50 micrograms / dose, 100 micrograms / dose, 200 micrograms / dose nasal spray, fentanyl solution

1. What Instanyl is and what it is used for

Instant contains the active substance fentanyl which belongs to a group of strong painkillers called opioids. Opioids block the pain signals to the brain. Instant acts quickly and is used to relieve breakthrough pain in adult cancer patients who are already being treated with opioids for their common pain. Breakthrough pain is an additional sudden pain that occurs even if you have taken your usual painkiller opioid medications.

2. What you need to know before using 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 do not take it regularly every day for at least a week, use a prescription opioid medicine (eg codeine , fentanyl , hydromorphone, morphine, oxycodone, pethidine) to treat persistent pain. If you have not used such medicines, do not use Instanyl, as this may increase the risk of your breathing becoming dangerously slow and / or shallow, or even stopping.
  • if you are taking a medicine containing sodium oxybate.
  • if you have short-term pain, other than breakthrough pain.
  • if you have severe breathing problems or suffer from a serious obstructive pulmonary disease .
  • if you have previously received radiation treatment for your face.
  • if you have recurrent nosebleeds.

Warnings and cautions

Talk to your doctor or pharmacist before using Instant:

  • if you have a long-term obstructive pulmonary disease , as your breathing may be impaired by Instanyl.
  • if you have heart problems, especially slow heart rate, low blood pressure or low blood volume.
  • if you have liver or kidney problems.
  • if you have problems with brain function, e.g. due to a brain tumor, a head injury or increased pressure inside the head.
  • if you have ever had adrenal insufficiency or sex hormone deficiency (androgen deficiency) with opioid use.
  • if you or someone in your family has ever abused or been addicted to alcohol, prescription drugs or illegal drugs.
  • if you are a smoker.
  • if you have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental problems.
  • if you are taking antidepressants or antipsychotics (see also section “Other medicines and Instanyl”).
  • if you are taking medicines called partial agonists / antagonists, e.g. buprenorphine, nalbufine and pentazocine (painkillers), as you may have symptoms of withdrawal syndrome. See the section “ Other medicines and Instanyl ” for more information.
  • if you use other nasal sprays, e.g. for colds or allergies .

If you experience difficulty breathing with Instant, it is very important that you contact your doctor or hospital immediately.

Talk to your doctor when using Instant about:

  • you feel pain or become more sensitive to pain (hyperalgesia) and it does not help with a higher dose of your medicine according to the doctor’s prescription .
  • You get a combination of the following symptoms: nausea, vomiting, anorexia , fatigue, weakness, dizziness and low blood pressure . When they occur at the same time, these symptoms can be a sign of so-called adrenal insufficiency, a condition which means that the adrenal glands do not produce enough hormones and which can be life-threatening.

If you experience recurrent nosebleeds or nasal discomfort during treatment with Instant, you must contact a doctor who will consider any alternative treatment for your breakthrough pain.

If you think you are becoming addicted to Instant, it is important that you tell your doctor.

Children and young people

Instant should not be given to 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.

Instant may affect or be affected by other medicines.

Take special care with any of the following medicines:

  • all medicines that normally make you sleepy (have a sedative effect), e.g. sleeping pills, anti-anxiety drugs, antihistamines or sedatives.Using such other medicines at the same time as Instanyl may cause deep sedation and affect the ability to breathe, which may lead to coma and be life threatening.
  • all drugs that can affect the way your body breaks down Instanyl, e.g.
    • ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV – infection )
    • or CYP3A4 inhibitors such as ketoconazole , itraconazole or fluconazole (used to treat fungal infections)
    • troleandomycin, clarithromycin or erythromycin (used to treat bacterial infections)
    • aprepitant (used to treat severe nausea)
    • diltiazem and verapamil (used to treat high blood pressure or heart disease)
  • medicines called monoamine oxidase inhibitors ( MAOIs ) (used for major depression), even if you have been treated with one for the past 2 weeks.
  • The risk of side effects is increased if you take medicines such as certain antidepressants or antipsychotics. Instanyl may interact with these medicines and you may experience changes in mental state (eg agitation, hallucinations, coma ), and other effects such as body temperature above 38 ° C, increased heart rate, unstable blood pressure and overactive reflexes, muscle stiffness, lack of coordination and / or gastrointestinal symptoms (eg nausea, vomiting, diarrhea). Your doctor will tell you if Instanyl is right for you.
  • drugs called partial agonists / antagonists, e.g. buprenorphine, nalbufine and pentazocine (painkillers). You may experience symptoms of withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors and sweating).
  • other nasal medicines, especially oxymetazoline, xylometazoline and similar medicines, used to relieve nasal congestion.

