BUSETALT 25 MICROGRAMMI/H Трансдермальный пластырь

Содержание инструкции

1. BUSETALT 25 micrograms/hour transdermal patch, 30 micrograms/hour transdermal patch, 40 micrograms/hour transdermal patch
   1. What is BUSETALT and what is it used for
   2. What you need to know before you use BUSETALT
   3. How to use BUSETALT transdermal patch
   4. Possible side effects
   5. How to store BUSETALT
   6. Contents of the pack and other information

BUSETALT 25 micrograms/hour transdermal patch, 30 micrograms/hour transdermal patch, 40 micrograms/hour transdermal patch

For use in adults

Read this leaflet carefully before you start to use this medicine as 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 BUSETALT is and what it is used for
• 2. What you need to know before you use BUSETALT
• 3. How to use BUSETALT
• 4. Possible side effects
• 5. How to store BUSETALT
• 6. Contents of the pack and other information

1. What is BUSETALT and what is it used for

BUSETALT transdermal patch contains the active ingredient buprenorphine, which belongs to a group of
medicines called potent analgesics or “pain relievers”.
BUSETALT is used in adults to relieve moderate to long-lasting pain that requires
the use of a potent pain reliever.
BUSETALT should not be used to relieve acute pain.

2. What you need to know before you use BUSETALT

Do not use BUSETALT

• if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).
• if you have breathing problems
• if you are drug dependent
• if you are taking a type of medicine known as a monoamine oxidase inhibitor (MAOI) (examples include tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid), or if you have taken this type of medicine in the last two weeks
• if you suffer from myasthenia gravis (a disorder in which muscles become weak)
• if you have experienced withdrawal symptoms - such as agitation, anxiety, tremor or sweating - in the past after stopping drinking alcohol.

BUSETALT should not be used to treat symptoms associated with stopping a medicine.

Warnings and precautions
Talk to your doctor or pharmacist before using BUSETALT in the following cases.

• if you have recently consumed a large amount of alcoholic beverages
• if you suffer from seizures, epileptic fits or convulsions
• if you suffer from sleep-related breathing disorders (sleep apnea)
• if you have a severe headache or nausea due to a head injury or if there is an increase in pressure in the skull (for example due to a brain disease). This is because the patches may worsen symptoms or mask the severity of a head injury
• if you suffer from dizziness or fainting
• if you have severe liver problems
• if you have previously suffered from drug or alcohol dependence
• if you have a fever, as this may result in greater amounts of the active ingredient being absorbed into the blood than normal
• if you suffer from depression or other conditions that are being treated with antidepressants.

The use of these medicines together with BUSETALT may lead to serotonin syndrome, a
potentially life-threatening condition (see “Other medicines and BUSETALT”)
If you have recently had surgery, consult your doctor before using these transdermal patches
BUSETALT may impair the normal production of hormones in the body such as cortisol or sex
hormones, especially if you have used high doses for a long period of time.
Sleep-related breathing disorders: BUSETALT may cause sleep-related breathing disorders such as
sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of
oxygen in the blood). Symptoms may include pauses in breathing during
sleep, nighttime awakenings due to labored breathing, difficulty staying asleep, or excessive daytime sleepiness.
If you or another person observe these symptoms, contact your doctor, who
may consider reducing the dose
For athletes: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.
The use of BUSETALT as a doping substance may pose a health risk.

Children and adolescents
BUSETALT should not be used in children and adolescents under 18 years of age.

Other medicines and BUSETALT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines can increase the side effects of BUSETALT and sometimes can cause
serious adverse reactions. Do not take other medicines while using BUSETALT without first
talking to your doctor, in particular:

• BUSETALT should not be used in combination with a type of medicine known as a monoamine oxidase inhibitor (MAOI) (examples include tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid), or if you have taken this type of medicine in the last two weeks.
• Antidepressants such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines may interact with BUSETALT and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor when you experience these symptoms.
• If you are taking medicines such as phenobarbital or phenytoin (commonly used to treat seizures, epileptic fits or convulsions), carbamazepine (used to treat seizures, epileptic fits or convulsions or some conditions characterized by pain) or rifampicin (a medicine for the treatment of tuberculosis), the effects of BUSETALT may be reduced.
• In some people BUSETALT may cause drowsiness, nausea or fainting, or slow down or weaken breathing. These side effects may be aggravated by taking other medicines that produce the same effects. These include some medicines used to treat pain, depression, anxiety, mental disorders, medicines used to help you sleep, medicines used to treat high blood pressure, such as clonidine, other opioids (which can be found in painkillers or some cough syrups, such as morphine, dextropropoxyphene, codeine, dextromethorphan, noscapine), antihistamines that induce sleep, or anesthetics, such as halothane.
• The concomitant use of BUSETALT and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when other therapeutic options are not possible. However, if your doctor prescribes BUSETALT together with sedatives, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor about all the sedatives you are taking and carefully follow the dose recommended by your doctor. It may be helpful to inform friends and relatives to be aware of the signs and symptoms listed above. Contact your doctor if these symptoms occur.

