SEPTRAPAT 5 MICROGRAMS/H Transdermal patch

Зміст інструкції

1. Septrapat 5 micrograms/hour transdermal patch, 10 micrograms/hour transdermal patch, 20 micrograms/hour transdermal patch
   1. What is Septrapat and what is it used for
   2. What you need to know before you use Septrapat
   3. How to use Septrapat
   4. Possible side effects
   5. How to store Septrapat
   6. Contents of the pack and other information

Septrapat 5 micrograms/hour transdermal patch, 10 micrograms/hour transdermal patch, 20 micrograms/hour transdermal patch

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

1. What is Septrapat and what is it used for

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

2. What you need to know before you use Septrapat

Do not use Septrapat :

• 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 (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 after stopping drinking alcohol.

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

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

• if you suffer from seizures, fits or convulsions;
• if you have a severe headache or nausea due to a head injury or in the presence of increased intracranial pressure (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 feel confused or faint;
• if you have severe liver problems;
• if you have previously suffered from drug or alcohol dependence;
• if you have acute alcohol intoxication;
• if you have a fever or are exposed to external heat, as this may result in the absorption of greater than normal amounts of the active ingredient into the blood;
• if you suffer from depression or other conditions treated with antidepressants. Use of these medicines together with Septrapat can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Septrapat”).

Sleep-related breathing disorders
Septrapat can 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, awakenings at night due to
shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or
another person notices these symptoms, see your doctor. The doctor may consider reducing the dose.
If you have recently had surgery, consult your doctor before using these patches.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.
The use of Septrapat as a doping agent can be dangerous to your health.

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

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

• antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines may interact with Septrapat and symptoms such as rhythmic and involuntary muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C may occur. See a doctor when these symptoms occur.
• Septrapat 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.
• If you are taking medicines such as phenobarbital or phenytoin (medicines commonly used to treat

seizures, fits or convulsions), carbamazepine (a medicine used to treat seizures, fits or convulsions, and some conditions characterized by pain) or rifampicin (a
medicine for the treatment of tuberculosis), the effects of Septrapat may be reduced.

• Septrapat can make some people feel sleepy, sick or weak, or cause them to breathe more slowly or weakly. These undesirable effects may be worsened 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, which induce sleep, or anesthetics, such as halothane.
• Septrapat should be used with caution if you are also taking benzodiazepines (medicines used to treat anxiety or to help you sleep). This combination can cause serious breathing problems.

The concomitant use of Septrapat and sedative medicines such as benzodiazepines or related medicines
increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can
be life-threatening. For this reason, concomitant use should only be considered when other therapeutic options are not possible.
However, if your doctor prescribes Septrapat together with sedative medicines, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow the dose
recommended by your doctor. It may be helpful to inform friends or family to pay attention to signs and
symptoms listed above. See your doctor if these symptoms occur.

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

Pregnancy, breastfeeding and fertility
Do not use Septrapat if you are pregnant or if you are breastfeeding, if you suspect or
are planning a pregnancy
Ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Septrapat can 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
applies in particular:

• 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 or blurred vision), do
not drive vehicles or use machines while using Septrapat, even for the 24 hours
following removal of the transdermal patch.

3. How to use Septrapat

Use this medicine following the instructions of your doctor or pharmacist exactly as they have told you. If you have
any doubts, ask your doctor or pharmacist.
Different strengths of Septrapat are available. Your doctor will decide which strength of Septrapat is most
suitable for your case.
During treatment, your doctor may replace the transdermal patch you are using with a smaller or
larger one if necessary, or tell you to use a combination of up to two transdermal patches.
Do not use a dose higher than the recommended one. You must not apply more than two
transdermal patches at the same time, up to a maximum total dose of 40 micrograms/hour.
If you think that the effect of Septrapat is too weak or too strong, consult your doctor or pharmacist.

