PACKAGE LEAFLET: INFORMATION FOR THE USER

Fentanyl 200 micrograms compressed lozenge with integral oromucosal applicator Fentanyl 400 micrograms compressed lozenge with integral oromucosal applicator Fentanyl 600 micrograms compressed lozenge with integral oromucosal applicator Fentanyl 800 micrograms compressed lozenge with integral oromucosal applicator Fentanyl 1200 micrograms compressed lozenge with integral oromucosal applicator Fentanyl 1600 micrograms compressed lozenge with integral oromucosal applicator

Read all of this leaflet carefully before you start using this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Fentanyl is and what it is used for

2.    Before you use Fentanyl

3.    How to use Fentanyl

4.    Possible side effects

5.    How to store Fentanyl

6.    Further information

1. WHAT FENTANYL IS AND WHAT IT IS USED FOR

Fentanyl contains the active ingredient fentanyl which is a strong pain-relieving medicine known as an

opioid. The Fentanyl unit comes as a lozenge on a stick.

•    It is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their persistent (around-the-clock) cancer pain. Breakthrough pain is additional sudden pain that occurs suddenly in spite of your having taken your usual opioid pain-relieving medicines.

•    Do not use Fentanyl if you have not been having a prescribed opioid medicine for persistent (around-the-clock) pain regularly every day, for at least a week. This is because if you are not having such a medicine, using Fentanyl may increase the chances of your breathing becoming dangerously slow or shallow, or even stopping.

•    Do not use Fentanyl to treat pain from injuries, surgery, headaches or migraines.

2. BEFORE YOU USE FENTANYL Do not use Fentanyl if

•    You are allergic (hypersensitive) to fentanyl or any of the other ingredients of Fentanyl (listed in Section 6).

•    You are currently taking monoamine-oxidase inhibitor (MAOI) medicines for severe depression (or have taken them in the past 2 weeks).

•    You have severe breathing problems or severe lung problems where you have an obstruction.

Do not use Fentanyl if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Fentanyl.

Take special care with Fentanyl

Keep using the opioid pain medicine you take for your persistent (around-the-clock) cancer pain during your Fentanyl treatment.

Fentanyl is not recommended for children below 16 years of age.

If you have any of the following talk to your doctor or pharmacist before starting Fentanyl:

•    Your other opioid pain medicine for your persistent (around-the-clock) cancer pain is not stabilised yet.

•    You have any illness that affects your breathing (such as asthma, wheezing, or shortness of breath).

•    You have a head injury or have had any loss of consciousness.

•    You have a very, very slow heart rate.

•    You have liver or kidney problems - this will affect how your system breaks down the medicine.

•    You have low blood pressure due to a low amount of fluid in your circulation.

•    You have diabetes.

•    You are over 65 years old - you may need a lower dose and any dose increase will be reviewed very carefully by your doctor.

Using other medicines

Do not use this medicine and tell your doctor or pharmacist if you are taking:

•    Other fentanyl treatments that have been prescribed for your breakthrough pain in the past. If you still have some of these fentanyl treatments at home, check with your pharmacist how to dispose of them.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This

includes medicines obtained without a prescription, including herbal medicines. In particular, tell your doctor

or pharmacist if you are taking any of the following medicines:

•    Any medicines which might make you sleepy - such as sleeping pills, medicines to treat anxiety, some medicines for allergic reaction (antihistamines), or tranquillisers.

•    Some muscle relaxants - such as baclofen, diazepam.

•    Any medicines that might affect how your body breaks down Fentanyl - such as ritonavir or other medicines that help control HIV infection, other so-called ‘CYP3A4 inhibitors’ such as ketoconazole, itraconazole, or fluconazole (used for fungal infections) and troleandomycin, clarithromycin, or erythromycin (medicines for bacterial infections) and so-called ‘CYP3A4 inducers’ such as rifampin or rifabutin (medicines for bacterial infections), carbamazepine, phenobarbital or phenytoin, (medicines used to treat convulsions/fits).

•    Any medicine which may reduce or reverse the effect of Fentanyl - such as naloxone, pentazocine, buprenorphine. These may lead to withdrawal symptoms.