Instanyl with food, drink and alcohol

Do not drink alcohol during treatment with Instant, as it may increase the risk of serious side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

You should not use Instant during pregnancy unless you have discussed this with your doctor.

You should not use Instant during childbirth as fentanyl can lead to severe breathing problems in the newborn baby.

Fentanyl may pass into breast milk and may cause side effects in the breast-fed baby. Do not use Instant if you are breastfeeding. You should not start breastfeeding until at least 5 days after the last dose of Instant.

Driving and using machines

Do not drive or use machines during treatment with Instant. Instant may cause dizziness, drowsiness, and visual disturbances, which may affect your ability to drive or use machines. 

3. How to use Instanyl

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dos en Instant is independent of your usual treatment for cancer pain.

When you first start using Instant, your doctor will work with you to find the dose that relieves your breakthrough pain.

The starting dose is a 50 microgram puff in a nostril each time you experience an episode of breakthrough pain. During the time the correct dose is being determined, your doctor may ask you to switch to a higher dose.

If your breakthrough pain is not relieved after 10 minutes, just take one more puff during this episode.

You should usually wait 4 hours before treating another episode of breakthrough pain. In exceptional cases, when a new episode occurs earlier, you can use Instant to treat it, but you must wait at least 2 hours before doing so. If you regularly have episodes of breakthrough pain at intervals of less than 4 hours, consult your doctor as your usual treatment for cancer pain may need to be changed.

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

If you experience more than four episodes of breakthrough pain per day, consult your doctor as your usual treatment for cancer pain may need to be changed.

You should check the boxes in the brochure on the top of the outer, child-resistant box to keep track of how many doses of Instant you have used.

Do not change the dose of Instant or your other pain medicines. Dose adjustment must be made together with the doctor.

Instant should be used in the nose.

Read the instructions for use at the end of this leaflet to learn how to use Instant

If you have used too much Instanyl or if you think that someone has accidentally used Instanyl

Contact a doctor, hospital, or emergency department for risk assessment and advice if you have used too much Instant.

Symptoms of overdose are:

Drowsiness, drowsiness, dizziness, decreased body temperature, slow heartbeat, difficulty coordinating arms and legs.

In severe cases, too much Instant can lead to coma, sedation, seizures, or severe difficulty breathing (very slow or shallow breathing).

If you experience any of the above symptoms, see a doctor immediately.

Information for carers

If you notice that the person taking Instanyl suddenly acts slowly, has difficulty breathing or if you have difficulty waking the person:

  • you should call an ambulance immediately.
  • while waiting for help, try to keep the person awake by talking to the person or occasionally gently shaking the person.
  • if the person has difficulty breathing, urge the person to breathe every 5 to 10 seconds.
  • if the person has stopped breathing, try to resuscitate him / her until the ambulance arrives.

Call an ambulance immediately if you think someone has accidentally taken Instant. Try to keep the person awake until the ambulance arrives.

If someone has accidentally taken Instant, they may experience the same symptoms like those described above for overdose.

If you forget to use Instanyl

If you still have breakthrough pain, you can take Instant according to your doctor’s instructions. If the breakthrough pain has passed, do not take Instant until the next episode of breakthrough pain.

If you stop using Instanyl

You should stop using Instant when you no longer have any breakthrough pain. However, you should continue to take your usual painkillers to treat your cancer pain. Contact your doctor to confirm the correct dose of one of your usual medicines if you are unsure. You may experience withdrawal symptoms similar to the possible side effects of Instant when you stop using Instant. If you notice any withdrawal symptoms, consult a doctor. Your doctor will evaluate whether you need medication to reduce or eliminate 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 often stop or decrease in intensity if you continue to use the medicine.

End treatment and contact a doctor, hospital, or emergency department immediately if you:

  • experiencing difficulty breathing,
  • has a rustling sound when you inhale,
  • experiencing a cramping pain,
  • gets extreme dizziness.

These side effects can be very serious.

Other side effects reported after using Instant:

Common (may affect up to 1 in 10 people): Drowsiness, dizziness, even difficulty keeping balance, headache, throat irritation, nausea, vomiting, hot flashes, feeling hot, extensive sweating.

Uncommon (may affect up to 1 in 100 people): Drowsiness, drowsiness, cramping muscle contractions, abnormal and even unpleasant sensation in the skin, taste changes, motion sickness, low blood pressure, severe breathing problems, nosebleeds, nose ulcers, runny nose, constipation, inflammation of the mouth, dry mouth, pain in the skin, itchy skin, fever.