BUSETALT with alcohol
Alcohol may worsen some of the side effects and you may feel unwell if you consume alcohol
while using BUSETALT. Drinking alcohol while using BUSETALT may also
affect your reaction time.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use BUSETALT if you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
unless your doctor has told you that the benefits outweigh the risks
to the mother and the unborn baby.

Driving and using machines
BUSETALT may affect your ability to react to such an extent that you may not be able to
react adequately or quickly enough in the event of unexpected or sudden events. This is particularly true:

• at the beginning of treatment
• if you are taking medicines for the treatment of anxiety or to help you sleep
• if the dose is increased

If this is the case (for example, you experience dizziness, drowsiness and blurred vision), you should not
drive or use machines while using BUSETALT, nor for the 24 hours after removing
the transdermal patch.

3. How to use BUSETALT transdermal patch

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Different dosages of BUSETALT are available. The doctor will decide which dose of buprenorphine transdermal
patch is most suitable for your case.
For buprenorphine transdermal patch doses below 25 micrograms/hour, your doctor will prescribe another
transdermal patch suitable for you.
When people use buprenorphine transdermal patches for the first time, they often experience
nausea and vomiting (see section 4). These generally subside after the first week of
treatment. It is a good idea to schedule a follow-up visit with your doctor one or two weeks after
starting to use BUSETALT transdermal patches, to ensure that you are taking the correct dose
and to manage any unwanted effects.
During treatment, the doctor may replace the transdermal patch you are using with a smaller
or larger one, if necessary, or instruct you to use a combination of two patches. Do not cut or divide the
patch or use a dose greater than the recommended one. Do not apply more than two transdermal
patches at the same time, up to a maximum total dose of 40 micrograms/hour.
If you feel that the effect of BUSETALT is too weak or too strong, consult your doctor or pharmacist.

Adults and elderly patients
Unless otherwise indicated by your doctor, apply a BUSETALT transdermal patch (as
described in detail below) and replace it every seven days, preferably at the same time. The
doctor may decide to adjust the dosage after 3-7 days, until optimal pain control is achieved. If your
doctor has advised you to take other pain relievers in addition to the transdermal patch, follow
their instructions scrupulously, otherwise you will not be able to fully benefit from the treatment with
BUSETALT. The transdermal patch must be applied for 3 full days before increasing the dose:
this is when a given dose exerts its maximum effect.

Patients with liver disease
In patients with liver disease, the effects and duration of action of BUSETALT may be
compromised, and the doctor will therefore subject you to more careful monitoring.

Use in children and adolescents
BUSETALT transdermal patches should not be used in patients under 18 years of age.

Method of administration
BUSETALT is for transdermal use.
BUSETALT works through the skin. After application, buprenorphine passes into the blood through
the skin.

Before applying BUSETALT transdermal patch

• Choose an area of intact, non-irritated skin on the upper arm, the outer arm, the upper chest, the upper back, or the lateral portion of the chest (see illustrations below). If you are unable to apply the transdermal patch yourself, ask for assistance.

• The BUSETALT transdermal patch must be applied to an area of skin that is relatively hairless or almost hairless. If suitable hairless areas are not available, cut the hair with a pair of scissors. Do not use a razor to cut the hair.
• Avoid red, irritated, or blemished skin, for example, large scars.
• The chosen area of skin must be dry and clean. If necessary, wash with cool or lukewarm water. Do not use soap, alcohol, oil, lotions, or other detergents. After a bath or hot shower, wait for the skin to be completely dry and cool. Do not apply lotions, creams, or ointments to the chosen area: this could prevent the transdermal patch from adhering correctly.