•    If you are due to have surgery requiring a general anaesthetic.

Using Fentanyl with food or drink

•    Fentanyl may be used before or after meals. However do not use during meals.

•    You may drink some water before using Fentanyl to help moisten your mouth. However, do not drink or eat anything while using Fentanyl.

•    Do not drink grapefruit juice while taking Fentanyl. This is because it may affect the way your body breaks down Fentanyl.

•    Do not drink alcohol while using Fentanyl. It can increase the chances of getting dangerous side effects. Pregnancy and breast-feeding

You should not use Fentanyl during pregnancy unless you have discussed this with your doctor. You should not use Fentanyl during child-birth because fentanyl may cause breathing difficulties in the new-born child. There is also a risk of the new-born child having withdrawal symptoms of the drug if Fentanyl is used for a long time during pregnancy.

Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. Do not use Fentanyl if you are breast-feeding unless you have discussed this with your doctor. Breast-feeding should not be restarted until at least 48 hours after the last use of Fentanyl.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines

This medicine may affect you being able to drive or use any tools or machines. Talk to your doctor about whether it is safe for you to drive, or use any tools or machines in the first few hours after taking Fentanyl.

Do not drive or use any tools or machines if you: feel sleepy or dizzy; have blurred or double vision; have difficulty in concentrating. It is important you know how you react to Fentanyl before driving or using any tools or machines.

Important information about some of the ingredients of Fentanyl

•    Fentanyl contains glucose and sucrose (types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before using Fentanyl.

•    Each lozenge contains about 2 grams of glucose. If you have diabetes, you need to take this into account.

•    The glucose in the lozenge may be harmful to the teeth. Always make sure you clean your teeth regularly.

3. HOW TO USE FENTANYL

When you first start using Fentanyl, your doctor will work with you to find the dose that will relieve your breakthrough pain. It is very important that you use Fentanyl exactly as the doctor tells you.

•    Do not change doses of Fentanyl or your other pain medicines on your own. Change in dose must be prescribed and checked by your doctor.

•    If you are not sure about the right dose or if you have questions about taking this medicine, talk to your doctor.

How the medicine gets into your body

When you place the lozenge in your mouth:

•    The lozenge dissolves and the active ingredient is released. It takes around 15 minutes for this to happen.

•    The active ingredient is absorbed through the lining of your mouth, into the blood system.

Taking the medicine like this allows it to be absorbed quickly. This means that it relieves your breakthrough pain quickly.

While the right dose is being found

You should start to feel some relief quickly while you are taking Fentanyl. However, while you and the doctor are finding out the dose that controls your breakthrough pain, you may not get enough pain relief 30 minutes after starting to use one Fentanyl unit (15 minutes from when you finish using the Fentanyl unit). If this happens, your doctor may allow you to use a second Fentanyl unit of the same strength for that same episode of breakthrough pain. Do not use a second unit unless your doctor tells you to. Never use more than two units to treat a single episode of breakthrough pain.

While the right dose is being found, you may need to have more than one strength of Fentanyl units at home. However, keep only the strengths of Fentanyl units you need in the house. This is to stop possible confusion or overdose. Talk to your pharmacist about how to dispose of any Fentanyl units you do not need.

How many units to use

Once the right dose has been found with your doctor, use 1 unit for an episode of breakthrough pain.

Talk to your doctor if your right dose of Fentanyl does not relieve your breakthrough pain for several episodes of breakthrough pain in a row. Your doctor will decide if your dose needs to be changed.

You must tell your doctor straight away if you are using Fentanyl more than four times per day. This is because he may wish to change your medicine for your persistent (around-the-clock) pain. When he has done this, when your persistent pain has been controlled, he may need to change your dose of Fentanyl. For the most effective relief, tell your doctor about your pain and how Fentanyl is working for you. This is so that the dose can be changed if needed.

How to use the medicine

Opening the pack - each Fentanyl unit is sealed in its own blister pack.

•    Open the pack when you are ready to use it. Do not open it in advance.

•    Hold the blister pack with the printed side away from you.

•    Hold the short tab end of the blister pack.

•    Put scissors close to the end of Fentanyl unit and cut the long tab end completely off (as shown).

