Do not change the dose of Instanyl or your other pain medicines on your own. Change in dose must be

done together with your doctor.

Instanyl is for nasal use.

Please read the instruction for use at the end of this leaflet to learn how to use Instanyl.

If you use more Instanyl than you should or if you think someone has accidentally used Instanyl

You should contact your doctor, hospital or emergency room for assessment of the risk and for advice

if you have taken more Instanyl than you should.

Symptoms of overdose are:

Sleepiness, drowiness, dizziness, reduced body temperature, slow heart beat, difficulties coordinating

arms and legs.

In serious cases taking too much Instanyl may cause coma, sedation, convulsions or severe breathing

difficulties (very slow or shallow breathing).

If you feel any of the above symptoms you should seek immediate medical assistance.

Note to carers

If you see the person taking Instanyl suddenly acting slowly, having difficulties breathing or if you

have difficulties waking the person up:

you should immediately call for emergency help.

while waiting for the emergency help, you must try to keep the person awake by talking to or

gently shaking the person every now and then.

if the person has difficulty breathing, you should prompt the person to breathe in every

5-10 seconds.

if the person has stopped breathing, you should attempt to resuscitate her/him until emergency

help arrives.

If you think someone has accidentally taken Instanyl, please seek immediate medical assistance. Try to

keep the person awake until emergency help arrives.

If someone has accidentally taken Instanyl, they may have the same symptoms as described above for

overdose.

If you forget to use Instanyl

If the breakthrough pain is still ongoing, you may take Instanyl as prescribed by your doctor. If the

breakthrough pain has stopped, do not take Instanyl until the next episode of breakthrough pain occurs.

If you stop using Instanyl

You should discontinue Instanyl when you no longer have any breakthrough pain. You should

however continue to take your usual pain relieving medicine to treat your cancer pain. Contact your

doctor to confirm the correct dose of your usual medicine if you are not sure.

You may experience withdrawal symptoms similar to the possible side effects of Instanyl when

discontinuing Instanyl. If you experience withdrawal symptoms, you should contact your doctor. Your

doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects will often stop or reduce in intensity with continued use of the product.

Discontinue the treatment and contact your doctor, hospital or emergency room immediately, if

you:

experience severe breathing difficulties.

have a rattling sound when you breathe in.

have convulsive pain.

experience extreme dizziness.

These side effects can be very serious.

Other side effects reported after use of Instanyl:

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

Sleepiness, dizziness even with difficulties keeping balance, headache, irritation of the throat, nausea,

vomiting, flushing, feeling very warm, excessive sweating.

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

Sleeplessness, drowsiness, convulsive muscle contractions, abnormal sensation of the skin even

unpleasant, change of taste, motion sickness, low blood pressure, severe breathing problems, nose

bleeds, nasal ulcer, runny nose, constipation, inflammation of the mouth, dry mouth, skin pain, itching

of the skin, fever.

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

Fall, diarrhoea, convulsions (fits), loss of consciousness, swelling of arms or legs, seeing or hearing

things that are not really there (hallucinations), drug dependence (addiction), drug abuse, fatigue,

malaise, withdrawal syndrome (may manifest by the occurrence of the following side effects nausea,

vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shortness of breath.

There have also been reports of patients developing a hole in the septum of the nose – the structure,

which separates the nostrils.

Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn

which can be life-threatening (see section 2)

You should tell your doctor if you experience recurrent episodes of nose bleeding or nasal discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Instanyl

The pain-relieving medicine in Instanyl is very strong and can be life-threatening to children.

Instanyl must be kept out of the sight and reach of children. Always place the nasal spray in the

child-resistant box after use.

Do not use Instanyl after the expiry date which is stated on the bottle after EXP. The expiry date refers

to the last day of the month.

Store below 30

C. Keep the nasal spray stored upright. Do not freeze. If Instanyl nasal spray is frozen

the spray pump may crack. If uncertain of how the pump has been stored, you should check the spray

pump before use.

Instanyl that has passed the expiry date or is no longer required, may still contain enough medicine to

be harmful to other people, especially children. Do not throw away any medicines via wastewater or

household waste. Any used or unused nasal spray should be returned systematically and suitably in the

child-resistant outer box and discarded according to local requirements or returned to the pharmacy.

Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to

protect the environment.

6.

Contents of the pack and other information

What Instanyl contains

The active substance is fentanyl. The content is:

50 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl. 1 puff

(100 microlitres) contains 50 micrograms fentanyl.

100 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl. 1 puff

(100 microlitres) contains 100 micrograms fentanyl.

200 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl. 1 puff

(100 microlitres) contains 200 micrograms fentanyl.

The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, and

purified water.

What Instanyl looks like and contents of the pack

Instanyl is a nasal spray, solution. The solution is clear and colourless. It is contained in a brown glass

bottle with a metering pump.

The nasal spray is supplied in a child-resistant outer box and comes in three different pack sizes:

1.8 ml (equal to 10 doses), 2.9 ml (equal to 20 doses) and 5.0 ml (equal to 40 doses).

Not all pack sizes may be marketed.

The labelling of the three Instanyl strengths is differentiated by colour:

50 micrograms/dose labelling is orange.

100 micrograms/dose labelling is purple.

200 micrograms/dose labelling is greenish-blue.

Marketing Authorisation Holder

Takeda Pharma A/S

Dybendal Alle 10

DK-2630 Taastrup

Denmark

Manufacturer

Takeda GmbH

Robert-Bosch-Strasse 8

D – 78224 Singen

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien/Luxembourg/

Luxemburg

Takeda Belgium

Tel./Tél.: +32 2 464 06 11

takeda-belgium@takeda.com

Lietuva

Takeda, UAB

Tel.: +370 521 09 070

България

Такеда България

Тел.: + 359 2 958 27 36

Magyarország

Takeda Pharma Kft.