Applying the transdermal patch
Step 1: Each transdermal patch is sealed in a sachet. Just before use, open the sachet
by tearing it where indicated. Remove the transdermal patch. Do not use the transdermal patch if the
sachet seal is already broken.
Step 2: The adhesive side of the transdermal patch is covered with a transparent film. Remove

carefully half of the film. Avoid touching the adhesive side of the transdermal patch.
Step 3: Apply the transdermal patch to the chosen area of skin and remove the remaining film

on the other side.
Step 4: Press the transdermal patch onto the skin with the palm of your hand and count slowly to 30.

Make sure that the transdermal patch is completely in contact with the skin, especially at the edges.

Wearing the transdermal patch
You must wear the transdermal patch for seven days. Provided it has been applied correctly, it is
unlikely that the transdermal patch will come off. If the edges of the transdermal patch start to detach,
they can be fixed with a skin-specific adhesive tape. You can shower, bathe, or
swim while wearing the transdermal patch.
Do not expose the transdermal patch to extreme temperatures (such as heating pads, electric blankets, heat lamps,
saunas, whirlpools and heated waterbeds, hot water bottles, etc.), as
this could result in greater absorption of the active ingredient into the blood than normal. External heat could also prevent the transdermal patch from adhering correctly. If you have a fever,
this could alter the effects of BUSETALT (see previous section, “ Warnings and

precautions” above).
In the unlikely event that the transdermal patch comes off before it is due to be replaced, do not reuse the same patch. Immediately apply a new one (see “Replacing the transdermal patch”, below).

Replacing the transdermal patch

• Remove the old transdermal patch.
• Fold it in half, with the adhesive side inside.
• Open and remove a new transdermal patch. Use the empty sachet to dispose of the old patch. Dispose of the sachet safely.
• Used patches still contain some active ingredient that may be dangerous for children or animals, so make sure that used patches are kept out of their sight and reach.
• Apply a new transdermal patch to a suitable and different skin site than the previous one (as described above). Do not apply a new transdermal patch to the same skin area for 3-4 weeks.
• Remember to change the transdermal patch at the same time. It is important to note the exact time of day.

Duration of treatment
The doctor will tell you how long you should continue treatment with BUSETALT. Do not stop the
treatment without consulting a doctor, as the pain may return and you may feel unwell (see also “If you stop using BUSETALT”, below).

If you use more BUSETALT than you should
As soon as you realize that you have used more patches than you should, remove all the patches
and immediately call your doctor or hospital. People who have taken an overdose of
buprenorphine may feel very sleepy and nauseous. They may also have difficulty breathing or
lose consciousness, and therefore require emergency treatment in hospital. When you ask
remaining, to show them to the doctor.

If you forget to use BUSETALT
Apply a new transdermal patch as soon as you remember. Also note the date, as
at this point the usual day of replacement may be different. If you delay replacing the
transdermal patch for a long time, the pain may return. In this case, contact your doctor.
Do not apply additional transdermal patches to make up for forgetting an application.

If you stop using BUSETALT
If you stop treatment with BUSETALT too early or suspend it, the pain may return. If
you want to stop treatment, consult your doctor. They will tell you what to do and whether you can switch to
treatment with other medicines.
Some people may experience unwanted effects when using potent pain relievers for a long
time and then stopping using them. The risk of experiencing effects after stopping BUSETALT is
very low. However, if you feel agitated, anxious, nervous, or if you experience tremors, if you are hyperactive, have
difficulty sleeping, or suffer from digestive problems, inform your doctor.
The analgesic effect of BUSETALT is maintained for some time after removing the transdermal
patch. You should not start taking another opioid pain reliever (potent analgesic)
within 24 hours of removing the transdermal patch.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects that may be associated with BUSETALT are similar to those observed with
other potent painkillers, and include difficulty breathing and hypotension.
This medicine can cause allergic reactions, although severe ones are rare. If you experience
sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, skin
rashes or itching, especially if affecting the whole body, remove the transdermal patch and inform
your doctor immediately.
There is a risk of developing dependence on BUSETALT.
The following side effects have also been reported in patients treated with BUSETALT.