•    Separate the printed backing from the blister pack and pull the printed backing completely off the blister pack.

•    Remove the Fentanyl unit from the blister pack and put the lozenge in your mouth straight away. Using the Fentanyl unit

•    Put the lozenge between your cheek and gum.

•    Using the handle, keep moving the lozenge round in your mouth, especially along your cheeks. Twirl

• To get the most effective relief, finish the lozenge completely in 15 minutes. If you finish too quickly, you will swallow more of the medicine and get less relief from your breakthrough pain.

•    Do not bite, suck or chew the lozenge. This would mean lower blood levels and less pain relief than when used as directed.

•    If for some reason you are not finishing the whole lozenge each time you have breakthrough pain, talk to your doctor.

How often you should use Fentanyl

Once a dose is found that effectively controls your pain, do not use more than four Fentanyl units each day. If you think you might need to use more than four Fentanyl units per day, talk to your doctor straight away.

How many Fentanyl units you should use

Do not use more than two units to treat any single episode of breakthrough pain.

If you use more Fentanyl than you should

The most common side effects of using too much are feeling sleepy, sick or dizzy.

•    If you begin to feel dizzy, sick, or very sleepy before the lozenge is completely dissolved, take it out of your mouth and call another person in your house to help you.

A serious side effect of Fentanyl is slow and/or shallow breathing. This can occur if your dose of Fentanyl is too high or if you take too much Fentanyl.

•    If this happens, get medical help straight away.

What to do if a child or adult accidentally takes Fentanyl

If you think someone has accidentally taken Fentanyl, get medical help straight away. Try to keep the person awake (by calling their name and shaking their arm or shoulder) until emergency help arrives.

If you forget to use Fentanyl

If you still have the breakthrough pain, you may use Fentanyl as your doctor has told you. If the breakthrough pain has stopped, do not use Fentanyl until the next breakthrough pain episode.

If you stop using Fentanyl

Do not stop using Fentanyl without talking to your doctor. There are usually no noticeable effects if you stop using Fentanyl. Keep taking your usual opioid medicine to treat your persistent (around-the-clock) pain as instructed by your doctor.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fentanyl can have side effects, although not everybody gets them. If you notice any of these, contact your doctor. The most serious side effects are shallow breathing, low blood pressure and shock.

You or your carer should REMOVE the Fentanyl unit from your mouth, contact your doctor immediately and call for emergency help if you experience any of the following serious side effects -you may need urgent medical attention:

•    Becoming very sleepy or having slow and/or shallow breathing.

•    Difficulty in breathing or dizziness, swelling of the tongue, lip or throat which may be early signs of

serious allergic reaction.

•    Note to Carers:

If you see that the patient taking Fentanyl has slow and/or shallow breathing or if you have a hard time waking the person up, take the following steps IMMEDIATELY:

-    Using the handle, remove the Fentanyl unit from the person’s mouth and keep it out of the reach of children or pets until it is disposed of.

-    CALL FOR EMERGENCY HELP.

-    While waiting for emergency help, if the person seems to be breathing slowly, prompt them to breathe every 5-10 seconds.

If you feel excessively dizzy, sleepy or otherwise ill while using Fentanyl, use the handle to remove the lozenge and dispose of it according to the instructions given in this leaflet (see Section 5). Then contact your doctor for further directions on using Fentanyl.

Very common side effects (affecting more than 1 in 10 people)

•    Vomiting, ,nausea/feeling sick, constipation, stomach (abdominal) pain

•    Asthenia (weakness), sleepiness, dizziness, headaches

•    Shortness of breath

Common side effects (affecting 1 to 10 people in 100)

•    Confusion, anxiety, seeing or hearing things that are not there (hallucinations),

•    depression, mood swings

•    Feeling unwell

•    Fit, muscle jerks, feeling of dizziness or "spinning", loss of consciousness, sedation, tingling or numbness, difficulty coordinating movements, increased or altered sensitivity to touch

•    Dry mouth, mouth inflammation, tongue problems (for example, burning sensation or ulcers), taste alteration