Tel.: +361 2707030

Česká republika

Takeda Pharmaceuticals Czech Republic s.r.o.

Tel.: + 420 234 722 722

Malta / Κύπρος

Takeda Pharma A/S

Tel./ Τηλ.: +45 46 77 11 11

Danmark

Takeda Pharma A/S

Tlf./Tel.: +45 46 77 11 11

Nederland

Takeda Nederland bv

Tel.: +31 23 56 68 777

Deutschland

Takeda GmbH

Tel.: +49 (0) 800 825 3325

medinfo@takeda.de

Norge

Takeda AS

Tlf.: +47 6676 3030

infonorge@takeda.com

Eesti

Takeda Pharma AS

Tel.: +372 6177 669

info@takeda.ee

Österreich

Takeda Pharma Ges.m.b.H.

Tel.: +43 (0) 800 20 80 50

Ελλάδα

TAKEDA ΕΛΛΑΣ Α.Ε.

Τηλ.: +30 210 6387800

gr.info@takeda.com

Polska

Takeda Pharma sp. z o.o.

Tel.: +48 22 608 13 00

España

Takeda Farmacéutica España S.A.

Tel.: +34 917 90 42 22

spain@takeda.com

Portugal

Takeda Farmacêuticos Portugal, Lda.

Tel.: + 351 21 120 1457

France

Takeda France S.A.S

Tel.: +33 1 46 25 16 16

România

Takeda Pharmaceuticals SRL

Tel.: +40 21 335 03 91

Hrvatska

Takeda Pharmaceuticals Croatia d.o.o

Tel: +385 1 377 88 96

Slovenija

Takeda GmbH Podružnica Slovenija

Tel.: +386 (0) 59 082 480

Ireland

Takeda Products Ireland Ltd.

Tel.: +353 (0) 1 6420021

Slovenská republika

Takeda Pharmaceuticals Slovakia s.r.o.

Tel.: +421 (2) 20 602 600

Ísland

Vistor hf.

Tel.: +354 535 7000

vistor@vistor.is

Suomi/Finland

Takeda Oy

Puh./Tel.: +358 20 746 5000

infoposti@takeda.com

Italia

Takeda Italia S.p.A.

Tel.: +39 06 502601

Sverige

Takeda Pharma AB

Tel.: +46 8 731 28 00

infosweden@takeda.com

Κύπρος

Takeda Pharma A/S

Τηλ: +45 46 77 11 11

Latvija

Takeda Latvia SIA

Tel.: +371 67840082

United Kingdom

Takeda UK Ltd

Tel.: +44 (0)1628 537 900

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

INSTRUCTIONS FOR USE OF INSTANYL NASAL SPRAY

Please read the following instructions carefully to learn how to use Instanyl nasal spray.

Preparing Instanyl nasal spray for use:

Before using the nasal spray for the first time:

It must be pumped 3 or 4 times (primed) until a fine mist appears.

During this priming process medicine will be expelled. Therefore:

Priming should be performed in a well ventilated area.

Do not point the nasal spray in the direction of yourself and other people.

Do not point in the direction of surfaces and objects that could come into contact

with other people, particularly children.

If you have not used Instanyl for more than 7 days the pump must be primed again by spraying

once before the next dose is taken.

Instanyl nasal spray should be used in the following way:

Blow your nose if it feels blocked or you have a cold.

You should sit or stand in upright position.

Remove the protective cap from the spray.

Hold the nasal spray upright.

Bend your head slightly forward.

Close one nostril by placing your finger against the side of your nose and insert the spray tip into

the other nostril (approximately 1 cm). It does not matter which nostril you use. If you have to

take a second dose after 10 minutes to get sufficient pain relief, this dose should be taken in the

other nostril.

Press the pump down quickly and completely with two fingers, once, while breathing in through

your nose. You must make sure the pump is pressed all the way down. You may not feel the dose

in your nose, but you have received it when you have pressed the pump.

Clean the nasal spray tip after use with a clean tissue, and then throw away the tissue afterwards.

If after 10 minutes you need a second dose of Instanyl to relieve your pain, repeat steps 1 to 8 in the

other nostril.

Always place Instanyl in the child-resistant box after use. Keep out of the sight and reach of

children.

Keep track of how many doses you have used and how many you have left in your nasal spray by

using the dose-counting card provided with Instanyl nasal spray. Every time you use Instanyl nasal

spray, make sure you or your carer fills in the information on the card.

If Instanyl nasal spray is blocked or does not spray properly:

If it is blocked, aim the nasal spray away from you (and any other people) and push firmly down

on the pump. This should clear any blockage.

If your nasal spray is still not working properly, talk to your pharmacist. Never try to fix the

nasal spray yourself or take it apart. This is because it may then give you the wrong dose.

Package leaflet: Information for the user

Instanyl 50 micrograms nasal spray, solution in single-dose container

Instanyl 100 micrograms nasal spray, solution in single-dose container

Instanyl 200 micrograms nasal spray, solution in single-dose container

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, nurse or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Instanyl is and what it is used for

What you need to know before you use Instanyl

How to use Instanyl

Possible side effects

How to store Instanyl

Contents of the pack and other information

1.

What Instanyl is and what it is used for

Instanyl contains the active substance fentanyl and belongs to a group of strong painkillers called

opioids. Opioids act by blocking the pain signals to the brain.

Instanyl acts rapidly and is used for relieving breakthrough pain in adult cancer patients already treated

with opioids for their usual pain. Breakthrough pain is an additional sudden pain that occurs despite

you having taken your usual opioid pain relieving medicines.

2.