Adults and elderly patients
Unless otherwise indicated by your doctor, apply one Septrapat transdermal patch (as
described in detail below) and replace it every seven days, preferably at the same time. Your
doctor may decide to adjust the dose 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 patch, follow
their instructions carefully, otherwise you will not be able to fully benefit from treatment
with Septrapat. The transdermal patch must be applied for 3 full days before increasing the
dose: this is the time it takes for a given dose to exert its maximum effect.

Patients with kidney disease/patients on dialysis
No dose adjustment is necessary in patients with kidney disease.

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

Patients under the age of 18 years
Septrapat must not be used in patients under the age of 18 years.

Method of administration
Septrapat is for transdermal use.
Septrapat works through the skin. After application, buprenorphine passes into the blood through
the skin.
Do not cut or divide the patch.

Before applying the transdermal patch

Choose an area of skin that is intact and not- irritated, on the upper arm, on the outer side of the arm, on the upper chest or on the upper back or on the lateral portion of the chest (see illustrations next to it). If you are unable to apply the transdermal patch yourself, ask for assistance.

Upper arm or or a r m F r o n t B a c k I n s i d e

• The transdermal patch must be applied to an area of skin that is relatively free of or almost free of hair. If no suitable hair-free areas are available, cut the hair with a pair of scissors. Do not use a razor to cut the hair.
• Avoid applying to skin that is red, irritated, or has other imperfections, such as 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 hot bath or shower, wait for the skin to be completely dry and cool. Do not apply lotions, creams, or ointments to the chosen area. This may prevent the patch from sticking properly.

Applying the transdermal patch

• Step 1: Each transdermal patch is sealed in a sachet. Just before use, cut the sachet with scissors along the sealed edge. Remove the transdermal patch. Do not use the transdermal patch if the sachet seal is broken.
• Step 2: The adhesive side of the transdermal patch is covered with a transparent film. Carefully remove one partof 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.

• 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 should 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
come off, they can be secured with a skin-specific adhesive tape. You can shower
and 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, and heated waterbeds, hot water bottle etc.), as
this could result in greater absorption of the active substance into the blood than
normal. External heat could also prevent the transdermal patch from adhering properly. If
you have a high fever, this may alter the effects of Septrapat (see section above, “Warnings
and precautions”).
If 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 transdermal patch.
• 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
Your doctor will tell you how long you should continue treatment with Septrapat. Do not stop the
treatment without consulting your doctor, as the pain may return and you may feel
unwell (see also “If you stop using Septrapat”, below).

If you use more Septrapat than you should
As soon as you realize that you have used more patches than you should have,
remove all the patches and call your doctor or hospital immediately. People who have taken
an overdose may feel very drowsy and unwell.
They may also have difficulty breathing or may lose consciousness, and may need
emergency treatment in hospital. When seeking medical help, be sure to take with you

If you forget to use Septrapat
Apply a new transdermal patch as soon as you remember. Also note the date,
as the usual day for replacement may now 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 a missed application.

If you stop using Septrapat
If you stop treatment with Septrapat too early or discontinue 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 side effects when using potent pain relievers for a long
time and then stopping them. The risk of experiencing effects after stopping Septrapat is
very low. However, if you feel restless, anxious, nervous, or if you experience tremors, if you are hyperactive, have
difficulty sleeping, or suffer from digestive problems, tell your doctor.
The analgesic effect of Septrapat is maintained for some time after the transdermal patch is removed.
Do not start taking another opioid pain reliever (potent pain reliever)
within 24 hours of removing the transdermal patch.
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 side effects that may be associated with buprenorphine patches 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 buprenorphine.
In patients treated with buprenorphine, the following side effects have also been reported.

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

• Headache, dizziness, drowsiness.
• Constipation, feeling unwell or even becoming ill.
• Itching.
• Skin rash, redness, itching, 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 disturbances, nervousness, tremor.
• Shortness of breath.
• Abdominal pain or discomfort, diarrhea, indigestion, dry mouth.
• Sweating, rash, skin eruptions.
• Fatigue, unusual feeling of weakness, muscle weakness, swelling of hands, ankles or feet.

