Busetalt

Patient Information Leaflet: Information for the User

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

For use in adults
Please read this leaflet carefully before using 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 BUSETALT is and what it is used for

BUSETALT transdermal patch contains the active substance buprenorphine, which belongs to a group of
medicines called strong analgesics or "painkillers".
BUSETALT is used in adults to relieve moderate, long-lasting pain that requires treatment with a strong painkiller.
BUSETALT must not be used to treat acute pain.

2. What you need to know before using BUSETALT

Do not use BUSETALT

• if you are allergic to buprenorphine or to 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 (MAO inhibitor) (examples include tranylcypromine, phenelzine, isocarbazide, moclobemide and linezolid), or if you have taken this type of medicine within the last two weeks
• if you suffer from severe myasthenia gravis (a disorder causing muscle weakness)
• if you have previously experienced withdrawal symptoms—such as restlessness, anxiety, tremor or sweating—after stopping alcohol consumption.

BUSETALT must not be used to treat symptoms associated with withdrawal from a medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using BUSETALT in the following cases:

• if you have recently consumed large amounts of alcoholic beverages
• if you suffer from seizures, epileptic attacks or convulsions
• if you have sleep-related breathing disorders (sleep apnoea)
• if you have a severe headache or nausea due to head trauma or increased intracranial pressure (e.g. 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 lead to increased absorption of the active substance into the bloodstream compared to normal
• if you suffer from depression or other conditions treated with antidepressants.

Using these medicines together with BUSETALT may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and BUSETALT”).
If you have recently undergone 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, particularly if high doses have been used over a long period of time.
Sleep-related breathing disorders: BUSETALT may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to laboured breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor, who may consider reducing the dose.
For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
The use of BUSETALT as a doping agent may pose a health risk.
Children and adolescents
BUSETALT must 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 may increase the side effects of BUSETALT and sometimes may cause serious adverse reactions. Do not take other medicines while using BUSETALT without first talking to your doctor, especially:

• BUSETALT must not be used in combination with a type of medicine known as a monoamine oxidase inhibitor (MAO inhibitor) (examples include tranylcypromine, phenelzine, isocarbazide, moclobemide and linezolid), or if you have taken this type of medicine within 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 controlling eye movement, restlessness, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, body temperature above 38 °C. Contact your doctor if you experience such symptoms.
• If you are taking medicines such as phenobarbital or phenytoin (commonly used to treat seizures, epileptic attacks or convulsions), carbamazepine (used to treat seizures, epileptic attacks or convulsions or certain pain conditions), or rifampicin (a medicine used to treat tuberculosis), the effects of BUSETALT may be reduced.
• In some people, BUSETALT may cause drowsiness, nausea or fainting, or may slow down or weaken breathing. These side effects may be worsened by taking other medicines that have similar effects at the same time. These include certain medicines used to treat pain, depression, anxiety, psychiatric or mental disorders, medicines used to promote sleep, medicines used to treat high blood pressure such as clonidine, other opioids (which may be found in painkillers or certain cough syrups, such as morphine, dextropropoxyphene, codeine, dextromethorphan, noscapine), sedating antihistamines, or anaesthetics such as halothane.
• Concomitant use of BUSETALT and sedative medicines 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 no other therapeutic options are possible. However, if your doctor prescribes BUSETALT together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and follow carefully the dose recommended by your doctor. It may be helpful to inform friends and relatives to watch for the symptoms listed above. Contact your doctor if such symptoms occur.

BUSETALT and 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use BUSETALT if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, unless your doctor has specifically instructed you to do so after carefully evaluating the benefits and risks for both mother and unborn child.
Driving and using machines
BUSETALT may affect your reaction ability to such an extent that you may not be able to react adequately or quickly enough in the event of unexpected or sudden incidents. This is particularly true:

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

If this applies to you (for example, if you experience dizziness, drowsiness or blurred vision), you must not drive or operate machinery while using BUSETALT, or for the 24 hours following removal of the transdermal patch.