What you need to know before you use Instanyl

Do not use Instanyl:

if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in

section 6).

if you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl,

hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least

a week, to control your persistent pain. If you have not been using these medicines you must not

use Instanyl, because it may increase the risk that breathing could become dangerously slow

and/or shallow, or even stop.

if you are taking a medicine which contains sodium oxybate.

if you suffer from short-term pain other than breakthrough pain.

if you have serious difficulties breathing or suffer from a serious obstructive lung disease.

if you have previously received facial radiotherapy.

if you suffer from recurrent episodes of nose bleeding.

Warnings and precautions

Talk to your doctor before using Instanyl, especially:

if you suffer from a long-term obstructive lung disease, your breathing may be impaired by

Instanyl.

if you have problems with your heart especially slow heart rate, low blood pressure or low

blood volume.

if you have problems with your liver or kidneys.

if you have problems with your brain function, e.g. due to a brain tumour, a head injury or

increased intracranial pressure.

if you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency)

with opioid use.

if you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and

Instanyl’.

if you take medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and

pentazocine (medicines for treatment of pain) as you may experience symptoms of withdrawal

syndrome. Please refer to the section

Other medicines and Instanyl

for more information.

if you use other nasal spray products, e.g. for common cold or allergy.

If you experience difficulties breathing while being treated with Instanyl, it is very important

that you contact your doctor or hospital immediately.

Consult your doctor while using Instanyl, if:

you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a

higher dosage of your medicine as prescribed by your doctor.

you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue,

weakness, dizziness and low blood pressure. Together these symptoms may be a sign of a

potentially life-threatening condition called adrenal insufficiency, a condition in which the

adrenal glands do not produce enough hormones.

If you experience recurrent nose bleeding or nasal discomfort whilst being treated with Instanyl, you

must contact your doctor, who will consider alternative treatment for your breakthrough pain.

If you think you are becoming dependent on Instanyl, it is important that you inform you doctor.

Children and adolescents

Instanyl should not be used in children and adolescents under 18 years of age.

Other medicines and Instanyl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

Instanyl may affect or be affected by other medicines.

Special care should be taken if you are treated with any of the following medicines:

any medicines which might normally make you sleepy (have a sedative effect) such as sleeping

pills, medicines to treat anxiety, antihistamines, or tranquillisers. The use of such other drugs at

the same time as Instanyl, may cause deep sedation and affect your ability to breath, which may

lead to come and be life-threatening.

any medicines that might have an effect on the way in which your body breaks down Instanyl,

such as:

ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV

infection);

CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment

of fungal infections);

troleandomycin, clarithromycin, or erythromycin (medicines for treatment of bacterial

infections);

aprepitant (used to treat severe nausea);

diltiazem and verapamil (medicines for treatment of high blood pressure or heart

diseases).

medicines called Monoamine Oxidase Inhibitors (MAOI) used for severe depression, even if

you have been treated with one in the past 2 weeks.

The risk of side effects increases if you are taking medicines such as certain antidepressants or

antipsychotics. Instanyl may interact with these medicines and you may experience mental

status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature

above 38 °C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes,

muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting,

diarrhoea). Your doctor will tell you whether Instanyl is suitable for you.

medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine

(medicines for treatment of pain). You could experience symptoms of withdrawal syndrome

(nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating).

other medicines taken via the nose, especially oxymetazoline, xylometazoline and similar

medicines, which are used for relief of nose congestions.

Instanyl with food, drink and alcohol

Do not drink alcohol whilst being treated with Instanyl, as it can increase the risk of experiencing

dangerous side effects.

Pregnancy and breast-feeding

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 taking any medicine.

Instanyl should not be used during pregnancy unless you have discussed this with your doctor.

Instanyl should not be used during childbirth because fentanyl may cause serious breathing problems

in the new-born child.

Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. Do not use

Instanyl if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last

dose of Instanyl.

Driving and using machines

You should not drive or use machinery whilst being treated with Instanyl. Instanyl can cause

dizziness, drowsiness and visual disturbances, which may affect your ability to drive or use machines.

3.

How to use Instanyl

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

The dose of Instanyl is independent of your usual cancer pain treatment.

When you first start using Instanyl, your doctor will work with you to find the dose that will relieve

your breakthrough pain.

The initial dose is one puff of 50 micrograms in one nostril each time you have an episode of

breakthrough pain. During the determination of your right dose, your doctor may instruct you to

change to a higher dose.

If your breakthrough pain is not relieved after 10 minutes, you may use only one puff more for this

episode.

Generally you should wait 4 hours before treating another episode of breakthrough pain. On

exceptional occasions where a new episode occurs earlier, you can use Instanyl to treat it but you must

wait at least 2 hours before doing so. If you regularly have breakthrough pain episodes that are less

than 4 hours apart, contact your doctor as your usual cancer pain treatment may have to be changed.

You can use Instanyl to treat up to four episodes of breakthrough pain per day.

If you experience more than four episodes of breakthrough pain per day, contact your doctor, as your

usual cancer pain treatment may have to be changed.

Do not change the dose of Instanyl or your other pain medicines on your own. Change in dose must be

done together with your doctor.

Instanyl is for nasal use.

Please read the instruction for use at the end of this leaflet to learn how to use Instanyl.

If you use more Instanyl than you should or if you think someone has accidentally used Instanyl

You should contact your doctor, hospital or emergency room for assessment of the risk and for advice

if you have taken more Instanyl than you should.

Symptoms of overdose are:

Sleepiness, drowiness, dizziness, reduced body temperature, slow heart beat, difficulties coordinating

arms and legs.

In serious cases taking too much Instanyl may cause coma, sedation, convulsions or severe breathing

difficulties (very slow or shallow breathing).

If you feel any of the above symptoms you should seek immediate medical assistance.

Note to carers

If you see the person taking Instanyl suddenly acting slowly, having difficulties breathing or if you

have difficulties waking the person up:

you should immediately call for emergency help.

while waiting for the emergency help, you must try to keep the person awake by talking to or

gently shaking the person every now and then.

if the person has difficulty breathing, you should prompt the person to breathe in every

5-10 seconds.

if the person has stopped breathing, you should attempt to resuscitate her/him until emergency

help arrives.

