DURLEVATEC 35 MICROGRAMS/HOUR Transdermal patch

Зміст інструкції

1. Durlevatec 35 micrograms/hour transdermal patch, 52.5 micrograms/hour transdermal patch, 70 micrograms/hour transdermal patch
   1. What is Durlevatec and what is it used for
   2. What you need to know before using Durlevatec
   3. How to use Durlevatec
   4. Possible side effects
   5. How to store Durlevatec
   6. Contents of the pack and other information

Durlevatec 35 micrograms/hour transdermal patch, 52.5 micrograms/hour transdermal patch, 70 micrograms/hour transdermal patch

Buprenorphine
Generic medicine

Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Durlevatec is and what it is used for
• 2. What you need to know before you use Durlevatec
• 3. How to use Durlevatec
• 4. Possible side effects
• 5. How to store Durlevatec
• 6. Contents of the pack and other information

1. What is Durlevatec and what is it used for

Durlevatec contains the active substance buprenorphine, a potent analgesic belonging to a
group of medicines called opioids. It acts on specific nerve cells in the spinal cord and
brain.
Durlevatec is used to treat

• cancer pain, of moderate to severe gradeand severe painthat has not responded to other types of analgesics. This medicine is not indicated for the treatment of short-term pain.

2. What you need to know before using Durlevatec

Do not use Durlevatec if:

• you are allergicto buprenorphine or any of the other ingredients of this medicine (listed in section 6).
• you are dependent on opioidsDurlevatec should not be used to treat withdrawal symptoms in individuals with drug dependence.
• you suffer from severe respiratory diseases
• you are taking or have taken in the last 2 weeks medicines known as monoamine oxidase inhibitors(MAOIs). These types of medicines are used to treat depression or Parkinson's disease.
• you suffer from myasthenia gravis(a severe form of muscle weakness);
• you suffer from delirium tremens(confusion and tremor caused by alcohol withdrawal, after excessive and habitual alcohol use or occasional and excessive alcohol consumption).

Warnings and precautions
Talk to your doctor or pharmacist before using Durlevatec:

• if you have recently drunk a lot of alcohol;
• if you suffer from seizures (epilepsy)
• if you have loss of consciousness due to unknown causes;
• if you are in a state of shock (cold sweat may be a sign of it)
• if you have increased pressure in the skull, e.g., following head injuries
• if you have breathing problems
• if you are taking medicines that decrease your breathing and listed under “Other medicines and Durlevatec”
• if your liver is not functioning properly; Patients with reduced liver function require careful monitoring by the doctor during treatment.
• If you have a fever or are exposed to external sources of heat Fever and external heat increase the permeability of the skin, which can cause an increase in the level of buprenorphine in the blood. Therefore, if you have a fever, consult your doctor. External heat sources - such as sauna, infrared lamp, electric blanket, hot water bottle - can prevent the transdermal patch from adhering correctly. Do not expose yourself to external heat sources.
• if you tend to abuse drugs or narcotics; See “Do not use Durlevatec”
• If you are an athlete This medicine may result in a positive doping test

In some people, dependence on strong pain relievers, such as
Durlevatec, may develop when used for long periods of time. In these people, withdrawal effects may occur when treatment is stopped. See section 3 “If you stop treatment with
Durlevatec”.
For those involved in competitive sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Children and adolescents
Durlevatec should not be used in children and adolescents under 18 years of age, as there is currently no experience with the use of the medicine in this age group.

Other medicines and Durlevatec
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The action of the following medicines may be altered or modify the action of Durlevatec:

• some medicines used to treat depression or Parkinson's disease, known as monoamine oxidase inhibitors(MAOIs) Do not use Durlevatec if you are being treated with, or have been treated in the last 2 weeks with monoamine oxidase inhibitors.
• sedativeand/or sleep-inducingmedicinesThe concomitant use of Durlevatec and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, respiratory distress (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatments are not possible. However, if your doctor prescribes Durlevatec with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about all the sedatives you are taking and carefully follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or

relatives to be aware of the signs and symptoms mentioned above. Contact your doctor if
these symptoms occur.

• anesthetics
• medicines for the treatment of depression
• medicines for the treatment of mental disorders or anxiety, with sedative effects
• other strong pain relievers(opioids)
• some medicines for the treatment of bacterial infections, such as erythromycin
• some medicines for the treatment of fungal infections, such as ketoconazole
• some medicines for the treatment of HIV(Human Immunodeficiency Virus) infections, such as ritonavir, indinavir, saquinavir
• dexamethasone, a medicine for the treatment of many conditions, including inflammation
• some medicines for the treatment of epilepsyor certain painful conditions, such as carbamazepineor phenytoin
• rifampicin, a medicine for the treatment of tuberculosis or some other infections

Durlevatec with food, beverages and alcohol
Avoid drinking alcohol and grapefruit-containing products while using Durlevatec, as
they may intensify the effects of buprenorphine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

• PregnancyThere is insufficient experience regarding the use of Durlevatec during pregnancy. For this reason, do not use Durlevatec transdermal patches if you are pregnant or may become pregnant during treatment.
• BreastfeedingBuprenorphine, the active ingredient contained in the transdermal patch, inhibits milk production and passes into breast milk. Therefore, you should not use Durlevatec if you are breastfeeding.