Has been reported (occurs in an unknown number of users):

Falls, diarrhea, convulsions (seizures), unconsciousness, swelling of arms and legs, seeing and hearing things that do not exist (hallucinations), drug addiction, drug abuse, fatigue, malaise, withdrawal syndrome (may manifest itself in the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), shortness of breath.

There have also been reports that a hole has formed in the nasal septum (separates the nostrils).

Long-term treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening (see section 2).

You should tell your doctor if you experience recurrent nosebleeds or nasal discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Instanyl

The painkiller in Instanyl is very strong and can be life-threatening for children. Instant must be kept out of the reach and sight of children. Always place the nasal spray in the child-resistant box after use.

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Keep the nasal spray upright. Do not freeze. If Instanyl nasal spray is frozen, the spray pump may crack. If you are unsure how the pump has been stored, check the spray pump before use.

Instanyl whose expiration date has passed or is no longer needed may still contain enough medicines to be harmful to other people, especially children. Medicines should not be disposed of via wastewater or household waste. All unused nasal sprays should always be returned in a systematic manner and preferably in the child-resistant box and discarded according to local requirements or handed in at the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is fentanyl . The content is:

50 micrograms / dose: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl . 1 puff (100 microliters) contains 50 micrograms of fentanyl .

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

200 micrograms / dose: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl . 1 puff (100 microliters) contains 200 micrograms of fentanyl .

The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate and purified water.

What the medicine looks like and contents of the pack

Instanyl is a nasal spray, solution. The solution is clear and colorless. It is stored in a brown glass bottle with a dosing pump.

The nasal spray is delivered in a child-resistant box and is available in three different pack sizes: 1.8 ml (equivalent to 10 doses ), 2.9 ml (equivalent to 20 doses ) and 5.0 ml (equivalent to 40 doses ).

Not all pack sizes may be marketed.

The three different dose strengths of Instanyl differ due to the different color of the labels:

50 micrograms / dose has an orange label

100 micrograms / dose has a purple label

200 micrograms / dose has a green-blue label.

Marketing Authorization Holder and Manufacturer

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

Curia AS

Solbærvegen 5

NO ‑ 2409 Elverum

Norway

Further information on this medicine can be obtained from the representative of the marketing authorization holder.

België / Belgique / Belgien / Luxembourg /LuxembourgTakeda BelgiumTel: +32 2 464 06 11takeda‑belgium@takeda.com  LithuaniaTakeda, UABTel: +370 521 09 070
BulgariaTakade BulgariaTel .: + 359 2 958 27 36 HungaryTakeda Pharma Kft.Tel .: +361 2707030
Czech RepublicTakeda Pharmaceuticals Czech Republic sroTel: + 420 234722722 Malta / ΚύπροςTakeda Pharma A / STel / :ηλ: +45 46 77 11 11
DenmarkTakeda Pharma A / STel: +45 46 77 11 11 The NetherlandsTakeda Nederland bvTel: +31 23 56 68 777
GermanyTakeda GmbHTel: +49 (0) 800 825 3325medinfo@takeda.de  NorwayTakeda ASTel: +47 6676 3030infonorge@takeda.com 
EestiTakeda Pharma ASTel: +372 6177 669info@takeda.ee AustriaTakeda Pharma Ges.mbHTel: +43 (0) 800 20 80 50
GreeceTAKEDA ΕΛΛΑΣ Α.Ε.:Ηλ: +30 210 6387800gr.info@takeda.com PolandTakeda Pharma sp. z ooTel .: +48 22 608 13 00
SpainTakeda Pharmacéutica España SATel: +34 917 90 42 22spain@takeda.com  PortugalTakeda Pharmacists Portugal, Lda.Tel: + 351 21 120 1457
FranceTakeda France SASTel: +33 1 46 25 16 16 RomaniaTakeda Pharmaceuticals SRLTel: +40 21 335 03 91
CroatiaTakeda Pharmaceuticals Croatia dooTel: +385 1 377 88 96 SloveniaTakeda GmbH Podružnica SlovenijaTel: +386 (0) 59 082 480
IrelandTakeda Products Ireland Ltd.Tel: +353 (0) 1 6420021 Slovak RepublicTakeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600
IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is  Finland / FinlandTakeda OyPuh / Tel: +358 20 746 5000infoposti@takeda.com 
ItalyTakeda Italia SpATel: +39 06 502601 SwedenTakeda Pharma ABTel: +46 8 731 28 00infosweden@takeda.com
ΚύπροςTakeda Pharma A / S:Ηλ: +45 46 77 11 11 United KingdomTakeda UK LtdTel: +44 (0) 1628 537 900
LatviaTakeda Latvia SIATel: +371 67840082

Muhammad Nadeem

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