If you think someone has accidentally taken Instanyl, please seek immediate medical assistance. Try to

keep the person awake until emergency help arrives.

If someone has accidentally taken Instanyl, they may have the same symptoms as described above for

overdose.

If you forget to use Instanyl

If the breakthrough pain is still ongoing, you may take Instanyl as prescribed by your doctor. If the

breakthrough pain has stopped, do not take Instanyl until the next episode of breakthrough pain occurs.

If you stop using Instanyl

You should discontinue Instanyl when you no longer have any breakthrough pain. You should

however continue to take your usual pain relieving medicine to treat your cancer pain. Contact your

doctor to confirm the correct dose of your usual medicine if you are not sure.

You may experience withdrawal symptoms similar to the possible side effects of Instanyl when

discontinuing Instanyl. If you experience withdrawal symptoms, you should contact your doctor. Your

doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects will often stop or reduce in intensity with continued use of the product.

Discontinue the treatment and contact your doctor, hospital or emergency room immediately, if

you:

experience severe breathing difficulties.

have a rattling sound when you breathe in.

have convulsive pain.

experience extreme dizziness.

These side effects can be very serious.

Other side effects reported after use of Instanyl:

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

Sleepiness, dizziness even with difficulties keeping balance, headache, irritation of the throat, nausea,

vomiting, flushing, feeling very warm, excessive sweating.

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

Sleeplessness, drowsiness, convulsive muscle contractions, abnormal sensation of the skin even

unpleasant, change of taste, motion sickness, low blood pressure, severe breathing problems, nose

bleeds, nasal ulcer, runny nose, constipation, inflammation of the mouth, dry mouth, skin pain, itching

of the skin, fever.

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

Fall, diarrhoea, convulsions (fits), loss of consciousness, swelling of arms or legs, seeing or hearing

things that are not really there (hallucinations), drug dependence (addiction), drug abuse, fatigue,

malaise, withdrawal syndrome (may manifest by the occurrence of the following side effects nausea,

vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shortness of breath.

There have also been reports of patients developing a hole in the septum of the nose – the structure,

which separates the nostrils.

Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn

which can be life-threatening (see section 2)

You should tell your doctor if you experience recurrent episodes of nose bleeding or nasal discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Instanyl

The pain-relieving medicine in Instanyl is very strong and can be life-threatening to children.

Instanyl must be kept out of reach and sight of children.

Do not use Instanyl after the expiry date which is stated on the carton and the single-dose container

after EXP. The expiry date refers to the last day of that month.

Store below 30

C. Keep the blister in the outer carton. Keep stored upright.

Instanyl can be harmful to other people, especially children. Do not throw away any medicines via

wastewater or household waste. Any unused single-dose containers should be returned systematically

and suitably in the child-resistant blister and discarded according to local requirements or returned to

the pharmacy. Ask your pharmacist how to dispose of medicines you no longer use. These measures

will help to protect the environment.

6.

Contents of the pack and other information

What Instanyl contains

The active substance is fentanyl. The content is:

50 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 50 micrograms

fentanyl.

100 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms

fentanyl.

200 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms

fentanyl.

The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, and

water for injections.

What Instanyl looks like and contents of the pack

Instanyl is a nasal spray, solution in a single-dose spray container. The solution is clear and colourless.

The single-dose container contains 1 dose of Instanyl and and is supplied in a child-resistant blister.

Instanyl comes in different pack sizes of 2, 6, 8 and 10 single-dose containers.

Not all pack sizes may be marketed.

The labelling of the three Instanyl strengths is differentiated by colour:

50 micrograms labelling is orange.

100 micrograms labelling is purple.

200 micrograms labelling is greenish-blue.

Marketing Authorisation Holder

Takeda Pharma A/S

Dybendal Alle 10

DK-2630 Taastrup

Denmark

Manufacturer

Takeda Pharma A/S

Dybendal Alle 10

DK-2630 Taastrup

Denmark

Takeda GmbH

Robert-Bosch-Strasse 8

D – 78224 Singen

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien/Luxembourg/

Luxemburg

Takeda Belgium

Tel./Tél.: +32 2 464 06 11

takeda-belgium@takeda.com

Lietuva

Takeda, UAB

Tel.: +370 521 09 070

България

Такеда България

Тел.: + 359 2 958 27 36

Magyarország

Takeda Pharma Kft.

Tel.: +361 2707030

Česká republika

Takeda Pharmaceuticals Czech Republic s.r.o.

Tel.: + 420 234 722 722

Malta / Κύπρος

Takeda Pharma A/S

Tel./ Τηλ.: +45 46 77 11 11

Danmark

Takeda Pharma A/S

Tlf./Tel.: +45 46 77 11 11

Nederland

Takeda Nederland bv

Tel.: +31 23 56 68 777

Deutschland

Takeda GmbH

Tel.: +49 (0) 800 825 3325

medinfo@takeda.de

Norge

Takeda AS

Tlf.: +47 6676 3030

infonorge@takeda.com

Eesti

Takeda Pharma AS

Tel.: +372 6177 669

info@takeda.ee

Österreich

Takeda Pharma Ges.m.b.H.

Tel.: +43 (0) 800 20 80 50

Ελλάδα

TAKEDA ΕΛΛΑΣ Α.Ε.

Τηλ.: +30 210 6387800

gr.info@takeda.com

Polska

Takeda Pharma sp. z o.o.

Tel.: +48 22 608 13 00

España

Takeda Farmacéutica España S.A.

Tel.: +34 917 90 42 22

spain@takeda.com

Portugal

Takeda Farmacêuticos Portugal, Lda.