Driving and using machines
Durlevatec can affect your ability to drive or use machines, especially:

• at the beginning of treatment
• when used as a substitute for another treatment
• when changing the dosage
• if you are also taking other medicines that affect the brain
• if you drink alcohol
• at the end of treatment

Do not drive or use machines:

• if you experience dizziness, drowsiness, double or blurred vision, or other effects that affect your ability to react
• for at least 24 hours after removing the transdermal patch

Consult your doctor or pharmacist if you have any doubts.

3. How to use Durlevatec

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
doubts, consult your doctor or pharmacist.
The doctor will determine the dose of Durlevatec that is suitable for you and decide on any changes to it, if
necessary. You will be prescribed the lowest possible dose suitable to provide adequate pain relief.
The recommended dose is:

• one transdermal patch every 3 or 4 days(maximum 96 hours)

For ease of use, you can replace the transdermal patch twice a week - always on the
same days – for example, always on Monday morning and Thursday evening. To help you remember when to
change the patch, note the replacement days on the outer box.
If your doctor has advised you to take other pain relievers in addition to the transdermal patch, follow
their instructions carefully, otherwise you will not be able to fully benefit from treatment
with Durlevatec.
This dose applies to all adults, regardless of age, including patients with
kidney disease.
Patients with liver disease require careful monitoring by the doctor.
Contact your doctor or pharmacist if you think the effect of Durlevatec is too weak or too
strong.

Method of administration
Transdermal use.
After application, the active ingredient reaches the blood by passing through the skin.

Before applying a transdermal patch

• Choose on the upper part of the body, an area of skin that is flat, clean and hair-free. Preferably use the chest in the area below the clavicle or the upper back. See illustrations 1a) and 1b). Ask for assistance if you cannot apply the transdermal patch yourself. 1 a) 1 b)

ChestBack

• If the chosen area is not hair-free, any hair must be trimmed with scissors. Do not shave the area.
• Avoid areas of skin that are reddened, irritated or have other alterations, for example, extensive scars.
• The skin area chosen for application must be dry and clean. If necessary, wash the area with cool or lukewarm water. Do not use soaps or other detergents. After a hot bath or shower, wait for the skin to be completely dry and cool. Do not use lotions, creams or ointments on the chosen area: this could prevent the correct adhesion of the transdermal patch.

Applying the transdermal patch

• 1) Each patch bears the inscription Buprenorphinum 35 µg/h, Buprenorphinum 52.5 µg/h or Buprenorphinum 70 µg/h.

• 2) Just before use, open the sachet by tearing it where indicated, as shown in the figure. Remove the transdermal patch.
• 3) The adhesive side of the transdermal patch is protected by a transparent film. Carefully remove half of the film. Avoid touching the adhesive part of the patch.
• 4) Apply the patch to the chosen skin area at point 1 and remove the remaining film.
• 5) Press the transdermal patch onto the skin with the palm of your hand. Make sure that the patch is completely in contact with the skin, especially at the edges.

Wearing the transdermal patch
Provided it has been applied correctly, the risk of it detaching is minimal. You can shower, bathe or swim while wearing the transdermal patch.
Do not expose the patch to extreme temperatures, such as saunas, infrared lamps, electric blankets and hot water bottles.
In the unlikely event that the patch detaches before it needs to be replaced, do not reuse the
same patch. Apply a new one immediately.

Replacing the transdermal patch
Remove the old transdermal patch and fold it in half, with the adhesive side inwards. Dispose of
the used patch safely.

Applya new patch alwaysto a differentarea of the skin, following steps 1 to 8
described previously. Wait at least one week before using the same skin area again.

Duration of treatment
Will be decided by the doctor. See also “If you stop using Durlevatec”.

If you use more Durlevatec than you should
Remove the excess patches and contact your doctor immediately.

Signs of overdose are:

• drowsiness
• nausea, vomiting
• pinpoint pupils
• difficulty breathing
• cardiovascular collapse

If you forget to use Durlevatec
Apply a new transdermal patch as soon as you remember and note the day. In this
case you will have to change your application habits.
For example, if you usually replace the patch on Monday and Thursday, but forgot and therefore
do not change the transdermal patch until Wednesday: from this moment on you will have to change it
on Wednesday and Saturday.
If you change the patch with a long delay, the pain may return. In this case contact your doctor.
Do not apply extra patches to make up for forgetting to apply it.

