Instanyl - patient leaflet, side effects, dosage

- 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

• 1. What Instanyl is and what it is used for

• 2. What you need to know before you use Instanyl

• 3. How to use Instanyl

• 4. Possible side effects

• 5. How to store Instanyl

• 6. 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 or pharmacist 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 or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).

• – 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 illnesses.

• – if you take antidepressants or antipsychotics (please also 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.

Sleep-related breathing disorders

Instanyl can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

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.

Repeated use of Instanyl may lead to dependence and abuse which may result in life-threatening overdose. If you think you are becoming dependent on Instanyl, it is important that you consult your 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 medicines 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 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

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda GmbH

Robert-Bosch-Strasse 8

D – 78224 Singen

Germany

Curida AS

Solbærvegen 5

NO-2409 Elverum

Norway

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

Belgie/Belgiqu­e/Belgien Takeda Belgium Tél/Tel: +32 2 464 06 11	Lietuva Takeda, UAB Tel.: +370 521 09 070
Efcnrapua Takega Etnrapua Ten.: + 359 2 958 27 36	Luxembourg/Lu­xemburg Takeda Belgium Tel/Tel: +32 2 464 06 11
Česká republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel.: + 420 234 722722	Magyarorszag Takeda Pharma Kft. Tel.: +361 2707030
Danmark Takeda Pharma A/S Tel: +45 46 77 11 11	Malta TAKEDA HELLAS S.A. Tel: +30 210 6387800
Deutschland Takeda GmbH Tel: +49 (0) 800 825 3325	Nederland Takeda Nederland B.V. Tel: +31 20 203 5492
Eesti Takeda Pharma AS Tel: +372 6177 669	Norge Takeda AS Tlf: +47 6676 3030
EXXáSa TAKEDA EAAAZ A.E. Tql: +30 210 6387800	Österreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800 20 80 50
España Takeda Farmacéutica España S.A. Tel: +34 917 90 42 22	Polska Takeda Pharma sp. z o.o. Tel.: +48 22 608 13 00

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

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

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:

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

• 2. You should sit or stand in upright position.

• 3. Remove the protective cap from the spray.

• 4. Hold the nasal spray upright.

• 5. Bend your head slightly forward.

• 6. 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.

• 7. 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.

• 8. 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.