Tel.: + 351 21 120 1457

France

Takeda France S.A.S

Tel.: + 33 1 46 25 16 16

România

Takeda Pharmaceuticals SRL

Tel.: +40 21 335 03 91

Hrvatska

Takeda Pharmaceuticals Croatia d.o.o

Tel: +385 1 377 88 96

Slovenija

Takeda GmbH Podružnica Slovenija

Tel.:+386 (0) 59 082 480

Ireland

Takeda Products Ireland Ltd.

Tel.: +353 (0) 1 6420021

Slovenská republika

Takeda Pharmaceuticals Slovakia s.r.o.

Tel.: +421 (2) 20 602 600

Ísland

Vistor hf.

Tel.: +354 535 7000

vistor@vistor.is

Suomi/Finland

Takeda Oy

Puh./Tel.: +358 20 746 5000

infoposti@takeda.com

Italia

Takeda Italia S.p.A.

Tel.: +39 06 502601

Sverige

Takeda Pharma AB

Tel.: +46 8 731 28 00

infosweden@takeda.com

Κύπρος

Takeda Pharma A/S

Τηλ: +45 46 77 11 11

Latvija

Takeda Latvia SIA

Tel.: +371 67840082

United Kingdom

Takeda UK Ltd

Tel.: +44 (0)1628 537 900

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

INSTRUCTIONS FOR USE OF INSTANYL SINGLE-DOSE NASAL SPRAY

Please read the following instructions carefully to learn how to use Instanyl single-dose nasal spray:

Each single-dose container is sealed in a child-resistant blister. Do not open the blister before you

are ready to use the spray. Each single-dose container contains only one dose of Instanyl. Do not

test before use.

To open cut with scissors along the line (above the scissors symbol) on the blister. Hold the edge

of the foil, peel the foil back and take the nasal spray out.

Blow your nose if it feels blocked or you have a cold.

Gently hold the single-dose container with your thumb supporting it at the plunger at the bottom

and your index and middle finger on either side of the spray tip (see drawing). Do not press the

plunger yet.

Block one nostril by placing your other index finger against the side of your nose and insert the

spray tip into the other nostril (approximately 1 cm). It does not matter which nostril you use. If

you have to take a second dose after 10 minutes to get sufficient pain relief, this dose should be

taken in the other nostril.

Keep your head upright

Press the plunger upwards firmly to release the dose with your thumb while inhaling gently

through the nose and then remove the spray container from the nose. You may not feel the dose in

your nose, but you have received it when the plunger has been pressed up.

Your single-dose container is now empty

Package leaflet: Information for the user

Instanyl 50 micrograms/dose nasal spray, solution

Instanyl 100 micrograms/dose nasal spray, solution

Instanyl 200 micrograms/dose 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, nurse or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Instanyl is and what it is used for

What you need to know before you use Instanyl

How to use Instanyl

Possible side effects

How to store Instanyl

Contents of the pack and other information

1.

What Instanyl is and what it is used for

Instanyl contains the active substance fentanyl and belongs to a group of strong painkillers called

opioids. Opioids act by blocking the pain signals to the brain.

Instanyl acts rapidly and is used for relieving breakthrough pain in adult cancer patients already treated

with opioids for their usual pain. Breakthrough pain is an additional sudden pain that occurs despite

you having taken your usual opioid pain relieving medicines.

2.

What you need to know before you use Instanyl

Do not use Instanyl:

if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in

section 6).

if you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl,

hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least

a week, to control your persistent pain. If you have not been using these medicines you must not

use Instanyl, because it may increase the risk that breathing could become dangerously slow

and/or shallow, or even stop.

If you are taking a medicine which contains sodium oxybate.

if you suffer from short-term pain other than breakthrough pain.

if you have serious difficulties breathing or suffer from a serious obstructive lung disease.

if you have previously received facial radiotherapy.

if you suffer from recurrent episodes of nose bleeding.

Warnings and precautions

Talk to your doctor before using Instanyl, especially:

if you suffer from a long-term obstructive lung disease, your breathing may be impaired by

Instanyl.

if you have problems with your heart especially slow heart rate, low blood pressure or low

blood volume.

if you have problems with your liver or kidneys.

if you have problems with your brain function, e.g. due to a brain tumour, a head injury or

increased intracranial pressure.

if you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency)

with opioid use.

if you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and

Instanyl’.

if you take medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and

pentazocine (medicines for treatment of pain) as you may experience symptoms of withdrawal

syndrome. Please refer to the section Other medicines and Instanyl for more information.

if you use other nasal spray products, e.g. for common cold or allergy.

If you experience difficulties breathing while being treated with Instanyl, it is very important

that you contact your doctor or hospital immediately.

Consult your doctor while using Instanyl, if:

you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a

higher dosage of your medicine as prescribed by your doctor.

you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue,

weakness, dizziness and low blood pressure. Together these symptoms may be a sign of a

potentially life-threatening condition called adrenal insufficiency, a condition in which the

adrenal glands do not produce enough hormones.

If you experience recurrent nose bleeding or nasal discomfort whilst being treated with Instanyl, you

must contact your doctor, who will consider alternative treatment for your breakthrough pain.

If you think you are becoming dependent on Instanyl, it is important that you inform you doctor.

Children and adolescents

Instanyl should not be used in children and adolescents under 18 years of age.

Other medicines and Instanyl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

Instanyl may affect or be affected by other medicines.

Special care should be taken if you are treated with any of the following medicines:

any medicines which might normally make you sleepy (have a sedative effect) such as sleeping

pills, medicines to treat anxiety, antihistamines, or tranquillisers. The use of such other drugs at

the same time as Instanyl, may cause deep sedation and affect your ability to breath, which may

lead to coma and be life-threatening.

any medicines that might have an effect on the way in which your body breaks down Instanyl,

such as:

ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV

infection);

CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment

of fungal infections);

troleandomycin, clarithromycin, or erythromycin (medicines for treatment of bacterial

infections);

aprepitant (used to treat severe nausea);

diltiazem and verapamil (medicines for treatment of high blood pressure or heart

diseases).

medicines called Monoamine Oxidase Inhibitors (MAOI) used for severe depression, even if

you have been treated with one in the past 2 weeks.