If you stop using Durlevatec
If you stop or discontinue treatment too early, the pain may return and you may feel unwell.
Contact your doctor who will decide on the necessary steps if you wish to stop treatment.
The risk of side effects after the end of treatment with Durlevatec transdermal patches is very
low. Consult your doctor if you feel excited, anxious, nervous, agitated, hyperactive, or if you have difficulty
sleeping or digestive problems.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious allergic reactions(very rare, may affect up to 1 in 10,000 people)

Remove the transdermal patch and contact your doctor immediatelyif you develop any
symptom of an allergic reaction such as:

• swelling of the face, lips, mouth, neck, eyes and throat
• shortness of breath, wheezing or difficulty swallowing or breathing
• rash, redness or itching that affects most of the body
• yellowing of the skin and eyes
• collapse, feeling of fainting

In some cases, delayed allergic reactions occur with signs of inflammation. In this case,

remove the transdermal patch and contact your doctor.
Other side effects may occur with the following frequencies:

Very common, may affect more than 1 in 10 people

• nausea
• redness of the skin, itching

Common, may affect up to 1 in 10 people

• dizziness
• headache
• shortness of breath
• vomiting, constipation
• skin changes and modifications
• sweating
• swelling of the tissues caused by excess fluid
• fatigue

Uncommon, may affect up to 1 in 100 people

• confusion
• sleep disorders, agitation
• sedation, drowsiness
• circulatory disorders, such as low blood pressure and, rarely, fainting
• dry mouth
• rash
• difficulty urinating, urinary retention
• fatigue, asthenia

Rare, may affect up to 1 in 1,000 people

• loss of appetite
• hallucinations, anxiety, nightmares
• decreased sexual desire
• reduced ability to concentrate
• speech or balance disorder
• drowsiness
• strange sensations at the skin level, such as numbness, tingling, prickling or burning
• visual disturbances such as blurred vision
• swelling of the eyelids
• hot flushes
• difficulty breathing
• heartburn
• urticaria
• decreased reduction of erection
• withdrawal symptoms
• reactions at the application site

Very rare, may affect up to 1 in 10,000 people

• dependence on the medicine
• mood swings
• muscle contractions
• alteration modification of taste
• pinpoint pupils
• ear or chest pain
• faster than normal breathing
• hiccups, nausea
• pustules, small blisters

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects
directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Durlevatec

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the sachet after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Used transdermal patches
should be folded in on themselves, with the adhesive layer facing inwards. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Durlevatec contains
The active substanceisbuprenorphine.
Durlevatec 35 micrograms/hour transdermal patch:
Each transdermal patch contains 20 mg of buprenorphine on a surface area of 25 cm², which releases 35
micrograms of buprenorphine per hour
Durlevatec 52.5 micrograms/hour transdermal patch:
Each transdermal patch contains 30 mg of buprenorphine on a surface area of 37.5 cm², which releases
52.55 micrograms of buprenorphine per hour
Durlevatec 70 micrograms/hour transdermal patch:
Each transdermal patch contains 40 mg of buprenorphine on a surface area of 50 cm², which releases 70
micrograms of buprenorphine per hour
The other ingredients are:
Protective film (to be removed before applying the patch): poly(ethylene
terephthalate) sheet, siliconized
Adhesive matrix (containing buprenorphine): levulinic acid, oleyl oleate, povidone K90,
poly[butyl acrylate-co-(2-ethylhexyl) acrylate-co-methyl methacrylate-co- N-tert-octylacrylamide] (32:32:15:20),
poly[acrylic acid-co-butyl acrylate-co-(2-ethylhexyl) acrylate-co-vinyl acetate] (5:15:75:5)
Release liner (between the adhesive matrices with and without buprenorphine): poly(ethylene
terephthalate) sheet
Adhesive matrix (without buprenorphine): acrylic adhesive
Support layer (printed): polyurethane support film, printing ink

Description of the appearance of Durlevatec and contents of the pack
Durlevatec is a light yellow/brown, rectangular transdermal patch with rounded edges,
bearing the following imprinted text:
Buprenorphinum 35 µg/h
Buprenorphinum 52.5 µg/h
Buprenorphinum 70 µg/h
Each transdermal patch is individually packaged in a child-resistant blister pack.
Box containing 3, 4, 5, 8, 10, 16 or 20 transdermal patches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Hexal AG, Industriestraße 25, 83607 Holzkirchen, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria Buprenocan 35 Mikrogramm/h – transdermales Pflaster
Buprenocan 52,5 Mikrogramm/h – transdermales Pflaster
Buprenocan 70 Mikrogramm/h – transdermales Pflaster
Italy Durlevatec
Germany Bupre-HEXAL 35 Mikrogramm/Stunde transdermales Pflaster
Bupre-HEXAL 52,5 Mikrogramm/Stunde transdermales Pflaster
Bupre-HEXAL 70 Mikrogramm/Stunde transdermales Pflaster