Fentanyl 400 microgram Teva, zuigtabletten voor oromucosaal gebruik

1. WHAT IS AND WHAT IT IS USED FOR

<TRADENAME> contains the active ingredient fentanyl which is a strong pain-relieving medicine known as an opioid. The <TRADENAME> 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 <TRADENAME> 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 <TRADENAME> may increase the chances of your breathing becoming dangerously slow or shallow, or even stopping.
• Do not use <TRADENAME> to treat pain from injuries, surgery, headaches or migraines.

2. BEFORE YOU USE

Do not use <TRADENAME> if

• You are allergic (hypersensitive) to fentanyl or any of the other ingredients of <TRADENAME> (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 <TRADENAME> if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using <TRADENAME>.

Take special care with <TRADENAME>

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

<TRADENAME> 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 <TRADENAME>:

• 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 <TRADENAME> - 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 <TRADENAME> – such as naloxone, pentazocine, buprenorphine. These may lead to withdrawal symptoms.
• If you are due to have surgery requiring a general anaesthetic.

Using <TRADENAME> with food or drink

• <TRADENAME> may be used before or after meals. However do not use during meals.
• You may drink some water before using <TRADENAME> to help moisten your mouth. However, do not drink or eat anything while using <TRADENAME>.
• Do not drink grapefruit juice while taking <TRADENAME>. This is because it may affect the way your body breaks down <TRADENAME>.
• Do not drink alcohol while using <TRADENAME>. It can increase the chances of getting dangerous side effects.

Pregnancy and breast-feeding

You should not use <TRADENAME> during pregnancy unless you have discussed this with your doctor. You should not use <TRADENAME> 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 <TRADENAME> 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 <TRADENAME> 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 <TRADENAME>.

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 <TRADENAME>.

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 <TRADENAME> before driving or using any tools or machines.

Important information about some of the ingredients of <TRADENAME>

• <TRADENAME> 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 <TRADENAME>.
• 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.

Like all medicines, <TRADENAME> 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 <TRADENAME> 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 <TRADENAME> 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 <TRADENAME> 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 <TRADENAME>, 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 <TRADENAME>.

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 <TRADENAME> lozenge but it is not known how often they may occur:

• Receding gums, inflammation of the gum , tooth loss

Whilst using <TRADENAME> 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

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

• Do not use <TRADENAME> after the expiry date shown on the package label and the carton.
• Do not store above 30°C.
• Always keep <TRADENAME> 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 <TRADENAME>, or if you have unused <TRADENAME> units in your home, return all unused packs to your doctor or pharmacist.

How to dispose of <TRADENAME> after use

Partially used <TRADENAME> 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.

What <TRADENAME> 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 <TRADENAME> looks like and contents of the pack

<TRADENAME> 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.

<TRADENAME> 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.

<TRADENAME> lozenges are supplied in individual blister packages.

Blister packages are supplied in cartons of 3, 6, 15 or 30 individual <TRADENAME> units. Not all pack size may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

Nederland

[To be completed nationally]

Manufacturer

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

In het register ingeschreven onder

RVG 111270

RVG 111271

RVG 111272

RVG 111273

This medicinal product is authorised in the Member States of the EEA under the following names:

France: FENTANYL TEVA, comprimé avec applicateur buccal Germany: FENTANYL-RATIOPHARM, Orales Transmucosales System Netherlands: FENTANYL TEVA, zuigtabletten voor oromucosaal gebruik

United Kingdom: FENTANYL, compressed lozenge with oromucosal applicator

This leaflet was last approved in februari 2013.