The risk of side effects increases if you are taking medicines such as certain antidepressants or

antipsychotics. Instanyl may interact with these medicines and you may experience mental

status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature

above 38 °C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes,

muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting,

diarrhoea). Your doctor will tell you whether Instanyl is suitable for you.

medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine

(medicines for treatment of pain). You could experience symptoms of withdrawal syndrome

(nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating).

Other medicines taken via the nose, especially oxymetazoline, xylometazoline and similar

medicines, which are used for relief of nose congestions.

Instanyl with food, drink and alcohol

Do not drink alcohol whilst being treated with Instanyl, as it can increase the risk of experiencing

dangerous side effects.

Pregnancy and breast-feeding

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 taking any medicine.

Instanyl should not be used during pregnancy unless you have discussed this with your doctor.

Instanyl should not be used during childbirth because fentanyl may cause serious breathing problems

in the new-born child.

Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. Do not use

Instanyl if you are breast-feeding. You should not start breast-feeding until at least 5 days after the

last dose of Instanyl.

Driving and using machines

You should not drive or use machinery whilst being treated with Instanyl. Instanyl can cause

dizziness, drowsiness and visual disturbances, which may affect your ability to drive or use machines.

3.

How to use Instanyl

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

The dose of Instanyl is independent of your usual cancer pain treatment.

When you first start using Instanyl, your doctor will work with you to find the dose that will relieve

your breakthrough pain.

The initial dose is one puff of 50 micrograms in one nostril each time you have an episode of

breakthrough pain. During the determination of your right dose, your doctor may instruct you to

change to a higher dose.

If your breakthrough pain is not relieved after 10 minutes, you may use only one puff more for this

episode.

Generally you should wait 4 hours before treating another episode of breakthrough pain. On

exceptional occasions where a new episode occurs earlier, you can use Instanyl to treat it but you must

wait at least 2 hours before doing so. If you regularly have breakthrough pain episodes that are less

than 4 hours apart, contact your doctor as your usual cancer pain treatment may have to be changed.

You can use Instanyl to treat up to four episodes of breakthrough pain per day.

If you experience more than four episodes of breakthrough pain per day, contact your doctor, as your

usual cancer pain treatment may have to be changed.

Do not change the dose of Instanyl or your other pain medicines on your own. Change in dose

must be done together with your doctor.

Instanyl incorporates an electronic dose counter, and a lock out period between doses to reduce the

risk of overdose, and helps you to use it adequately.The dose counter enables you, and your doctor, to

monitor and adapt your use. After two doses are taken within 60 minutes, Instanyl will lock for a

period of 2 hours, from the first dose taken, until another dose can be administered.

Instanyl is for nasal use.

Please read the instruction for use at the end of this leaflet to learn how to use the nasal spray.

If you use more Instanyl than you should or if you think someone has accidentally used Instanyl

You should contact your doctor, hospital or emergency room for assessment of the risk and for advice

if you have taken more Instanyl than you should.

Symptoms of overdose are:

Sleepiness, drowiness, dizziness, reduced body temperature, slow heart beat, difficulties coordinating

arms and legs.

In serious cases taking too much Instanyl may cause coma, sedation, convulsions or severe breathing

difficulties (very slow or shallow breathing).

If you feel any of the above symptoms you should seek immediate medical assistance.

Note to carers

If you see the person taking Instanyl suddenly acting slowly, having difficulties breathing or if you

have difficulties waking the person up:

you should immediately call for emergency help.

while waiting for the emergency help, you must try to keep the person awake by talking to or

gently shaking the person every now and then.

if the person has difficulty breathing, you should prompt the person to breathe in every

5-10 seconds.

if the person has stopped breathing, you should attempt to resuscitate her/him until emergency

help arrives.

If you think someone has accidentally taken Instanyl, please seek immediate medical assistance. Try to

keep the person awake until emergency help arrives.

If someone has accidentally taken Instanyl, they may have the same symptoms as described above for

overdose.

If you forget to use Instanyl

If the breakthrough pain is still ongoing, you may take Instanyl as prescribed by your doctor. If the

breakthrough pain has stopped, do not take Instanyl until the next episode of breakthrough pain occurs.

If you stop using Instanyl

You should discontinue Instanyl when you no longer have any breakthrough pain. You should

however continue to take your usual pain relieving medicine to treat your cancer pain. Contact your

doctor to confirm the correct dose of your usual medicine if you are not sure.

You may experience withdrawal symptoms similar to the possible side effects of Instanyl when

discontinuing Instanyl. If you experience withdrawal symptoms, you should contact your doctor. Your

doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects will often stop or reduce in intensity with continued use of the product.

Discontinue the treatment and contact your doctor, hospital or emergency room immediately, if

you:

experience severe breathing difficulties.

have a rattling sound when you breathe in.

have convulsive pain.

experience extreme dizziness.

These side effects can be very serious.

Other side effects reported after use of Instanyl:

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

Sleepiness, dizziness even with difficulties keeping balance, headache, irritation of the throat, nausea,

vomiting, flushing, feeling very warm, excessive sweating.

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

Sleeplessness, drowsiness, convulsive muscle contractions, abnormal sensation of the skin even

unpleasant, change of taste, motion sickness, low blood pressure, severe breathing problems, nose

bleeds, nasal ulcer, runny nose, constipation, inflammation of the mouth, dry mouth, skin pain, itching

of the skin, fever.