Uncommon(may affect up to 1 in 100 people)

• Mood swings, restlessness, agitation, feeling of extreme happiness, hallucinations, nightmares, decreased sexual drive, aggression.
• Changes in 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.
• Whistling or ringing in the ears, feeling of dizziness or lightheadedness.
• High or low blood pressure, chest pain, fast or irregular heartbeat.
• Cough, hiccups, wheezing.
• Flatulence.
• Weight loss.
• Dry skin.
• Spasms, discomfort and pain.
• Difficulty starting urination.
• Fever.
• An increase in accidental injuries (e.g. falls).
• Withdrawal symptoms such as agitation, anxiety, sweating or tremor after stopping use of the buprenorphine patches.

If you need to have blood tests, remind your doctor that you are using buprenorphine transdermal
patches. This is important, because buprenorphine 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.
• Difficulty swallowing.
• Local allergic reaction, with marked signs of swelling (in these cases treatment should be stopped).
• Swelling and irritation inside the nose.
• Decreased erection, sexual dysfunction.
• Flu-like illness.
• Redness of the skin.
• Dehydration.

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

• Muscle contractions.
• Ear pain.
• Blisters. Frequency not known(the frequency cannot be estimated from available data)
• Seizures, attacks or convulsions.
• Inflammation of the bowel 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 buprenorphine during pregnancy may include acute crying, irritability and restlessness, agitation (tremors), difficulty feeding, swelling and failure to gain weight.
• Contact dermatitis (skin rash with inflammation that may include a burning sensation), skin discoloration.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Septrapat

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.
This medicine does not require any special storage conditions.
Do not use the transdermal patch if the sachet seal is broken.
Used transdermal patches must be folded back 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 Septrapat patches contain
The active ingredient is buprenorphine.
Septrapat 5 micrograms/hour transdermal patch
Each transdermal patch contains 5 mg of buprenorphine in an area of 6.25 cm², releasing a nominal
value of 5 micrograms of buprenorphine per hour
Septrapat 10 micrograms/hour transdermal patch
Each transdermal patch contains 10 mg of buprenorphine in an area of 12.5 cm², releasing a nominal
value of 10 micrograms of buprenorphine per hour
Septrapat 20 micrograms/hour transdermal patch
Each transdermal patch contains 20 mg of buprenorphine in an area of 25 cm², releasing a nominal
value of 20 micrograms of buprenorphine per hour
The other ingredients are:
Adhesive matrix (containing buprenorphine): povidone K90, Levulinic acid, Oleyl oleate, Poly[acrylic acid–co–butyl acrylate–co–(2–ethylhexyl) acrylate–co–vinyl acetate] (5:15:75:5)
Adhesive matrix (without buprenorphine) Poly[(2-ethylhexyl) acrylate-co-glycidyl methacrylate-co-(2-hydroxyethyl)
acrylate-co-vinyl acetate] (68:0.15:5:27),
Release liner between the adhesive matrices with and without buprenorphine: polyethylene terephthalate film,
Backing film: polyester,
Protective film: siliconized polyethylene terephthalate film
Blue printing ink.

Description of the appearance of Septrapat and contents of the pack
Transdermal patch.
Three dosages are available.
[5 micrograms/hour]
Each transdermal patch is beige in color with rounded edges and printed in blue
“Buprenorphin” and “5 μg/h”
[10 micrograms/hour]
Each transdermal patch is beige in color with rounded edges and printed in blue
“Buprenorphin” and “10 μg/h”
[20 micrograms/hour]
Each transdermal patch is beige in color with rounded edges and printed in blue
“Buprenorphin” and “20 μg/h”
Each transdermal patch is sealed in a child-resistant blister pack. The transdermal
patches are available in packs containing 4 transdermal patches.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Manufacturer
Tesa Labtec GmbH, Heykenaukamp 10, 21147 Hamburg, Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Germany: Buseven 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
Buseven 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster
Buseven 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster
Italy: Septrapat