•    Wind, abdominal bloating, indigestion, , decreased appetite, weight loss

•    Blurred or double vision

•    Sweating, skin rash, itchy skin

•    Difficulty passing urine

•    Accidental injury (for example, falls)

Uncommon side effects (affecting 1 to 10 people in 1000)

•    Tooth decay, paralysis of the gut, mouth ulcers, gum bleeding

•    Coma, slurred speech

•    Abnormal dreams, feeling detached, abnormal thinking, excessive feeling of well being

•    Widening of blood vessels Hives,

The following side effects have also been reported with the use of Fentanyl lozenge but it is not known how often they may occur:

• Receding gums, inflammation of the gum , tooth loss

Whilst using Fentanyl you may experience irritation, pain and ulcer at the application site and gum bleeding.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

5.    HOW TO STORE FENTANYL

The pain-relieving medicine in Fentanyl is very strong and could be life-threatening if taken accidentally by a child. Fentanyl must be kept out of the reach and sight of children.

•    Do not use Fentanyl after the expiry date shown on the package label and the carton.

•    Do not store above 30°C.

•    Always keep Fentanyl in its blister package until you are ready to use it. Do not use if the blister package has been damaged or opened before you are ready to use it.

•    If you are no longer using Fentanyl, or if you have unused Fentanyl units in your home, return all unused packs to your doctor or pharmacist.

How to dispose of Fentanyl after use

Partially used Fentanyl lozenge may contain enough medicine to be harmful or life-threatening to a child. Even if there is a little or no medicine left on the handle, the handle itself must be properly disposed of as follows:

•    If the medicine is totally gone, throw the handle away in a waste container that is out of reach of children and pets.

•    If any medicine remains on the handle, place the lozenge under hot running water to dissolve the remainder and then throw the handle away in a waste container that is out of the reach of children and pets.

•    If you do not finish the entire lozenge and you cannot immediately dissolve the remaining medicine, put the lozenge out of the reach of children and pets until such a time as you can dispose of the partially used lozenge as instructed above.

•    Do not flush partially used lozenge, handles, or the blister packaging down the toilet.

6.    FURTHER INFORMATION What Fentanyl contains:

The active substance is fentanyl. Each individual lozenge contains either:

•    200 micrograms fentanyl (as citrate),

•    400 micrograms fentanyl (as citrate),

•    600 micrograms fentanyl (as citrate),

•    800 micrograms fentanyl (as citrate),

•    1200 micrograms fentanyl (as citrate),

•    1600 micrograms fentanyl (as citrate).

The other ingredients are:

Lozenge:

Dextrates hydrated (equivalent to approximately 2 grams of glucose).

Citric acid, disodium phosphate, artificial berry flavour (maltodextrin, propylene glycol, artificial flavours, and triethylcitrate), magnesium stearate.

Edible glue used to attach the lozenge to the handle

Modified maize based food starch E1450, confectioner’s sugar (as sucrose and maize starch), water.

Imprinting ink

Water, de-waxed white shellac, propylene glycol, blue synthetic coal tar dye E133 What Fentanyl looks like and contents of the pack

Fentanyl consists of a white to off-white solid lozenge attached to a handle for oromucosal application. The lozenge may appear slightly mottled on storage. This is due to slight changes in the flavouring agent of the product and does not affect how the product works in any way.

Fentanyl exists in 6 different strengths: 200, 400, 600, 800, 1200 and 1600 micrograms. The dosage strength is marked on the white lozenge, on the handle, on the blister package and on the carton to ensure that you are taking the right medicine. Each strength is associated with a specific colour.

Fentanyl lozenges are supplied in individual blister packages.

Blister packages are supplied in cartons of 3, 6, 15 or 30 individual Fentanyl units.

Not all pack size may be marketed.

Marketing Authorisation Holder

Teva UK Limited, Eastbourne, BN22 9AG, UK Manufacturer

Anesta LLC

4745 Wiley Post Way, Salt Lake City

Utah 84116

USA

OR¹

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

This leaflet was last revised in 04/2013.

PL 00289/1718 PL 00289/1719 PL 00289/1720 PL 00289/1721 PL 00289/1722 PL 00289/1723

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Only the actual site of batch release will appear on the printed version of the leaflet