Very common(may affect more than 1 in 10 people)

• headache, dizziness, drowsiness
• constipation, feeling unwell and vomiting,
• itchy skin, redness of the skin
• rash, itching, redness, inflammation or swelling of the skin at the application site

Common(may affect up to 1 in 10 people)

• loss of appetite
• confusion, depression, anxiety, sleep disorders, nervousness, tremor
• shortness of breath
• abdominal pain or discomfort, diarrhea, indigestion, dry mouth
• sweating, rash, skin eruptions
• fatigue, feeling of unusual weakness, muscle weakness, edema (such as swelling of the hands, ankles or feet)

Uncommon(may affect up to 1 in 100 people)

• restlessness, agitation, feeling of extreme happiness, hallucinations, nightmares, decreased sexual drive, aggression
• altered taste, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness
• memory loss, migraine, fainting, problems with concentration or coordination
• dry eyes, blurred vision
• ringing or buzzing in the ears
• feeling of vertigo or lightheadedness
• high or low blood pressure, chest pain, fast heartbeat, feeling your heartbeat, hot flushes
• cough, hiccups, wheezing
• flatulence
• weight loss
• dry skin
• spasms, discomfort and pain
• difficulty starting urination, difficulty urinating, involuntary urination
• fever
• an increase in accidental injuries (for example falls)
• withdrawal symptoms, such as agitation, anxiety, sweating or tremor, after stopping BUSETALT

If you need to have blood tests, remind your doctor that you are using BUSETALT. This is
important, because BUSETALT can alter liver function, and this could affect the results
of some blood tests.

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

• Angina (chest pain associated with heart disease)
• Mental disorders
• Difficulty maintaining balance
• Swelling of the eyelids or face, reduced pupil size
• Difficulty breathing, worsening of asthma, hyperventilation
• Feeling of fainting, especially when standing up
• Hot flushes
• Difficulty swallowing, ileus
• Local allergic reaction, with marked signs of swelling (in these cases treatment should be discontinued)
• Swelling and irritation inside the nose
• Decreased erection, sexual dysfunction
• Flu-like illness
• Dehydration

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

• Muscle contractions
• Mood swings
• Ear pain
• Blisters
• Dependence

Frequency not known(frequency cannot be estimated based on available data)

• Problems with breathing during sleep (sleep apnea syndrome), see section 2 “Warnings and precautions”
• Convulsions, epileptic seizures or fits
• Inflammation of the intestinal wall. Symptoms may include fever, vomiting and pain or discomfort in the stomach.
• Abdominal pain or discomfort similar to colic
• Feeling detached from oneself
• Withdrawal symptoms in children born to mothers who have taken BUSETALT during pregnancy may include acute crying, irritability and restlessness, agitation (tremors), difficulty feeding, sweating and failure to gain weight
• Contact dermatitis (skin rash with inflammation that may include a burning sensation), change in skin color

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through
the national reporting system at https://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 BUSETALT

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 pack and on the sachet, after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not use the transdermal patch if you notice that the seal of the sachet is not intact.
Used transdermal patches must be folded over on themselves, with the adhesive layer facing inwards, and
disposed of safely.
Do not dispose of any medicine in wastewater or household waste. 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 BUSETALT contains

• The active ingredient is buprenorphine

BUSETALT 25 micrograms/hour transdermal patch
Each transdermal patch contains 25 mg of buprenorphine per 31.25 cm and releases 25 micrograms of
buprenorphine per hour.
BUSETALT 30 micrograms/hour transdermal patch
Each transdermal patch contains 30 mg of buprenorphine per 37.5 cm and releases 30 micrograms of
buprenorphine per hour.
BUSETALT 40 micrograms/hour transdermal patch
Each transdermal patch contains 40 mg of buprenorphine per 50 cm and releases 40 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[acrylic acid-co-butyl acrylate-co-(2-ethylhexyl)- acrylate-co-vinyl acetate] (5:15:75:5) Release film (between the adhesive matrices with and without buprenorphine): poly(ethylene terephthalate) sheet Patch cover: acrylic adhesive, polyurethane support film, printing ink

Description of the appearance of BUSETALT and contents of the pack
BUSETALT is a rectangular transdermal patch of light brown/yellow color, with rounded edges.
The transdermal patch bears the following inscriptions:
Buprenorphinum 25 µg/h
Buprenorphinum 30 µg/h
Buprenorphinum 40 µg/h
Each transdermal patch is individually packaged in a child-resistant blister pack.
Carton containing 4, 8 or 12 transdermal patches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Largo Umberto 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
names:
GermanyBupre - 1 A Pharma 7 Tage 25 Mikrogramm/Stunde transdermales Pflaster
Bupre - 1 A Pharma 7 Tage 30 Mikrogramm/Stunde transdermales Pflaster
Bupre - 1 A Pharma 7 Tage 40 Mikrogramm/Stunde transdermales Pflaster

ItalyBUSETALT