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

Fall, diarrhoea, convulsions (fits), loss of consciousness, swelling of arms or legs, seeing or hearing

things that are not really there (hallucinations), drug dependence (addiction), drug abuse, fatigue,

malaise, withdrawal syndrome (may manifest by the occurrence of the following side effects nausea,

vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shortness of breath.

There have also been reports of patients developing a hole in the septum of the nose – the structure,

which separates the nostrils.

Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn

which can be life-threatening (see section 2)

You should tell your doctor if you experience recurrent episodes of nose bleeding or nasal discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Instanyl

The pain-relieving medicine in Instanyl is very strong and can be life-threatening to children.

Instanyl must be kept out of the sight and reach of children. Always close after use by puting the

child-resistant cap back on to the nasal spray.

Do not use Instanyl after the expiry date which is stated on the nasal spray after EXP. The expiry date

refers to the last day of the month.

Store below 30

C. Do not freeze. If Instanyl nasal spray is frozen the spray pump may crack. If

uncertain of how the pump has been stored, you should check the spray pump before use.

Instanyl that has passed the expiry date or is no longer required, may still contain enough medicine to

be harmful to other people, especially children.

This instrument is labelled in accordance with the EU Waste Electrical and Electronic

Equipment Directive (WEEE). Do not throw away any medicines via wastewater or household

waste. Any used or unused nasal spray should be returned systematically and discarded

according to local requirements or returned to the pharmacy. Ask your pharmacist how to

dispose of medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Instanyl contains

The active substance is fentanyl. The content is:

50 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl. 1 puff

(100 microlitres) contains 50 micrograms fentanyl.

100 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl. 1 puff

(100 microlitres) contains 100 micrograms fentanyl.

200 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl. 1 puff

(100 microlitres) contains 200 micrograms fentanyl.

The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, and

purified water.

What Instanyl looks like and contents of the pack

Instanyl DoseGuard is a nasal spray, solution. The solution is clear and colourless. It is contained in a

nasal spray with a metering pump, an electronic display, a dose counter, an in-built lock-out

mechanism and a child-resistant cap.

The nasal spray comes in four different pack sizes: 2.0 ml (equal to 10 doses), 3.2 ml (equal to

20 doses), 4.3 ml (equal to 30 doses) and 5.3 ml (equal to 40 doses).

Not all pack sizes may be marketed.

The labelling of the three Instanyl strengths is differentiated by colour:

50 micrograms/dose labelling is orange.

100 micrograms/dose labelling is purple.

200 micrograms/dose labelling is greenish-blue.

Marketing Authorisation Holder

Takeda Pharma A/S

Dybendal Alle 10

DK-2630 Taastrup

Denmark

Manufacturer

Takeda GmbH

Robert-Bosch-Strasse 8

D – 78224 Singen

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien/Luxembourg/

Luxemburg

Takeda Belgium

Tel./Tél.: +32 2 464 06 11

takeda-belgium@takeda.com

Lietuva

Takeda, UAB

Tel.: +370 521 09 070

България

Такеда България

Тел.: + 359 2 958 27 36

Magyarország

Takeda Pharma Kft.

Tel.: +361 2707030

Česká republika

Takeda Pharmaceuticals Czech Republic s.r.o.

Tel.: + 420 234 722 722

Malta / Κύπρος

Takeda Pharma A/S

Tel./ Τηλ.: +45 46 77 11 11

Danmark

Takeda Pharma A/S

Tlf./Tel.: +45 46 77 11 11

Nederland

Takeda Nederland bv

Tel.: +31 23 56 68 777

Deutschland

Takeda GmbH

Tel.: +49 (0) 800 825 3325

medinfo@takeda.de

Norge

Takeda AS

Tlf.: +47 6676 3030

infonorge@takeda.com

Eesti

Takeda Pharma AS

Tel.: +372 6177 669

info@takeda.ee

Österreich

Takeda Pharma Ges.m.b.H.

Tel.: +43 (0) 800 20 80 50

Ελλάδα

TAKEDA ΕΛΛΑΣ Α.Ε.

Τηλ.: +30 210 6387800

gr.info@takeda.com

Polska

Takeda Pharma sp. z o.o.

Tel.: +48 22 608 13 00

España

Takeda Farmacéutica España S.A.

Tel.: +34 917 90 42 22

spain@takeda.com

Portugal

Takeda Farmacêuticos Portugal, Lda.

Tel.: + 351 21 120 1457

France

Takeda France S.A.S

Tel.: +33 1 46 25 16 16

România

Takeda Pharmaceuticals SRL

Tel.: +40 21 335 03 91

Hrvatska

Takeda Pharmaceuticals Croatia d.o.o

Tel: +385 1 377 88 96

Slovenija

Takeda GmbH Podružnica Slovenija

Tel.: +386 (0) 59 082 480

Ireland

Takeda Products Ireland Ltd.

Tel.: +353 (0) 1 6420021

Slovenská republika

Takeda Pharmaceuticals Slovakia s.r.o.

Tel.: +421 (2) 20 602 600

Ísland

Vistor hf.

Tel.: +354 535 7000

vistor@vistor.is

Suomi/Finland

Takeda Oy

Puh./Tel.: +358 20 746 5000

infoposti@takeda.com

Italia

Takeda Italia S.p.A.

Tel.: +39 06 502601

Sverige

Takeda Pharma AB

Tel.: +46 8 731 28 00

infosweden@takeda.com

Κύπρος

Takeda Pharma A/S

Τηλ: +45 46 77 11 11

Latvija

Takeda Latvia SIA

Tel.: +371 67840082

United Kingdom

Takeda UK Ltd

Tel.: +44 (0)1628 537 900

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

INSTRUCTIONS FOR USE OF INSTANYL

Please read the following instructions carefully to learn how to use the Instanyl nasal spray.