3. How to use BUSETALT transdermal patch

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Different BUSETALT dosage strengths are available. Your doctor will decide which buprenorphine transdermal patch strength is most suitable for your condition.
For buprenorphine transdermal patch doses below 25 micrograms/hour, your doctor will prescribe another transdermal patch appropriate for you.
When people first start using buprenorphine transdermal patches, they often experience nausea and vomiting (see section 4). These symptoms usually resolve after the first week of treatment. It is advisable to schedule a follow-up visit with your doctor one or two weeks after starting BUSETALT transdermal patches to ensure you are receiving the correct dose and to manage any side effects.
During treatment, your 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 higher dose than recommended. 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 instructed by your doctor, apply one BUSETALT transdermal patch (as described in detail below) and replace it every seven days, preferably at the same time of day. Your doctor may decide to adjust the dose after 3–7 days to achieve optimal pain control. If your doctor has advised you to take additional painkillers alongside the transdermal patch, follow these instructions carefully; otherwise, you may not receive the full benefit of treatment with BUSETALT. The transdermal patch must be used for 3 full days before increasing the dose: this is the time required for a given dose to reach its maximum effect.

Patients with liver disease
In patients with liver disease, the effects and duration of action of BUSETALT may be altered, and your doctor will therefore monitor you more closely.

Use in children and adolescents
BUSETALT transdermal patches must 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 bloodstream through the skin.

Before applying the BUSETALT transdermal patch

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

• The BUSETALT transdermal patch should be applied to a relatively hair-free or nearly hair-free area of skin. If suitable hair-free areas are not available, trim the hair with scissors. Do not use a razor to remove hair.
• Avoid red, irritated skin or skin with other abnormalities, such as large scars.
• The selected skin area must be dry and clean. If necessary, wash with cold or lukewarm water. Do not use soap, alcohol, oil, lotions, or other cleansers. After a warm bath or shower, wait until the skin is completely dry and cool. Do not apply lotions, creams, or ointments to the selected area: this could prevent the transdermal patch from adhering properly.

Applying the transdermal patch
Step 1: Each transdermal patch is sealed in a pouch. Just before use, open the pouch by tearing at the marked spot. Remove the transdermal patch. Do not use the patch if the pouch seal is already broken.

Step 2: The adhesive side of the transdermal patch is covered by a transparent protective liner. Carefully remove half of the liner. Avoid touching the adhesive surface of the patch.

Step 3: Apply the transdermal patch to the selected skin area and remove the remaining liner on the other side.

Step 4: Press the transdermal patch onto the skin with the palm of your hand and count slowly to 30. Ensure that the patch is fully 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 correctly applied, it is unlikely that the patch will detach. If the edges of the transdermal patch begin to lift, they may be secured with a special skin tape. You may take showers, 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, hot tubs, heated water beds, hot water bottles, etc.), as this could cause increased absorption of the active ingredient into the bloodstream compared to normal. External heat may also prevent the transdermal patch from adhering properly. If you develop a fever, this could alter the effects of BUSETALT (see previous section, “Warnings and precautions” above).
In the unlikely event that the transdermal patch detaches before it is due to be replaced, do not reuse the same patch. Apply a new one immediately (see “Replacing the transdermal patch” below).

Replacing the transdermal patch

• Remove the old transdermal patch.
• Fold it in half with the adhesive side inward.
• Open and remove a new transdermal patch. Use the empty pouch to dispose of the old patch. Dispose of the pouch safely.
• Used patches still contain some active ingredient, which could be dangerous for children or animals. Ensure that used patches are kept out of sight and reach of children and pets.
• Apply a new transdermal patch to a different, suitable skin site (as described above). Do not apply a new patch to the same skin area for 3–4 weeks.
• Remember to change the transdermal patch at the same time each week. It is important to note the exact time and day.

Duration of treatment
Your doctor will tell you how long you should continue treatment with BUSETALT. Do not stop treatment without consulting your doctor, as 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 you have used more patches than recommended, remove all patches and contact your doctor or go to hospital immediately. People who have taken an excessive dose of buprenorphine may experience severe drowsiness and nausea. They may also have breathing difficulties or lose consciousness and may require emergency treatment in hospital. When seeking medical help, make sure to bring this patient information leaflet and any remaining patches with you to show the doctor.