The Instanyl nasal spray has:

An in-built lock-out mechanism which controls how often the nasal spray can be used

A child-resistant cap, which must be put on the nasal spray, when the nasal spray is not used

An electronic display which:

gives instruction on number of priming strokes

shows the number of doses left

shows whether the nasal spray is locked or ready for use

How to remove and re-attach the child-resistant cap

Remove the child-resistant cap by pressing on both sides of the

cap, and then turn the cap counter clockwise and lift it off.

To re-attach, place the child-resistant cap on the nasal spray and

turn the cap clockwise.

Always close after use by putting the child-resistant cap back

on to the nasal spray.

Preparing the Instanyl nasal spray

Before using the nasal spray for the first time, it must be

pumped 5 times (primed) to give a full dose of Instanyl.

During this priming process product will be expelled.

Therefore:

Priming should be performed in a well ventilated area.

Do not point the nasal spray in the direction of yourself

and other people.

Do not point in the direction of surfaces and objects that

could come into contact with other people, particularly

children.

Press on the white button on the side of the nasal spray.

The display will now turn on and show ‘P5’.

Hold the nasal spray upright and pump the nasal spray

once in the air. The display now shows ‘P4’ and a lock

symbol appears.

When the lock symbol starts flashing, press the white

side button; the lock symbol disappears in the display.

Hold the nasal spray upright and pump the nasal spray

in the air again. The display now shows ‘P3’ and the

lock symbol.

Repeat this procedure for ‘P2’ and ‘P1’ (press the white

button and pump) until the display changes to show the

number of doses in the nasal spray (i.e. 10, 20, 30 or

40 doses) and flashing lock symbol.

The nasal spray is now ready for use.

Depending on the nasal spray, the starting number can be 10,

20, 30 or 40.

How to use Instanyl nasal spray

The nasal spray can only be used when the lock symbol is not visible in the display.

Blow your nose if it feels blocked or you have a cold.

You should sit or stand in upright position.

Hold the nasal spray upright.

Press the white button on the side of the nasal spray (the

flashing lock symbol disappears).

Bend your head slightly forward.

Close one nostril by placing your finger against the side of

your nose and insert the spray tip into the other nostril.

Press the pump down completely with two fingers one time

while breathing through the nose.

You will hear a ‘click’ sound when the pump is pressed

down completely and the nasal spray has delivered the

dose.

The display counts down one number and the lock symbol

is displayed shortly.

If after 10 minutes you need a second dose of Instanyl to

relieve your pain, repeat step 1 to 7 in the other nostril.

Remember to clean the nasal spray tip after use with a clean

tissue, and then discard afterwards.

Remember to press the white button on the side before

pumping the nasal spray.

Remember to always put the child-resistant cap back on to

the nasal spray and close it after use.

The nasal spray allows for up to two doses per breakthrough

pain episodes.

After the second dose within 1 hour the nasal spray is locked.

The lock symbol appears in the display together with a

countdown-clock symbol, which shows the remaining time left

of the locking period (each black mark equals 10 minutes).

When the time has passed the lock symbol starts flashing.

The nasal spray is now ready for use, when the next

breakthrough pain episode occurs.

You should wait for 4 hours before treating the next episode of

breakthrough pain.

You can use Instanyl to treat up to 4 episodes of breakthrough

pain per day. If you experience more than 4 episodes of

breakthrough pain per day, you should contact your doctor as

your usual cancer pain treatment may have to be changed.

The nasal spray is empty when the display shows ‘0’ and the

lock symbol appears.

Do not throw away Instanyl via wastewater or household waste.

Any used or unused nasal spray should be returned

systematically and discarded according to local requirements or

returned to the pharmacy. Ask your pharmacist.

If you have not used Instanyl for 7 days or more, the nasal spray

must be primed again by spraying once before the next dose is

taken. This is indicated by a ‘P’ in the display.

During this priming process product will be expelled.

Therefore:

Priming should be performed in a well ventilated area.

Do not point the nasal spray in the direction of yourself and

other people.

Do not point in the direction of surfaces and objects that

could come into contact with other people, particularly

children.

Once primed, the display shows the number of doses left and the

nasal spray is ready for use again.

If the display shows a battery symbol, this means that the battery

life is about to run out. The number of doses in the display

changes to ‘5’. This is the approximate number of doses that can

be delivered from the nasal spray, before the battery is too low

and the display turns off.

If the battery symbol appears in the display, it is recommended

that you contact your doctor to get a new nasal spray.

Symbols in the

electronic display

Explanation

The nasal spray must be pumped 5 times (primed), before it can be used (see

section ‘Preparing the Instanyl nasal spray’). The display counts downward

after each pump (P5, P4, P3, P2 and P1). The nasal spray is ready, when the

display shows the number of doses (i.e. 10, 20, 30 or 40 doses).

When priming, please refer to the above safety instructions.

The nasal spray has not been used for 7 days or more.

The ‘P’ symbol disappears from the display, when the nasal spray is primed

again, by spraying once.

When priming, please refer to the above safety instructions

LOCK symbol

The nasal spray is locked and cannot be used.

The lock symbol starts flashing, when the locking period is over. The symbol

disappears from the display, when the white button on the side of the nasal

spray is pressed.

COUNTDOWN-CLOCK symbol

Shows how much time is left of the locking period.

The countdown-clock is counting downwards. Each black mark equals

10 minutes; the maximum locking period is 2 hours.

The COUNTDOWN-CLOCK symbol is displayed together with the

LOCK-symbol.

The number of doses left in the nasal spray. After each dose, the number is

counting downwards on the display. Depending on the nasal spray, the starting

number can be 10, 20, 30 or 40.

BATTERY symbol

The battery life is about to run out. The number of doses in the display changes

to 5. This is the approximate number of doses that can be delivered from the

nasal spray, before the battery is too low and the display turns off. The battery

cannot be replaced and you need to get a new nasal spray.

If you experience that the nasal spray does not work as described in the “Instructions for use”

please contact your doctor or pharmacist.