If you forget to use BUSETALT
Apply a new transdermal patch as soon as you remember. Also note the date, as your usual patch replacement day may now be different. If you delay replacing the patch significantly, your pain may return. In this case, contact your doctor.
Do not apply extra transdermal patches to make up for a missed application.

If you stop using BUSETALT
If you stop treatment with BUSETALT too early or discontinue it, your pain may return. If you wish to stop treatment, consult your doctor. He or she will advise you on what to do and whether you can switch to another medicine.
Some people may experience unwanted effects when they stop using strong painkillers after long-term use. The risk of experiencing effects after stopping BUSETALT is very low. However, if you feel restless, anxious, nervous, or experience tremors, hyperactivity, difficulty sleeping, or digestive problems, inform your doctor.
The analgesic effect of BUSETALT persists for some time after removal of the transdermal patch. You must not start taking another opioid analgesic (strong painkiller) within 24 hours after removing the transdermal patch.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The serious side effects that may be associated with BUSETALT are similar to those observed with other strong painkillers and include breathing difficulties and hypotension.
This medicine may cause allergic reactions, although severe reactions are rare. If you experience sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if affecting the whole body, remove the transdermal patch and contact 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, nausea, vomiting
• itchy skin, skin redness
• skin rash, itching, redness, inflammation or swelling 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, diarrhoea, indigestion, dry mouth
• sweating, rash, skin eruptions
• fatigue, feeling unusually weak, muscle weakness, oedema (such as swelling of the hands, ankles or feet)

Uncommon (may affect up to 1 in 100 people)

• restlessness, agitation, feelings of extreme happiness, hallucinations, nightmares, decreased sexual desire, 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
• sensation of dizziness or vertigo
• high or low blood pressure, chest pain, rapid heartbeat, awareness of heartbeat, hot flushes
• cough, hiccups, wheezing
• flatulence
• weight loss
• dry skin
• spasms, discomfort and pain
• difficulty starting urination, difficulty passing urine, involuntary urination
• fever
• increased incidence of accidental injuries (e.g. falls)
• withdrawal symptoms such as agitation, anxiety, sweating or tremor after stopping BUSETALT

If you need to undergo blood tests, remember to inform your doctor that you are using BUSETALT. This is important because BUSETALT may affect liver function, which could influence the results of certain 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
• Breathing difficulties, worsening of asthma, hyperventilation
• Feeling faint, especially when standing
• Skin flushing
• Difficulty swallowing, ileus
• Local allergic reaction with marked signs of swelling (in such cases treatment must be discontinued)
• Nasal swelling and irritation
• Decreased erection, sexual dysfunction
• Influenza-like illness
• Dehydration

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

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

Frequency not known (cannot be estimated from the available data)

• Breathing problems during sleep (sleep apnoea syndrome); see section 2 "Warnings and precautions"
• Convulsions, epileptic seizures or fits
• Inflammation of the intestinal wall. Symptoms may include fever, vomiting and stomach pain or discomfort.
• Abdominal pain or discomfort resembling colic
• Feeling detached from oneself
• Withdrawal symptoms in babies born to mothers who took BUSETALT during pregnancy may include high-pitched crying, irritability and restlessness, agitation (tremors), feeding difficulties, sweating and failure to gain weight
• Contact dermatitis (skin rash with inflammation which may include a burning sensation), skin colour changes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the packaging and on the sachet, after
Exp. The expiry date refers to the last day of that month.
Do not store 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 in half with the adhesive side facing inwards and disposed of safely.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What BUSETALT contains

• The active substance 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.

• Other components 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)
  Spacer film (between adhesive matrices with and without buprenorphine): poly(ethylene terephthalate) sheet
  Patch cover: acrylic adhesive, polyurethane backing film, printing ink

Description of the appearance of BUSETALT and package contents
BUSETALT is a rectangular, light brown/yellow transdermal patch with rounded edges.
The transdermal patch displays 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 pouch.
Pack sizes: 4, 8 or 12 transdermal patches.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Germany Bupre-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
Italy BUSETALT